Master Class

This Master Class is the second in a three-part series on the topic of preeclampsia, which is a relatively common complication of pregnancy that can result in severe morbidity and mortality if not well managed. In light of this, we have decided to dedicate a significant amount of coverage to this topic.

In the previous Master Class article, we covered one end of the spectrum—severe preeclampsia. This Master Class focuses on the more common presentation of mild preeclampsia, which sometimes presents in a manner similar to that of gestational hypertension alone.

Mild gestational hypertension-preeclampsia affects up to 10% of all pregnancies. Because it is a relatively common complication of pregnancy, it is critically important that the practitioner develops a clinical algorithm for diagnosis—one that distinguishes mild gestational hypertension-preeclampsia from gestational hypertension alone—and institutes an appropriate management protocol.

Dr. Baha M. Sibai, our guest professor previously on the topic of severe preeclampsia, will help us with this Master Class. He focuses here on the salient differences between gestational hypertension and mild preeclampsia and how these conditions should be managed in the antepartum, intrapartum, and postpartum periods.

Dr. Sibai is an international expert on preeclampsia and eclampsia and a world leader in clinical care and research in this field. He is professor of obstetrics and gynecology at the University of Cincinnati, and has contributed to more than 350 studies in peer-reviewed journals on these topics.

In the third and final part of the series on preeclampsia, Dr. Sibai will address the risk of recurrent preeclampsia and how subsequent pregnancies in women with a history of previous preeclampsia should be managed.

This Master Class is the second in a three-part series on the topic of preeclampsia, which is a relatively common complication of pregnancy that can result in severe morbidity and mortality if not well managed. In light of this, we have decided to dedicate a significant amount of coverage to this topic.

In the previous Master Class article, we covered one end of the spectrum—severe preeclampsia. This Master Class focuses on the more common presentation of mild preeclampsia, which sometimes presents in a manner similar to that of gestational hypertension alone.

Mild gestational hypertension-preeclampsia affects up to 10% of all pregnancies. Because it is a relatively common complication of pregnancy, it is critically important that the practitioner develops a clinical algorithm for diagnosis—one that distinguishes mild gestational hypertension-preeclampsia from gestational hypertension alone—and institutes an appropriate management protocol.

Dr. Baha M. Sibai, our guest professor previously on the topic of severe preeclampsia, will help us with this Master Class. He focuses here on the salient differences between gestational hypertension and mild preeclampsia and how these conditions should be managed in the antepartum, intrapartum, and postpartum periods.

Dr. Sibai is an international expert on preeclampsia and eclampsia and a world leader in clinical care and research in this field. He is professor of obstetrics and gynecology at the University of Cincinnati, and has contributed to more than 350 studies in peer-reviewed journals on these topics.

In the third and final part of the series on preeclampsia, Dr. Sibai will address the risk of recurrent preeclampsia and how subsequent pregnancies in women with a history of previous preeclampsia should be managed.

This Master Class is the second in a three-part series on the topic of preeclampsia, which is a relatively common complication of pregnancy that can result in severe morbidity and mortality if not well managed. In light of this, we have decided to dedicate a significant amount of coverage to this topic.

In the previous Master Class article, we covered one end of the spectrum—severe preeclampsia. This Master Class focuses on the more common presentation of mild preeclampsia, which sometimes presents in a manner similar to that of gestational hypertension alone.

Mild gestational hypertension-preeclampsia affects up to 10% of all pregnancies. Because it is a relatively common complication of pregnancy, it is critically important that the practitioner develops a clinical algorithm for diagnosis—one that distinguishes mild gestational hypertension-preeclampsia from gestational hypertension alone—and institutes an appropriate management protocol.

Dr. Baha M. Sibai, our guest professor previously on the topic of severe preeclampsia, will help us with this Master Class. He focuses here on the salient differences between gestational hypertension and mild preeclampsia and how these conditions should be managed in the antepartum, intrapartum, and postpartum periods.

Dr. Sibai is an international expert on preeclampsia and eclampsia and a world leader in clinical care and research in this field. He is professor of obstetrics and gynecology at the University of Cincinnati, and has contributed to more than 350 studies in peer-reviewed journals on these topics.

In the third and final part of the series on preeclampsia, Dr. Sibai will address the risk of recurrent preeclampsia and how subsequent pregnancies in women with a history of previous preeclampsia should be managed.

Hysterectomy has been a first natural and successful application for robotics in gynecologic and reproductive care, but it is also now clear that robot-assisted laparoscopic myomectomy takes full advantage—even more so—of what robotic technology brings to the table.

Conventional laparoscopic myomectomy has been so challenging that relatively few gynecologic surgeons have been willing and/or able to move away from the traditional open approach for treating symptomatic leiomyomata. Laparotomy thus has remained the standard for myomectomy, leaving many women with a limited number of minimally invasive options if they want to preserve their uterus or fertility, and leaving our health care system shouldering millions of dollars in costs associated with invasive approaches.

It is interesting to note that the total direct cost of treating uterine fibroids in 2000 was estimated at $2.1 billion. Most of the cost, the authors wrote, resulted from inpatient care, particularly hysterectomy (Am. J. Obstet. Gynec. 2006;195:955-64).

With all that robotics offers to us, I believe this is about to change.

The Rationale

Two prospective trials have shown less postoperative morbidity and faster recovery with laparoscopic myomectomy. Yet the endoscopic management of leiomyomata is so technically challenging that the majority of cases are still performed via laparotomy. (Few would challenge the notion, I believe, that it is one of the more challenging procedures in minimally invasive surgery.)

The complexity of dissection and, in particular, the complexity of repair with multilayer-sutured closures present challenges that not only require advanced laparoscopic skills but also are associated with a steep learning curve. These challenges have consistently raised concerns about whether laparoscopy increases conversion rates and whether it can lead to uterine rupture.

There also are longstanding, published limitations placed on the kinds of tumors that can be treated with conventional laparoscopy in order to minimize the risk of conversion to laparotomy. It is often stated that cases involving fibroids greater than or equal to 5 cm, intramural fibroids, an anterior location, and preoperative use of GnRH agonists are too difficult to handle laparoscopically and are likely to increase the conversion rate (Human Reprod. 2001;16:1726-31).

Current robotic technology essentially erases almost all of the limitations of conventional laparoscopy. The features of the technology—improved dexterity and precision of the instruments as well as the three-dimensional imaging—allow the endoscopic approach to be more accurately modeled after (and reflective of) traditional open techniques.

The da Vinci surgical system, which is the only Food and Drug Administration-approved robotic device for use in gynecologic surgery, provides us with a means to overcome the difficulties associated with hysterotomy, enucleation, repair, and extraction that we encounter with the conventional laparoscopic management of fibroids.

The Setup

The da Vinci system comprises a surgeon's console, a vision system that provides three-dimensional imaging through a 12-mm endoscope, and a patientside cart with robotic arms and various EndoWrist instruments.

At the console, the surgeon controls the instruments, the camera, and an energy source, all via a stereoscopic viewer, hand manipulators, and foot pedals. One of the robotic arms holds the endoscope while the other two or three arms hold the instruments.

The instruments come in either 8- or 5-mm sizes and possess 7 degrees of movement, a range that replicates or surpasses the human hand's full range of motion.

Overall, the technique itself for robot-assisted laparoscopic myomectomy does not differ significantly from what is done in conventional laparoscopy, except that the critical steps of hysterotomy, enucleation, and repair are dramatically facilitated while the surgeon adheres to the principles of open surgery.

The bottom line is that robotics affords us the ability to perform the procedure as if it were being done as an open procedure, with the only change being the route of access.

We first place a 12-mm port at or above the umbilicus, depending on the size of the uterus, to accommodate the endoscope and camera arm. As a general rule, I advise leaving at least a handsbreadth distance (approximately 8-10 cm) between the endoscope and the top of an elevated uterus or leiomyoma during bimanual examination, with the patient under anesthesia.

This spacing is important during myomectomy because the enucleation process will result in the leiomyoma projecting out toward the endoscope. By leaving an adequate working space at the beginning, we are able to compensate for a loss of optical working distance and maintain our ability to manipulate our instruments.

We then place an 8-mm port in the left and right lower quadrants, placing them more cephalad and lateral in the case of larger uteri or leiomyomata. These ports will mount directly to the operating robotic arms.

A fourth trocar (a 12- to 15-mm port that will facilitate the introduction of suture as well as instrumentation used for retraction, suction/irrigation, and other tasks of the assistant) can be placed between the camera port and either the left or right lower-quadrant port.

Just as with robotic hysterectomy, a fourth robotic arm can be added for patients who are obese or have a large uterus; this can be used for added retraction of tissues.

The key point to be made about setup is that the ports must be placed far enough away from each other and from the target tissue to avoid instrument-arm collisions.

We recommend that all patients undergo radiologic imaging prior to myomectomy. In our practice, we favor MRI for assessing the size, number, and location of the fibroids as well as for ruling out adenomyosis and for planning the location(s) of the hysterotomy incision. All of this information is particularly helpful given the absence of haptic (tactile) feedback with the robotic approach.

The Technique

Prior to hysterotomy, a dilute concentration of vasopressin is injected into the myometrium surrounding the myoma, as an adjunct for hemostasis. Once adequate blanching is noted, we begin each case with either a bipolar Maryland forceps or Gyrus ACMI Inc.'s PK dissecting forceps on the left arm, and hot shears or a permanent cautery hook (both monopolar devices) on the right arm. Our hysterotomy can be made in either a horizontal or vertical axis because we will be less limited with robotic instruments than we would be in a conventional laparoscopy.

The fibroid can then be enucleated while the bedside assistant provides additional traction/countertraction with a conventional laparoscopic tenaculum or corkscrew. An alternative is to use the fourth robotic arm with an EndoWrist tenaculum. Care must be taken to avoid excessive traction during the enucleation phase in order to maintain hemostasis and to not prematurely avulse the fibroid. Patience is key.

The removed fibroid is placed in the posterior cul-de-sac—or in one of the paracolic gutters if it is larger—for retrieval at the end of the surgery. When we remove multiple and smaller fibroids, it is important to maintain a myoma count. Tagging each of them with long suture can be helpful for retrieval at the end of the case.

At this point, we usually exchange our instruments for a large needle driver on the left arm and a mega needle driver with a high-force grip and integrated cutting mechanism on the right arm. We typically incorporate a multilayer closure for the myometrium, using either interrupted sutures of 0-Vicryl on CT-2 needles cut to 6 inches, or running sutures of 0-Vicryl on CT-2 needles cut to 11 inches.

With the increased articulation and dexterity of our instruments, our ability to repair a defect is affected much less by the orientation of the incisions or the location than it would be in conventional laparoscopy.

To close the uterine serosa, we use a running baseball stitch with 3-0 Vicryl on an SH needle. If multiple fibroids must be removed, we prefer to repair each uterine defect after enucleation before moving on to another tumor. This way, we're taking advantage of the effects of vasopressin at each site. We try to remove as many fibroids as possible through a given hysterotomy.

Before retrieving excised fibroids, the robot-assist device is undocked. Specimens are then retrieved via a tissue morcellator that is placed through the accessory port. Another option is to use the endoscopic port site, but this requires the use of a 5-mm 0-degree laparoscope placed through one of the lateral trocars.

All operative sites are irrigated, hemostasis is ensured under low-pressure settings, and an adhesion barrier is placed over all uterine incisions. We typically apply a slurry of finely chopped Seprafilm as an adhesion barrier (an off-label use).

With robotic myomectomy, as with any of the robotically assisted gynecologic procedures, the importance of the bedside assistant cannot be overestimated. In addition to providing traction/countertraction (we usually don't need to use a fourth robotic arm because our assistants are skilled), the assistant introduces and removes suture, provides irrigation, and manages any accessory port activity (J. Robotic Surg. 2007;1:69-74).

The Patients, the Outcomes

With robotics, there really are not many patients we cannot address. There are no absolute inclusion criteria, and no absolute cutoffs. It's all relative. We determine whether a patient is a candidate for a robotic myomectomy based on the size and mobility of her uterus as well as the size, number, and location of her fibroids.

For example, a patient whose height is 4 feet 10 inches and who is obese with a short truncated torso, a uterus that is not very mobile, and an 8-cm fibroid located over the broad ligament may be a poorer candidate than would a taller patient of average weight with an 8-cm intramural fibroid in a uterus that is extremely mobile. This is where the art of medicine comes into play.

Overall, however, the robotic approach overcomes challenges like obesity, and puts us at a greater advantage as surgeons—giving us an ability to suture more effectively and to approach complex pathology much more aggressively—than does conventional laparoscopy.

It takes some time to get used to the dramatic paradigm shift of operating remotely from the patient through a robotic interface. Learning to overcome the lack of tactile feedback is also part of the learning curve. The key is to not attempt more than you can handle early in the learning process. Then, as your experience grows, your ability to tackle complex gynecologic pathology will come. In other words, start with a symptomatic 4- to 5-cm fundal subserosal fibroid before approaching the 10-cm broad-ligament fibroid.

We started doing robotic myomectomies in 2001. In our first published series of 35 cases, the mean myoma weight was 223.2 g. The mean number of myomas removed was 1.6, and the mean diameter was 7.9 cm. The average estimated blood loss was 169 mL and no blood transfusions were necessary. Three of the cases were converted to laparotomy, two because of the absence of tactile feedback and a third because of cardiogenic shock secondary to vasopressin (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).

Since that early experience, we have not had to convert a patient to a laparotomy secondary to an absence of tactile feedback.

When we later compared surgical outcomes with those of traditional laparotomy through a retrospective case-matched analysis of 58 patients, we found that although operative times were significantly longer in the robotic group (a mean of 231 minutes vs. a mean of 154 minutes), postoperative complication rates were higher in the laparotomy group.

In all, there were 14 postoperative complications in 12 patients in the laparotomy group, including wound dehiscence; hematoma; blood loss and anemia requiring transfusion; and deep vein thrombosis followed by respiratory arrest and renal failure. In the robotic group, there were three postoperative complications: aspiration pneumonia, port-site cellulitis, and chest pain.

Estimated blood loss was significantly higher in the laparotomy group than in the robotic group (a mean of 365 mL v. 196 mL), and transfusions were required in two patients who underwent laparotomy. Length of stay was also higher: 3.6 days in the laparotomy group, compared with 1.5 days in the robotic group. (J. Min. Invasive Gynecol. 2007;14:698-705).

We have also analyzed the effects of our experience over time and have presented these data at the AAGL annual meeting in November 2007. We found a notable trend toward both lower blood loss and shorter operative time with experience. Additionally, we evolved from an average length of stay of 1.5 days to a completely outpatient procedure. We even noted an increasing ability to tackle more complex fibroid cases over time, particularly those involving submucosal and deep intramural fibroids.

More recently, we have begun long-term follow-up of our patients. Preliminary pregnancy data show us that women who have undergone a robot-assisted laparoscopic myomectomy in the past 5 years have indeed become pregnant and have carried their pregnancies through with no complications and no uterine ruptures.

A hysterotomy is underway with an EndoWrist cautery hook and Gyrus dissecting forceps.

A fibroid enucleation is facilitated by an EndoWrist tenaculum.

A myometrial defect is repaired with EndoWrist needle drivers and 0-Vicryl suture. Photos courtesy Dr. Arnold Advincula

Robotic Myomectomy: The Time Has Come

In the last edition of the Master Class in gynecology, Dr. Javier Magrina, professor of ob.gyn. and director of female pelvic medicine and reconstructive surgery at the Mayo Clinic in Scottsdale, Ariz., ably described the benefits and technique of robotic-assisted hysterectomy.

In this second installment on robotic-assisted surgery, I have asked Dr. Arnold P. Advincula, clinical associate professor of ob.gyn. at the University of Michigan, Ann Arbor, to discuss robotic-assisted laparoscopic myomectomy.

Other than laparoscopic tubal anastomosis, there is no procedure in minimally invasive gynecologic surgery that is more dependent on the ability to be facile with laparoscopic suturing techniques than laparoscopic myomectomy. Certainly, the physician's need to visualize the repair on a television screen while using limited wrist motion for suture placement limits the vast majority of gynecologists from routinely and effectively performing this procedure.

Dr. Advincula holds several departmental positions at the University of Michigan. He is the director of the minimally invasive surgery and chronic pelvic pain program, the director of the minimally invasive surgery fellowship, and the codirector of the university's endometriosis center. Dr. Advincula is also a member of the board of trustees of the AAGL and is associate editor of the journal The Female Patient, coeditor of the Journal of Robotic Surgery, and a member of the editorial board of the International Journal of Gynecology & Obstetrics.

Dr. Advincula not only is an avid clinical researcher and educator, having published nearly 50 articles in peer-reviewed journals, but also is a fixture on both the national and international lecture circuits on the topic of minimally invasive gynecologic surgery.

Hysterectomy has been a first natural and successful application for robotics in gynecologic and reproductive care, but it is also now clear that robot-assisted laparoscopic myomectomy takes full advantage—even more so—of what robotic technology brings to the table.

Conventional laparoscopic myomectomy has been so challenging that relatively few gynecologic surgeons have been willing and/or able to move away from the traditional open approach for treating symptomatic leiomyomata. Laparotomy thus has remained the standard for myomectomy, leaving many women with a limited number of minimally invasive options if they want to preserve their uterus or fertility, and leaving our health care system shouldering millions of dollars in costs associated with invasive approaches.

It is interesting to note that the total direct cost of treating uterine fibroids in 2000 was estimated at $2.1 billion. Most of the cost, the authors wrote, resulted from inpatient care, particularly hysterectomy (Am. J. Obstet. Gynec. 2006;195:955-64).

With all that robotics offers to us, I believe this is about to change.

The Rationale

Two prospective trials have shown less postoperative morbidity and faster recovery with laparoscopic myomectomy. Yet the endoscopic management of leiomyomata is so technically challenging that the majority of cases are still performed via laparotomy. (Few would challenge the notion, I believe, that it is one of the more challenging procedures in minimally invasive surgery.)

The complexity of dissection and, in particular, the complexity of repair with multilayer-sutured closures present challenges that not only require advanced laparoscopic skills but also are associated with a steep learning curve. These challenges have consistently raised concerns about whether laparoscopy increases conversion rates and whether it can lead to uterine rupture.

There also are longstanding, published limitations placed on the kinds of tumors that can be treated with conventional laparoscopy in order to minimize the risk of conversion to laparotomy. It is often stated that cases involving fibroids greater than or equal to 5 cm, intramural fibroids, an anterior location, and preoperative use of GnRH agonists are too difficult to handle laparoscopically and are likely to increase the conversion rate (Human Reprod. 2001;16:1726-31).

Current robotic technology essentially erases almost all of the limitations of conventional laparoscopy. The features of the technology—improved dexterity and precision of the instruments as well as the three-dimensional imaging—allow the endoscopic approach to be more accurately modeled after (and reflective of) traditional open techniques.

The da Vinci surgical system, which is the only Food and Drug Administration-approved robotic device for use in gynecologic surgery, provides us with a means to overcome the difficulties associated with hysterotomy, enucleation, repair, and extraction that we encounter with the conventional laparoscopic management of fibroids.

The Setup

The da Vinci system comprises a surgeon's console, a vision system that provides three-dimensional imaging through a 12-mm endoscope, and a patientside cart with robotic arms and various EndoWrist instruments.

At the console, the surgeon controls the instruments, the camera, and an energy source, all via a stereoscopic viewer, hand manipulators, and foot pedals. One of the robotic arms holds the endoscope while the other two or three arms hold the instruments.

The instruments come in either 8- or 5-mm sizes and possess 7 degrees of movement, a range that replicates or surpasses the human hand's full range of motion.

Overall, the technique itself for robot-assisted laparoscopic myomectomy does not differ significantly from what is done in conventional laparoscopy, except that the critical steps of hysterotomy, enucleation, and repair are dramatically facilitated while the surgeon adheres to the principles of open surgery.

The bottom line is that robotics affords us the ability to perform the procedure as if it were being done as an open procedure, with the only change being the route of access.

We first place a 12-mm port at or above the umbilicus, depending on the size of the uterus, to accommodate the endoscope and camera arm. As a general rule, I advise leaving at least a handsbreadth distance (approximately 8-10 cm) between the endoscope and the top of an elevated uterus or leiomyoma during bimanual examination, with the patient under anesthesia.

This spacing is important during myomectomy because the enucleation process will result in the leiomyoma projecting out toward the endoscope. By leaving an adequate working space at the beginning, we are able to compensate for a loss of optical working distance and maintain our ability to manipulate our instruments.

We then place an 8-mm port in the left and right lower quadrants, placing them more cephalad and lateral in the case of larger uteri or leiomyomata. These ports will mount directly to the operating robotic arms.

A fourth trocar (a 12- to 15-mm port that will facilitate the introduction of suture as well as instrumentation used for retraction, suction/irrigation, and other tasks of the assistant) can be placed between the camera port and either the left or right lower-quadrant port.

Just as with robotic hysterectomy, a fourth robotic arm can be added for patients who are obese or have a large uterus; this can be used for added retraction of tissues.

The key point to be made about setup is that the ports must be placed far enough away from each other and from the target tissue to avoid instrument-arm collisions.

We recommend that all patients undergo radiologic imaging prior to myomectomy. In our practice, we favor MRI for assessing the size, number, and location of the fibroids as well as for ruling out adenomyosis and for planning the location(s) of the hysterotomy incision. All of this information is particularly helpful given the absence of haptic (tactile) feedback with the robotic approach.

The Technique

Prior to hysterotomy, a dilute concentration of vasopressin is injected into the myometrium surrounding the myoma, as an adjunct for hemostasis. Once adequate blanching is noted, we begin each case with either a bipolar Maryland forceps or Gyrus ACMI Inc.'s PK dissecting forceps on the left arm, and hot shears or a permanent cautery hook (both monopolar devices) on the right arm. Our hysterotomy can be made in either a horizontal or vertical axis because we will be less limited with robotic instruments than we would be in a conventional laparoscopy.

The fibroid can then be enucleated while the bedside assistant provides additional traction/countertraction with a conventional laparoscopic tenaculum or corkscrew. An alternative is to use the fourth robotic arm with an EndoWrist tenaculum. Care must be taken to avoid excessive traction during the enucleation phase in order to maintain hemostasis and to not prematurely avulse the fibroid. Patience is key.

The removed fibroid is placed in the posterior cul-de-sac—or in one of the paracolic gutters if it is larger—for retrieval at the end of the surgery. When we remove multiple and smaller fibroids, it is important to maintain a myoma count. Tagging each of them with long suture can be helpful for retrieval at the end of the case.

At this point, we usually exchange our instruments for a large needle driver on the left arm and a mega needle driver with a high-force grip and integrated cutting mechanism on the right arm. We typically incorporate a multilayer closure for the myometrium, using either interrupted sutures of 0-Vicryl on CT-2 needles cut to 6 inches, or running sutures of 0-Vicryl on CT-2 needles cut to 11 inches.

With the increased articulation and dexterity of our instruments, our ability to repair a defect is affected much less by the orientation of the incisions or the location than it would be in conventional laparoscopy.

To close the uterine serosa, we use a running baseball stitch with 3-0 Vicryl on an SH needle. If multiple fibroids must be removed, we prefer to repair each uterine defect after enucleation before moving on to another tumor. This way, we're taking advantage of the effects of vasopressin at each site. We try to remove as many fibroids as possible through a given hysterotomy.

Before retrieving excised fibroids, the robot-assist device is undocked. Specimens are then retrieved via a tissue morcellator that is placed through the accessory port. Another option is to use the endoscopic port site, but this requires the use of a 5-mm 0-degree laparoscope placed through one of the lateral trocars.

All operative sites are irrigated, hemostasis is ensured under low-pressure settings, and an adhesion barrier is placed over all uterine incisions. We typically apply a slurry of finely chopped Seprafilm as an adhesion barrier (an off-label use).

With robotic myomectomy, as with any of the robotically assisted gynecologic procedures, the importance of the bedside assistant cannot be overestimated. In addition to providing traction/countertraction (we usually don't need to use a fourth robotic arm because our assistants are skilled), the assistant introduces and removes suture, provides irrigation, and manages any accessory port activity (J. Robotic Surg. 2007;1:69-74).

The Patients, the Outcomes

With robotics, there really are not many patients we cannot address. There are no absolute inclusion criteria, and no absolute cutoffs. It's all relative. We determine whether a patient is a candidate for a robotic myomectomy based on the size and mobility of her uterus as well as the size, number, and location of her fibroids.

For example, a patient whose height is 4 feet 10 inches and who is obese with a short truncated torso, a uterus that is not very mobile, and an 8-cm fibroid located over the broad ligament may be a poorer candidate than would a taller patient of average weight with an 8-cm intramural fibroid in a uterus that is extremely mobile. This is where the art of medicine comes into play.

Overall, however, the robotic approach overcomes challenges like obesity, and puts us at a greater advantage as surgeons—giving us an ability to suture more effectively and to approach complex pathology much more aggressively—than does conventional laparoscopy.

It takes some time to get used to the dramatic paradigm shift of operating remotely from the patient through a robotic interface. Learning to overcome the lack of tactile feedback is also part of the learning curve. The key is to not attempt more than you can handle early in the learning process. Then, as your experience grows, your ability to tackle complex gynecologic pathology will come. In other words, start with a symptomatic 4- to 5-cm fundal subserosal fibroid before approaching the 10-cm broad-ligament fibroid.

We started doing robotic myomectomies in 2001. In our first published series of 35 cases, the mean myoma weight was 223.2 g. The mean number of myomas removed was 1.6, and the mean diameter was 7.9 cm. The average estimated blood loss was 169 mL and no blood transfusions were necessary. Three of the cases were converted to laparotomy, two because of the absence of tactile feedback and a third because of cardiogenic shock secondary to vasopressin (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).

Since that early experience, we have not had to convert a patient to a laparotomy secondary to an absence of tactile feedback.

When we later compared surgical outcomes with those of traditional laparotomy through a retrospective case-matched analysis of 58 patients, we found that although operative times were significantly longer in the robotic group (a mean of 231 minutes vs. a mean of 154 minutes), postoperative complication rates were higher in the laparotomy group.

In all, there were 14 postoperative complications in 12 patients in the laparotomy group, including wound dehiscence; hematoma; blood loss and anemia requiring transfusion; and deep vein thrombosis followed by respiratory arrest and renal failure. In the robotic group, there were three postoperative complications: aspiration pneumonia, port-site cellulitis, and chest pain.

Estimated blood loss was significantly higher in the laparotomy group than in the robotic group (a mean of 365 mL v. 196 mL), and transfusions were required in two patients who underwent laparotomy. Length of stay was also higher: 3.6 days in the laparotomy group, compared with 1.5 days in the robotic group. (J. Min. Invasive Gynecol. 2007;14:698-705).

We have also analyzed the effects of our experience over time and have presented these data at the AAGL annual meeting in November 2007. We found a notable trend toward both lower blood loss and shorter operative time with experience. Additionally, we evolved from an average length of stay of 1.5 days to a completely outpatient procedure. We even noted an increasing ability to tackle more complex fibroid cases over time, particularly those involving submucosal and deep intramural fibroids.

More recently, we have begun long-term follow-up of our patients. Preliminary pregnancy data show us that women who have undergone a robot-assisted laparoscopic myomectomy in the past 5 years have indeed become pregnant and have carried their pregnancies through with no complications and no uterine ruptures.

A hysterotomy is underway with an EndoWrist cautery hook and Gyrus dissecting forceps.

A fibroid enucleation is facilitated by an EndoWrist tenaculum.

A myometrial defect is repaired with EndoWrist needle drivers and 0-Vicryl suture. Photos courtesy Dr. Arnold Advincula

Robotic Myomectomy: The Time Has Come

In the last edition of the Master Class in gynecology, Dr. Javier Magrina, professor of ob.gyn. and director of female pelvic medicine and reconstructive surgery at the Mayo Clinic in Scottsdale, Ariz., ably described the benefits and technique of robotic-assisted hysterectomy.

In this second installment on robotic-assisted surgery, I have asked Dr. Arnold P. Advincula, clinical associate professor of ob.gyn. at the University of Michigan, Ann Arbor, to discuss robotic-assisted laparoscopic myomectomy.

Other than laparoscopic tubal anastomosis, there is no procedure in minimally invasive gynecologic surgery that is more dependent on the ability to be facile with laparoscopic suturing techniques than laparoscopic myomectomy. Certainly, the physician's need to visualize the repair on a television screen while using limited wrist motion for suture placement limits the vast majority of gynecologists from routinely and effectively performing this procedure.

Dr. Advincula holds several departmental positions at the University of Michigan. He is the director of the minimally invasive surgery and chronic pelvic pain program, the director of the minimally invasive surgery fellowship, and the codirector of the university's endometriosis center. Dr. Advincula is also a member of the board of trustees of the AAGL and is associate editor of the journal The Female Patient, coeditor of the Journal of Robotic Surgery, and a member of the editorial board of the International Journal of Gynecology & Obstetrics.

Dr. Advincula not only is an avid clinical researcher and educator, having published nearly 50 articles in peer-reviewed journals, but also is a fixture on both the national and international lecture circuits on the topic of minimally invasive gynecologic surgery.

Hysterectomy has been a first natural and successful application for robotics in gynecologic and reproductive care, but it is also now clear that robot-assisted laparoscopic myomectomy takes full advantage—even more so—of what robotic technology brings to the table.

Conventional laparoscopic myomectomy has been so challenging that relatively few gynecologic surgeons have been willing and/or able to move away from the traditional open approach for treating symptomatic leiomyomata. Laparotomy thus has remained the standard for myomectomy, leaving many women with a limited number of minimally invasive options if they want to preserve their uterus or fertility, and leaving our health care system shouldering millions of dollars in costs associated with invasive approaches.

It is interesting to note that the total direct cost of treating uterine fibroids in 2000 was estimated at $2.1 billion. Most of the cost, the authors wrote, resulted from inpatient care, particularly hysterectomy (Am. J. Obstet. Gynec. 2006;195:955-64).

With all that robotics offers to us, I believe this is about to change.

The Rationale

Two prospective trials have shown less postoperative morbidity and faster recovery with laparoscopic myomectomy. Yet the endoscopic management of leiomyomata is so technically challenging that the majority of cases are still performed via laparotomy. (Few would challenge the notion, I believe, that it is one of the more challenging procedures in minimally invasive surgery.)

The complexity of dissection and, in particular, the complexity of repair with multilayer-sutured closures present challenges that not only require advanced laparoscopic skills but also are associated with a steep learning curve. These challenges have consistently raised concerns about whether laparoscopy increases conversion rates and whether it can lead to uterine rupture.

There also are longstanding, published limitations placed on the kinds of tumors that can be treated with conventional laparoscopy in order to minimize the risk of conversion to laparotomy. It is often stated that cases involving fibroids greater than or equal to 5 cm, intramural fibroids, an anterior location, and preoperative use of GnRH agonists are too difficult to handle laparoscopically and are likely to increase the conversion rate (Human Reprod. 2001;16:1726-31).

Current robotic technology essentially erases almost all of the limitations of conventional laparoscopy. The features of the technology—improved dexterity and precision of the instruments as well as the three-dimensional imaging—allow the endoscopic approach to be more accurately modeled after (and reflective of) traditional open techniques.

The da Vinci surgical system, which is the only Food and Drug Administration-approved robotic device for use in gynecologic surgery, provides us with a means to overcome the difficulties associated with hysterotomy, enucleation, repair, and extraction that we encounter with the conventional laparoscopic management of fibroids.

The Setup

The da Vinci system comprises a surgeon's console, a vision system that provides three-dimensional imaging through a 12-mm endoscope, and a patientside cart with robotic arms and various EndoWrist instruments.

At the console, the surgeon controls the instruments, the camera, and an energy source, all via a stereoscopic viewer, hand manipulators, and foot pedals. One of the robotic arms holds the endoscope while the other two or three arms hold the instruments.

The instruments come in either 8- or 5-mm sizes and possess 7 degrees of movement, a range that replicates or surpasses the human hand's full range of motion.

Overall, the technique itself for robot-assisted laparoscopic myomectomy does not differ significantly from what is done in conventional laparoscopy, except that the critical steps of hysterotomy, enucleation, and repair are dramatically facilitated while the surgeon adheres to the principles of open surgery.

The bottom line is that robotics affords us the ability to perform the procedure as if it were being done as an open procedure, with the only change being the route of access.

We first place a 12-mm port at or above the umbilicus, depending on the size of the uterus, to accommodate the endoscope and camera arm. As a general rule, I advise leaving at least a handsbreadth distance (approximately 8-10 cm) between the endoscope and the top of an elevated uterus or leiomyoma during bimanual examination, with the patient under anesthesia.

This spacing is important during myomectomy because the enucleation process will result in the leiomyoma projecting out toward the endoscope. By leaving an adequate working space at the beginning, we are able to compensate for a loss of optical working distance and maintain our ability to manipulate our instruments.

We then place an 8-mm port in the left and right lower quadrants, placing them more cephalad and lateral in the case of larger uteri or leiomyomata. These ports will mount directly to the operating robotic arms.

A fourth trocar (a 12- to 15-mm port that will facilitate the introduction of suture as well as instrumentation used for retraction, suction/irrigation, and other tasks of the assistant) can be placed between the camera port and either the left or right lower-quadrant port.

Just as with robotic hysterectomy, a fourth robotic arm can be added for patients who are obese or have a large uterus; this can be used for added retraction of tissues.

The key point to be made about setup is that the ports must be placed far enough away from each other and from the target tissue to avoid instrument-arm collisions.

We recommend that all patients undergo radiologic imaging prior to myomectomy. In our practice, we favor MRI for assessing the size, number, and location of the fibroids as well as for ruling out adenomyosis and for planning the location(s) of the hysterotomy incision. All of this information is particularly helpful given the absence of haptic (tactile) feedback with the robotic approach.

The Technique

Prior to hysterotomy, a dilute concentration of vasopressin is injected into the myometrium surrounding the myoma, as an adjunct for hemostasis. Once adequate blanching is noted, we begin each case with either a bipolar Maryland forceps or Gyrus ACMI Inc.'s PK dissecting forceps on the left arm, and hot shears or a permanent cautery hook (both monopolar devices) on the right arm. Our hysterotomy can be made in either a horizontal or vertical axis because we will be less limited with robotic instruments than we would be in a conventional laparoscopy.

The fibroid can then be enucleated while the bedside assistant provides additional traction/countertraction with a conventional laparoscopic tenaculum or corkscrew. An alternative is to use the fourth robotic arm with an EndoWrist tenaculum. Care must be taken to avoid excessive traction during the enucleation phase in order to maintain hemostasis and to not prematurely avulse the fibroid. Patience is key.

The removed fibroid is placed in the posterior cul-de-sac—or in one of the paracolic gutters if it is larger—for retrieval at the end of the surgery. When we remove multiple and smaller fibroids, it is important to maintain a myoma count. Tagging each of them with long suture can be helpful for retrieval at the end of the case.

At this point, we usually exchange our instruments for a large needle driver on the left arm and a mega needle driver with a high-force grip and integrated cutting mechanism on the right arm. We typically incorporate a multilayer closure for the myometrium, using either interrupted sutures of 0-Vicryl on CT-2 needles cut to 6 inches, or running sutures of 0-Vicryl on CT-2 needles cut to 11 inches.

With the increased articulation and dexterity of our instruments, our ability to repair a defect is affected much less by the orientation of the incisions or the location than it would be in conventional laparoscopy.

To close the uterine serosa, we use a running baseball stitch with 3-0 Vicryl on an SH needle. If multiple fibroids must be removed, we prefer to repair each uterine defect after enucleation before moving on to another tumor. This way, we're taking advantage of the effects of vasopressin at each site. We try to remove as many fibroids as possible through a given hysterotomy.

Before retrieving excised fibroids, the robot-assist device is undocked. Specimens are then retrieved via a tissue morcellator that is placed through the accessory port. Another option is to use the endoscopic port site, but this requires the use of a 5-mm 0-degree laparoscope placed through one of the lateral trocars.

All operative sites are irrigated, hemostasis is ensured under low-pressure settings, and an adhesion barrier is placed over all uterine incisions. We typically apply a slurry of finely chopped Seprafilm as an adhesion barrier (an off-label use).

With robotic myomectomy, as with any of the robotically assisted gynecologic procedures, the importance of the bedside assistant cannot be overestimated. In addition to providing traction/countertraction (we usually don't need to use a fourth robotic arm because our assistants are skilled), the assistant introduces and removes suture, provides irrigation, and manages any accessory port activity (J. Robotic Surg. 2007;1:69-74).

The Patients, the Outcomes

With robotics, there really are not many patients we cannot address. There are no absolute inclusion criteria, and no absolute cutoffs. It's all relative. We determine whether a patient is a candidate for a robotic myomectomy based on the size and mobility of her uterus as well as the size, number, and location of her fibroids.

For example, a patient whose height is 4 feet 10 inches and who is obese with a short truncated torso, a uterus that is not very mobile, and an 8-cm fibroid located over the broad ligament may be a poorer candidate than would a taller patient of average weight with an 8-cm intramural fibroid in a uterus that is extremely mobile. This is where the art of medicine comes into play.

Overall, however, the robotic approach overcomes challenges like obesity, and puts us at a greater advantage as surgeons—giving us an ability to suture more effectively and to approach complex pathology much more aggressively—than does conventional laparoscopy.

It takes some time to get used to the dramatic paradigm shift of operating remotely from the patient through a robotic interface. Learning to overcome the lack of tactile feedback is also part of the learning curve. The key is to not attempt more than you can handle early in the learning process. Then, as your experience grows, your ability to tackle complex gynecologic pathology will come. In other words, start with a symptomatic 4- to 5-cm fundal subserosal fibroid before approaching the 10-cm broad-ligament fibroid.

We started doing robotic myomectomies in 2001. In our first published series of 35 cases, the mean myoma weight was 223.2 g. The mean number of myomas removed was 1.6, and the mean diameter was 7.9 cm. The average estimated blood loss was 169 mL and no blood transfusions were necessary. Three of the cases were converted to laparotomy, two because of the absence of tactile feedback and a third because of cardiogenic shock secondary to vasopressin (J. Am. Assoc. Gynecol. Laparosc. 2004;11:511-8).

Since that early experience, we have not had to convert a patient to a laparotomy secondary to an absence of tactile feedback.

When we later compared surgical outcomes with those of traditional laparotomy through a retrospective case-matched analysis of 58 patients, we found that although operative times were significantly longer in the robotic group (a mean of 231 minutes vs. a mean of 154 minutes), postoperative complication rates were higher in the laparotomy group.

In all, there were 14 postoperative complications in 12 patients in the laparotomy group, including wound dehiscence; hematoma; blood loss and anemia requiring transfusion; and deep vein thrombosis followed by respiratory arrest and renal failure. In the robotic group, there were three postoperative complications: aspiration pneumonia, port-site cellulitis, and chest pain.

Estimated blood loss was significantly higher in the laparotomy group than in the robotic group (a mean of 365 mL v. 196 mL), and transfusions were required in two patients who underwent laparotomy. Length of stay was also higher: 3.6 days in the laparotomy group, compared with 1.5 days in the robotic group. (J. Min. Invasive Gynecol. 2007;14:698-705).

We have also analyzed the effects of our experience over time and have presented these data at the AAGL annual meeting in November 2007. We found a notable trend toward both lower blood loss and shorter operative time with experience. Additionally, we evolved from an average length of stay of 1.5 days to a completely outpatient procedure. We even noted an increasing ability to tackle more complex fibroid cases over time, particularly those involving submucosal and deep intramural fibroids.

More recently, we have begun long-term follow-up of our patients. Preliminary pregnancy data show us that women who have undergone a robot-assisted laparoscopic myomectomy in the past 5 years have indeed become pregnant and have carried their pregnancies through with no complications and no uterine ruptures.

A hysterotomy is underway with an EndoWrist cautery hook and Gyrus dissecting forceps.

A fibroid enucleation is facilitated by an EndoWrist tenaculum.

A myometrial defect is repaired with EndoWrist needle drivers and 0-Vicryl suture. Photos courtesy Dr. Arnold Advincula

Robotic Myomectomy: The Time Has Come

In the last edition of the Master Class in gynecology, Dr. Javier Magrina, professor of ob.gyn. and director of female pelvic medicine and reconstructive surgery at the Mayo Clinic in Scottsdale, Ariz., ably described the benefits and technique of robotic-assisted hysterectomy.

In this second installment on robotic-assisted surgery, I have asked Dr. Arnold P. Advincula, clinical associate professor of ob.gyn. at the University of Michigan, Ann Arbor, to discuss robotic-assisted laparoscopic myomectomy.

Other than laparoscopic tubal anastomosis, there is no procedure in minimally invasive gynecologic surgery that is more dependent on the ability to be facile with laparoscopic suturing techniques than laparoscopic myomectomy. Certainly, the physician's need to visualize the repair on a television screen while using limited wrist motion for suture placement limits the vast majority of gynecologists from routinely and effectively performing this procedure.

Dr. Advincula holds several departmental positions at the University of Michigan. He is the director of the minimally invasive surgery and chronic pelvic pain program, the director of the minimally invasive surgery fellowship, and the codirector of the university's endometriosis center. Dr. Advincula is also a member of the board of trustees of the AAGL and is associate editor of the journal The Female Patient, coeditor of the Journal of Robotic Surgery, and a member of the editorial board of the International Journal of Gynecology & Obstetrics.

Dr. Advincula not only is an avid clinical researcher and educator, having published nearly 50 articles in peer-reviewed journals, but also is a fixture on both the national and international lecture circuits on the topic of minimally invasive gynecologic surgery.

Preeclampsia is one of the most challenging and high-risk conditions that obstetric specialists will confront in their clinical practices.

This condition continues to be a vexing problem because the etiology remains evasive, not only in its onset, but often in its manifestations and complications as well.

Patients who develop preeclampsia fall into three categories. One subset of patients develops preeclampsia that remains mild and does not cause any major complications. Another subset develops a more advanced preeclampsia with some complications that are usually manageable, often without grave risk to the pregnancy.

The third subset of patients develops a severe form of preeclampsia based on precise, defined criteria. This form of preeclampsia may present in premature pregnancies, where the condition creates the greatest challenge and raises a clinical conundrum: Is it best to deliver the patient, or to embrace expectant management?

Because the severe form of preeclampsia is such a difficult problem and the outcome of the pregnancy hinges on the clinician's choice of the right approach, we thought it was important to dedicate a Master Class to the management of these high-risk patients.

I have invited Dr. Baha M. Sibai, an international expert on preeclampsia and eclampsia and a world leader in both clinical care and research in this field, to provide a thorough discussion of this difficult topic.

Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and has contributed to more than 350 studies in peer-reviewed journals on the subject of preeclampsia and eclampsia.

Preeclampsia is one of the most challenging and high-risk conditions that obstetric specialists will confront in their clinical practices.

This condition continues to be a vexing problem because the etiology remains evasive, not only in its onset, but often in its manifestations and complications as well.

Patients who develop preeclampsia fall into three categories. One subset of patients develops preeclampsia that remains mild and does not cause any major complications. Another subset develops a more advanced preeclampsia with some complications that are usually manageable, often without grave risk to the pregnancy.

The third subset of patients develops a severe form of preeclampsia based on precise, defined criteria. This form of preeclampsia may present in premature pregnancies, where the condition creates the greatest challenge and raises a clinical conundrum: Is it best to deliver the patient, or to embrace expectant management?

Because the severe form of preeclampsia is such a difficult problem and the outcome of the pregnancy hinges on the clinician's choice of the right approach, we thought it was important to dedicate a Master Class to the management of these high-risk patients.

I have invited Dr. Baha M. Sibai, an international expert on preeclampsia and eclampsia and a world leader in both clinical care and research in this field, to provide a thorough discussion of this difficult topic.

Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and has contributed to more than 350 studies in peer-reviewed journals on the subject of preeclampsia and eclampsia.

Preeclampsia is one of the most challenging and high-risk conditions that obstetric specialists will confront in their clinical practices.

This condition continues to be a vexing problem because the etiology remains evasive, not only in its onset, but often in its manifestations and complications as well.

Patients who develop preeclampsia fall into three categories. One subset of patients develops preeclampsia that remains mild and does not cause any major complications. Another subset develops a more advanced preeclampsia with some complications that are usually manageable, often without grave risk to the pregnancy.

The third subset of patients develops a severe form of preeclampsia based on precise, defined criteria. This form of preeclampsia may present in premature pregnancies, where the condition creates the greatest challenge and raises a clinical conundrum: Is it best to deliver the patient, or to embrace expectant management?

Because the severe form of preeclampsia is such a difficult problem and the outcome of the pregnancy hinges on the clinician's choice of the right approach, we thought it was important to dedicate a Master Class to the management of these high-risk patients.

I have invited Dr. Baha M. Sibai, an international expert on preeclampsia and eclampsia and a world leader in both clinical care and research in this field, to provide a thorough discussion of this difficult topic.

Dr. Sibai is professor of obstetrics and gynecology at the University of Cincinnati and has contributed to more than 350 studies in peer-reviewed journals on the subject of preeclampsia and eclampsia.

Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

Since the first published report of a robotic hysterectomy appeared in 2001, we have gained enough experience to know that next to vaginal hysterectomy, which I believe is still the preferred approach whenever possible, the robotic approach is the next-best technique that gynecologic surgeons can offer patients.

The robotic system we use today—the da Vinci surgical system—was designed to overcome the surgical limitations of conventional laparoscopy. Indeed, it has.

My colleagues and I at the Mayo Clinic, and others elsewhere, have seen similar operating times, reduced blood loss, and shorter hospitalization for both simple and radical hysterectomies as compared with the laparotomy approach. We have experienced firsthand the increased accuracy and precision that robotics promised. Suturing is easier with robotics than with laparoscopy. The advantages of robotics—from instrument articulation to the steady three-dimensional vision—have been more than expected, surpassing the advantages of conventional laparoscopy. Our operating time for robotic radical hysterectomy, in fact, is significantly shorter than that of laparoscopy.

The learning curve for performing robotic hysterectomy, moreover, seems surprisingly short. In a case-series analysis of robotic simple hysterectomies, we found it interesting that the time spent in the operating room flattened after 20-25 cases.

A prospective, randomized study comparing robotic hysterectomy with conventional laparoscopic surgery should be completed at the Mayo Clinic by the end of this year. In the meantime, robotic hysterectomy is generally offered to patients at Mayo as an alternative whenever a laparoscopic hysterectomy is being considered.

Patients are beginning to ask for it, and indeed, there are instances when we strongly prefer the robotic approach regardless of patient demand—for example, when patients have a history of adhesions, advanced endometriosis, gynecologic cancer, or genitourinary fistula, or when we have to perform pelvic floor repair procedures or other additional procedures that require extensive suturing. Obesity is an excellent application for robotic technology, which is something we have learned as our operating time has not been influenced by a patient's body mass index.

Evolution of Robotics

We started performing hysterectomies with the Zeus MicroWrist surgical system in 2003. The system, which was approved by the Food and Drug Administration in 2002 for general and laparoscopic surgery, enabled the surgeon to operate three robotic arms while sitting a distance away from the operating table.

This Zeus system was an advance over the Aesop robotic device, a voice-activated robotic arm designed to operate the laparoscope. Released in 1994, Aesop was the first robotic system approved to assist in laparoscopic procedures. With Aesop, the surgeon would direct the robotic movement of the laparoscope through voice commands while working manually with regular instruments. Video quality thus improved, and the need for an assistant was obviated when only two instruments were needed.

With the development of the Zeus system, surgeons gained two more robotic arms (in addition to the laparoscope-operating arm) as well as some of the other advantages afforded by robotics, such as articulating tips and a downscaling of movement.

The da Vinci surgical system that we use currently is an improvement over Zeus. It was originally approved for procedures in the abdominal and pelvic cavity, but in 2005 it received special approval for the performance of robotic hysterectomy. At this point, because of various changes in the industry's structure, it is the only robotic system manufactured for laparoscopic procedures.

In an evolution that reflects likely future changes as well, a second generation of the da Vinci system, released in 2006, has longer instruments, lighter arms, and increased flexion-extension and lateral excursion, among other improvements.

Instrumentation and Process

We now refer to the approach as “robotic” hysterectomy rather than “robotic-assisted” laparoscopic hysterectomy because—although a surgical assistant is still needed for several key functions, such as suction and irrigation—the procedure is, with these latest advancements, largely robotic in nature.

With most hysterectomies, as with most pelvic operations, four trocar sites are used: three for the robotic arms (one of which is for the laparoscope) and one for the assistant, who will manually perform suction, irrigation, vessel sealing, tissue retraction, and specimen retrieval. When we have a patient with cancer, obesity, a large uterus, advanced endometriosis, or adhesions, we add a fourth robotic arm. This additional arm allows for the added retraction of tissues.

We use the open Hasson technique to place a 12-mm robotic trocar (the first of the three main trocars) in the umbilical area for the laparoscope. Two 8-mm robotic trocars are then placed bilaterally, 10 cm to the right and left of the umbilicus. This placement provides an operative field that extends, in most patients, from the lower pelvis up to the inferior mesenteric artery.

For the assistant, a 10-mm trocar is placed 3 cm cranial and right between the umbilicus and the left robotic trocar. Through this port, the assistant performs the functions that are not yet available robotically: vessel sealing, suction, irrigation, tissue retraction, specimen retrieval, and the introduction and retrieval of sutures and needles. When a fourth robotic arm is used, that trocar is placed 10 cm lateral and 10 cm caudal to the right robotic trocar.

The robotic tower with three arms is situated between the patient's legs. We have noticed that if the column is parked very close to the patient's perineum, there is inadequate space for the scrub nurse to mobilize and manipulate a vaginal probe, maintain the pneumoperitoneum during vaginal incision, and retrieve specimens vaginally. Ideally, the robotic column should rest at about the level of the patient's feet and not any closer.

The middle robotic arm is attached to the umbilical trocar where the laparoscope has been inserted. A monopolar spatula, or scissors, is inserted through the right lateral trocar, and a plasma-kinetic dissecting forceps is inserted through the left lateral trocar. When needed for suturing, a needle-holder replaces the spatula. When a fourth robotic arm is needed, a robotic instrument called a Prograsp is used.

The surgeon sits, unscrubbed, on a console that in our operating suite is about 12 feet away from the patient. Here the surgeon can manipulate the robotic arms that maneuver the instruments and the laparoscopic camera, as well as communicate verbally with the assistant. When the surgeon is playing the role of assistant and the trainee is at the console, the surgeon can direct the trainee by means of telestration to pinpoint anatomical structures and planes of dissection, or to indicate areas of potential visceral damage by drawing circles, arrows, or dots.

When the ovaries are to be removed, which in our practice is more common than not, our first step with robotic simple hysterectomy is to incise the pelvic peritoneum at the level of the pelvic brim to identify the ureters and the points at which they cross the ovarian vessels. We then coagulate and divide the infundibulopelvic ligament that contains the ovarian vessels.

The ureters are then traced and followed to the point where they cross the uterine arteries. Because we cannot palpate the tissues in robotic surgery and therefore need to see, we dissect the ureters anytime they appear close to the cervix or if there is parametrial pathology. Doing so prevents injury.

After this, the bladder must be dissected from the cervix and upper vagina, and at least 2 cm caudal to the anterior vaginal fornix. A vaginal probe that is inserted into the vagina by the scrub nurse is used to identify where the vagina joins the cervix and to define the level of incision on the vagina.

A vessel-sealing device is used to coagulate and transect the uterine arteries and the cardinal ligaments. At that point—and not any sooner—the vagina is transected immediately distal to the cervix and the uterus is detached and removed, along with the ovaries in most cases, through the vaginal opening. (When the ovaries are not removed, they are left attached to the ipsilateral round ligament.) The scrub nurse holds the labia majora to the midline over the surgical instrument used to remove the uterus, and that is enough to maintain the pneumoperitoneum.

Inflation of a sterile occluding balloon with 60 mL of saline is used to maintain the pneumoperitoneum after removal of the specimen vaginally.

The right monopolar spatula is then removed and replaced with a needle-holder, and the vaginal cuff is closed with a 15-cm precut 0 continuous polyglyconate absorbable suture starting at the right angle and going toward the midline. A similar 15-cm suture is applied from the left to the midline until it meets the other suture. The uterosacral ligaments are incorporated at each vaginal angle and at the midline in order to support the vagina. We use a LapraTy suture clip at each end of the sutures to eliminate the need for intracorporeal knot tying.

Using these small precut sutures is most helpful. A suture that is 30 cm long simply takes too long to pull through the tissues. In general, the use of smaller, shorter sutures is essential in robotic surgery.

For robotic hysterectomies as well as any other robotic gynecologic surgery, I also advise using slow, deliberate, precise movements. Such pacing alleviates the risk of bleeding, which dramatically slows the procedure down when it occurs.

At the end of the procedure, the robotic arms are disengaged from the trocars, the robotic column is moved away, and the fascia at the umbilical site is closed. The other trocar sites require closure of only the skin. We always perform a cystoscopy after injection of intravenous indigo carmine to ensure that there are bilateral ureteral jets and no injury to the bladder.

When we plan to send the patient home on the day of the robotic hysterectomy—something we started doing when we observed how well patients were faring with this approach—we modify the anesthesia regimen somewhat.

We give each patient dexamethasone preoperatively, apply an antinausea patch behind her ear, and administer two additional medications to prevent nausea: Zofran (ondansetron) and aprepitant. Then, at the end of the hysterectomy, we inject both the right and the left pelvic plexus (sympathetic and parasympathetic) with a cocktail of morphine, vasopressin, and Marcaine (bupivacaine). We also infiltrate the trocar sites with Marcaine, and before the patient is awakened from anesthesia, we administer intravenous ketorolac. When she is awake, the patient will then have minimal discomfort.

Additionally, normal saline (200 mL) is left in the bladder at the end of the cystoscopy so that the patient will have the urge to empty her bladder in the next hour rather than the need to wait up to 5 hours to empty her bladder before being able to go home.

In our preoperative discussions with patients, we do inform them that the incisions are placed a little higher than with conventional laparoscopy. Only once has one of our patients expressed cosmetic concern and opted for a laparoscopic approach with suprapubic trocar placement.

Hysterectomy has been a natural beginning application for robotic technology in gynecologic surgery. Experience with the approach has applications, in turn, for other gynecologic procedures because the same instrumentation and usually the same port placement are used.

Patient Outcomes

In a series of 91 consecutive patients who underwent robotic simple hysterectomy at Mayo (with or without salpingo-oophorectomy or concomitant appendectomy) between March 2004 and December 2005, we had no conversions to conventional laparoscopy or laparotomy, no bladder or ureteral injuries, and few intraoperative and postoperative complications (Am. J. Obstet. Gynecol. 2007;197:113.e1-4).

Our one intraoperative complication was an enterotomy that was repaired robotically in a patient with extensive pelvic adhesions. (We have learned that complications can be repaired robotically without having to convert to laparotomy.)

Postoperatively, one patient with cardiomyopathy required admission to intensive care for 24 hours for exacerbation of heart failure, and another patient required admission for vaginal cuff abscess. Three patients were readmitted for ileus, pneumonia, and colitis. The mean estimated blood loss was 79 mL, and the mean hospital stay was 1.3 days. (Indications in the patients, whose mean age was 50 years, included menometrorrhagia in 43% and ovarian neoplasm in 20%.)

In the evaluation of robotic surgery and analysis of the experience, it is important to break down the total process into several components: docking time (the time required to attach the robotic arms to the trocars), console time (the surgeon's time dedicated exclusively to performing the hysterectomy), and total operating time (from incision to closure).

For surgeons who haven't used the robotic system, a common misperception is that it takes a long time to set up for each procedure. In our series, however, the mean docking time was only 2.9 minutes.

The mean console time was 79 minutes, and the total mean operating time was 122 minutes, which was 14 minutes shorter than conventional laparoscopy. A mean of 43 minutes was required for setup and close, which included trocar placement, exploration, and the removal of trocars, closure, and cystoscopy. (The time for setup and close has not been reported before in laparoscopic surgery.)

Our surgical time was minimized by having a dedicated robotic team and by using certain surgical strategies, such as the use of only three instruments (monopolar spatula, bipolar grasper, and needle-holder) for the entire procedure—a practice that also reduces cost—and the use of precut, short sutures and suture clips. The optimal robotic team can comprise two surgeons or one surgeon and one assistant, as well as at least two nurses who are well versed in the robotic instrumentation and system. The assistant also plays a major role in fixing any malfunctions of the robotic instruments or arms, and in switching robotic instruments.

Console time clearly decreased over time as we performed more simple hysterectomies. It was not significantly affected by the performance of an appendectomy, but it was affected by uterine weight and the lysis of adhesions. In our practice, we prefer a vaginal approach for the larger uterus that requires more morcellation. In general, our threshold for the robotic approach is a uterus of 12-14 weeks' gestational size.

All of these findings—from reduced operating times to shorter hospitalizations and fewer complications—have applied to our experience with robotic radical hysterectomy as well. In one analysis of 16 patients undergoing robotic radical hysterectomy, we found that total operating time was 66 minutes shorter than it had been for laparoscopic radical hysterectomy.

An increased body mass index did not prolong operating times in any of our patient groups. In fact, we have noticed that for patients who are obese, surgical time is longer with laparoscopy than with robotics. This reflects one of the advantages of the robotic approach: It bypasses the fulcrum effect, which is inherent to conventional laparoscopy and which is especially challenging in patients with a thick abdominal wall. Surgeons using the articulated instrumentation of a robotic system will use the same manual effort regardless of how thick the abdominal wall is.

The lack of tactile feedback is viewed by some as a limitation of robotics, but after a short time of practice, it is easily compensated for by the depth of perception that three-dimensional vision affords.

In addition, the articulation of the instruments facilitates dissection of the tissues and suturing, such as closure of the vaginal cuff in hysterectomies. And as with other gynecologic surgeries, the downscaling of the surgeon's movements in a 3:1 or 5:1 ratio leads to increased accuracy and precision. (In such downscaling, when the surgeon's hand moves 3 cm or 5 cm, the tip of the instrument moves only 1 cm.)

We still believe that when the hysterectomy can be performed vaginally, the vaginal approach is preferable to robotics or to laparoscopy. This is because any study that has compared vaginal hysterectomy with another approach has demonstrated a faster operating time with the vaginal procedure, as well as lower cost.

When a patient is not a candidate for a vaginal hysterectomy, or when the gynecologist is not comfortable with the approach, however, then the robotic approach is indeed preferable to conventional laparoscopy.

Four robotic trocars are placed in preparation for pelvic surgery with the da Vinci robotic system.

The da Vinci robotic system is shown in operation, with the assistant sitting to the left of the patient.

The Zeus robotic system consists of two working arms and another to hold the laparoscope. Photos courtesy Dr. Javier Magrina

Robotics: Enabling Technology for the Gyn.

The first proponents of robotics in surgery were the cardiac surgeons, but it was the urologists who truly popularized robotic surgery. Hospitals around the country have purchased the da Vinci surgical system mainly for urologists who wanted to perform robot-assisted radical prostatectomies. Interestingly enough, the robot has enabled physicians who were virtually untrained in laparoscopic surgery to feel comfortable with a laparoscopic approach.

Even though gynecologists were the first surgical specialists to perform laparoscopic surgery on a routine basis, the acceptance of minimally invasive gynecologic surgery within our specialty remains dismally low. In a recent study submitted to the National Women's Health Resource Center by the Lewin Group, only 15% of more than 600,000 hysterectomies performed per annum in the United States are accomplished via a minimally invasive technique. This is especially sobering when one considers that 80% of the cholecystectomies are performed laparoscopically.

Given the above, it is interesting to speculate on the potential impact of robotic surgery in gynecology. Initially, it appears that gynecologists who were not previously performing advanced minimally invasive surgery are able to do so with this enabling technology.

I have put together a minisymposium on robotic surgery in gynecology that will be covered in the next four issues. With my esteemed faculty, I will discuss the topics of robotic-assisted laparoscopic hysterectomy, robotic-assisted laparoscopic myomectomy, robotic-assisted laparoscopic sacrocolpopexy, and robotic-assisted node dissection.

The first author is Dr. Javier Magrina, head of the division of gynecologic oncology, director of female pelvic medicine and reconstructive surgery, and professor of obstetrics and gynecology at the Mayo Clinic, Scottsdale, Ariz.

Dr. Magrina has written extensively and lectured throughout the world on robotic surgery, from a standpoint of both benign as well as malignant disease. For the past 2 years, he has served on the board of trustees of the AAGL and remains very active in the Society of Gynecologic Oncologists and the Society of Laparoendoscopic Surgeons.

It is a pleasure to have Dr. Magrina as the author of our Master Class in Gynecologic Surgery on robotic-assisted laparoscopic hysterectomy.

Female sex, exposure to prenatal corticosteroid therapy, singleton birth, and increased birth weight (in 100-g increments) each improve an infant's chances of a positive outcome with intensive care.

The magnitude of the benefit is similar to that of an extra week of gestational age, Dr. Jon E. Tyson and his associates at the National Institute of Child Health and Human Development (NICHD) wrote in the April 17 New England Journal of Medicine.

Decisions about admitting extremely premature infants to intensive care are “highly controversial,” with most centers in the United States selecting patients solely on the basis of gestational age thresholds. “Such care is likely to be routinely administered at 25 weeks' gestation but may be provided only with parental agreement at 23–24 weeks, and only 'comfort care' may be given at 22 weeks,” the investigators noted.

The researchers assessed a cohort of 4,446 infants born at 22–25 weeks' gestation at 19 medical centers in the NICHD's neonatal research network between 1998 and 2004. At a corrected age of 18–22 months, 49% of the study subjects had died, and 61% had died or sustained profound impairment.

Factors that might contribute to outcome were examined, and the four listed above were found to significantly improve the rates of survival and survival without impairment. The improvements were equivalent to a 1-week increase in gestational age, said Dr. Tyson of the University of Texas at Houston and associates.

“For example, among infants born midway between 24 and 25 completed weeks of gestation, the estimated likelihood of death or profound impairment was 33% for a 750-g, appropriate-for-gestational-age female singleton who received prenatal corticosteroids, but 87% for a 525-g, small-for-gestational-age male twin who did not receive prenatal corticosteroids,” they wrote.

Even among the highest-risk infants—those born before 24 weeks with a birth weight of 600 g or less—outcomes varied considerably according to these four risk factors. The maximum potential rate of survival without profound impairment was as low as 5% for boys weighing 401–500 g born at 22 weeks, but as high as 38% for girls weighing 501–600 g born at 24 weeks (N.Engl. J. Med;358:1672–81).

Nevertheless, in actual practice it turned out that girls were less likely than boys and that singletons were less likely than multiples to receive intensive care when they had the same likelihood of a favorable outcome.

Weighing the additional four factors into the decision “is likely to promote treatment decisions that are less arbitrary, more individualized, more transparent, and better justified than decisions based solely on gestational-age thresholds,” the investigators said.

To assist physicians faced with such decisions, the authors provided a Web-based tool (www.nichd.nih.gov/neonatalestimates

Dr. Tyson and associates added that in assessing outcomes, they included factors such as treatment cost, resource use, parental distress, and “infant suffering due to painful procedures, prolonged intubation, and such complications as intracranial hemorrhage, necrotizing enterocolitis, and recurrent episodes of hypoxia.”

“Barring major therapeutic advances, our findings indicate that extending intensive care to all of the most immature infants would entail considerable suffering, resource use, and cost in order to benefit only a small proportion of infants,” they noted.

Female sex, exposure to prenatal corticosteroid therapy, singleton birth, and increased birth weight (in 100-g increments) each improve an infant's chances of a positive outcome with intensive care.

The magnitude of the benefit is similar to that of an extra week of gestational age, Dr. Jon E. Tyson and his associates at the National Institute of Child Health and Human Development (NICHD) wrote in the April 17 New England Journal of Medicine.

Decisions about admitting extremely premature infants to intensive care are “highly controversial,” with most centers in the United States selecting patients solely on the basis of gestational age thresholds. “Such care is likely to be routinely administered at 25 weeks' gestation but may be provided only with parental agreement at 23–24 weeks, and only 'comfort care' may be given at 22 weeks,” the investigators noted.

The researchers assessed a cohort of 4,446 infants born at 22–25 weeks' gestation at 19 medical centers in the NICHD's neonatal research network between 1998 and 2004. At a corrected age of 18–22 months, 49% of the study subjects had died, and 61% had died or sustained profound impairment.

Factors that might contribute to outcome were examined, and the four listed above were found to significantly improve the rates of survival and survival without impairment. The improvements were equivalent to a 1-week increase in gestational age, said Dr. Tyson of the University of Texas at Houston and associates.

“For example, among infants born midway between 24 and 25 completed weeks of gestation, the estimated likelihood of death or profound impairment was 33% for a 750-g, appropriate-for-gestational-age female singleton who received prenatal corticosteroids, but 87% for a 525-g, small-for-gestational-age male twin who did not receive prenatal corticosteroids,” they wrote.

Even among the highest-risk infants—those born before 24 weeks with a birth weight of 600 g or less—outcomes varied considerably according to these four risk factors. The maximum potential rate of survival without profound impairment was as low as 5% for boys weighing 401–500 g born at 22 weeks, but as high as 38% for girls weighing 501–600 g born at 24 weeks (N.Engl. J. Med;358:1672–81).

Nevertheless, in actual practice it turned out that girls were less likely than boys and that singletons were less likely than multiples to receive intensive care when they had the same likelihood of a favorable outcome.

Weighing the additional four factors into the decision “is likely to promote treatment decisions that are less arbitrary, more individualized, more transparent, and better justified than decisions based solely on gestational-age thresholds,” the investigators said.

To assist physicians faced with such decisions, the authors provided a Web-based tool (www.nichd.nih.gov/neonatalestimates

Dr. Tyson and associates added that in assessing outcomes, they included factors such as treatment cost, resource use, parental distress, and “infant suffering due to painful procedures, prolonged intubation, and such complications as intracranial hemorrhage, necrotizing enterocolitis, and recurrent episodes of hypoxia.”

“Barring major therapeutic advances, our findings indicate that extending intensive care to all of the most immature infants would entail considerable suffering, resource use, and cost in order to benefit only a small proportion of infants,” they noted.

Female sex, exposure to prenatal corticosteroid therapy, singleton birth, and increased birth weight (in 100-g increments) each improve an infant's chances of a positive outcome with intensive care.

The magnitude of the benefit is similar to that of an extra week of gestational age, Dr. Jon E. Tyson and his associates at the National Institute of Child Health and Human Development (NICHD) wrote in the April 17 New England Journal of Medicine.

Decisions about admitting extremely premature infants to intensive care are “highly controversial,” with most centers in the United States selecting patients solely on the basis of gestational age thresholds. “Such care is likely to be routinely administered at 25 weeks' gestation but may be provided only with parental agreement at 23–24 weeks, and only 'comfort care' may be given at 22 weeks,” the investigators noted.

The researchers assessed a cohort of 4,446 infants born at 22–25 weeks' gestation at 19 medical centers in the NICHD's neonatal research network between 1998 and 2004. At a corrected age of 18–22 months, 49% of the study subjects had died, and 61% had died or sustained profound impairment.

Factors that might contribute to outcome were examined, and the four listed above were found to significantly improve the rates of survival and survival without impairment. The improvements were equivalent to a 1-week increase in gestational age, said Dr. Tyson of the University of Texas at Houston and associates.

“For example, among infants born midway between 24 and 25 completed weeks of gestation, the estimated likelihood of death or profound impairment was 33% for a 750-g, appropriate-for-gestational-age female singleton who received prenatal corticosteroids, but 87% for a 525-g, small-for-gestational-age male twin who did not receive prenatal corticosteroids,” they wrote.

Even among the highest-risk infants—those born before 24 weeks with a birth weight of 600 g or less—outcomes varied considerably according to these four risk factors. The maximum potential rate of survival without profound impairment was as low as 5% for boys weighing 401–500 g born at 22 weeks, but as high as 38% for girls weighing 501–600 g born at 24 weeks (N.Engl. J. Med;358:1672–81).

Nevertheless, in actual practice it turned out that girls were less likely than boys and that singletons were less likely than multiples to receive intensive care when they had the same likelihood of a favorable outcome.

Weighing the additional four factors into the decision “is likely to promote treatment decisions that are less arbitrary, more individualized, more transparent, and better justified than decisions based solely on gestational-age thresholds,” the investigators said.

To assist physicians faced with such decisions, the authors provided a Web-based tool (www.nichd.nih.gov/neonatalestimates

Dr. Tyson and associates added that in assessing outcomes, they included factors such as treatment cost, resource use, parental distress, and “infant suffering due to painful procedures, prolonged intubation, and such complications as intracranial hemorrhage, necrotizing enterocolitis, and recurrent episodes of hypoxia.”

“Barring major therapeutic advances, our findings indicate that extending intensive care to all of the most immature infants would entail considerable suffering, resource use, and cost in order to benefit only a small proportion of infants,” they noted.

How many of us are thoroughly, truly prepared to manage shoulder dystocia, to use forceps, or to perform a vaginal breech delivery?

It is not a silly question to ask ourselves, since these are critical, high-risk situations and skills that most of us do not encounter as frequently as routine vaginal delivery. When we are not practicing critical skills, we tend to lose them.

The question is increasingly important, moreover, because technological advances are making obstetric simulation more feasible and affordable for a variety of different settings. Realistic, low-fidelity mannequins that take up little space in an office or an old exam room are now relatively inexpensive.

Obstetric simulation training has become a tool that we simply must take advantage of. It is not only making its way into academia, with a small but growing body of literature showing that it improves competence and performance when a real event occurs, but is also gaining acceptance among practicing physicians as a valuable means of practicing skills and preparing for obstetric emergencies, such as shoulder dystocia, breech vaginal delivery, postpartum hemorrhage, and eclampsia.

I see and hear about attending physicians who join residents in the growing number of simulation programs that exist in academic institutions because they realize that they, too, can benefit from the practice. The American College of Obstetricians and Gynecologists is watching this trend; its Task Force on Simulation is examining the role of simulation in obstetrics and ways in which practicing obstetricians can take advantage of simulation technology.

Some professional liability organizations, meanwhile, are considering giving physicians discounts on their malpractice insurance premiums if they practice simulation; Harvard-affiliated obstetricians have been offered such discounts, and Kaiser Permanente is implementing simulation programs (including birth simulation training) as part of its initiatives for quality and patient safety.

It seems only a matter of time before more health care institutions draw on obstetric simulation to help practicing physicians update and reinforce their skills, and before certifying bodies also embrace the notion. (General surgery is on the cusp of establishing simulation centers for certification and recertification.)

In the meantime, obstetricians can take it upon themselves to use available technology and prepare for the high-acuity, low-frequency emergencies that are encountered by every obstetrician at some time.

Safety, Liability

That obstetric simulation is on the radar screen—and probably on its way to becoming mainstream—makes perfect sense.

Professionals in the airline industry, the military, and the nuclear power industry are already using simulation for teaching and for maintaining and evaluating skills. Simulation is a safety-first tool in these industries, and it often utilizes evidence-based protocols.

In medicine, we make evidence-based decisions all the time, and patient safety is a huge issue. The Joint Commission on Accreditation of Healthcare Organizations recently looked at all perinatal sentinel events across the country in all types of institutions, and found that 47% were linked with staff competence issues. Among the other identified root causes were communication issues (72%), the orientation and training process (40%), and organization culture as a barrier to effective communication and teamwork (55%). Simulation could play a significant role in addressing each of these issues.

Shoulder dystocia complicates up to 2% of all vaginal deliveries, and potentially causes permanent brachial plexus injury, clavicular fracture, hypoxic brain injury, and other significant long-term complications. Although we encounter shoulder dystocia infrequently, the risk for serious and permanent injury to the infant is so high that we ought to be prepared.

Similarly, approximately 3%–4% of singleton babies are in the breech position, yet only a minority of obstetricians are able to perform vaginal breech deliveries. In one recent study, only 33% of surveyed attending physicians performed vaginal breech deliveries. The rest do not do them anymore.

Although vaginal breech deliveries are discouraged, vaginal delivery is sometimes unavoidable or even preferable. (When the breech is on the perineum, for instance, it's riskier to go to cesarean delivery). We are putting our patients and ourselves at risk by not practicing and knowing how to do this with proper technique,

We do not like to talk about the litigation aspect, but we cannot hide it: Fetal injury that is related to emergencies like shoulder dystocia is a potential source of medical malpractice lawsuits and one that we can minimize by reinforcing and maintaining our skills through simulation.

Today's Simulators

Obstetricians worry about how they can do a simulation. Many think of simulators as too big, too expensive, and not lifelike. Some worry about doing a simulation in front of others and are too intimidated to try.

Some of the simulators available today are expensive. A full-body, high-fidelity obstetric simulator with all the bells and whistles—touch-screen computer technology that enables manipulation of the labor course, for instance, and varying vital signs and fetal heart rhythms—can cost up to $40,000.

These expensive models are often purchased by academic institutions that are interested in simulation for a multitude of purposes, including team training, but such models are not necessary to simulate at least several obstetric emergencies, including vaginal breech delivery, shoulder dystocia, and the use of forceps.

For these situations, low-fidelity simulators—which may be just a model of the pelvis through which a model baby can be manually pushed—are perfectly fine. They can be purchased for $2,000-$3,000, stored in a closet, and placed in an extra exam room where physicians can practice, either with a mentor or expert or by themselves.

Nothing is as real as a true patient or a real-life situation, of course, but many of these mannequins are surprisingly lifelike, with features like an anatomically correct bony pelvis, a stretchable perineum, and a silicone pelvic-floor musculature. A mannequin's cervix, for instance, really feels like a cervix.

When I was in resident training, I practiced using the forceps on a high-fidelity mannequin. This gave me an opportunity to practice all the necessary maneuvers and to know whether I performed all critical tasks, from inserting the posterior blade first, for instance, to holding the left blade of the forceps with my left hand while using my right hand as a guide.

Later, when I was in a real and urgent situation requiring forceps, I knew just what to do. It worked like clockwork. Simulation on a low-fidelity mannequin, if that was what my institution had had, would have been just as beneficial.

Simulation also provides opportunities to create protocols. In the middle of a forceps delivery simulation, for instance, you may realize that “this needs to be done all the time just like this.” Alternatively, you may think, “Let's not do it this way next time.”

Similarly, simulation affords us opportunities to practice and fine-tune communication and teamwork.

Improved Competence

I recently oversaw a resident who had previously done simulation training with high-fidelity mannequins as part of her curriculum at the Washington Hospital Center, and was now in a real and difficult delivery involving shoulder dystocia.

She performed the recommended initial maneuvers—like placing the patient in the McRobert's position and applying suprapubic pressure—but without success. She then immediately proceeded, without any prompting, to deliver the posterior arm, which relieved the shoulder dystocia. Afterward, the resident told me that “if I hadn't done the shoulder dystocia simulation lab, I would not have known to do that.” I hear such stories often.

Studies are beginning to document the effects of obstetric simulation training on competence and performance.

In a study published several years ago, for instance, residents at Georgetown University in Washington and the Uniformed Services University of Health Sciences in Bethesda, Md., were randomized to receive training on shoulder dystocia management using a high-fidelity obstetric simulator or to receive no special training. Each resident was subsequently tested without prior notice in another simulation scenario.

Those who had practiced shoulder dystocia management on mannequins completed more critical tasks and had significantly higher scores on timeliness of their interactions, proper performance of maneuvers, and overall performance (Obstet. Gynecol. 2004:103;1224–8).

Although not randomized, another more recent study at Georgetown University showed that high-fidelity simulation training improved resident performance of vaginal breech delivery. Residents were more likely after simulation training to perform critical maneuvers correctly and to deliver in a safe manner than they were before the training (Obstet. Gynecol. 2006:107;86–9).

Research from the University of Bristol (England) is also yielding interesting results. Investigators there have reported, for instance, that obstetric emergency training courses using simulation were associated with a significant reduction in low 5-minute APGAR scores and lower rates of hypoxic-ischemic encephalopathy (BJOG 2006;113:177–82).

Another study of shoulder dystocia has shown that, whereas training with high-fidelity mannequins provides additional benefits, training with low-fidelity mannequins is also effective in improving management of the obstetric situation by obstetricians and midwives (Obstet. Gynecol. 2006;108:1477–85).

A study from the Bristol investigators in which participants were tested on a standardized simulation before a simulation workshop, and then at 3 weeks, 6 months, and 12 months afterward, shows that improved performance appears to be sustained. Those who were proficient 3 weeks after the training retained their skills at the later dates. The researchers concluded that annual training may be adequate for some physicians, whereas others may need more frequent practice (Obstet. Gynecol. 2007;110:1069–74).

Soon-to-be-published research that we have recently completed at Georgetown University and the Washington Hospital Center similarly indicates that obstetricians generally should strive for continuing simulation training at least once a year. Residents in our study who were initially taught on the simulator scored higher when tested a year later than did residents who received no simulation training. Overall, however, everyone's scores declined.

Obstetric simulation is part of our future. New physicians of the future will enter practice having done simulation training in a variety of high-acuity, low-frequency scenarios—rather than learning solely through lectures and impromptu teaching after events have occurred—and those of us already in practice will likely find that working occasionally with low-fidelity mannequins enables us to provide better, safer patient care while reducing our liability risk.

Dr. Marsha Solomon, chief resident at the Washington Hospital Center, is shown performing a simulated forceps delivery in the photo at left. In the photo at right, Dr. Solomon performs a simulated breech vaginal delivery. Photos courtesy Dr. Tamika C. Auguste

Obstetric Simulation

Do you think that you would like to have your next airplane flight piloted by someone who has not flown a plane in several years or who has little experience in landing?

Pilots are among the professionals who gain their greatest experience and expertise through the development of skills using various simulation technologies.

Simulation training is common in the aviation industry, as it is in aeronautics and in some branches of engineering, which makes this question significantly less worrisome and less relevant than if simulation were not common.

Medicine in general—and obstetrics in particular—has been practiced worldwide using the apprenticeship model, in which residents and interns work with attending physicians to learn the art of medicine.

While caring for patients with various disorders and in various scenarios, physicians-in-training work alongside the more senior practitioners, taking on progressive amounts of responsibility. Experience is gained accordingly.

This approach has been very successful over the years, and will remain so. It may be enhanced, however, as the simulation approach is slowly integrated into medicine and into obstetrics training.

The use of simulation training in medicine makes intuitive sense. The acquisition of the greatest possible skill or expertise—or the enhancement of skills if there is a hiatus in practice—makes sense from quality-of-care and patient-safety perspectives, and also because of the litigious environment in which we live and practice.

The question, “How would you like to have your baby delivered by an obstetrician who has not used forceps or managed shoulder dystocia in over a year?” is a valid one for patients who realize that less-common delivery scenarios are unpredictable.

This month's Master Class will focus on the utility, practicability, and application of simulation technology in obstetrics as a means of maximizing not only the skills of the resident, but also the skills of the practicing clinician.

Our guest author, Dr. Tamika C. Auguste, is the director of obstetric simulation at Washington Hospital Center and assistant professor of obstetrics/gynecology at Georgetown University in Washington. She speaks in various forums on the issue of simulation for both residents and practicing physicians, and is fast becoming a young leader and expert from whom we can expect to hear more in the future.

Key Points on Simulation

1. Simulation can be used to practice classic obstetric skills and high-risk, low-frequency obstetric emergencies.

2. Simulation is not only for those in academic medicine but also for those in private practice.

3. Low-fidelity simulators can be just as useful as high-fidelity simulators.

4. Simulation is becoming the norm in residency training programs.

How many of us are thoroughly, truly prepared to manage shoulder dystocia, to use forceps, or to perform a vaginal breech delivery?

It is not a silly question to ask ourselves, since these are critical, high-risk situations and skills that most of us do not encounter as frequently as routine vaginal delivery. When we are not practicing critical skills, we tend to lose them.

The question is increasingly important, moreover, because technological advances are making obstetric simulation more feasible and affordable for a variety of different settings. Realistic, low-fidelity mannequins that take up little space in an office or an old exam room are now relatively inexpensive.

Obstetric simulation training has become a tool that we simply must take advantage of. It is not only making its way into academia, with a small but growing body of literature showing that it improves competence and performance when a real event occurs, but is also gaining acceptance among practicing physicians as a valuable means of practicing skills and preparing for obstetric emergencies, such as shoulder dystocia, breech vaginal delivery, postpartum hemorrhage, and eclampsia.

I see and hear about attending physicians who join residents in the growing number of simulation programs that exist in academic institutions because they realize that they, too, can benefit from the practice. The American College of Obstetricians and Gynecologists is watching this trend; its Task Force on Simulation is examining the role of simulation in obstetrics and ways in which practicing obstetricians can take advantage of simulation technology.

Some professional liability organizations, meanwhile, are considering giving physicians discounts on their malpractice insurance premiums if they practice simulation; Harvard-affiliated obstetricians have been offered such discounts, and Kaiser Permanente is implementing simulation programs (including birth simulation training) as part of its initiatives for quality and patient safety.

It seems only a matter of time before more health care institutions draw on obstetric simulation to help practicing physicians update and reinforce their skills, and before certifying bodies also embrace the notion. (General surgery is on the cusp of establishing simulation centers for certification and recertification.)

In the meantime, obstetricians can take it upon themselves to use available technology and prepare for the high-acuity, low-frequency emergencies that are encountered by every obstetrician at some time.

Safety, Liability

That obstetric simulation is on the radar screen—and probably on its way to becoming mainstream—makes perfect sense.

Professionals in the airline industry, the military, and the nuclear power industry are already using simulation for teaching and for maintaining and evaluating skills. Simulation is a safety-first tool in these industries, and it often utilizes evidence-based protocols.

In medicine, we make evidence-based decisions all the time, and patient safety is a huge issue. The Joint Commission on Accreditation of Healthcare Organizations recently looked at all perinatal sentinel events across the country in all types of institutions, and found that 47% were linked with staff competence issues. Among the other identified root causes were communication issues (72%), the orientation and training process (40%), and organization culture as a barrier to effective communication and teamwork (55%). Simulation could play a significant role in addressing each of these issues.

Shoulder dystocia complicates up to 2% of all vaginal deliveries, and potentially causes permanent brachial plexus injury, clavicular fracture, hypoxic brain injury, and other significant long-term complications. Although we encounter shoulder dystocia infrequently, the risk for serious and permanent injury to the infant is so high that we ought to be prepared.

Similarly, approximately 3%–4% of singleton babies are in the breech position, yet only a minority of obstetricians are able to perform vaginal breech deliveries. In one recent study, only 33% of surveyed attending physicians performed vaginal breech deliveries. The rest do not do them anymore.

Although vaginal breech deliveries are discouraged, vaginal delivery is sometimes unavoidable or even preferable. (When the breech is on the perineum, for instance, it's riskier to go to cesarean delivery). We are putting our patients and ourselves at risk by not practicing and knowing how to do this with proper technique,

We do not like to talk about the litigation aspect, but we cannot hide it: Fetal injury that is related to emergencies like shoulder dystocia is a potential source of medical malpractice lawsuits and one that we can minimize by reinforcing and maintaining our skills through simulation.

Today's Simulators

Obstetricians worry about how they can do a simulation. Many think of simulators as too big, too expensive, and not lifelike. Some worry about doing a simulation in front of others and are too intimidated to try.

Some of the simulators available today are expensive. A full-body, high-fidelity obstetric simulator with all the bells and whistles—touch-screen computer technology that enables manipulation of the labor course, for instance, and varying vital signs and fetal heart rhythms—can cost up to $40,000.

These expensive models are often purchased by academic institutions that are interested in simulation for a multitude of purposes, including team training, but such models are not necessary to simulate at least several obstetric emergencies, including vaginal breech delivery, shoulder dystocia, and the use of forceps.

For these situations, low-fidelity simulators—which may be just a model of the pelvis through which a model baby can be manually pushed—are perfectly fine. They can be purchased for $2,000-$3,000, stored in a closet, and placed in an extra exam room where physicians can practice, either with a mentor or expert or by themselves.

Nothing is as real as a true patient or a real-life situation, of course, but many of these mannequins are surprisingly lifelike, with features like an anatomically correct bony pelvis, a stretchable perineum, and a silicone pelvic-floor musculature. A mannequin's cervix, for instance, really feels like a cervix.

When I was in resident training, I practiced using the forceps on a high-fidelity mannequin. This gave me an opportunity to practice all the necessary maneuvers and to know whether I performed all critical tasks, from inserting the posterior blade first, for instance, to holding the left blade of the forceps with my left hand while using my right hand as a guide.

Later, when I was in a real and urgent situation requiring forceps, I knew just what to do. It worked like clockwork. Simulation on a low-fidelity mannequin, if that was what my institution had had, would have been just as beneficial.

Simulation also provides opportunities to create protocols. In the middle of a forceps delivery simulation, for instance, you may realize that “this needs to be done all the time just like this.” Alternatively, you may think, “Let's not do it this way next time.”

Similarly, simulation affords us opportunities to practice and fine-tune communication and teamwork.

Improved Competence

I recently oversaw a resident who had previously done simulation training with high-fidelity mannequins as part of her curriculum at the Washington Hospital Center, and was now in a real and difficult delivery involving shoulder dystocia.

She performed the recommended initial maneuvers—like placing the patient in the McRobert's position and applying suprapubic pressure—but without success. She then immediately proceeded, without any prompting, to deliver the posterior arm, which relieved the shoulder dystocia. Afterward, the resident told me that “if I hadn't done the shoulder dystocia simulation lab, I would not have known to do that.” I hear such stories often.

Studies are beginning to document the effects of obstetric simulation training on competence and performance.

In a study published several years ago, for instance, residents at Georgetown University in Washington and the Uniformed Services University of Health Sciences in Bethesda, Md., were randomized to receive training on shoulder dystocia management using a high-fidelity obstetric simulator or to receive no special training. Each resident was subsequently tested without prior notice in another simulation scenario.

Those who had practiced shoulder dystocia management on mannequins completed more critical tasks and had significantly higher scores on timeliness of their interactions, proper performance of maneuvers, and overall performance (Obstet. Gynecol. 2004:103;1224–8).

Although not randomized, another more recent study at Georgetown University showed that high-fidelity simulation training improved resident performance of vaginal breech delivery. Residents were more likely after simulation training to perform critical maneuvers correctly and to deliver in a safe manner than they were before the training (Obstet. Gynecol. 2006:107;86–9).

Research from the University of Bristol (England) is also yielding interesting results. Investigators there have reported, for instance, that obstetric emergency training courses using simulation were associated with a significant reduction in low 5-minute APGAR scores and lower rates of hypoxic-ischemic encephalopathy (BJOG 2006;113:177–82).

Another study of shoulder dystocia has shown that, whereas training with high-fidelity mannequins provides additional benefits, training with low-fidelity mannequins is also effective in improving management of the obstetric situation by obstetricians and midwives (Obstet. Gynecol. 2006;108:1477–85).

A study from the Bristol investigators in which participants were tested on a standardized simulation before a simulation workshop, and then at 3 weeks, 6 months, and 12 months afterward, shows that improved performance appears to be sustained. Those who were proficient 3 weeks after the training retained their skills at the later dates. The researchers concluded that annual training may be adequate for some physicians, whereas others may need more frequent practice (Obstet. Gynecol. 2007;110:1069–74).

Soon-to-be-published research that we have recently completed at Georgetown University and the Washington Hospital Center similarly indicates that obstetricians generally should strive for continuing simulation training at least once a year. Residents in our study who were initially taught on the simulator scored higher when tested a year later than did residents who received no simulation training. Overall, however, everyone's scores declined.

Obstetric simulation is part of our future. New physicians of the future will enter practice having done simulation training in a variety of high-acuity, low-frequency scenarios—rather than learning solely through lectures and impromptu teaching after events have occurred—and those of us already in practice will likely find that working occasionally with low-fidelity mannequins enables us to provide better, safer patient care while reducing our liability risk.

Dr. Marsha Solomon, chief resident at the Washington Hospital Center, is shown performing a simulated forceps delivery in the photo at left. In the photo at right, Dr. Solomon performs a simulated breech vaginal delivery. Photos courtesy Dr. Tamika C. Auguste

Obstetric Simulation

Do you think that you would like to have your next airplane flight piloted by someone who has not flown a plane in several years or who has little experience in landing?

Pilots are among the professionals who gain their greatest experience and expertise through the development of skills using various simulation technologies.

Simulation training is common in the aviation industry, as it is in aeronautics and in some branches of engineering, which makes this question significantly less worrisome and less relevant than if simulation were not common.

Medicine in general—and obstetrics in particular—has been practiced worldwide using the apprenticeship model, in which residents and interns work with attending physicians to learn the art of medicine.

While caring for patients with various disorders and in various scenarios, physicians-in-training work alongside the more senior practitioners, taking on progressive amounts of responsibility. Experience is gained accordingly.

This approach has been very successful over the years, and will remain so. It may be enhanced, however, as the simulation approach is slowly integrated into medicine and into obstetrics training.

The use of simulation training in medicine makes intuitive sense. The acquisition of the greatest possible skill or expertise—or the enhancement of skills if there is a hiatus in practice—makes sense from quality-of-care and patient-safety perspectives, and also because of the litigious environment in which we live and practice.

The question, “How would you like to have your baby delivered by an obstetrician who has not used forceps or managed shoulder dystocia in over a year?” is a valid one for patients who realize that less-common delivery scenarios are unpredictable.

This month's Master Class will focus on the utility, practicability, and application of simulation technology in obstetrics as a means of maximizing not only the skills of the resident, but also the skills of the practicing clinician.

Our guest author, Dr. Tamika C. Auguste, is the director of obstetric simulation at Washington Hospital Center and assistant professor of obstetrics/gynecology at Georgetown University in Washington. She speaks in various forums on the issue of simulation for both residents and practicing physicians, and is fast becoming a young leader and expert from whom we can expect to hear more in the future.

Key Points on Simulation

1. Simulation can be used to practice classic obstetric skills and high-risk, low-frequency obstetric emergencies.

2. Simulation is not only for those in academic medicine but also for those in private practice.

3. Low-fidelity simulators can be just as useful as high-fidelity simulators.

4. Simulation is becoming the norm in residency training programs.

How many of us are thoroughly, truly prepared to manage shoulder dystocia, to use forceps, or to perform a vaginal breech delivery?

It is not a silly question to ask ourselves, since these are critical, high-risk situations and skills that most of us do not encounter as frequently as routine vaginal delivery. When we are not practicing critical skills, we tend to lose them.

The question is increasingly important, moreover, because technological advances are making obstetric simulation more feasible and affordable for a variety of different settings. Realistic, low-fidelity mannequins that take up little space in an office or an old exam room are now relatively inexpensive.

Obstetric simulation training has become a tool that we simply must take advantage of. It is not only making its way into academia, with a small but growing body of literature showing that it improves competence and performance when a real event occurs, but is also gaining acceptance among practicing physicians as a valuable means of practicing skills and preparing for obstetric emergencies, such as shoulder dystocia, breech vaginal delivery, postpartum hemorrhage, and eclampsia.

I see and hear about attending physicians who join residents in the growing number of simulation programs that exist in academic institutions because they realize that they, too, can benefit from the practice. The American College of Obstetricians and Gynecologists is watching this trend; its Task Force on Simulation is examining the role of simulation in obstetrics and ways in which practicing obstetricians can take advantage of simulation technology.

Some professional liability organizations, meanwhile, are considering giving physicians discounts on their malpractice insurance premiums if they practice simulation; Harvard-affiliated obstetricians have been offered such discounts, and Kaiser Permanente is implementing simulation programs (including birth simulation training) as part of its initiatives for quality and patient safety.

It seems only a matter of time before more health care institutions draw on obstetric simulation to help practicing physicians update and reinforce their skills, and before certifying bodies also embrace the notion. (General surgery is on the cusp of establishing simulation centers for certification and recertification.)

In the meantime, obstetricians can take it upon themselves to use available technology and prepare for the high-acuity, low-frequency emergencies that are encountered by every obstetrician at some time.

Safety, Liability

That obstetric simulation is on the radar screen—and probably on its way to becoming mainstream—makes perfect sense.

Professionals in the airline industry, the military, and the nuclear power industry are already using simulation for teaching and for maintaining and evaluating skills. Simulation is a safety-first tool in these industries, and it often utilizes evidence-based protocols.

In medicine, we make evidence-based decisions all the time, and patient safety is a huge issue. The Joint Commission on Accreditation of Healthcare Organizations recently looked at all perinatal sentinel events across the country in all types of institutions, and found that 47% were linked with staff competence issues. Among the other identified root causes were communication issues (72%), the orientation and training process (40%), and organization culture as a barrier to effective communication and teamwork (55%). Simulation could play a significant role in addressing each of these issues.

Shoulder dystocia complicates up to 2% of all vaginal deliveries, and potentially causes permanent brachial plexus injury, clavicular fracture, hypoxic brain injury, and other significant long-term complications. Although we encounter shoulder dystocia infrequently, the risk for serious and permanent injury to the infant is so high that we ought to be prepared.

Similarly, approximately 3%–4% of singleton babies are in the breech position, yet only a minority of obstetricians are able to perform vaginal breech deliveries. In one recent study, only 33% of surveyed attending physicians performed vaginal breech deliveries. The rest do not do them anymore.

Although vaginal breech deliveries are discouraged, vaginal delivery is sometimes unavoidable or even preferable. (When the breech is on the perineum, for instance, it's riskier to go to cesarean delivery). We are putting our patients and ourselves at risk by not practicing and knowing how to do this with proper technique,

We do not like to talk about the litigation aspect, but we cannot hide it: Fetal injury that is related to emergencies like shoulder dystocia is a potential source of medical malpractice lawsuits and one that we can minimize by reinforcing and maintaining our skills through simulation.

Today's Simulators

Obstetricians worry about how they can do a simulation. Many think of simulators as too big, too expensive, and not lifelike. Some worry about doing a simulation in front of others and are too intimidated to try.

Some of the simulators available today are expensive. A full-body, high-fidelity obstetric simulator with all the bells and whistles—touch-screen computer technology that enables manipulation of the labor course, for instance, and varying vital signs and fetal heart rhythms—can cost up to $40,000.

These expensive models are often purchased by academic institutions that are interested in simulation for a multitude of purposes, including team training, but such models are not necessary to simulate at least several obstetric emergencies, including vaginal breech delivery, shoulder dystocia, and the use of forceps.

For these situations, low-fidelity simulators—which may be just a model of the pelvis through which a model baby can be manually pushed—are perfectly fine. They can be purchased for $2,000-$3,000, stored in a closet, and placed in an extra exam room where physicians can practice, either with a mentor or expert or by themselves.

Nothing is as real as a true patient or a real-life situation, of course, but many of these mannequins are surprisingly lifelike, with features like an anatomically correct bony pelvis, a stretchable perineum, and a silicone pelvic-floor musculature. A mannequin's cervix, for instance, really feels like a cervix.

When I was in resident training, I practiced using the forceps on a high-fidelity mannequin. This gave me an opportunity to practice all the necessary maneuvers and to know whether I performed all critical tasks, from inserting the posterior blade first, for instance, to holding the left blade of the forceps with my left hand while using my right hand as a guide.

Later, when I was in a real and urgent situation requiring forceps, I knew just what to do. It worked like clockwork. Simulation on a low-fidelity mannequin, if that was what my institution had had, would have been just as beneficial.

Simulation also provides opportunities to create protocols. In the middle of a forceps delivery simulation, for instance, you may realize that “this needs to be done all the time just like this.” Alternatively, you may think, “Let's not do it this way next time.”

Similarly, simulation affords us opportunities to practice and fine-tune communication and teamwork.

Improved Competence

I recently oversaw a resident who had previously done simulation training with high-fidelity mannequins as part of her curriculum at the Washington Hospital Center, and was now in a real and difficult delivery involving shoulder dystocia.

She performed the recommended initial maneuvers—like placing the patient in the McRobert's position and applying suprapubic pressure—but without success. She then immediately proceeded, without any prompting, to deliver the posterior arm, which relieved the shoulder dystocia. Afterward, the resident told me that “if I hadn't done the shoulder dystocia simulation lab, I would not have known to do that.” I hear such stories often.

Studies are beginning to document the effects of obstetric simulation training on competence and performance.

In a study published several years ago, for instance, residents at Georgetown University in Washington and the Uniformed Services University of Health Sciences in Bethesda, Md., were randomized to receive training on shoulder dystocia management using a high-fidelity obstetric simulator or to receive no special training. Each resident was subsequently tested without prior notice in another simulation scenario.

Those who had practiced shoulder dystocia management on mannequins completed more critical tasks and had significantly higher scores on timeliness of their interactions, proper performance of maneuvers, and overall performance (Obstet. Gynecol. 2004:103;1224–8).

Although not randomized, another more recent study at Georgetown University showed that high-fidelity simulation training improved resident performance of vaginal breech delivery. Residents were more likely after simulation training to perform critical maneuvers correctly and to deliver in a safe manner than they were before the training (Obstet. Gynecol. 2006:107;86–9).

Research from the University of Bristol (England) is also yielding interesting results. Investigators there have reported, for instance, that obstetric emergency training courses using simulation were associated with a significant reduction in low 5-minute APGAR scores and lower rates of hypoxic-ischemic encephalopathy (BJOG 2006;113:177–82).

Another study of shoulder dystocia has shown that, whereas training with high-fidelity mannequins provides additional benefits, training with low-fidelity mannequins is also effective in improving management of the obstetric situation by obstetricians and midwives (Obstet. Gynecol. 2006;108:1477–85).

A study from the Bristol investigators in which participants were tested on a standardized simulation before a simulation workshop, and then at 3 weeks, 6 months, and 12 months afterward, shows that improved performance appears to be sustained. Those who were proficient 3 weeks after the training retained their skills at the later dates. The researchers concluded that annual training may be adequate for some physicians, whereas others may need more frequent practice (Obstet. Gynecol. 2007;110:1069–74).

Soon-to-be-published research that we have recently completed at Georgetown University and the Washington Hospital Center similarly indicates that obstetricians generally should strive for continuing simulation training at least once a year. Residents in our study who were initially taught on the simulator scored higher when tested a year later than did residents who received no simulation training. Overall, however, everyone's scores declined.

Obstetric simulation is part of our future. New physicians of the future will enter practice having done simulation training in a variety of high-acuity, low-frequency scenarios—rather than learning solely through lectures and impromptu teaching after events have occurred—and those of us already in practice will likely find that working occasionally with low-fidelity mannequins enables us to provide better, safer patient care while reducing our liability risk.

Dr. Marsha Solomon, chief resident at the Washington Hospital Center, is shown performing a simulated forceps delivery in the photo at left. In the photo at right, Dr. Solomon performs a simulated breech vaginal delivery. Photos courtesy Dr. Tamika C. Auguste

Obstetric Simulation

Do you think that you would like to have your next airplane flight piloted by someone who has not flown a plane in several years or who has little experience in landing?

Pilots are among the professionals who gain their greatest experience and expertise through the development of skills using various simulation technologies.

Simulation training is common in the aviation industry, as it is in aeronautics and in some branches of engineering, which makes this question significantly less worrisome and less relevant than if simulation were not common.

Medicine in general—and obstetrics in particular—has been practiced worldwide using the apprenticeship model, in which residents and interns work with attending physicians to learn the art of medicine.

While caring for patients with various disorders and in various scenarios, physicians-in-training work alongside the more senior practitioners, taking on progressive amounts of responsibility. Experience is gained accordingly.

This approach has been very successful over the years, and will remain so. It may be enhanced, however, as the simulation approach is slowly integrated into medicine and into obstetrics training.

The use of simulation training in medicine makes intuitive sense. The acquisition of the greatest possible skill or expertise—or the enhancement of skills if there is a hiatus in practice—makes sense from quality-of-care and patient-safety perspectives, and also because of the litigious environment in which we live and practice.

The question, “How would you like to have your baby delivered by an obstetrician who has not used forceps or managed shoulder dystocia in over a year?” is a valid one for patients who realize that less-common delivery scenarios are unpredictable.

This month's Master Class will focus on the utility, practicability, and application of simulation technology in obstetrics as a means of maximizing not only the skills of the resident, but also the skills of the practicing clinician.

Our guest author, Dr. Tamika C. Auguste, is the director of obstetric simulation at Washington Hospital Center and assistant professor of obstetrics/gynecology at Georgetown University in Washington. She speaks in various forums on the issue of simulation for both residents and practicing physicians, and is fast becoming a young leader and expert from whom we can expect to hear more in the future.

Key Points on Simulation

1. Simulation can be used to practice classic obstetric skills and high-risk, low-frequency obstetric emergencies.

2. Simulation is not only for those in academic medicine but also for those in private practice.

3. Low-fidelity simulators can be just as useful as high-fidelity simulators.

4. Simulation is becoming the norm in residency training programs.

As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

As Dr. James Presthus discussed, in-office hysteroscopy not only makes good economic sense, it is good patient care. The office hysteroscope is critical for thoroughly evaluating abnormal uterine bleeding (the most common indication) and for more accurately diagnosing its common causes while maintaining the valuable ability to “see and treat.” For the diagnosis of abnormal uterine bleeding, hysteroscopy is simply an essential, integral part of good patient care. Once you add the office hysteroscope to your diagnostic armamentarium, you will find it difficult to imagine practicing ambulatory gynecology without it.

Office hysteroscopy plays a much larger role beyond diagnosis, however, because it enables us to remove polyps and adhesions, to do biopsies, and to perform minor therapeutic and operative procedures—such as hysteroscopic sterilization using the Essure system and global endometrial ablation—in a setting where our patients are comfortable and relaxed.

Control of pain (or the perception that patients will not tolerate the procedure) seems to be the greatest concern of physicians who are considering adding in-office hysteroscopy to their practice. It need not be. Patients tolerate in-office hysteroscopy extremely well.

A small hysteroscope is no larger than a Pipelle endometrial suction curette. Showing the patient a picture of both instruments, side by side, is truly worth a thousand words. Add to that the reduction in anxiety thanks to familiar surroundings, the conversations with office staff who often know the patient on a first-name basis, and a visualization of the procedure, and the discomfort that would be experienced in an operating room quickly dissipates.

Diagnostic hysteroscopy with a 3-mm flexible hysteroscope, in fact, does not require any anesthesia. Nevertheless, because studies indicate that a minority of patients find distention of the uterus uncomfortable and because we take a “see and treat” approach to in-office hysteroscopy, we use a small paracervical block. This way, virtually 100% of our patients are completely comfortable, and we are ready to move on to treatment if needed.

This is exactly what we tell our patients: that the small injection of local anesthetic will help them to tolerate the procedure, especially if we find a polyp or other abnormal tissue and want to remove it on the spot rather than subject them to a second procedure at a later date.

Both the Essure procedure and global endometrial ablation—we use a thermal ablation device called the Hydro ThermAblator (HTA) system—can be performed under local anesthesia with oral premedication at home.

When you embark on in-office operative hysteroscopy, it is vital to be aware of state regulations regarding in-office surgery. Almost 20 states now have rules that differentiate procedures into level I surgery and level II surgery, depending largely on the types of anesthesia used.

The South Carolina Board of Medical Examiners, for instance, defines level I surgery as including minor procedures in which “[oral] preoperative medication and/or unsupplemented local anesthesia” is used in quantities no greater than the manufacturer's recommended dose, with “no drug-induced alteration of consciousness other than preoperative minimal [oral] anxiolysis of the patient.”

Level II office surgery includes procedures that “require the administration of minimal or moderate intravenous, intramuscular, or rectal sedation/analgesia, thus making postoperative monitoring necessary.” Offices performing level II surgery must receive certification and follow various regulations and standards aimed at ensuring patient safety. A significant amount of office-based surgery done today involves the use of parenteral narcotics and thus is considered level II surgery. The protocols we use for in-office hysteroscopy and hysteroscopic procedures, however, are all level I.

For ablation, the HTA system is ideally suited for office use under minimal or level I sedation because it operates at low pressure (50 mm Hg) and is a “no touch” technique. Many of the other nonhysteroscopic global ablation technologies have also been used in the office setting, but—in order to ensure patient comfort—they may require parenteral narcotics, which are considered moderate or level II sedation.

Instrumentation and Setup

For diagnostic hysteroscopy, I favor a 3-mm flexible hysteroscope. I also prefer using normal warmed saline as a distension medium, and I have found that hanging the saline in a 1,000-cc bag on a tall IV pole, with standard IV tubing and with a pressure cuff to maintain distention, is an ideal setup. We use the C-Fusor pressure infusor bag.

Injecting the saline with a 60-cc syringe is another option and is certainly adequate for a quick diagnostic procedure. The disadvantage to this approach, however, is the likelihood of needing to continually change syringes if polyp removal or another treatment is needed, or if the patient has a patulous cervix and transcervical fluid loss occurs.

Some physicians prefer not to purchase a flexible scope and instead choose a continuous-flow diagnostic/operative hysteroscope. For the physician who is just starting out and wants one piece of equipment with the most versatility, I would recommend a 5.5-mm continuous flow hysteroscope with a 5-Fr operating channel. The Bettocchi 4.5-mm continuous flow hysteroscope is another alternative.

In either case, the use of these rigid scopes demands the use of a tenaculum as well. Because application of a tenaculum is often uncomfortable for the patient, local anesthetic should be used at the tenaculum site, as well as a small paracervical block in case the cervix needs to be dilated.

When a rigid hysteroscope is used diagnostically, an open-sided speculum should be used, because a closed speculum will restrict the free movement of the scope. After the hysteroscope is inserted through the cervix, the open-sided speculum is removed to allow for free lateral movement of the scope. Such a choice is irrelevant when a flexible hysteroscope is used because the end of the scope moves freely and flexes up to 110 degrees, allowing for adequate visualization of the cornua and the tubal ostia.

[Note: Vaginoscopy, a new technique, popularized in Italy, entails the insertion of a small-diameter rigid or flexible scope directly into the vagina without the use of a speculum, and then right into the cervix and uterus without the use of a tenaculum. The procedure appears to be well tolerated by patients, but it may not work well in patients with a narrow cervical os.]

Insertion of the hysteroscope through the cervix should always be done under direct visualization with fluid running and a camera always at the 12:00 position. It rarely is necessary to dilate the cervix when using a 3-mm flexible hysteroscope, even in nulliparous or postmenopausal women. Once the scope passes the external os, fluid pressure will sufficiently dilate the cervical canal. Dilatation is more often necessary when a 5.5-mm operative hysteroscope is used, though rarely for multiparous women.

When a polyp is visualized during a diagnostic hysteroscopy performed with a 3-mm flexible hysteroscope, the cervix can then be dilated to 5 mm or 6 mm if necessary, and the polyp can be removed using a Randall stone forceps inserted to the area where the polyp was visualized. Alternatively, a 2- to 3-mm-long laryngeal polyp forceps can be placed into the uterus alongside the flexible hysteroscope and used to remove the polyp under direct visualization.

Other forceps that are useful for polyp removal are the Kelly, Sopher, and Javerts polyp forceps. These instruments are 7 mm in diameter and are easily inserted if the cervix is dilated using standard Hegar or Pratt dilators to 6–7 mm. This can be done without any patient discomfort if a paracervical block has been administered initially.

The use of a continuous flow operative scope with a 5-Fr to 7-Fr operative channel instead of the diagnostic scope is another option for polyp removal, foreign body removal, or directed biopsy. It is most important not to attempt to pull a biopsy out through the operative channel, but rather to move the entire scope from the cervix with the specimen in view.

Our basic instrument tray for diagnostic and operative hysteroscopy, therefore, consists of an open-sided speculum; a series of Hagar dilators; a single-tooth tenaculum; a stainless steel or glass medicine cup; polyp forceps and Randall stone forceps; 9-inch ring forceps; two surgical towels; a 10-cc control syringe; a 22-gauge spinal needle; and 10 4-by-4-inch sponges. (We buy nonsterile sponges in packages of 500 and put 10 on each instrument tray, and then we steam-autoclave each kit.)

We always have a second sterile tenaculum in case the patient has a patulous cervix. A Gimpleson four-prong tenaculum is also valuable for the control of transcervical leakage.

Other basic equipment includes a camera system, a monitor (the new flat-panel monitors available from scope manufacturers are lightweight and compact), a light source (preferably xenon), and if possible, a video printer. We do not sterilize our cameras because the cameras will last longer if they are not subject to soaking or steam autoclaving. Instead, we simply fold an 11-by-17-inch Steri-Drape with an adhesive edge over the nonsterile camera.

For the Essure procedure, we use a sterile under-buttock drape with a fluid collection pouch to keep track of inflow and outflow.

Every procedure room should also have basic safety equipment: an oxygen supply with a mask or nasal cannula; a positive pressure manual resuscitator (Ambu bag); and monitoring equipment for pulse and blood pressure. We use a Dinamap automatic blood pressure and pulse monitor, which frees the nurse to concentrate on talking with the patient.

An automatic electronic defibrillator is optional, but it certainly is a good piece of relatively inexpensive equipment for any medical office to have, and I encourage its inclusion in any in-office hysteroscopy setup. A pulse oximeter is mandatory only for level II procedures. With office hysteroscopy, you likely will never use one (we have not), but it is nice to know it's there to use if a patient has a change in consciousness.

When level II procedures are being performed using parenteral narcotics and/or sedatives, a fully stocked crash cart is required, and an ACLS (advanced cardiac life support)-certified staff member who is not performing the procedure must be present to monitor the patient.

Anesthesia and Patient Comfort

At the Kaiser Permanente San Rafael (Calif.) Medical Center, we have performed more than 12,000 gynecologic office procedures—from diagnostic hysteroscopies to hysteroscopic sterilizations and endometrial ablations—under local anesthesia with minimal oral sedation, over a 25-year period.

For diagnostic and minor operative hysteroscopy, we generally instruct patients to take 400–800 mg ibuprofen at home 1 hour before the procedure. We administer a paracervical block consisting of 5–10 mL of 1% lidocaine to the cervical vaginal junction superficially through the mucosa at 3:00 and 9:00.

Whenever a tenaculum is used, we also inject the anterior lip of the cervix with approximately 1–2 mL of local anesthetic before the tenaculum is applied, and then leave the room for 5–10 minutes to allow the block to set properly.

Remember, as with any office gynecologic procedure, it is important to use a “no-touch” technique, as the uterine wall is innervated by both sympathetic and parasympathetic fibers. It is unnecessary to sound the uterus; the old but still common practice of sounding is uncomfortable for the patient and may provoke uterine contractions that make distention of the uterus difficult. It may also cause perforation and is simply unnecessary.

Our oral premedication regimen for HTA and Essure procedures consists of 800 mg ibuprofen (Motrin), 10 mg diazepam (Valium), and two hydrocodone/acetaminophen (Vicodin) tablets taken at home 1–2 hours before the procedure. Patients are instructed to arrive 30 minutes prior to their scheduled appointment, at which time they are given an intramuscular injection of 30 mg ketorolac (Toradol) and 0.4 mg atropine.

Toradol is a prostaglandin synthetase inhibitor and has a peripheral effect as well. Atropine is used to prevent vasovagal reactions. The patient should be warned that she may experience dry mouth, but that this is preferable to the extreme discomfort felt during a vasovagal episode.

We then administer a paracervical/intracervical block with 1% mepivacaine (Carbocaine, Polocaine), which is longer acting than lidocaine. We inject 2 mL in the anterior lip of the cervix before it is grasped with a tenaculum; we place the needle against the cervix and ask the patient to cough, which results in self-injection. We then inject 10 mL in the cervicovaginal junction on each side at 3:00 and 9:00. These injections are given superficially, just under the mucosa, to raise a weal.

We inject an additional 5 mL intracervically about 1–2 cm deep at 8:00 and 4:00, and 5 mL submucosally at 6:00 between the uterosacrals. The total amount of mepivacaine given is 37 mL, or 370 mg (the recommended maximum dose is 400 mg).

Again, it is important to leave the room for 10–15 minutes to allow the block to set properly. We recommend that the physician leave while the nurse stays to monitor the patient and help her relax.

The Essure procedure can be done with less oral anesthesia and a smaller paracervical or intracervical block than endometrial ablation requires, but because our patients tolerate our ablation anesthesia regimen so well, we use it for both procedures.

In a study of 249 endometrial ablations performed at Kaiser Permanente San Rafael over 5.5 years using the HTA system, only one procedure was discontinued because of pain, and two patients were admitted overnight for cramping and nausea. The overall success rate was 90.6%, despite 40% of our patients having submucous myomas. The only complications were four cases of postoperative endometritis, with two of those patients requiring hospitalization for intravenous antibiotics, and two cases of procedure failure due to false passages.

We have not had any adverse anesthetic reactions in our patients who have undergone HTA over the years, or in any of the thousands of other women who were given similar paracervical blocks for office gynecologic procedures.

Postprocedure recovery is rarely necessary for these level I procedures. Our nurses monitor patients' blood pressure for 10–15 minutes after the procedures are completed and ensure that patients are feeling well and are ambulatory. This monitoring is done in the procedure room. Patients who don't feel well enough to leave in that time period are brought into another exam room and are discharged when they are ready. This is very rare.

Our patients also receive written postoperative instructions that tell them to report any increase in abdominal pain, any fever, any foul-smelling discharge, and—after endometrial ablation—the absence of any discharge.

Most of the time, patients will just wave good-bye, pleased to have had their procedure done in the office.

For level II procedures, the postrecovery protocol is much more complex.

The South Carolina rule, for instance, states that monitoring in the recovery area must include both pulse oximetry and noninvasive blood pressure measurement, and that the patient must be assessed for level of consciousness, pain relief, or any untoward complication.

Most states require that the patient be monitored for at least 30 minutes and, depending on which drugs were administered, for as long as 2 hours.

Again, it is important for physicians who plan to use anything but minimal sedation in the office to know their state requirements, if any. These can usually be obtained online from the state department of health services.

A photo of a 3-mm flexible hysteroscope with other commonly used office instruments reassures patients. Courtesy Dr. Mark Glasser

A 42-year-old patient with a 4-cm type 0 myoma was treated in the office with the HTA system (preoperative view at left). The patient has been amenorrheic for more than 6 years (postprocedure view at right). Photos courtesy Dr. Mark Glasser

The Medex C-Fusor is placed around a bag of normal saline, which is used to maintain distention pressure. Courtesy Dr. Mark Glasser

This image shows paracervical block injection sites (dots) and doses of 1% mepivicaine (arrows) injected at each site. Courtesy Dr. Mark Glasser

In-Office Gynecologic Surgery, Part 2

In the last Master Class in Gynecologic Surgery, Dr. James Presthus provided the reader with an overview on in-office gynecologic surgery. Hysteroscopy, the standard of care in the diagnosis and treatment of abnormal uterine bleeding, is a procedure that lends itself especially readily to an office environment.

Dr. Presthus pointed out that the physician “can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.” He emphasized that despite the use of less anesthesia, patients routinely tolerate the procedure well.

Dr. Presthus gave us the “why” behind his recommendation that the gynecologist commit to office-based surgery.

Now, Dr. Mark Glasser provides us with the “how and what” considerations of in-office gynecologic surgery, focusing on hysteroscopy, global endometrial ablation, and the Essure tubal occlusion procedure.

Not only does Dr. Glasser make recommendations on instrumentation, he also discusses the surgical technique of hysteroscopy and the anesthesia concerns that can arise. This article is an excellent primer for those considering in-office hysteroscopy.

From 1992 until 2006, Dr. Glasser was the director of advanced gynecologic laparoscopy training for the Kaiser Northern California Region. He is a past member of the board of trustees of the AAGL and continues to serve on the national advisory committee of the AAGL and the editorial board of the Journal of Minimally Invasive Gynecology.

Nausea and vomiting are common in pregnancy and can have a significant negative effect on women's health. Approximately half of all pregnant women in the United States have nausea and vomiting in early pregnancy, and about 25% have nausea alone. Only about 25% of pregnant women are free of any such problem.

The problem presents across a broad spectrum of severity, with the most severe form being hyperemesis gravidarum, a condition characterized by persistent vomiting, weight loss greater than 5%, ketonuria, electrolyte abnormalities, hypokalemia, and dehydration; this condition usually results in the need for hospitalization, treatment with intravenous fluids, and even intravenous feeding. Approximately 1% of pregnant women have vomiting severe enough to require hospitalization.

Persistent mild nausea, however, can also be a significant problem worthy of attentive management. It is not just “morning sickness” for many of these women. Approximately 35% of women with nausea during pregnancy lose time from work, and 25% cannot function well at home throughout the day.

Nausea and vomiting can significantly impair their routines, can negatively affect their relationships with their husbands and children, and are sometimes cited as reasons for an otherwise undesired pregnancy termination.

Women who are suffering from nausea and vomiting in pregnancy frequently do not seek or receive specific therapy out of concern over safety, yet such fear is often based on misinformation and misperceptions regarding teratogenesis. Women have numerous safe and effective options, including therapy with vitamin B₆ and doxylamine, as well as ginger and other nonpharmacologic approaches, and treatment with various antiemetic drugs.

Etiology, Differential Diagnosis

Some patients can identify the triggers of their nausea and thus can avoid aggravating odors or foods. Dietary modifications include eating frequent and small meals; taking fluids between meals; eating primarily bland, dry, and high-protein foods; and avoiding fatty or spicy foods.

Discontinuing prenatal vitamin tablets containing iron also can help, as the iron can contribute to nausea. Women who are having trouble can switch to a multivitamin with no or low iron for the first trimester and can resume prenatal vitamins after 3 months, or they can switch to folic acid alone, which is all that is needed to prevent birth defects.

We must also consider other diagnoses that can cause nausea and vomiting in pregnancy, from gastroenteritis, pancreatitis, appendicitis, and other gastrointestinal disorders, to gastrourologic problems such as pyelonephritis and various metabolic disorders.

There are sometimes clues that the nausea and vomiting cannot be attributed to the pregnancy alone: Fever, abdominal pain, and headache, for instance, result from something other than the pregnancy, as do serious changes in liver enzymes, bilirubin, and amylase or lipase.

Nausea and vomiting that begin later in the pregnancy also cannot be attributed to the pregnancy itself. The problem has an early onset, usually starting at the time of the missed menstrual period. It is fully manifested by 10 weeks of gestation, and—although it usually improves as the pregnancy progresses further—the problem may persist until the placenta is delivered.

In any case, a patient who has not had any nausea in the first 3 months of her pregnancy and begins experiencing nausea and headache at 16 weeks of gestation is probably having a migraine headache.

Many believe that nausea and vomiting are related to the presence of human chorionic gonadotropin (HCG), because HCG can stimulate the ovaries to produce estrogen, and estrogen can contribute to nausea. Indeed, the start, peak, and resolution of nausea and vomiting in pregnancy correlate closely with the curve of HCG concentration. Nausea and vomiting are also more common in patients with multiple gestations and hydatidiform moles, obstetric situations in which HCG is high.

Hormonal influences do not explain, however, why some women have problems with nausea and others do not.

Over the years, some have believed that the problem is psychological, but I and many others strongly discount this belief. Any psychological problems these women have are not a cause of their nausea and vomiting, but rather are an effect.

Gastrointestinal dysmotility and Helicobacter pylori infection have been cited as other possible associations. H. pylori seropositivity has been associated with hyperemesis or serious nausea and vomiting, but data are conflicting and investigators have not studied whether the problem resolves after treatment for the infection. Ulcer disease should register as a possibility in any differential diagnosis, particularly if the woman has pain, but whether it is more broadly causative of the nausea and vomiting of pregnancy is uncertain.

There is also some evidence that the nausea and vomiting of pregnancy may be related to vitamin B₆ deficiency, and indeed, a significant number of women respond to vitamin B₆ supplementation. Overall, however, the etiology of nausea and vomiting in pregnancy are unknown.

Vitamin-Based Therapy and Doxylamine

Vitamin B₆ is a good initial therapy for women whose nausea and vomiting cannot be managed with dietary change. It has been more widely tested for safety and efficacy than has any other vitamin-based therapy for the problem, and it is inexpensive and widely available.

In a study from our group conducted many years ago, pregnant patients with nausea and vomiting were randomized to 3 days of vitamin B₆ or a placebo at a dosage of 25 mg three times a day. Half of the patients stopped vomiting, and most patients with severe nausea reported a diminution to mild or moderate nausea. Several years later, another group of investigators used 10 mg of vitamin B₆ three times a day in a larger, randomized, placebo-controlled study. After 5 days of therapy, they also documented a significant decrease in nausea.

A once-a-day, extended-release formulation of vitamin B₆ (PremesisRx) is a good first-line option. It delivers 75 mg of vitamin B₆ over 24 hours—which is easier than taking 25 mg three times a day—and contains some vitamin B12, calcium carbonate, and 1 mg of folic acid. (The level of folic acid makes the formulation a prescription therapy.)

If vitamin B₆ alone is not successful, the antihistamine doxylamine can be added in a combination similar to the formulation that was available in Bendectin from 1956 to 1983. It is estimated that Bendectin was used by more than 30 million women during this time period and, at one point, by approximately 40% of pregnant women.

Although no other agent given in pregnancy has more conclusive safety data with regard to the incidence of birth defects (more than 6,000 patients exposed to the combination have been compared with more than 6,000 controls), Bendectin was removed from the U.S. market in 1983 by the manufacturer because of lawsuits that alleged a teratogenic effect.

The combination has been continually available in Canada as Diclectin (a sustained-release formulation), and interestingly, there are significantly fewer hospitalizations for nausea and vomiting in pregnancy in Canada than in the United States.

A version of the combination can be created by combining vitamin B₆ with the over-the-counter sleep aid Unisom SleepTabs, which contains 25 mg of doxylamine per tablet. The dose of doxylamine in Bendectin was 10 mg, and two tablets were recommended at night, so one full tablet of Unisom can be taken at night, along with a half tablet in the morning and a half-tablet in the afternoon if some nausea persists and, of course, 25 mg of vitamin B₆ at each of these times of the day.

The combination of vitamin B₆ and doxylamine can bring fast and dramatic relief for many patients, leading to significant improvements in the quality of their lives. There is always concern for obstetricians that a mother will claim that a child's birth defect was caused by a drug prescribed during the first trimester, but this is unlikely to happen with the combination of vitamin B₆ and doxylamine because legal precedents already hold that the drug does not cause birth defects.

Interestingly, some studies have suggested that women who have taken multivitamins containing vitamin B₆ before pregnancy have less nausea and vomiting.

Nonpharmacologic Approaches

Ginger ale has been a traditional remedy for nausea in various populations, and among pregnant women with nausea and vomiting, ginger is the alternative therapy with the strongest evidence base. The data on ginger have accumulated to the point at which concerns about its possible adverse effects have largely dissipated, which makes it worthy of consideration as a second-line agent.

Two small, randomized, double-blind trials used 250-mg ground ginger capsules or placebo four times a day, one in 70 outpatients with nausea and vomiting and one in women who were hospitalized with hyperemesis gravidarum. Investigators of both trials reported significantly reduced nausea and reductions in vomiting among the women in the ginger groups (Obstet. Gynecol. 2001;97:577–82; Eur. J. Obstet. Gynecol. Reprod. Biol. 1990;38:19–24).

Among more recent randomized trials was one of approximately 300 women that compared ginger with vitamin B₆. Women who received identical-looking capsules three times a day of 25 mg vitamin B₆ or 350 mg ginger had similar levels of improvement in nausea and vomiting at 1 week, 2 weeks, and 3 weeks.

There were no differences in fetal outcome or congenital anomalies; the only difference was that the women taking ginger reported more heartburn and belching (Obstet. Gynecol. 2004;103:639–45).

In a literature review, a group of Italian investigators identified six double-blind, randomized, controlled trials with a total of 675 participants that met criteria for methodological quality for the evaluation of efficacy. Of these six trials, four demonstrated the superiority of ginger over placebo, and two demonstrated the equivalence of ginger with vitamin B₆.

To review safety, the investigators looked at an observational cohort study involving 187 women as well as at the randomized trials. The studies showed no significant side effects and no adverse effects on pregnancy outcome (Obstet. Gynecol. 2005;105:849).

Acupuncture is another therapy worthy of consideration and one that can be added to the treatment regimen at any time. It has now been studied in two randomized trials in pregnant women who had nausea and vomiting, and although the results do not demonstrate broad efficacy, the findings together suggest that the therapy can be worth a try (Obstet. Gynecol. 2001:97;184–8; J. Pain Symptom Manage. 2000:20;273–9).

Nerve stimulation of the P6 acupuncture point also appears to decrease the nausea and vomiting of pregnancy for some women, whereas acupressure with devices like the Sea-Band or the Bioband appears to be less effective.

Antiemetic Drugs

Ginger and vitamin B₆—alone or in combination with doxylamine—do not work for everyone. In unsuccessful cases, we can move on to try other antihistamines and, if necessary, to consider the four other categories of antiemetic drugs: phenothiazines, prokinetic agents, serotonin (5-HT3) antagonists, and corticosteroids.

With the exception of doxylamine, which is a Food and Drug Administration category A drug, none are FDA approved for use in pregnancy. The drugs are underutilized, however, largely because of misperceptions of teratogenic risk.

In a supplement to the American Journal of Obstetrics and Gynecology on nausea and vomiting in pregnancy, Dr. L.A. Magee and associates reported on an evidence-based review of the safety and effectiveness of available antiemetics. They concluded that many medications, particularly the antihistamines and phenothiazines, are safe and effective for the treatment of varying degrees of nausea and vomiting (Am. J. Obstet. Gynecol. 2002:186;S256–61).

In the same supplement, Dr. Gideon Koren addressed the issue of perceived versus true risk of medications for nausea and vomiting, and presents an algorithm for management that includes a hierarchical use of antiemetic drugs based on the strength of evidence of fetal safety (Am. J. Obstet. Gynecol. 2002:186;S248–52).

Although few studies have compared the antihistamines for nausea and vomiting in pregnancy, sedation seems to be a main difference among the various drugs, with some—such as diphenhydramine (Benadryl)—sedating more than others. In addition to doxylamine and diphenhydramine, we can consider using dimenhydrinate (Dramamine), meclizine (Antivert), hydroxyzine (Vistaril, Atarax), and cetirizine (Zyrtec).

If the antihistamines as a class are not effective, the phenothiazines are a good choice. Promethazine (Phenergan) is widely used for nausea and vomiting in pregnancy, and prochlorperazine (Compazine) and chlorpromazine (Thorazine) are other options.

Possible adverse side effects of the phenothiazines include sedation, hypotension, dry mouth, and extrapyramidal symptoms. Compazine tablets are placed inside the cheek—a formulation that is helpful for women with moderate and severe nausea—and are generally well tolerated, with less drowsiness and sedation than the antihistamines.

The phenothiazine droperidol (Inapsine) was popular for some time, but there were reports of cardiac deaths and, in 2001, the FDA issued a black box warning stating that all patients need a 12-lead ECG before, during, and after administration. This drug has, consequently, fallen out of favor.

Metoclopramide (Reglan) can help some women when other drugs have failed. It is a prokinetic agent, increasing upper gastrointestinal motility and lower esophageal sphincter tone. A review of Medicaid data showed no increased risk of birth defects in 303 newborns in Michigan born to mothers who had ingested this drug.

The serotonin (5-HT3) antagonist ondansetron (Zofran) has been one of the most heavily marketed drugs for postoperative nausea and vomiting, and from the start many women and their obstetricians used the drug as a first-line or near-first-line antiemetic choice for nausea and vomiting in pregnancy, despite its high cost and the relative paucity of information on its use in pregnancy.

Several years of use and studies of several hundred patients have increased the comfort level related to ondansetron use. In general, this drug and the serotonin antagonists dolasetron (Anzemet) and granisetron (Kytril) are now felt to be safe. All are FDA category B drugs.

Zofran comes in an oral disintegrating tablet that, like Compazine, is useful in patients who have difficulty swallowing or who do not feel they are able to drink. In a randomized trial, Zofran was compared with Phenergan and was found to have similar efficacy, but with less sedation.

Corticosteroids may not be as beneficial as many first thought—there are now conflicting data about their effectiveness—and some studies have suggested an increased risk of cleft lip and palate when these agents are used before 10 weeks' gestation. The drugs are recommended, therefore, only after 10 weeks' gestation and in cases in which other medications have failed.

Neither I nor any member of my family has any financial connections with the pharmaceutical industry.

A Fairly Common Condition

Nausea and vomiting in pregnancy are fairly common conditions. By themselves, they are neither life threatening nor threatening to the pregnancy, but they are nevertheless terribly uncomfortable, displeasing, and sometimes disabling.

Nausea and vomiting can often interfere with a patient's ability to perform household or workplace duties and can be destabilizing to a patient's life at a time when there otherwise is joy and happiness. Sometimes, nausea and vomiting can be so severe that they result in hospitalization and intravenous feeding.

For all these reasons, they cannot be overlooked.

Unfortunately, they are also mysterious. Nausea and vomiting in pregnancy are relatively uncommon in the populations of certain continents, such as Africa and Asia, but relatively common among North American women. They occur for varying lengths of time in some North American women and not at all in others. The causation, in short, is unclear and likely complicated. A number of hypotheses have been advanced, but none has been proved.

Despite the uncertainties, the frequency and effects of nausea and vomiting in pregnancy demand our attention. It therefore seems important to present a Master Class on the subject and to review the various treatments that have been tried and are available for patients who struggle with the condition.

Some of these approaches will work for our patients, and some will not. With these options before us, however, we can offer our patients the very best care.

Here to address the issue is Dr. Jennifer R. Niebyl, professor and chair of the department of obstetrics and gynecology at the University of Iowa Hospitals and Clinics, Iowa City.

Dr. Niebyl is an expert in the area of drugs and pregnancy and an expert in maternal-fetal medicine, with a special interest in nausea and vomiting in pregnancy.

Key Points

▸ Vitamin B6 and doxylamine should be first-line therapy for nausea and vomiting in pregnancy.

▸ No antiemetic has been found to have any teratogenic risk.

▸ Some alternative remedies, such as ginger and acupuncture, have been shown to be effective.

Treatments for Nausea/Vomiting

Vitamin B6

PremesisRx

Antihistamines

Doxylamine (Unisom)

Dimenhydrinate (Dramamine)

Diphenhydramine (Benadryl)

Meclizine (Antivert)

Hydroxyzine (Vistaril, Atarax)

Cetirizine (Zyrtec)

Phenothiazines

Promethazine (Phenergan)

Prochlorperazine (Compazine)

Chlorpromazine (Thorazine)

Prokinetic Agent

Metoclopramide (Reglan)

5-HT3 Receptor Antagonists

Ondansetron (Zofran)

Dolasetron (Anzemet)

Granisetron (Kytril)

Corticosteroids

Acupuncture

Ginger

Nausea and vomiting are common in pregnancy and can have a significant negative effect on women's health. Approximately half of all pregnant women in the United States have nausea and vomiting in early pregnancy, and about 25% have nausea alone. Only about 25% of pregnant women are free of any such problem.

The problem presents across a broad spectrum of severity, with the most severe form being hyperemesis gravidarum, a condition characterized by persistent vomiting, weight loss greater than 5%, ketonuria, electrolyte abnormalities, hypokalemia, and dehydration; this condition usually results in the need for hospitalization, treatment with intravenous fluids, and even intravenous feeding. Approximately 1% of pregnant women have vomiting severe enough to require hospitalization.

Persistent mild nausea, however, can also be a significant problem worthy of attentive management. It is not just “morning sickness” for many of these women. Approximately 35% of women with nausea during pregnancy lose time from work, and 25% cannot function well at home throughout the day.

Nausea and vomiting can significantly impair their routines, can negatively affect their relationships with their husbands and children, and are sometimes cited as reasons for an otherwise undesired pregnancy termination.

Women who are suffering from nausea and vomiting in pregnancy frequently do not seek or receive specific therapy out of concern over safety, yet such fear is often based on misinformation and misperceptions regarding teratogenesis. Women have numerous safe and effective options, including therapy with vitamin B₆ and doxylamine, as well as ginger and other nonpharmacologic approaches, and treatment with various antiemetic drugs.

Etiology, Differential Diagnosis

Some patients can identify the triggers of their nausea and thus can avoid aggravating odors or foods. Dietary modifications include eating frequent and small meals; taking fluids between meals; eating primarily bland, dry, and high-protein foods; and avoiding fatty or spicy foods.

Discontinuing prenatal vitamin tablets containing iron also can help, as the iron can contribute to nausea. Women who are having trouble can switch to a multivitamin with no or low iron for the first trimester and can resume prenatal vitamins after 3 months, or they can switch to folic acid alone, which is all that is needed to prevent birth defects.

We must also consider other diagnoses that can cause nausea and vomiting in pregnancy, from gastroenteritis, pancreatitis, appendicitis, and other gastrointestinal disorders, to gastrourologic problems such as pyelonephritis and various metabolic disorders.

There are sometimes clues that the nausea and vomiting cannot be attributed to the pregnancy alone: Fever, abdominal pain, and headache, for instance, result from something other than the pregnancy, as do serious changes in liver enzymes, bilirubin, and amylase or lipase.

Nausea and vomiting that begin later in the pregnancy also cannot be attributed to the pregnancy itself. The problem has an early onset, usually starting at the time of the missed menstrual period. It is fully manifested by 10 weeks of gestation, and—although it usually improves as the pregnancy progresses further—the problem may persist until the placenta is delivered.

In any case, a patient who has not had any nausea in the first 3 months of her pregnancy and begins experiencing nausea and headache at 16 weeks of gestation is probably having a migraine headache.

Many believe that nausea and vomiting are related to the presence of human chorionic gonadotropin (HCG), because HCG can stimulate the ovaries to produce estrogen, and estrogen can contribute to nausea. Indeed, the start, peak, and resolution of nausea and vomiting in pregnancy correlate closely with the curve of HCG concentration. Nausea and vomiting are also more common in patients with multiple gestations and hydatidiform moles, obstetric situations in which HCG is high.

Hormonal influences do not explain, however, why some women have problems with nausea and others do not.

Over the years, some have believed that the problem is psychological, but I and many others strongly discount this belief. Any psychological problems these women have are not a cause of their nausea and vomiting, but rather are an effect.

Gastrointestinal dysmotility and Helicobacter pylori infection have been cited as other possible associations. H. pylori seropositivity has been associated with hyperemesis or serious nausea and vomiting, but data are conflicting and investigators have not studied whether the problem resolves after treatment for the infection. Ulcer disease should register as a possibility in any differential diagnosis, particularly if the woman has pain, but whether it is more broadly causative of the nausea and vomiting of pregnancy is uncertain.

There is also some evidence that the nausea and vomiting of pregnancy may be related to vitamin B₆ deficiency, and indeed, a significant number of women respond to vitamin B₆ supplementation. Overall, however, the etiology of nausea and vomiting in pregnancy are unknown.

Vitamin-Based Therapy and Doxylamine

Vitamin B₆ is a good initial therapy for women whose nausea and vomiting cannot be managed with dietary change. It has been more widely tested for safety and efficacy than has any other vitamin-based therapy for the problem, and it is inexpensive and widely available.

In a study from our group conducted many years ago, pregnant patients with nausea and vomiting were randomized to 3 days of vitamin B₆ or a placebo at a dosage of 25 mg three times a day. Half of the patients stopped vomiting, and most patients with severe nausea reported a diminution to mild or moderate nausea. Several years later, another group of investigators used 10 mg of vitamin B₆ three times a day in a larger, randomized, placebo-controlled study. After 5 days of therapy, they also documented a significant decrease in nausea.

A once-a-day, extended-release formulation of vitamin B₆ (PremesisRx) is a good first-line option. It delivers 75 mg of vitamin B₆ over 24 hours—which is easier than taking 25 mg three times a day—and contains some vitamin B12, calcium carbonate, and 1 mg of folic acid. (The level of folic acid makes the formulation a prescription therapy.)

If vitamin B₆ alone is not successful, the antihistamine doxylamine can be added in a combination similar to the formulation that was available in Bendectin from 1956 to 1983. It is estimated that Bendectin was used by more than 30 million women during this time period and, at one point, by approximately 40% of pregnant women.

Although no other agent given in pregnancy has more conclusive safety data with regard to the incidence of birth defects (more than 6,000 patients exposed to the combination have been compared with more than 6,000 controls), Bendectin was removed from the U.S. market in 1983 by the manufacturer because of lawsuits that alleged a teratogenic effect.

The combination has been continually available in Canada as Diclectin (a sustained-release formulation), and interestingly, there are significantly fewer hospitalizations for nausea and vomiting in pregnancy in Canada than in the United States.

A version of the combination can be created by combining vitamin B₆ with the over-the-counter sleep aid Unisom SleepTabs, which contains 25 mg of doxylamine per tablet. The dose of doxylamine in Bendectin was 10 mg, and two tablets were recommended at night, so one full tablet of Unisom can be taken at night, along with a half tablet in the morning and a half-tablet in the afternoon if some nausea persists and, of course, 25 mg of vitamin B₆ at each of these times of the day.

The combination of vitamin B₆ and doxylamine can bring fast and dramatic relief for many patients, leading to significant improvements in the quality of their lives. There is always concern for obstetricians that a mother will claim that a child's birth defect was caused by a drug prescribed during the first trimester, but this is unlikely to happen with the combination of vitamin B₆ and doxylamine because legal precedents already hold that the drug does not cause birth defects.

Interestingly, some studies have suggested that women who have taken multivitamins containing vitamin B₆ before pregnancy have less nausea and vomiting.

Nonpharmacologic Approaches

Ginger ale has been a traditional remedy for nausea in various populations, and among pregnant women with nausea and vomiting, ginger is the alternative therapy with the strongest evidence base. The data on ginger have accumulated to the point at which concerns about its possible adverse effects have largely dissipated, which makes it worthy of consideration as a second-line agent.

Two small, randomized, double-blind trials used 250-mg ground ginger capsules or placebo four times a day, one in 70 outpatients with nausea and vomiting and one in women who were hospitalized with hyperemesis gravidarum. Investigators of both trials reported significantly reduced nausea and reductions in vomiting among the women in the ginger groups (Obstet. Gynecol. 2001;97:577–82; Eur. J. Obstet. Gynecol. Reprod. Biol. 1990;38:19–24).

Among more recent randomized trials was one of approximately 300 women that compared ginger with vitamin B₆. Women who received identical-looking capsules three times a day of 25 mg vitamin B₆ or 350 mg ginger had similar levels of improvement in nausea and vomiting at 1 week, 2 weeks, and 3 weeks.

There were no differences in fetal outcome or congenital anomalies; the only difference was that the women taking ginger reported more heartburn and belching (Obstet. Gynecol. 2004;103:639–45).

In a literature review, a group of Italian investigators identified six double-blind, randomized, controlled trials with a total of 675 participants that met criteria for methodological quality for the evaluation of efficacy. Of these six trials, four demonstrated the superiority of ginger over placebo, and two demonstrated the equivalence of ginger with vitamin B₆.

To review safety, the investigators looked at an observational cohort study involving 187 women as well as at the randomized trials. The studies showed no significant side effects and no adverse effects on pregnancy outcome (Obstet. Gynecol. 2005;105:849).

Acupuncture is another therapy worthy of consideration and one that can be added to the treatment regimen at any time. It has now been studied in two randomized trials in pregnant women who had nausea and vomiting, and although the results do not demonstrate broad efficacy, the findings together suggest that the therapy can be worth a try (Obstet. Gynecol. 2001:97;184–8; J. Pain Symptom Manage. 2000:20;273–9).

Nerve stimulation of the P6 acupuncture point also appears to decrease the nausea and vomiting of pregnancy for some women, whereas acupressure with devices like the Sea-Band or the Bioband appears to be less effective.

Antiemetic Drugs

Ginger and vitamin B₆—alone or in combination with doxylamine—do not work for everyone. In unsuccessful cases, we can move on to try other antihistamines and, if necessary, to consider the four other categories of antiemetic drugs: phenothiazines, prokinetic agents, serotonin (5-HT3) antagonists, and corticosteroids.

With the exception of doxylamine, which is a Food and Drug Administration category A drug, none are FDA approved for use in pregnancy. The drugs are underutilized, however, largely because of misperceptions of teratogenic risk.

In a supplement to the American Journal of Obstetrics and Gynecology on nausea and vomiting in pregnancy, Dr. L.A. Magee and associates reported on an evidence-based review of the safety and effectiveness of available antiemetics. They concluded that many medications, particularly the antihistamines and phenothiazines, are safe and effective for the treatment of varying degrees of nausea and vomiting (Am. J. Obstet. Gynecol. 2002:186;S256–61).

In the same supplement, Dr. Gideon Koren addressed the issue of perceived versus true risk of medications for nausea and vomiting, and presents an algorithm for management that includes a hierarchical use of antiemetic drugs based on the strength of evidence of fetal safety (Am. J. Obstet. Gynecol. 2002:186;S248–52).

Although few studies have compared the antihistamines for nausea and vomiting in pregnancy, sedation seems to be a main difference among the various drugs, with some—such as diphenhydramine (Benadryl)—sedating more than others. In addition to doxylamine and diphenhydramine, we can consider using dimenhydrinate (Dramamine), meclizine (Antivert), hydroxyzine (Vistaril, Atarax), and cetirizine (Zyrtec).

If the antihistamines as a class are not effective, the phenothiazines are a good choice. Promethazine (Phenergan) is widely used for nausea and vomiting in pregnancy, and prochlorperazine (Compazine) and chlorpromazine (Thorazine) are other options.

Possible adverse side effects of the phenothiazines include sedation, hypotension, dry mouth, and extrapyramidal symptoms. Compazine tablets are placed inside the cheek—a formulation that is helpful for women with moderate and severe nausea—and are generally well tolerated, with less drowsiness and sedation than the antihistamines.

The phenothiazine droperidol (Inapsine) was popular for some time, but there were reports of cardiac deaths and, in 2001, the FDA issued a black box warning stating that all patients need a 12-lead ECG before, during, and after administration. This drug has, consequently, fallen out of favor.

Metoclopramide (Reglan) can help some women when other drugs have failed. It is a prokinetic agent, increasing upper gastrointestinal motility and lower esophageal sphincter tone. A review of Medicaid data showed no increased risk of birth defects in 303 newborns in Michigan born to mothers who had ingested this drug.

The serotonin (5-HT3) antagonist ondansetron (Zofran) has been one of the most heavily marketed drugs for postoperative nausea and vomiting, and from the start many women and their obstetricians used the drug as a first-line or near-first-line antiemetic choice for nausea and vomiting in pregnancy, despite its high cost and the relative paucity of information on its use in pregnancy.

Several years of use and studies of several hundred patients have increased the comfort level related to ondansetron use. In general, this drug and the serotonin antagonists dolasetron (Anzemet) and granisetron (Kytril) are now felt to be safe. All are FDA category B drugs.

Zofran comes in an oral disintegrating tablet that, like Compazine, is useful in patients who have difficulty swallowing or who do not feel they are able to drink. In a randomized trial, Zofran was compared with Phenergan and was found to have similar efficacy, but with less sedation.

Corticosteroids may not be as beneficial as many first thought—there are now conflicting data about their effectiveness—and some studies have suggested an increased risk of cleft lip and palate when these agents are used before 10 weeks' gestation. The drugs are recommended, therefore, only after 10 weeks' gestation and in cases in which other medications have failed.

Neither I nor any member of my family has any financial connections with the pharmaceutical industry.

A Fairly Common Condition

Nausea and vomiting in pregnancy are fairly common conditions. By themselves, they are neither life threatening nor threatening to the pregnancy, but they are nevertheless terribly uncomfortable, displeasing, and sometimes disabling.

Nausea and vomiting can often interfere with a patient's ability to perform household or workplace duties and can be destabilizing to a patient's life at a time when there otherwise is joy and happiness. Sometimes, nausea and vomiting can be so severe that they result in hospitalization and intravenous feeding.

For all these reasons, they cannot be overlooked.

Unfortunately, they are also mysterious. Nausea and vomiting in pregnancy are relatively uncommon in the populations of certain continents, such as Africa and Asia, but relatively common among North American women. They occur for varying lengths of time in some North American women and not at all in others. The causation, in short, is unclear and likely complicated. A number of hypotheses have been advanced, but none has been proved.

Despite the uncertainties, the frequency and effects of nausea and vomiting in pregnancy demand our attention. It therefore seems important to present a Master Class on the subject and to review the various treatments that have been tried and are available for patients who struggle with the condition.

Some of these approaches will work for our patients, and some will not. With these options before us, however, we can offer our patients the very best care.

Here to address the issue is Dr. Jennifer R. Niebyl, professor and chair of the department of obstetrics and gynecology at the University of Iowa Hospitals and Clinics, Iowa City.

Dr. Niebyl is an expert in the area of drugs and pregnancy and an expert in maternal-fetal medicine, with a special interest in nausea and vomiting in pregnancy.

Key Points

▸ Vitamin B6 and doxylamine should be first-line therapy for nausea and vomiting in pregnancy.

▸ No antiemetic has been found to have any teratogenic risk.

▸ Some alternative remedies, such as ginger and acupuncture, have been shown to be effective.

Treatments for Nausea/Vomiting

Vitamin B6

PremesisRx

Antihistamines

Doxylamine (Unisom)

Dimenhydrinate (Dramamine)

Diphenhydramine (Benadryl)

Meclizine (Antivert)

Hydroxyzine (Vistaril, Atarax)

Cetirizine (Zyrtec)

Phenothiazines

Promethazine (Phenergan)

Prochlorperazine (Compazine)

Chlorpromazine (Thorazine)

Prokinetic Agent

Metoclopramide (Reglan)

5-HT3 Receptor Antagonists

Ondansetron (Zofran)

Dolasetron (Anzemet)

Granisetron (Kytril)

Corticosteroids

Acupuncture

Ginger

Nausea and vomiting are common in pregnancy and can have a significant negative effect on women's health. Approximately half of all pregnant women in the United States have nausea and vomiting in early pregnancy, and about 25% have nausea alone. Only about 25% of pregnant women are free of any such problem.

The problem presents across a broad spectrum of severity, with the most severe form being hyperemesis gravidarum, a condition characterized by persistent vomiting, weight loss greater than 5%, ketonuria, electrolyte abnormalities, hypokalemia, and dehydration; this condition usually results in the need for hospitalization, treatment with intravenous fluids, and even intravenous feeding. Approximately 1% of pregnant women have vomiting severe enough to require hospitalization.

Persistent mild nausea, however, can also be a significant problem worthy of attentive management. It is not just “morning sickness” for many of these women. Approximately 35% of women with nausea during pregnancy lose time from work, and 25% cannot function well at home throughout the day.

Nausea and vomiting can significantly impair their routines, can negatively affect their relationships with their husbands and children, and are sometimes cited as reasons for an otherwise undesired pregnancy termination.

Women who are suffering from nausea and vomiting in pregnancy frequently do not seek or receive specific therapy out of concern over safety, yet such fear is often based on misinformation and misperceptions regarding teratogenesis. Women have numerous safe and effective options, including therapy with vitamin B₆ and doxylamine, as well as ginger and other nonpharmacologic approaches, and treatment with various antiemetic drugs.

Etiology, Differential Diagnosis

Some patients can identify the triggers of their nausea and thus can avoid aggravating odors or foods. Dietary modifications include eating frequent and small meals; taking fluids between meals; eating primarily bland, dry, and high-protein foods; and avoiding fatty or spicy foods.

Discontinuing prenatal vitamin tablets containing iron also can help, as the iron can contribute to nausea. Women who are having trouble can switch to a multivitamin with no or low iron for the first trimester and can resume prenatal vitamins after 3 months, or they can switch to folic acid alone, which is all that is needed to prevent birth defects.

We must also consider other diagnoses that can cause nausea and vomiting in pregnancy, from gastroenteritis, pancreatitis, appendicitis, and other gastrointestinal disorders, to gastrourologic problems such as pyelonephritis and various metabolic disorders.

There are sometimes clues that the nausea and vomiting cannot be attributed to the pregnancy alone: Fever, abdominal pain, and headache, for instance, result from something other than the pregnancy, as do serious changes in liver enzymes, bilirubin, and amylase or lipase.

Nausea and vomiting that begin later in the pregnancy also cannot be attributed to the pregnancy itself. The problem has an early onset, usually starting at the time of the missed menstrual period. It is fully manifested by 10 weeks of gestation, and—although it usually improves as the pregnancy progresses further—the problem may persist until the placenta is delivered.

In any case, a patient who has not had any nausea in the first 3 months of her pregnancy and begins experiencing nausea and headache at 16 weeks of gestation is probably having a migraine headache.

Many believe that nausea and vomiting are related to the presence of human chorionic gonadotropin (HCG), because HCG can stimulate the ovaries to produce estrogen, and estrogen can contribute to nausea. Indeed, the start, peak, and resolution of nausea and vomiting in pregnancy correlate closely with the curve of HCG concentration. Nausea and vomiting are also more common in patients with multiple gestations and hydatidiform moles, obstetric situations in which HCG is high.

Hormonal influences do not explain, however, why some women have problems with nausea and others do not.

Over the years, some have believed that the problem is psychological, but I and many others strongly discount this belief. Any psychological problems these women have are not a cause of their nausea and vomiting, but rather are an effect.

Gastrointestinal dysmotility and Helicobacter pylori infection have been cited as other possible associations. H. pylori seropositivity has been associated with hyperemesis or serious nausea and vomiting, but data are conflicting and investigators have not studied whether the problem resolves after treatment for the infection. Ulcer disease should register as a possibility in any differential diagnosis, particularly if the woman has pain, but whether it is more broadly causative of the nausea and vomiting of pregnancy is uncertain.

There is also some evidence that the nausea and vomiting of pregnancy may be related to vitamin B₆ deficiency, and indeed, a significant number of women respond to vitamin B₆ supplementation. Overall, however, the etiology of nausea and vomiting in pregnancy are unknown.

Vitamin-Based Therapy and Doxylamine

Vitamin B₆ is a good initial therapy for women whose nausea and vomiting cannot be managed with dietary change. It has been more widely tested for safety and efficacy than has any other vitamin-based therapy for the problem, and it is inexpensive and widely available.

In a study from our group conducted many years ago, pregnant patients with nausea and vomiting were randomized to 3 days of vitamin B₆ or a placebo at a dosage of 25 mg three times a day. Half of the patients stopped vomiting, and most patients with severe nausea reported a diminution to mild or moderate nausea. Several years later, another group of investigators used 10 mg of vitamin B₆ three times a day in a larger, randomized, placebo-controlled study. After 5 days of therapy, they also documented a significant decrease in nausea.

A once-a-day, extended-release formulation of vitamin B₆ (PremesisRx) is a good first-line option. It delivers 75 mg of vitamin B₆ over 24 hours—which is easier than taking 25 mg three times a day—and contains some vitamin B12, calcium carbonate, and 1 mg of folic acid. (The level of folic acid makes the formulation a prescription therapy.)

If vitamin B₆ alone is not successful, the antihistamine doxylamine can be added in a combination similar to the formulation that was available in Bendectin from 1956 to 1983. It is estimated that Bendectin was used by more than 30 million women during this time period and, at one point, by approximately 40% of pregnant women.

Although no other agent given in pregnancy has more conclusive safety data with regard to the incidence of birth defects (more than 6,000 patients exposed to the combination have been compared with more than 6,000 controls), Bendectin was removed from the U.S. market in 1983 by the manufacturer because of lawsuits that alleged a teratogenic effect.

The combination has been continually available in Canada as Diclectin (a sustained-release formulation), and interestingly, there are significantly fewer hospitalizations for nausea and vomiting in pregnancy in Canada than in the United States.

A version of the combination can be created by combining vitamin B₆ with the over-the-counter sleep aid Unisom SleepTabs, which contains 25 mg of doxylamine per tablet. The dose of doxylamine in Bendectin was 10 mg, and two tablets were recommended at night, so one full tablet of Unisom can be taken at night, along with a half tablet in the morning and a half-tablet in the afternoon if some nausea persists and, of course, 25 mg of vitamin B₆ at each of these times of the day.

The combination of vitamin B₆ and doxylamine can bring fast and dramatic relief for many patients, leading to significant improvements in the quality of their lives. There is always concern for obstetricians that a mother will claim that a child's birth defect was caused by a drug prescribed during the first trimester, but this is unlikely to happen with the combination of vitamin B₆ and doxylamine because legal precedents already hold that the drug does not cause birth defects.

Interestingly, some studies have suggested that women who have taken multivitamins containing vitamin B₆ before pregnancy have less nausea and vomiting.

Nonpharmacologic Approaches

Ginger ale has been a traditional remedy for nausea in various populations, and among pregnant women with nausea and vomiting, ginger is the alternative therapy with the strongest evidence base. The data on ginger have accumulated to the point at which concerns about its possible adverse effects have largely dissipated, which makes it worthy of consideration as a second-line agent.

Two small, randomized, double-blind trials used 250-mg ground ginger capsules or placebo four times a day, one in 70 outpatients with nausea and vomiting and one in women who were hospitalized with hyperemesis gravidarum. Investigators of both trials reported significantly reduced nausea and reductions in vomiting among the women in the ginger groups (Obstet. Gynecol. 2001;97:577–82; Eur. J. Obstet. Gynecol. Reprod. Biol. 1990;38:19–24).

Among more recent randomized trials was one of approximately 300 women that compared ginger with vitamin B₆. Women who received identical-looking capsules three times a day of 25 mg vitamin B₆ or 350 mg ginger had similar levels of improvement in nausea and vomiting at 1 week, 2 weeks, and 3 weeks.

There were no differences in fetal outcome or congenital anomalies; the only difference was that the women taking ginger reported more heartburn and belching (Obstet. Gynecol. 2004;103:639–45).

In a literature review, a group of Italian investigators identified six double-blind, randomized, controlled trials with a total of 675 participants that met criteria for methodological quality for the evaluation of efficacy. Of these six trials, four demonstrated the superiority of ginger over placebo, and two demonstrated the equivalence of ginger with vitamin B₆.

To review safety, the investigators looked at an observational cohort study involving 187 women as well as at the randomized trials. The studies showed no significant side effects and no adverse effects on pregnancy outcome (Obstet. Gynecol. 2005;105:849).

Acupuncture is another therapy worthy of consideration and one that can be added to the treatment regimen at any time. It has now been studied in two randomized trials in pregnant women who had nausea and vomiting, and although the results do not demonstrate broad efficacy, the findings together suggest that the therapy can be worth a try (Obstet. Gynecol. 2001:97;184–8; J. Pain Symptom Manage. 2000:20;273–9).

Nerve stimulation of the P6 acupuncture point also appears to decrease the nausea and vomiting of pregnancy for some women, whereas acupressure with devices like the Sea-Band or the Bioband appears to be less effective.

Antiemetic Drugs

Ginger and vitamin B₆—alone or in combination with doxylamine—do not work for everyone. In unsuccessful cases, we can move on to try other antihistamines and, if necessary, to consider the four other categories of antiemetic drugs: phenothiazines, prokinetic agents, serotonin (5-HT3) antagonists, and corticosteroids.

With the exception of doxylamine, which is a Food and Drug Administration category A drug, none are FDA approved for use in pregnancy. The drugs are underutilized, however, largely because of misperceptions of teratogenic risk.

In a supplement to the American Journal of Obstetrics and Gynecology on nausea and vomiting in pregnancy, Dr. L.A. Magee and associates reported on an evidence-based review of the safety and effectiveness of available antiemetics. They concluded that many medications, particularly the antihistamines and phenothiazines, are safe and effective for the treatment of varying degrees of nausea and vomiting (Am. J. Obstet. Gynecol. 2002:186;S256–61).

In the same supplement, Dr. Gideon Koren addressed the issue of perceived versus true risk of medications for nausea and vomiting, and presents an algorithm for management that includes a hierarchical use of antiemetic drugs based on the strength of evidence of fetal safety (Am. J. Obstet. Gynecol. 2002:186;S248–52).

Although few studies have compared the antihistamines for nausea and vomiting in pregnancy, sedation seems to be a main difference among the various drugs, with some—such as diphenhydramine (Benadryl)—sedating more than others. In addition to doxylamine and diphenhydramine, we can consider using dimenhydrinate (Dramamine), meclizine (Antivert), hydroxyzine (Vistaril, Atarax), and cetirizine (Zyrtec).

If the antihistamines as a class are not effective, the phenothiazines are a good choice. Promethazine (Phenergan) is widely used for nausea and vomiting in pregnancy, and prochlorperazine (Compazine) and chlorpromazine (Thorazine) are other options.

Possible adverse side effects of the phenothiazines include sedation, hypotension, dry mouth, and extrapyramidal symptoms. Compazine tablets are placed inside the cheek—a formulation that is helpful for women with moderate and severe nausea—and are generally well tolerated, with less drowsiness and sedation than the antihistamines.

The phenothiazine droperidol (Inapsine) was popular for some time, but there were reports of cardiac deaths and, in 2001, the FDA issued a black box warning stating that all patients need a 12-lead ECG before, during, and after administration. This drug has, consequently, fallen out of favor.

Metoclopramide (Reglan) can help some women when other drugs have failed. It is a prokinetic agent, increasing upper gastrointestinal motility and lower esophageal sphincter tone. A review of Medicaid data showed no increased risk of birth defects in 303 newborns in Michigan born to mothers who had ingested this drug.

The serotonin (5-HT3) antagonist ondansetron (Zofran) has been one of the most heavily marketed drugs for postoperative nausea and vomiting, and from the start many women and their obstetricians used the drug as a first-line or near-first-line antiemetic choice for nausea and vomiting in pregnancy, despite its high cost and the relative paucity of information on its use in pregnancy.

Several years of use and studies of several hundred patients have increased the comfort level related to ondansetron use. In general, this drug and the serotonin antagonists dolasetron (Anzemet) and granisetron (Kytril) are now felt to be safe. All are FDA category B drugs.

Zofran comes in an oral disintegrating tablet that, like Compazine, is useful in patients who have difficulty swallowing or who do not feel they are able to drink. In a randomized trial, Zofran was compared with Phenergan and was found to have similar efficacy, but with less sedation.

Corticosteroids may not be as beneficial as many first thought—there are now conflicting data about their effectiveness—and some studies have suggested an increased risk of cleft lip and palate when these agents are used before 10 weeks' gestation. The drugs are recommended, therefore, only after 10 weeks' gestation and in cases in which other medications have failed.

Neither I nor any member of my family has any financial connections with the pharmaceutical industry.

A Fairly Common Condition

Nausea and vomiting in pregnancy are fairly common conditions. By themselves, they are neither life threatening nor threatening to the pregnancy, but they are nevertheless terribly uncomfortable, displeasing, and sometimes disabling.

Nausea and vomiting can often interfere with a patient's ability to perform household or workplace duties and can be destabilizing to a patient's life at a time when there otherwise is joy and happiness. Sometimes, nausea and vomiting can be so severe that they result in hospitalization and intravenous feeding.

For all these reasons, they cannot be overlooked.

Unfortunately, they are also mysterious. Nausea and vomiting in pregnancy are relatively uncommon in the populations of certain continents, such as Africa and Asia, but relatively common among North American women. They occur for varying lengths of time in some North American women and not at all in others. The causation, in short, is unclear and likely complicated. A number of hypotheses have been advanced, but none has been proved.

Despite the uncertainties, the frequency and effects of nausea and vomiting in pregnancy demand our attention. It therefore seems important to present a Master Class on the subject and to review the various treatments that have been tried and are available for patients who struggle with the condition.

Some of these approaches will work for our patients, and some will not. With these options before us, however, we can offer our patients the very best care.

Here to address the issue is Dr. Jennifer R. Niebyl, professor and chair of the department of obstetrics and gynecology at the University of Iowa Hospitals and Clinics, Iowa City.

Dr. Niebyl is an expert in the area of drugs and pregnancy and an expert in maternal-fetal medicine, with a special interest in nausea and vomiting in pregnancy.

Key Points

▸ Vitamin B6 and doxylamine should be first-line therapy for nausea and vomiting in pregnancy.

▸ No antiemetic has been found to have any teratogenic risk.

▸ Some alternative remedies, such as ginger and acupuncture, have been shown to be effective.

Treatments for Nausea/Vomiting

Vitamin B6

PremesisRx

Antihistamines

Doxylamine (Unisom)

Dimenhydrinate (Dramamine)

Diphenhydramine (Benadryl)

Meclizine (Antivert)

Hydroxyzine (Vistaril, Atarax)

Cetirizine (Zyrtec)

Phenothiazines

Promethazine (Phenergan)

Prochlorperazine (Compazine)

Chlorpromazine (Thorazine)

Prokinetic Agent

Metoclopramide (Reglan)

5-HT3 Receptor Antagonists

Ondansetron (Zofran)

Dolasetron (Anzemet)

Granisetron (Kytril)

Corticosteroids

Acupuncture

Ginger

The levels of burnout in our specialty are increasing as too many of us—90% of the 42,000 ob.gyns in the United States—continue to pursue generalist careers.

We attempt to do it all, from primary care to obstetrics to surgery, and are being pulled in too many directions while losing any sense of control in our professional and personal lives.

There are alternatives to the model of being everything to every patient, however, and adopting office-based procedures can be a key component to making changes successfully.

Most of us perform in-office endometrial biopsies, colposcopy with biopsies, LEEP (loop electrosurgical excision procedures), and IUD insertions. Yet it is estimated that fewer than 30% of ob.gyns. do appreciable hysteroscopy in any setting, and fewer than 5%–10% do office hysteroscopy.

Many of us believe that office-based procedures are potentially dangerous and that they are painful and will not be tolerated by patients.

We argue against an increased level of office-based procedures on the premise that the equipment costs too much, the required skill level is too high, we don't see enough patients who are candidates for these procedures, we don't have procedure rooms, or the integration of more procedures into our existing schedules is just too complex or difficult.

Increasingly, these beliefs are countered by contrasting realities: more medical knowledge, more training opportunities, more reasonably priced equipment, and appropriate third-party reimbursement for office-based hysteroscopic procedures.

These realities have made hysteroscopy the base technology for a successful gynecology-focused office-based practice.

With commitment, those ob.gyns. who enjoy doing procedures can build successful office-based practices by offering a full spectrum of diagnostic and minor operative hysteroscopic procedures that are just as safe, tolerable, and effective as they are in the hospital.

In doing so, they can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.

Less Anesthesia, More Accuracy

The most significant misconception among ob.gyns.–and probably the largest barrier to wider use of in-office hysteroscopy—relates to pain.

The perceptions are fueled by the operating room experience, where intravenous sedation causes patients to lose inhibition and the ability to follow directions and control their actions.

Patients perceive touch and other stimuli as pain, and the loss of inhibition often escalates as the anesthesist applies even more IV sedation in an effort to make them more comfortable.

This is often perceived as intolerance for pain, and ob.gyns. leave the operating room thinking that if patients cannot tolerate hysteroscopy in that setting, they will certainly not tolerate it in the office.

In reality, patients can tolerate procedures very well—and with less anesthesia—if they know what to expect and if they're in control of their bodies and the overall situation. This happens more readily in the office environment, which is familiar, less intimidating, and more comfortable for patients.

In addition to the comfort that comes with familiarity, the office environment offers distractions that lessen the perception and feeling of pain, and the small-diameter hysteroscopes that are available to us today are no larger than a Pipelle curette and can usually be guided easily through the cervix without dilation, paracervical blocks, or the use of a tenaculum. A simple diagnostic hysteroscopy takes, on average, 5 minutes or less and is extremely well tolerated. It is less painful than an endometrial biopsy.

Patients are often interested in watching the video monitor during a hysteroscopic procedure. Their understanding and comfort level are greater when they can see the findings—can see in living color, for instance, what polyps, fibroids, or intrauterine adhesions are.

Of equal or more importance, hysteroscopy provides a focused view that has significant and measurable clinical benefits.

Ob.gyns. are more attuned to ultrasound; it's readily available, and the global view of the pelvis, uterus, and adnexa that it provides is often viewed as adequate. Saline infusion sonography has certainly improved diagnostic accuracy.

Hysteroscopy, however, offers a more focused view and gives us the ability to investigate and to do a targeted biopsy under direct vision. It simply provides for greater accuracy and more thorough care. Hysteroscopy should be viewed as complementary to ultrasound rather than as an alternative.

Hysteroscopy is the standard for evaluating abnormal uterine bleeding (AUB), a problem that affects more than 10 million women a year and is the reason for 25% of all gynecologic clinic visits.

Although endometrial biopsy is effective for diagnosing diffuse disease such as hyperplasia and carcinoma, it often misses focal lesions like endometrial polyps and fibroids, which are common causes of AUB.

Hysteroscopy should be considered in all patients who require an endometrial biopsy. It has been shown to have a sensitivity of 100% and a specificity of 95% in evaluating the uterine cavity.

It allows us both to diagnose more accurately and often to “see and treat” at the same time, avoiding the courses of unsuccessful hormonal therapy and multiple visits and procedures that too often result from a reliance on endometrial biopsy and ultrasound alone.

Office cystoscopy is a routine part of urologists' practice. With hysteroscopy, we have the technology and capability as ob.gyns. to similarly diagnose and treat common problems in a cost-effective, readily acceptable way. We must more seriously ask ourselves, why not?

Are our reasons not to embrace hysteroscopy really good enough?

Better Fits for a New Era

Ob.gyns. are often at a loss to explain why they seem to be working harder and harder while not getting anywhere, or while losing control, income, and/or the gratification of strong physician-patient relationships.

In a 2004 survey of approximately 830 District III ob.gyns., 64% reported symptoms of burnout; 16% wanted to quit medicine, and 40% said they planned to retire early. To maintain income or prevent a significant decrease in earnings, many had increased patient volume by 20%–30%.

Part of the challenge we face stems from declining reimbursement and the loss of entrepreneurship that often comes with larger group practices. But we also have an inefficient specialty. Many of us leave our offices for labor and delivery and for long OR cases that are unpredictable, that challenge the flow and efficiency of our office practices and the stability of our family lives, and that bring us reimbursement rates that do not account for waiting and time lost between cases. Often the reimbursement we receive when we are away from the office will not cover the cost of office overhead.

This is something we ought to analyze now. Depending on our professional interests, personal needs, and surgical and labor/delivery volumes, such a mix may be gratifying and completely acceptable, or it may be taxing, inefficient, and a cause of burnout.

An office-based ob.gyn. model of care can give us greater control of our practice, our scheduling, our patient relationships, and our lifestyle. Given the elimination of unproductive time, and the fact that professional fees remain the same regardless of setting and that facility fees go to the physician, we can also increase our reimbursement.

Substantial time and financial savings, moreover, are passed on to patients and payers. There is no wasted time: no separate office visits, for instance, for preoperative histories and physicals. When it comes to procedures, patients can arrive 10-30 minutes beforehand and leave in less than 30 minutes. In many cases a patient will be responsible for the cost of an office visit copay, compared with a large deductible and percentage of hospital costs.

I recently saw an interview with Warren Buffett in which he was asked why he is so successful in choosing investments. How was he able to predict the future? He replied that he could not predict the future, but he could recognize what was becoming obsolete. The era in which the model of care relied on a single ob.gyn. who could provide equally competent general primary care, obstetrical care, and the full spectrum of gynecologic surgery to the patient is rapidly becoming obsolete.

The specialty of ob.gyn. is destined to change. Many of us eventually will need to discover and carve out or fine-tune our roles. Today's generalist model of ob.gyn. will evolve into three components in the future: the office-based ob.gyn., the hospital laborist, and the pelvic surgeon.

Greatest in number will be the office-based ob.gyns. who provide well-woman primary care, office-based obstetrics (prenatal care), and a range of office-based procedures, from hysteroscopy and endometrial ablations to incontinence procedures, ultrasound, IUDs, cystoscopy, LEEP cones, and perhaps some “lifestyle” procedures such as laser hair reduction and varicose vein treatment. Considering the demand for such services, they likely will make up about 70% of the specialty.

The ability to have one office, fewer partners, no hospital responsibilities, and control over one's schedule can provide a career that is interesting and rewarding.

Ob.gyn. laborists will be modeled after internal medicine “hospitalists,” and will handle routine deliveries and inpatient obstetrical management. The laborist will work a certain number of shifts each month and will have enough time to be able to balance his or her personal and professional life.

Pelvic surgeons will perform laparoscopy, operative hysteroscopy, and abdominal, vaginal, and robotic surgery. They will provide women with state-of-the-art surgical care and will not have to balance surgery with primary care.

Skills and Set-Up

Ob.gyns. who are performing endometrial biopsies and inserting IUDs are more than capable of doing diagnostic and minor operative hysteroscopy in the office.

The average ob.gyn., in fact, will be competent with the basic hysteroscopic technique for diagnosis after just two to five cases, and the skills honed by doing office diagnostic hysteroscopy will often lay the foundation for adding operative procedures for which there is growing demand, such as hysteroscopic sterilization and global endometrial ablation.

A 2002 survey of women found that sterilization is the most popular method of contraception (favored by 28%), and that women today rarely favor a tubal ligation. Since it has been on the market, the Essure procedure has had successful placement rates of more than 96%.

Hysteroscopic sterilization and global endometrial ablation are both safe and effective for the general ob.gyn. to perform in the office—and just as capably as the best gynecologic surgeon—if he or she is credentialed in the procedure and first has experience and comfort with the procedure in the hospital setting. As a transition, the office setting can be simulated in the OR, with the office staff brought in to observe and prepare for assisting, for instance, and implementing various pain management strategies. The office staff can also learn how to clean and care for the equipment.

Many physicians wonder what will happen if they are unable to complete a procedure in the office. Attempts will inevitably sometimes fail because of access problems, patient intolerance, equipment failure, or a complication. But with experience and proper patient selection, this will rarely happen. And if it does—if you're having some difficulty with the ablation set-up, for instance—keep in mind that it is only an office visit, and that the patient can be rescheduled for the operating room.

It is not necessary to remodel your office or have a “procedure room.” A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Increasingly, equipment is reasonably priced and companies are able to work with ob.gyns. on favorable leasing arrangements. This has taken away the hurdle of price; in fact, one hysteroscopy procedure a week will pay for the equipment.

The reimbursement issues are also favorable. Office hysteroscopy with biopsy is reimbursed at the same rate in the office as in the OR, and in 2005 global codes were approved for hysteroscopic sterilization and endometrial ablation—another development that makes the investment in hysteroscopy equipment a financially sound decision.

Preparing for office-based procedures takes initiative: Anesthesia guidelines and requirements for facility maintenance must be learned, for instance, and a policy and procedures manual that includes protocols for managing complications must be developed.

There is an unappreciated amount of training support, however—both for technical procedural training and for the range of logistical issues—to be had from experienced colleagues, professional societies, and industry. Ob.gyns. who enjoy procedures are better positioned than ever before to take advantage of it.

Diagnostic hysteroscopy with a small hysteroscope is less painful than an endometrial biopsy. Such a hysteroscope is smaller than an IUD (left).

A typical diagnostic hysteroscopy tray for in-office procedures includes a small hysteroscope and sheath, an os finder, and a single-tooth tenaculum. Photos courtesy Dr. James B. Presthus

It is not necessary to remodel your office. A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Courtesy Dr. James B. Presthus

In-Office Surgery Can Boost Practice

Given the constant threat of falling reimbursement, ob.gyns. throughout the country are exercising options on how to maintain a successful practice. For some, introducing new treatments has proved successful. We are all well aware of gynecologists who get involved in various aesthetic techniques and plastic procedures. However, for others, this option represents a marked departure from their practice profile.

It would appear that the introduction of in-office gynecologic surgery will offer many ob.gyns. the opportunity to add value to their practice, yet stay within the limits of the procedures they were trained to perform while in residency—that is, within an ob.gyn.'s “comfort zone.”

A second advantage of in-office gynecologic surgery is that it allows the physician to maintain efficiency.

Let's face it: Operating rooms are fraught with delays. Performing surgery within the confines of the office allows the gynecologist to be free of the yoke of OR tardiness.

Finally, procedures may actually be compensated better in the office than in the operating room, whether that OR is in an outpatient surgery center or in a hospital. Examples are hysteroscopic tubal occlusion or endometrial ablation.

I have invited Dr. James B. Presthus, who is currently practicing gynecology at Minnesota Gynecology and Surgery in Edina, Minn., to lead this discussion on office-based surgery. Dr. Presthus is an active member of the American Association of Gynecologic Laparoscopists, the American Urogynecology Association, the International Pelvic Pain Society, and many other professional organizations. He is a clinical professor of obstetrics and gynecology at the University of Minnesota, Minneapolis.

The levels of burnout in our specialty are increasing as too many of us—90% of the 42,000 ob.gyns in the United States—continue to pursue generalist careers.

We attempt to do it all, from primary care to obstetrics to surgery, and are being pulled in too many directions while losing any sense of control in our professional and personal lives.

There are alternatives to the model of being everything to every patient, however, and adopting office-based procedures can be a key component to making changes successfully.

Most of us perform in-office endometrial biopsies, colposcopy with biopsies, LEEP (loop electrosurgical excision procedures), and IUD insertions. Yet it is estimated that fewer than 30% of ob.gyns. do appreciable hysteroscopy in any setting, and fewer than 5%–10% do office hysteroscopy.

Many of us believe that office-based procedures are potentially dangerous and that they are painful and will not be tolerated by patients.

We argue against an increased level of office-based procedures on the premise that the equipment costs too much, the required skill level is too high, we don't see enough patients who are candidates for these procedures, we don't have procedure rooms, or the integration of more procedures into our existing schedules is just too complex or difficult.

Increasingly, these beliefs are countered by contrasting realities: more medical knowledge, more training opportunities, more reasonably priced equipment, and appropriate third-party reimbursement for office-based hysteroscopic procedures.

These realities have made hysteroscopy the base technology for a successful gynecology-focused office-based practice.

With commitment, those ob.gyns. who enjoy doing procedures can build successful office-based practices by offering a full spectrum of diagnostic and minor operative hysteroscopic procedures that are just as safe, tolerable, and effective as they are in the hospital.

In doing so, they can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.

Less Anesthesia, More Accuracy

The most significant misconception among ob.gyns.–and probably the largest barrier to wider use of in-office hysteroscopy—relates to pain.

The perceptions are fueled by the operating room experience, where intravenous sedation causes patients to lose inhibition and the ability to follow directions and control their actions.

Patients perceive touch and other stimuli as pain, and the loss of inhibition often escalates as the anesthesist applies even more IV sedation in an effort to make them more comfortable.

This is often perceived as intolerance for pain, and ob.gyns. leave the operating room thinking that if patients cannot tolerate hysteroscopy in that setting, they will certainly not tolerate it in the office.

In reality, patients can tolerate procedures very well—and with less anesthesia—if they know what to expect and if they're in control of their bodies and the overall situation. This happens more readily in the office environment, which is familiar, less intimidating, and more comfortable for patients.

In addition to the comfort that comes with familiarity, the office environment offers distractions that lessen the perception and feeling of pain, and the small-diameter hysteroscopes that are available to us today are no larger than a Pipelle curette and can usually be guided easily through the cervix without dilation, paracervical blocks, or the use of a tenaculum. A simple diagnostic hysteroscopy takes, on average, 5 minutes or less and is extremely well tolerated. It is less painful than an endometrial biopsy.

Patients are often interested in watching the video monitor during a hysteroscopic procedure. Their understanding and comfort level are greater when they can see the findings—can see in living color, for instance, what polyps, fibroids, or intrauterine adhesions are.

Of equal or more importance, hysteroscopy provides a focused view that has significant and measurable clinical benefits.

Ob.gyns. are more attuned to ultrasound; it's readily available, and the global view of the pelvis, uterus, and adnexa that it provides is often viewed as adequate. Saline infusion sonography has certainly improved diagnostic accuracy.

Hysteroscopy, however, offers a more focused view and gives us the ability to investigate and to do a targeted biopsy under direct vision. It simply provides for greater accuracy and more thorough care. Hysteroscopy should be viewed as complementary to ultrasound rather than as an alternative.

Hysteroscopy is the standard for evaluating abnormal uterine bleeding (AUB), a problem that affects more than 10 million women a year and is the reason for 25% of all gynecologic clinic visits.

Although endometrial biopsy is effective for diagnosing diffuse disease such as hyperplasia and carcinoma, it often misses focal lesions like endometrial polyps and fibroids, which are common causes of AUB.

Hysteroscopy should be considered in all patients who require an endometrial biopsy. It has been shown to have a sensitivity of 100% and a specificity of 95% in evaluating the uterine cavity.

It allows us both to diagnose more accurately and often to “see and treat” at the same time, avoiding the courses of unsuccessful hormonal therapy and multiple visits and procedures that too often result from a reliance on endometrial biopsy and ultrasound alone.

Office cystoscopy is a routine part of urologists' practice. With hysteroscopy, we have the technology and capability as ob.gyns. to similarly diagnose and treat common problems in a cost-effective, readily acceptable way. We must more seriously ask ourselves, why not?

Are our reasons not to embrace hysteroscopy really good enough?

Better Fits for a New Era

Ob.gyns. are often at a loss to explain why they seem to be working harder and harder while not getting anywhere, or while losing control, income, and/or the gratification of strong physician-patient relationships.

In a 2004 survey of approximately 830 District III ob.gyns., 64% reported symptoms of burnout; 16% wanted to quit medicine, and 40% said they planned to retire early. To maintain income or prevent a significant decrease in earnings, many had increased patient volume by 20%–30%.

Part of the challenge we face stems from declining reimbursement and the loss of entrepreneurship that often comes with larger group practices. But we also have an inefficient specialty. Many of us leave our offices for labor and delivery and for long OR cases that are unpredictable, that challenge the flow and efficiency of our office practices and the stability of our family lives, and that bring us reimbursement rates that do not account for waiting and time lost between cases. Often the reimbursement we receive when we are away from the office will not cover the cost of office overhead.

This is something we ought to analyze now. Depending on our professional interests, personal needs, and surgical and labor/delivery volumes, such a mix may be gratifying and completely acceptable, or it may be taxing, inefficient, and a cause of burnout.

An office-based ob.gyn. model of care can give us greater control of our practice, our scheduling, our patient relationships, and our lifestyle. Given the elimination of unproductive time, and the fact that professional fees remain the same regardless of setting and that facility fees go to the physician, we can also increase our reimbursement.

Substantial time and financial savings, moreover, are passed on to patients and payers. There is no wasted time: no separate office visits, for instance, for preoperative histories and physicals. When it comes to procedures, patients can arrive 10-30 minutes beforehand and leave in less than 30 minutes. In many cases a patient will be responsible for the cost of an office visit copay, compared with a large deductible and percentage of hospital costs.

I recently saw an interview with Warren Buffett in which he was asked why he is so successful in choosing investments. How was he able to predict the future? He replied that he could not predict the future, but he could recognize what was becoming obsolete. The era in which the model of care relied on a single ob.gyn. who could provide equally competent general primary care, obstetrical care, and the full spectrum of gynecologic surgery to the patient is rapidly becoming obsolete.

The specialty of ob.gyn. is destined to change. Many of us eventually will need to discover and carve out or fine-tune our roles. Today's generalist model of ob.gyn. will evolve into three components in the future: the office-based ob.gyn., the hospital laborist, and the pelvic surgeon.

Greatest in number will be the office-based ob.gyns. who provide well-woman primary care, office-based obstetrics (prenatal care), and a range of office-based procedures, from hysteroscopy and endometrial ablations to incontinence procedures, ultrasound, IUDs, cystoscopy, LEEP cones, and perhaps some “lifestyle” procedures such as laser hair reduction and varicose vein treatment. Considering the demand for such services, they likely will make up about 70% of the specialty.

The ability to have one office, fewer partners, no hospital responsibilities, and control over one's schedule can provide a career that is interesting and rewarding.

Ob.gyn. laborists will be modeled after internal medicine “hospitalists,” and will handle routine deliveries and inpatient obstetrical management. The laborist will work a certain number of shifts each month and will have enough time to be able to balance his or her personal and professional life.

Pelvic surgeons will perform laparoscopy, operative hysteroscopy, and abdominal, vaginal, and robotic surgery. They will provide women with state-of-the-art surgical care and will not have to balance surgery with primary care.

Skills and Set-Up

Ob.gyns. who are performing endometrial biopsies and inserting IUDs are more than capable of doing diagnostic and minor operative hysteroscopy in the office.

The average ob.gyn., in fact, will be competent with the basic hysteroscopic technique for diagnosis after just two to five cases, and the skills honed by doing office diagnostic hysteroscopy will often lay the foundation for adding operative procedures for which there is growing demand, such as hysteroscopic sterilization and global endometrial ablation.

A 2002 survey of women found that sterilization is the most popular method of contraception (favored by 28%), and that women today rarely favor a tubal ligation. Since it has been on the market, the Essure procedure has had successful placement rates of more than 96%.

Hysteroscopic sterilization and global endometrial ablation are both safe and effective for the general ob.gyn. to perform in the office—and just as capably as the best gynecologic surgeon—if he or she is credentialed in the procedure and first has experience and comfort with the procedure in the hospital setting. As a transition, the office setting can be simulated in the OR, with the office staff brought in to observe and prepare for assisting, for instance, and implementing various pain management strategies. The office staff can also learn how to clean and care for the equipment.

Many physicians wonder what will happen if they are unable to complete a procedure in the office. Attempts will inevitably sometimes fail because of access problems, patient intolerance, equipment failure, or a complication. But with experience and proper patient selection, this will rarely happen. And if it does—if you're having some difficulty with the ablation set-up, for instance—keep in mind that it is only an office visit, and that the patient can be rescheduled for the operating room.

It is not necessary to remodel your office or have a “procedure room.” A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Increasingly, equipment is reasonably priced and companies are able to work with ob.gyns. on favorable leasing arrangements. This has taken away the hurdle of price; in fact, one hysteroscopy procedure a week will pay for the equipment.

The reimbursement issues are also favorable. Office hysteroscopy with biopsy is reimbursed at the same rate in the office as in the OR, and in 2005 global codes were approved for hysteroscopic sterilization and endometrial ablation—another development that makes the investment in hysteroscopy equipment a financially sound decision.

Preparing for office-based procedures takes initiative: Anesthesia guidelines and requirements for facility maintenance must be learned, for instance, and a policy and procedures manual that includes protocols for managing complications must be developed.

There is an unappreciated amount of training support, however—both for technical procedural training and for the range of logistical issues—to be had from experienced colleagues, professional societies, and industry. Ob.gyns. who enjoy procedures are better positioned than ever before to take advantage of it.

Diagnostic hysteroscopy with a small hysteroscope is less painful than an endometrial biopsy. Such a hysteroscope is smaller than an IUD (left).

A typical diagnostic hysteroscopy tray for in-office procedures includes a small hysteroscope and sheath, an os finder, and a single-tooth tenaculum. Photos courtesy Dr. James B. Presthus

It is not necessary to remodel your office. A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Courtesy Dr. James B. Presthus

In-Office Surgery Can Boost Practice

Given the constant threat of falling reimbursement, ob.gyns. throughout the country are exercising options on how to maintain a successful practice. For some, introducing new treatments has proved successful. We are all well aware of gynecologists who get involved in various aesthetic techniques and plastic procedures. However, for others, this option represents a marked departure from their practice profile.

It would appear that the introduction of in-office gynecologic surgery will offer many ob.gyns. the opportunity to add value to their practice, yet stay within the limits of the procedures they were trained to perform while in residency—that is, within an ob.gyn.'s “comfort zone.”

A second advantage of in-office gynecologic surgery is that it allows the physician to maintain efficiency.

Let's face it: Operating rooms are fraught with delays. Performing surgery within the confines of the office allows the gynecologist to be free of the yoke of OR tardiness.

Finally, procedures may actually be compensated better in the office than in the operating room, whether that OR is in an outpatient surgery center or in a hospital. Examples are hysteroscopic tubal occlusion or endometrial ablation.

I have invited Dr. James B. Presthus, who is currently practicing gynecology at Minnesota Gynecology and Surgery in Edina, Minn., to lead this discussion on office-based surgery. Dr. Presthus is an active member of the American Association of Gynecologic Laparoscopists, the American Urogynecology Association, the International Pelvic Pain Society, and many other professional organizations. He is a clinical professor of obstetrics and gynecology at the University of Minnesota, Minneapolis.

The levels of burnout in our specialty are increasing as too many of us—90% of the 42,000 ob.gyns in the United States—continue to pursue generalist careers.

We attempt to do it all, from primary care to obstetrics to surgery, and are being pulled in too many directions while losing any sense of control in our professional and personal lives.

There are alternatives to the model of being everything to every patient, however, and adopting office-based procedures can be a key component to making changes successfully.

Most of us perform in-office endometrial biopsies, colposcopy with biopsies, LEEP (loop electrosurgical excision procedures), and IUD insertions. Yet it is estimated that fewer than 30% of ob.gyns. do appreciable hysteroscopy in any setting, and fewer than 5%–10% do office hysteroscopy.

Many of us believe that office-based procedures are potentially dangerous and that they are painful and will not be tolerated by patients.

We argue against an increased level of office-based procedures on the premise that the equipment costs too much, the required skill level is too high, we don't see enough patients who are candidates for these procedures, we don't have procedure rooms, or the integration of more procedures into our existing schedules is just too complex or difficult.

Increasingly, these beliefs are countered by contrasting realities: more medical knowledge, more training opportunities, more reasonably priced equipment, and appropriate third-party reimbursement for office-based hysteroscopic procedures.

These realities have made hysteroscopy the base technology for a successful gynecology-focused office-based practice.

With commitment, those ob.gyns. who enjoy doing procedures can build successful office-based practices by offering a full spectrum of diagnostic and minor operative hysteroscopic procedures that are just as safe, tolerable, and effective as they are in the hospital.

In doing so, they can provide more thorough and efficient care in a more comfortable, familiar, and cost-effective setting.

Less Anesthesia, More Accuracy

The most significant misconception among ob.gyns.–and probably the largest barrier to wider use of in-office hysteroscopy—relates to pain.

The perceptions are fueled by the operating room experience, where intravenous sedation causes patients to lose inhibition and the ability to follow directions and control their actions.

Patients perceive touch and other stimuli as pain, and the loss of inhibition often escalates as the anesthesist applies even more IV sedation in an effort to make them more comfortable.

This is often perceived as intolerance for pain, and ob.gyns. leave the operating room thinking that if patients cannot tolerate hysteroscopy in that setting, they will certainly not tolerate it in the office.

In reality, patients can tolerate procedures very well—and with less anesthesia—if they know what to expect and if they're in control of their bodies and the overall situation. This happens more readily in the office environment, which is familiar, less intimidating, and more comfortable for patients.

In addition to the comfort that comes with familiarity, the office environment offers distractions that lessen the perception and feeling of pain, and the small-diameter hysteroscopes that are available to us today are no larger than a Pipelle curette and can usually be guided easily through the cervix without dilation, paracervical blocks, or the use of a tenaculum. A simple diagnostic hysteroscopy takes, on average, 5 minutes or less and is extremely well tolerated. It is less painful than an endometrial biopsy.

Patients are often interested in watching the video monitor during a hysteroscopic procedure. Their understanding and comfort level are greater when they can see the findings—can see in living color, for instance, what polyps, fibroids, or intrauterine adhesions are.

Of equal or more importance, hysteroscopy provides a focused view that has significant and measurable clinical benefits.

Ob.gyns. are more attuned to ultrasound; it's readily available, and the global view of the pelvis, uterus, and adnexa that it provides is often viewed as adequate. Saline infusion sonography has certainly improved diagnostic accuracy.

Hysteroscopy, however, offers a more focused view and gives us the ability to investigate and to do a targeted biopsy under direct vision. It simply provides for greater accuracy and more thorough care. Hysteroscopy should be viewed as complementary to ultrasound rather than as an alternative.

Hysteroscopy is the standard for evaluating abnormal uterine bleeding (AUB), a problem that affects more than 10 million women a year and is the reason for 25% of all gynecologic clinic visits.

Although endometrial biopsy is effective for diagnosing diffuse disease such as hyperplasia and carcinoma, it often misses focal lesions like endometrial polyps and fibroids, which are common causes of AUB.

Hysteroscopy should be considered in all patients who require an endometrial biopsy. It has been shown to have a sensitivity of 100% and a specificity of 95% in evaluating the uterine cavity.

It allows us both to diagnose more accurately and often to “see and treat” at the same time, avoiding the courses of unsuccessful hormonal therapy and multiple visits and procedures that too often result from a reliance on endometrial biopsy and ultrasound alone.

Office cystoscopy is a routine part of urologists' practice. With hysteroscopy, we have the technology and capability as ob.gyns. to similarly diagnose and treat common problems in a cost-effective, readily acceptable way. We must more seriously ask ourselves, why not?

Are our reasons not to embrace hysteroscopy really good enough?

Better Fits for a New Era

Ob.gyns. are often at a loss to explain why they seem to be working harder and harder while not getting anywhere, or while losing control, income, and/or the gratification of strong physician-patient relationships.

In a 2004 survey of approximately 830 District III ob.gyns., 64% reported symptoms of burnout; 16% wanted to quit medicine, and 40% said they planned to retire early. To maintain income or prevent a significant decrease in earnings, many had increased patient volume by 20%–30%.

Part of the challenge we face stems from declining reimbursement and the loss of entrepreneurship that often comes with larger group practices. But we also have an inefficient specialty. Many of us leave our offices for labor and delivery and for long OR cases that are unpredictable, that challenge the flow and efficiency of our office practices and the stability of our family lives, and that bring us reimbursement rates that do not account for waiting and time lost between cases. Often the reimbursement we receive when we are away from the office will not cover the cost of office overhead.

This is something we ought to analyze now. Depending on our professional interests, personal needs, and surgical and labor/delivery volumes, such a mix may be gratifying and completely acceptable, or it may be taxing, inefficient, and a cause of burnout.

An office-based ob.gyn. model of care can give us greater control of our practice, our scheduling, our patient relationships, and our lifestyle. Given the elimination of unproductive time, and the fact that professional fees remain the same regardless of setting and that facility fees go to the physician, we can also increase our reimbursement.

Substantial time and financial savings, moreover, are passed on to patients and payers. There is no wasted time: no separate office visits, for instance, for preoperative histories and physicals. When it comes to procedures, patients can arrive 10-30 minutes beforehand and leave in less than 30 minutes. In many cases a patient will be responsible for the cost of an office visit copay, compared with a large deductible and percentage of hospital costs.

I recently saw an interview with Warren Buffett in which he was asked why he is so successful in choosing investments. How was he able to predict the future? He replied that he could not predict the future, but he could recognize what was becoming obsolete. The era in which the model of care relied on a single ob.gyn. who could provide equally competent general primary care, obstetrical care, and the full spectrum of gynecologic surgery to the patient is rapidly becoming obsolete.

The specialty of ob.gyn. is destined to change. Many of us eventually will need to discover and carve out or fine-tune our roles. Today's generalist model of ob.gyn. will evolve into three components in the future: the office-based ob.gyn., the hospital laborist, and the pelvic surgeon.

Greatest in number will be the office-based ob.gyns. who provide well-woman primary care, office-based obstetrics (prenatal care), and a range of office-based procedures, from hysteroscopy and endometrial ablations to incontinence procedures, ultrasound, IUDs, cystoscopy, LEEP cones, and perhaps some “lifestyle” procedures such as laser hair reduction and varicose vein treatment. Considering the demand for such services, they likely will make up about 70% of the specialty.

The ability to have one office, fewer partners, no hospital responsibilities, and control over one's schedule can provide a career that is interesting and rewarding.

Ob.gyn. laborists will be modeled after internal medicine “hospitalists,” and will handle routine deliveries and inpatient obstetrical management. The laborist will work a certain number of shifts each month and will have enough time to be able to balance his or her personal and professional life.

Pelvic surgeons will perform laparoscopy, operative hysteroscopy, and abdominal, vaginal, and robotic surgery. They will provide women with state-of-the-art surgical care and will not have to balance surgery with primary care.

Skills and Set-Up

Ob.gyns. who are performing endometrial biopsies and inserting IUDs are more than capable of doing diagnostic and minor operative hysteroscopy in the office.

The average ob.gyn., in fact, will be competent with the basic hysteroscopic technique for diagnosis after just two to five cases, and the skills honed by doing office diagnostic hysteroscopy will often lay the foundation for adding operative procedures for which there is growing demand, such as hysteroscopic sterilization and global endometrial ablation.

A 2002 survey of women found that sterilization is the most popular method of contraception (favored by 28%), and that women today rarely favor a tubal ligation. Since it has been on the market, the Essure procedure has had successful placement rates of more than 96%.

Hysteroscopic sterilization and global endometrial ablation are both safe and effective for the general ob.gyn. to perform in the office—and just as capably as the best gynecologic surgeon—if he or she is credentialed in the procedure and first has experience and comfort with the procedure in the hospital setting. As a transition, the office setting can be simulated in the OR, with the office staff brought in to observe and prepare for assisting, for instance, and implementing various pain management strategies. The office staff can also learn how to clean and care for the equipment.

Many physicians wonder what will happen if they are unable to complete a procedure in the office. Attempts will inevitably sometimes fail because of access problems, patient intolerance, equipment failure, or a complication. But with experience and proper patient selection, this will rarely happen. And if it does—if you're having some difficulty with the ablation set-up, for instance—keep in mind that it is only an office visit, and that the patient can be rescheduled for the operating room.

It is not necessary to remodel your office or have a “procedure room.” A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Increasingly, equipment is reasonably priced and companies are able to work with ob.gyns. on favorable leasing arrangements. This has taken away the hurdle of price; in fact, one hysteroscopy procedure a week will pay for the equipment.

The reimbursement issues are also favorable. Office hysteroscopy with biopsy is reimbursed at the same rate in the office as in the OR, and in 2005 global codes were approved for hysteroscopic sterilization and endometrial ablation—another development that makes the investment in hysteroscopy equipment a financially sound decision.

Preparing for office-based procedures takes initiative: Anesthesia guidelines and requirements for facility maintenance must be learned, for instance, and a policy and procedures manual that includes protocols for managing complications must be developed.

There is an unappreciated amount of training support, however—both for technical procedural training and for the range of logistical issues—to be had from experienced colleagues, professional societies, and industry. Ob.gyns. who enjoy procedures are better positioned than ever before to take advantage of it.

Diagnostic hysteroscopy with a small hysteroscope is less painful than an endometrial biopsy. Such a hysteroscope is smaller than an IUD (left).

A typical diagnostic hysteroscopy tray for in-office procedures includes a small hysteroscope and sheath, an os finder, and a single-tooth tenaculum. Photos courtesy Dr. James B. Presthus

It is not necessary to remodel your office. A normal exam room will almost always suffice for diagnostic and simple operative hysteroscopic procedures. Courtesy Dr. James B. Presthus

In-Office Surgery Can Boost Practice

Given the constant threat of falling reimbursement, ob.gyns. throughout the country are exercising options on how to maintain a successful practice. For some, introducing new treatments has proved successful. We are all well aware of gynecologists who get involved in various aesthetic techniques and plastic procedures. However, for others, this option represents a marked departure from their practice profile.

It would appear that the introduction of in-office gynecologic surgery will offer many ob.gyns. the opportunity to add value to their practice, yet stay within the limits of the procedures they were trained to perform while in residency—that is, within an ob.gyn.'s “comfort zone.”

A second advantage of in-office gynecologic surgery is that it allows the physician to maintain efficiency.

Let's face it: Operating rooms are fraught with delays. Performing surgery within the confines of the office allows the gynecologist to be free of the yoke of OR tardiness.

Finally, procedures may actually be compensated better in the office than in the operating room, whether that OR is in an outpatient surgery center or in a hospital. Examples are hysteroscopic tubal occlusion or endometrial ablation.

I have invited Dr. James B. Presthus, who is currently practicing gynecology at Minnesota Gynecology and Surgery in Edina, Minn., to lead this discussion on office-based surgery. Dr. Presthus is an active member of the American Association of Gynecologic Laparoscopists, the American Urogynecology Association, the International Pelvic Pain Society, and many other professional organizations. He is a clinical professor of obstetrics and gynecology at the University of Minnesota, Minneapolis.

The array-CGH test, which is already being used postnatally, will give obstetricians, geneticists, and their patients the opportunity in the prenatal setting to detect significantly more and smaller changes in the amount of chromosomal material present in individuals—and in significantly less time than a standard chromosome karyotype would take.

It may someday take the place of our standard techniques for cytogenetic analysis, but for now, it is a valuable addition to the available diagnostic tests.

Advances Over FISH

The technology, which has also been called chromosomal microarray, was first used to analyze gains and losses in chromosomal material in tumors and tumor cell lines. It is now a valuable tool in the postnatal testing of individuals with birth defects.

Between one-half and two-thirds of children with serious developmental abnormalities go undiagnosed and have a normal karyotype, so from a postnatal perspective, this new test has been welcomed at Johns Hopkins University and the Kennedy Krieger Institute, both in Baltimore, as well as at other institutions. Having a diagnosis facilitates the most appropriate therapy and allows parents to plan for future pregnancies and possible prenatal testing.

Yet it is the prenatal period for which array-CGH may have an even greater impact. Phenotypic features are not as apparent in the womb as at birth, making it more difficult to target testing with technology like rapid fluorescent in situ hybridization (FISH).

Along with standard karyotype analysis, the FISH technique has been the mainstay of cytogenetic analysis. It provides a targeted look at areas of the karyotype that are known to be associated with disease as a result of either the duplication or deletion of genetic material. In other words, it detects gains and losses in chromosomal material for just one or a few chromosome regions at a time.

Performing array-CGH is like doing FISH hundreds of times at once. Array-CGH testing may target the same chromosomal regions (and thus similar disorders) as a series of FISH tests, but array-CGH will target these regions at a much higher resolution, enabling the detection of much smaller deletions and duplications; it can also assess many regions associated with genetic disorders in a single test.

If we see on a prenatal ultrasound that a fetus has cardiac problems, for example, we might suspect the DiGeorge syndrome. The obstetrician today would probably perform an amniocentesis and order both a karyotype and FISH with a specific probe for the DiGeorge syndrome, which we know is caused by a deletion on chromosome 22, just as he or she would do in the postnatal period for a child with the syndrome's more obvious phenotypic features.

In the near future, the obstetrician facing this prenatal situation will likely proceed differently than he or she would in the postnatal period. The obstetrician will use array-CGH instead of FISH in order to cast a wider net—one that can catch a deletion on chromosome 22, as well as other possible deletions which may cause the heart defect.

Right now, the available array-CGH platforms can detect more than 40 syndromic chromosomal disorders. Just as with FISH, a normal result rules out only those conditions that correspond to the deletions or duplications that are covered on the array.

How Array-CGH Works

The technique involves labeling the patient's DNA in one fluorescent dye, labeling DNA from a normal control with a different fluorescent dye, allowing the DNA from both to mix, and then applying the mixture to a slide that contains small segments of DNA from known chromosomal regions.

The slide serves as the platform or the array. The mixture of the patient's DNA and the normal control DNA is allowed to match up, or hybridize, with the complementary DNA segments on the slide.

A scanner then reads the intensities of the two different dyes, determining their relative strength at each of the DNA spots on the array. If a patient has less DNA in a specified region of the genome—a deletion of chromosomal material—then the color of the control sample will be stronger at that point on the array. If a patient has more DNA in this specific region—a duplication of chromosomal material—then the color of the patient's sample will be stronger at that location.

Analysis can be performed on direct chorionic villi or amniotic fluid, or alternatively on cultured cells. For direct analysis, it might be necessary to amplify the amount of DNA obtained before running it on an array. In this case, it is essential that the amplification is uniform and does not introduce any bias.

Although many laboratories are using cultured cells at this point, some studies are demonstrating the feasibility of relying on uncultured samples, and ultimately, this is the direction in which we're heading. Direct testing of fetal DNA will save time and give us rapid results.

The Limitations of Array-CGH

Unlike standard karyotyping, array-CGH cannot detect defects in which the total amount of chromosomal material is unchanged. The test cannot, for instance, detect balance rearrangements, such as balanced reciprocal translocations, balanced Robertsonian translocations, and inversions.

In a couple with multiple miscarriages, a karyotype is still the appropriate test to perform on the parents' blood because a balanced rearrangement is what you would be looking for. You would not request array-CGH because balanced rearrangements are not detectable with this technique. On the other hand, array-CGH could be very useful on the products of conception from a miscarriage because very small deletions and duplications could be found.

Array-CGH also cannot detect point mutations, or small changes in the genes, like those that cause hemophilia or sickle cell disease. It is designed to detect the syndromes caused by duplications or deletions of larger amounts of chromosomal material. And it will not detect abnormalities that are not covered by the array.

Chromosomal mosaicism, in which only some cells show a particular abnormality, may or may not be more readily detected by array-CGH than by standard techniques.

On one hand, mosaicism may be more readily detected with array-CGH than with standard karyotype analysis because abnormal cells often do not divide as well and may be lost during the culture process that is part of the standard karyotyping methodology. On the other hand, experts believe that array-CGH may not detect mosaicism below a certain level—below the level, some say, at which the abnormality affects fewer than 15%–30% of cells.

Array-CGH will also inevitably detect normal variants (benign duplications and deletions that are not associated with any abnormal phenotype). Some variants will be difficult to explain. This has been true for karyotyping as well, and just as we have in the past, we will want to minimize parents' anxiety over the unknowns.

When we find variants of uncertain significance, we will turn to the parents, checking their blood samples for the same losses or gains of chromosomal material.

The Near Future

The clinicians and cytogeneticists who are using and offering array-CGH are on a learning curve. Experts seem to have been successful in ensuring that the test works for the disorders that are covered; there is an enormous amount of information and data being shared by centers and labs on what variants are associated with the normal phenotype, and on other issues as well.

At Johns Hopkins University and the Kennedy Krieger Institute, we have postnatal experience to draw upon as we bring array-CGH into the prenatal arena. Of the children with developmental delay and dysmorphic features who have had array-CGH, we have been able to give a specific syndromic diagnosis to approximately 5%–8%, depending on the array platform we utilize. In about 12%, we have detected variants that we know—through parental testing and the use of databases—are normal. In a much smaller percentage (3.4%) of these children, we have found variants that we cannot yet explain.

Until we learn more, we plan to limit prenatal array-CGH to cases in which there is a known abnormality on ultrasound, rather than offer the test more broadly as a screening tool for chromosomal abnormalities in high-risk pregnancies. And although we are moving in the postnatal setting toward more of a whole-genome screening, we will use targeted arrays in the prenatal setting.

Within this context—that of ultrasound-detected anomalies and targeted arrays—we can expect that 5%–10% of tests will provide a clear diagnosis.

The question of whether array-CGH could replace a karyotype in prenatal testing is an interesting one. For now, there are too many questions and issues (mosaicism and normal variants, for instance) to do away with karyotyping. We believe the role of array-CGH is to enhance our current approaches to prenatal testing, and in this sense, it is an exciting development.

Figure A shows a hybridized array of >4,200 BAC clones; B, one area enlarged; C, plot for chromosome 1 based on fluorescence ratios (patient vs. control DNA) showing normal copy number. Courtesy Dr. Denise Batista

Prenatal Diagnosis

In our contemporary society, where women and their physicians continue to seek as much information as possible early in their pregnancies, the field of prenatal diagnosis has rapidly become a well-established and central part of obstetrics. Prenatal diagnosis performed in the first trimester has become common practice—a far cry from the days in the not-so-distant past when the ultimate outcome of the fetus was not learned until the day of delivery.

As obstetricians and perinatologists, we benefit from being aware of and fully informed about the evolving technology that continues to move the field of prenatal diagnosis forward. The array of current prenatal diagnostic tools includes both invasive and noninvasive techniques that enable parents to assess the genetic, chromosomal, and biochemical aspects of their fetus considerably before the time of viability.

Parents and their physicians are using this information to guide them in pursuing potential therapeutic applications and interventions or, in some cases, interruption of the pregnancy.

Now there is a new technique called array-based comparative genomic hybridization, or array-CGH, which is entering the prenatal arena with promises of more comprehensive and faster detection capabilities than we now are afforded with the two current “gold standard” techniques: microscopic karyotype analysis and rapid fluorescent in situ hybridization.

Array-CGH is far from perfect in evaluating chromosomal material. It can only detect instances where there is a significant addition or deletion of genetic material. And, of course, it can only evaluate those genes encoded on the array.

As with every other prenatal diagnostic tool developed to date, the future use of this new technique involves many questions, including which variants are normal as opposed to abnormal, the technique's potential role as a screening tool, and other often vexing ambiguities and issues. However, its use in prenatal diagnosis will build upon a body of national experience in the postnatal setting.

To familiarize us with the new technology and discuss its role in prenatal diagnosis, I have invited Dr. Karin J. Blakemore to serve as the guest professor of this month's Master Class.

Dr. Blakemore is the director of maternal-fetal medicine and the Prenatal Genetics Service at Johns Hopkins University School of Medicine in Baltimore—an institution that is gearing up to use array-CGH as part of its armamentarium for prenatal diagnosis.

She is joined by her colleague Denise Batista, Ph.D., who is an assistant professor in the Johns Hopkins department of pathology and codirector of the university's prenatal cytogenetics laboratory. Dr. Batista also serves as the director of the cytogenetics laboratory at the Kennedy Krieger Institute in Baltimore.

Key Points for Array-CGH

▸ Detects: Unbalanced rearrangements, aneuploidy, gains and losses of regions represented in the array.

▸ Won't detect: Balanced rearrangements, point mutations, (possibly) low-level mosaicism.

▸ Pick-up rate: Estimated as 5%–10% from postnatal studies of developmentally delayed/dysmorphic children.

▸ Confirmation: By FISH probes.

▸ Parental studies: Might be necessary to sort out normal variants versus clinically significant changes.

▸ Copy number variants: Might find copy number variants of unknown significance.

▸ Platforms: Several commercial and home-brew arrays available with different genomic coverage.

The array-CGH test, which is already being used postnatally, will give obstetricians, geneticists, and their patients the opportunity in the prenatal setting to detect significantly more and smaller changes in the amount of chromosomal material present in individuals—and in significantly less time than a standard chromosome karyotype would take.

It may someday take the place of our standard techniques for cytogenetic analysis, but for now, it is a valuable addition to the available diagnostic tests.

Advances Over FISH

The technology, which has also been called chromosomal microarray, was first used to analyze gains and losses in chromosomal material in tumors and tumor cell lines. It is now a valuable tool in the postnatal testing of individuals with birth defects.

Between one-half and two-thirds of children with serious developmental abnormalities go undiagnosed and have a normal karyotype, so from a postnatal perspective, this new test has been welcomed at Johns Hopkins University and the Kennedy Krieger Institute, both in Baltimore, as well as at other institutions. Having a diagnosis facilitates the most appropriate therapy and allows parents to plan for future pregnancies and possible prenatal testing.

Yet it is the prenatal period for which array-CGH may have an even greater impact. Phenotypic features are not as apparent in the womb as at birth, making it more difficult to target testing with technology like rapid fluorescent in situ hybridization (FISH).

Along with standard karyotype analysis, the FISH technique has been the mainstay of cytogenetic analysis. It provides a targeted look at areas of the karyotype that are known to be associated with disease as a result of either the duplication or deletion of genetic material. In other words, it detects gains and losses in chromosomal material for just one or a few chromosome regions at a time.

Performing array-CGH is like doing FISH hundreds of times at once. Array-CGH testing may target the same chromosomal regions (and thus similar disorders) as a series of FISH tests, but array-CGH will target these regions at a much higher resolution, enabling the detection of much smaller deletions and duplications; it can also assess many regions associated with genetic disorders in a single test.

If we see on a prenatal ultrasound that a fetus has cardiac problems, for example, we might suspect the DiGeorge syndrome. The obstetrician today would probably perform an amniocentesis and order both a karyotype and FISH with a specific probe for the DiGeorge syndrome, which we know is caused by a deletion on chromosome 22, just as he or she would do in the postnatal period for a child with the syndrome's more obvious phenotypic features.

In the near future, the obstetrician facing this prenatal situation will likely proceed differently than he or she would in the postnatal period. The obstetrician will use array-CGH instead of FISH in order to cast a wider net—one that can catch a deletion on chromosome 22, as well as other possible deletions which may cause the heart defect.

Right now, the available array-CGH platforms can detect more than 40 syndromic chromosomal disorders. Just as with FISH, a normal result rules out only those conditions that correspond to the deletions or duplications that are covered on the array.

How Array-CGH Works

The technique involves labeling the patient's DNA in one fluorescent dye, labeling DNA from a normal control with a different fluorescent dye, allowing the DNA from both to mix, and then applying the mixture to a slide that contains small segments of DNA from known chromosomal regions.

The slide serves as the platform or the array. The mixture of the patient's DNA and the normal control DNA is allowed to match up, or hybridize, with the complementary DNA segments on the slide.

A scanner then reads the intensities of the two different dyes, determining their relative strength at each of the DNA spots on the array. If a patient has less DNA in a specified region of the genome—a deletion of chromosomal material—then the color of the control sample will be stronger at that point on the array. If a patient has more DNA in this specific region—a duplication of chromosomal material—then the color of the patient's sample will be stronger at that location.

Analysis can be performed on direct chorionic villi or amniotic fluid, or alternatively on cultured cells. For direct analysis, it might be necessary to amplify the amount of DNA obtained before running it on an array. In this case, it is essential that the amplification is uniform and does not introduce any bias.

Although many laboratories are using cultured cells at this point, some studies are demonstrating the feasibility of relying on uncultured samples, and ultimately, this is the direction in which we're heading. Direct testing of fetal DNA will save time and give us rapid results.

The Limitations of Array-CGH

Unlike standard karyotyping, array-CGH cannot detect defects in which the total amount of chromosomal material is unchanged. The test cannot, for instance, detect balance rearrangements, such as balanced reciprocal translocations, balanced Robertsonian translocations, and inversions.

In a couple with multiple miscarriages, a karyotype is still the appropriate test to perform on the parents' blood because a balanced rearrangement is what you would be looking for. You would not request array-CGH because balanced rearrangements are not detectable with this technique. On the other hand, array-CGH could be very useful on the products of conception from a miscarriage because very small deletions and duplications could be found.

Array-CGH also cannot detect point mutations, or small changes in the genes, like those that cause hemophilia or sickle cell disease. It is designed to detect the syndromes caused by duplications or deletions of larger amounts of chromosomal material. And it will not detect abnormalities that are not covered by the array.

Chromosomal mosaicism, in which only some cells show a particular abnormality, may or may not be more readily detected by array-CGH than by standard techniques.

On one hand, mosaicism may be more readily detected with array-CGH than with standard karyotype analysis because abnormal cells often do not divide as well and may be lost during the culture process that is part of the standard karyotyping methodology. On the other hand, experts believe that array-CGH may not detect mosaicism below a certain level—below the level, some say, at which the abnormality affects fewer than 15%–30% of cells.

Array-CGH will also inevitably detect normal variants (benign duplications and deletions that are not associated with any abnormal phenotype). Some variants will be difficult to explain. This has been true for karyotyping as well, and just as we have in the past, we will want to minimize parents' anxiety over the unknowns.

When we find variants of uncertain significance, we will turn to the parents, checking their blood samples for the same losses or gains of chromosomal material.

The Near Future

The clinicians and cytogeneticists who are using and offering array-CGH are on a learning curve. Experts seem to have been successful in ensuring that the test works for the disorders that are covered; there is an enormous amount of information and data being shared by centers and labs on what variants are associated with the normal phenotype, and on other issues as well.

At Johns Hopkins University and the Kennedy Krieger Institute, we have postnatal experience to draw upon as we bring array-CGH into the prenatal arena. Of the children with developmental delay and dysmorphic features who have had array-CGH, we have been able to give a specific syndromic diagnosis to approximately 5%–8%, depending on the array platform we utilize. In about 12%, we have detected variants that we know—through parental testing and the use of databases—are normal. In a much smaller percentage (3.4%) of these children, we have found variants that we cannot yet explain.

Until we learn more, we plan to limit prenatal array-CGH to cases in which there is a known abnormality on ultrasound, rather than offer the test more broadly as a screening tool for chromosomal abnormalities in high-risk pregnancies. And although we are moving in the postnatal setting toward more of a whole-genome screening, we will use targeted arrays in the prenatal setting.

Within this context—that of ultrasound-detected anomalies and targeted arrays—we can expect that 5%–10% of tests will provide a clear diagnosis.

The question of whether array-CGH could replace a karyotype in prenatal testing is an interesting one. For now, there are too many questions and issues (mosaicism and normal variants, for instance) to do away with karyotyping. We believe the role of array-CGH is to enhance our current approaches to prenatal testing, and in this sense, it is an exciting development.

Figure A shows a hybridized array of >4,200 BAC clones; B, one area enlarged; C, plot for chromosome 1 based on fluorescence ratios (patient vs. control DNA) showing normal copy number. Courtesy Dr. Denise Batista

Prenatal Diagnosis

In our contemporary society, where women and their physicians continue to seek as much information as possible early in their pregnancies, the field of prenatal diagnosis has rapidly become a well-established and central part of obstetrics. Prenatal diagnosis performed in the first trimester has become common practice—a far cry from the days in the not-so-distant past when the ultimate outcome of the fetus was not learned until the day of delivery.

As obstetricians and perinatologists, we benefit from being aware of and fully informed about the evolving technology that continues to move the field of prenatal diagnosis forward. The array of current prenatal diagnostic tools includes both invasive and noninvasive techniques that enable parents to assess the genetic, chromosomal, and biochemical aspects of their fetus considerably before the time of viability.

Parents and their physicians are using this information to guide them in pursuing potential therapeutic applications and interventions or, in some cases, interruption of the pregnancy.

Now there is a new technique called array-based comparative genomic hybridization, or array-CGH, which is entering the prenatal arena with promises of more comprehensive and faster detection capabilities than we now are afforded with the two current “gold standard” techniques: microscopic karyotype analysis and rapid fluorescent in situ hybridization.

Array-CGH is far from perfect in evaluating chromosomal material. It can only detect instances where there is a significant addition or deletion of genetic material. And, of course, it can only evaluate those genes encoded on the array.

As with every other prenatal diagnostic tool developed to date, the future use of this new technique involves many questions, including which variants are normal as opposed to abnormal, the technique's potential role as a screening tool, and other often vexing ambiguities and issues. However, its use in prenatal diagnosis will build upon a body of national experience in the postnatal setting.

To familiarize us with the new technology and discuss its role in prenatal diagnosis, I have invited Dr. Karin J. Blakemore to serve as the guest professor of this month's Master Class.

Dr. Blakemore is the director of maternal-fetal medicine and the Prenatal Genetics Service at Johns Hopkins University School of Medicine in Baltimore—an institution that is gearing up to use array-CGH as part of its armamentarium for prenatal diagnosis.

She is joined by her colleague Denise Batista, Ph.D., who is an assistant professor in the Johns Hopkins department of pathology and codirector of the university's prenatal cytogenetics laboratory. Dr. Batista also serves as the director of the cytogenetics laboratory at the Kennedy Krieger Institute in Baltimore.

Key Points for Array-CGH

▸ Detects: Unbalanced rearrangements, aneuploidy, gains and losses of regions represented in the array.

▸ Won't detect: Balanced rearrangements, point mutations, (possibly) low-level mosaicism.

▸ Pick-up rate: Estimated as 5%–10% from postnatal studies of developmentally delayed/dysmorphic children.

▸ Confirmation: By FISH probes.

▸ Parental studies: Might be necessary to sort out normal variants versus clinically significant changes.

▸ Copy number variants: Might find copy number variants of unknown significance.

▸ Platforms: Several commercial and home-brew arrays available with different genomic coverage.

The array-CGH test, which is already being used postnatally, will give obstetricians, geneticists, and their patients the opportunity in the prenatal setting to detect significantly more and smaller changes in the amount of chromosomal material present in individuals—and in significantly less time than a standard chromosome karyotype would take.

It may someday take the place of our standard techniques for cytogenetic analysis, but for now, it is a valuable addition to the available diagnostic tests.

Advances Over FISH

The technology, which has also been called chromosomal microarray, was first used to analyze gains and losses in chromosomal material in tumors and tumor cell lines. It is now a valuable tool in the postnatal testing of individuals with birth defects.

Between one-half and two-thirds of children with serious developmental abnormalities go undiagnosed and have a normal karyotype, so from a postnatal perspective, this new test has been welcomed at Johns Hopkins University and the Kennedy Krieger Institute, both in Baltimore, as well as at other institutions. Having a diagnosis facilitates the most appropriate therapy and allows parents to plan for future pregnancies and possible prenatal testing.

Yet it is the prenatal period for which array-CGH may have an even greater impact. Phenotypic features are not as apparent in the womb as at birth, making it more difficult to target testing with technology like rapid fluorescent in situ hybridization (FISH).

Along with standard karyotype analysis, the FISH technique has been the mainstay of cytogenetic analysis. It provides a targeted look at areas of the karyotype that are known to be associated with disease as a result of either the duplication or deletion of genetic material. In other words, it detects gains and losses in chromosomal material for just one or a few chromosome regions at a time.

Performing array-CGH is like doing FISH hundreds of times at once. Array-CGH testing may target the same chromosomal regions (and thus similar disorders) as a series of FISH tests, but array-CGH will target these regions at a much higher resolution, enabling the detection of much smaller deletions and duplications; it can also assess many regions associated with genetic disorders in a single test.

If we see on a prenatal ultrasound that a fetus has cardiac problems, for example, we might suspect the DiGeorge syndrome. The obstetrician today would probably perform an amniocentesis and order both a karyotype and FISH with a specific probe for the DiGeorge syndrome, which we know is caused by a deletion on chromosome 22, just as he or she would do in the postnatal period for a child with the syndrome's more obvious phenotypic features.

In the near future, the obstetrician facing this prenatal situation will likely proceed differently than he or she would in the postnatal period. The obstetrician will use array-CGH instead of FISH in order to cast a wider net—one that can catch a deletion on chromosome 22, as well as other possible deletions which may cause the heart defect.

Right now, the available array-CGH platforms can detect more than 40 syndromic chromosomal disorders. Just as with FISH, a normal result rules out only those conditions that correspond to the deletions or duplications that are covered on the array.

How Array-CGH Works

The technique involves labeling the patient's DNA in one fluorescent dye, labeling DNA from a normal control with a different fluorescent dye, allowing the DNA from both to mix, and then applying the mixture to a slide that contains small segments of DNA from known chromosomal regions.

The slide serves as the platform or the array. The mixture of the patient's DNA and the normal control DNA is allowed to match up, or hybridize, with the complementary DNA segments on the slide.

A scanner then reads the intensities of the two different dyes, determining their relative strength at each of the DNA spots on the array. If a patient has less DNA in a specified region of the genome—a deletion of chromosomal material—then the color of the control sample will be stronger at that point on the array. If a patient has more DNA in this specific region—a duplication of chromosomal material—then the color of the patient's sample will be stronger at that location.

Analysis can be performed on direct chorionic villi or amniotic fluid, or alternatively on cultured cells. For direct analysis, it might be necessary to amplify the amount of DNA obtained before running it on an array. In this case, it is essential that the amplification is uniform and does not introduce any bias.

Although many laboratories are using cultured cells at this point, some studies are demonstrating the feasibility of relying on uncultured samples, and ultimately, this is the direction in which we're heading. Direct testing of fetal DNA will save time and give us rapid results.

The Limitations of Array-CGH

Unlike standard karyotyping, array-CGH cannot detect defects in which the total amount of chromosomal material is unchanged. The test cannot, for instance, detect balance rearrangements, such as balanced reciprocal translocations, balanced Robertsonian translocations, and inversions.

In a couple with multiple miscarriages, a karyotype is still the appropriate test to perform on the parents' blood because a balanced rearrangement is what you would be looking for. You would not request array-CGH because balanced rearrangements are not detectable with this technique. On the other hand, array-CGH could be very useful on the products of conception from a miscarriage because very small deletions and duplications could be found.

Array-CGH also cannot detect point mutations, or small changes in the genes, like those that cause hemophilia or sickle cell disease. It is designed to detect the syndromes caused by duplications or deletions of larger amounts of chromosomal material. And it will not detect abnormalities that are not covered by the array.

Chromosomal mosaicism, in which only some cells show a particular abnormality, may or may not be more readily detected by array-CGH than by standard techniques.

On one hand, mosaicism may be more readily detected with array-CGH than with standard karyotype analysis because abnormal cells often do not divide as well and may be lost during the culture process that is part of the standard karyotyping methodology. On the other hand, experts believe that array-CGH may not detect mosaicism below a certain level—below the level, some say, at which the abnormality affects fewer than 15%–30% of cells.

Array-CGH will also inevitably detect normal variants (benign duplications and deletions that are not associated with any abnormal phenotype). Some variants will be difficult to explain. This has been true for karyotyping as well, and just as we have in the past, we will want to minimize parents' anxiety over the unknowns.

When we find variants of uncertain significance, we will turn to the parents, checking their blood samples for the same losses or gains of chromosomal material.

The Near Future

The clinicians and cytogeneticists who are using and offering array-CGH are on a learning curve. Experts seem to have been successful in ensuring that the test works for the disorders that are covered; there is an enormous amount of information and data being shared by centers and labs on what variants are associated with the normal phenotype, and on other issues as well.

At Johns Hopkins University and the Kennedy Krieger Institute, we have postnatal experience to draw upon as we bring array-CGH into the prenatal arena. Of the children with developmental delay and dysmorphic features who have had array-CGH, we have been able to give a specific syndromic diagnosis to approximately 5%–8%, depending on the array platform we utilize. In about 12%, we have detected variants that we know—through parental testing and the use of databases—are normal. In a much smaller percentage (3.4%) of these children, we have found variants that we cannot yet explain.

Until we learn more, we plan to limit prenatal array-CGH to cases in which there is a known abnormality on ultrasound, rather than offer the test more broadly as a screening tool for chromosomal abnormalities in high-risk pregnancies. And although we are moving in the postnatal setting toward more of a whole-genome screening, we will use targeted arrays in the prenatal setting.

Within this context—that of ultrasound-detected anomalies and targeted arrays—we can expect that 5%–10% of tests will provide a clear diagnosis.

The question of whether array-CGH could replace a karyotype in prenatal testing is an interesting one. For now, there are too many questions and issues (mosaicism and normal variants, for instance) to do away with karyotyping. We believe the role of array-CGH is to enhance our current approaches to prenatal testing, and in this sense, it is an exciting development.

Figure A shows a hybridized array of >4,200 BAC clones; B, one area enlarged; C, plot for chromosome 1 based on fluorescence ratios (patient vs. control DNA) showing normal copy number. Courtesy Dr. Denise Batista

Prenatal Diagnosis

In our contemporary society, where women and their physicians continue to seek as much information as possible early in their pregnancies, the field of prenatal diagnosis has rapidly become a well-established and central part of obstetrics. Prenatal diagnosis performed in the first trimester has become common practice—a far cry from the days in the not-so-distant past when the ultimate outcome of the fetus was not learned until the day of delivery.

As obstetricians and perinatologists, we benefit from being aware of and fully informed about the evolving technology that continues to move the field of prenatal diagnosis forward. The array of current prenatal diagnostic tools includes both invasive and noninvasive techniques that enable parents to assess the genetic, chromosomal, and biochemical aspects of their fetus considerably before the time of viability.

Parents and their physicians are using this information to guide them in pursuing potential therapeutic applications and interventions or, in some cases, interruption of the pregnancy.

Now there is a new technique called array-based comparative genomic hybridization, or array-CGH, which is entering the prenatal arena with promises of more comprehensive and faster detection capabilities than we now are afforded with the two current “gold standard” techniques: microscopic karyotype analysis and rapid fluorescent in situ hybridization.

Array-CGH is far from perfect in evaluating chromosomal material. It can only detect instances where there is a significant addition or deletion of genetic material. And, of course, it can only evaluate those genes encoded on the array.

As with every other prenatal diagnostic tool developed to date, the future use of this new technique involves many questions, including which variants are normal as opposed to abnormal, the technique's potential role as a screening tool, and other often vexing ambiguities and issues. However, its use in prenatal diagnosis will build upon a body of national experience in the postnatal setting.

To familiarize us with the new technology and discuss its role in prenatal diagnosis, I have invited Dr. Karin J. Blakemore to serve as the guest professor of this month's Master Class.

Dr. Blakemore is the director of maternal-fetal medicine and the Prenatal Genetics Service at Johns Hopkins University School of Medicine in Baltimore—an institution that is gearing up to use array-CGH as part of its armamentarium for prenatal diagnosis.

She is joined by her colleague Denise Batista, Ph.D., who is an assistant professor in the Johns Hopkins department of pathology and codirector of the university's prenatal cytogenetics laboratory. Dr. Batista also serves as the director of the cytogenetics laboratory at the Kennedy Krieger Institute in Baltimore.

Key Points for Array-CGH

▸ Detects: Unbalanced rearrangements, aneuploidy, gains and losses of regions represented in the array.

▸ Won't detect: Balanced rearrangements, point mutations, (possibly) low-level mosaicism.

▸ Pick-up rate: Estimated as 5%–10% from postnatal studies of developmentally delayed/dysmorphic children.

▸ Confirmation: By FISH probes.

▸ Parental studies: Might be necessary to sort out normal variants versus clinically significant changes.

▸ Copy number variants: Might find copy number variants of unknown significance.

▸ Platforms: Several commercial and home-brew arrays available with different genomic coverage.