Lila O’Connor, Editor

Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.¹

Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues²: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.^3,4

Details of the study

To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.²

In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.²

Bottom line

Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).

The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.²

Caveats

The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.²

Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.¹

Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues²: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.^3,4

Details of the study

To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.²

In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.²

Bottom line

Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).

The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.²

Caveats

The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.²

Antiplatelet agents (mainly low-dose aspirin) have been shown to reduce the risk of preeclampsia in women at risk for the condition. The American College of Obstetricians and Gynecologists currently supports consideration of the use of low-dose aspirin (81 mg/day), initiated between 12 and 28 weeks of gestation, for the prevention of preeclampsia in women at high risk.¹

Can antiplatelet agents also reduce the risk of preterm birth? It is a reasonable question, postulate van Vliet and colleagues²: Women with a history of preeclampsia also have an increased risk of spontaneous preterm birth (SPB), and vice versa. Uteroplacental ischemia is present in cases of preeclampsia, and research is showing that uteroplacental ischemia also plays a role in the etiology of spontaneous preterm labor.^3,4

Details of the study

To investigate their research question, van Vliet and colleagues performed an additional analysis of the Perinatal Antiplatelet Review of International Studies Individual Participant Data meta-analysis. The original meta-analysis involved the data of 32,217 women at risk for preeclampsia who were randomly assigned to low-dose aspirin-dipyridamole or placebo (no treatment); the study revealed a moderate risk reduction for preeclampsia as well as a significant reduction in preterm birth at less than 34 weeks of gestation in women treated with antiplatelets.²

In the additional analysis, for women with an SPB who began antiplatelet treatment before 20 weeks of gestation, the researchers assessed the time between 20 weeks and spontaneous preterm delivery, iatrogenic preterm delivery, and any preterm delivery. Overall, 9.7% of women (n = 2,670) had an SPB before 37 weeks of gestation, 2.8% (n = 773) had an SPB before 34 weeks of gestation, and 0.5% (n = 151) had an SPB before 28 weeks of gestation. Antiplatelet agents were associated with a significant reduction in the risk of SPB before 37 weeks (relative risk [RR], 0.93; 95% confidence interval [CI], 0.86–0.996) and before 34 weeks (RR, 0.86; 95% CI, 0.76–0.99). The RR of having an SPB at less than 37 weeks of gestation was 0.83 for women with a previous pregnancy and 0.98 for women in their first pregnancy.²

Bottom line

Antiplatelet use resulted in a 7% reduction in SPB risk in women at risk for preeclampsia. Antiplatelet use resulted in a 14% reduction in moderate to very preterm birth risk (<34 weeks’ gestation).

The authors advise that their study “provides clinicians with the best available evidence to counsel women regarding who might benefit from” antiplatelet use during pregnancy and suggest that antiplatelet use may be a promising intervention for women at high risk for SPB, especially in high-risk women with a previous pregnancy.²

Caveats

The researchers found no difference among those receiving and not receiving antiplatelets in the incidence of antepartum hemorrhage (RR, 1.02; 95% CI, 0.90–1.15), placental abruption (RR, 1.13; 95% CI, 0.87–1.48), or neonatal bleeding (RR, 0.93; 95% CI, 0.80–1.09). The incidence of postpartum hemorrhage (PPH) was again found to be borderline significant (RR, 1.06; 95% CI, 1.00–1.13), but it was more frequent. The authors caution that the SPB reduction that they found in their study (as well as the reduced risk for preeclampsia with low-dose aspirin use) be balanced against the potential higher risk for PPH.²

With more than 1,000 diseases for which genetic testing is available, and with the completion of the Human Genome Project, more patients are requesting genetic testing and more clinicians are utilizing such testing; it has become mainstream.¹ This increased utilization has resulted in increased cost as well, say Ruzzo and colleagues, who presented research on genetic testing costs and compliance with clinical best practices at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG).² But, according to previous research say Ruzzo and colleagues, these costs can be quelled by involving genetic counselors in the test-ordering process.

Just how much cost savings can be achieved? In their quality improvement project, the investigators found that 38.6% of 44 genetic tests reviewed were inappropriately ordered—either they were not indicated (21%), misordered for false reassurance (7%), or inadequately ordered (10.5%). If the tests were ordered as appropriately recommended, a cost savings of $20,912.58 would have been realized, according to the researchers.

Ruzzo and colleagues reviewed 114 charts over a 3-month period for adherence with published clinical practice guidelines. All of the charts were associated with a genetic test billing code for common tests ordered through LabCorp (for cystic fibrosis, BRCA mutation, factor V Leiden, prothrombin, alpha-thalassemia, hemochromatosis, and cell-free DNA).

The researchers concluded that genetic counselor review or involvement in genetic test ordering can decrease inappropriate spending and improve patient care. They pointed out that the 114 charts reviewed represent a fraction of genetic tests ordered at their institution, and further study should broaden the research scope to determine the full extent of the problem.

Ruzzo and colleagues were awarded first prize for their research as presented at ACOG.
 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

With more than 1,000 diseases for which genetic testing is available, and with the completion of the Human Genome Project, more patients are requesting genetic testing and more clinicians are utilizing such testing; it has become mainstream.¹ This increased utilization has resulted in increased cost as well, say Ruzzo and colleagues, who presented research on genetic testing costs and compliance with clinical best practices at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG).² But, according to previous research say Ruzzo and colleagues, these costs can be quelled by involving genetic counselors in the test-ordering process.

Just how much cost savings can be achieved? In their quality improvement project, the investigators found that 38.6% of 44 genetic tests reviewed were inappropriately ordered—either they were not indicated (21%), misordered for false reassurance (7%), or inadequately ordered (10.5%). If the tests were ordered as appropriately recommended, a cost savings of $20,912.58 would have been realized, according to the researchers.

Ruzzo and colleagues reviewed 114 charts over a 3-month period for adherence with published clinical practice guidelines. All of the charts were associated with a genetic test billing code for common tests ordered through LabCorp (for cystic fibrosis, BRCA mutation, factor V Leiden, prothrombin, alpha-thalassemia, hemochromatosis, and cell-free DNA).

The researchers concluded that genetic counselor review or involvement in genetic test ordering can decrease inappropriate spending and improve patient care. They pointed out that the 114 charts reviewed represent a fraction of genetic tests ordered at their institution, and further study should broaden the research scope to determine the full extent of the problem.

Ruzzo and colleagues were awarded first prize for their research as presented at ACOG.
 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

With more than 1,000 diseases for which genetic testing is available, and with the completion of the Human Genome Project, more patients are requesting genetic testing and more clinicians are utilizing such testing; it has become mainstream.¹ This increased utilization has resulted in increased cost as well, say Ruzzo and colleagues, who presented research on genetic testing costs and compliance with clinical best practices at the 2017 Annual Clinical and Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG).² But, according to previous research say Ruzzo and colleagues, these costs can be quelled by involving genetic counselors in the test-ordering process.

Just how much cost savings can be achieved? In their quality improvement project, the investigators found that 38.6% of 44 genetic tests reviewed were inappropriately ordered—either they were not indicated (21%), misordered for false reassurance (7%), or inadequately ordered (10.5%). If the tests were ordered as appropriately recommended, a cost savings of $20,912.58 would have been realized, according to the researchers.

Ruzzo and colleagues reviewed 114 charts over a 3-month period for adherence with published clinical practice guidelines. All of the charts were associated with a genetic test billing code for common tests ordered through LabCorp (for cystic fibrosis, BRCA mutation, factor V Leiden, prothrombin, alpha-thalassemia, hemochromatosis, and cell-free DNA).

The researchers concluded that genetic counselor review or involvement in genetic test ordering can decrease inappropriate spending and improve patient care. They pointed out that the 114 charts reviewed represent a fraction of genetic tests ordered at their institution, and further study should broaden the research scope to determine the full extent of the problem.

Ruzzo and colleagues were awarded first prize for their research as presented at ACOG.
 

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In the 11 studies that have examined the incidence of leiomyosarcoma (LMS) since the 2014 communications by the US Food and Drug Administration (FDA),¹ Dr. Matthew Siedhoff and colleagues found that the cumulative LMS incidence in 318,006 women was 0.0017%, or approximately 1 in 600. This is according to data Dr. Seidhoff presented November 16, 2016, at the 45th annual AAGL Global Congress on MIGS.² This reported risk is smaller than the 1 in 350 cited by the FDA in its 2014 notice.¹ Dr. Seidhoff concluded that, particularly in women aged younger than 50 years, minimally invasive hysterectomy remains a safe option for the informed patient to consider.

Regardless of the incidence of unsuspected LMS found in the studies published since 2014, what have been the practice changes among gynecologic surgeons as a result of the FDA’s 2014 actions? Kerac N. Falk, MD, explored this question with his colleagues at the Icahn School of Medicine in New York, New York. He presented these findings to AAGL congress attendees on November 16 in Orlando, Florida.³ Notably, of 197 responders to a survey sent to members of the Society of Gynecologic Oncologists, 12.5% reported decreasing their use of power morcellation. A full 38.8% reported discontinuing altogether the use of a power morcellator.

One in 5 (20%) of gyn oncologists previously using power morcellation reported switching to laparotomy. Importantly, the drive for the switch was “driven by media, patient request, and the FDA rather than physician choice,” Falk said.

What if physicians, and patients, have another choice?

Here at the AAGL meeting, Olympus announced the FDA clearance, marketing, and initial training on its contained tissue extraction system—the PneumoLiner containment device and its accompanying laparoscopic PK Morcellator (FIGURE).

Both tools, FDA cleared in April and October 2016, respectively, provide low-risk, appropriate women with “an improved safety device,” said Jubilee Brown, MD, AAGL representative on power morcellation to the FDA and Associate Director of Gynecologic Oncology at the Levine Cancer Institute of the Carolinas HealthCare System in Charlotte, North Carolina.

“We have found at our institution that we have had to do more opens and minilaps on patients without the option for power morcellation, and this new device offers a way for us not to have to do that. Minimally invasive surgery stays truly minimally invasive surgery,” said Dr. Brown.

“Although I have a handful of patients who have chosen open surgery over minimally invasive surgery when MIS was appropriate, by and large most patients prefer the minimally invasive approach to surgery—especially when they learn that they have reduced risk for complications, blood loss, and pain; will be back to normal life faster; and will have less cosmetic incisions,” said Dr. Brown. “We all have tried workarounds, but for low-risk, appropriate patients under FDA guidelines, this new device by Olympus brings us back to minimally invasive options, and that is a good thing.”

How does the Olympus containment system work?

The PneumoLiner is the first containment device to receive FDA market clearance that is designed for use with certain laparoscopic morcellators to isolate uterine tissue that is not suspected to contain cancer.⁴

The containment bag and morcellator are not indicated for use in women with tissue that is known or suspected to contain malignancy; and should not be used for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or candidates for en bloc tissue removal vaginally or via mini-laparotomy.⁴

When insufflated, the PneumoLiner bag allows for space and surgeon visibility throughout the power morcellation procedure while maintaining a barrier to the escape of fluids, cells, and tissue fragments. The bag creates a barrier between the targeted tissue and nontargeted abdominal contents, minimizing the risk of inadvertent damage to adjacent structures, says Olympus.⁴ See this video, which demonstrates the procedure.

Surgeon training on new device use is rigid, comprehensive, and not to be overlooked

“This is one of the rare times in my career when, right out of the gate, we have a very rigid and comprehensive way of educating and training physicians on the proper utilization of a new technology (avoiding the cart-before-the-horse phenomenon, in which a clinician is given the tools without the proper education),” said AAGL immediate past president Arnold Advincula, MD, “and it is important to underscore that.” Dr. Advincula is the Levine Family Professor, Vice-Chair of Women’s Health, and Chief of Gynecology at Sloane Women’s Hospital, Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.

Training plans

Instead of its sales force, Olympus is having surgeons train other surgeons. Clinical Education Specialists, a small, select group of individuals within the company, also will be able to train. The required training follows a rigid protocol that was validated and submitted to the FDA as part of the approval process, said Jerilyn Hitchings, Director of Procedure Marketing at Olympus. After training up to 40 surgeons in the past 3 weeks, Olympus expects to train another 100 at AAGL.

“We have strict criteria for training, including that they are advanced laparoscopists,” fulfilling a minimum number of surgeries within a 90-day period, said Hitchings.

The 1-hour training requires surgeons to perform a 4-step protocol and demonstrate unaided proficiency at training conclusion. Olympus will not sell its product to a facility until an advanced surgeon has been trained there, according to Hitchings. And many physicians are approaching their institutions inquiring about training now, she reports.

Applications for training will be submitted to the Olympus Professional Education Team for approval. “We want this to go well. We know that there are many physicians who are hoping that this becomes a good reality, and we want to make sure that it is done properly. The training process adheres to that agenda.”

Having the technology is step 1

OBG Management Board of Editors member Dr. Advincula struck an optimistic tone in his June 2016 Guest Editorial for the journal,⁶ indicating his belief that the “tissue morcellation pendulum,” which has swung toward non−minimally invasive approaches since 2014, can change direction. At the Olympus containment system official introduction event at AAGL, he expressed the same optimism:

“We now have technology that has the promise of being able to deliver to women a safe way to undergo tissue extraction, to undergo a minimally invasive surgical procedure. …When you combine innovation and education together, you ultimately are going to advance MIS worldwide. With all the things going on around the world today, I think it is important that women be able to have a choice, an autonomous choice with her physician. Having the technology that allows physicians to extract tissue safely, to give women the option of undergoing a minimally invasive surgery, is critically important. I look forward to seeing how we can continue to advance surgery. Partnership with clinicians and with industry, such as Olympus, is going to be key to the success of how we advance women’s health care in general.”

What do AAGL attendees have to say about it?

“It’s a good thing for the minimally invasive market,” said John B. Gebhart, MD, MS, vaginal hysterectomy representative at the star-studded Operating with the Stars event on Thursday, November 17, and Professor of Obstetrics and Gynecology at the Mayo Clinic in Rochester, Minnesota.

May Thomassee, MD, who practices in Lafayette, Louisiana, said that, for the past 3 years, she has been performing extracorporeal morcellation at her institution. “I think the new containment bag and morcellator devices that are attempting to be safer are a very good thing; however, my concern of introducing this new technology, such as bags, is that it may increase the cost within our health care system. We have had great success, and patients feel that they have options when we offer them—after informed consent and appropriate preoperative workup—an abdominal, vaginal, or extracorporeal morcellation approach.”

As a developer and proponent of the Extracorporeal Tissue Extraction (ExCITE) technique, Mireille Truong, MD, who demonstrated the ExCITE surgical approach with Dr. Advincula as part of the Research and Science Plenary here at AAGL, said, “I think the PneumoLiner is a great example of creativity and innovation. It’s good that we now have an FDA-approved device to offer and counsel patients as one of many options.” She added that, overall, the morcellation controversy has been “a positive experience. We have learned better as a community about how to approach new technology.”

In the 11 studies that have examined the incidence of leiomyosarcoma (LMS) since the 2014 communications by the US Food and Drug Administration (FDA),¹ Dr. Matthew Siedhoff and colleagues found that the cumulative LMS incidence in 318,006 women was 0.0017%, or approximately 1 in 600. This is according to data Dr. Seidhoff presented November 16, 2016, at the 45th annual AAGL Global Congress on MIGS.² This reported risk is smaller than the 1 in 350 cited by the FDA in its 2014 notice.¹ Dr. Seidhoff concluded that, particularly in women aged younger than 50 years, minimally invasive hysterectomy remains a safe option for the informed patient to consider.

Regardless of the incidence of unsuspected LMS found in the studies published since 2014, what have been the practice changes among gynecologic surgeons as a result of the FDA’s 2014 actions? Kerac N. Falk, MD, explored this question with his colleagues at the Icahn School of Medicine in New York, New York. He presented these findings to AAGL congress attendees on November 16 in Orlando, Florida.³ Notably, of 197 responders to a survey sent to members of the Society of Gynecologic Oncologists, 12.5% reported decreasing their use of power morcellation. A full 38.8% reported discontinuing altogether the use of a power morcellator.

One in 5 (20%) of gyn oncologists previously using power morcellation reported switching to laparotomy. Importantly, the drive for the switch was “driven by media, patient request, and the FDA rather than physician choice,” Falk said.

What if physicians, and patients, have another choice?

Here at the AAGL meeting, Olympus announced the FDA clearance, marketing, and initial training on its contained tissue extraction system—the PneumoLiner containment device and its accompanying laparoscopic PK Morcellator (FIGURE).

Both tools, FDA cleared in April and October 2016, respectively, provide low-risk, appropriate women with “an improved safety device,” said Jubilee Brown, MD, AAGL representative on power morcellation to the FDA and Associate Director of Gynecologic Oncology at the Levine Cancer Institute of the Carolinas HealthCare System in Charlotte, North Carolina.

“We have found at our institution that we have had to do more opens and minilaps on patients without the option for power morcellation, and this new device offers a way for us not to have to do that. Minimally invasive surgery stays truly minimally invasive surgery,” said Dr. Brown.

“Although I have a handful of patients who have chosen open surgery over minimally invasive surgery when MIS was appropriate, by and large most patients prefer the minimally invasive approach to surgery—especially when they learn that they have reduced risk for complications, blood loss, and pain; will be back to normal life faster; and will have less cosmetic incisions,” said Dr. Brown. “We all have tried workarounds, but for low-risk, appropriate patients under FDA guidelines, this new device by Olympus brings us back to minimally invasive options, and that is a good thing.”

How does the Olympus containment system work?

The PneumoLiner is the first containment device to receive FDA market clearance that is designed for use with certain laparoscopic morcellators to isolate uterine tissue that is not suspected to contain cancer.⁴

The containment bag and morcellator are not indicated for use in women with tissue that is known or suspected to contain malignancy; and should not be used for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or candidates for en bloc tissue removal vaginally or via mini-laparotomy.⁴

When insufflated, the PneumoLiner bag allows for space and surgeon visibility throughout the power morcellation procedure while maintaining a barrier to the escape of fluids, cells, and tissue fragments. The bag creates a barrier between the targeted tissue and nontargeted abdominal contents, minimizing the risk of inadvertent damage to adjacent structures, says Olympus.⁴ See this video, which demonstrates the procedure.

Surgeon training on new device use is rigid, comprehensive, and not to be overlooked

“This is one of the rare times in my career when, right out of the gate, we have a very rigid and comprehensive way of educating and training physicians on the proper utilization of a new technology (avoiding the cart-before-the-horse phenomenon, in which a clinician is given the tools without the proper education),” said AAGL immediate past president Arnold Advincula, MD, “and it is important to underscore that.” Dr. Advincula is the Levine Family Professor, Vice-Chair of Women’s Health, and Chief of Gynecology at Sloane Women’s Hospital, Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.

Training plans

Instead of its sales force, Olympus is having surgeons train other surgeons. Clinical Education Specialists, a small, select group of individuals within the company, also will be able to train. The required training follows a rigid protocol that was validated and submitted to the FDA as part of the approval process, said Jerilyn Hitchings, Director of Procedure Marketing at Olympus. After training up to 40 surgeons in the past 3 weeks, Olympus expects to train another 100 at AAGL.

“We have strict criteria for training, including that they are advanced laparoscopists,” fulfilling a minimum number of surgeries within a 90-day period, said Hitchings.

The 1-hour training requires surgeons to perform a 4-step protocol and demonstrate unaided proficiency at training conclusion. Olympus will not sell its product to a facility until an advanced surgeon has been trained there, according to Hitchings. And many physicians are approaching their institutions inquiring about training now, she reports.

Applications for training will be submitted to the Olympus Professional Education Team for approval. “We want this to go well. We know that there are many physicians who are hoping that this becomes a good reality, and we want to make sure that it is done properly. The training process adheres to that agenda.”

Having the technology is step 1

OBG Management Board of Editors member Dr. Advincula struck an optimistic tone in his June 2016 Guest Editorial for the journal,⁶ indicating his belief that the “tissue morcellation pendulum,” which has swung toward non−minimally invasive approaches since 2014, can change direction. At the Olympus containment system official introduction event at AAGL, he expressed the same optimism:

“We now have technology that has the promise of being able to deliver to women a safe way to undergo tissue extraction, to undergo a minimally invasive surgical procedure. …When you combine innovation and education together, you ultimately are going to advance MIS worldwide. With all the things going on around the world today, I think it is important that women be able to have a choice, an autonomous choice with her physician. Having the technology that allows physicians to extract tissue safely, to give women the option of undergoing a minimally invasive surgery, is critically important. I look forward to seeing how we can continue to advance surgery. Partnership with clinicians and with industry, such as Olympus, is going to be key to the success of how we advance women’s health care in general.”

What do AAGL attendees have to say about it?

“It’s a good thing for the minimally invasive market,” said John B. Gebhart, MD, MS, vaginal hysterectomy representative at the star-studded Operating with the Stars event on Thursday, November 17, and Professor of Obstetrics and Gynecology at the Mayo Clinic in Rochester, Minnesota.

May Thomassee, MD, who practices in Lafayette, Louisiana, said that, for the past 3 years, she has been performing extracorporeal morcellation at her institution. “I think the new containment bag and morcellator devices that are attempting to be safer are a very good thing; however, my concern of introducing this new technology, such as bags, is that it may increase the cost within our health care system. We have had great success, and patients feel that they have options when we offer them—after informed consent and appropriate preoperative workup—an abdominal, vaginal, or extracorporeal morcellation approach.”

As a developer and proponent of the Extracorporeal Tissue Extraction (ExCITE) technique, Mireille Truong, MD, who demonstrated the ExCITE surgical approach with Dr. Advincula as part of the Research and Science Plenary here at AAGL, said, “I think the PneumoLiner is a great example of creativity and innovation. It’s good that we now have an FDA-approved device to offer and counsel patients as one of many options.” She added that, overall, the morcellation controversy has been “a positive experience. We have learned better as a community about how to approach new technology.”

In the 11 studies that have examined the incidence of leiomyosarcoma (LMS) since the 2014 communications by the US Food and Drug Administration (FDA),¹ Dr. Matthew Siedhoff and colleagues found that the cumulative LMS incidence in 318,006 women was 0.0017%, or approximately 1 in 600. This is according to data Dr. Seidhoff presented November 16, 2016, at the 45th annual AAGL Global Congress on MIGS.² This reported risk is smaller than the 1 in 350 cited by the FDA in its 2014 notice.¹ Dr. Seidhoff concluded that, particularly in women aged younger than 50 years, minimally invasive hysterectomy remains a safe option for the informed patient to consider.

Regardless of the incidence of unsuspected LMS found in the studies published since 2014, what have been the practice changes among gynecologic surgeons as a result of the FDA’s 2014 actions? Kerac N. Falk, MD, explored this question with his colleagues at the Icahn School of Medicine in New York, New York. He presented these findings to AAGL congress attendees on November 16 in Orlando, Florida.³ Notably, of 197 responders to a survey sent to members of the Society of Gynecologic Oncologists, 12.5% reported decreasing their use of power morcellation. A full 38.8% reported discontinuing altogether the use of a power morcellator.

One in 5 (20%) of gyn oncologists previously using power morcellation reported switching to laparotomy. Importantly, the drive for the switch was “driven by media, patient request, and the FDA rather than physician choice,” Falk said.

What if physicians, and patients, have another choice?

Here at the AAGL meeting, Olympus announced the FDA clearance, marketing, and initial training on its contained tissue extraction system—the PneumoLiner containment device and its accompanying laparoscopic PK Morcellator (FIGURE).

Both tools, FDA cleared in April and October 2016, respectively, provide low-risk, appropriate women with “an improved safety device,” said Jubilee Brown, MD, AAGL representative on power morcellation to the FDA and Associate Director of Gynecologic Oncology at the Levine Cancer Institute of the Carolinas HealthCare System in Charlotte, North Carolina.

“We have found at our institution that we have had to do more opens and minilaps on patients without the option for power morcellation, and this new device offers a way for us not to have to do that. Minimally invasive surgery stays truly minimally invasive surgery,” said Dr. Brown.

“Although I have a handful of patients who have chosen open surgery over minimally invasive surgery when MIS was appropriate, by and large most patients prefer the minimally invasive approach to surgery—especially when they learn that they have reduced risk for complications, blood loss, and pain; will be back to normal life faster; and will have less cosmetic incisions,” said Dr. Brown. “We all have tried workarounds, but for low-risk, appropriate patients under FDA guidelines, this new device by Olympus brings us back to minimally invasive options, and that is a good thing.”

How does the Olympus containment system work?

The PneumoLiner is the first containment device to receive FDA market clearance that is designed for use with certain laparoscopic morcellators to isolate uterine tissue that is not suspected to contain cancer.⁴

The containment bag and morcellator are not indicated for use in women with tissue that is known or suspected to contain malignancy; and should not be used for removal of uterine tissue containing suspected fibroids in patients who are peri- or post-menopausal, or candidates for en bloc tissue removal vaginally or via mini-laparotomy.⁴

When insufflated, the PneumoLiner bag allows for space and surgeon visibility throughout the power morcellation procedure while maintaining a barrier to the escape of fluids, cells, and tissue fragments. The bag creates a barrier between the targeted tissue and nontargeted abdominal contents, minimizing the risk of inadvertent damage to adjacent structures, says Olympus.⁴ See this video, which demonstrates the procedure.

Surgeon training on new device use is rigid, comprehensive, and not to be overlooked

“This is one of the rare times in my career when, right out of the gate, we have a very rigid and comprehensive way of educating and training physicians on the proper utilization of a new technology (avoiding the cart-before-the-horse phenomenon, in which a clinician is given the tools without the proper education),” said AAGL immediate past president Arnold Advincula, MD, “and it is important to underscore that.” Dr. Advincula is the Levine Family Professor, Vice-Chair of Women’s Health, and Chief of Gynecology at Sloane Women’s Hospital, Columbia University Medical Center/New York-Presbyterian Hospital, New York, New York.

Training plans

Instead of its sales force, Olympus is having surgeons train other surgeons. Clinical Education Specialists, a small, select group of individuals within the company, also will be able to train. The required training follows a rigid protocol that was validated and submitted to the FDA as part of the approval process, said Jerilyn Hitchings, Director of Procedure Marketing at Olympus. After training up to 40 surgeons in the past 3 weeks, Olympus expects to train another 100 at AAGL.

“We have strict criteria for training, including that they are advanced laparoscopists,” fulfilling a minimum number of surgeries within a 90-day period, said Hitchings.

The 1-hour training requires surgeons to perform a 4-step protocol and demonstrate unaided proficiency at training conclusion. Olympus will not sell its product to a facility until an advanced surgeon has been trained there, according to Hitchings. And many physicians are approaching their institutions inquiring about training now, she reports.

Applications for training will be submitted to the Olympus Professional Education Team for approval. “We want this to go well. We know that there are many physicians who are hoping that this becomes a good reality, and we want to make sure that it is done properly. The training process adheres to that agenda.”

Having the technology is step 1

OBG Management Board of Editors member Dr. Advincula struck an optimistic tone in his June 2016 Guest Editorial for the journal,⁶ indicating his belief that the “tissue morcellation pendulum,” which has swung toward non−minimally invasive approaches since 2014, can change direction. At the Olympus containment system official introduction event at AAGL, he expressed the same optimism:

“We now have technology that has the promise of being able to deliver to women a safe way to undergo tissue extraction, to undergo a minimally invasive surgical procedure. …When you combine innovation and education together, you ultimately are going to advance MIS worldwide. With all the things going on around the world today, I think it is important that women be able to have a choice, an autonomous choice with her physician. Having the technology that allows physicians to extract tissue safely, to give women the option of undergoing a minimally invasive surgery, is critically important. I look forward to seeing how we can continue to advance surgery. Partnership with clinicians and with industry, such as Olympus, is going to be key to the success of how we advance women’s health care in general.”

What do AAGL attendees have to say about it?

“It’s a good thing for the minimally invasive market,” said John B. Gebhart, MD, MS, vaginal hysterectomy representative at the star-studded Operating with the Stars event on Thursday, November 17, and Professor of Obstetrics and Gynecology at the Mayo Clinic in Rochester, Minnesota.

May Thomassee, MD, who practices in Lafayette, Louisiana, said that, for the past 3 years, she has been performing extracorporeal morcellation at her institution. “I think the new containment bag and morcellator devices that are attempting to be safer are a very good thing; however, my concern of introducing this new technology, such as bags, is that it may increase the cost within our health care system. We have had great success, and patients feel that they have options when we offer them—after informed consent and appropriate preoperative workup—an abdominal, vaginal, or extracorporeal morcellation approach.”

As a developer and proponent of the Extracorporeal Tissue Extraction (ExCITE) technique, Mireille Truong, MD, who demonstrated the ExCITE surgical approach with Dr. Advincula as part of the Research and Science Plenary here at AAGL, said, “I think the PneumoLiner is a great example of creativity and innovation. It’s good that we now have an FDA-approved device to offer and counsel patients as one of many options.” She added that, overall, the morcellation controversy has been “a positive experience. We have learned better as a community about how to approach new technology.”

Although patients have more assisted reproductive techniques (ART) available in recent years, management of infertility through minimally invasive surgical avenues can confront quality of life (QoL) and pathology concerns with birth rates equal to those with ART. This was a main takeaway in a packed ballroom in Orlando, Florida, at the 45th Global Congress of the AAGL. In this session, G. David Adamson, MD, brought together 3 top minimally invasive gynecologic surgeons to discuss clinical decisions in the overall and specific surgical management of: endometriomas and endometriosis, including deeply infiltrating disease; pelvic adhesions; distal tubal injury/occlusion; and proximal tubal occlusion by hysteroscopy.

Tommaso Falcone, MD, maintained that many patients (up to 85%) have pain with endometriomas, and addressing QoL for these women, with surgery versus managing their infertility only with in vitro fertilization (IVF), is an important consideration. Dr. Adamson noted that, “although there are no RCT data to guide management of endometriomas, we do have reasonable data to counsel patients on surgery versus IVF, with clinical considerations including patient age, presence of pain, and size of the endometrioma.”

Antonio Gargiulo, MD, advised attendees that when counseling patients on the role of laparoscopy in adhesiolysis to consider (1) that adhesions interfere with gamete and embryo transplant, (2) retrospective data from a small study show a positive effect of adhesiolysis in infertility, and (3) that the effect is dependent on the ASRM Adhesion Score. Regarding laparoscopy for distal tubal inclusion, he noted that case selection is important, as surgery can restore anatomic integrity but not functional integrity. In addition, he pointed out that neosalpingectomy before IVF should be considered in young women with mild hydrosalpinges when male factor infertility is present.

For proximal tubal occlusion, Dr. Gargiulo noted that hysteroscopy catheterization has diagnostic and therapeutic value, with contraindications including infection, inflammation, male factor infertility, and prior tubal surgery.

“Surgeons must offer and understand ART alternatives so that they can offer patient-centered choices,” said Dr. Gargiulo.

Finally, when does Dr. Leila Adamyan of the Federal State Institution Research Center for Obstetrics, Gynecology, and Perinatology of the V.I. Kulakov Russian Federation perform myomectomy before IVF? In the presence of:

• submucosal myoma
• myoma greater than 4 cm in size
• multiple myoma.

When sarcoma is suspected, she advises the use of endobags.

Although patients have more assisted reproductive techniques (ART) available in recent years, management of infertility through minimally invasive surgical avenues can confront quality of life (QoL) and pathology concerns with birth rates equal to those with ART. This was a main takeaway in a packed ballroom in Orlando, Florida, at the 45th Global Congress of the AAGL. In this session, G. David Adamson, MD, brought together 3 top minimally invasive gynecologic surgeons to discuss clinical decisions in the overall and specific surgical management of: endometriomas and endometriosis, including deeply infiltrating disease; pelvic adhesions; distal tubal injury/occlusion; and proximal tubal occlusion by hysteroscopy.

Tommaso Falcone, MD, maintained that many patients (up to 85%) have pain with endometriomas, and addressing QoL for these women, with surgery versus managing their infertility only with in vitro fertilization (IVF), is an important consideration. Dr. Adamson noted that, “although there are no RCT data to guide management of endometriomas, we do have reasonable data to counsel patients on surgery versus IVF, with clinical considerations including patient age, presence of pain, and size of the endometrioma.”

Antonio Gargiulo, MD, advised attendees that when counseling patients on the role of laparoscopy in adhesiolysis to consider (1) that adhesions interfere with gamete and embryo transplant, (2) retrospective data from a small study show a positive effect of adhesiolysis in infertility, and (3) that the effect is dependent on the ASRM Adhesion Score. Regarding laparoscopy for distal tubal inclusion, he noted that case selection is important, as surgery can restore anatomic integrity but not functional integrity. In addition, he pointed out that neosalpingectomy before IVF should be considered in young women with mild hydrosalpinges when male factor infertility is present.

For proximal tubal occlusion, Dr. Gargiulo noted that hysteroscopy catheterization has diagnostic and therapeutic value, with contraindications including infection, inflammation, male factor infertility, and prior tubal surgery.

“Surgeons must offer and understand ART alternatives so that they can offer patient-centered choices,” said Dr. Gargiulo.

Finally, when does Dr. Leila Adamyan of the Federal State Institution Research Center for Obstetrics, Gynecology, and Perinatology of the V.I. Kulakov Russian Federation perform myomectomy before IVF? In the presence of:

• submucosal myoma
• myoma greater than 4 cm in size
• multiple myoma.

When sarcoma is suspected, she advises the use of endobags.

Although patients have more assisted reproductive techniques (ART) available in recent years, management of infertility through minimally invasive surgical avenues can confront quality of life (QoL) and pathology concerns with birth rates equal to those with ART. This was a main takeaway in a packed ballroom in Orlando, Florida, at the 45th Global Congress of the AAGL. In this session, G. David Adamson, MD, brought together 3 top minimally invasive gynecologic surgeons to discuss clinical decisions in the overall and specific surgical management of: endometriomas and endometriosis, including deeply infiltrating disease; pelvic adhesions; distal tubal injury/occlusion; and proximal tubal occlusion by hysteroscopy.

Tommaso Falcone, MD, maintained that many patients (up to 85%) have pain with endometriomas, and addressing QoL for these women, with surgery versus managing their infertility only with in vitro fertilization (IVF), is an important consideration. Dr. Adamson noted that, “although there are no RCT data to guide management of endometriomas, we do have reasonable data to counsel patients on surgery versus IVF, with clinical considerations including patient age, presence of pain, and size of the endometrioma.”

Antonio Gargiulo, MD, advised attendees that when counseling patients on the role of laparoscopy in adhesiolysis to consider (1) that adhesions interfere with gamete and embryo transplant, (2) retrospective data from a small study show a positive effect of adhesiolysis in infertility, and (3) that the effect is dependent on the ASRM Adhesion Score. Regarding laparoscopy for distal tubal inclusion, he noted that case selection is important, as surgery can restore anatomic integrity but not functional integrity. In addition, he pointed out that neosalpingectomy before IVF should be considered in young women with mild hydrosalpinges when male factor infertility is present.

For proximal tubal occlusion, Dr. Gargiulo noted that hysteroscopy catheterization has diagnostic and therapeutic value, with contraindications including infection, inflammation, male factor infertility, and prior tubal surgery.

“Surgeons must offer and understand ART alternatives so that they can offer patient-centered choices,” said Dr. Gargiulo.

Finally, when does Dr. Leila Adamyan of the Federal State Institution Research Center for Obstetrics, Gynecology, and Perinatology of the V.I. Kulakov Russian Federation perform myomectomy before IVF? In the presence of:

• submucosal myoma
• myoma greater than 4 cm in size
• multiple myoma.

When sarcoma is suspected, she advises the use of endobags.