Society of Gynecologic Surgeons (SGS): Annual Scientific Meeting

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2916-15
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2015

Power morcellation debate: Crunching the data

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Power morcellation debate: Crunching the data

ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

RTEmagicC_3bd59d6_Sokol_Eric_R.jpg.jpg
Dr. Eric R. Sokol

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

RTEmagicC_3bd59d6_Brown_Jubilee_HOUSTON.jpg.jpg
Dr. Jubilee Brown

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

 

 

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.

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ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

RTEmagicC_3bd59d6_Sokol_Eric_R.jpg.jpg
Dr. Eric R. Sokol

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

RTEmagicC_3bd59d6_Brown_Jubilee_HOUSTON.jpg.jpg
Dr. Jubilee Brown

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

 

 

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.

ORLANDO – Independent of the objective data, the top hits for a Google search of power morcellation are advertisements from lawyers seeking malpractice clients, observed one of four experts participating in a debate at the annual scientific meeting of the Society of Gynecologic Surgeons.

In this opening salvo for the con position, Dr. Eric R. Sokol, an ob.gyn. and urogynecologist at Stanford (Calif.) University, acknowledged, “I am going to appeal a little bit more to your emotions to start.”

RTEmagicC_3bd59d6_Sokol_Eric_R.jpg.jpg
Dr. Eric R. Sokol

The emotional appeal may have resonated. Despite compelling data provided by those providing the pro position, a loose poll at the meeting suggested that only a handful of gynecologic surgeons in the audience still consider power morcellation a viable routine tool for the removal of fibroids.

Use of power morcellation of fibroids has been challenged on the basis of evidence that it is capable of spreading cancerous tissue if used in a woman with unsuspected uterine sarcoma. After convening a panel of experts, the Food and Drug Administration issued a safety communication April 17, 2014 that officially “discourages” use of this device for uterine fibroids.

However, not all experts accept the position that this device should be discouraged in all patients, including one of those who addressed the FDA panel and provided the pro position in the SGS debate. Dr. Jubilee Brown, an ob.gyn. in the department of gynecologic oncology and reproductive medicine at the University of Texas M.D. Anderson Cancer Center, Houston, outlined how a benefit-to-risk analysis still favors power morcellation in at least some individuals.

“We should improve but not abandon power morcellation,” Dr. Brown said. “Power morcellation with appropriate informed consent should remain available to appropriately screened, low-risk women.”

Dr. Brown based this position largely on two decision analyses that show minimally invasive laparoscopic hysterectomy with power morcellation of fibroids is safer than an open abdominal approach, which is the most commonly used alternative. One analysis by Dr. Matthew T. Siedhoff and his associates has been recently published (Am. J. Obstet. Gynecol. 2015 [doi:10.1016/j.ajog.2015.03.006]) while the other, for which Dr. Brown is an author, is in press.

RTEmagicC_3bd59d6_Brown_Jubilee_HOUSTON.jpg.jpg
Dr. Jubilee Brown

The bottom line for both was that minimally invasive hysterectomy with power morcellation would produce a lower mortality rate than abdominal laparotomy when considering all the risks for both. Specifically, the open, abdominal approach is associated with more fatal surgery-related complications, compensating for the greater but rare risk of cancer-related deaths associated with power morcellation.

To establish true benefit-to-risk equations, Dr. Brown argued that it is essential to rely on objective data. The risks posed by power morcellation for spreading cancer have “been sensationalized in the media” without fully considering how rare these cancers are. In her reading of the published data, 1 case occurs in every 452 patients to 6,400 patients.

“No one is going to argue that this [power morcellation] is a no-risk procedure,“ Dr. Brown observed, but she maintained it is important to consider this risk in context, which includes the complications associated with alternative approaches.

As a participant on the con side, Dr. Sokol rebutted with some data of his own, including a worst-case estimate that suggests the case rate of uterine sarcomas among candidates for hysterectomy may be as high as 1 in 352. However, he suggested that arguing about case rates may not be the critical issue. Rather, other risks of power morcellation deserve consideration.

“We frame this debate about the risk of sarcoma, but I think there are a lot of other issues surrounding morcellation that are important, including the risk of spreading benign disease,” Dr. Sokol maintained at the meeting jointly sponsored by the American College of Surgeons.

Citing a published analysis of a large insurance database with 36,470 women who underwent morcellation (JAMA 2014;312:1253-5), Dr. Sokol noted that the proportion of patients with pathology climbs markedly when it includes those with findings in addition to sarcoma. Specifically, while the case rate of uterine cancer was 2.7 per 1,000 patients, there were an additional 0.7 cases of gynecologic cancers of other types, 1.1 cases of uterine neoplasms with uncertain malignant potential, and 10 cases of endometrial hyperplasia.

“The prevalence of malignancy was 0.34%, but the prevalence of neoplastic conditions was 1.5%, and that is a pretty significant number,” he observed.

Beyond these data, Dr. Sokol focused on conceptual risks. As an example, he proposed that most clinicians would hesitate to employ a morcellator on tissue that appeared infected, and he suggested that this hesitation should apply in tissue with an unknown risk of neoplastic transformation.

 

 

“Cancer can spread much like an infection,” he maintained. “Why would you treat uterine fibroids or other masses that could be cancerous differently [than you would an infection]?”

One answer might be to reduce the risk of morcellated tissue from being disseminated in the peritoneal cavity, according to Dr. Andrew Sokol, an ob.gyn. and urologist at Georgetown University, Washington. The brother of Dr. Eric Sokol and serving on the pro side of the debate, Dr. Sokol suggested that containment bag attachments are being developed for power morcellator devices, and these appear to preserve the benefits while mitigating the risks.

Citing some early data from controlled studies indicating that surgical outcomes using containment bags are similar to those without a bag, Dr. Sokol suggested that containment bags might be the way to improve rather than abandon power morcellation.

Despite the potential risk of rupture and the need for more data, “these bags have the potential to maintain the advantages of minimally invasive surgery,” said Dr. Sokol, although he acknowledged that no containment bags have been approved by the FDA.

The final panelist in the debate rejected both minimally invasive surgery with power morcellation and open abdominal hysterectomies as a first choice in most women. Rather, Dr. Carl Zimmerman, professor of obstetrics and gynecology at Vanderbilt University Medical Center, Nashville, Tenn., maintained hysterectomies should most often be performed vaginally and morcellation of the fibroid should be performed extracorporeally.

“I was unable to find a single report of spread of malignant tumor” when morcellation of the fibroid was performed outside the body after a vaginal hysterectomy, Dr. Zimmerman reported. He expressed dismay that employing vaginal surgery has not been much discussed in any of the statements guiding clinicians to alternatives for power morcellation.

One reason vaginal hysterectomy is being overlooked, according to Dr. Zimmerman, is a decline in training for this technique. He believes that surgeons should either learn to perform vaginal hysterectomies or be prepared to refer patients to those experienced with this procedure.

“What do we need to do as surgeons? We need to have a working knowledge of all the surgical approaches to a given problem, and then we are ethically obligated to help our patients to chose the correct one in terms of safety, cost, and recovery,” Dr. Zimmerman said. For many women with fibroids, he believes the correct choice would be a vaginal hysterectomy that avoids both morcellation in the peritoneal space and the disadvantages of an open approach.

The debate was initially framed by a case. In the description, a 44-year-old woman with menorrhagia and fibroids had multiple features suggesting a low risk of uterine sarcoma, including a recent biopsy of the endometrium that proved benign. In this case, Dr. Brown described minimally invasive surgery with power morcellation as an “excellent option,” while Dr. Eric Sokol maintained the FDA advisory remained applicable.

However, for the minority of surgeons in the audience who sided with Dr. Brown, one issue may be reimbursement. Ten days after the SGS debate, a survey conducted by and published in the Wall Street Journal (April 3, 2015) found that insurance companies covering more than 90 million Americans have established or are considering restrictions on reimbursement for power morcellation. Increasingly, the choice is being taken out of the hands of both surgeons and patients.

Dr. Jubilee Brown, Dr. Andrew Sokol, Dr. Eric Sokol, and Dr. Carl Zimmerman reported no relevant financial disclosures.

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Power morcellation debate: Crunching the data
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Expert blasts robotic hysterectomy evidence

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Expert blasts robotic hysterectomy evidence

ORLANDO – The proportion of hysterectomies performed with robotic assistance has been growing steadily in the absence of objective evidence that this approach is superior to alternatives, according to Dr. David Grimes, an ob.gyn. at the University of North Carolina at Chapel Hill.

As part of his keynote lecture at the annual scientific meeting of the Society of Gynecologic Surgeons, Dr. Grimes cautioned surgeons that there are few randomized controlled trials of robotic hysterectomy, and published evidence has not established any use for robotic surgery in gynecology.

“Robotic hysterectomy is an expensive, unproven technology that is associated with a further degradation in the surgical training that our residents now get, and it is replacing the preferred means of hysterectomy, which is vaginal,” said Dr. Grimes.

RTEmagicC_8ac5347_Grimes_David_A_NC.jpg.jpg
Dr. David Grimes

He pointed to a 2009 committee opinion from the American College of Obstetricians and Gynecologists that cites vaginal hysterectomy as the approach of choice because it is the safest and most cost-effective way to remove a noncancerous uterus (Obstet. Gynecol. 2009;114;1156-8).

Dr. Grimes also cited a recently published joint committee opinion from ACOG and SGS that reviewed data suggesting that robotic hysterectomy has higher costs but no advantage in regard to morbidity, when compared with laparotomy for benign hysterectomies. For gynecologic malignancies, robotic surgery was found less expensive than open hysterectomy across multiple studies because of shorter hospital stays (Obstet. Gynecol. 2015;125:760-7).

Data supporting the benefits of robotic surgery remain sparse, according to Dr. Grimes. He cited a Cochrane Review based on six studies that found there is only “low-quality” evidence on which to conclude that robotic hysterectomy is as safe as conventional laparotomy and only “moderate-quality” evidence that it reduces hospital stays (Cochrane Database Syst. Rev. 2014 Dec. 10;12:CD011422). The authors of the review emphasized that more research is needed.

The United Kingdom’s National Health Service and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists have drawn similar conclusions, according to Dr. Grimes.

But even without clear evidence, the rates of robotic hysterectomy in the United States have been climbing at the same time that rates of vaginal hysterectomy have fallen, said Dr. Grimes, who estimated that approximately 2,500 U.S. hospitals now offer robotic surgery. The growth, he said, is due largely to “aggressive marketing.”

Dr. Grimes proposed that to protect patient safety, the use of robotic surgery should be restricted to formal clinical trial protocols approved by an institutional review board.

“Any use of the robot today off protocol is uncontrolled human experimentation,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.

RTEmagicC_8ac5347_Rardin_%20Charles%20_%20RI.jpg.jpg
Dr. Charles R. Rardin

Dr. Charles R. Rardin, chairman of the SGS Program Committee and director of the robotic surgery program at Women & Infants Hospital of Rhode Island, said “the audience very much appreciated the candor and dedication” expressed by Dr. Grimes for high-quality evidence, but he did not offer a direct endorsement from SGS of the characterization of robotic hysterectomy as experimental.

“SGS has always hosted a vigorous and academic dialogue regarding the pros and cons of robotic surgery,” Dr. Rardin said. “We advocate well-designed research to determine which patients are likely to benefit from robotic surgery. We emphasize that case selection should be based on the best available relevant data as well as expert opinion, and surgical consent should include risks related to the robotic approach.”

Dr. Grimes and Dr. Rardin reported having no relevant financial disclosures.

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ORLANDO – The proportion of hysterectomies performed with robotic assistance has been growing steadily in the absence of objective evidence that this approach is superior to alternatives, according to Dr. David Grimes, an ob.gyn. at the University of North Carolina at Chapel Hill.

As part of his keynote lecture at the annual scientific meeting of the Society of Gynecologic Surgeons, Dr. Grimes cautioned surgeons that there are few randomized controlled trials of robotic hysterectomy, and published evidence has not established any use for robotic surgery in gynecology.

“Robotic hysterectomy is an expensive, unproven technology that is associated with a further degradation in the surgical training that our residents now get, and it is replacing the preferred means of hysterectomy, which is vaginal,” said Dr. Grimes.

RTEmagicC_8ac5347_Grimes_David_A_NC.jpg.jpg
Dr. David Grimes

He pointed to a 2009 committee opinion from the American College of Obstetricians and Gynecologists that cites vaginal hysterectomy as the approach of choice because it is the safest and most cost-effective way to remove a noncancerous uterus (Obstet. Gynecol. 2009;114;1156-8).

Dr. Grimes also cited a recently published joint committee opinion from ACOG and SGS that reviewed data suggesting that robotic hysterectomy has higher costs but no advantage in regard to morbidity, when compared with laparotomy for benign hysterectomies. For gynecologic malignancies, robotic surgery was found less expensive than open hysterectomy across multiple studies because of shorter hospital stays (Obstet. Gynecol. 2015;125:760-7).

Data supporting the benefits of robotic surgery remain sparse, according to Dr. Grimes. He cited a Cochrane Review based on six studies that found there is only “low-quality” evidence on which to conclude that robotic hysterectomy is as safe as conventional laparotomy and only “moderate-quality” evidence that it reduces hospital stays (Cochrane Database Syst. Rev. 2014 Dec. 10;12:CD011422). The authors of the review emphasized that more research is needed.

The United Kingdom’s National Health Service and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists have drawn similar conclusions, according to Dr. Grimes.

But even without clear evidence, the rates of robotic hysterectomy in the United States have been climbing at the same time that rates of vaginal hysterectomy have fallen, said Dr. Grimes, who estimated that approximately 2,500 U.S. hospitals now offer robotic surgery. The growth, he said, is due largely to “aggressive marketing.”

Dr. Grimes proposed that to protect patient safety, the use of robotic surgery should be restricted to formal clinical trial protocols approved by an institutional review board.

“Any use of the robot today off protocol is uncontrolled human experimentation,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.

RTEmagicC_8ac5347_Rardin_%20Charles%20_%20RI.jpg.jpg
Dr. Charles R. Rardin

Dr. Charles R. Rardin, chairman of the SGS Program Committee and director of the robotic surgery program at Women & Infants Hospital of Rhode Island, said “the audience very much appreciated the candor and dedication” expressed by Dr. Grimes for high-quality evidence, but he did not offer a direct endorsement from SGS of the characterization of robotic hysterectomy as experimental.

“SGS has always hosted a vigorous and academic dialogue regarding the pros and cons of robotic surgery,” Dr. Rardin said. “We advocate well-designed research to determine which patients are likely to benefit from robotic surgery. We emphasize that case selection should be based on the best available relevant data as well as expert opinion, and surgical consent should include risks related to the robotic approach.”

Dr. Grimes and Dr. Rardin reported having no relevant financial disclosures.

ORLANDO – The proportion of hysterectomies performed with robotic assistance has been growing steadily in the absence of objective evidence that this approach is superior to alternatives, according to Dr. David Grimes, an ob.gyn. at the University of North Carolina at Chapel Hill.

As part of his keynote lecture at the annual scientific meeting of the Society of Gynecologic Surgeons, Dr. Grimes cautioned surgeons that there are few randomized controlled trials of robotic hysterectomy, and published evidence has not established any use for robotic surgery in gynecology.

“Robotic hysterectomy is an expensive, unproven technology that is associated with a further degradation in the surgical training that our residents now get, and it is replacing the preferred means of hysterectomy, which is vaginal,” said Dr. Grimes.

RTEmagicC_8ac5347_Grimes_David_A_NC.jpg.jpg
Dr. David Grimes

He pointed to a 2009 committee opinion from the American College of Obstetricians and Gynecologists that cites vaginal hysterectomy as the approach of choice because it is the safest and most cost-effective way to remove a noncancerous uterus (Obstet. Gynecol. 2009;114;1156-8).

Dr. Grimes also cited a recently published joint committee opinion from ACOG and SGS that reviewed data suggesting that robotic hysterectomy has higher costs but no advantage in regard to morbidity, when compared with laparotomy for benign hysterectomies. For gynecologic malignancies, robotic surgery was found less expensive than open hysterectomy across multiple studies because of shorter hospital stays (Obstet. Gynecol. 2015;125:760-7).

Data supporting the benefits of robotic surgery remain sparse, according to Dr. Grimes. He cited a Cochrane Review based on six studies that found there is only “low-quality” evidence on which to conclude that robotic hysterectomy is as safe as conventional laparotomy and only “moderate-quality” evidence that it reduces hospital stays (Cochrane Database Syst. Rev. 2014 Dec. 10;12:CD011422). The authors of the review emphasized that more research is needed.

The United Kingdom’s National Health Service and the Royal Australian and New Zealand College of Obstetricians and Gynaecologists have drawn similar conclusions, according to Dr. Grimes.

But even without clear evidence, the rates of robotic hysterectomy in the United States have been climbing at the same time that rates of vaginal hysterectomy have fallen, said Dr. Grimes, who estimated that approximately 2,500 U.S. hospitals now offer robotic surgery. The growth, he said, is due largely to “aggressive marketing.”

Dr. Grimes proposed that to protect patient safety, the use of robotic surgery should be restricted to formal clinical trial protocols approved by an institutional review board.

“Any use of the robot today off protocol is uncontrolled human experimentation,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.

RTEmagicC_8ac5347_Rardin_%20Charles%20_%20RI.jpg.jpg
Dr. Charles R. Rardin

Dr. Charles R. Rardin, chairman of the SGS Program Committee and director of the robotic surgery program at Women & Infants Hospital of Rhode Island, said “the audience very much appreciated the candor and dedication” expressed by Dr. Grimes for high-quality evidence, but he did not offer a direct endorsement from SGS of the characterization of robotic hysterectomy as experimental.

“SGS has always hosted a vigorous and academic dialogue regarding the pros and cons of robotic surgery,” Dr. Rardin said. “We advocate well-designed research to determine which patients are likely to benefit from robotic surgery. We emphasize that case selection should be based on the best available relevant data as well as expert opinion, and surgical consent should include risks related to the robotic approach.”

Dr. Grimes and Dr. Rardin reported having no relevant financial disclosures.

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Bundled gynecologic surgery payments modified on appeal

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ORLANDO – At least some coding edits introduced by the National Correct Coding Initiative that eliminated billing for additional gynecological surgeries performed at the time of vaginal hysterectomy have been effectively challenged by a group of professional organizations led by the American Urogynecologic Society.

In an update at the annual scientific meeting of the Society of Gynecologic Surgeons (SGS), which was among the organizations contributing to the effort, surgeons were told that some of the National Correct Coding Initiative (NCCI) bundling of procedures introduced on Oct. 1, 2014, will be modified to allow separate billing beginning April 1, 2015, including retroactively billing for procedures performed before the modification.

“The NCCI enacted wide sweeping pair edits that limited the types of additional procedures that could be billed at the time of vaginal hysterectomy. For the reconstructive vaginal surgeon, this eliminated the ability to bill for additional procedures, such as combined colporrhaphy and apical vaginal suspensions,” reported Dr. Marc Toglia, who served as vice chair of the Committee for Coding and Health Policy for American Urogynecologic Society (AUGS) that led the challenge.

The bundled procedures proposed by the NCCI are part of a larger effort to avoid paying surgeons twice for surgeries that are commonly performed together without significantly increasing operating time, according to Dr. Toglia. He reported that these particular coding edits were enacted by the Centers for Medicaid & Medicare Services despite strong opposition from AUGS, SGS, the American College of Obstetricians and Gynecologists (ACOG), and others.

“While pair edits are not uncommon – for example, you cannot bill separately for cystoscopy at the time that a pubovaginal sling is performed for urinary incontinence – AUGS felt that NCCI was incorrectly combining procedures performed for different indications and requiring substantially more work than the base procedure,” Dr. Toglia explained. “The NCCI seemed focused on the fact that procedures commonly performed at the same time of vaginal hysterectomy were routinely part of this procedure.”

The NCCI revisited the Oct. 1, 2014, coding edits in the face of the continued opposition led by AUGS. As a result, modifiers can be used to allow billing for some procedures, such as colporrhaphy, done at the same time as vaginal hysterectomy or to bill for complex procedures that required substantial additional work. However, not all the coding edits have yet to be successfully challenged. A set of six bundling codes planned for implementation on April 1 have so far only been postponed until July 1.

Referring to the modifiers, Dr. Toglia, who is chief of female pelvic medicine and reconstructive surgery for the Main Line Health System in Philadelphia, explained that “the edits were not changed. Rather, there is now a work-around.”

Practical information about how to properly employ the coding modifications can be obtained at the AUGS website. The website also has more information about initiatives to challenge other coding modifications that have been proposed and are now being challenged by AUGS.

The efforts by Dr. Toglia were strongly endorsed by Dr. Andrew J. Walter, who was installed as the new president of SGS immediately after the coding initiatives were described. In an interview, Dr. Walter, who is in private practice in Roseville, Calif., suggested that it is not just a question of protecting income but avoiding disincentives. He believes surgeons should not be discouraged from combining procedures when the goal is to improve outcome and patient well being.

“SGS, AUGS, and other professional societies need to work together to ensure that reimbursement is fair and serves the interest of excellent medical care,” Dr. Walter said.

Dr. Toglia and Dr. Walter reported no relevant financial disclosures.

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ORLANDO – At least some coding edits introduced by the National Correct Coding Initiative that eliminated billing for additional gynecological surgeries performed at the time of vaginal hysterectomy have been effectively challenged by a group of professional organizations led by the American Urogynecologic Society.

In an update at the annual scientific meeting of the Society of Gynecologic Surgeons (SGS), which was among the organizations contributing to the effort, surgeons were told that some of the National Correct Coding Initiative (NCCI) bundling of procedures introduced on Oct. 1, 2014, will be modified to allow separate billing beginning April 1, 2015, including retroactively billing for procedures performed before the modification.

“The NCCI enacted wide sweeping pair edits that limited the types of additional procedures that could be billed at the time of vaginal hysterectomy. For the reconstructive vaginal surgeon, this eliminated the ability to bill for additional procedures, such as combined colporrhaphy and apical vaginal suspensions,” reported Dr. Marc Toglia, who served as vice chair of the Committee for Coding and Health Policy for American Urogynecologic Society (AUGS) that led the challenge.

The bundled procedures proposed by the NCCI are part of a larger effort to avoid paying surgeons twice for surgeries that are commonly performed together without significantly increasing operating time, according to Dr. Toglia. He reported that these particular coding edits were enacted by the Centers for Medicaid & Medicare Services despite strong opposition from AUGS, SGS, the American College of Obstetricians and Gynecologists (ACOG), and others.

“While pair edits are not uncommon – for example, you cannot bill separately for cystoscopy at the time that a pubovaginal sling is performed for urinary incontinence – AUGS felt that NCCI was incorrectly combining procedures performed for different indications and requiring substantially more work than the base procedure,” Dr. Toglia explained. “The NCCI seemed focused on the fact that procedures commonly performed at the same time of vaginal hysterectomy were routinely part of this procedure.”

The NCCI revisited the Oct. 1, 2014, coding edits in the face of the continued opposition led by AUGS. As a result, modifiers can be used to allow billing for some procedures, such as colporrhaphy, done at the same time as vaginal hysterectomy or to bill for complex procedures that required substantial additional work. However, not all the coding edits have yet to be successfully challenged. A set of six bundling codes planned for implementation on April 1 have so far only been postponed until July 1.

Referring to the modifiers, Dr. Toglia, who is chief of female pelvic medicine and reconstructive surgery for the Main Line Health System in Philadelphia, explained that “the edits were not changed. Rather, there is now a work-around.”

Practical information about how to properly employ the coding modifications can be obtained at the AUGS website. The website also has more information about initiatives to challenge other coding modifications that have been proposed and are now being challenged by AUGS.

The efforts by Dr. Toglia were strongly endorsed by Dr. Andrew J. Walter, who was installed as the new president of SGS immediately after the coding initiatives were described. In an interview, Dr. Walter, who is in private practice in Roseville, Calif., suggested that it is not just a question of protecting income but avoiding disincentives. He believes surgeons should not be discouraged from combining procedures when the goal is to improve outcome and patient well being.

“SGS, AUGS, and other professional societies need to work together to ensure that reimbursement is fair and serves the interest of excellent medical care,” Dr. Walter said.

Dr. Toglia and Dr. Walter reported no relevant financial disclosures.

ORLANDO – At least some coding edits introduced by the National Correct Coding Initiative that eliminated billing for additional gynecological surgeries performed at the time of vaginal hysterectomy have been effectively challenged by a group of professional organizations led by the American Urogynecologic Society.

In an update at the annual scientific meeting of the Society of Gynecologic Surgeons (SGS), which was among the organizations contributing to the effort, surgeons were told that some of the National Correct Coding Initiative (NCCI) bundling of procedures introduced on Oct. 1, 2014, will be modified to allow separate billing beginning April 1, 2015, including retroactively billing for procedures performed before the modification.

“The NCCI enacted wide sweeping pair edits that limited the types of additional procedures that could be billed at the time of vaginal hysterectomy. For the reconstructive vaginal surgeon, this eliminated the ability to bill for additional procedures, such as combined colporrhaphy and apical vaginal suspensions,” reported Dr. Marc Toglia, who served as vice chair of the Committee for Coding and Health Policy for American Urogynecologic Society (AUGS) that led the challenge.

The bundled procedures proposed by the NCCI are part of a larger effort to avoid paying surgeons twice for surgeries that are commonly performed together without significantly increasing operating time, according to Dr. Toglia. He reported that these particular coding edits were enacted by the Centers for Medicaid & Medicare Services despite strong opposition from AUGS, SGS, the American College of Obstetricians and Gynecologists (ACOG), and others.

“While pair edits are not uncommon – for example, you cannot bill separately for cystoscopy at the time that a pubovaginal sling is performed for urinary incontinence – AUGS felt that NCCI was incorrectly combining procedures performed for different indications and requiring substantially more work than the base procedure,” Dr. Toglia explained. “The NCCI seemed focused on the fact that procedures commonly performed at the same time of vaginal hysterectomy were routinely part of this procedure.”

The NCCI revisited the Oct. 1, 2014, coding edits in the face of the continued opposition led by AUGS. As a result, modifiers can be used to allow billing for some procedures, such as colporrhaphy, done at the same time as vaginal hysterectomy or to bill for complex procedures that required substantial additional work. However, not all the coding edits have yet to be successfully challenged. A set of six bundling codes planned for implementation on April 1 have so far only been postponed until July 1.

Referring to the modifiers, Dr. Toglia, who is chief of female pelvic medicine and reconstructive surgery for the Main Line Health System in Philadelphia, explained that “the edits were not changed. Rather, there is now a work-around.”

Practical information about how to properly employ the coding modifications can be obtained at the AUGS website. The website also has more information about initiatives to challenge other coding modifications that have been proposed and are now being challenged by AUGS.

The efforts by Dr. Toglia were strongly endorsed by Dr. Andrew J. Walter, who was installed as the new president of SGS immediately after the coding initiatives were described. In an interview, Dr. Walter, who is in private practice in Roseville, Calif., suggested that it is not just a question of protecting income but avoiding disincentives. He believes surgeons should not be discouraged from combining procedures when the goal is to improve outcome and patient well being.

“SGS, AUGS, and other professional societies need to work together to ensure that reimbursement is fair and serves the interest of excellent medical care,” Dr. Walter said.

Dr. Toglia and Dr. Walter reported no relevant financial disclosures.

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Vesicovaginal fistulas after hysterectomy linked to urinary tract injury

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ORLANDO – Injuring the bladder during a hysterectomy is associated with a greater likelihood of developing a postoperative vesicovaginal fistula, according to a retrospective analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

In data captured from 641,056 hysterectomies performed in California, New York, and Florida in 2005-2010, the odds ratio of a vesicovaginal fistula was nearly 19 times higher if a urinary tract injury was sustained at the time of hysterectomy, a complication that increased in frequency during the 5-year study period, reported Dr. Rony A. Adam, professor of obstetrics and gynecology in the division of female pelvic and reconstructive surgery at Vanderbilt University Medical Center, Nashville, Tenn.

“Although we do not know all the factors that impact formation of vesicovaginal fistula post hysterectomy, it is clear that bladder injury at the time of hysterectomy even when identified and repaired is significantly associated [with this complication],” Dr. Adam reported at the meeting, jointly sponsored by the American College of Surgeons.

The statistical analyses were conducted with the inpatient and ambulatory surgery databases from the Healthcare Cost and Utilization Project (HCUP) for the three states. The large geographically diverse populations were considered by the authors to be nationally representative.

For this analysis, vesicovaginal fistulas and urinary tract injuries were tracked for total abdominal hysterectomy, subtotal abdominal hysterectomy, and total vaginal hysterectomy with or without laparoscopic assistance. Over the 5-year study period, urinary tract injuries climbed steadily in all three groups. When the last year of analysis was compared with the first, a greater increase in odds ratio was observed in the total abdominal group (1.88) than in the subtotal (1.27) or the vaginal (1.26) groups, but each increase was significant.

“The uniformly increasing bladder injury rate may be explained by the increasing cesarean section rates,” according to Dr. Adam, who cited evidence suggesting that cesarean section increases risk of urinary tract injuries in subsequent hysterectomy.

The rate of vesicovaginal fistulas was 21.07 per 1,000 women when a urinary tract injury was incurred during hysterectomy versus 0.95 per 1,000 women when it was not (odds ratio, 18.91). The overall rate of vesicovaginal injury increased in the last year of the study relative to the first (OR, 1.28), although this increase fell just short of statistical significant (P = .059).

“It is possible that surgeons have gotten better at detecting and repairing urinary tract injury, which could explain why the vesicovaginal fistula rate has remained stable in the face of an increasing rate of urinary tract injuries,” Dr. Adam reported.

Not only did the rate of urinary tract injuries climb faster over the study period in those undergoing total abdominal hysterectomy, but also there was a stronger association in patients undergoing this form of hysterectomy between urinary tract injury and vesicovaginal fistula formation, said Dr. Adam. Overall, the OR for vesicovaginal fistula after urinary tract injury was about half as great when either subtotal or vaginal hysterectomy was compared to total abdominal hysterectomy

Although Dr. Adam emphasized that a retrospective study of this type can only establish an association and cannot confirm causation, he said that this study suggests urinary tract injury may be a useful quality-of-care measure for performance of hysterectomy. The SGS-invited discussant Dr. Blair Washington, a urogynecologist at Virginia Mason Hospital and Medical Center, Seattle, agreed.

“Characterizing morbidity associated with hysterectomy is increasingly important as we define benchmarks for quality outcomes in the changing health care economy,” Dr. Washington said. Calling this study “outstanding,” she suggested these data are potentially helpful for counseling patients about risks of hysterectomy, and identifying and evaluating strategies that will help to improve outcomes.

Dr. Adam reported no relevant financial disclosures.

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ORLANDO – Injuring the bladder during a hysterectomy is associated with a greater likelihood of developing a postoperative vesicovaginal fistula, according to a retrospective analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

In data captured from 641,056 hysterectomies performed in California, New York, and Florida in 2005-2010, the odds ratio of a vesicovaginal fistula was nearly 19 times higher if a urinary tract injury was sustained at the time of hysterectomy, a complication that increased in frequency during the 5-year study period, reported Dr. Rony A. Adam, professor of obstetrics and gynecology in the division of female pelvic and reconstructive surgery at Vanderbilt University Medical Center, Nashville, Tenn.

“Although we do not know all the factors that impact formation of vesicovaginal fistula post hysterectomy, it is clear that bladder injury at the time of hysterectomy even when identified and repaired is significantly associated [with this complication],” Dr. Adam reported at the meeting, jointly sponsored by the American College of Surgeons.

The statistical analyses were conducted with the inpatient and ambulatory surgery databases from the Healthcare Cost and Utilization Project (HCUP) for the three states. The large geographically diverse populations were considered by the authors to be nationally representative.

For this analysis, vesicovaginal fistulas and urinary tract injuries were tracked for total abdominal hysterectomy, subtotal abdominal hysterectomy, and total vaginal hysterectomy with or without laparoscopic assistance. Over the 5-year study period, urinary tract injuries climbed steadily in all three groups. When the last year of analysis was compared with the first, a greater increase in odds ratio was observed in the total abdominal group (1.88) than in the subtotal (1.27) or the vaginal (1.26) groups, but each increase was significant.

“The uniformly increasing bladder injury rate may be explained by the increasing cesarean section rates,” according to Dr. Adam, who cited evidence suggesting that cesarean section increases risk of urinary tract injuries in subsequent hysterectomy.

The rate of vesicovaginal fistulas was 21.07 per 1,000 women when a urinary tract injury was incurred during hysterectomy versus 0.95 per 1,000 women when it was not (odds ratio, 18.91). The overall rate of vesicovaginal injury increased in the last year of the study relative to the first (OR, 1.28), although this increase fell just short of statistical significant (P = .059).

“It is possible that surgeons have gotten better at detecting and repairing urinary tract injury, which could explain why the vesicovaginal fistula rate has remained stable in the face of an increasing rate of urinary tract injuries,” Dr. Adam reported.

Not only did the rate of urinary tract injuries climb faster over the study period in those undergoing total abdominal hysterectomy, but also there was a stronger association in patients undergoing this form of hysterectomy between urinary tract injury and vesicovaginal fistula formation, said Dr. Adam. Overall, the OR for vesicovaginal fistula after urinary tract injury was about half as great when either subtotal or vaginal hysterectomy was compared to total abdominal hysterectomy

Although Dr. Adam emphasized that a retrospective study of this type can only establish an association and cannot confirm causation, he said that this study suggests urinary tract injury may be a useful quality-of-care measure for performance of hysterectomy. The SGS-invited discussant Dr. Blair Washington, a urogynecologist at Virginia Mason Hospital and Medical Center, Seattle, agreed.

“Characterizing morbidity associated with hysterectomy is increasingly important as we define benchmarks for quality outcomes in the changing health care economy,” Dr. Washington said. Calling this study “outstanding,” she suggested these data are potentially helpful for counseling patients about risks of hysterectomy, and identifying and evaluating strategies that will help to improve outcomes.

Dr. Adam reported no relevant financial disclosures.

ORLANDO – Injuring the bladder during a hysterectomy is associated with a greater likelihood of developing a postoperative vesicovaginal fistula, according to a retrospective analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

In data captured from 641,056 hysterectomies performed in California, New York, and Florida in 2005-2010, the odds ratio of a vesicovaginal fistula was nearly 19 times higher if a urinary tract injury was sustained at the time of hysterectomy, a complication that increased in frequency during the 5-year study period, reported Dr. Rony A. Adam, professor of obstetrics and gynecology in the division of female pelvic and reconstructive surgery at Vanderbilt University Medical Center, Nashville, Tenn.

“Although we do not know all the factors that impact formation of vesicovaginal fistula post hysterectomy, it is clear that bladder injury at the time of hysterectomy even when identified and repaired is significantly associated [with this complication],” Dr. Adam reported at the meeting, jointly sponsored by the American College of Surgeons.

The statistical analyses were conducted with the inpatient and ambulatory surgery databases from the Healthcare Cost and Utilization Project (HCUP) for the three states. The large geographically diverse populations were considered by the authors to be nationally representative.

For this analysis, vesicovaginal fistulas and urinary tract injuries were tracked for total abdominal hysterectomy, subtotal abdominal hysterectomy, and total vaginal hysterectomy with or without laparoscopic assistance. Over the 5-year study period, urinary tract injuries climbed steadily in all three groups. When the last year of analysis was compared with the first, a greater increase in odds ratio was observed in the total abdominal group (1.88) than in the subtotal (1.27) or the vaginal (1.26) groups, but each increase was significant.

“The uniformly increasing bladder injury rate may be explained by the increasing cesarean section rates,” according to Dr. Adam, who cited evidence suggesting that cesarean section increases risk of urinary tract injuries in subsequent hysterectomy.

The rate of vesicovaginal fistulas was 21.07 per 1,000 women when a urinary tract injury was incurred during hysterectomy versus 0.95 per 1,000 women when it was not (odds ratio, 18.91). The overall rate of vesicovaginal injury increased in the last year of the study relative to the first (OR, 1.28), although this increase fell just short of statistical significant (P = .059).

“It is possible that surgeons have gotten better at detecting and repairing urinary tract injury, which could explain why the vesicovaginal fistula rate has remained stable in the face of an increasing rate of urinary tract injuries,” Dr. Adam reported.

Not only did the rate of urinary tract injuries climb faster over the study period in those undergoing total abdominal hysterectomy, but also there was a stronger association in patients undergoing this form of hysterectomy between urinary tract injury and vesicovaginal fistula formation, said Dr. Adam. Overall, the OR for vesicovaginal fistula after urinary tract injury was about half as great when either subtotal or vaginal hysterectomy was compared to total abdominal hysterectomy

Although Dr. Adam emphasized that a retrospective study of this type can only establish an association and cannot confirm causation, he said that this study suggests urinary tract injury may be a useful quality-of-care measure for performance of hysterectomy. The SGS-invited discussant Dr. Blair Washington, a urogynecologist at Virginia Mason Hospital and Medical Center, Seattle, agreed.

“Characterizing morbidity associated with hysterectomy is increasingly important as we define benchmarks for quality outcomes in the changing health care economy,” Dr. Washington said. Calling this study “outstanding,” she suggested these data are potentially helpful for counseling patients about risks of hysterectomy, and identifying and evaluating strategies that will help to improve outcomes.

Dr. Adam reported no relevant financial disclosures.

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<p><b>Key clinical point:</b> Vesicovaginal fistulas following hysterectomy are strongly related to urinary tract injuries incurred during surgery, according to data from &gt; 600,000 hysterectomies.
</p><p><b>Major finding: </b>When the urinary tract is injured during hysterectomy, a complication that increased steadily over the recent study period, the odds of a vesicovaginal fistula increased almost 19-fold.
</p><p><b>Data source:</b> Retrospective database analysis of 641,056 hysterectomies.
</p><p><b>Disclosures: </b>Dr. Adam reported no relevant financial disclosures.</p>

Penalties for high infection rates expected to be unfair

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ORLANDO – Financial penalties designed to induce hospitals with high surgical site infection rates to improve this aspect of quality of care are likely to be distributed unfairly, according to an analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The plan, to be initiated in 2016 as part of the Hospital-Acquired Condition (HAC) Reduction Program of the Centers for Medicare & Medicaid, is to levy a 1% penalty for all hospitals that fall into the quartile with the greatest rate of surgical site infections (SSI), but only a proportion of these appear to be outliers, reported Dr. Daniel M. Morgan, an ob.gyn. at the University of Michigan, Ann Arbor.

RTEmagicC_92a47a2_Morgan_Daniel_M_MICHIGAN.jpg.jpg
Dr. Daniel M. Morgan

Leaving aside the question of whether all hospitals in the bottom 25% for avoiding SSI are true outliers and, therefore, deserve a penalty, the study in Michigan suggested that the methodology proposed to rank SSI rates does not appear to be properly adjusted for risk.

In this study, SSI associated with hysterectomy was evaluated in 49 hospitals participating in a statewide surgical quality collaborative in which at least 10 hysterectomies were performed. Using data from the 16,000 hysterectomies in this database, hospitals were stratified by SSI rates using the National Healthcare Safety Network (NHSN) protocol (Infect. Control Hosp. Epidemiol. 2011;32:970-86). This is the methodology planned for the HAC reduction program.

While risk adjustment with the NHSN model was restricted to age, American Society of Anesthesiologists (ASA) class, surgical time, use of laparoscopy, and bed size, the Michigan initiative used a multivariate mixed logistic regression model to identify other factors found to significantly influence SSI rates. These included body mass index (BMI) >30, a gynecologic cancer diagnosis, and payment for services through Medicaid.

Using a quartile stratification, 12 of the 49 hospitals would warrant a penalty under the proposed HAC reduction program, but using the Michigan risk adjustment, 8 of these hospitals, or two-thirds of the total, would not have SSI rates significantly different from the mean and would be penalized unfairly.

Several of the hospitals changed quartiles when the Michigan risk adjustment methodology used the additional risk modifiers over those employed in the NHSN protocol. A change in ranking was more common in smaller hospitals relative to those with more than 500 beds, Dr. Morgan said at the meeting, jointly sponsored by the American College of Surgeons.

These data predict “some serious deficiencies in the planned protocol” that will result in “inappropriate targeting of some hospitals that fall into the bottom quartile,” Dr. Morgan said.

It is reasonable to target SSI rates as a strategy to improve quality of care, according to the SGS-invited discussant for this study, Dr. Kristen Matteson, an ob.gyn. at Brown University, Providence, R.I. She said that SSI is an important cause of morbidity and a significant driver of increased costs and it is appropriate to target those with ineffective or substandard processes for preventing infection. However, defining the outliers, “as demonstrated by these authors, it is a complicated process,” she said.

In an interview, Dr. Matteson suggested that it is not only developing a methodology for accurate risk adjustment but also confirming that the bottom 25% actually have rates that are clinically different than higher quartiles. Mathematically, there is always a bottom 25% on any scale, so it makes more sense to develop a cut-off that establishes true outliers rather than those that happen to fall in the bottom quartile.

These policies are going to be implemented soon, and data such as those in this study suggest that they may target hospitals that do not deserve to be targeted, Dr. Matteson said.

Dr. Morgan reported no relevant financial disclosures.

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ORLANDO – Financial penalties designed to induce hospitals with high surgical site infection rates to improve this aspect of quality of care are likely to be distributed unfairly, according to an analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The plan, to be initiated in 2016 as part of the Hospital-Acquired Condition (HAC) Reduction Program of the Centers for Medicare & Medicaid, is to levy a 1% penalty for all hospitals that fall into the quartile with the greatest rate of surgical site infections (SSI), but only a proportion of these appear to be outliers, reported Dr. Daniel M. Morgan, an ob.gyn. at the University of Michigan, Ann Arbor.

RTEmagicC_92a47a2_Morgan_Daniel_M_MICHIGAN.jpg.jpg
Dr. Daniel M. Morgan

Leaving aside the question of whether all hospitals in the bottom 25% for avoiding SSI are true outliers and, therefore, deserve a penalty, the study in Michigan suggested that the methodology proposed to rank SSI rates does not appear to be properly adjusted for risk.

In this study, SSI associated with hysterectomy was evaluated in 49 hospitals participating in a statewide surgical quality collaborative in which at least 10 hysterectomies were performed. Using data from the 16,000 hysterectomies in this database, hospitals were stratified by SSI rates using the National Healthcare Safety Network (NHSN) protocol (Infect. Control Hosp. Epidemiol. 2011;32:970-86). This is the methodology planned for the HAC reduction program.

While risk adjustment with the NHSN model was restricted to age, American Society of Anesthesiologists (ASA) class, surgical time, use of laparoscopy, and bed size, the Michigan initiative used a multivariate mixed logistic regression model to identify other factors found to significantly influence SSI rates. These included body mass index (BMI) >30, a gynecologic cancer diagnosis, and payment for services through Medicaid.

Using a quartile stratification, 12 of the 49 hospitals would warrant a penalty under the proposed HAC reduction program, but using the Michigan risk adjustment, 8 of these hospitals, or two-thirds of the total, would not have SSI rates significantly different from the mean and would be penalized unfairly.

Several of the hospitals changed quartiles when the Michigan risk adjustment methodology used the additional risk modifiers over those employed in the NHSN protocol. A change in ranking was more common in smaller hospitals relative to those with more than 500 beds, Dr. Morgan said at the meeting, jointly sponsored by the American College of Surgeons.

These data predict “some serious deficiencies in the planned protocol” that will result in “inappropriate targeting of some hospitals that fall into the bottom quartile,” Dr. Morgan said.

It is reasonable to target SSI rates as a strategy to improve quality of care, according to the SGS-invited discussant for this study, Dr. Kristen Matteson, an ob.gyn. at Brown University, Providence, R.I. She said that SSI is an important cause of morbidity and a significant driver of increased costs and it is appropriate to target those with ineffective or substandard processes for preventing infection. However, defining the outliers, “as demonstrated by these authors, it is a complicated process,” she said.

In an interview, Dr. Matteson suggested that it is not only developing a methodology for accurate risk adjustment but also confirming that the bottom 25% actually have rates that are clinically different than higher quartiles. Mathematically, there is always a bottom 25% on any scale, so it makes more sense to develop a cut-off that establishes true outliers rather than those that happen to fall in the bottom quartile.

These policies are going to be implemented soon, and data such as those in this study suggest that they may target hospitals that do not deserve to be targeted, Dr. Matteson said.

Dr. Morgan reported no relevant financial disclosures.

ORLANDO – Financial penalties designed to induce hospitals with high surgical site infection rates to improve this aspect of quality of care are likely to be distributed unfairly, according to an analysis presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The plan, to be initiated in 2016 as part of the Hospital-Acquired Condition (HAC) Reduction Program of the Centers for Medicare & Medicaid, is to levy a 1% penalty for all hospitals that fall into the quartile with the greatest rate of surgical site infections (SSI), but only a proportion of these appear to be outliers, reported Dr. Daniel M. Morgan, an ob.gyn. at the University of Michigan, Ann Arbor.

RTEmagicC_92a47a2_Morgan_Daniel_M_MICHIGAN.jpg.jpg
Dr. Daniel M. Morgan

Leaving aside the question of whether all hospitals in the bottom 25% for avoiding SSI are true outliers and, therefore, deserve a penalty, the study in Michigan suggested that the methodology proposed to rank SSI rates does not appear to be properly adjusted for risk.

In this study, SSI associated with hysterectomy was evaluated in 49 hospitals participating in a statewide surgical quality collaborative in which at least 10 hysterectomies were performed. Using data from the 16,000 hysterectomies in this database, hospitals were stratified by SSI rates using the National Healthcare Safety Network (NHSN) protocol (Infect. Control Hosp. Epidemiol. 2011;32:970-86). This is the methodology planned for the HAC reduction program.

While risk adjustment with the NHSN model was restricted to age, American Society of Anesthesiologists (ASA) class, surgical time, use of laparoscopy, and bed size, the Michigan initiative used a multivariate mixed logistic regression model to identify other factors found to significantly influence SSI rates. These included body mass index (BMI) >30, a gynecologic cancer diagnosis, and payment for services through Medicaid.

Using a quartile stratification, 12 of the 49 hospitals would warrant a penalty under the proposed HAC reduction program, but using the Michigan risk adjustment, 8 of these hospitals, or two-thirds of the total, would not have SSI rates significantly different from the mean and would be penalized unfairly.

Several of the hospitals changed quartiles when the Michigan risk adjustment methodology used the additional risk modifiers over those employed in the NHSN protocol. A change in ranking was more common in smaller hospitals relative to those with more than 500 beds, Dr. Morgan said at the meeting, jointly sponsored by the American College of Surgeons.

These data predict “some serious deficiencies in the planned protocol” that will result in “inappropriate targeting of some hospitals that fall into the bottom quartile,” Dr. Morgan said.

It is reasonable to target SSI rates as a strategy to improve quality of care, according to the SGS-invited discussant for this study, Dr. Kristen Matteson, an ob.gyn. at Brown University, Providence, R.I. She said that SSI is an important cause of morbidity and a significant driver of increased costs and it is appropriate to target those with ineffective or substandard processes for preventing infection. However, defining the outliers, “as demonstrated by these authors, it is a complicated process,” she said.

In an interview, Dr. Matteson suggested that it is not only developing a methodology for accurate risk adjustment but also confirming that the bottom 25% actually have rates that are clinically different than higher quartiles. Mathematically, there is always a bottom 25% on any scale, so it makes more sense to develop a cut-off that establishes true outliers rather than those that happen to fall in the bottom quartile.

These policies are going to be implemented soon, and data such as those in this study suggest that they may target hospitals that do not deserve to be targeted, Dr. Matteson said.

Dr. Morgan reported no relevant financial disclosures.

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<p><b>Key clinical point:</b> A plan to penalize those hospitals with the highest surgical site infection rates appears likely to levy fines unfairly, according to risk-adjusted calculations on a representative hospital sample in Michigan.
</p><p><b>Major finding:</b> Lowering surgical site infections is part of an effort to improve quality of care, but at least half of hospitals to be penalized under current plans for high infection rates after hysterectomy will not differ significantly from the mean.
</p><p><b>Data source: </b>Database analysis.
</p><p><b>Disclosures:</b> Dr. Morgan reported no relevant financial disclosures.</p>

High rates of oophorectomy documented in premenopausal women

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ORLANDO – At the time of benign hysterectomy, 44% of premenopausal women underwent bilateral oophorectomy or salpingo-oophorectomy although approximately half of these procedures were performed in women with histologically normal ovaries, according to data presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

This rate of normal ovary removal appears high in the context of American College of Obstetricians and Gynecologists practice recommendations, said Dr. Natalie Karp, a fellow in obstetrics and gynecology at the University of Michigan, Ann Arbor. Referring to ACOG Practice Bulletin 89 entitled “Elective and Risk-Reducing Salpingo-oophorectomy”(Obstet. Gynecol. 2008;111:231-41), the recommendation is to preserve ovaries in the absence of pathology or genetically established cancer risk.

In this study, the focus was on bilateral oophorectomies performed in women 50 years of age or younger undergoing a benign hysterectomy. In the 52 Michigan hospitals participating in a statewide surgical quality collaborative, 6,789 procedures were available for analysis. Of the 44% with oophorectomy, 21% had a benign pathology, 0.2% had cancer, and the remaining 23% had no pathology.

Of the 23% with no pathology, some were likely to have requested oophorectomy because of concern for cancer, but only 3.8% of all subjects had “family history of breast, ovary, or other malignancy involving gynecologic organs” listed as an indication. Whether others requested oophorectomy out of concern for cancer even without a family history is unknown, but it is likely that the proportion of patients having normal ovaries removed is still substantial.

“If we apply these findings nationally, at least 22,000 women annually have their ovaries removed without a compelling indication,” reported Dr. Karp, who based this “broad estimate” on premenopausal women undergoing hysterectomy for indications not typically associated with pathology affecting the ovaries, such as cervical dysplasia or fibroids. The rate would climb higher if any indication for hysterectomy was included.

In a multivariate logistic regression analysis, removal of normal ovaries was more likely in women closer to menopause (ages 46-50) than younger women, in those who underwent abdominal relative to vaginal hysterectomy, in those with other pathology such as endometriosis or cervical dysplasia relative to no pathology, and in those with a family history of cancer, Dr. Karp said at the meeting jointly sponsored by the American College of Surgeons.

In those with normal ovaries and no genetic predisposition for ovarian cancer, it is important to consider both risks and benefits of oophorectomy, according to Dr. Karp. In addition to an increased potential for complications from an extra surgical procedure, removal of the ovaries may increase cardiovascular risk, accelerate bone loss, and adversely affect sexual function.

“We must ensure that we are counseling our patients effectively and documenting the decisions that they make,” Dr. Karp advised. It is not known what proportion of premenopausal women with normal ovaries in this analysis opted for oophorectomy because of a family history of ovarian cancer, but it is likely to be a minority.

These data are timely because of a potential “Angelina Jolie effect,” suggested the SGS-invited discussant Dr. Eman Elkadry, a Boston ob.gyn. who specializes in female pelvic medicine and reconstructive surgery. Referring both to the recent New York Times editorial by filmmaker Angelina Jolie Pitt (March 24, 2015) and to the many news reports that surrounded her decision to undergo prophylactic salpingo-oophorectomy, Dr. Elkadry suggested that there may be an accelerated trend toward prophylactic oophorectomy.

“The decision to remove ovaries is very complex,” cautioned Dr. Elkadry, who agreed that clinicians need to be prepared to explain both risks and benefits to patients who may be influenced by a variety of factors unrelated to objective evidence or detailed risk analysis.

Based on the large sample size and the fact that both academic and community hospitals were included in the mix of institutions contributing data to this analysis, Dr. Elkadry said that the substantial rate of prophylactic oophorectomy identified in Michigan “is probably generalizable” across the country. She also said that the data are consistent with other reports in the literature that “many ovaries are being removed that are completely normal.”

Dr. Natalie Karp reported no relevant financial disclosures.

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ORLANDO – At the time of benign hysterectomy, 44% of premenopausal women underwent bilateral oophorectomy or salpingo-oophorectomy although approximately half of these procedures were performed in women with histologically normal ovaries, according to data presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

This rate of normal ovary removal appears high in the context of American College of Obstetricians and Gynecologists practice recommendations, said Dr. Natalie Karp, a fellow in obstetrics and gynecology at the University of Michigan, Ann Arbor. Referring to ACOG Practice Bulletin 89 entitled “Elective and Risk-Reducing Salpingo-oophorectomy”(Obstet. Gynecol. 2008;111:231-41), the recommendation is to preserve ovaries in the absence of pathology or genetically established cancer risk.

In this study, the focus was on bilateral oophorectomies performed in women 50 years of age or younger undergoing a benign hysterectomy. In the 52 Michigan hospitals participating in a statewide surgical quality collaborative, 6,789 procedures were available for analysis. Of the 44% with oophorectomy, 21% had a benign pathology, 0.2% had cancer, and the remaining 23% had no pathology.

Of the 23% with no pathology, some were likely to have requested oophorectomy because of concern for cancer, but only 3.8% of all subjects had “family history of breast, ovary, or other malignancy involving gynecologic organs” listed as an indication. Whether others requested oophorectomy out of concern for cancer even without a family history is unknown, but it is likely that the proportion of patients having normal ovaries removed is still substantial.

“If we apply these findings nationally, at least 22,000 women annually have their ovaries removed without a compelling indication,” reported Dr. Karp, who based this “broad estimate” on premenopausal women undergoing hysterectomy for indications not typically associated with pathology affecting the ovaries, such as cervical dysplasia or fibroids. The rate would climb higher if any indication for hysterectomy was included.

In a multivariate logistic regression analysis, removal of normal ovaries was more likely in women closer to menopause (ages 46-50) than younger women, in those who underwent abdominal relative to vaginal hysterectomy, in those with other pathology such as endometriosis or cervical dysplasia relative to no pathology, and in those with a family history of cancer, Dr. Karp said at the meeting jointly sponsored by the American College of Surgeons.

In those with normal ovaries and no genetic predisposition for ovarian cancer, it is important to consider both risks and benefits of oophorectomy, according to Dr. Karp. In addition to an increased potential for complications from an extra surgical procedure, removal of the ovaries may increase cardiovascular risk, accelerate bone loss, and adversely affect sexual function.

“We must ensure that we are counseling our patients effectively and documenting the decisions that they make,” Dr. Karp advised. It is not known what proportion of premenopausal women with normal ovaries in this analysis opted for oophorectomy because of a family history of ovarian cancer, but it is likely to be a minority.

These data are timely because of a potential “Angelina Jolie effect,” suggested the SGS-invited discussant Dr. Eman Elkadry, a Boston ob.gyn. who specializes in female pelvic medicine and reconstructive surgery. Referring both to the recent New York Times editorial by filmmaker Angelina Jolie Pitt (March 24, 2015) and to the many news reports that surrounded her decision to undergo prophylactic salpingo-oophorectomy, Dr. Elkadry suggested that there may be an accelerated trend toward prophylactic oophorectomy.

“The decision to remove ovaries is very complex,” cautioned Dr. Elkadry, who agreed that clinicians need to be prepared to explain both risks and benefits to patients who may be influenced by a variety of factors unrelated to objective evidence or detailed risk analysis.

Based on the large sample size and the fact that both academic and community hospitals were included in the mix of institutions contributing data to this analysis, Dr. Elkadry said that the substantial rate of prophylactic oophorectomy identified in Michigan “is probably generalizable” across the country. She also said that the data are consistent with other reports in the literature that “many ovaries are being removed that are completely normal.”

Dr. Natalie Karp reported no relevant financial disclosures.

ORLANDO – At the time of benign hysterectomy, 44% of premenopausal women underwent bilateral oophorectomy or salpingo-oophorectomy although approximately half of these procedures were performed in women with histologically normal ovaries, according to data presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

This rate of normal ovary removal appears high in the context of American College of Obstetricians and Gynecologists practice recommendations, said Dr. Natalie Karp, a fellow in obstetrics and gynecology at the University of Michigan, Ann Arbor. Referring to ACOG Practice Bulletin 89 entitled “Elective and Risk-Reducing Salpingo-oophorectomy”(Obstet. Gynecol. 2008;111:231-41), the recommendation is to preserve ovaries in the absence of pathology or genetically established cancer risk.

In this study, the focus was on bilateral oophorectomies performed in women 50 years of age or younger undergoing a benign hysterectomy. In the 52 Michigan hospitals participating in a statewide surgical quality collaborative, 6,789 procedures were available for analysis. Of the 44% with oophorectomy, 21% had a benign pathology, 0.2% had cancer, and the remaining 23% had no pathology.

Of the 23% with no pathology, some were likely to have requested oophorectomy because of concern for cancer, but only 3.8% of all subjects had “family history of breast, ovary, or other malignancy involving gynecologic organs” listed as an indication. Whether others requested oophorectomy out of concern for cancer even without a family history is unknown, but it is likely that the proportion of patients having normal ovaries removed is still substantial.

“If we apply these findings nationally, at least 22,000 women annually have their ovaries removed without a compelling indication,” reported Dr. Karp, who based this “broad estimate” on premenopausal women undergoing hysterectomy for indications not typically associated with pathology affecting the ovaries, such as cervical dysplasia or fibroids. The rate would climb higher if any indication for hysterectomy was included.

In a multivariate logistic regression analysis, removal of normal ovaries was more likely in women closer to menopause (ages 46-50) than younger women, in those who underwent abdominal relative to vaginal hysterectomy, in those with other pathology such as endometriosis or cervical dysplasia relative to no pathology, and in those with a family history of cancer, Dr. Karp said at the meeting jointly sponsored by the American College of Surgeons.

In those with normal ovaries and no genetic predisposition for ovarian cancer, it is important to consider both risks and benefits of oophorectomy, according to Dr. Karp. In addition to an increased potential for complications from an extra surgical procedure, removal of the ovaries may increase cardiovascular risk, accelerate bone loss, and adversely affect sexual function.

“We must ensure that we are counseling our patients effectively and documenting the decisions that they make,” Dr. Karp advised. It is not known what proportion of premenopausal women with normal ovaries in this analysis opted for oophorectomy because of a family history of ovarian cancer, but it is likely to be a minority.

These data are timely because of a potential “Angelina Jolie effect,” suggested the SGS-invited discussant Dr. Eman Elkadry, a Boston ob.gyn. who specializes in female pelvic medicine and reconstructive surgery. Referring both to the recent New York Times editorial by filmmaker Angelina Jolie Pitt (March 24, 2015) and to the many news reports that surrounded her decision to undergo prophylactic salpingo-oophorectomy, Dr. Elkadry suggested that there may be an accelerated trend toward prophylactic oophorectomy.

“The decision to remove ovaries is very complex,” cautioned Dr. Elkadry, who agreed that clinicians need to be prepared to explain both risks and benefits to patients who may be influenced by a variety of factors unrelated to objective evidence or detailed risk analysis.

Based on the large sample size and the fact that both academic and community hospitals were included in the mix of institutions contributing data to this analysis, Dr. Elkadry said that the substantial rate of prophylactic oophorectomy identified in Michigan “is probably generalizable” across the country. She also said that the data are consistent with other reports in the literature that “many ovaries are being removed that are completely normal.”

Dr. Natalie Karp reported no relevant financial disclosures.

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<p><b>Key clinical point: </b>A substantial minority of premenopausal women who undergo oophorectomy have histologically normal ovaries, according to detailed analysis of a representative sample in the state of Michigan.
</p><p><b>Major finding: </b>Despite current guidelines encouraging ovary preservation at the time of hysterectomy in premenopausal women, 23% of women in a series of 6,789 benign hysterectomies had normal ovaries removed.
</p><p><b>Data source: </b>Analysis of prospectively collected data.
</p><p><b>Disclosures:</b> Dr. Natalie Karp reported no relevant financial disclosures.</p>

ACOG taking steps to increase vaginal hysterectomy rates

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ORLANDO – The American College of Obstetricians and Gynecologists is taking steps intended to reverse the declining rates of vaginal hysterectomy, the preferred procedure for benign indications, according to an outline of plans presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The immediate focus is on building skills both during and after training programs, said Dr. Sandra A. Carson, ACOG’s vice president for education. She reported that overall rates of hysterectomies have been declining over the past decade, but the decline has been especially steep for vaginal procedures. This has an adverse impact on training.

“Data show that over the past 10 years, residents have performed on average 8 fewer hysterectomies, but the average number of vaginal hysterectomies has been essentially halved to 17 or 18 over 4 years of residency training,” said Dr. Carson, who made her remarks as part of the invited TeLinde lecture.

This rate of vaginal hysterectomies during training is generally considered to be insufficient to provide training graduates with the confidence to perform them in routine practice, she said.

The vaginal approach has long been identified by ACOG as the preferred route of hysterectomy for benign disease because of evidence of better outcomes and fewer complications. In an ACOG committee opinion #444 entitled “Choosing the Route of Hysterectomy for Benign Disease” (reaffirmed in 2011), laparoscopic, abdominal, and robotic procedures were characterized as alternatives when vaginal hysterectomy is not feasible (Obstet. Gynecol. 2009;114:1156-8).

“We know that vaginal hysterectomy overall is better for women, so we need to get honest with ourselves about doing something about the trends,” she said at the SGS meeting, jointly sponsored by the American College of Surgeons.

Of strategies to reverse the trend, training is key, said Dr. Carson. This has led ACOG to develop several programs, including a CME-accredited surgical skills training module that includes objectives, instruction, information on how to construct a low-cost simulator, and an assessment tool. There is also a program available designed to help teachers teach vaginal hysterectomy.

ACOG also is developing a task force of teachers for mentoring. The goal is to advise surgeons who have learned the techniques of vaginal hysterectomy but may not yet have the confidence to perform them on their own. Ten experts already have volunteered to serve on the task force, and several training programs have expressed interest in receiving this form of support, Dr. Carson said.

However, she acknowledged several potential obstacles for widespread implementation of the task force that require resolution, such as providing credentialing, liability insurance, and reimbursement for advisers. ACOG has been active in considering solutions for each of these, such as using operating room cameras that would allow advisers to participate remotely.

In addition to training, however, Dr. Carson reported that ACOG is looking at strategies to align incentives that would encourage vaginal hysterectomies. This could include convincing third-party payers to provide greater reimbursement for an approach that may be less costly than alternatives, particularly robotic hysterectomy.

“We all need to decide that this is the right thing for women, but if you want to do this, we want to help you,” Dr. Carson told the audience of gynecologic surgeons.

Concern about the declining rates of vaginal hysterectomy is not new, said Dr. Ernest G. Lockrow, professor and vice chairman obstetrics and gynecology, Uniformed Services University of the Health Services, Bethesda, Md. In an interview, he suggested that there has long been hand-wringing about how to halt the decline in the approach. What is new, according to Dr. Lockrow, is the ACOG commitment for change.

“Based on what we heard today, it appears that ACOG is getting a little more serious about doing something about this issue,” Dr. Lockrow said. He is not certain how effective the strategies outlined by Dr. Carson will be in turning around current trends, “but I think we are seeing some steps in the right direction.”

Dr. Carson reported no relevant financial disclosures

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ORLANDO – The American College of Obstetricians and Gynecologists is taking steps intended to reverse the declining rates of vaginal hysterectomy, the preferred procedure for benign indications, according to an outline of plans presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The immediate focus is on building skills both during and after training programs, said Dr. Sandra A. Carson, ACOG’s vice president for education. She reported that overall rates of hysterectomies have been declining over the past decade, but the decline has been especially steep for vaginal procedures. This has an adverse impact on training.

“Data show that over the past 10 years, residents have performed on average 8 fewer hysterectomies, but the average number of vaginal hysterectomies has been essentially halved to 17 or 18 over 4 years of residency training,” said Dr. Carson, who made her remarks as part of the invited TeLinde lecture.

This rate of vaginal hysterectomies during training is generally considered to be insufficient to provide training graduates with the confidence to perform them in routine practice, she said.

The vaginal approach has long been identified by ACOG as the preferred route of hysterectomy for benign disease because of evidence of better outcomes and fewer complications. In an ACOG committee opinion #444 entitled “Choosing the Route of Hysterectomy for Benign Disease” (reaffirmed in 2011), laparoscopic, abdominal, and robotic procedures were characterized as alternatives when vaginal hysterectomy is not feasible (Obstet. Gynecol. 2009;114:1156-8).

“We know that vaginal hysterectomy overall is better for women, so we need to get honest with ourselves about doing something about the trends,” she said at the SGS meeting, jointly sponsored by the American College of Surgeons.

Of strategies to reverse the trend, training is key, said Dr. Carson. This has led ACOG to develop several programs, including a CME-accredited surgical skills training module that includes objectives, instruction, information on how to construct a low-cost simulator, and an assessment tool. There is also a program available designed to help teachers teach vaginal hysterectomy.

ACOG also is developing a task force of teachers for mentoring. The goal is to advise surgeons who have learned the techniques of vaginal hysterectomy but may not yet have the confidence to perform them on their own. Ten experts already have volunteered to serve on the task force, and several training programs have expressed interest in receiving this form of support, Dr. Carson said.

However, she acknowledged several potential obstacles for widespread implementation of the task force that require resolution, such as providing credentialing, liability insurance, and reimbursement for advisers. ACOG has been active in considering solutions for each of these, such as using operating room cameras that would allow advisers to participate remotely.

In addition to training, however, Dr. Carson reported that ACOG is looking at strategies to align incentives that would encourage vaginal hysterectomies. This could include convincing third-party payers to provide greater reimbursement for an approach that may be less costly than alternatives, particularly robotic hysterectomy.

“We all need to decide that this is the right thing for women, but if you want to do this, we want to help you,” Dr. Carson told the audience of gynecologic surgeons.

Concern about the declining rates of vaginal hysterectomy is not new, said Dr. Ernest G. Lockrow, professor and vice chairman obstetrics and gynecology, Uniformed Services University of the Health Services, Bethesda, Md. In an interview, he suggested that there has long been hand-wringing about how to halt the decline in the approach. What is new, according to Dr. Lockrow, is the ACOG commitment for change.

“Based on what we heard today, it appears that ACOG is getting a little more serious about doing something about this issue,” Dr. Lockrow said. He is not certain how effective the strategies outlined by Dr. Carson will be in turning around current trends, “but I think we are seeing some steps in the right direction.”

Dr. Carson reported no relevant financial disclosures

ORLANDO – The American College of Obstetricians and Gynecologists is taking steps intended to reverse the declining rates of vaginal hysterectomy, the preferred procedure for benign indications, according to an outline of plans presented at the annual scientific meeting of the Society of Gynecologic Surgeons.

The immediate focus is on building skills both during and after training programs, said Dr. Sandra A. Carson, ACOG’s vice president for education. She reported that overall rates of hysterectomies have been declining over the past decade, but the decline has been especially steep for vaginal procedures. This has an adverse impact on training.

“Data show that over the past 10 years, residents have performed on average 8 fewer hysterectomies, but the average number of vaginal hysterectomies has been essentially halved to 17 or 18 over 4 years of residency training,” said Dr. Carson, who made her remarks as part of the invited TeLinde lecture.

This rate of vaginal hysterectomies during training is generally considered to be insufficient to provide training graduates with the confidence to perform them in routine practice, she said.

The vaginal approach has long been identified by ACOG as the preferred route of hysterectomy for benign disease because of evidence of better outcomes and fewer complications. In an ACOG committee opinion #444 entitled “Choosing the Route of Hysterectomy for Benign Disease” (reaffirmed in 2011), laparoscopic, abdominal, and robotic procedures were characterized as alternatives when vaginal hysterectomy is not feasible (Obstet. Gynecol. 2009;114:1156-8).

“We know that vaginal hysterectomy overall is better for women, so we need to get honest with ourselves about doing something about the trends,” she said at the SGS meeting, jointly sponsored by the American College of Surgeons.

Of strategies to reverse the trend, training is key, said Dr. Carson. This has led ACOG to develop several programs, including a CME-accredited surgical skills training module that includes objectives, instruction, information on how to construct a low-cost simulator, and an assessment tool. There is also a program available designed to help teachers teach vaginal hysterectomy.

ACOG also is developing a task force of teachers for mentoring. The goal is to advise surgeons who have learned the techniques of vaginal hysterectomy but may not yet have the confidence to perform them on their own. Ten experts already have volunteered to serve on the task force, and several training programs have expressed interest in receiving this form of support, Dr. Carson said.

However, she acknowledged several potential obstacles for widespread implementation of the task force that require resolution, such as providing credentialing, liability insurance, and reimbursement for advisers. ACOG has been active in considering solutions for each of these, such as using operating room cameras that would allow advisers to participate remotely.

In addition to training, however, Dr. Carson reported that ACOG is looking at strategies to align incentives that would encourage vaginal hysterectomies. This could include convincing third-party payers to provide greater reimbursement for an approach that may be less costly than alternatives, particularly robotic hysterectomy.

“We all need to decide that this is the right thing for women, but if you want to do this, we want to help you,” Dr. Carson told the audience of gynecologic surgeons.

Concern about the declining rates of vaginal hysterectomy is not new, said Dr. Ernest G. Lockrow, professor and vice chairman obstetrics and gynecology, Uniformed Services University of the Health Services, Bethesda, Md. In an interview, he suggested that there has long been hand-wringing about how to halt the decline in the approach. What is new, according to Dr. Lockrow, is the ACOG commitment for change.

“Based on what we heard today, it appears that ACOG is getting a little more serious about doing something about this issue,” Dr. Lockrow said. He is not certain how effective the strategies outlined by Dr. Carson will be in turning around current trends, “but I think we are seeing some steps in the right direction.”

Dr. Carson reported no relevant financial disclosures

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