Surgery

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Nearly half of female surgeons (42%) who were recently surveyed have had a miscarriage or stillbirth – twice the rate of women aged 30-40 years in the general population – according to an article published online July 28 in JAMA Surgery.

The authors, led by Erika L. Rangel, MD, division of general and gastrointestinal surgery, department of surgery, Brigham and Women’s Hospital, Boston, found that after the losses, the women took little or no time off.

Of 692 surgeons surveyed, 347 female surgeons had experienced a pregnancy loss. Of those, 244 had had a miscarriage at less than 10 weeks’ gestation, 92 had had a miscarriage between 10 and 20 weeks’ gestation, and 11 had had a stillbirth (loss at 20 weeks or later).
 

Most took no time off after miscarriage

After a miscarriage, 225 of 336 women (75%) took no time off work, and after a stillbirth, 5 of 11 (45%) took off 1 week or less, the authors found.

The study addressed an issue that people have talked about anecdotally or on social media, Dr. Rangel told this news organization.

“This was finally an opportunity to do a study of enough magnitude to show that there is a very quantifiable difference in complication rate, use of IVF [in vitro fertilization], and the age at which we have children. These are not just anecdotal stories,” she said.

For the study, a self-administered questionnaire was distributed electronically. Answers were collected from November 2020 to January 2021 through multiple U.S. surgical societies and social media among attending and resident surgeons with children. The control group for the study comprised 158 male surgeons who answered questions regarding their partners’ pregnancies.

Female surgeons had fewer children compared with male surgeons and their female partners (mean [SD],1.8 [0.8], versus 2.3 [1.1]; P < .001) and were more likely to delay having children because of surgical training (450 of 692 [65.0%] versus 69 of 158 [43.7%]; P < .001).

In addition, Dr. Rangel and colleagues found that 57% of female surgeons worked more than 60 hours a week during pregnancy and that 37% took more than six overnight calls.

The data show that female surgeons who operated 12 or more hours per week during the last trimester of pregnancy were at higher risk compared with those who operated fewer hours (odds ratio, 1.57; 95% confidence interval, 1.08-2.26).

“Pregnant surgeons should not be operating more than 12 hours a week when they are in the third trimester,” Dr. Rangel said.

“That is a modifiable risk factor,” she told this news organization. “It’s a very brief period of support – a couple of months of support for a woman who may do 25-30 more years of serving the public with surgical skills.”

She said that training programs should be organized so as to have colleagues cover operating room (OR) shifts to reduce the operating hours for pregnant colleagues. In addition, advanced practice health care professionals should be paid to take up the paperwork and perform non-OR care to reduce the stigma associated with pregnant trainees overburdening other surgical trainees.
 

‘It’s too big an ask’

Obstetrician-gynecologist Maryam Siddiqui, MD, said in an interview that she was particularly struck by the number of female surgeons who experience involuntary childlessness.

“That’s a big ask for people who want childbearing to be a part of the fulfillment of their life. It’s too big,” said Dr. Siddiqui, a gynecologic surgeon at UChicago Medicine.

She said the amount of detail in the article and the large number of participants were persuasive factors that can support establishing a more humane system than one in which one person at a time has to ask for change.

Pointing to the finding that three-fourths of the women in the study who had had miscarriages didn’t take time off, she said, “That’s not really humane. But they’re afraid to ask or they don’t want to reveal they’re trying [to get pregnant]. Why should you be afraid of building your family?”

The authors also found other adverse outcomes. Female surgeons were more likely to have musculoskeletal disorders compared with female nonsurgeon partners (36.9% versus 18.4%; P < .001), and they were more likely to undergo nonelective cesarean delivery (25.5% versus 15.3%; P = .01) and to experience postpartum depression (11.1% versus 5.7%; P = .04).

Dr. Siddiqui said the conditions that surgeons encounter on their return to work after childbirth are “a perfect storm” for postpartum depression among women who are not accustomed to being reliant on others.

Women often feel coerced into returning to work before they are physically or emotionally ready, then toggle back and forth from night shift to day shift, losing sleep, she said. “We can do better.”

One of the solutions, she said, is to provide better work coverage for the surgeon while she is pregnant and when she returns to work. That includes properly compensating the person covering for the surgeon by giving that person extra pay or additional time off.

“You have to value both people,” she said. “If both people are valued, there’s still collegiality.”

She acknowledged that that kind of compensation may be more readily available at large academic centers.

At UChicago, she said, they are creative with scheduling in training. For women at the height of pregnancy, rotations are less intensive, and trauma rotations are avoided.

Dr. Siddiqui said one of the most important aspects of the article is the authors’ list of two dozen ways, both big and small, to improve conditions.

Adopting such changes will become increasingly important for hiring and retaining female surgeons. “You want to work someplace where you’re respected as a whole person,” she said.

Sarah Blair, MD, a surgical oncologist at University of California, San Diego, stated that the number of miscarriages in particular provides disturbing proof of a problem women in surgery frequently discuss.

For nearly a decade, she led a women-in-surgery committee at UCSD in which they discussed such issues regarding pregnancy and medicine.

She said she hopes these data can help push for change in flexibility in residency so that women can graduate on time and have the families they want.

“There’s a movement away from time-based training to competency-based training, so maybe that will help women,” she said.
 

‘We have to figure this out’

“We will have to figure this out, because more than half of the people in medical school are women, and there are a lot more women in surgery than when I trained more than 20 years ago. It’s not a problem that’s going away,” she said.

One sign of improvement happened recently, Dr. Rangel said.

As previously reported, according to the American Board of Medical Specialties, as of July 1, 2021, residents and fellows are allowed a minimum 6 weeks away for medical leave or caregiving once during training, without having to use vacation time or sick leave and without having to extend their training.

“That’s huge,” she said. “But we still have a long way to go, because the residency programs still don’t have to have policy that abides that. It merely says you can take 6 weeks off and take your boards. It doesn’t say that the residency program has to allow you to take 6 weeks off.”

The authors noted that the United States and Papua New Guinea are the only countries in the world without federally mandated paid parental leave.

“Most U.S. female surgeons rely on their employer for this benefit, but only half of top-ranked medical schools offer paid leave, and 33%-65% of U.S. surgical training programs lack clear maternity leave policies,” she said.

Funding for the study was provided by the department of surgery at Brigham and Women’s Hospital. The study authors, Dr. Blair, and Dr. Siddiqui have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Cervical insufficiency is an important cause of preterm birth and complicates up to 1% of pregnancies. It is typically diagnosed as painless cervical dilation without contractions, often in the second trimester at around 16-18 weeks, but the clinical presentation can be variable. In some cases, a rescue cerclage can be placed to prevent second trimester loss or preterm birth.

A recent landmark randomized controlled trial of abdominal vs. vaginal cerclage – the MAVRIC trial (Multicentre Abdominal vs. Vaginal Randomized Intervention of Cerclage)¹ published in 2020 – has offered significant validation for the belief that an abdominal approach is the preferred approach for patients with cervical insufficiency and a prior failed vaginal cerclage.

Obstetricians traditionally have had a high threshold for placement of an abdominal cerclage given the need for cesarean delivery and the morbidity of an open procedure. Laparoscopic abdominal cerclage has lowered this threshold and is increasingly the preferred method for cerclage placement. Reported complication rates are generally lower than for open abdominal cerclage, and neonatal survival rates are similar or improved.

In our experience, the move toward laparoscopic abdominal cerclage is largely a patient-driven shift. Since 2007, at Brigham and Women’s Hospital in Boston, we have performed over 150 laparoscopic abdominal cerclage placements. The majority of patients had at least one prior second-trimester loss (many of them had multiple losses), with many having also failed a transvaginal cerclage.

In an analysis of 137 of these cases published recently in Fertility and Sterility, the neonatal survival rate was 93.8% in the 80 pregnancies that followed and extended beyond the first trimester, and the mean gestational age at delivery was 36.9 weeks.² (First trimester losses are typically excluded from the denominator because they are unlikely to be the result of cervical insufficiency.)

History and outcomes data

The vaginal cerclage has long been a mainstay of therapy because it is a simple procedure. The McDonald technique, described in the 1950s, uses a simple purse string suture at the cervico-vaginal juncture, and the Shirodkar approach, also described in the 1950s, involves placing the cerclage higher on the cervix, as close to the internal os as possible. The Shirodkar technique is more complex, requiring more dissection, and is used less often than the McDonald approach.

The abdominal cerclage, first reported in 1965,³ is placed higher on the cervix, right near the juncture of the lower uterine segment and the cervix, and has generally been thought to provide optimal integrity. It is this point of placement – right at the juncture where membranes begin protruding into the cervix as it shortens and softens – that offers the strongest defense against cervical insufficiency.

The laparoscopic abdominal approach has been gaining popularity since it was first reported in 1998.⁴ Its traditional indication has been after a prior failed vaginal cerclage or when the cervix is too short to place a vaginal cerclage – as a result of a congenital anomaly or cervical conization, for instance.

Some of my patients have had one pregnancy loss in which cervical insufficiency was suspected and have sought laparoscopic abdominal cerclage without attempting a vaginal cerclage. Data to support this scenario are unavailable, but given the psychological trauma of pregnancy loss and the minimally invasive and low-risk nature of laparoscopic abdominal cerclage, I have been inclined to agree to preventive laparoscopic abdominal procedures without a trial of a vaginal cerclage. I believe this is a reasonable option.

The recently published MAVRIC trial included only abdominal cerclages performed using an open approach, but it provides good data for the scenario in which a vaginal cerclage has failed.

The rates of preterm birth at less than 32 weeks were significantly lower with abdominal cerclage than with low vaginal cerclage (McDonald technique) or high vaginal cerclage (Shirodkar technique) (8% vs. 33%, and 8% vs. 38%). No neonatal deaths occurred.

The analysis covered 111 women who conceived and had known pregnancy outcomes, out of 139 who were recruited and randomized. Cerclage placement occurred either between 10 and 16 weeks of gestation for vaginal cerclages and at 14 weeks for abdominal cerclages or before conception for those assigned to receive an abdominal or high vaginal cerclage.

Reviews of the literature done by our group1 and others have found equivalent outcomes between abdominal cerclages placed through laparotomy and through laparoscopy. The largest systematic review analyzed 31 studies involving 1,844 patients and found that neonatal survival rates were significantly greater in the laparoscopic group (97% vs. 90%), as were rates of deliveries after 34 weeks of gestation (83% vs. 76%).⁵

The better outcomes in the laparoscopic group may at least partly reflect improved laparoscopic surgeon techniques and improvements in neonatal care over time. At the minimum, we can conclude that neonatal outcomes are at least equivalent when an abdominal cerclage is placed through laparotomy or with a minimally invasive approach.

Our technique

Laparoscopic cerclages are much more easily placed – and with less risk of surgical complications or blood loss – in patients who are not pregnant. Postconception cerclage placement also carries a unique, small risk of fetal loss (estimated to occur in 1.2% of laparoscopic cases and 3% of open cases). ¹ We therefore prefer to perform the procedure before pregnancy, though we do place abdominal cerclages in early pregnancy as well. (Approximately 10% of the 137 patients in our analysis were pregnant at the time of cerclage placement. ¹ )

The procedure, described here for the nonpregnant patient, typically requires 3-4 ports. My preference is to use a 10-mm scope at the umbilicus, two 5-mm ipsilateral ports, and an additional 5-mm port for my assistant. We generally use a uterine manipulator to help with dissection and facilitate the correct angulation of the suture needle.

Dr. Jon I. Einarsson

Dr. Jon I. Einarsson

Dr. Jon I. Einarsson

Direct insertion of the needle simplifies the procedure and has not led to any complications thus far.

We prefer to insert the suture posteriorly at the level of the internal os just above the insertion of the uterosacral ligaments. It is helpful to view the uterus and cervix as an hourglass, with the level of the internal os is at the narrowest point of the hourglass.

The suture is passed carefully between the uterine vessels and the cervical stroma. The uterine artery should be lateral to placement of the needle, and the uterosacral ligament should be below. The surgeon should see a pulsation of the uterine artery. The use of blunt needles is advantageous because, especially when newer to the procedure, the surgeon can place the needle in slightly more medial than may be deemed necessary so as to avert the uterine vessels, then adjust placement slightly more laterally if resistance is met.

Suture placement should follow a fairly low-impact path. Encountering too much resistance with the needle signals passage into the cervix and necessitates redirection of the needle with a slightly more lateral placement. Twisting the uterus with the uterine manipulator can be helpful throughout this process.

Once the needles are passed through, they are cut off the Mersilene tape and removed. For suturing, it’s important that the first and second knots are tied down snuggly and flat.

Dr. Jon I. Einarsson

I usually ask my assistant to hold down the first knot so that it doesn’t unravel while I tie the second knot. I usually tie 6 square knots with the tape.

Dr. Jon I. Einarsson

The edges of the tape are then trimmed, and with a 2.0 silk suture, the ends are secured to the lower uterine segment to prevent a theoretical risk of erosion into the bladder.

Dr. Jon I. Einarsson

We then close the overlying vesicouterine peritoneum with 2-0 Monocryl suture, tying it intracorporally. Closing the peritoneum posteriorly is generally not necessary.

Dr. Jon I. Einarsson

A note on patient care

We recommend that patients not become pregnant for 2 months after the laparoscopic abdominal cerclage is placed, and that they receive obstetrical care as high-risk patients. The cerclage can be removed at the time of cesarean delivery if the patient has completed childbearing. Otherwise, if the cerclage appears normal, it can be left in place for future pregnancies.

In the event of a miscarriage, a dilatation and evacuation procedure can be performed with an abdominal cerclage in place, up to 18 weeks of pregnancy. Beyond this point, the patient likely will need to have the cerclage removed laparoscopically to allow vaginal passing of the fetus.

References

1. Shennan A et al. Am J Obstet Gynecol. 2020;222(3):261.E1-261.E9.

2. Clark NV & Einarsson JI. Fertil Steril. 2020;113:717-22.

3. Benson RC & Durfee RB. Obstet Gynecol. 1965;25:145-55.

4. Lesser KB et al. Obstet Gynecol. 1998;91:855-6.

5. Moawad GN et al. J Minim Invasive Gynecol. 2018;25:277-86.
 

Cervical insufficiency is an important cause of preterm birth and complicates up to 1% of pregnancies. It is typically diagnosed as painless cervical dilation without contractions, often in the second trimester at around 16-18 weeks, but the clinical presentation can be variable. In some cases, a rescue cerclage can be placed to prevent second trimester loss or preterm birth.

A recent landmark randomized controlled trial of abdominal vs. vaginal cerclage – the MAVRIC trial (Multicentre Abdominal vs. Vaginal Randomized Intervention of Cerclage)¹ published in 2020 – has offered significant validation for the belief that an abdominal approach is the preferred approach for patients with cervical insufficiency and a prior failed vaginal cerclage.

Obstetricians traditionally have had a high threshold for placement of an abdominal cerclage given the need for cesarean delivery and the morbidity of an open procedure. Laparoscopic abdominal cerclage has lowered this threshold and is increasingly the preferred method for cerclage placement. Reported complication rates are generally lower than for open abdominal cerclage, and neonatal survival rates are similar or improved.

In our experience, the move toward laparoscopic abdominal cerclage is largely a patient-driven shift. Since 2007, at Brigham and Women’s Hospital in Boston, we have performed over 150 laparoscopic abdominal cerclage placements. The majority of patients had at least one prior second-trimester loss (many of them had multiple losses), with many having also failed a transvaginal cerclage.

In an analysis of 137 of these cases published recently in Fertility and Sterility, the neonatal survival rate was 93.8% in the 80 pregnancies that followed and extended beyond the first trimester, and the mean gestational age at delivery was 36.9 weeks.² (First trimester losses are typically excluded from the denominator because they are unlikely to be the result of cervical insufficiency.)

History and outcomes data

The vaginal cerclage has long been a mainstay of therapy because it is a simple procedure. The McDonald technique, described in the 1950s, uses a simple purse string suture at the cervico-vaginal juncture, and the Shirodkar approach, also described in the 1950s, involves placing the cerclage higher on the cervix, as close to the internal os as possible. The Shirodkar technique is more complex, requiring more dissection, and is used less often than the McDonald approach.

The abdominal cerclage, first reported in 1965,³ is placed higher on the cervix, right near the juncture of the lower uterine segment and the cervix, and has generally been thought to provide optimal integrity. It is this point of placement – right at the juncture where membranes begin protruding into the cervix as it shortens and softens – that offers the strongest defense against cervical insufficiency.

The laparoscopic abdominal approach has been gaining popularity since it was first reported in 1998.⁴ Its traditional indication has been after a prior failed vaginal cerclage or when the cervix is too short to place a vaginal cerclage – as a result of a congenital anomaly or cervical conization, for instance.

Some of my patients have had one pregnancy loss in which cervical insufficiency was suspected and have sought laparoscopic abdominal cerclage without attempting a vaginal cerclage. Data to support this scenario are unavailable, but given the psychological trauma of pregnancy loss and the minimally invasive and low-risk nature of laparoscopic abdominal cerclage, I have been inclined to agree to preventive laparoscopic abdominal procedures without a trial of a vaginal cerclage. I believe this is a reasonable option.

The recently published MAVRIC trial included only abdominal cerclages performed using an open approach, but it provides good data for the scenario in which a vaginal cerclage has failed.

The rates of preterm birth at less than 32 weeks were significantly lower with abdominal cerclage than with low vaginal cerclage (McDonald technique) or high vaginal cerclage (Shirodkar technique) (8% vs. 33%, and 8% vs. 38%). No neonatal deaths occurred.

The analysis covered 111 women who conceived and had known pregnancy outcomes, out of 139 who were recruited and randomized. Cerclage placement occurred either between 10 and 16 weeks of gestation for vaginal cerclages and at 14 weeks for abdominal cerclages or before conception for those assigned to receive an abdominal or high vaginal cerclage.

Reviews of the literature done by our group1 and others have found equivalent outcomes between abdominal cerclages placed through laparotomy and through laparoscopy. The largest systematic review analyzed 31 studies involving 1,844 patients and found that neonatal survival rates were significantly greater in the laparoscopic group (97% vs. 90%), as were rates of deliveries after 34 weeks of gestation (83% vs. 76%).⁵

The better outcomes in the laparoscopic group may at least partly reflect improved laparoscopic surgeon techniques and improvements in neonatal care over time. At the minimum, we can conclude that neonatal outcomes are at least equivalent when an abdominal cerclage is placed through laparotomy or with a minimally invasive approach.

Our technique

Laparoscopic cerclages are much more easily placed – and with less risk of surgical complications or blood loss – in patients who are not pregnant. Postconception cerclage placement also carries a unique, small risk of fetal loss (estimated to occur in 1.2% of laparoscopic cases and 3% of open cases). ¹ We therefore prefer to perform the procedure before pregnancy, though we do place abdominal cerclages in early pregnancy as well. (Approximately 10% of the 137 patients in our analysis were pregnant at the time of cerclage placement. ¹ )

The procedure, described here for the nonpregnant patient, typically requires 3-4 ports. My preference is to use a 10-mm scope at the umbilicus, two 5-mm ipsilateral ports, and an additional 5-mm port for my assistant. We generally use a uterine manipulator to help with dissection and facilitate the correct angulation of the suture needle.

Dr. Jon I. Einarsson

Dr. Jon I. Einarsson

Dr. Jon I. Einarsson

Direct insertion of the needle simplifies the procedure and has not led to any complications thus far.

We prefer to insert the suture posteriorly at the level of the internal os just above the insertion of the uterosacral ligaments. It is helpful to view the uterus and cervix as an hourglass, with the level of the internal os is at the narrowest point of the hourglass.

The suture is passed carefully between the uterine vessels and the cervical stroma. The uterine artery should be lateral to placement of the needle, and the uterosacral ligament should be below. The surgeon should see a pulsation of the uterine artery. The use of blunt needles is advantageous because, especially when newer to the procedure, the surgeon can place the needle in slightly more medial than may be deemed necessary so as to avert the uterine vessels, then adjust placement slightly more laterally if resistance is met.

Suture placement should follow a fairly low-impact path. Encountering too much resistance with the needle signals passage into the cervix and necessitates redirection of the needle with a slightly more lateral placement. Twisting the uterus with the uterine manipulator can be helpful throughout this process.

Once the needles are passed through, they are cut off the Mersilene tape and removed. For suturing, it’s important that the first and second knots are tied down snuggly and flat.

Dr. Jon I. Einarsson

I usually ask my assistant to hold down the first knot so that it doesn’t unravel while I tie the second knot. I usually tie 6 square knots with the tape.

Dr. Jon I. Einarsson

The edges of the tape are then trimmed, and with a 2.0 silk suture, the ends are secured to the lower uterine segment to prevent a theoretical risk of erosion into the bladder.

Dr. Jon I. Einarsson

We then close the overlying vesicouterine peritoneum with 2-0 Monocryl suture, tying it intracorporally. Closing the peritoneum posteriorly is generally not necessary.

Dr. Jon I. Einarsson

A note on patient care

We recommend that patients not become pregnant for 2 months after the laparoscopic abdominal cerclage is placed, and that they receive obstetrical care as high-risk patients. The cerclage can be removed at the time of cesarean delivery if the patient has completed childbearing. Otherwise, if the cerclage appears normal, it can be left in place for future pregnancies.

In the event of a miscarriage, a dilatation and evacuation procedure can be performed with an abdominal cerclage in place, up to 18 weeks of pregnancy. Beyond this point, the patient likely will need to have the cerclage removed laparoscopically to allow vaginal passing of the fetus.

References

1. Shennan A et al. Am J Obstet Gynecol. 2020;222(3):261.E1-261.E9.

2. Clark NV & Einarsson JI. Fertil Steril. 2020;113:717-22.

3. Benson RC & Durfee RB. Obstet Gynecol. 1965;25:145-55.

4. Lesser KB et al. Obstet Gynecol. 1998;91:855-6.

5. Moawad GN et al. J Minim Invasive Gynecol. 2018;25:277-86.
 

Cervical insufficiency is an important cause of preterm birth and complicates up to 1% of pregnancies. It is typically diagnosed as painless cervical dilation without contractions, often in the second trimester at around 16-18 weeks, but the clinical presentation can be variable. In some cases, a rescue cerclage can be placed to prevent second trimester loss or preterm birth.

A recent landmark randomized controlled trial of abdominal vs. vaginal cerclage – the MAVRIC trial (Multicentre Abdominal vs. Vaginal Randomized Intervention of Cerclage)¹ published in 2020 – has offered significant validation for the belief that an abdominal approach is the preferred approach for patients with cervical insufficiency and a prior failed vaginal cerclage.

Obstetricians traditionally have had a high threshold for placement of an abdominal cerclage given the need for cesarean delivery and the morbidity of an open procedure. Laparoscopic abdominal cerclage has lowered this threshold and is increasingly the preferred method for cerclage placement. Reported complication rates are generally lower than for open abdominal cerclage, and neonatal survival rates are similar or improved.

In our experience, the move toward laparoscopic abdominal cerclage is largely a patient-driven shift. Since 2007, at Brigham and Women’s Hospital in Boston, we have performed over 150 laparoscopic abdominal cerclage placements. The majority of patients had at least one prior second-trimester loss (many of them had multiple losses), with many having also failed a transvaginal cerclage.

In an analysis of 137 of these cases published recently in Fertility and Sterility, the neonatal survival rate was 93.8% in the 80 pregnancies that followed and extended beyond the first trimester, and the mean gestational age at delivery was 36.9 weeks.² (First trimester losses are typically excluded from the denominator because they are unlikely to be the result of cervical insufficiency.)

History and outcomes data

The vaginal cerclage has long been a mainstay of therapy because it is a simple procedure. The McDonald technique, described in the 1950s, uses a simple purse string suture at the cervico-vaginal juncture, and the Shirodkar approach, also described in the 1950s, involves placing the cerclage higher on the cervix, as close to the internal os as possible. The Shirodkar technique is more complex, requiring more dissection, and is used less often than the McDonald approach.

The abdominal cerclage, first reported in 1965,³ is placed higher on the cervix, right near the juncture of the lower uterine segment and the cervix, and has generally been thought to provide optimal integrity. It is this point of placement – right at the juncture where membranes begin protruding into the cervix as it shortens and softens – that offers the strongest defense against cervical insufficiency.

The laparoscopic abdominal approach has been gaining popularity since it was first reported in 1998.⁴ Its traditional indication has been after a prior failed vaginal cerclage or when the cervix is too short to place a vaginal cerclage – as a result of a congenital anomaly or cervical conization, for instance.

Some of my patients have had one pregnancy loss in which cervical insufficiency was suspected and have sought laparoscopic abdominal cerclage without attempting a vaginal cerclage. Data to support this scenario are unavailable, but given the psychological trauma of pregnancy loss and the minimally invasive and low-risk nature of laparoscopic abdominal cerclage, I have been inclined to agree to preventive laparoscopic abdominal procedures without a trial of a vaginal cerclage. I believe this is a reasonable option.

The recently published MAVRIC trial included only abdominal cerclages performed using an open approach, but it provides good data for the scenario in which a vaginal cerclage has failed.

The rates of preterm birth at less than 32 weeks were significantly lower with abdominal cerclage than with low vaginal cerclage (McDonald technique) or high vaginal cerclage (Shirodkar technique) (8% vs. 33%, and 8% vs. 38%). No neonatal deaths occurred.

The analysis covered 111 women who conceived and had known pregnancy outcomes, out of 139 who were recruited and randomized. Cerclage placement occurred either between 10 and 16 weeks of gestation for vaginal cerclages and at 14 weeks for abdominal cerclages or before conception for those assigned to receive an abdominal or high vaginal cerclage.

Reviews of the literature done by our group1 and others have found equivalent outcomes between abdominal cerclages placed through laparotomy and through laparoscopy. The largest systematic review analyzed 31 studies involving 1,844 patients and found that neonatal survival rates were significantly greater in the laparoscopic group (97% vs. 90%), as were rates of deliveries after 34 weeks of gestation (83% vs. 76%).⁵

The better outcomes in the laparoscopic group may at least partly reflect improved laparoscopic surgeon techniques and improvements in neonatal care over time. At the minimum, we can conclude that neonatal outcomes are at least equivalent when an abdominal cerclage is placed through laparotomy or with a minimally invasive approach.

Our technique

Laparoscopic cerclages are much more easily placed – and with less risk of surgical complications or blood loss – in patients who are not pregnant. Postconception cerclage placement also carries a unique, small risk of fetal loss (estimated to occur in 1.2% of laparoscopic cases and 3% of open cases). ¹ We therefore prefer to perform the procedure before pregnancy, though we do place abdominal cerclages in early pregnancy as well. (Approximately 10% of the 137 patients in our analysis were pregnant at the time of cerclage placement. ¹ )

The procedure, described here for the nonpregnant patient, typically requires 3-4 ports. My preference is to use a 10-mm scope at the umbilicus, two 5-mm ipsilateral ports, and an additional 5-mm port for my assistant. We generally use a uterine manipulator to help with dissection and facilitate the correct angulation of the suture needle.

Dr. Jon I. Einarsson

Dr. Jon I. Einarsson

Dr. Jon I. Einarsson

Direct insertion of the needle simplifies the procedure and has not led to any complications thus far.

We prefer to insert the suture posteriorly at the level of the internal os just above the insertion of the uterosacral ligaments. It is helpful to view the uterus and cervix as an hourglass, with the level of the internal os is at the narrowest point of the hourglass.

The suture is passed carefully between the uterine vessels and the cervical stroma. The uterine artery should be lateral to placement of the needle, and the uterosacral ligament should be below. The surgeon should see a pulsation of the uterine artery. The use of blunt needles is advantageous because, especially when newer to the procedure, the surgeon can place the needle in slightly more medial than may be deemed necessary so as to avert the uterine vessels, then adjust placement slightly more laterally if resistance is met.

Suture placement should follow a fairly low-impact path. Encountering too much resistance with the needle signals passage into the cervix and necessitates redirection of the needle with a slightly more lateral placement. Twisting the uterus with the uterine manipulator can be helpful throughout this process.

Once the needles are passed through, they are cut off the Mersilene tape and removed. For suturing, it’s important that the first and second knots are tied down snuggly and flat.

Dr. Jon I. Einarsson

I usually ask my assistant to hold down the first knot so that it doesn’t unravel while I tie the second knot. I usually tie 6 square knots with the tape.

Dr. Jon I. Einarsson

The edges of the tape are then trimmed, and with a 2.0 silk suture, the ends are secured to the lower uterine segment to prevent a theoretical risk of erosion into the bladder.

Dr. Jon I. Einarsson

We then close the overlying vesicouterine peritoneum with 2-0 Monocryl suture, tying it intracorporally. Closing the peritoneum posteriorly is generally not necessary.

Dr. Jon I. Einarsson

A note on patient care

We recommend that patients not become pregnant for 2 months after the laparoscopic abdominal cerclage is placed, and that they receive obstetrical care as high-risk patients. The cerclage can be removed at the time of cesarean delivery if the patient has completed childbearing. Otherwise, if the cerclage appears normal, it can be left in place for future pregnancies.

In the event of a miscarriage, a dilatation and evacuation procedure can be performed with an abdominal cerclage in place, up to 18 weeks of pregnancy. Beyond this point, the patient likely will need to have the cerclage removed laparoscopically to allow vaginal passing of the fetus.

References

1. Shennan A et al. Am J Obstet Gynecol. 2020;222(3):261.E1-261.E9.

2. Clark NV & Einarsson JI. Fertil Steril. 2020;113:717-22.

3. Benson RC & Durfee RB. Obstet Gynecol. 1965;25:145-55.

4. Lesser KB et al. Obstet Gynecol. 1998;91:855-6.

5. Moawad GN et al. J Minim Invasive Gynecol. 2018;25:277-86.
 

Preterm birth remains a significant cause of infant morbidity and mortality. A well-established cause of preterm birth is cervical insufficiency, which occurs in approximately 1% of pregnancies and up to 8% of recurrent miscarriages and midtrimester pregnancy loss. A cerclage, a purse-string suture around the cervix, is placed to treat cervical insufficiency and, thus, prevent second-trimester loss and preterm birth. While, traditionally, placement of the cerclage was performed via a vaginal route, over the past 50 years, abdominal cerclage has been utilized in cases in which a vaginal cerclage has failed or the cervix is extremely short. The advantage of the abdominal approach is the ability to place the suture at the level of the internal os. Moreover, there is no potential risk of ascending infection and resultant preterm labor or premature rupture of membranes secondary to a foreign body in the vagina, as in the case of vaginal cerclage. There has been a reluctance to perform abdominal cerclage as a first-time treatment secondary to the need for cesarean section, risk of hemorrhage at the uterine vessels, and in the past, the need for a laparotomy.

With the introduction of a laparoscopic or robot-assisted approach to abdominal cerclage in preterm birth prevention, there has been an upsurge in the popularity of abdominal cerclage as the first-line surgical procedure, especially after a failed vaginal cerclage. In 2018, Moawad et al., in a systematic review of laparoscopic abdominal cerclage, noted slight improvement in neonatal outcomes with laparoscopy vs. laparotomy.

For this edition of the Master Class in gynecologic surgery, I have enlisted the assistance of Jon I. Einarsson, MD, PhD, MPH, who is chief of the division of minimally invasive gynecology at Brigham and Women’s Hospital and professor of obstetrics/gynecology at Harvard Medical School, Boston. Dr. Einarsson is a past president of the American Association of Gynecologic Laparoscopists. He is a very well-known, published clinical researcher and surgical innovator. Dr. Einarsson is the founder of Freyja Healthcare, a privately held medical device company advancing women’s health through innovation.

It is a pleasure and honor to welcome my friend and colleague, Dr. Jon I. Einarsson, to this edition of the Master Class in gynecologic surgery.

Dr. Miller is professor of obstetrics and gynecology in the department of clinical sciences, Rosalind Franklin University, North Chicago, and director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Miller reported that he has no disclosures relevant to this Master Class. Email him at [email protected].

Preterm birth remains a significant cause of infant morbidity and mortality. A well-established cause of preterm birth is cervical insufficiency, which occurs in approximately 1% of pregnancies and up to 8% of recurrent miscarriages and midtrimester pregnancy loss. A cerclage, a purse-string suture around the cervix, is placed to treat cervical insufficiency and, thus, prevent second-trimester loss and preterm birth. While, traditionally, placement of the cerclage was performed via a vaginal route, over the past 50 years, abdominal cerclage has been utilized in cases in which a vaginal cerclage has failed or the cervix is extremely short. The advantage of the abdominal approach is the ability to place the suture at the level of the internal os. Moreover, there is no potential risk of ascending infection and resultant preterm labor or premature rupture of membranes secondary to a foreign body in the vagina, as in the case of vaginal cerclage. There has been a reluctance to perform abdominal cerclage as a first-time treatment secondary to the need for cesarean section, risk of hemorrhage at the uterine vessels, and in the past, the need for a laparotomy.

With the introduction of a laparoscopic or robot-assisted approach to abdominal cerclage in preterm birth prevention, there has been an upsurge in the popularity of abdominal cerclage as the first-line surgical procedure, especially after a failed vaginal cerclage. In 2018, Moawad et al., in a systematic review of laparoscopic abdominal cerclage, noted slight improvement in neonatal outcomes with laparoscopy vs. laparotomy.

For this edition of the Master Class in gynecologic surgery, I have enlisted the assistance of Jon I. Einarsson, MD, PhD, MPH, who is chief of the division of minimally invasive gynecology at Brigham and Women’s Hospital and professor of obstetrics/gynecology at Harvard Medical School, Boston. Dr. Einarsson is a past president of the American Association of Gynecologic Laparoscopists. He is a very well-known, published clinical researcher and surgical innovator. Dr. Einarsson is the founder of Freyja Healthcare, a privately held medical device company advancing women’s health through innovation.

It is a pleasure and honor to welcome my friend and colleague, Dr. Jon I. Einarsson, to this edition of the Master Class in gynecologic surgery.

Dr. Miller is professor of obstetrics and gynecology in the department of clinical sciences, Rosalind Franklin University, North Chicago, and director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Miller reported that he has no disclosures relevant to this Master Class. Email him at [email protected].

Preterm birth remains a significant cause of infant morbidity and mortality. A well-established cause of preterm birth is cervical insufficiency, which occurs in approximately 1% of pregnancies and up to 8% of recurrent miscarriages and midtrimester pregnancy loss. A cerclage, a purse-string suture around the cervix, is placed to treat cervical insufficiency and, thus, prevent second-trimester loss and preterm birth. While, traditionally, placement of the cerclage was performed via a vaginal route, over the past 50 years, abdominal cerclage has been utilized in cases in which a vaginal cerclage has failed or the cervix is extremely short. The advantage of the abdominal approach is the ability to place the suture at the level of the internal os. Moreover, there is no potential risk of ascending infection and resultant preterm labor or premature rupture of membranes secondary to a foreign body in the vagina, as in the case of vaginal cerclage. There has been a reluctance to perform abdominal cerclage as a first-time treatment secondary to the need for cesarean section, risk of hemorrhage at the uterine vessels, and in the past, the need for a laparotomy.

With the introduction of a laparoscopic or robot-assisted approach to abdominal cerclage in preterm birth prevention, there has been an upsurge in the popularity of abdominal cerclage as the first-line surgical procedure, especially after a failed vaginal cerclage. In 2018, Moawad et al., in a systematic review of laparoscopic abdominal cerclage, noted slight improvement in neonatal outcomes with laparoscopy vs. laparotomy.

For this edition of the Master Class in gynecologic surgery, I have enlisted the assistance of Jon I. Einarsson, MD, PhD, MPH, who is chief of the division of minimally invasive gynecology at Brigham and Women’s Hospital and professor of obstetrics/gynecology at Harvard Medical School, Boston. Dr. Einarsson is a past president of the American Association of Gynecologic Laparoscopists. He is a very well-known, published clinical researcher and surgical innovator. Dr. Einarsson is the founder of Freyja Healthcare, a privately held medical device company advancing women’s health through innovation.

It is a pleasure and honor to welcome my friend and colleague, Dr. Jon I. Einarsson, to this edition of the Master Class in gynecologic surgery.

Dr. Miller is professor of obstetrics and gynecology in the department of clinical sciences, Rosalind Franklin University, North Chicago, and director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. Dr. Miller reported that he has no disclosures relevant to this Master Class. Email him at [email protected].

Background: Patients diagnosed with a hip fracture are at substantial risk of major complications and mortality. Observational studies have suggested that accelerated surgery for a hip fracture is associated with lower risk of mortality and major complications.

Practical limitations include the additional resources needed for an accelerated surgical pathway such as staffing and operating room time. Furthermore, this study included only patients diagnosed during regular working hours.

Bottom line: Among patients with a hip fracture, accelerated surgery did not lower the risk of the coprimary outcomes of mortality or a composite of major complications at 90 days compared with standard care.

Citation: Borges F et al. Accelerated surgery versus standard care in hip fracture (HIP ATTACK): An international, randomised, controlled trial. Lancet. 2020 Feb 29; 395(10225), 698-708.

Dr. Miller is assistant professor of medicine, section of hospital medicine, at the University of Virginia School of Medicine, Charlottesville.

Background: Patients diagnosed with a hip fracture are at substantial risk of major complications and mortality. Observational studies have suggested that accelerated surgery for a hip fracture is associated with lower risk of mortality and major complications.

Practical limitations include the additional resources needed for an accelerated surgical pathway such as staffing and operating room time. Furthermore, this study included only patients diagnosed during regular working hours.

Bottom line: Among patients with a hip fracture, accelerated surgery did not lower the risk of the coprimary outcomes of mortality or a composite of major complications at 90 days compared with standard care.

Citation: Borges F et al. Accelerated surgery versus standard care in hip fracture (HIP ATTACK): An international, randomised, controlled trial. Lancet. 2020 Feb 29; 395(10225), 698-708.

Dr. Miller is assistant professor of medicine, section of hospital medicine, at the University of Virginia School of Medicine, Charlottesville.

Background: Patients diagnosed with a hip fracture are at substantial risk of major complications and mortality. Observational studies have suggested that accelerated surgery for a hip fracture is associated with lower risk of mortality and major complications.

Practical limitations include the additional resources needed for an accelerated surgical pathway such as staffing and operating room time. Furthermore, this study included only patients diagnosed during regular working hours.

Bottom line: Among patients with a hip fracture, accelerated surgery did not lower the risk of the coprimary outcomes of mortality or a composite of major complications at 90 days compared with standard care.

Citation: Borges F et al. Accelerated surgery versus standard care in hip fracture (HIP ATTACK): An international, randomised, controlled trial. Lancet. 2020 Feb 29; 395(10225), 698-708.

Dr. Miller is assistant professor of medicine, section of hospital medicine, at the University of Virginia School of Medicine, Charlottesville.

Hysteroscopic mechanical morcellators have gained popularity given their ease of use. Consequently, the resectoscope loop is being used less frequently, which has resulted in less familiarity with this device. The resectoscope loop, however, not only is cost effective but also allows for multiple distinct advantages, such as cold loop dissection of myomas and the ability to obtain electrosurgical hemostasis during operative hysteroscopy.

In this article, we review the basics of electrosurgical principles, compare outcomes associated with monopolar and bipolar resectoscopes, and discuss tips and tricks for optimizing surgical techniques when using the resectoscope loop for hysteroscopic myomectomy.

Evolution of hysteroscopy

The term hysteroscopy comes from the Greek words hystera, for uterus, and skopeo, meaning “to see.” The idea to investigate the uterus dates back to the year 1000 when physicians used a mirror with light to peer into the vaginal vault.

The first known successful hysteroscopy occurred in 1869 when Pantaleoni used an endoscope with a light source to identify uterine polyps in a 60-year-old woman with abnormal uterine bleeding. In 1898, Simon Duplay and Spiro Clado published the first textbook on hysteroscopy in which they described several models of hysteroscopic instruments and techniques.

In the 1950s, Harold Horace Hopkins and Karl Storz modified the shape and length of lenses within the endoscope by substituting longer cylindrical lenses for the old spherical lenses; this permitted improved image brightness and sharpness as well as a smaller diameter of the hysteroscope. Between the 1970s and 1980s, technological improvements allowed for the creation of practical and usable hysteroscopic instruments such as the resectoscope. The resectoscope, originally used in urology for transurethral resection of the prostate, was modified for hysteroscopy by incorporating the use of electrosurgical currents to aid in procedures.

Over the past few decades, continued refinements in technology have improved visualization and surgical techniques. For example, image clarity has been markedly improved, and narrow hysteroscope diameters, as small as 3 to 5 mm, require minimal to no cervical dilation.

Monopolar and bipolar resectoscopes

Electrosurgery is the application of an alternating electrical current to tissue to achieve the clinical effects of surgical cutting or hemostasis via cell vaporization or coagulation. Current runs from the electrosurgical unit (ESU) to the active electrode of the surgical instrument, then goes from the active electrode through the patient’s tissue to the return electrode, and then travels back to the ESU. This flow of current creates an electrical circuit (FIGURE).

All electrosurgical devices have an active and a return electrode. The difference between monopolar and bipolar resectoscope devices lies in how the resectoscope loop is constructed. Bipolar resectoscope loops house the active and return electrodes on the same tip of the surgical device, which limits how much of the current flows through the patient. Alternatively, monopolar resectoscopes have only the active electrode on the tip of the device and the return electrode is off the surgical field, so the current flows through more of the patient. On monopolar electrosurgical devices, the current runs from the ESU to the active electrode (monopolar loop), which is then applied to tissue to produce the desired tissue effect. The current then travels via a path of least resistance from the surgical field through the patient to the return electrode, which is usually placed on the patient’s thigh, and then back to the ESU. The return electrode is often referred to as the grounding pad.

Continue to: How monopolar energy works...

How monopolar energy works

When first developed, all resectoscopes used monopolar energy. As such, throughout the 1990s, the monopolar resectoscope was the gold standard for performing electrosurgical hysteroscopy. Because the current travels a long distance between the active and the return electrode in a monopolar setup, a hypotonic, nonelectrolyte-rich medium (a poor conductor), such as glycine 1.5%, mannitol 5%, or sorbitol 3%, must be used. If an electrolyte-rich medium, such as normal saline, is used with a monopolar device, the current would be dispersed throughout the medium outside the operative field, causing unwanted tissue effects.

Although nonelectrolyte distension media improve visibility when encountering bleeding, they can be associated with hyponatremia, hyperglycemia, and even lifethreatening cerebral edema. Furthermore, glycine use is contraindicated in patients with renal or hepatic failure since oxidative deamination may cause hyperammonemia. Because of these numerous risk factors, the fluid deficit for hypotonic, nonelectrolyte distension media is limited to 1,000 mL, with a suggested maximum fluid deficit of 750 mL for elderly or fragile patients. Additionally, because the return electrode is off the surgical field in monopolar surgery, there is a risk of current diversion to the cervix, vagina, or vulva because the current travels between the active electrode on the surgical field to the return electrode on the patient’s thigh. The risk of current diversion is greater if there is damage to electrode insulation, loss of contact between the external sheath and the cervix, or direct coupling between the electrode and the surrounding tissue.

Advantages of the bipolar resectoscope

Because of the potential risks associated with the monopolar resectoscope, over the past 25 years the bipolar resectoscope emerged as an alternative due to its numerous benefits (TABLE 1).

Unlike monopolar resectoscopes, bipolar resectoscopes require an electrolyte-rich distension medium such as 0.9% normal saline or lactated Ringer’s. These isotonic distension media allow a much higher fluid deficit (2,500 mL for healthy patients, 1,500 mL for elderly patients or patients with comorbidities) as the isotonic solution is safer to use. Furthermore, it allows for lower voltage settings and decreased electrical spread compared to the monopolar resectoscope since the current stays between the 2 electrodes. Because isotonic media are miscible with blood, however, a potential drawback is that in cases with bleeding, visibility may be more limited compared to hypotonic distension media.

Evidence on fertility outcomes

Several studies have compared operative and fertility outcomes with the use of monopolar versus bipolar hysteroscopy.

In a randomized controlled trial (RCT) comparing outcomes after hysteroscopy with a monopolar (glycine 1.5%) versus bipolar (0.9% normal saline) 26 French resectoscope loop, Berg and colleagues found that the only significant difference between the 2 groups was that the change in serum sodium pre and postoperatively was greater in the monopolar group despite having a smaller mean fluid deficit (765 mL vs 1,227 mL).¹

Similarly, in a study of fertility outcomes after monopolar versus bipolar hysteroscopic myomectomy with use of a 26 French resectoscope Collins knife, Roy and colleagues found no significant differences in postoperative pregnancy rates or successful pregnancy outcomes, operative time, fluid deficit, or improvement in menstrual symptoms.² However, the monopolar group had a much higher incidence of postoperative hyponatremia (30% vs 0%) that required additional days of hospitalization despite similar fluid deficits of between 600 and 700 mL.²

Similar findings were noted in another RCT that compared operative outcomes between monopolar and bipolar resectoscope usage during metroplasty for infertility, with a postoperative hyponatremia incidence of 17.1% in the monopolar group versus 0% in the bipolar group despite similar fluid deficits.³ Energy type had no effect on reproductive outcomes in either group.³

Continue to: How does the resectoscope compare with mechanical tissue removal systems?...

In 2005, the first hysteroscopic mechanical tissue removal system was introduced in the United States, providing an additional treatment method for such intrauterine masses as fibroids and polyps.

Advantages. Rather than using an electrical current, these tissue removal systems use a rotating blade with suction that is introduced through a specially designed rigid hysteroscopic sheath. As the instrument incises the pathology, the tissue is removed from the intrauterine cavity and collected in a specimen bag inside the fluid management system. This immediate removal of tissue allows for insertion of the device only once during initial entry, decreasing both the risk of perforation and operative times. Furthermore, mechanical tissue removal systems can be used with isotonic media, negating the risks associated with hypotonic media. Currently, the 2 mechanical tissue removal systems available in the United States are the TruClear and the MyoSure hysteroscopic tissue removal systems.

Studies comparing mechanical tissue removal of polyps and myomas with conventional resectoscope resection have found that mechanical tissue removal is associated with reduced operative time, fluid deficit, and number of instrument insertions.^4-8 However, studies have found no significant difference in postoperative patient satisfaction.^7,9

Additionally, hysteroscopic tissue removal systems have an easier learning curve. Van Dongen and colleagues conducted an RCT to compare resident-in-training comfort levels when learning to use both a mechanical tissue removal system and a traditional resectoscope; they found increased comfort with the hysteroscopic tissue removal system, suggesting greater ease of use.¹⁰

Drawbacks. Despite their many benefits, mechanical tissue removal systems have some disadvantages when compared with the resectoscope. First, mechanical tissue removal systems are associated with higher instrument costs. In addition, they have extremely limited ability to achieve hemostasis when encountering blood vessels during resection, resulting in poor visibility especially when resecting large myomas with feeding vessels.

Hysteroscopic mechanical tissue removal systems typically use higher intrauterine pressures for uterine distension compared with the resectoscope, especially when trying to improve visibility in a bloody surgical field. Increasing the intrauterine pressure with the distension media allows for compression of the blood vessels. As a result, however, submucosal fibroids classified as FIGO 2 (International Federation of Gynecology and Obstetrics) may be less visible since the higher intrauterine pressure can compress both blood vessels and submucosal fibroids

Additionally, mechanical tissue removal systems have limited ability to resect the intramural component of FIGO 1 or FIGO 2 submucosal fibroids since the intramural portion is embedded in the myometrium. Use of the resectoscope loop instead allows for a technique called the cold loop dissection, which uses the resectoscope loop to bluntly dissect and enucleate the intramural component of FIGO 1 and FIGO 2 submucosal myomas from the surrounding myometrium without activating the current. This blunt cold loop dissection technique allows for a deeper and more thorough resection. Often, if the pseudocapsule plane is identified, even the intramural component of FIGO 1 or FIGO 2 submucosal fibroids can be resected, enabling complete removal.

Lastly, mechanical tissue removal systems are not always faster than resectoscopes for all pathology. We prefer using the resectoscope for larger myomas (>3 cm) as the resectoscope allows for resection and removal of larger myoma chips, helping to decrease operative times. Given the many benefits of the resectoscope, we argue that the resectoscope loop remains a crucial instrument in operative gynecology and that learners should continue to hone their hysteroscopic skills with both the resectoscope and mechanical tissue removal systems.

Tips and tricks for hysteroscopic myomectomy with the resectoscope loop

In the video below, "Bipolar resectoscope: Optimizing safe myomectomy," we review specific surgical techniques for optimizing outcomes and safety with the resectoscope loop. These include:

• bow-and-arrow technique
• identification of the fibroid anatomy (pseudocapsule plane)
• blunt cold loop dissection
• the push-and-tuck method
• efficient electrosurgical hemostasis (TABLE 2).

Although we use bipolar energy during this resection, the resection technique using the monopolar loop is the same.

Vidyard Video

The takeaway

The resectoscope loop is a valuable tool that offers gynecologic surgeons a wider range of techniques for myomectomy. It also offers several surgical and clinical advantages. It is important to train residents in the use of both hysteroscopic mechanical tissue removal systems and resectoscope loops. ●

Hysteroscopic mechanical morcellators have gained popularity given their ease of use. Consequently, the resectoscope loop is being used less frequently, which has resulted in less familiarity with this device. The resectoscope loop, however, not only is cost effective but also allows for multiple distinct advantages, such as cold loop dissection of myomas and the ability to obtain electrosurgical hemostasis during operative hysteroscopy.

In this article, we review the basics of electrosurgical principles, compare outcomes associated with monopolar and bipolar resectoscopes, and discuss tips and tricks for optimizing surgical techniques when using the resectoscope loop for hysteroscopic myomectomy.

Evolution of hysteroscopy

The term hysteroscopy comes from the Greek words hystera, for uterus, and skopeo, meaning “to see.” The idea to investigate the uterus dates back to the year 1000 when physicians used a mirror with light to peer into the vaginal vault.

The first known successful hysteroscopy occurred in 1869 when Pantaleoni used an endoscope with a light source to identify uterine polyps in a 60-year-old woman with abnormal uterine bleeding. In 1898, Simon Duplay and Spiro Clado published the first textbook on hysteroscopy in which they described several models of hysteroscopic instruments and techniques.

In the 1950s, Harold Horace Hopkins and Karl Storz modified the shape and length of lenses within the endoscope by substituting longer cylindrical lenses for the old spherical lenses; this permitted improved image brightness and sharpness as well as a smaller diameter of the hysteroscope. Between the 1970s and 1980s, technological improvements allowed for the creation of practical and usable hysteroscopic instruments such as the resectoscope. The resectoscope, originally used in urology for transurethral resection of the prostate, was modified for hysteroscopy by incorporating the use of electrosurgical currents to aid in procedures.

Over the past few decades, continued refinements in technology have improved visualization and surgical techniques. For example, image clarity has been markedly improved, and narrow hysteroscope diameters, as small as 3 to 5 mm, require minimal to no cervical dilation.

Monopolar and bipolar resectoscopes

Electrosurgery is the application of an alternating electrical current to tissue to achieve the clinical effects of surgical cutting or hemostasis via cell vaporization or coagulation. Current runs from the electrosurgical unit (ESU) to the active electrode of the surgical instrument, then goes from the active electrode through the patient’s tissue to the return electrode, and then travels back to the ESU. This flow of current creates an electrical circuit (FIGURE).

All electrosurgical devices have an active and a return electrode. The difference between monopolar and bipolar resectoscope devices lies in how the resectoscope loop is constructed. Bipolar resectoscope loops house the active and return electrodes on the same tip of the surgical device, which limits how much of the current flows through the patient. Alternatively, monopolar resectoscopes have only the active electrode on the tip of the device and the return electrode is off the surgical field, so the current flows through more of the patient. On monopolar electrosurgical devices, the current runs from the ESU to the active electrode (monopolar loop), which is then applied to tissue to produce the desired tissue effect. The current then travels via a path of least resistance from the surgical field through the patient to the return electrode, which is usually placed on the patient’s thigh, and then back to the ESU. The return electrode is often referred to as the grounding pad.

Continue to: How monopolar energy works...

How monopolar energy works

When first developed, all resectoscopes used monopolar energy. As such, throughout the 1990s, the monopolar resectoscope was the gold standard for performing electrosurgical hysteroscopy. Because the current travels a long distance between the active and the return electrode in a monopolar setup, a hypotonic, nonelectrolyte-rich medium (a poor conductor), such as glycine 1.5%, mannitol 5%, or sorbitol 3%, must be used. If an electrolyte-rich medium, such as normal saline, is used with a monopolar device, the current would be dispersed throughout the medium outside the operative field, causing unwanted tissue effects.

Although nonelectrolyte distension media improve visibility when encountering bleeding, they can be associated with hyponatremia, hyperglycemia, and even lifethreatening cerebral edema. Furthermore, glycine use is contraindicated in patients with renal or hepatic failure since oxidative deamination may cause hyperammonemia. Because of these numerous risk factors, the fluid deficit for hypotonic, nonelectrolyte distension media is limited to 1,000 mL, with a suggested maximum fluid deficit of 750 mL for elderly or fragile patients. Additionally, because the return electrode is off the surgical field in monopolar surgery, there is a risk of current diversion to the cervix, vagina, or vulva because the current travels between the active electrode on the surgical field to the return electrode on the patient’s thigh. The risk of current diversion is greater if there is damage to electrode insulation, loss of contact between the external sheath and the cervix, or direct coupling between the electrode and the surrounding tissue.

Advantages of the bipolar resectoscope

Because of the potential risks associated with the monopolar resectoscope, over the past 25 years the bipolar resectoscope emerged as an alternative due to its numerous benefits (TABLE 1).

Unlike monopolar resectoscopes, bipolar resectoscopes require an electrolyte-rich distension medium such as 0.9% normal saline or lactated Ringer’s. These isotonic distension media allow a much higher fluid deficit (2,500 mL for healthy patients, 1,500 mL for elderly patients or patients with comorbidities) as the isotonic solution is safer to use. Furthermore, it allows for lower voltage settings and decreased electrical spread compared to the monopolar resectoscope since the current stays between the 2 electrodes. Because isotonic media are miscible with blood, however, a potential drawback is that in cases with bleeding, visibility may be more limited compared to hypotonic distension media.

Evidence on fertility outcomes

Several studies have compared operative and fertility outcomes with the use of monopolar versus bipolar hysteroscopy.

In a randomized controlled trial (RCT) comparing outcomes after hysteroscopy with a monopolar (glycine 1.5%) versus bipolar (0.9% normal saline) 26 French resectoscope loop, Berg and colleagues found that the only significant difference between the 2 groups was that the change in serum sodium pre and postoperatively was greater in the monopolar group despite having a smaller mean fluid deficit (765 mL vs 1,227 mL).¹

Similarly, in a study of fertility outcomes after monopolar versus bipolar hysteroscopic myomectomy with use of a 26 French resectoscope Collins knife, Roy and colleagues found no significant differences in postoperative pregnancy rates or successful pregnancy outcomes, operative time, fluid deficit, or improvement in menstrual symptoms.² However, the monopolar group had a much higher incidence of postoperative hyponatremia (30% vs 0%) that required additional days of hospitalization despite similar fluid deficits of between 600 and 700 mL.²

Similar findings were noted in another RCT that compared operative outcomes between monopolar and bipolar resectoscope usage during metroplasty for infertility, with a postoperative hyponatremia incidence of 17.1% in the monopolar group versus 0% in the bipolar group despite similar fluid deficits.³ Energy type had no effect on reproductive outcomes in either group.³

Continue to: How does the resectoscope compare with mechanical tissue removal systems?...

In 2005, the first hysteroscopic mechanical tissue removal system was introduced in the United States, providing an additional treatment method for such intrauterine masses as fibroids and polyps.

Advantages. Rather than using an electrical current, these tissue removal systems use a rotating blade with suction that is introduced through a specially designed rigid hysteroscopic sheath. As the instrument incises the pathology, the tissue is removed from the intrauterine cavity and collected in a specimen bag inside the fluid management system. This immediate removal of tissue allows for insertion of the device only once during initial entry, decreasing both the risk of perforation and operative times. Furthermore, mechanical tissue removal systems can be used with isotonic media, negating the risks associated with hypotonic media. Currently, the 2 mechanical tissue removal systems available in the United States are the TruClear and the MyoSure hysteroscopic tissue removal systems.

Studies comparing mechanical tissue removal of polyps and myomas with conventional resectoscope resection have found that mechanical tissue removal is associated with reduced operative time, fluid deficit, and number of instrument insertions.^4-8 However, studies have found no significant difference in postoperative patient satisfaction.^7,9

Additionally, hysteroscopic tissue removal systems have an easier learning curve. Van Dongen and colleagues conducted an RCT to compare resident-in-training comfort levels when learning to use both a mechanical tissue removal system and a traditional resectoscope; they found increased comfort with the hysteroscopic tissue removal system, suggesting greater ease of use.¹⁰

Drawbacks. Despite their many benefits, mechanical tissue removal systems have some disadvantages when compared with the resectoscope. First, mechanical tissue removal systems are associated with higher instrument costs. In addition, they have extremely limited ability to achieve hemostasis when encountering blood vessels during resection, resulting in poor visibility especially when resecting large myomas with feeding vessels.

Hysteroscopic mechanical tissue removal systems typically use higher intrauterine pressures for uterine distension compared with the resectoscope, especially when trying to improve visibility in a bloody surgical field. Increasing the intrauterine pressure with the distension media allows for compression of the blood vessels. As a result, however, submucosal fibroids classified as FIGO 2 (International Federation of Gynecology and Obstetrics) may be less visible since the higher intrauterine pressure can compress both blood vessels and submucosal fibroids

Additionally, mechanical tissue removal systems have limited ability to resect the intramural component of FIGO 1 or FIGO 2 submucosal fibroids since the intramural portion is embedded in the myometrium. Use of the resectoscope loop instead allows for a technique called the cold loop dissection, which uses the resectoscope loop to bluntly dissect and enucleate the intramural component of FIGO 1 and FIGO 2 submucosal myomas from the surrounding myometrium without activating the current. This blunt cold loop dissection technique allows for a deeper and more thorough resection. Often, if the pseudocapsule plane is identified, even the intramural component of FIGO 1 or FIGO 2 submucosal fibroids can be resected, enabling complete removal.

Lastly, mechanical tissue removal systems are not always faster than resectoscopes for all pathology. We prefer using the resectoscope for larger myomas (>3 cm) as the resectoscope allows for resection and removal of larger myoma chips, helping to decrease operative times. Given the many benefits of the resectoscope, we argue that the resectoscope loop remains a crucial instrument in operative gynecology and that learners should continue to hone their hysteroscopic skills with both the resectoscope and mechanical tissue removal systems.

Tips and tricks for hysteroscopic myomectomy with the resectoscope loop

In the video below, "Bipolar resectoscope: Optimizing safe myomectomy," we review specific surgical techniques for optimizing outcomes and safety with the resectoscope loop. These include:

• bow-and-arrow technique
• identification of the fibroid anatomy (pseudocapsule plane)
• blunt cold loop dissection
• the push-and-tuck method
• efficient electrosurgical hemostasis (TABLE 2).

Although we use bipolar energy during this resection, the resection technique using the monopolar loop is the same.

Vidyard Video

The takeaway

The resectoscope loop is a valuable tool that offers gynecologic surgeons a wider range of techniques for myomectomy. It also offers several surgical and clinical advantages. It is important to train residents in the use of both hysteroscopic mechanical tissue removal systems and resectoscope loops. ●

Hysteroscopic mechanical morcellators have gained popularity given their ease of use. Consequently, the resectoscope loop is being used less frequently, which has resulted in less familiarity with this device. The resectoscope loop, however, not only is cost effective but also allows for multiple distinct advantages, such as cold loop dissection of myomas and the ability to obtain electrosurgical hemostasis during operative hysteroscopy.

In this article, we review the basics of electrosurgical principles, compare outcomes associated with monopolar and bipolar resectoscopes, and discuss tips and tricks for optimizing surgical techniques when using the resectoscope loop for hysteroscopic myomectomy.

Evolution of hysteroscopy

The term hysteroscopy comes from the Greek words hystera, for uterus, and skopeo, meaning “to see.” The idea to investigate the uterus dates back to the year 1000 when physicians used a mirror with light to peer into the vaginal vault.

The first known successful hysteroscopy occurred in 1869 when Pantaleoni used an endoscope with a light source to identify uterine polyps in a 60-year-old woman with abnormal uterine bleeding. In 1898, Simon Duplay and Spiro Clado published the first textbook on hysteroscopy in which they described several models of hysteroscopic instruments and techniques.

In the 1950s, Harold Horace Hopkins and Karl Storz modified the shape and length of lenses within the endoscope by substituting longer cylindrical lenses for the old spherical lenses; this permitted improved image brightness and sharpness as well as a smaller diameter of the hysteroscope. Between the 1970s and 1980s, technological improvements allowed for the creation of practical and usable hysteroscopic instruments such as the resectoscope. The resectoscope, originally used in urology for transurethral resection of the prostate, was modified for hysteroscopy by incorporating the use of electrosurgical currents to aid in procedures.

Over the past few decades, continued refinements in technology have improved visualization and surgical techniques. For example, image clarity has been markedly improved, and narrow hysteroscope diameters, as small as 3 to 5 mm, require minimal to no cervical dilation.

Monopolar and bipolar resectoscopes

Electrosurgery is the application of an alternating electrical current to tissue to achieve the clinical effects of surgical cutting or hemostasis via cell vaporization or coagulation. Current runs from the electrosurgical unit (ESU) to the active electrode of the surgical instrument, then goes from the active electrode through the patient’s tissue to the return electrode, and then travels back to the ESU. This flow of current creates an electrical circuit (FIGURE).

All electrosurgical devices have an active and a return electrode. The difference between monopolar and bipolar resectoscope devices lies in how the resectoscope loop is constructed. Bipolar resectoscope loops house the active and return electrodes on the same tip of the surgical device, which limits how much of the current flows through the patient. Alternatively, monopolar resectoscopes have only the active electrode on the tip of the device and the return electrode is off the surgical field, so the current flows through more of the patient. On monopolar electrosurgical devices, the current runs from the ESU to the active electrode (monopolar loop), which is then applied to tissue to produce the desired tissue effect. The current then travels via a path of least resistance from the surgical field through the patient to the return electrode, which is usually placed on the patient’s thigh, and then back to the ESU. The return electrode is often referred to as the grounding pad.

Continue to: How monopolar energy works...

How monopolar energy works

When first developed, all resectoscopes used monopolar energy. As such, throughout the 1990s, the monopolar resectoscope was the gold standard for performing electrosurgical hysteroscopy. Because the current travels a long distance between the active and the return electrode in a monopolar setup, a hypotonic, nonelectrolyte-rich medium (a poor conductor), such as glycine 1.5%, mannitol 5%, or sorbitol 3%, must be used. If an electrolyte-rich medium, such as normal saline, is used with a monopolar device, the current would be dispersed throughout the medium outside the operative field, causing unwanted tissue effects.

Although nonelectrolyte distension media improve visibility when encountering bleeding, they can be associated with hyponatremia, hyperglycemia, and even lifethreatening cerebral edema. Furthermore, glycine use is contraindicated in patients with renal or hepatic failure since oxidative deamination may cause hyperammonemia. Because of these numerous risk factors, the fluid deficit for hypotonic, nonelectrolyte distension media is limited to 1,000 mL, with a suggested maximum fluid deficit of 750 mL for elderly or fragile patients. Additionally, because the return electrode is off the surgical field in monopolar surgery, there is a risk of current diversion to the cervix, vagina, or vulva because the current travels between the active electrode on the surgical field to the return electrode on the patient’s thigh. The risk of current diversion is greater if there is damage to electrode insulation, loss of contact between the external sheath and the cervix, or direct coupling between the electrode and the surrounding tissue.

Advantages of the bipolar resectoscope

Because of the potential risks associated with the monopolar resectoscope, over the past 25 years the bipolar resectoscope emerged as an alternative due to its numerous benefits (TABLE 1).

Unlike monopolar resectoscopes, bipolar resectoscopes require an electrolyte-rich distension medium such as 0.9% normal saline or lactated Ringer’s. These isotonic distension media allow a much higher fluid deficit (2,500 mL for healthy patients, 1,500 mL for elderly patients or patients with comorbidities) as the isotonic solution is safer to use. Furthermore, it allows for lower voltage settings and decreased electrical spread compared to the monopolar resectoscope since the current stays between the 2 electrodes. Because isotonic media are miscible with blood, however, a potential drawback is that in cases with bleeding, visibility may be more limited compared to hypotonic distension media.

Evidence on fertility outcomes

Several studies have compared operative and fertility outcomes with the use of monopolar versus bipolar hysteroscopy.

In a randomized controlled trial (RCT) comparing outcomes after hysteroscopy with a monopolar (glycine 1.5%) versus bipolar (0.9% normal saline) 26 French resectoscope loop, Berg and colleagues found that the only significant difference between the 2 groups was that the change in serum sodium pre and postoperatively was greater in the monopolar group despite having a smaller mean fluid deficit (765 mL vs 1,227 mL).¹

Similarly, in a study of fertility outcomes after monopolar versus bipolar hysteroscopic myomectomy with use of a 26 French resectoscope Collins knife, Roy and colleagues found no significant differences in postoperative pregnancy rates or successful pregnancy outcomes, operative time, fluid deficit, or improvement in menstrual symptoms.² However, the monopolar group had a much higher incidence of postoperative hyponatremia (30% vs 0%) that required additional days of hospitalization despite similar fluid deficits of between 600 and 700 mL.²

Similar findings were noted in another RCT that compared operative outcomes between monopolar and bipolar resectoscope usage during metroplasty for infertility, with a postoperative hyponatremia incidence of 17.1% in the monopolar group versus 0% in the bipolar group despite similar fluid deficits.³ Energy type had no effect on reproductive outcomes in either group.³

Continue to: How does the resectoscope compare with mechanical tissue removal systems?...

In 2005, the first hysteroscopic mechanical tissue removal system was introduced in the United States, providing an additional treatment method for such intrauterine masses as fibroids and polyps.

Advantages. Rather than using an electrical current, these tissue removal systems use a rotating blade with suction that is introduced through a specially designed rigid hysteroscopic sheath. As the instrument incises the pathology, the tissue is removed from the intrauterine cavity and collected in a specimen bag inside the fluid management system. This immediate removal of tissue allows for insertion of the device only once during initial entry, decreasing both the risk of perforation and operative times. Furthermore, mechanical tissue removal systems can be used with isotonic media, negating the risks associated with hypotonic media. Currently, the 2 mechanical tissue removal systems available in the United States are the TruClear and the MyoSure hysteroscopic tissue removal systems.

Studies comparing mechanical tissue removal of polyps and myomas with conventional resectoscope resection have found that mechanical tissue removal is associated with reduced operative time, fluid deficit, and number of instrument insertions.^4-8 However, studies have found no significant difference in postoperative patient satisfaction.^7,9

Additionally, hysteroscopic tissue removal systems have an easier learning curve. Van Dongen and colleagues conducted an RCT to compare resident-in-training comfort levels when learning to use both a mechanical tissue removal system and a traditional resectoscope; they found increased comfort with the hysteroscopic tissue removal system, suggesting greater ease of use.¹⁰

Drawbacks. Despite their many benefits, mechanical tissue removal systems have some disadvantages when compared with the resectoscope. First, mechanical tissue removal systems are associated with higher instrument costs. In addition, they have extremely limited ability to achieve hemostasis when encountering blood vessels during resection, resulting in poor visibility especially when resecting large myomas with feeding vessels.

Hysteroscopic mechanical tissue removal systems typically use higher intrauterine pressures for uterine distension compared with the resectoscope, especially when trying to improve visibility in a bloody surgical field. Increasing the intrauterine pressure with the distension media allows for compression of the blood vessels. As a result, however, submucosal fibroids classified as FIGO 2 (International Federation of Gynecology and Obstetrics) may be less visible since the higher intrauterine pressure can compress both blood vessels and submucosal fibroids

Additionally, mechanical tissue removal systems have limited ability to resect the intramural component of FIGO 1 or FIGO 2 submucosal fibroids since the intramural portion is embedded in the myometrium. Use of the resectoscope loop instead allows for a technique called the cold loop dissection, which uses the resectoscope loop to bluntly dissect and enucleate the intramural component of FIGO 1 and FIGO 2 submucosal myomas from the surrounding myometrium without activating the current. This blunt cold loop dissection technique allows for a deeper and more thorough resection. Often, if the pseudocapsule plane is identified, even the intramural component of FIGO 1 or FIGO 2 submucosal fibroids can be resected, enabling complete removal.

Lastly, mechanical tissue removal systems are not always faster than resectoscopes for all pathology. We prefer using the resectoscope for larger myomas (>3 cm) as the resectoscope allows for resection and removal of larger myoma chips, helping to decrease operative times. Given the many benefits of the resectoscope, we argue that the resectoscope loop remains a crucial instrument in operative gynecology and that learners should continue to hone their hysteroscopic skills with both the resectoscope and mechanical tissue removal systems.

Tips and tricks for hysteroscopic myomectomy with the resectoscope loop

In the video below, "Bipolar resectoscope: Optimizing safe myomectomy," we review specific surgical techniques for optimizing outcomes and safety with the resectoscope loop. These include:

• bow-and-arrow technique
• identification of the fibroid anatomy (pseudocapsule plane)
• blunt cold loop dissection
• the push-and-tuck method
• efficient electrosurgical hemostasis (TABLE 2).

Although we use bipolar energy during this resection, the resection technique using the monopolar loop is the same.

Vidyard Video

The takeaway

The resectoscope loop is a valuable tool that offers gynecologic surgeons a wider range of techniques for myomectomy. It also offers several surgical and clinical advantages. It is important to train residents in the use of both hysteroscopic mechanical tissue removal systems and resectoscope loops. ●

Two chronic gynecologic conditions notably affect a woman’s quality of life (QoL), including fertility – one is endometriosis, and the other is a fibroid uterus. For a benign tumor, fibroids have an impressive prevalence found in approximately 50%-60% of women during their reproductive years. By menopause, it is estimated that 70% of woman have a fibroid, yet the true incidence is unknown given that only 25% of women experience symptoms bothersome enough to warrant intervention. This month’s article reviews the burden of fibroids and the latest management options that may potentially avoid surgery.

Background

Fibroids are monoclonal tumors of uterine smooth muscle that originate from the myometrium. Risk factors include family history, being premenopausal, increasing time since last delivery, obesity, and hypertension (ACOG Practice Bulletin no. 228 Jun 2021: Obstet Gynecol. 2021 Jun 1;137[6]:e100-e15) but oral hormonal contraception, depot medroxyprogesterone acetate (MPA), and increased parity reduce the risk of fibroids. Compared with White women, Black women have a 2-3 times higher prevalence of fibroids, develop them at a younger age, and present with larger fibroids.

The FIGO leiomyoma classification is the agreed upon system for identifying fibroid location. Symptoms are all too familiar to gynecologists, with life-threatening hemorrhage with severe anemia being the most feared, particularly for FIGO types 1-5. Transvaginal ultrasound is the simplest imaging tool for evaluation.

Adapted from Int J Gynecol Obstet. 2011;113:3-13.

Fibroids and fertility

Fibroids can impair fertility in several ways: alteration of local anatomy, including the detrimental effects of abnormal uterine bleeding; functional changes by increasing uterine contractions and impairing endometrium and myometrial blood supply; and changes to the local hormonal environment that could impair egg/sperm transport, or embryo implantation (Hum Reprod Update. 2017;22:665-86).

Prior to consideration of surgery, saline infusion sonogram can determine the degree of impact on the endometrium, which is most applicable to the infertility patient, but can also allow guidance toward the appropriate surgical approach.
 

Treatment options – medical

Management of fibroids is based on a woman’s age, desire for fertility, symptoms, and location of the fibroid(s). Expectant observation of a woman with fibroids may be a reasonable approach, provided the lack of symptoms impairing QoL and of anemia. Typically, there is no change in fibroid size during the short term, considered less than 1 year. Regarding fertility, studies are heterogeneous so there is no definitive conclusion that fibroids impair natural fertility (Reprod Biomed Online. 2021;43:100-10). Spontaneous regression, defined by a reduction in fibroid volume of greater than 20%, has been noted to occur in 7.0% of fibroids (Curr Obstet Gynecol Rep. 2018;7[3]:117-21).

When fertility is not desired, medical management of fibroids is the initial conservative approach. GnRH agonists have been utilized for temporary relief of menometrorrhagia because of fibroids and to reduce their volume, particularly preoperatively. However, extended treatment can induce bone mineral density loss. Add-back therapy (tibolone, raloxifene, estriol, and ipriflavone) is of value in reducing bone loss while MPA and tibolone may manage vasomotor symptoms. More recently, the use of a GnRH antagonist (elagolix) along with add-back therapy has been approved for up to 24 months by the Food and Drug Administration and has demonstrated a more than 50% amenorrhea rate at 12 months (Obstet Gynecol. 2020;135:1313-26).

Progesterone plays an important role in fibroid growth, but the mechanism is unclear. Although not FDA approved, selective progesterone receptor modulators (SPRM) act directly on fibroid size reduction at the level of the pituitary to induce amenorrhea through inhibition of ovulation. Also, more than one course of SPRMs can provide benefit for bleeding control and volume reduction. The SPRM ulipristal acetate for four courses of 3 months demonstrated 73.5% of patients experienced a fibroid volume reduction of greater than 25% and were amenorrheic (Fertil Steril. 2017;108:416-25). GnRH agonists or SPRMs may benefit women if the fibroid is larger than 3 cm or anemia exists, thereby precluding immediate surgery.

Other medication options include the levonorgestrel IUD, combined hormonal contraceptives, and tranexamic acid – all of which have limited data on effective results of treating abnormal uterine bleeding.
 

Treatment options – surgical

Fibroids are the most common reason for hysterectomy as they are the contributing indication in approximately one-third of surgeries. When future fertility is desired, current surgical options include hysteroscopic and laparoscopic (including robotic) myomectomy. Hysteroscopy is the standard approach for FIGO type 1 fibroids and can also manage some type 2 fibroids provided they are less than 3 cm and the latter is greater than 5 mm from the serosa. Type 2 fibroids may benefit from a “two-step” removal to allow the myometrium to contract and extrude the fibroid. In light of the risk of fluid overload with nonelectrolyte solutions that enable the use of monopolar cautery, many procedures are now performed with bipolar cautery or morcellators.

Laparoscopy (including robotic) has outcomes similar to those of laparotomy although the risk of uterine rupture with the former requires careful attention to thorough closure of the myometrial defect. Robotic myomectomy has outcomes similar to those of standard laparoscopy with less blood loss, but operating times may be prolonged (Best Pract Res Clin Obstet Gynaecol. 2018;46:113-9).

The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women (Fertil Steril 2017;108;416-25). The rate of recurrence after myomectomy can be as great as 60% when patients are followed up to 5 years. Intramural fibroids greater than 2.85 cm and not distorting the uterine cavity may decrease in vitro fertilization (IVF) success (Fertil Steril 2014;101:716-21).
 

Noninvasive treatment modalities

Uterine artery embolization (UAE) is the most popular minimally invasive alternative to surgical myomectomy. Risks include postembolization syndrome (pain, fever, nausea, leukocytosis, and occasionally malaise), infection, and damage to fertility. Rarely, loss of ovarian function can occur, particularly in women above age 45. Because of the disruption of uterine blood flow, UAE increases the risk of accelerating ovarian aging and infertility as well as atrophic endometrium. In addition, pregnancy complications are increased including miscarriage, preterm labor, and postpartum hemorrhage. There is debate regarding the need for cesarean section at time of delivery given the potential for weakening of the uterine wall following UAE.

High-intensity focused ultrasound (HIFU) is guided by ultrasound or MRI and involves a high-energy-density ultrasound wave passing through the skin. The wave is absorbed and transformed into heat, causing the tissue protein to coagulate, and to be absorbed by the body. The procedure is scarless, carries a minimal risk of infection, and offers less pain compared with traditional approaches. However, HIFU is time consuming, and skin burns and unintentional tissue injury are a risk. A meta-analysis demonstrated improved symptoms of fibroids at 6 and 12 months (J Min Invasive Gynecol. 2021 in press).

Ultrasound-guided microwave ablation (MWA) uses an ablative electrode that is directly inserted into the target tissue via transcutaneous or transcervical approach via ultrasound guidance using microwave to produce heat for tissue coagulation necrosis. The advantages of MWA compared with HIFU and RFA are a higher tissue temperature, larger ablation volume, shorter operating time, less pain and no adverse major events (J Min Invasive Gynecol. 2021, in press).
 

Conclusion

The current literature cannot conclude that fibroids reduce the likelihood of achieving pregnancy with or without fertility treatment, based on a specific size, number, or location (not including submucosal or cavity-distorting intramural fibroids). Definitive evidence on the efficacy of myomectomy to improve fertility remains limited. Hysteroscopic myomectomy presumably improves pregnancy rates, but there is uncertainty as to its role in reducing miscarriage. Novel nonsurgical modalities are available and are expected to continue being developed but clarity on fertility outcomes is needed.
 

Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no conflicts of interests. Please contact him at [email protected].

Two chronic gynecologic conditions notably affect a woman’s quality of life (QoL), including fertility – one is endometriosis, and the other is a fibroid uterus. For a benign tumor, fibroids have an impressive prevalence found in approximately 50%-60% of women during their reproductive years. By menopause, it is estimated that 70% of woman have a fibroid, yet the true incidence is unknown given that only 25% of women experience symptoms bothersome enough to warrant intervention. This month’s article reviews the burden of fibroids and the latest management options that may potentially avoid surgery.

Background

Fibroids are monoclonal tumors of uterine smooth muscle that originate from the myometrium. Risk factors include family history, being premenopausal, increasing time since last delivery, obesity, and hypertension (ACOG Practice Bulletin no. 228 Jun 2021: Obstet Gynecol. 2021 Jun 1;137[6]:e100-e15) but oral hormonal contraception, depot medroxyprogesterone acetate (MPA), and increased parity reduce the risk of fibroids. Compared with White women, Black women have a 2-3 times higher prevalence of fibroids, develop them at a younger age, and present with larger fibroids.

The FIGO leiomyoma classification is the agreed upon system for identifying fibroid location. Symptoms are all too familiar to gynecologists, with life-threatening hemorrhage with severe anemia being the most feared, particularly for FIGO types 1-5. Transvaginal ultrasound is the simplest imaging tool for evaluation.

Adapted from Int J Gynecol Obstet. 2011;113:3-13.

Fibroids and fertility

Fibroids can impair fertility in several ways: alteration of local anatomy, including the detrimental effects of abnormal uterine bleeding; functional changes by increasing uterine contractions and impairing endometrium and myometrial blood supply; and changes to the local hormonal environment that could impair egg/sperm transport, or embryo implantation (Hum Reprod Update. 2017;22:665-86).

Prior to consideration of surgery, saline infusion sonogram can determine the degree of impact on the endometrium, which is most applicable to the infertility patient, but can also allow guidance toward the appropriate surgical approach.
 

Treatment options – medical

Management of fibroids is based on a woman’s age, desire for fertility, symptoms, and location of the fibroid(s). Expectant observation of a woman with fibroids may be a reasonable approach, provided the lack of symptoms impairing QoL and of anemia. Typically, there is no change in fibroid size during the short term, considered less than 1 year. Regarding fertility, studies are heterogeneous so there is no definitive conclusion that fibroids impair natural fertility (Reprod Biomed Online. 2021;43:100-10). Spontaneous regression, defined by a reduction in fibroid volume of greater than 20%, has been noted to occur in 7.0% of fibroids (Curr Obstet Gynecol Rep. 2018;7[3]:117-21).

When fertility is not desired, medical management of fibroids is the initial conservative approach. GnRH agonists have been utilized for temporary relief of menometrorrhagia because of fibroids and to reduce their volume, particularly preoperatively. However, extended treatment can induce bone mineral density loss. Add-back therapy (tibolone, raloxifene, estriol, and ipriflavone) is of value in reducing bone loss while MPA and tibolone may manage vasomotor symptoms. More recently, the use of a GnRH antagonist (elagolix) along with add-back therapy has been approved for up to 24 months by the Food and Drug Administration and has demonstrated a more than 50% amenorrhea rate at 12 months (Obstet Gynecol. 2020;135:1313-26).

Progesterone plays an important role in fibroid growth, but the mechanism is unclear. Although not FDA approved, selective progesterone receptor modulators (SPRM) act directly on fibroid size reduction at the level of the pituitary to induce amenorrhea through inhibition of ovulation. Also, more than one course of SPRMs can provide benefit for bleeding control and volume reduction. The SPRM ulipristal acetate for four courses of 3 months demonstrated 73.5% of patients experienced a fibroid volume reduction of greater than 25% and were amenorrheic (Fertil Steril. 2017;108:416-25). GnRH agonists or SPRMs may benefit women if the fibroid is larger than 3 cm or anemia exists, thereby precluding immediate surgery.

Other medication options include the levonorgestrel IUD, combined hormonal contraceptives, and tranexamic acid – all of which have limited data on effective results of treating abnormal uterine bleeding.
 

Treatment options – surgical

Fibroids are the most common reason for hysterectomy as they are the contributing indication in approximately one-third of surgeries. When future fertility is desired, current surgical options include hysteroscopic and laparoscopic (including robotic) myomectomy. Hysteroscopy is the standard approach for FIGO type 1 fibroids and can also manage some type 2 fibroids provided they are less than 3 cm and the latter is greater than 5 mm from the serosa. Type 2 fibroids may benefit from a “two-step” removal to allow the myometrium to contract and extrude the fibroid. In light of the risk of fluid overload with nonelectrolyte solutions that enable the use of monopolar cautery, many procedures are now performed with bipolar cautery or morcellators.

Laparoscopy (including robotic) has outcomes similar to those of laparotomy although the risk of uterine rupture with the former requires careful attention to thorough closure of the myometrial defect. Robotic myomectomy has outcomes similar to those of standard laparoscopy with less blood loss, but operating times may be prolonged (Best Pract Res Clin Obstet Gynaecol. 2018;46:113-9).

The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women (Fertil Steril 2017;108;416-25). The rate of recurrence after myomectomy can be as great as 60% when patients are followed up to 5 years. Intramural fibroids greater than 2.85 cm and not distorting the uterine cavity may decrease in vitro fertilization (IVF) success (Fertil Steril 2014;101:716-21).
 

Noninvasive treatment modalities

Uterine artery embolization (UAE) is the most popular minimally invasive alternative to surgical myomectomy. Risks include postembolization syndrome (pain, fever, nausea, leukocytosis, and occasionally malaise), infection, and damage to fertility. Rarely, loss of ovarian function can occur, particularly in women above age 45. Because of the disruption of uterine blood flow, UAE increases the risk of accelerating ovarian aging and infertility as well as atrophic endometrium. In addition, pregnancy complications are increased including miscarriage, preterm labor, and postpartum hemorrhage. There is debate regarding the need for cesarean section at time of delivery given the potential for weakening of the uterine wall following UAE.

High-intensity focused ultrasound (HIFU) is guided by ultrasound or MRI and involves a high-energy-density ultrasound wave passing through the skin. The wave is absorbed and transformed into heat, causing the tissue protein to coagulate, and to be absorbed by the body. The procedure is scarless, carries a minimal risk of infection, and offers less pain compared with traditional approaches. However, HIFU is time consuming, and skin burns and unintentional tissue injury are a risk. A meta-analysis demonstrated improved symptoms of fibroids at 6 and 12 months (J Min Invasive Gynecol. 2021 in press).

Ultrasound-guided microwave ablation (MWA) uses an ablative electrode that is directly inserted into the target tissue via transcutaneous or transcervical approach via ultrasound guidance using microwave to produce heat for tissue coagulation necrosis. The advantages of MWA compared with HIFU and RFA are a higher tissue temperature, larger ablation volume, shorter operating time, less pain and no adverse major events (J Min Invasive Gynecol. 2021, in press).
 

Conclusion

The current literature cannot conclude that fibroids reduce the likelihood of achieving pregnancy with or without fertility treatment, based on a specific size, number, or location (not including submucosal or cavity-distorting intramural fibroids). Definitive evidence on the efficacy of myomectomy to improve fertility remains limited. Hysteroscopic myomectomy presumably improves pregnancy rates, but there is uncertainty as to its role in reducing miscarriage. Novel nonsurgical modalities are available and are expected to continue being developed but clarity on fertility outcomes is needed.
 

Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no conflicts of interests. Please contact him at [email protected].

Two chronic gynecologic conditions notably affect a woman’s quality of life (QoL), including fertility – one is endometriosis, and the other is a fibroid uterus. For a benign tumor, fibroids have an impressive prevalence found in approximately 50%-60% of women during their reproductive years. By menopause, it is estimated that 70% of woman have a fibroid, yet the true incidence is unknown given that only 25% of women experience symptoms bothersome enough to warrant intervention. This month’s article reviews the burden of fibroids and the latest management options that may potentially avoid surgery.

Background

Fibroids are monoclonal tumors of uterine smooth muscle that originate from the myometrium. Risk factors include family history, being premenopausal, increasing time since last delivery, obesity, and hypertension (ACOG Practice Bulletin no. 228 Jun 2021: Obstet Gynecol. 2021 Jun 1;137[6]:e100-e15) but oral hormonal contraception, depot medroxyprogesterone acetate (MPA), and increased parity reduce the risk of fibroids. Compared with White women, Black women have a 2-3 times higher prevalence of fibroids, develop them at a younger age, and present with larger fibroids.

The FIGO leiomyoma classification is the agreed upon system for identifying fibroid location. Symptoms are all too familiar to gynecologists, with life-threatening hemorrhage with severe anemia being the most feared, particularly for FIGO types 1-5. Transvaginal ultrasound is the simplest imaging tool for evaluation.

Adapted from Int J Gynecol Obstet. 2011;113:3-13.

Fibroids and fertility

Fibroids can impair fertility in several ways: alteration of local anatomy, including the detrimental effects of abnormal uterine bleeding; functional changes by increasing uterine contractions and impairing endometrium and myometrial blood supply; and changes to the local hormonal environment that could impair egg/sperm transport, or embryo implantation (Hum Reprod Update. 2017;22:665-86).

Prior to consideration of surgery, saline infusion sonogram can determine the degree of impact on the endometrium, which is most applicable to the infertility patient, but can also allow guidance toward the appropriate surgical approach.
 

Treatment options – medical

Management of fibroids is based on a woman’s age, desire for fertility, symptoms, and location of the fibroid(s). Expectant observation of a woman with fibroids may be a reasonable approach, provided the lack of symptoms impairing QoL and of anemia. Typically, there is no change in fibroid size during the short term, considered less than 1 year. Regarding fertility, studies are heterogeneous so there is no definitive conclusion that fibroids impair natural fertility (Reprod Biomed Online. 2021;43:100-10). Spontaneous regression, defined by a reduction in fibroid volume of greater than 20%, has been noted to occur in 7.0% of fibroids (Curr Obstet Gynecol Rep. 2018;7[3]:117-21).

When fertility is not desired, medical management of fibroids is the initial conservative approach. GnRH agonists have been utilized for temporary relief of menometrorrhagia because of fibroids and to reduce their volume, particularly preoperatively. However, extended treatment can induce bone mineral density loss. Add-back therapy (tibolone, raloxifene, estriol, and ipriflavone) is of value in reducing bone loss while MPA and tibolone may manage vasomotor symptoms. More recently, the use of a GnRH antagonist (elagolix) along with add-back therapy has been approved for up to 24 months by the Food and Drug Administration and has demonstrated a more than 50% amenorrhea rate at 12 months (Obstet Gynecol. 2020;135:1313-26).

Progesterone plays an important role in fibroid growth, but the mechanism is unclear. Although not FDA approved, selective progesterone receptor modulators (SPRM) act directly on fibroid size reduction at the level of the pituitary to induce amenorrhea through inhibition of ovulation. Also, more than one course of SPRMs can provide benefit for bleeding control and volume reduction. The SPRM ulipristal acetate for four courses of 3 months demonstrated 73.5% of patients experienced a fibroid volume reduction of greater than 25% and were amenorrheic (Fertil Steril. 2017;108:416-25). GnRH agonists or SPRMs may benefit women if the fibroid is larger than 3 cm or anemia exists, thereby precluding immediate surgery.

Other medication options include the levonorgestrel IUD, combined hormonal contraceptives, and tranexamic acid – all of which have limited data on effective results of treating abnormal uterine bleeding.
 

Treatment options – surgical

Fibroids are the most common reason for hysterectomy as they are the contributing indication in approximately one-third of surgeries. When future fertility is desired, current surgical options include hysteroscopic and laparoscopic (including robotic) myomectomy. Hysteroscopy is the standard approach for FIGO type 1 fibroids and can also manage some type 2 fibroids provided they are less than 3 cm and the latter is greater than 5 mm from the serosa. Type 2 fibroids may benefit from a “two-step” removal to allow the myometrium to contract and extrude the fibroid. In light of the risk of fluid overload with nonelectrolyte solutions that enable the use of monopolar cautery, many procedures are now performed with bipolar cautery or morcellators.

Laparoscopy (including robotic) has outcomes similar to those of laparotomy although the risk of uterine rupture with the former requires careful attention to thorough closure of the myometrial defect. Robotic myomectomy has outcomes similar to those of standard laparoscopy with less blood loss, but operating times may be prolonged (Best Pract Res Clin Obstet Gynaecol. 2018;46:113-9).

The rate of myomectomy is reported to be 9.2 per 10,000 woman-years in Black women and 1.3 per 10,000 woman years in White women (Fertil Steril 2017;108;416-25). The rate of recurrence after myomectomy can be as great as 60% when patients are followed up to 5 years. Intramural fibroids greater than 2.85 cm and not distorting the uterine cavity may decrease in vitro fertilization (IVF) success (Fertil Steril 2014;101:716-21).
 

Noninvasive treatment modalities

Uterine artery embolization (UAE) is the most popular minimally invasive alternative to surgical myomectomy. Risks include postembolization syndrome (pain, fever, nausea, leukocytosis, and occasionally malaise), infection, and damage to fertility. Rarely, loss of ovarian function can occur, particularly in women above age 45. Because of the disruption of uterine blood flow, UAE increases the risk of accelerating ovarian aging and infertility as well as atrophic endometrium. In addition, pregnancy complications are increased including miscarriage, preterm labor, and postpartum hemorrhage. There is debate regarding the need for cesarean section at time of delivery given the potential for weakening of the uterine wall following UAE.

High-intensity focused ultrasound (HIFU) is guided by ultrasound or MRI and involves a high-energy-density ultrasound wave passing through the skin. The wave is absorbed and transformed into heat, causing the tissue protein to coagulate, and to be absorbed by the body. The procedure is scarless, carries a minimal risk of infection, and offers less pain compared with traditional approaches. However, HIFU is time consuming, and skin burns and unintentional tissue injury are a risk. A meta-analysis demonstrated improved symptoms of fibroids at 6 and 12 months (J Min Invasive Gynecol. 2021 in press).

Ultrasound-guided microwave ablation (MWA) uses an ablative electrode that is directly inserted into the target tissue via transcutaneous or transcervical approach via ultrasound guidance using microwave to produce heat for tissue coagulation necrosis. The advantages of MWA compared with HIFU and RFA are a higher tissue temperature, larger ablation volume, shorter operating time, less pain and no adverse major events (J Min Invasive Gynecol. 2021, in press).
 

Conclusion

The current literature cannot conclude that fibroids reduce the likelihood of achieving pregnancy with or without fertility treatment, based on a specific size, number, or location (not including submucosal or cavity-distorting intramural fibroids). Definitive evidence on the efficacy of myomectomy to improve fertility remains limited. Hysteroscopic myomectomy presumably improves pregnancy rates, but there is uncertainty as to its role in reducing miscarriage. Novel nonsurgical modalities are available and are expected to continue being developed but clarity on fertility outcomes is needed.
 

Dr. Trolice is director of Fertility CARE – The IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando. He has no conflicts of interests. Please contact him at [email protected].

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.

Black women undergoing hysterectomies were significantly more likely to be treated by low-volume surgeons than high-volume surgeons, and to experience perioperative complications as a result, based on data from more than 300,000 patients.

“Outcomes for hysterectomy, for both benign and malignant disease, are improved when the procedure is performed at high-volume hospitals and by high-volume surgeons,” Anne Knisely, MD, of Columbia University, New York, and colleagues wrote.

Historically, Black patients have been less likely to be referred to high-volume hospitals, the researchers noted. Recent efforts to regionalize surgical procedures to high-volume hospitals aim to reduce disparities and improve care for all patients, but the data on disparities in care within high-volume hospitals are limited, they said.

In a study published in Obstetrics & Gynecology, the researchers identified 300,586 women who underwent hysterectomy in New York state between 2000 and 2014. The researchers divided surgeons at these hospitals into volume groups based on average annual hysterectomy volume.

The women were treated by 5,505 surgeons at 59 hospitals. Overall, Black women comprised significantly more of the patients treated by low-volume surgeons compared with high-volume surgeons (19.4% vs. 14.3%; adjusted odds ratio, 1.26), and more women treated by low-volume surgeons had Medicare insurance compared with those treated by high-volume surgeons (20.6% vs. 14.5%; aOR, 1.22).

A majority of the patients (262,005 patients) were treated by a total of 1,377 high-volume surgeons, while 2,105 low-volume surgeons treated 2,900 patients. Abdominal hysterectomies accounted for 57.5% of the procedures, followed by laparoscopic (23.9%), vaginal (13.2%), and robotic assisted (5.3%). Approximately two-thirds (64.4%) of the patients were aged 40-59 years; 63.7% were White, 15.1% were Black, and 8.5% were Hispanic.

The overall complication rate was significantly higher in patients treated by low-volume surgeons, compared with high-volume surgeons (31.0% vs. 10.3%), including intraoperative complications, surgical-site complications, medical complications, and transfusions. The perioperative mortality rate also was significantly higher for patients of low-volume surgeons compared with high-volume surgeons (2.2% vs. 0.2%).

Low-volume surgeons were more likely to perform urgent or emergent procedures, compared with high-volume surgeons (26.1% vs 6.4%), and to perform abdominal hysterectomy versus minimally invasive hysterectomy compared with high-volume surgeons (77.8% vs. 54.7%), the researchers added.

The study findings were limited by several factors, including the observational design and possible undercoding of outcomes, inclusion only of New York state patients, lack of data on clinical characteristics such as surgical history and complexity, lack of data on surgeon characteristics, and changing practice patterns over time, the researchers noted.

However, “this study demonstrates increased perioperative morbidity and mortality for patients who underwent hysterectomy by low-volume surgeons, in comparison with high-volume surgeons, at high-volume hospitals,” and that Black patients were more likely to be treated by low-volume surgeons, they said. “Although centralization of complex surgical care to higher-volume hospitals may have benefit, there are additional surgeon-level factors that must be considered to address disparities in access to high-quality care for patients undergoing hysterectomy.”

Explore range of issues to improve access

“It is always beneficial to review morbidity and mortality statistics,” Constance Bohon, MD, a gynecologist in private practice in Washington, D.C., said in an interview. “With a heightened awareness of equity and equality, now is a good time to review the data with that focus in mind. Hospital committees review the data on a regular basis, but they may not have looked closely at demographics in the past.

“It was always my understanding that for many procedures, including surgery, volume impacts outcome, so the finding that low-volume surgeons had worse outcomes than high-volume surgeons was not particularly surprising,” said Dr. Bohon. However, the question of how hospitals might address disparities in access to high-volume surgeons “is a difficult question, because there are a variety of issues that may not be caused by disparities,” she added. “It may be that the high-volume surgeons do not take Medicare. It may be that some of the emergent/urgent surgeries come from patients seen in the ED and the high-volume surgeons may not take call or see new patients in the ED. There may be a difference in the preop testing done that may be more extensive with the high-volume surgeons as compared with the low-volume surgeons. It may be that it is easier to get an appointment with a low-volume rather than a high-volume surgeon.

“Additional research is needed to determine whether there is an algorithm that can be created to determine risk for morbidity or mortality based on factors such as the number of years in practice, the number of hysterectomies per year, and the age of the physician,” Dr. Bohon explained. “The patient data could include preexisting risk factors such as weight, preexisting medical conditions, prior surgeries, and current medications, along with demographics. It would be interesting to determine whether low-risk patients have similar outcomes with low- as compared with high-volume surgeons while high-risk patients do not. The demographics could then be evaluated to determine if disparities exist for both low- and high-risk patients.”

The study received no outside funding. One coauthor disclosed serving as a consultant for Clovis Oncology, receiving research funding from Merck, and receiving royalties from UpToDate. Lead author Dr. Knisely had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose, but serves on the Ob.Gyn. News editorial advisory board.

The Food and Drug Administration has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive.

MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.

According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:

• MAGEC Spinal Bracing and Distraction System
• MAGEC 2 Spinal Bracing and Distraction System
• MAGEC System
• MAGEC System Model X Device
• MAGEC System Model X Rod
• MAGEC System Rods

Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.

In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.

The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.

To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive.

MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.

According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:

• MAGEC Spinal Bracing and Distraction System
• MAGEC 2 Spinal Bracing and Distraction System
• MAGEC System
• MAGEC System Model X Device
• MAGEC System Model X Rod
• MAGEC System Rods

Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.

In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.

The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.

To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has issued a notice about potential mechanical failures and biocompatibility concerns with MAGEC system devices from NuVasive.

MAGEC is a surgical magnetic rod system used to treat early-onset scoliosis (EOS) in children under 10 years of age. The magnetic system can help avoid invasive surgeries, as growth rods can be adjusted with an external remote control. MAGEC is the only FDA-approved pure distraction-based system for EOS and is the most-used technology for EOS treatment in the United States, Aakash Agarwal, PhD, director of research and clinical affairs at Spinal Balance in Swanton, Ohio, said in an interview.

According to the notice, there are reports of endcap separation and O-ring seal failure in the following six MAGEC devices:

• MAGEC Spinal Bracing and Distraction System
• MAGEC 2 Spinal Bracing and Distraction System
• MAGEC System
• MAGEC System Model X Device
• MAGEC System Model X Rod
• MAGEC System Rods

Endcap separation can potentially expose the patient’s tissue to internal components of the device that have not been completely tested for biocompatibility.

In February 2020, NuVasive recalled its MAGEC System Model X rods to address reports of endcap separation issues. The FDA cleared a modified version of the device designed to mitigate these events in July 2020. In April 2021, NuVasive informed providers of potential biocompatibility concerns and placed a voluntary shipping hold on the MAGEC device system. The shipping hold was lifted July 15, the company announced.

The FDA is currently not recommending removal of functioning MAGEC devices, noting that it is “in the best interest of patients” to continue to make the system available. The overall benefits of the device outweigh the known risks, and the restricted use for a 2-year implantation time for children under 10 years of age will further mitigate these risks, the FDA said in the statement.

To report adverse events related to MAGEC devices, patients, caregivers, and providers can submit a report through MedWatch, the FDA safety information and adverse event reporting program.

A version of this article first appeared on Medscape.com.

The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.^1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.⁴ Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.⁵

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.⁵ According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.⁶ Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.⁷ Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.⁸

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.⁹ Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.¹⁰ A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.¹¹ Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.^12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.¹⁴ The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.^15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.¹⁸

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.¹⁹ These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,²⁰ calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.²¹ Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.²²

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.²³ These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.²⁴

Continue to: How to ensure that BIPOC women get the best management...

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.²⁵ Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.²⁶ Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.⁸ Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.²⁷ Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.²⁸ It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.²⁹ As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,³⁰ this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.³¹ Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.³² Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.⁵ Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;³³ therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.³⁴ Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,³⁵ found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).³⁶

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.³⁵ Much work remains to be done for our health care systems to provide equitable care.

The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.^1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.⁴ Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.⁵

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.⁵ According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.⁶ Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.⁷ Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.⁸

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.⁹ Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.¹⁰ A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.¹¹ Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.^12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.¹⁴ The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.^15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.¹⁸

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.¹⁹ These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,²⁰ calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.²¹ Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.²²

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.²³ These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.²⁴

Continue to: How to ensure that BIPOC women get the best management...

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.²⁵ Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.²⁶ Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.⁸ Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.²⁷ Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.²⁸ It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.²⁹ As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,³⁰ this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.³¹ Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.³² Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.⁵ Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;³³ therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.³⁴ Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,³⁵ found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).³⁶

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.³⁵ Much work remains to be done for our health care systems to provide equitable care.

The historical mistreatment of Black bodies in gynecologic care has bled into present day inequities—from surgeries performed on enslaved Black women and sterilization of low-income Black women under federally funded programs, to higher rates of adverse health-related outcomes among Black women compared with their non-Black counterparts.^1-3 Not only is the foundation of gynecology imperfect, so too is its current-day structure.

It is not enough to identify and describe racial inequities in health care; action plans to provide equitable care are called for. In this report, we aim to 1) contextualize the data on disparities in minimally invasive gynecologic surgery, specifically hysterectomy and myomectomy candidates and postsurgical outcomes, and 2) provide recommendations to close racial gaps in gynecologic treatment for more equitable experiences for minority women.

Black women and uterine fibroids

Uterine leiomyomas, or fibroids, are not only the most common benign pelvic tumor but they also cause a significant medical and financial burden in the United States, with estimated direct costs of $4.1 ̶ 9.4 billion.⁴ Fibroids can affect fertility and cause pain, bulk symptoms, heavy bleeding, anemia requiring blood transfusion, and poor pregnancy outcomes. The burden of disease for uterine fibroids is greatest for Black women. While race is a social construct, women with African ancestry (who we tend to identify as having darker skin) have disproportionately higher rates of uterine fibroids. Black women experience symptoms at a younger age, spanning more of their reproductive years compared with their non-Black counterparts and their disease is often more severe compared with White women.⁵

The incidence of fibroids is 2 to 3 times higher in Black women compared with White women.⁵ According to ultrasound-based studies, the prevalence of fibroids among women aged 18 to 30 years was 26% among Black and 7% among White asymptomatic women.⁶ Earlier onset and more severe symptoms mean that there is a larger potential for impact on fertility for Black women. This coupled with the historical context of mistreatment of Black bodies makes the need for personalized medicine and culturally sensitive care critical. The disproportionately higher rates of uterine fibroids in Black women has been attributed to many factors, including socioeconomic status, health-care access, genetics, and lifestyle and environmental exposures, but the underlying causes of racial/ethnic differences remain unclear.⁷ Amazingly little data exist not only on patient preferences for management approach but also on the influence of genetic and epigenetic mediators and environmental factors that may play a role in fibroid development to guide optimal management and treatment outcomes for Black women with uterine fibroids.⁸

Inequitable management of uterine fibroids

Although tumor size, location, and patient risk factors are used to determine the best treatment approach, the American College of Obstetricians and Gynecologists (ACOG) guidelines suggest that the use of alternative treatments to surgery should be first-line management instead of hysterectomy for most benign conditions.⁹ Conservative management will often help alleviate symptoms, slow the growth of fibroid(s), or bridge women to menopause, and treatment options include hormonal contraception, gonadotropin-releasing hormone agonists, hysteroscopic resection, uterine artery embolization, magnetic resonance-guided focused ultrasound, and myomectomy.

The rate of conservative management prior to hysterectomy varies by setting, reflecting potential bias in treatment decisions. Some medical settings have reported a 29% alternative management rate prior to hysterectomy, while others report much higher rates.¹⁰ A study using patient data from Kaiser Permanente Northern California (KPNC) showed that, within a large, diverse, and integrated health care system, more than 80% of patients received alternative treatments before undergoing hysterectomy; for those with symptomatic leiomyomas, 74.1% used alternative treatments prior to hysterectomy, and in logistic regression there was not a difference by race.¹¹ Nationally, Black women are more likely to have hysterectomy or myomectomy compared with a nonsurgical uterine-sparing therapy.^12,13

With about 600,000 cases per year within the United States, the hysterectomy is the most frequently performed benign gynecologic surgery.¹⁴ The most common indication is for “symptomatic fibroid uterus.” The approach to decision making for route of hysterectomy involves multiple patient and surgeon factors, including history of vaginal delivery, body mass index, history of previous surgery, uterine size, informed patient preference, and surgeon volume.^15-17 ACOG recommends a minimally invasive hysterectomy (MIH) whenever feasible given its benefits in postoperative pain, recovery time, and blood loss. Myomectomy, particularly among women in their reproductive years desiring management of leiomyomas, is a uterine-sparing procedure versus hysterectomy. Minimally invasive myomectomy (MIM), compared with an open abdominal route, provides for lower drop in hemoglobin levels, shorter hospital stay, less adhesion formation, and decreased postoperative pain.¹⁸

Racial variations in hysterectomy rates persist overall and according to hysterectomy type. Black women are 2 to 3 times more likely to undergo hysterectomy for leiomyomas than other racial groups.¹⁹ These differences in rates have been shown to persist even when burden of disease is the same. One study found that Black women had increased odds of hysterectomy compared with their White counterparts even when there was no difference in mean fibroid volume by race,²⁰ calling into question provider bias. Even in a universal insurance setting, Black patients have been found to have higher rates of open hysterectomies.²¹ Previous studies found that, despite growing frequency of laparoscopic and robotic-assisted hysterectomies, patients of a minority race had decreased odds of undergoing a MIH compared with their White counterparts.²²

While little data exist on route of myomectomy by race, a recent study found minority women were more likely to undergo abdominal myomectomy compared with White women; Black women were twice as likely to undergo abdominal myomectomy (adjusted odds ratio [aOR], 1.9; 95% confidence interval [CI], 1.7–2.0), Asian American women were more than twice as likely (aOR, 2.3; 95% CI, 1.8–2.8), and Hispanic American women were 50% more likely to undergo abdominal myomectomy (aOR, 1.5; 95% CI, 1.2–1.9) when compared with White women.²³ These differences remained after controlling for potential confounders, and there appeared to be an interaction between race and fibroid weight such that racial bias alone may not explain the differences.

Finally, Black women have higher perioperative complication rates compared with non-Black women. Postoperative complications including blood transfusion after myomectomy have been shown to be twice as high among Black women compared with White women. However, once uterine size, comorbidities, and fibroid number were controlled, race was not associated with higher complications. Black women, compared with White women, have been found to have 50% increased odds of morbidity after an abdominal myomectomy.²⁴

Continue to: How to ensure that BIPOC women get the best management...

Eliminating disparities and providing equitable and patient-centered care for Black, Indigenous, and people of color (BIPOC) women will require research, education, training, and targeted quality improvement initiatives.

Research into fibroids and comparative treatment outcomes

Uterine fibroids, despite their major public health impact, remain understudied. With Black women carrying the highest fibroid prevalence and severity burden, especially in their childbearing years, it is imperative that research efforts be focused on outcomes by race and ethnicity. Given the significant economic impact of fibroids, more efforts should be directed toward primary prevention of fibroid formation as well as secondary prevention and limitation of fibroid growth by affordable, effective, and safe means. For example, Bratka and colleagues researched the role of vitamin D in inhibiting growth of leiomyoma cells in animal models.²⁵ Other innovative forms of management under investigation include aromatase inhibitors, green tea, cabergoline, elagolix, paricalcitol, and epigallocatechin gallate.²⁶ Considerations such as stress, diet, and environmental risk factors have yet to be investigated in large studies.

Research contributing to evidence-based guidelines that address the needs of different patient populations affected by uterine fibroids is critical.⁸ Additionally, research conducted by Black women about Black women should be prioritized. In March 2021, the Stephanie Tubbs Jones Uterine Fibroid Research and Education Act of 2021 was introduced to fund $150 million in research supported by the National Institutes of Health (NIH). This is an opportunity to develop a research database to inform evidence-based culturally informed care regarding fertility counseling, medical management, and optimal surgical approach, as well as to award funding to minority researchers. There are disparities in distribution of funds from the NIH to minority researchers. Under-represented minorities are awarded fewer NIH grants compared with their counterparts despite initiatives to increase funding. Furthermore, in 2011, Black applicants for NIH funding were two-thirds as likely as White applicants to receive grants from 2000 ̶ 2006, even when accounting for publication record and training.²⁷ Funding BIPOC researchers fuels diversity-driven investigation and can be useful in the charge to increase fibroid research.

Education and training: Changing the work force

Achieving equity requires change in provider work force. In a study of trends across multiple specialties including obstetrics and gynecology, Blacks and Latinx are more under-represented in 2016 than in 1990 across all specialties except for Black women in obstetrics and gynecology.²⁸ It is well documented that under-represented minorities are more likely to engage in practice, research, service, and mentorship activities aligned with their identity.²⁹ As a higher proportion of under-represented minority obstetricians and gynecologists practice in medically underserved areas,³⁰ this presents a unique opportunity for gynecologists to improve care for and increase research involvement among BIPOC women.

Increasing BIPOC representation in medical and health care institutions and practices is not enough, however, to achieve health equity. Data from the Association of American Medical Colleges demonstrate that between 1978 and 2017 the total number of full-time obstetrics and gynecology faculty rose nearly fourfold from 1,688 to 6,347; however, the greatest rise in proportion of faculty who were nontenured was among women who were under-represented minorities.³¹ Additionally, there are disparities in wage by race even after controlling for hours worked and state of residence.³² Medical and academic centers and health care institutions and practices should proactively and systematically engage in the recruitment and retention of under-represented minority physicians and people in leadership roles. This will involve creating safe and inclusive work environments, with equal pay and promotion structures.

Quality initiatives to address provider bias

Provider bias should be addressed in clinical decision making and counseling of patients. Studies focused on ultrasonography have shown an estimated cumulative incidence of fibroids by age 50 of greater than 80% for Black women and nearly 70% for White women.⁵ Due to the prevalence and burden of fibroids among Black women there may be a provider bias in approach to management. Addressing this bias requires quality improvement efforts and investigation into patient and provider factors in management of fibroids. Black women have been a vulnerable population in medicine due to instances of mistreatment, and often times mistrust can play a role in how a patient views his or her care decisions. A patient-centered strategy allows patient factors such as age, uterine size, and cultural background to be considered such that a provider can tailor an approach that is best for the patient. Previous minority women focus groups have demonstrated that women have a strong desire for elective treatment;³³ therefore, providers should listen openly to patients about their values and their perspectives on how fibroids affect their lives. Provider bias toward surgical volume, incentive for surgery, and implicit bias need to be addressed at every institution to work toward equitable and cost-effective care.

Integrated health care systems like Southern and Northern California Permanente Medical Group, using quality initiatives, have increased their minimally invasive surgery rates. Southern California Permanente Medical Group reached a 78% rate of MIH in a system of more than 350 surgeons performing benign indication hysterectomies as reported in 2011.³⁴ Similarly, a study within KPNC, an institution with an MIH rate greater than 95%,³⁵ found that racial disparities in route of MIH were eliminated through a quality improvement initiative described in detail in 2018 (FIGURE and TABLE).³⁶

Conclusions

There are recognized successes in the gynecology field’s efforts to address racial disparities. Prior studies provide insight into opportunities to improve care in medical management of leiomyomas, minimally invasive route of hysterectomy and myomectomy, postsurgical outcomes, and institutional leadership. Particularly, when systemwide approaches are taken in the delivery of health care it is possible to significantly diminish racial disparities in gynecology.³⁵ Much work remains to be done for our health care systems to provide equitable care.

In 2019, doctors in London saw a 5-year old girl from rural Ethiopia with an enormous tumor extending from her cheek to her lower jaw. Her name was Negalem and the tumor was a vascular malformation, a life-threatening web of tangled blood vessels.

Surgery to remove it was impossible, the doctors told the foundation advocating for the girl. The child would never make it off the operating table. After a closer examination, the London group still declined to do the procedure, but told the child’s parents and advocates that if anyone was going to attempt this, they’d need to get the little girl to New York.

In New York City, on 64th St. in Manhattan, is the Vascular Birthmark Institute, founded by Milton Waner, MD, who has exclusively treated hemangiomas and vascular malformations for the last 30 years. “I’m the only person in the [United] States whose practice is exclusively [treating] vascular anomalies,” Dr. Waner said in an interview.

Dr. Waner has assembled a multidisciplinary team of experts at the institute’s offices in Lenox Hill – including his wife Teresa O, MD, a facial plastic and reconstructive surgeon and neurospecialist. “People often ask how the hell do you spend so much time with your spouse?” Dr. Waner says. “We work extremely well together. We complement each other.”

Dr. O and Dr. Waner each manage half of the cases at VBI. And in January they received an email about Negalem. After corresponding with the child’s advocate and reviewing images, they agreed to do the surgery, fully aware that they were one of only a handful of surgical teams in the world who could help her.

A version of this article first appeared on Medscape.com.

In 2019, doctors in London saw a 5-year old girl from rural Ethiopia with an enormous tumor extending from her cheek to her lower jaw. Her name was Negalem and the tumor was a vascular malformation, a life-threatening web of tangled blood vessels.

Surgery to remove it was impossible, the doctors told the foundation advocating for the girl. The child would never make it off the operating table. After a closer examination, the London group still declined to do the procedure, but told the child’s parents and advocates that if anyone was going to attempt this, they’d need to get the little girl to New York.

In New York City, on 64th St. in Manhattan, is the Vascular Birthmark Institute, founded by Milton Waner, MD, who has exclusively treated hemangiomas and vascular malformations for the last 30 years. “I’m the only person in the [United] States whose practice is exclusively [treating] vascular anomalies,” Dr. Waner said in an interview.

Dr. Waner has assembled a multidisciplinary team of experts at the institute’s offices in Lenox Hill – including his wife Teresa O, MD, a facial plastic and reconstructive surgeon and neurospecialist. “People often ask how the hell do you spend so much time with your spouse?” Dr. Waner says. “We work extremely well together. We complement each other.”

Dr. O and Dr. Waner each manage half of the cases at VBI. And in January they received an email about Negalem. After corresponding with the child’s advocate and reviewing images, they agreed to do the surgery, fully aware that they were one of only a handful of surgical teams in the world who could help her.

A version of this article first appeared on Medscape.com.

In 2019, doctors in London saw a 5-year old girl from rural Ethiopia with an enormous tumor extending from her cheek to her lower jaw. Her name was Negalem and the tumor was a vascular malformation, a life-threatening web of tangled blood vessels.

Surgery to remove it was impossible, the doctors told the foundation advocating for the girl. The child would never make it off the operating table. After a closer examination, the London group still declined to do the procedure, but told the child’s parents and advocates that if anyone was going to attempt this, they’d need to get the little girl to New York.

In New York City, on 64th St. in Manhattan, is the Vascular Birthmark Institute, founded by Milton Waner, MD, who has exclusively treated hemangiomas and vascular malformations for the last 30 years. “I’m the only person in the [United] States whose practice is exclusively [treating] vascular anomalies,” Dr. Waner said in an interview.

Dr. Waner has assembled a multidisciplinary team of experts at the institute’s offices in Lenox Hill – including his wife Teresa O, MD, a facial plastic and reconstructive surgeon and neurospecialist. “People often ask how the hell do you spend so much time with your spouse?” Dr. Waner says. “We work extremely well together. We complement each other.”

Dr. O and Dr. Waner each manage half of the cases at VBI. And in January they received an email about Negalem. After corresponding with the child’s advocate and reviewing images, they agreed to do the surgery, fully aware that they were one of only a handful of surgical teams in the world who could help her.

A version of this article first appeared on Medscape.com.