OBG Management

In this Update we review the results of 4 recent investigations that have important implications:

• the first analysis of the US Zika Virus Infection in Pregnancy Registry
• a study revealing an improved antibiotic regimen to prevent postcesarean infection
• an important new methodology for reducing the rate of perinatal transmission of hepatitis B virus (HBV) infection
• the risks and benefits of combination antiretroviral therapy (ART) in pregnancy.

Zika virus-associated birth defect rates similar regardless of symptom presence; first-trimester exposure has highest rate of anomalies

Honein MA, Dawson AL, Petersen EE, et al; US Zika Pregnancy Registry Collaboration. Birth defects among fetuses and infants of US women with evidence of possible Zika virus infection during pregnancy. JAMA. 2017;317(1):59-68.

Honein and colleagues provide a summary of the data from the US Zika Virus in Pregnancy Registry (a collaboration between the Centers for Disease Control and Prevention and state and local health departments), estimating the proportion of fetuses and infants with birth defects based on maternal symptoms of Zika virus infection and  trimester of possible infection.

Related article:
Zika virus: Counseling considerations for this emerging perinatal threat

Details of the study

The authors evaluated the outcomes of 442 women who had laboratory evidence of a possible Zika virus infection during pregnancy. Overall, 26 infants (6%; 95% confidence interval (CI), 4%-8%) had evidence of birth defects related to the Zika virus. Of note, abnormalities were detected in 16 of the 271 children (6%; 95% CI, 4%-9%) born to women who were asymptomatic and 10 of 167 (6%; 95% CI, 3%-11%) children delivered to women with symptomatic infections. 

The most common birth defect was microcephaly, although other serious central nervous system abnormalities were noted as well. Nine of 85 women (11%; 95% CI, 6%-19%) who had exposure only during the first trimester had infants with birth defects. There were no documented abnormalities in infants born to mothers who developed Zika virus infection only in the second or third trimester. 

Related article:
Zika virus update: A rapidly moving target

Key study findings

This article is important for several reasons. First, the authors describe the largest series of pregnant women in the United States with Zika virus infection. All of these patients developed Zika virus infection as a result of foreign travel or exposure to sexual partners who had traveled to Zika virus endemic areas. Second, the authors confirmed findings that previously had been based only on mathematical models rather than on actual case series. Specifically, they demonstrated that the risk of a serious birth defect following first-trimester exposure to Zika virus infection was approximately 11%, with a 95% CI that extended from 6% to 19%. Finally, Honein and colleagues highlighted the key fact that the risk of a serious birth defect was comparable in mothers who had either an asymptomatic or a symptomatic infection, a finding that seems somewhat counterintuitive.

Read about prophylaxis for postcesarean infection

Two antibiotics before cesarean delivery reduce infection rates further than one agent

Tita AT, Szychowski JM, Boggess K, et al; for the C/SOAP Trial Consortium. Adjunctive azithromycin prophylaxis for cesarean delivery. N Engl J Med. 2016;375(13):1231-1241.

Tita and colleagues reported the results of a multicenter trial that was designed to assess whether a combination of 2 antibiotics, including one that specifically targets ureaplasma species, provided more effective prophylaxis against postcesarean infection than single-agent prophylaxis.

Details of the study

The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) trial was conducted at 14 centers in the United States and included 2,013 women who were at least at 24 weeks' gestation and who had a cesarean delivery during labor or after membrane rupture.

The authors randomly assigned 1,019 women to receive 500 mg of intravenous azithromycin plus conventional single-agent prophylaxis (usually cefazolin) and 994 women to receive a placebo plus conventional prophylaxis. The primary outcome was the composite of endometritis, wound infection, or other infection occurring within 6 weeks.

The authors observed that the primary outcome occurred in 62 women (6.1%) who received azithromycin plus conventional prophylaxis and in 119 women (12%) who received only single-agent prophylaxis. The relative risk of developing a postoperative infection was 0.51 in women who received the combined therapy. There were significant differences between the 2 groups in both the rates of endometritis (3.8% vs 6.1%, P = .02) and wound infection (2.4% vs 6.6%, P<.001). There were no differences between the groups in the frequency of the secondary neonatal composite outcome, which included neonatal death and serious neonatal complications.

Related article:
Preventing infection after cesarean delivery: 5 more evidence-based measures to consider

Efficacy of dual-agent prophylaxis

At present, the standard of care is to administer prophylactic antibiotics to all women having cesarean delivery, including women having a scheduled cesarean in the absence of labor or ruptured membranes. Multiple studies have shown clearly that prophylaxis reduces the frequency of endometritis and, in high-risk patient populations, wound infection, and that prophylaxis is most beneficial when administered prior to the time the surgical incision is made. The most commonly used drug for prophylaxis is cefazolin, a first-generation cephalosporin. The usual recommended dose is 2 g, administered immediately prior to surgery.^3,4

Although most centers in the United States traditionally have used just a single antibiotic for prophylaxis, selected recent reports indicate that expanding the spectrum of activity of prophylactic antibiotics can result in additional beneficial effects. Specifically, Tita and colleagues evaluated an indigent patient population with an inherently high rate of postoperative infection.⁵ They showed that adding azithromycin 500 mg to cefazolin significantly reduced the rate of postcesarean endometritis. In a follow-up report from the same institution, Tita and colleagues demonstrated that adding azithromycin also significantly reduced the frequency of wound infection.⁶ Of note, in both these investigations, the antibiotics were administered after cord clamping. In a subsequent report, Ward and Duff showed that the combination of azithromycin plus cefazolin administered preoperatively resulted in a combined rate of endometritis and wound infection that was less than 3%.⁷

Related article:
Preventing infection after cesarean delivery: Evidence-based guidance

C/SOAP trial confirmed lower infection rates with combined regimen

Results of the present study confirm the findings of these 3 investigations. The trial included a large sample size. The study was carefully designed, and the end points were clearly defined. It included only patients at increased risk for postoperative infection by virtue of being in labor or having ruptured membranes at the time of cesarean delivery. Patients who received standard prophylaxis, usually cefazolin, plus azithromycin had a significantly lower risk of postcesarean endometritis and wound infection compared with patients who received a single antibiotic. The overall risk of infection was reduced by an impressive 50%.  
 

Read about reducing HBV transmission

Tenofovir treatment in pregnant women with HBV reduces vertical transmission

Pan CQ, Duan Z, Dai E, et al; China Study Group for the Mother-to-Child Transmission of Hepatitis B. Tenofovir to prevent hepatitis B transmission in mothers with high viral load. N Engl J Med. 2016;374(24):2324-2334.

A multicenter, open-label, randomized, parallel-group investigation was conducted from March 2012 to June 2013 at academic tertiary care centers in 5 geographic regions of China. Two hundred mothers, who were positive for both hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) and who had HBV DNA concentrations of 200,000 IU/mL or greater, were randomly assigned in a 1:1 ratio to either tenofovir or to usual treatment. Exclusion criteria were coexistent viral infections or medical conditions, renal failure, laboratory abnormalities, fetal deformities, and use of many medications.

Related article:
5 ways to reduce infection risk during pregnancy

Details of the study

Women in the active treatment group received tenofovir 300 mg by mouth daily from 30 to 32 weeks' gestation until postpartum week 4. Patients were monitored every 4 weeks in the antepartum period for adverse events and laboratory abnormalities. In the postpartum period, mother-infant dyads were evaluated at weeks 4, 12, 24, and 28.

Primary outcomes were the rates of mother-to-child transmission and birth defects with, or without, tenofovir exposure. Secondary outcomes were the percentage of mothers who had an HBV DNA serum concentration of less than 200,000 IU/mL at delivery and the percentage of mothers with HBeAg or HBsAg loss or seroconversion at postpartum week 28. Safety outcomes included the adverse event profile of tenofovir in mothers and safety events in the mother-infant dyads. These outcomes encompassed  all adverse events and drug discontinuations in patients who received at least one dose of tenofovir.

Sixty-eight percent of mothers in the tenofovir group, compared with 2% of mothers in the control group, had HBV levels less than 200,000 IU/mL at delivery (P<.001). The rate of mother-to-child HBV transmission at postpartum week 28 was lower in the tenofovir group. In the intention-to-treat analysis, the rate was 5% (95% CI, 1-10; 5 of 97 infants) in the tenofovir group versus 18% (95% CI, 10-26; 18 of 100 infants) in the control group (P = .007). In the per-protocol analysis, the rate was 0% (95% CI, 0-3; 0 of 92 infants) in the tenofovir group versus 7% (95% CI, 2-12; 6 of 88 infants) in the control group (P = .01). Maternal and infant safety profiles were similar between the 2 groups, with the exception of elevated creatinine kinase and alanine aminotransferase levels in mothers treated with tenofovir. Maternal HBV serologic titers did not differ significantly between the 2 groups.

Study strengths and limitations

This study's strengths include a multicenter, randomized controlled design, with strict inclusion and exclusion criteria. The results are clinically relevant and of global impact, with potential to decrease morbidity and  mortality from HBV infection in children born to infected mothers. 

A limitation, however, is that the study was probably underpowered to detect small differences in the rate of birth defects between the tenofovir and usual-care treatment groups. Additionally, some patients ceased taking tenofovir in the postpartum time period. Abrupt cessation may be associated with acute, severe HBV exacerbation.  

Benefits of ART for reducing mother-to-baby HIV transmission outweigh higher risk of adverse outcomes

Fowler MG, Qin M, Fiscus SA, et al; IMPAACT 1077BF/1077FF PROMISE Study Team. Benefits and risks of antiretroviral therapy for perinatal HIV prevention. N Engl J Med. 2016;375(18):1726-1737.

Part of the larger PROMISE (Promoting Maternal and Infant Survival Everywhere) trial, a study by Fowler and colleagues compared the relative efficacy and safety of various proven ART strategies for prevention of mother-to-child transmission of HIV infection in women with relatively high CD4 counts.

Details of the study

The trial was conducted at 14 sites in 7 countries. Patients were stratified according to HBV coinfection status and country of origin. The primary efficacy outcome was frequency of early infant HIV infection.

Women were randomly assigned to 1 of 3 treatment categories:

• zidovudine alone (zidovudine plus a single intrapartum dose of nevirapine, followed by 6 to 14 days of tenofovir plus emtricitabine postpartum)  
• zidovudine-based ART (zidovudine in combination with lamivudine and lopinavir-ritonavir)  
• tenofovir-based ART (tenofovir in combination with emtricitabine and lopinavir-ritonavir). 

All regimens were continued through 6 to 14 days postpartum. All infants received nevirapine at birth and in the immediate postpartum period.

Two trial periods. During period 1 (April 2011-September 2012), safety data on tenofovir in pregnancy were limited. Women without HBV coinfection were assigned only to zidovudine alone or zidovudine-based ART. During period 2 (October 2012-October 2014), since more information about tenofovir use in pregnancy was available, the study protocol was modified to allow women to be assigned to any of the 3 regimens, regardless of their HBV status.

Inclusion criteria were as follows: CD4 count of at least 350 cells/mm3 (or country-specific threshold for initiating triple-drug ART, if that threshold was higher), gestation of at least 14 weeks and not in labor, no previous use of triple-drug ART, no clinical or immune-related indication for triple-drug ART, hemoglobin level of at least 6.5 g/dL, an absolute neutrophil count of at least 750 cells/mm3, an alanine aminotransferase level of less than 2.5 times the upper limit of normal range, an estimated creatinine clearance of greater than 60 mL/min, and no serious pregnancy complications. Patients were excluded if they had active tuberculosis, HBV infection requiring treatment, a structural or conduction heart defect, or a fetus with a serious congenital malformation.

Primary outcomes. The primary efficacy outcome was early infant HIV infection, defined as a positive infant HIV nucleic acid test result at birth or at 1 week postpartum. The primary safety outcome was a composite of adverse events.

Adverse events in mothers were defined as hematologic abnormalities, abnormal blood chemical values, or abnormal signs/symptoms during pregnancy through 1 week postpartum. Severe pregnancy composite outcomes were low birth weight (<2,500 g), preterm delivery before 37 weeks' gestation, spontaneous abortion (<20 weeks), stillbirth (≥20 weeks), or congenital anomaly. Adverse events in infants were defined as death from any cause, hematologic abnormalities or abnormal blood chemical values, and abnormal signs/symptoms through 1 week postpartum.

A total of 3,490 mother-infant sets were included in the analysis (2,261 during trial period 1 and 1,229 during trial period 2). Baseline maternal characteristics were well balanced between groups. Most women were African, young (median age, 26 years), and asymptomatic.

Related article:
2016 Update on infectious disease

Study results

The combined maternal ART-treated groups had significantly lower rates of early transmission of HIV infection compared with the zidovudine-alone group (0.5% vs 1.8%, -1.3 percentage points; CI, -2.1 to -0.4). The zidovudine-based ART-treated group had a significantly higher rate of infant HIV-free survival through postpartum week 1 than did the zidovudine-alone group (P = .001) or the tenofovir-based ART group (P = .002).

When examining trial periods 1 and 2 combined, the zidovudine-based ART group experienced significantly higher rates of any adverse event than those receiving zidovudine alone (21.1% vs 17.3%, P = .008) and higher rates of abnormal blood chemical values (5.8% vs 1.3%, P<.001). During period 2 alone, the tenofovir-based ART group had significantly higher rates of abnormal blood chemical values than did the zidovudine-alone group (2.9% vs 0.8%, P = .03). There were no significant differences between the 2 ART treatment groups. No maternal deaths occurred during the study, and the trial-drug discontinuation rate was low (2%-5%) and did not vary among the 3 groups.

During trial periods 1 and 2, the zidovudine-based ART group had significantly higher rates of adverse pregnancy outcomes than did the zidovudine-alone group (40% vs 27.5%, P<.001). These included low birth weight less than 2,500 g (23% vs 12%) and preterm delivery before 37 weeks (20.5% vs 13.1%). During trial period 2, the tenofovir-based ART group had significantly higher rates of adverse pregnancy outcomes than did the zidovudine-alone group (34.7% vs 27.2%, P = .04). There were no significant differences for any outcome between the 2 ART-treated groups, and there were no significant differences in stillbirth or spontaneous abortion and congenital anomalies among the 3 groups.

Regarding severe pregnancy outcomes, there were no significant differences (composite or individual) between the zidovudine-based ART group and the zidovudine-alone group. The tenofovir-based ART group experienced significantly higher rates of composite severe adverse pregnancy outcomes compared with the zidovudine-based ART group (9.2% vs 4.3%, P = .02), and very preterm birth before 34 weeks (6.0% vs 2.6%, P = .04).

Infant safety outcomes were also examined. There were no significant differences for composite or individual adverse neonatal outcomes other than death. The tenofovir-based ART group experienced a significantly higher rate of infant death than did the zidovudine-based ART group (4.4% vs 0.6%, P<.001). However, a post hoc analysis suggested that extreme prematurity contributed to the infant mortality.

Limitations of the study

This study had minor limitations. It divided patients into only 2 major categories with respect to gestational age--more than or less than 34 weeks. Some maternal medical conditions, such as malaria, were not controlled for. In addition, breastfeeding and formula feeding were combined for analysis, and we know that breastfeeding would inherently confer a higher risk of HIV transmission. 

Nevertheless, this study was thoughtfully designed and carefully conducted, and the results are of significant global impact.  

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

In this Update we review the results of 4 recent investigations that have important implications:

• the first analysis of the US Zika Virus Infection in Pregnancy Registry
• a study revealing an improved antibiotic regimen to prevent postcesarean infection
• an important new methodology for reducing the rate of perinatal transmission of hepatitis B virus (HBV) infection
• the risks and benefits of combination antiretroviral therapy (ART) in pregnancy.

Zika virus-associated birth defect rates similar regardless of symptom presence; first-trimester exposure has highest rate of anomalies

Honein MA, Dawson AL, Petersen EE, et al; US Zika Pregnancy Registry Collaboration. Birth defects among fetuses and infants of US women with evidence of possible Zika virus infection during pregnancy. JAMA. 2017;317(1):59-68.

Honein and colleagues provide a summary of the data from the US Zika Virus in Pregnancy Registry (a collaboration between the Centers for Disease Control and Prevention and state and local health departments), estimating the proportion of fetuses and infants with birth defects based on maternal symptoms of Zika virus infection and  trimester of possible infection.

Related article:
Zika virus: Counseling considerations for this emerging perinatal threat

Details of the study

The authors evaluated the outcomes of 442 women who had laboratory evidence of a possible Zika virus infection during pregnancy. Overall, 26 infants (6%; 95% confidence interval (CI), 4%-8%) had evidence of birth defects related to the Zika virus. Of note, abnormalities were detected in 16 of the 271 children (6%; 95% CI, 4%-9%) born to women who were asymptomatic and 10 of 167 (6%; 95% CI, 3%-11%) children delivered to women with symptomatic infections. 

The most common birth defect was microcephaly, although other serious central nervous system abnormalities were noted as well. Nine of 85 women (11%; 95% CI, 6%-19%) who had exposure only during the first trimester had infants with birth defects. There were no documented abnormalities in infants born to mothers who developed Zika virus infection only in the second or third trimester. 

Related article:
Zika virus update: A rapidly moving target

Key study findings

This article is important for several reasons. First, the authors describe the largest series of pregnant women in the United States with Zika virus infection. All of these patients developed Zika virus infection as a result of foreign travel or exposure to sexual partners who had traveled to Zika virus endemic areas. Second, the authors confirmed findings that previously had been based only on mathematical models rather than on actual case series. Specifically, they demonstrated that the risk of a serious birth defect following first-trimester exposure to Zika virus infection was approximately 11%, with a 95% CI that extended from 6% to 19%. Finally, Honein and colleagues highlighted the key fact that the risk of a serious birth defect was comparable in mothers who had either an asymptomatic or a symptomatic infection, a finding that seems somewhat counterintuitive.

Read about prophylaxis for postcesarean infection

Two antibiotics before cesarean delivery reduce infection rates further than one agent

Tita AT, Szychowski JM, Boggess K, et al; for the C/SOAP Trial Consortium. Adjunctive azithromycin prophylaxis for cesarean delivery. N Engl J Med. 2016;375(13):1231-1241.

Tita and colleagues reported the results of a multicenter trial that was designed to assess whether a combination of 2 antibiotics, including one that specifically targets ureaplasma species, provided more effective prophylaxis against postcesarean infection than single-agent prophylaxis.

Details of the study

The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) trial was conducted at 14 centers in the United States and included 2,013 women who were at least at 24 weeks' gestation and who had a cesarean delivery during labor or after membrane rupture.

The authors randomly assigned 1,019 women to receive 500 mg of intravenous azithromycin plus conventional single-agent prophylaxis (usually cefazolin) and 994 women to receive a placebo plus conventional prophylaxis. The primary outcome was the composite of endometritis, wound infection, or other infection occurring within 6 weeks.

The authors observed that the primary outcome occurred in 62 women (6.1%) who received azithromycin plus conventional prophylaxis and in 119 women (12%) who received only single-agent prophylaxis. The relative risk of developing a postoperative infection was 0.51 in women who received the combined therapy. There were significant differences between the 2 groups in both the rates of endometritis (3.8% vs 6.1%, P = .02) and wound infection (2.4% vs 6.6%, P<.001). There were no differences between the groups in the frequency of the secondary neonatal composite outcome, which included neonatal death and serious neonatal complications.

Related article:
Preventing infection after cesarean delivery: 5 more evidence-based measures to consider

Efficacy of dual-agent prophylaxis

At present, the standard of care is to administer prophylactic antibiotics to all women having cesarean delivery, including women having a scheduled cesarean in the absence of labor or ruptured membranes. Multiple studies have shown clearly that prophylaxis reduces the frequency of endometritis and, in high-risk patient populations, wound infection, and that prophylaxis is most beneficial when administered prior to the time the surgical incision is made. The most commonly used drug for prophylaxis is cefazolin, a first-generation cephalosporin. The usual recommended dose is 2 g, administered immediately prior to surgery.^3,4

Although most centers in the United States traditionally have used just a single antibiotic for prophylaxis, selected recent reports indicate that expanding the spectrum of activity of prophylactic antibiotics can result in additional beneficial effects. Specifically, Tita and colleagues evaluated an indigent patient population with an inherently high rate of postoperative infection.⁵ They showed that adding azithromycin 500 mg to cefazolin significantly reduced the rate of postcesarean endometritis. In a follow-up report from the same institution, Tita and colleagues demonstrated that adding azithromycin also significantly reduced the frequency of wound infection.⁶ Of note, in both these investigations, the antibiotics were administered after cord clamping. In a subsequent report, Ward and Duff showed that the combination of azithromycin plus cefazolin administered preoperatively resulted in a combined rate of endometritis and wound infection that was less than 3%.⁷

Related article:
Preventing infection after cesarean delivery: Evidence-based guidance

C/SOAP trial confirmed lower infection rates with combined regimen

Results of the present study confirm the findings of these 3 investigations. The trial included a large sample size. The study was carefully designed, and the end points were clearly defined. It included only patients at increased risk for postoperative infection by virtue of being in labor or having ruptured membranes at the time of cesarean delivery. Patients who received standard prophylaxis, usually cefazolin, plus azithromycin had a significantly lower risk of postcesarean endometritis and wound infection compared with patients who received a single antibiotic. The overall risk of infection was reduced by an impressive 50%.  
 

Read about reducing HBV transmission

Tenofovir treatment in pregnant women with HBV reduces vertical transmission

Pan CQ, Duan Z, Dai E, et al; China Study Group for the Mother-to-Child Transmission of Hepatitis B. Tenofovir to prevent hepatitis B transmission in mothers with high viral load. N Engl J Med. 2016;374(24):2324-2334.

A multicenter, open-label, randomized, parallel-group investigation was conducted from March 2012 to June 2013 at academic tertiary care centers in 5 geographic regions of China. Two hundred mothers, who were positive for both hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) and who had HBV DNA concentrations of 200,000 IU/mL or greater, were randomly assigned in a 1:1 ratio to either tenofovir or to usual treatment. Exclusion criteria were coexistent viral infections or medical conditions, renal failure, laboratory abnormalities, fetal deformities, and use of many medications.

Related article:
5 ways to reduce infection risk during pregnancy

Details of the study

Women in the active treatment group received tenofovir 300 mg by mouth daily from 30 to 32 weeks' gestation until postpartum week 4. Patients were monitored every 4 weeks in the antepartum period for adverse events and laboratory abnormalities. In the postpartum period, mother-infant dyads were evaluated at weeks 4, 12, 24, and 28.

Primary outcomes were the rates of mother-to-child transmission and birth defects with, or without, tenofovir exposure. Secondary outcomes were the percentage of mothers who had an HBV DNA serum concentration of less than 200,000 IU/mL at delivery and the percentage of mothers with HBeAg or HBsAg loss or seroconversion at postpartum week 28. Safety outcomes included the adverse event profile of tenofovir in mothers and safety events in the mother-infant dyads. These outcomes encompassed  all adverse events and drug discontinuations in patients who received at least one dose of tenofovir.

Sixty-eight percent of mothers in the tenofovir group, compared with 2% of mothers in the control group, had HBV levels less than 200,000 IU/mL at delivery (P<.001). The rate of mother-to-child HBV transmission at postpartum week 28 was lower in the tenofovir group. In the intention-to-treat analysis, the rate was 5% (95% CI, 1-10; 5 of 97 infants) in the tenofovir group versus 18% (95% CI, 10-26; 18 of 100 infants) in the control group (P = .007). In the per-protocol analysis, the rate was 0% (95% CI, 0-3; 0 of 92 infants) in the tenofovir group versus 7% (95% CI, 2-12; 6 of 88 infants) in the control group (P = .01). Maternal and infant safety profiles were similar between the 2 groups, with the exception of elevated creatinine kinase and alanine aminotransferase levels in mothers treated with tenofovir. Maternal HBV serologic titers did not differ significantly between the 2 groups.

Study strengths and limitations

This study's strengths include a multicenter, randomized controlled design, with strict inclusion and exclusion criteria. The results are clinically relevant and of global impact, with potential to decrease morbidity and  mortality from HBV infection in children born to infected mothers. 

A limitation, however, is that the study was probably underpowered to detect small differences in the rate of birth defects between the tenofovir and usual-care treatment groups. Additionally, some patients ceased taking tenofovir in the postpartum time period. Abrupt cessation may be associated with acute, severe HBV exacerbation.  

Benefits of ART for reducing mother-to-baby HIV transmission outweigh higher risk of adverse outcomes

Fowler MG, Qin M, Fiscus SA, et al; IMPAACT 1077BF/1077FF PROMISE Study Team. Benefits and risks of antiretroviral therapy for perinatal HIV prevention. N Engl J Med. 2016;375(18):1726-1737.

Part of the larger PROMISE (Promoting Maternal and Infant Survival Everywhere) trial, a study by Fowler and colleagues compared the relative efficacy and safety of various proven ART strategies for prevention of mother-to-child transmission of HIV infection in women with relatively high CD4 counts.

Details of the study

The trial was conducted at 14 sites in 7 countries. Patients were stratified according to HBV coinfection status and country of origin. The primary efficacy outcome was frequency of early infant HIV infection.

Women were randomly assigned to 1 of 3 treatment categories:

• zidovudine alone (zidovudine plus a single intrapartum dose of nevirapine, followed by 6 to 14 days of tenofovir plus emtricitabine postpartum)  
• zidovudine-based ART (zidovudine in combination with lamivudine and lopinavir-ritonavir)  
• tenofovir-based ART (tenofovir in combination with emtricitabine and lopinavir-ritonavir). 

All regimens were continued through 6 to 14 days postpartum. All infants received nevirapine at birth and in the immediate postpartum period.

Two trial periods. During period 1 (April 2011-September 2012), safety data on tenofovir in pregnancy were limited. Women without HBV coinfection were assigned only to zidovudine alone or zidovudine-based ART. During period 2 (October 2012-October 2014), since more information about tenofovir use in pregnancy was available, the study protocol was modified to allow women to be assigned to any of the 3 regimens, regardless of their HBV status.

Inclusion criteria were as follows: CD4 count of at least 350 cells/mm3 (or country-specific threshold for initiating triple-drug ART, if that threshold was higher), gestation of at least 14 weeks and not in labor, no previous use of triple-drug ART, no clinical or immune-related indication for triple-drug ART, hemoglobin level of at least 6.5 g/dL, an absolute neutrophil count of at least 750 cells/mm3, an alanine aminotransferase level of less than 2.5 times the upper limit of normal range, an estimated creatinine clearance of greater than 60 mL/min, and no serious pregnancy complications. Patients were excluded if they had active tuberculosis, HBV infection requiring treatment, a structural or conduction heart defect, or a fetus with a serious congenital malformation.

Primary outcomes. The primary efficacy outcome was early infant HIV infection, defined as a positive infant HIV nucleic acid test result at birth or at 1 week postpartum. The primary safety outcome was a composite of adverse events.

Adverse events in mothers were defined as hematologic abnormalities, abnormal blood chemical values, or abnormal signs/symptoms during pregnancy through 1 week postpartum. Severe pregnancy composite outcomes were low birth weight (<2,500 g), preterm delivery before 37 weeks' gestation, spontaneous abortion (<20 weeks), stillbirth (≥20 weeks), or congenital anomaly. Adverse events in infants were defined as death from any cause, hematologic abnormalities or abnormal blood chemical values, and abnormal signs/symptoms through 1 week postpartum.

A total of 3,490 mother-infant sets were included in the analysis (2,261 during trial period 1 and 1,229 during trial period 2). Baseline maternal characteristics were well balanced between groups. Most women were African, young (median age, 26 years), and asymptomatic.

Related article:
2016 Update on infectious disease

Study results

The combined maternal ART-treated groups had significantly lower rates of early transmission of HIV infection compared with the zidovudine-alone group (0.5% vs 1.8%, -1.3 percentage points; CI, -2.1 to -0.4). The zidovudine-based ART-treated group had a significantly higher rate of infant HIV-free survival through postpartum week 1 than did the zidovudine-alone group (P = .001) or the tenofovir-based ART group (P = .002).

When examining trial periods 1 and 2 combined, the zidovudine-based ART group experienced significantly higher rates of any adverse event than those receiving zidovudine alone (21.1% vs 17.3%, P = .008) and higher rates of abnormal blood chemical values (5.8% vs 1.3%, P<.001). During period 2 alone, the tenofovir-based ART group had significantly higher rates of abnormal blood chemical values than did the zidovudine-alone group (2.9% vs 0.8%, P = .03). There were no significant differences between the 2 ART treatment groups. No maternal deaths occurred during the study, and the trial-drug discontinuation rate was low (2%-5%) and did not vary among the 3 groups.

During trial periods 1 and 2, the zidovudine-based ART group had significantly higher rates of adverse pregnancy outcomes than did the zidovudine-alone group (40% vs 27.5%, P<.001). These included low birth weight less than 2,500 g (23% vs 12%) and preterm delivery before 37 weeks (20.5% vs 13.1%). During trial period 2, the tenofovir-based ART group had significantly higher rates of adverse pregnancy outcomes than did the zidovudine-alone group (34.7% vs 27.2%, P = .04). There were no significant differences for any outcome between the 2 ART-treated groups, and there were no significant differences in stillbirth or spontaneous abortion and congenital anomalies among the 3 groups.

Regarding severe pregnancy outcomes, there were no significant differences (composite or individual) between the zidovudine-based ART group and the zidovudine-alone group. The tenofovir-based ART group experienced significantly higher rates of composite severe adverse pregnancy outcomes compared with the zidovudine-based ART group (9.2% vs 4.3%, P = .02), and very preterm birth before 34 weeks (6.0% vs 2.6%, P = .04).

Infant safety outcomes were also examined. There were no significant differences for composite or individual adverse neonatal outcomes other than death. The tenofovir-based ART group experienced a significantly higher rate of infant death than did the zidovudine-based ART group (4.4% vs 0.6%, P<.001). However, a post hoc analysis suggested that extreme prematurity contributed to the infant mortality.

Limitations of the study

This study had minor limitations. It divided patients into only 2 major categories with respect to gestational age--more than or less than 34 weeks. Some maternal medical conditions, such as malaria, were not controlled for. In addition, breastfeeding and formula feeding were combined for analysis, and we know that breastfeeding would inherently confer a higher risk of HIV transmission. 

Nevertheless, this study was thoughtfully designed and carefully conducted, and the results are of significant global impact.  

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

In this Update we review the results of 4 recent investigations that have important implications:

• the first analysis of the US Zika Virus Infection in Pregnancy Registry
• a study revealing an improved antibiotic regimen to prevent postcesarean infection
• an important new methodology for reducing the rate of perinatal transmission of hepatitis B virus (HBV) infection
• the risks and benefits of combination antiretroviral therapy (ART) in pregnancy.

Zika virus-associated birth defect rates similar regardless of symptom presence; first-trimester exposure has highest rate of anomalies

Honein MA, Dawson AL, Petersen EE, et al; US Zika Pregnancy Registry Collaboration. Birth defects among fetuses and infants of US women with evidence of possible Zika virus infection during pregnancy. JAMA. 2017;317(1):59-68.

Honein and colleagues provide a summary of the data from the US Zika Virus in Pregnancy Registry (a collaboration between the Centers for Disease Control and Prevention and state and local health departments), estimating the proportion of fetuses and infants with birth defects based on maternal symptoms of Zika virus infection and  trimester of possible infection.

Related article:
Zika virus: Counseling considerations for this emerging perinatal threat

Details of the study

The authors evaluated the outcomes of 442 women who had laboratory evidence of a possible Zika virus infection during pregnancy. Overall, 26 infants (6%; 95% confidence interval (CI), 4%-8%) had evidence of birth defects related to the Zika virus. Of note, abnormalities were detected in 16 of the 271 children (6%; 95% CI, 4%-9%) born to women who were asymptomatic and 10 of 167 (6%; 95% CI, 3%-11%) children delivered to women with symptomatic infections. 

The most common birth defect was microcephaly, although other serious central nervous system abnormalities were noted as well. Nine of 85 women (11%; 95% CI, 6%-19%) who had exposure only during the first trimester had infants with birth defects. There were no documented abnormalities in infants born to mothers who developed Zika virus infection only in the second or third trimester. 

Related article:
Zika virus update: A rapidly moving target

Key study findings

This article is important for several reasons. First, the authors describe the largest series of pregnant women in the United States with Zika virus infection. All of these patients developed Zika virus infection as a result of foreign travel or exposure to sexual partners who had traveled to Zika virus endemic areas. Second, the authors confirmed findings that previously had been based only on mathematical models rather than on actual case series. Specifically, they demonstrated that the risk of a serious birth defect following first-trimester exposure to Zika virus infection was approximately 11%, with a 95% CI that extended from 6% to 19%. Finally, Honein and colleagues highlighted the key fact that the risk of a serious birth defect was comparable in mothers who had either an asymptomatic or a symptomatic infection, a finding that seems somewhat counterintuitive.

Read about prophylaxis for postcesarean infection

Two antibiotics before cesarean delivery reduce infection rates further than one agent

Tita AT, Szychowski JM, Boggess K, et al; for the C/SOAP Trial Consortium. Adjunctive azithromycin prophylaxis for cesarean delivery. N Engl J Med. 2016;375(13):1231-1241.

Tita and colleagues reported the results of a multicenter trial that was designed to assess whether a combination of 2 antibiotics, including one that specifically targets ureaplasma species, provided more effective prophylaxis against postcesarean infection than single-agent prophylaxis.

Details of the study

The Cesarean Section Optimal Antibiotic Prophylaxis (C/SOAP) trial was conducted at 14 centers in the United States and included 2,013 women who were at least at 24 weeks' gestation and who had a cesarean delivery during labor or after membrane rupture.

The authors randomly assigned 1,019 women to receive 500 mg of intravenous azithromycin plus conventional single-agent prophylaxis (usually cefazolin) and 994 women to receive a placebo plus conventional prophylaxis. The primary outcome was the composite of endometritis, wound infection, or other infection occurring within 6 weeks.

The authors observed that the primary outcome occurred in 62 women (6.1%) who received azithromycin plus conventional prophylaxis and in 119 women (12%) who received only single-agent prophylaxis. The relative risk of developing a postoperative infection was 0.51 in women who received the combined therapy. There were significant differences between the 2 groups in both the rates of endometritis (3.8% vs 6.1%, P = .02) and wound infection (2.4% vs 6.6%, P<.001). There were no differences between the groups in the frequency of the secondary neonatal composite outcome, which included neonatal death and serious neonatal complications.

Related article:
Preventing infection after cesarean delivery: 5 more evidence-based measures to consider

Efficacy of dual-agent prophylaxis

At present, the standard of care is to administer prophylactic antibiotics to all women having cesarean delivery, including women having a scheduled cesarean in the absence of labor or ruptured membranes. Multiple studies have shown clearly that prophylaxis reduces the frequency of endometritis and, in high-risk patient populations, wound infection, and that prophylaxis is most beneficial when administered prior to the time the surgical incision is made. The most commonly used drug for prophylaxis is cefazolin, a first-generation cephalosporin. The usual recommended dose is 2 g, administered immediately prior to surgery.^3,4

Although most centers in the United States traditionally have used just a single antibiotic for prophylaxis, selected recent reports indicate that expanding the spectrum of activity of prophylactic antibiotics can result in additional beneficial effects. Specifically, Tita and colleagues evaluated an indigent patient population with an inherently high rate of postoperative infection.⁵ They showed that adding azithromycin 500 mg to cefazolin significantly reduced the rate of postcesarean endometritis. In a follow-up report from the same institution, Tita and colleagues demonstrated that adding azithromycin also significantly reduced the frequency of wound infection.⁶ Of note, in both these investigations, the antibiotics were administered after cord clamping. In a subsequent report, Ward and Duff showed that the combination of azithromycin plus cefazolin administered preoperatively resulted in a combined rate of endometritis and wound infection that was less than 3%.⁷

Related article:
Preventing infection after cesarean delivery: Evidence-based guidance

C/SOAP trial confirmed lower infection rates with combined regimen

Results of the present study confirm the findings of these 3 investigations. The trial included a large sample size. The study was carefully designed, and the end points were clearly defined. It included only patients at increased risk for postoperative infection by virtue of being in labor or having ruptured membranes at the time of cesarean delivery. Patients who received standard prophylaxis, usually cefazolin, plus azithromycin had a significantly lower risk of postcesarean endometritis and wound infection compared with patients who received a single antibiotic. The overall risk of infection was reduced by an impressive 50%.  
 

Read about reducing HBV transmission

Tenofovir treatment in pregnant women with HBV reduces vertical transmission

Pan CQ, Duan Z, Dai E, et al; China Study Group for the Mother-to-Child Transmission of Hepatitis B. Tenofovir to prevent hepatitis B transmission in mothers with high viral load. N Engl J Med. 2016;374(24):2324-2334.

A multicenter, open-label, randomized, parallel-group investigation was conducted from March 2012 to June 2013 at academic tertiary care centers in 5 geographic regions of China. Two hundred mothers, who were positive for both hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) and who had HBV DNA concentrations of 200,000 IU/mL or greater, were randomly assigned in a 1:1 ratio to either tenofovir or to usual treatment. Exclusion criteria were coexistent viral infections or medical conditions, renal failure, laboratory abnormalities, fetal deformities, and use of many medications.

Related article:
5 ways to reduce infection risk during pregnancy

Details of the study

Women in the active treatment group received tenofovir 300 mg by mouth daily from 30 to 32 weeks' gestation until postpartum week 4. Patients were monitored every 4 weeks in the antepartum period for adverse events and laboratory abnormalities. In the postpartum period, mother-infant dyads were evaluated at weeks 4, 12, 24, and 28.

Primary outcomes were the rates of mother-to-child transmission and birth defects with, or without, tenofovir exposure. Secondary outcomes were the percentage of mothers who had an HBV DNA serum concentration of less than 200,000 IU/mL at delivery and the percentage of mothers with HBeAg or HBsAg loss or seroconversion at postpartum week 28. Safety outcomes included the adverse event profile of tenofovir in mothers and safety events in the mother-infant dyads. These outcomes encompassed  all adverse events and drug discontinuations in patients who received at least one dose of tenofovir.

Sixty-eight percent of mothers in the tenofovir group, compared with 2% of mothers in the control group, had HBV levels less than 200,000 IU/mL at delivery (P<.001). The rate of mother-to-child HBV transmission at postpartum week 28 was lower in the tenofovir group. In the intention-to-treat analysis, the rate was 5% (95% CI, 1-10; 5 of 97 infants) in the tenofovir group versus 18% (95% CI, 10-26; 18 of 100 infants) in the control group (P = .007). In the per-protocol analysis, the rate was 0% (95% CI, 0-3; 0 of 92 infants) in the tenofovir group versus 7% (95% CI, 2-12; 6 of 88 infants) in the control group (P = .01). Maternal and infant safety profiles were similar between the 2 groups, with the exception of elevated creatinine kinase and alanine aminotransferase levels in mothers treated with tenofovir. Maternal HBV serologic titers did not differ significantly between the 2 groups.

Study strengths and limitations

This study's strengths include a multicenter, randomized controlled design, with strict inclusion and exclusion criteria. The results are clinically relevant and of global impact, with potential to decrease morbidity and  mortality from HBV infection in children born to infected mothers. 

A limitation, however, is that the study was probably underpowered to detect small differences in the rate of birth defects between the tenofovir and usual-care treatment groups. Additionally, some patients ceased taking tenofovir in the postpartum time period. Abrupt cessation may be associated with acute, severe HBV exacerbation.  

Benefits of ART for reducing mother-to-baby HIV transmission outweigh higher risk of adverse outcomes

Fowler MG, Qin M, Fiscus SA, et al; IMPAACT 1077BF/1077FF PROMISE Study Team. Benefits and risks of antiretroviral therapy for perinatal HIV prevention. N Engl J Med. 2016;375(18):1726-1737.

Part of the larger PROMISE (Promoting Maternal and Infant Survival Everywhere) trial, a study by Fowler and colleagues compared the relative efficacy and safety of various proven ART strategies for prevention of mother-to-child transmission of HIV infection in women with relatively high CD4 counts.

Details of the study

The trial was conducted at 14 sites in 7 countries. Patients were stratified according to HBV coinfection status and country of origin. The primary efficacy outcome was frequency of early infant HIV infection.

Women were randomly assigned to 1 of 3 treatment categories:

• zidovudine alone (zidovudine plus a single intrapartum dose of nevirapine, followed by 6 to 14 days of tenofovir plus emtricitabine postpartum)  
• zidovudine-based ART (zidovudine in combination with lamivudine and lopinavir-ritonavir)  
• tenofovir-based ART (tenofovir in combination with emtricitabine and lopinavir-ritonavir). 

All regimens were continued through 6 to 14 days postpartum. All infants received nevirapine at birth and in the immediate postpartum period.

Two trial periods. During period 1 (April 2011-September 2012), safety data on tenofovir in pregnancy were limited. Women without HBV coinfection were assigned only to zidovudine alone or zidovudine-based ART. During period 2 (October 2012-October 2014), since more information about tenofovir use in pregnancy was available, the study protocol was modified to allow women to be assigned to any of the 3 regimens, regardless of their HBV status.

Inclusion criteria were as follows: CD4 count of at least 350 cells/mm3 (or country-specific threshold for initiating triple-drug ART, if that threshold was higher), gestation of at least 14 weeks and not in labor, no previous use of triple-drug ART, no clinical or immune-related indication for triple-drug ART, hemoglobin level of at least 6.5 g/dL, an absolute neutrophil count of at least 750 cells/mm3, an alanine aminotransferase level of less than 2.5 times the upper limit of normal range, an estimated creatinine clearance of greater than 60 mL/min, and no serious pregnancy complications. Patients were excluded if they had active tuberculosis, HBV infection requiring treatment, a structural or conduction heart defect, or a fetus with a serious congenital malformation.

Primary outcomes. The primary efficacy outcome was early infant HIV infection, defined as a positive infant HIV nucleic acid test result at birth or at 1 week postpartum. The primary safety outcome was a composite of adverse events.

Adverse events in mothers were defined as hematologic abnormalities, abnormal blood chemical values, or abnormal signs/symptoms during pregnancy through 1 week postpartum. Severe pregnancy composite outcomes were low birth weight (<2,500 g), preterm delivery before 37 weeks' gestation, spontaneous abortion (<20 weeks), stillbirth (≥20 weeks), or congenital anomaly. Adverse events in infants were defined as death from any cause, hematologic abnormalities or abnormal blood chemical values, and abnormal signs/symptoms through 1 week postpartum.

A total of 3,490 mother-infant sets were included in the analysis (2,261 during trial period 1 and 1,229 during trial period 2). Baseline maternal characteristics were well balanced between groups. Most women were African, young (median age, 26 years), and asymptomatic.

Related article:
2016 Update on infectious disease

Study results

The combined maternal ART-treated groups had significantly lower rates of early transmission of HIV infection compared with the zidovudine-alone group (0.5% vs 1.8%, -1.3 percentage points; CI, -2.1 to -0.4). The zidovudine-based ART-treated group had a significantly higher rate of infant HIV-free survival through postpartum week 1 than did the zidovudine-alone group (P = .001) or the tenofovir-based ART group (P = .002).

When examining trial periods 1 and 2 combined, the zidovudine-based ART group experienced significantly higher rates of any adverse event than those receiving zidovudine alone (21.1% vs 17.3%, P = .008) and higher rates of abnormal blood chemical values (5.8% vs 1.3%, P<.001). During period 2 alone, the tenofovir-based ART group had significantly higher rates of abnormal blood chemical values than did the zidovudine-alone group (2.9% vs 0.8%, P = .03). There were no significant differences between the 2 ART treatment groups. No maternal deaths occurred during the study, and the trial-drug discontinuation rate was low (2%-5%) and did not vary among the 3 groups.

During trial periods 1 and 2, the zidovudine-based ART group had significantly higher rates of adverse pregnancy outcomes than did the zidovudine-alone group (40% vs 27.5%, P<.001). These included low birth weight less than 2,500 g (23% vs 12%) and preterm delivery before 37 weeks (20.5% vs 13.1%). During trial period 2, the tenofovir-based ART group had significantly higher rates of adverse pregnancy outcomes than did the zidovudine-alone group (34.7% vs 27.2%, P = .04). There were no significant differences for any outcome between the 2 ART-treated groups, and there were no significant differences in stillbirth or spontaneous abortion and congenital anomalies among the 3 groups.

Regarding severe pregnancy outcomes, there were no significant differences (composite or individual) between the zidovudine-based ART group and the zidovudine-alone group. The tenofovir-based ART group experienced significantly higher rates of composite severe adverse pregnancy outcomes compared with the zidovudine-based ART group (9.2% vs 4.3%, P = .02), and very preterm birth before 34 weeks (6.0% vs 2.6%, P = .04).

Infant safety outcomes were also examined. There were no significant differences for composite or individual adverse neonatal outcomes other than death. The tenofovir-based ART group experienced a significantly higher rate of infant death than did the zidovudine-based ART group (4.4% vs 0.6%, P<.001). However, a post hoc analysis suggested that extreme prematurity contributed to the infant mortality.

Limitations of the study

This study had minor limitations. It divided patients into only 2 major categories with respect to gestational age--more than or less than 34 weeks. Some maternal medical conditions, such as malaria, were not controlled for. In addition, breastfeeding and formula feeding were combined for analysis, and we know that breastfeeding would inherently confer a higher risk of HIV transmission. 

Nevertheless, this study was thoughtfully designed and carefully conducted, and the results are of significant global impact.  

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

CASE Patient wants minimally invasive surgery for her fibroids, and no hysterectomy

A 44-year-old G1P1 woman comes to the office to discuss her uterine fibroids, heavy menstrual bleeding, and urinary frequency. Treatment with oral contraceptives has not been effective in reducing the bleeding. She now wants surgical treatment without a hysterectomy (the hysterectomy was recommended by her previous gynecologist). On examination, a 14-week-size irregular uterus is felt. Myomectomy is discussed, and the patient asks if minimally invasive surgery (MIS) is possible. Complete blood cell count testing shows a hemoglobin level of 9.4 g/dL. Pelvic magnetic resonance imaging (MRI) shows a 6-cm type 2 posterior fundal fibroid and a 6-cm type 5 posterior lower-uterine-segment fibroid (FIGURE 1). These 2 fibroids have regular contours, and enhancement is not increased with contrast, consistent with benign fibroids.

Determining that laparoscopic myomectomy is a good option

Fibroids may affect quality of life—they may cause heavy menstrual bleeding, pelvic pain or pressure, or urinary frequency or incontinence. For many women who want large or numerous fibroids removed but the uterus preserved, abdominal myomectomy is required. Smaller and less numerous fibroids usually can be managed laparoscopically or with robotic assistance.

A systematic review of 6 randomized, controlled trials comparing laparoscopic and open myomectomy in 576 patients found that, although laparoscopic myomectomy was associated with longer operative time (approximately 13 minutes), it was also linked to less operative blood loss, fewer overall complications, reduced postoperative pain, and faster recovery.¹ However, wide application of the laparoscopic approach may be limited by the size and number of fibroids that can be reasonably removed and by the surgical skill needed for fibroid excision and laparoscopic suturing.

Four imaging modalities can be used for fibroids: transvaginal sonography (TVS), saline-infusion sonography (SIS), hysteroscopy, and MRI. TVS is the most readily available and least costly modality used to differentiate fibroids from other pelvic pathology; SIS provides contrast for the endometrial cavity and better defines submucous fibroids; and hysteroscopy detects visually apparent distortion of the cavity. MRI, however, provides the most complete evaluation of size, position, and number of fibroids.

A study comparing TVS, SIS, hysteroscopy, and MRI found that number and position of fibroids were best identified with MRI.² In addition, with MRI, the proximity of the fibroids and uterus to the bladder, rectum, and iliac bones can be evaluated. As tactility in laparoscopic and robot-assisted surgery is very limited, surgeons who use MRI to accurately assess fibroids preoperatively may be able to avoid missing them during the procedure.³ MRI also can be used reliably to diagnose adenomyosis and may be able to help identify uterine sarcoma.

Tip. For all women considering laparoscopic or robot-assisted myomectomy, I order pelvic MRI with and without contrast. Having the radiologist limit the number of MRI sequences may reduce the cost and make it comparable to that of other imaging modalities. I request T2-weighted MRI scans in the coronal, sagittal, and axial planes; in addition, to determine distortion of the uterine cavity by submucous fibroids, I request scans in the planes parallel with and perpendicular to the uterine axis. One gadolinium-enhanced T1-weighted MRI scan is needed to evaluate perfusion.

Although radiologists are experts in image interpretation, they are unfamiliar with the treatments and surgical issues that gynecologists must consider. Reading MRI scans for fibroids is straightforward, and gynecologists who regularly treat women with fibroids should consider viewing images with a radiologist until they become proficient.

Related article:
Surgical management of broad ligament fibroids

Surgeons who have the experience and skill and know the size, number, and position of fibroids are able to select the appropriate candidates for laparoscopic myomectomy. Authors of a study of 2,050 laparoscopic myomectomies found that fibroids larger than 5 cm, removal of more than 3 fibroids, and broad ligament fibroids were more likely to be associated with major complications, including visceral injury, conversion to laparotomy, and bleeding requiring blood transfusion.⁴

In laparoscopic myomectomy, uterus reconstruction requires laparoscopic suturing. Although robot-assisted myomectomy may make laparoscopic suturing easier, the added cost, longer operative time, and unimproved outcomes must be considered too.

Read about trocar placement and managing blood loss

Trocar placement

Place the patient in the dorsal lithotomy position.

Tip. For most women, I do not use a uterine manipulator, as my assistant can manipulate the uterus with laparoscopic graspers.

Port placement should be based on the position and size of the fibroids to be removed. Laparoscopic suturing is more ergonomic with 2 ports placed on one side of the patient (FIGURE 2). For suture access, a 12-mm port is placed about 2 cm medial to the iliac crest and a 5-mm port is placed medial to the 12-mm port, near the level of the umbilicus. Lateral trocars should be placed high, above the superior aspect of the uterus, to make it easier to access the fibroids, and lateral to the inferior epigastric vessels, to avoid injuring those vessels. If the uterus is near or above the umbilicus, a left upper quadrant approach may be used, with the access ports placed above the umbilicus.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Managing intraoperative blood loss

I use a combination of 3 agents to reduce intraoperative blood loss during laparoscopic myomectomy: preoperative misoprostol and tranexamic acid and intraoperative vasopressin. Although there are no data showing an advantage in using these drugs together, the agents have different mechanisms of action and no negative interactions.

Injected below the vascular pseudocapsule, 20 units of vasopressin in 100 mL of normal saline causes vasoconstriction of capillaries, small arterioles, and venules. Avoid intravascular injection given that bradycardia and cardiovascular collapse have been reported (rare cases). Loss of peripheral pulses, bradycardia, unmeasurable blood pressure, and cardiac complications have been reported after myometrial injection of ≥5 units of vasopressin.⁵

Although vasopressin is a powerful vasoconstrictor, these clinical findings are often interpreted as severe hypotension. However, evaluation of peripheral arterial blood flow by Doppler ultrasonography has revealed severe vasospasm and increased proximal blood pressure.⁵ Keep this potential reaction in mind to avoid misinterpreting findings and treating a patient with vasopressors. Presence of palpable carotid pulses and maintenance of normal partial pressure of end-tidal carbon dioxide can help differentiate peripheral vasospasm from global hypotension.

Use of vasopressin to reduce blood loss during myomectomy is off-label. On occasion, I apply a tourniquet around the lower uterine segment, including the infundibular pelvic ligaments. I use a red Robinson catheter, throw 1 tie in front of the uterus, pull with graspers on both ends until it is tight, and then clamp the half-knot with a locking grasper.

Tip. Although a salvage-type autologous blood transfusion device may be used during laparoscopic or robot-assisted myomectomy, cases in which this device is considered for very large or multiple fibroids might be better managed with abdominal myomectomy.

Read about surgical technique

Surgical technique

After injecting vasopressin, I use a high-frequency mechanical vibration scalpel to incise the myometrium directly over a prominent fibroid and carry the incision deeply until fibroid tissue is definite. Alternatively, a monopolar laparoscopic needle can be used in cut mode—which also limits damage to the myometrium.

Tip. The course of vessels over a fibroid is unpredictable, and we cannot be certain that any uterine incision will avoid bleeding. Therefore, I make transverse incisions, which allow more ergonomic laparoscopic suturing.

It is important to incise completely through the myometrium and through the pink-red pseudocapsule containing the vascular network surrounding the fibroid. This plane is often deeper than usually recognized and can be identified just over the white fibroid.

The fibroid is grasped with a tenaculum for traction, and countertraction is applied with a grasper on the myometrial edges. Once the fibroid is reached, graspers and the mechanical vibration scalpel are used to tease the pseudocapsule away from the fibroid (VIDEO).

Watch the video that accompanies this article:

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Laparoscopic myomectomy technique

 

 

 

Tip. Staying under the pseudocapsule reduces bleeding and may preserve the tissue’s growth factors and neurotransmitters, which are thought to promote wound healing.⁶

Dissection with the mechanical vibration scalpel (or monopolar needle) should be performed under visual control to identify the tissue adhering to the fibroid, which is desiccated and then divided. The fibroid is dissected until free of the myometrium and is placed in the right lower abdomen. Small fibroids can be strung together on a long suture so none will be lost. Using bipolar paddles, desiccate large bleeding vessels in the myometrial defect sparingly, with care taken to avoid devascularizing the myometrium, which might compromise wound healing. Myometrial repair should be performed in accordance with the accepted surgical technique used in laparotomy.

Place delayed absorbable sutures in 2 or 3 layers, as needed, to reapproximate the myometrium and secure hemostasis.

Tip: I use 0 polydioxanone interrupted figure-of-8 sutures, but continuous running sutures with or without barbs also can be used. For the serosa, I use a continuous barbed suture in a baseball stitch, which buries both the raw edges of the serosa and the barbs for smooth closure (FIGURE 3). These closure methods have not been compared to see which provides superior wound healing or subsequent wound strength.

The fibroid can be morcellated with an electromechanical morcellator or a scalpel (hand morcellation). Either instrument can be used in contained or uncontained fashion. I insert an electromechanical morcellator through the right lower quadrant incision and morcellate tissue in the anterior midpelvis. Safety requires careful control of the rotating blade and scrutiny of the bowel, bladder, and major vessels. Our operating room has 4 rules for morcellator use:

1. The blade is activated only under direct visualization.
2. Both the surgeon and the assistant must say “ready” before the blade is activated.
3. The hand holding the morcellator must remain still while tissue is being drawn into the device.
4. Any undue resistance from the tissue is cause to stop the blade. This precaution is taken because there is a tendency to drop the blade in an attempt to overcome the resistance.

Tip: I limit rotational forces and scattering of tissue by “pulsing” the blade on and off when morcellating softer tissue.

Various methods of contained morcellation (morcellation in a containment bag) have been described.⁷ In one method, tissue is placed in a bag, the neck of the bag is brought through an enlarged umbilical incision, and the tissue is cut into small pieces until it is entirely removed. Another method is to use an electromechanical morcellator with a specially designed containment bag inside the abdomen. The bag is introduced through a 12-mm port and unfurled inside the abdomen; the specimen is placed in the bag; the neck of the bag is brought out through the port; the bag is insufflated with carbon dioxide; the laparoscope, a 5-mm grasper, and the morcellator tip are passed into the bag; and morcellation is performed. Early studies of contained morcellation reported longer operating times, leaking bags, and visceral injuries. In 2016, the US Food and Drug Administration (FDA) cleared the PneumoLiner containment system but required that its manufacturer (Advanced Surgical Concepts) warn patients and health care providers that its bag has not been proved to reduce the risk of spreading cancer during morcellation procedures.⁸

During laparoscopic myomectomy, fibroid removal by myometrial dissection disperses tissue fragments, and the unprotected fibroid is usually stored in the abdomen until hemostasis is secured and suturing completed. Limiting the rotational forces that lead to further dispersement and irrigating copiously to remove tissue fragments help eliminate residual tissue.

The pelvis and the abdomen are irrigated with normal saline (approximately 3 L) and suctioned multiple times.

Tip. Alternating between the Trendelenburg and reverse Trendelenburg positions allows fluid to wash tissue down to the pelvis, where it is more easily seen and removed.

Careful inspection for tissue fragments and copious irrigation and suctioning are important in reducing the risk that tissue fragments will remain in the peritoneal cavity and parasitic fibroids will develop. In cases of occult leiomyosarcoma (LMS), this step may be particularly important.

I place a knitted fabric of modified cellulose over the hysterotomy suture lines to reduce the incidence of adhesion formation. Once the procedure is complete, the local anesthetic bupivicaine is injected deep into the incision sites. Injecting anesthetic before making the incisions does not provide better pain relief; injecting after the procedure provides pain relief for 6 hours.⁹

Related article:
Robot-assisted laparoscopic myomectomy

Morcellation and risk of leiomyosarcoma

Given the need to prevent laparoscopic morcellators from inadvertently spreading tissue within the peritoneal cavity of women with occult LMS, the FDA issued a safety communication in 2014 warning against their use in the majority of women who undergo myomectomy or hysterectomy for fibroids.¹⁰ However, Pritts and colleagues estimated the prevalence of LMS in women who had surgery for presumed uterine fibroids at about 1 in 2,000 (0.05%), significantly lower than the FDA’s estimate of 1 in 350.^10,11 In 2015, a large population-based prospective registry study found 2 cases of occult LMS in 8,720 fibroid surgery patients (0.02%).¹²

Related article:
The FDA’s review of the data on open power morcellation was “inadequate, irresponsible” and a “disservice to women”

Since LMS metastasizes through the bloodstream, there is no reliable evidence that morcellation influences survival or that electromechanical morcellation is inferior to vaginal or mini-laparotomy morcellation with a scalpel. According to recent publications, compared with MIS, open abdominal surgery is associated with more morbidity and mortality in women.¹³ Since the FDA advisory was issued, the number of abdominal surgeries has increased, as has the number of related complications.¹³

I use electromechanical morcellation techniques for women who want MIS. All surgical procedures have potential risks, and patients’ and physicians’ understanding of risks forms the foundation of medical decision making. The possibility of occult LMS should be considered by women and their gynecologists, and proper informed consent, noting both the LMS risk and the increased risks of abdominal surgery, should be obtained.

Related article:
Tissue extraction: Can the pendulum change direction?

Risk of uterine rupture after laparoscopic myomectomy

After abdominal myomectomy, uterine rupture during pregnancy or delivery is rare, according to reviews of delivery records of many thousands of women.¹⁴ Operative techniques, instruments, and energy sources used during laparoscopic or robot-assisted myomectomy may differ from those used during laparotomy, and anecdotal communications suggest that uterine rupture may be more common after laparoscopic or robot-assisted myomectomy. A meta-analysis of 56 articles (3,685 pregnancies) published between 1970 and 2013 found 29 cases of uterine rupture after myomectomy, with no statistical difference in rupture risk between laparoscopic and abdominal myomectomy.¹⁵ As most reports are case studies or small case series, the incidence of rupture cannot be reliably calculated.

There is no consensus regarding the factors that may increase the risk of uterine rupture after laparoscopic myomectomy. Three factors are postulated to interfere with myometrial wound healing and increase uterine rupture risk: failure to adequately suture myometrial defects, excessive use of monopolar or bipolar electrosurgery with devascularization of the myometrium, and lack of hemostasis with subsequent hematoma formation.¹⁶ It seems prudent that surgeons should adhere to time-tested techniques for abdominal myomectomy. Even with use of ideal surgical techniques, however, individual wound-healing characteristics may predispose to uterine rupture.

CASE Resolved

After giving proper informed consent, the patient underwent laparoscopic myomectomy and electromechanical morcellation. Her 2 fibroids were removed, with a blood loss of 200 mL, and that afternoon she was discharged from the surgery center with written postoperative instructions and oral pain medication. A telephone call the next day found her comfortable, with no nausea or vomiting, and happy to be fibroid free. Pathologic inspection of the morcellated tissue confirmed that the fibroids were benign. At 2-week follow-up, the patient was no longer taking pain medication and was ready to return to work and normal activity. Her fatigue persisted, though, and she arranged to take time to rest during the day.

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

CASE Patient wants minimally invasive surgery for her fibroids, and no hysterectomy

A 44-year-old G1P1 woman comes to the office to discuss her uterine fibroids, heavy menstrual bleeding, and urinary frequency. Treatment with oral contraceptives has not been effective in reducing the bleeding. She now wants surgical treatment without a hysterectomy (the hysterectomy was recommended by her previous gynecologist). On examination, a 14-week-size irregular uterus is felt. Myomectomy is discussed, and the patient asks if minimally invasive surgery (MIS) is possible. Complete blood cell count testing shows a hemoglobin level of 9.4 g/dL. Pelvic magnetic resonance imaging (MRI) shows a 6-cm type 2 posterior fundal fibroid and a 6-cm type 5 posterior lower-uterine-segment fibroid (FIGURE 1). These 2 fibroids have regular contours, and enhancement is not increased with contrast, consistent with benign fibroids.

Determining that laparoscopic myomectomy is a good option

Fibroids may affect quality of life—they may cause heavy menstrual bleeding, pelvic pain or pressure, or urinary frequency or incontinence. For many women who want large or numerous fibroids removed but the uterus preserved, abdominal myomectomy is required. Smaller and less numerous fibroids usually can be managed laparoscopically or with robotic assistance.

A systematic review of 6 randomized, controlled trials comparing laparoscopic and open myomectomy in 576 patients found that, although laparoscopic myomectomy was associated with longer operative time (approximately 13 minutes), it was also linked to less operative blood loss, fewer overall complications, reduced postoperative pain, and faster recovery.¹ However, wide application of the laparoscopic approach may be limited by the size and number of fibroids that can be reasonably removed and by the surgical skill needed for fibroid excision and laparoscopic suturing.

Four imaging modalities can be used for fibroids: transvaginal sonography (TVS), saline-infusion sonography (SIS), hysteroscopy, and MRI. TVS is the most readily available and least costly modality used to differentiate fibroids from other pelvic pathology; SIS provides contrast for the endometrial cavity and better defines submucous fibroids; and hysteroscopy detects visually apparent distortion of the cavity. MRI, however, provides the most complete evaluation of size, position, and number of fibroids.

A study comparing TVS, SIS, hysteroscopy, and MRI found that number and position of fibroids were best identified with MRI.² In addition, with MRI, the proximity of the fibroids and uterus to the bladder, rectum, and iliac bones can be evaluated. As tactility in laparoscopic and robot-assisted surgery is very limited, surgeons who use MRI to accurately assess fibroids preoperatively may be able to avoid missing them during the procedure.³ MRI also can be used reliably to diagnose adenomyosis and may be able to help identify uterine sarcoma.

Tip. For all women considering laparoscopic or robot-assisted myomectomy, I order pelvic MRI with and without contrast. Having the radiologist limit the number of MRI sequences may reduce the cost and make it comparable to that of other imaging modalities. I request T2-weighted MRI scans in the coronal, sagittal, and axial planes; in addition, to determine distortion of the uterine cavity by submucous fibroids, I request scans in the planes parallel with and perpendicular to the uterine axis. One gadolinium-enhanced T1-weighted MRI scan is needed to evaluate perfusion.

Although radiologists are experts in image interpretation, they are unfamiliar with the treatments and surgical issues that gynecologists must consider. Reading MRI scans for fibroids is straightforward, and gynecologists who regularly treat women with fibroids should consider viewing images with a radiologist until they become proficient.

Related article:
Surgical management of broad ligament fibroids

Surgeons who have the experience and skill and know the size, number, and position of fibroids are able to select the appropriate candidates for laparoscopic myomectomy. Authors of a study of 2,050 laparoscopic myomectomies found that fibroids larger than 5 cm, removal of more than 3 fibroids, and broad ligament fibroids were more likely to be associated with major complications, including visceral injury, conversion to laparotomy, and bleeding requiring blood transfusion.⁴

In laparoscopic myomectomy, uterus reconstruction requires laparoscopic suturing. Although robot-assisted myomectomy may make laparoscopic suturing easier, the added cost, longer operative time, and unimproved outcomes must be considered too.

Read about trocar placement and managing blood loss

Trocar placement

Place the patient in the dorsal lithotomy position.

Tip. For most women, I do not use a uterine manipulator, as my assistant can manipulate the uterus with laparoscopic graspers.

Port placement should be based on the position and size of the fibroids to be removed. Laparoscopic suturing is more ergonomic with 2 ports placed on one side of the patient (FIGURE 2). For suture access, a 12-mm port is placed about 2 cm medial to the iliac crest and a 5-mm port is placed medial to the 12-mm port, near the level of the umbilicus. Lateral trocars should be placed high, above the superior aspect of the uterus, to make it easier to access the fibroids, and lateral to the inferior epigastric vessels, to avoid injuring those vessels. If the uterus is near or above the umbilicus, a left upper quadrant approach may be used, with the access ports placed above the umbilicus.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Managing intraoperative blood loss

I use a combination of 3 agents to reduce intraoperative blood loss during laparoscopic myomectomy: preoperative misoprostol and tranexamic acid and intraoperative vasopressin. Although there are no data showing an advantage in using these drugs together, the agents have different mechanisms of action and no negative interactions.

Injected below the vascular pseudocapsule, 20 units of vasopressin in 100 mL of normal saline causes vasoconstriction of capillaries, small arterioles, and venules. Avoid intravascular injection given that bradycardia and cardiovascular collapse have been reported (rare cases). Loss of peripheral pulses, bradycardia, unmeasurable blood pressure, and cardiac complications have been reported after myometrial injection of ≥5 units of vasopressin.⁵

Although vasopressin is a powerful vasoconstrictor, these clinical findings are often interpreted as severe hypotension. However, evaluation of peripheral arterial blood flow by Doppler ultrasonography has revealed severe vasospasm and increased proximal blood pressure.⁵ Keep this potential reaction in mind to avoid misinterpreting findings and treating a patient with vasopressors. Presence of palpable carotid pulses and maintenance of normal partial pressure of end-tidal carbon dioxide can help differentiate peripheral vasospasm from global hypotension.

Use of vasopressin to reduce blood loss during myomectomy is off-label. On occasion, I apply a tourniquet around the lower uterine segment, including the infundibular pelvic ligaments. I use a red Robinson catheter, throw 1 tie in front of the uterus, pull with graspers on both ends until it is tight, and then clamp the half-knot with a locking grasper.

Tip. Although a salvage-type autologous blood transfusion device may be used during laparoscopic or robot-assisted myomectomy, cases in which this device is considered for very large or multiple fibroids might be better managed with abdominal myomectomy.

Read about surgical technique

Surgical technique

After injecting vasopressin, I use a high-frequency mechanical vibration scalpel to incise the myometrium directly over a prominent fibroid and carry the incision deeply until fibroid tissue is definite. Alternatively, a monopolar laparoscopic needle can be used in cut mode—which also limits damage to the myometrium.

Tip. The course of vessels over a fibroid is unpredictable, and we cannot be certain that any uterine incision will avoid bleeding. Therefore, I make transverse incisions, which allow more ergonomic laparoscopic suturing.

It is important to incise completely through the myometrium and through the pink-red pseudocapsule containing the vascular network surrounding the fibroid. This plane is often deeper than usually recognized and can be identified just over the white fibroid.

The fibroid is grasped with a tenaculum for traction, and countertraction is applied with a grasper on the myometrial edges. Once the fibroid is reached, graspers and the mechanical vibration scalpel are used to tease the pseudocapsule away from the fibroid (VIDEO).

Watch the video that accompanies this article:

---

Laparoscopic myomectomy technique

 

 

 

Tip. Staying under the pseudocapsule reduces bleeding and may preserve the tissue’s growth factors and neurotransmitters, which are thought to promote wound healing.⁶

Dissection with the mechanical vibration scalpel (or monopolar needle) should be performed under visual control to identify the tissue adhering to the fibroid, which is desiccated and then divided. The fibroid is dissected until free of the myometrium and is placed in the right lower abdomen. Small fibroids can be strung together on a long suture so none will be lost. Using bipolar paddles, desiccate large bleeding vessels in the myometrial defect sparingly, with care taken to avoid devascularizing the myometrium, which might compromise wound healing. Myometrial repair should be performed in accordance with the accepted surgical technique used in laparotomy.

Place delayed absorbable sutures in 2 or 3 layers, as needed, to reapproximate the myometrium and secure hemostasis.

Tip: I use 0 polydioxanone interrupted figure-of-8 sutures, but continuous running sutures with or without barbs also can be used. For the serosa, I use a continuous barbed suture in a baseball stitch, which buries both the raw edges of the serosa and the barbs for smooth closure (FIGURE 3). These closure methods have not been compared to see which provides superior wound healing or subsequent wound strength.

The fibroid can be morcellated with an electromechanical morcellator or a scalpel (hand morcellation). Either instrument can be used in contained or uncontained fashion. I insert an electromechanical morcellator through the right lower quadrant incision and morcellate tissue in the anterior midpelvis. Safety requires careful control of the rotating blade and scrutiny of the bowel, bladder, and major vessels. Our operating room has 4 rules for morcellator use:

1. The blade is activated only under direct visualization.
2. Both the surgeon and the assistant must say “ready” before the blade is activated.
3. The hand holding the morcellator must remain still while tissue is being drawn into the device.
4. Any undue resistance from the tissue is cause to stop the blade. This precaution is taken because there is a tendency to drop the blade in an attempt to overcome the resistance.

Tip: I limit rotational forces and scattering of tissue by “pulsing” the blade on and off when morcellating softer tissue.

Various methods of contained morcellation (morcellation in a containment bag) have been described.⁷ In one method, tissue is placed in a bag, the neck of the bag is brought through an enlarged umbilical incision, and the tissue is cut into small pieces until it is entirely removed. Another method is to use an electromechanical morcellator with a specially designed containment bag inside the abdomen. The bag is introduced through a 12-mm port and unfurled inside the abdomen; the specimen is placed in the bag; the neck of the bag is brought out through the port; the bag is insufflated with carbon dioxide; the laparoscope, a 5-mm grasper, and the morcellator tip are passed into the bag; and morcellation is performed. Early studies of contained morcellation reported longer operating times, leaking bags, and visceral injuries. In 2016, the US Food and Drug Administration (FDA) cleared the PneumoLiner containment system but required that its manufacturer (Advanced Surgical Concepts) warn patients and health care providers that its bag has not been proved to reduce the risk of spreading cancer during morcellation procedures.⁸

During laparoscopic myomectomy, fibroid removal by myometrial dissection disperses tissue fragments, and the unprotected fibroid is usually stored in the abdomen until hemostasis is secured and suturing completed. Limiting the rotational forces that lead to further dispersement and irrigating copiously to remove tissue fragments help eliminate residual tissue.

The pelvis and the abdomen are irrigated with normal saline (approximately 3 L) and suctioned multiple times.

Tip. Alternating between the Trendelenburg and reverse Trendelenburg positions allows fluid to wash tissue down to the pelvis, where it is more easily seen and removed.

Careful inspection for tissue fragments and copious irrigation and suctioning are important in reducing the risk that tissue fragments will remain in the peritoneal cavity and parasitic fibroids will develop. In cases of occult leiomyosarcoma (LMS), this step may be particularly important.

I place a knitted fabric of modified cellulose over the hysterotomy suture lines to reduce the incidence of adhesion formation. Once the procedure is complete, the local anesthetic bupivicaine is injected deep into the incision sites. Injecting anesthetic before making the incisions does not provide better pain relief; injecting after the procedure provides pain relief for 6 hours.⁹

Related article:
Robot-assisted laparoscopic myomectomy

Morcellation and risk of leiomyosarcoma

Given the need to prevent laparoscopic morcellators from inadvertently spreading tissue within the peritoneal cavity of women with occult LMS, the FDA issued a safety communication in 2014 warning against their use in the majority of women who undergo myomectomy or hysterectomy for fibroids.¹⁰ However, Pritts and colleagues estimated the prevalence of LMS in women who had surgery for presumed uterine fibroids at about 1 in 2,000 (0.05%), significantly lower than the FDA’s estimate of 1 in 350.^10,11 In 2015, a large population-based prospective registry study found 2 cases of occult LMS in 8,720 fibroid surgery patients (0.02%).¹²

Related article:
The FDA’s review of the data on open power morcellation was “inadequate, irresponsible” and a “disservice to women”

Since LMS metastasizes through the bloodstream, there is no reliable evidence that morcellation influences survival or that electromechanical morcellation is inferior to vaginal or mini-laparotomy morcellation with a scalpel. According to recent publications, compared with MIS, open abdominal surgery is associated with more morbidity and mortality in women.¹³ Since the FDA advisory was issued, the number of abdominal surgeries has increased, as has the number of related complications.¹³

I use electromechanical morcellation techniques for women who want MIS. All surgical procedures have potential risks, and patients’ and physicians’ understanding of risks forms the foundation of medical decision making. The possibility of occult LMS should be considered by women and their gynecologists, and proper informed consent, noting both the LMS risk and the increased risks of abdominal surgery, should be obtained.

Related article:
Tissue extraction: Can the pendulum change direction?

Risk of uterine rupture after laparoscopic myomectomy

After abdominal myomectomy, uterine rupture during pregnancy or delivery is rare, according to reviews of delivery records of many thousands of women.¹⁴ Operative techniques, instruments, and energy sources used during laparoscopic or robot-assisted myomectomy may differ from those used during laparotomy, and anecdotal communications suggest that uterine rupture may be more common after laparoscopic or robot-assisted myomectomy. A meta-analysis of 56 articles (3,685 pregnancies) published between 1970 and 2013 found 29 cases of uterine rupture after myomectomy, with no statistical difference in rupture risk between laparoscopic and abdominal myomectomy.¹⁵ As most reports are case studies or small case series, the incidence of rupture cannot be reliably calculated.

There is no consensus regarding the factors that may increase the risk of uterine rupture after laparoscopic myomectomy. Three factors are postulated to interfere with myometrial wound healing and increase uterine rupture risk: failure to adequately suture myometrial defects, excessive use of monopolar or bipolar electrosurgery with devascularization of the myometrium, and lack of hemostasis with subsequent hematoma formation.¹⁶ It seems prudent that surgeons should adhere to time-tested techniques for abdominal myomectomy. Even with use of ideal surgical techniques, however, individual wound-healing characteristics may predispose to uterine rupture.

CASE Resolved

After giving proper informed consent, the patient underwent laparoscopic myomectomy and electromechanical morcellation. Her 2 fibroids were removed, with a blood loss of 200 mL, and that afternoon she was discharged from the surgery center with written postoperative instructions and oral pain medication. A telephone call the next day found her comfortable, with no nausea or vomiting, and happy to be fibroid free. Pathologic inspection of the morcellated tissue confirmed that the fibroids were benign. At 2-week follow-up, the patient was no longer taking pain medication and was ready to return to work and normal activity. Her fatigue persisted, though, and she arranged to take time to rest during the day.

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

CASE Patient wants minimally invasive surgery for her fibroids, and no hysterectomy

A 44-year-old G1P1 woman comes to the office to discuss her uterine fibroids, heavy menstrual bleeding, and urinary frequency. Treatment with oral contraceptives has not been effective in reducing the bleeding. She now wants surgical treatment without a hysterectomy (the hysterectomy was recommended by her previous gynecologist). On examination, a 14-week-size irregular uterus is felt. Myomectomy is discussed, and the patient asks if minimally invasive surgery (MIS) is possible. Complete blood cell count testing shows a hemoglobin level of 9.4 g/dL. Pelvic magnetic resonance imaging (MRI) shows a 6-cm type 2 posterior fundal fibroid and a 6-cm type 5 posterior lower-uterine-segment fibroid (FIGURE 1). These 2 fibroids have regular contours, and enhancement is not increased with contrast, consistent with benign fibroids.

Determining that laparoscopic myomectomy is a good option

Fibroids may affect quality of life—they may cause heavy menstrual bleeding, pelvic pain or pressure, or urinary frequency or incontinence. For many women who want large or numerous fibroids removed but the uterus preserved, abdominal myomectomy is required. Smaller and less numerous fibroids usually can be managed laparoscopically or with robotic assistance.

A systematic review of 6 randomized, controlled trials comparing laparoscopic and open myomectomy in 576 patients found that, although laparoscopic myomectomy was associated with longer operative time (approximately 13 minutes), it was also linked to less operative blood loss, fewer overall complications, reduced postoperative pain, and faster recovery.¹ However, wide application of the laparoscopic approach may be limited by the size and number of fibroids that can be reasonably removed and by the surgical skill needed for fibroid excision and laparoscopic suturing.

Four imaging modalities can be used for fibroids: transvaginal sonography (TVS), saline-infusion sonography (SIS), hysteroscopy, and MRI. TVS is the most readily available and least costly modality used to differentiate fibroids from other pelvic pathology; SIS provides contrast for the endometrial cavity and better defines submucous fibroids; and hysteroscopy detects visually apparent distortion of the cavity. MRI, however, provides the most complete evaluation of size, position, and number of fibroids.

A study comparing TVS, SIS, hysteroscopy, and MRI found that number and position of fibroids were best identified with MRI.² In addition, with MRI, the proximity of the fibroids and uterus to the bladder, rectum, and iliac bones can be evaluated. As tactility in laparoscopic and robot-assisted surgery is very limited, surgeons who use MRI to accurately assess fibroids preoperatively may be able to avoid missing them during the procedure.³ MRI also can be used reliably to diagnose adenomyosis and may be able to help identify uterine sarcoma.

Tip. For all women considering laparoscopic or robot-assisted myomectomy, I order pelvic MRI with and without contrast. Having the radiologist limit the number of MRI sequences may reduce the cost and make it comparable to that of other imaging modalities. I request T2-weighted MRI scans in the coronal, sagittal, and axial planes; in addition, to determine distortion of the uterine cavity by submucous fibroids, I request scans in the planes parallel with and perpendicular to the uterine axis. One gadolinium-enhanced T1-weighted MRI scan is needed to evaluate perfusion.

Although radiologists are experts in image interpretation, they are unfamiliar with the treatments and surgical issues that gynecologists must consider. Reading MRI scans for fibroids is straightforward, and gynecologists who regularly treat women with fibroids should consider viewing images with a radiologist until they become proficient.

Related article:
Surgical management of broad ligament fibroids

Surgeons who have the experience and skill and know the size, number, and position of fibroids are able to select the appropriate candidates for laparoscopic myomectomy. Authors of a study of 2,050 laparoscopic myomectomies found that fibroids larger than 5 cm, removal of more than 3 fibroids, and broad ligament fibroids were more likely to be associated with major complications, including visceral injury, conversion to laparotomy, and bleeding requiring blood transfusion.⁴

In laparoscopic myomectomy, uterus reconstruction requires laparoscopic suturing. Although robot-assisted myomectomy may make laparoscopic suturing easier, the added cost, longer operative time, and unimproved outcomes must be considered too.

Read about trocar placement and managing blood loss

Trocar placement

Place the patient in the dorsal lithotomy position.

Tip. For most women, I do not use a uterine manipulator, as my assistant can manipulate the uterus with laparoscopic graspers.

Port placement should be based on the position and size of the fibroids to be removed. Laparoscopic suturing is more ergonomic with 2 ports placed on one side of the patient (FIGURE 2). For suture access, a 12-mm port is placed about 2 cm medial to the iliac crest and a 5-mm port is placed medial to the 12-mm port, near the level of the umbilicus. Lateral trocars should be placed high, above the superior aspect of the uterus, to make it easier to access the fibroids, and lateral to the inferior epigastric vessels, to avoid injuring those vessels. If the uterus is near or above the umbilicus, a left upper quadrant approach may be used, with the access ports placed above the umbilicus.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Managing intraoperative blood loss

I use a combination of 3 agents to reduce intraoperative blood loss during laparoscopic myomectomy: preoperative misoprostol and tranexamic acid and intraoperative vasopressin. Although there are no data showing an advantage in using these drugs together, the agents have different mechanisms of action and no negative interactions.

Injected below the vascular pseudocapsule, 20 units of vasopressin in 100 mL of normal saline causes vasoconstriction of capillaries, small arterioles, and venules. Avoid intravascular injection given that bradycardia and cardiovascular collapse have been reported (rare cases). Loss of peripheral pulses, bradycardia, unmeasurable blood pressure, and cardiac complications have been reported after myometrial injection of ≥5 units of vasopressin.⁵

Although vasopressin is a powerful vasoconstrictor, these clinical findings are often interpreted as severe hypotension. However, evaluation of peripheral arterial blood flow by Doppler ultrasonography has revealed severe vasospasm and increased proximal blood pressure.⁵ Keep this potential reaction in mind to avoid misinterpreting findings and treating a patient with vasopressors. Presence of palpable carotid pulses and maintenance of normal partial pressure of end-tidal carbon dioxide can help differentiate peripheral vasospasm from global hypotension.

Use of vasopressin to reduce blood loss during myomectomy is off-label. On occasion, I apply a tourniquet around the lower uterine segment, including the infundibular pelvic ligaments. I use a red Robinson catheter, throw 1 tie in front of the uterus, pull with graspers on both ends until it is tight, and then clamp the half-knot with a locking grasper.

Tip. Although a salvage-type autologous blood transfusion device may be used during laparoscopic or robot-assisted myomectomy, cases in which this device is considered for very large or multiple fibroids might be better managed with abdominal myomectomy.

Read about surgical technique

Surgical technique

After injecting vasopressin, I use a high-frequency mechanical vibration scalpel to incise the myometrium directly over a prominent fibroid and carry the incision deeply until fibroid tissue is definite. Alternatively, a monopolar laparoscopic needle can be used in cut mode—which also limits damage to the myometrium.

Tip. The course of vessels over a fibroid is unpredictable, and we cannot be certain that any uterine incision will avoid bleeding. Therefore, I make transverse incisions, which allow more ergonomic laparoscopic suturing.

It is important to incise completely through the myometrium and through the pink-red pseudocapsule containing the vascular network surrounding the fibroid. This plane is often deeper than usually recognized and can be identified just over the white fibroid.

The fibroid is grasped with a tenaculum for traction, and countertraction is applied with a grasper on the myometrial edges. Once the fibroid is reached, graspers and the mechanical vibration scalpel are used to tease the pseudocapsule away from the fibroid (VIDEO).

Watch the video that accompanies this article:

---

Laparoscopic myomectomy technique

 

 

 

Tip. Staying under the pseudocapsule reduces bleeding and may preserve the tissue’s growth factors and neurotransmitters, which are thought to promote wound healing.⁶

Dissection with the mechanical vibration scalpel (or monopolar needle) should be performed under visual control to identify the tissue adhering to the fibroid, which is desiccated and then divided. The fibroid is dissected until free of the myometrium and is placed in the right lower abdomen. Small fibroids can be strung together on a long suture so none will be lost. Using bipolar paddles, desiccate large bleeding vessels in the myometrial defect sparingly, with care taken to avoid devascularizing the myometrium, which might compromise wound healing. Myometrial repair should be performed in accordance with the accepted surgical technique used in laparotomy.

Place delayed absorbable sutures in 2 or 3 layers, as needed, to reapproximate the myometrium and secure hemostasis.

Tip: I use 0 polydioxanone interrupted figure-of-8 sutures, but continuous running sutures with or without barbs also can be used. For the serosa, I use a continuous barbed suture in a baseball stitch, which buries both the raw edges of the serosa and the barbs for smooth closure (FIGURE 3). These closure methods have not been compared to see which provides superior wound healing or subsequent wound strength.

The fibroid can be morcellated with an electromechanical morcellator or a scalpel (hand morcellation). Either instrument can be used in contained or uncontained fashion. I insert an electromechanical morcellator through the right lower quadrant incision and morcellate tissue in the anterior midpelvis. Safety requires careful control of the rotating blade and scrutiny of the bowel, bladder, and major vessels. Our operating room has 4 rules for morcellator use:

1. The blade is activated only under direct visualization.
2. Both the surgeon and the assistant must say “ready” before the blade is activated.
3. The hand holding the morcellator must remain still while tissue is being drawn into the device.
4. Any undue resistance from the tissue is cause to stop the blade. This precaution is taken because there is a tendency to drop the blade in an attempt to overcome the resistance.

Tip: I limit rotational forces and scattering of tissue by “pulsing” the blade on and off when morcellating softer tissue.

Various methods of contained morcellation (morcellation in a containment bag) have been described.⁷ In one method, tissue is placed in a bag, the neck of the bag is brought through an enlarged umbilical incision, and the tissue is cut into small pieces until it is entirely removed. Another method is to use an electromechanical morcellator with a specially designed containment bag inside the abdomen. The bag is introduced through a 12-mm port and unfurled inside the abdomen; the specimen is placed in the bag; the neck of the bag is brought out through the port; the bag is insufflated with carbon dioxide; the laparoscope, a 5-mm grasper, and the morcellator tip are passed into the bag; and morcellation is performed. Early studies of contained morcellation reported longer operating times, leaking bags, and visceral injuries. In 2016, the US Food and Drug Administration (FDA) cleared the PneumoLiner containment system but required that its manufacturer (Advanced Surgical Concepts) warn patients and health care providers that its bag has not been proved to reduce the risk of spreading cancer during morcellation procedures.⁸

During laparoscopic myomectomy, fibroid removal by myometrial dissection disperses tissue fragments, and the unprotected fibroid is usually stored in the abdomen until hemostasis is secured and suturing completed. Limiting the rotational forces that lead to further dispersement and irrigating copiously to remove tissue fragments help eliminate residual tissue.

The pelvis and the abdomen are irrigated with normal saline (approximately 3 L) and suctioned multiple times.

Tip. Alternating between the Trendelenburg and reverse Trendelenburg positions allows fluid to wash tissue down to the pelvis, where it is more easily seen and removed.

Careful inspection for tissue fragments and copious irrigation and suctioning are important in reducing the risk that tissue fragments will remain in the peritoneal cavity and parasitic fibroids will develop. In cases of occult leiomyosarcoma (LMS), this step may be particularly important.

I place a knitted fabric of modified cellulose over the hysterotomy suture lines to reduce the incidence of adhesion formation. Once the procedure is complete, the local anesthetic bupivicaine is injected deep into the incision sites. Injecting anesthetic before making the incisions does not provide better pain relief; injecting after the procedure provides pain relief for 6 hours.⁹

Related article:
Robot-assisted laparoscopic myomectomy

Morcellation and risk of leiomyosarcoma

Given the need to prevent laparoscopic morcellators from inadvertently spreading tissue within the peritoneal cavity of women with occult LMS, the FDA issued a safety communication in 2014 warning against their use in the majority of women who undergo myomectomy or hysterectomy for fibroids.¹⁰ However, Pritts and colleagues estimated the prevalence of LMS in women who had surgery for presumed uterine fibroids at about 1 in 2,000 (0.05%), significantly lower than the FDA’s estimate of 1 in 350.^10,11 In 2015, a large population-based prospective registry study found 2 cases of occult LMS in 8,720 fibroid surgery patients (0.02%).¹²

Related article:
The FDA’s review of the data on open power morcellation was “inadequate, irresponsible” and a “disservice to women”

Since LMS metastasizes through the bloodstream, there is no reliable evidence that morcellation influences survival or that electromechanical morcellation is inferior to vaginal or mini-laparotomy morcellation with a scalpel. According to recent publications, compared with MIS, open abdominal surgery is associated with more morbidity and mortality in women.¹³ Since the FDA advisory was issued, the number of abdominal surgeries has increased, as has the number of related complications.¹³

I use electromechanical morcellation techniques for women who want MIS. All surgical procedures have potential risks, and patients’ and physicians’ understanding of risks forms the foundation of medical decision making. The possibility of occult LMS should be considered by women and their gynecologists, and proper informed consent, noting both the LMS risk and the increased risks of abdominal surgery, should be obtained.

Related article:
Tissue extraction: Can the pendulum change direction?

Risk of uterine rupture after laparoscopic myomectomy

After abdominal myomectomy, uterine rupture during pregnancy or delivery is rare, according to reviews of delivery records of many thousands of women.¹⁴ Operative techniques, instruments, and energy sources used during laparoscopic or robot-assisted myomectomy may differ from those used during laparotomy, and anecdotal communications suggest that uterine rupture may be more common after laparoscopic or robot-assisted myomectomy. A meta-analysis of 56 articles (3,685 pregnancies) published between 1970 and 2013 found 29 cases of uterine rupture after myomectomy, with no statistical difference in rupture risk between laparoscopic and abdominal myomectomy.¹⁵ As most reports are case studies or small case series, the incidence of rupture cannot be reliably calculated.

There is no consensus regarding the factors that may increase the risk of uterine rupture after laparoscopic myomectomy. Three factors are postulated to interfere with myometrial wound healing and increase uterine rupture risk: failure to adequately suture myometrial defects, excessive use of monopolar or bipolar electrosurgery with devascularization of the myometrium, and lack of hemostasis with subsequent hematoma formation.¹⁶ It seems prudent that surgeons should adhere to time-tested techniques for abdominal myomectomy. Even with use of ideal surgical techniques, however, individual wound-healing characteristics may predispose to uterine rupture.

CASE Resolved

After giving proper informed consent, the patient underwent laparoscopic myomectomy and electromechanical morcellation. Her 2 fibroids were removed, with a blood loss of 200 mL, and that afternoon she was discharged from the surgery center with written postoperative instructions and oral pain medication. A telephone call the next day found her comfortable, with no nausea or vomiting, and happy to be fibroid free. Pathologic inspection of the morcellated tissue confirmed that the fibroids were benign. At 2-week follow-up, the patient was no longer taking pain medication and was ready to return to work and normal activity. Her fatigue persisted, though, and she arranged to take time to rest during the day.

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

As it does annually, the Centers for Medicare & Medicaid Services (CMS) has announced changes to the resource-based relative value scale (RBRVS) physician payment system. This system is not static, and each year the CMS identifies codes to review that appear to be either overvalued or undervalued. While the CMS leads this process, the American Medical Association (AMA), working in conjunction with national medical specialty societies, provides annual recommended updates and changes to the CMS via its AMA/Specialty Society RVS Update Committee (RUC).

RVUs defined

Relative value units (RVUs), assigned to most codes found in the AMA’s Current Procedural Terminology (CPT) book, are calculated based on 3 elements: physician work, practice expense, and malpractice cost. For Medicare reimbursement purposes, these elements are adjusted by the current geographic index, and this adjusted RVU is then multiplied by the Medicare calculated annual conversion factor (in fiscal year 2017, that amount is $35.8887) to determine the final allowable for any given provider.

Commercial payers who use the RBRVS system for reimbursement usually calculate their own conversion factors, which they may or may not publish. Such calculation can be based on a percentage increase over the Medicare rate or other factors.

In-office hysteroscopy procedure reimbursement increases

This year, some notable increases and decreases in the practice expense element will impact payment to ObGyn practices. The best news is that for practices in which clinicians have been removing polyps or performing endometrial sampling or a full dilation and curettage (D & C) using a hysteroscope in the office, practice expense reimbursement now will improve dramatically. The practice expense RVU for CPT code 58558, Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy, with or without D & C, has been increased more than 450% in this setting, with an increase from 6.11 in 2016 to 33.82 as of January 2, 2017, which reduces to a 237% increase when the change to the total RVU is calculated.

More new-found income. The only other procedure showing at least a 10% increase in reimbursement in the office setting is the professional component for the ultrasonic guidance for aspiration of ova.

When your reimbursements will decrease

Unfortunately, reimbursement has also been decreased for some CPT code procedures. The urodynamic study code 51784, Electromyography studies (EMG) of anal or urethral sphincter, other than needle, any technique, has decreased in RVU value by about 64%. This is due to cutting by half the physician work, practice expense, and malpractice cost RVU elements. Although hit with a somewhat smaller decrease, code 58562, Hysteroscopy, surgical; with removal of impacted foreign body, also suffered a decrease in all 3 RVU elements in the office setting, amounting to about a 19% decrease.

In the facility setting, the RVU for the code for vaginoplasty has been increased by 10%, but 11 procedures have lost between 11% and 19% of their previous RVU levels in this setting, and more than half are for hysteroscopic procedures. The complete list of codes that have incurred at least a 10% RVU change in 2017 are listed in TABLES 1 and 2 according to place of service.

Related article:
GYN coding changes to note for your maximized reimbursement

What’s up next for review and possible adjustment

Finally, as a reminder to all providers, the CMS has identified 3 procedure codes that are potentially misvalued due to their being reported more than 50% of the time with an evaluation and management (E/M) service. These codes represent 0-day procedures and will be evaluated during 2017:

• 57150, Irrigation of vagina and/or application of medicament for treatment of bacterial, parasitic, or fungoid disease
• 57160, Fitting and insertion of pessary or other intravaginal support device
• 58100, Endometrial sampling (biopsy) with or without endocervical sampling (biopsy), without cervical dilation, any method (separate procedure).

The CMS has made it clear that all 0-day procedure codes include evaluation services on the date of service, including the decision to do the procedure. If the CMS examination of data finds that the documentation does not support a separate and significant E/M service at the time of the procedure, the agency will consider adjusting the physician work component. All providers should therefore examine their reporting of an E/M service with 0-day procedures to ensure that the documentation clearly supports doing so.

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

As it does annually, the Centers for Medicare & Medicaid Services (CMS) has announced changes to the resource-based relative value scale (RBRVS) physician payment system. This system is not static, and each year the CMS identifies codes to review that appear to be either overvalued or undervalued. While the CMS leads this process, the American Medical Association (AMA), working in conjunction with national medical specialty societies, provides annual recommended updates and changes to the CMS via its AMA/Specialty Society RVS Update Committee (RUC).

RVUs defined

Relative value units (RVUs), assigned to most codes found in the AMA’s Current Procedural Terminology (CPT) book, are calculated based on 3 elements: physician work, practice expense, and malpractice cost. For Medicare reimbursement purposes, these elements are adjusted by the current geographic index, and this adjusted RVU is then multiplied by the Medicare calculated annual conversion factor (in fiscal year 2017, that amount is $35.8887) to determine the final allowable for any given provider.

Commercial payers who use the RBRVS system for reimbursement usually calculate their own conversion factors, which they may or may not publish. Such calculation can be based on a percentage increase over the Medicare rate or other factors.

In-office hysteroscopy procedure reimbursement increases

This year, some notable increases and decreases in the practice expense element will impact payment to ObGyn practices. The best news is that for practices in which clinicians have been removing polyps or performing endometrial sampling or a full dilation and curettage (D & C) using a hysteroscope in the office, practice expense reimbursement now will improve dramatically. The practice expense RVU for CPT code 58558, Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy, with or without D & C, has been increased more than 450% in this setting, with an increase from 6.11 in 2016 to 33.82 as of January 2, 2017, which reduces to a 237% increase when the change to the total RVU is calculated.

More new-found income. The only other procedure showing at least a 10% increase in reimbursement in the office setting is the professional component for the ultrasonic guidance for aspiration of ova.

When your reimbursements will decrease

Unfortunately, reimbursement has also been decreased for some CPT code procedures. The urodynamic study code 51784, Electromyography studies (EMG) of anal or urethral sphincter, other than needle, any technique, has decreased in RVU value by about 64%. This is due to cutting by half the physician work, practice expense, and malpractice cost RVU elements. Although hit with a somewhat smaller decrease, code 58562, Hysteroscopy, surgical; with removal of impacted foreign body, also suffered a decrease in all 3 RVU elements in the office setting, amounting to about a 19% decrease.

In the facility setting, the RVU for the code for vaginoplasty has been increased by 10%, but 11 procedures have lost between 11% and 19% of their previous RVU levels in this setting, and more than half are for hysteroscopic procedures. The complete list of codes that have incurred at least a 10% RVU change in 2017 are listed in TABLES 1 and 2 according to place of service.

Related article:
GYN coding changes to note for your maximized reimbursement

What’s up next for review and possible adjustment

Finally, as a reminder to all providers, the CMS has identified 3 procedure codes that are potentially misvalued due to their being reported more than 50% of the time with an evaluation and management (E/M) service. These codes represent 0-day procedures and will be evaluated during 2017:

• 57150, Irrigation of vagina and/or application of medicament for treatment of bacterial, parasitic, or fungoid disease
• 57160, Fitting and insertion of pessary or other intravaginal support device
• 58100, Endometrial sampling (biopsy) with or without endocervical sampling (biopsy), without cervical dilation, any method (separate procedure).

The CMS has made it clear that all 0-day procedure codes include evaluation services on the date of service, including the decision to do the procedure. If the CMS examination of data finds that the documentation does not support a separate and significant E/M service at the time of the procedure, the agency will consider adjusting the physician work component. All providers should therefore examine their reporting of an E/M service with 0-day procedures to ensure that the documentation clearly supports doing so.

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

As it does annually, the Centers for Medicare & Medicaid Services (CMS) has announced changes to the resource-based relative value scale (RBRVS) physician payment system. This system is not static, and each year the CMS identifies codes to review that appear to be either overvalued or undervalued. While the CMS leads this process, the American Medical Association (AMA), working in conjunction with national medical specialty societies, provides annual recommended updates and changes to the CMS via its AMA/Specialty Society RVS Update Committee (RUC).

RVUs defined

Relative value units (RVUs), assigned to most codes found in the AMA’s Current Procedural Terminology (CPT) book, are calculated based on 3 elements: physician work, practice expense, and malpractice cost. For Medicare reimbursement purposes, these elements are adjusted by the current geographic index, and this adjusted RVU is then multiplied by the Medicare calculated annual conversion factor (in fiscal year 2017, that amount is $35.8887) to determine the final allowable for any given provider.

Commercial payers who use the RBRVS system for reimbursement usually calculate their own conversion factors, which they may or may not publish. Such calculation can be based on a percentage increase over the Medicare rate or other factors.

In-office hysteroscopy procedure reimbursement increases

This year, some notable increases and decreases in the practice expense element will impact payment to ObGyn practices. The best news is that for practices in which clinicians have been removing polyps or performing endometrial sampling or a full dilation and curettage (D & C) using a hysteroscope in the office, practice expense reimbursement now will improve dramatically. The practice expense RVU for CPT code 58558, Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy, with or without D & C, has been increased more than 450% in this setting, with an increase from 6.11 in 2016 to 33.82 as of January 2, 2017, which reduces to a 237% increase when the change to the total RVU is calculated.

More new-found income. The only other procedure showing at least a 10% increase in reimbursement in the office setting is the professional component for the ultrasonic guidance for aspiration of ova.

When your reimbursements will decrease

Unfortunately, reimbursement has also been decreased for some CPT code procedures. The urodynamic study code 51784, Electromyography studies (EMG) of anal or urethral sphincter, other than needle, any technique, has decreased in RVU value by about 64%. This is due to cutting by half the physician work, practice expense, and malpractice cost RVU elements. Although hit with a somewhat smaller decrease, code 58562, Hysteroscopy, surgical; with removal of impacted foreign body, also suffered a decrease in all 3 RVU elements in the office setting, amounting to about a 19% decrease.

In the facility setting, the RVU for the code for vaginoplasty has been increased by 10%, but 11 procedures have lost between 11% and 19% of their previous RVU levels in this setting, and more than half are for hysteroscopic procedures. The complete list of codes that have incurred at least a 10% RVU change in 2017 are listed in TABLES 1 and 2 according to place of service.

Related article:
GYN coding changes to note for your maximized reimbursement

What’s up next for review and possible adjustment

Finally, as a reminder to all providers, the CMS has identified 3 procedure codes that are potentially misvalued due to their being reported more than 50% of the time with an evaluation and management (E/M) service. These codes represent 0-day procedures and will be evaluated during 2017:

• 57150, Irrigation of vagina and/or application of medicament for treatment of bacterial, parasitic, or fungoid disease
• 57160, Fitting and insertion of pessary or other intravaginal support device
• 58100, Endometrial sampling (biopsy) with or without endocervical sampling (biopsy), without cervical dilation, any method (separate procedure).

The CMS has made it clear that all 0-day procedure codes include evaluation services on the date of service, including the decision to do the procedure. If the CMS examination of data finds that the documentation does not support a separate and significant E/M service at the time of the procedure, the agency will consider adjusting the physician work component. All providers should therefore examine their reporting of an E/M service with 0-day procedures to ensure that the documentation clearly supports doing so.

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

EXPERT COMMENTARY

The role of lymphadenectomy for endometrial cancer has evolved considerably over the last 30 years. While pathologic assessment of the nodes provides important information to tailor adjuvant therapy, 2 randomized trials both reported no survival benefit in women who underwent lymphadenectomy compared with hysterectomy alone.^1,2 Further, these trials revealed that lymphadenectomy was associated with significant short- and long-term sequelae.

SLN biopsy, a procedure in which a small number of nodes that represent the first drainage basins of a primary tumor are removed, has been proposed as an alternative to traditional lymphadenectomy. Although SLN biopsy is commonly used for other solid tumors, few large, multicenter studies have been conducted to evaluate the technique’s safety in endometrial cancer.

Related article:
2016 Update on cancer

Details of the study

The Fluorescence Imaging for Robotic Endometrial Sentinel lymph node biopsy (FIRES) trial was a prospective trial evaluating the performance characteristics of SLN biopsy in women with clinical stage 1 endometrial cancer at 10 sites in the United States. After cervical injection of indocyanine green, patients underwent robot-assisted hysterectomy with SLN biopsy followed by pelvic lymphadenectomy. Para-aortic lymphadenectomy was performed at the discretion of the attending surgeon. The study’s primary end point was sensitivity of SLN biopsy for detecting metastatic disease in women who had mapping.

Over approximately 3 years, 385 patients were enrolled. Overall, 86% of patients had mapping of at least 1 SLN and 52% had bilateral mapping. Positive nodes were found in 12% of the study population. Among women who had SLNs identified, 35 of 36 nodal metastases were identified (97% sensitivity). Negative SLNs correctly predicted the absence of metastases (negative predictive value) in 99.6% of patients.

Overall, the procedure was well tolerated. Adverse events were noted in 9% of patients, and approximately two-thirds were considered serious adverse events. The most common adverse events were neurologic complications, respiratory distress, nausea and vomiting, and bowel injury in 3 patients. One ureteral injury occurred during SLN biopsy.

Related article:
Does laparoscopic versus open abdominal surgery for stage I endometrial cancer affect oncologic outcomes?

Study strengths and weaknesses

The FIRES study provides strong evidence for the effectiveness of SLN biopsy in women with apparent early stage endometrial cancer. The procedure not only was highly accurate in identifying nodal disease but it also had acceptable adverse events. Further, many of the benefits of SLN biopsy, such as a reduction in lymphedema, will require long-term follow-up.

Consider study results in context. As oncologists consider the role of SLN biopsy in practice, this work should be interpreted in the context of the study design. The study was performed by only 18 surgeons at 10 centers. Prior to study initiation, each site and surgeon underwent formal training and observation to ensure that the technique for SLN biopsy was adequate. Clearly, there will be a learning curve for SLN biopsy, and this study’s results may not immediately be generalizable.

Despite rigorous quality control procedures, there was no nodal mapping in 48% of the hemi-pelvises. In practice, these patients require lymph node dissection. The authors estimated that 50% of patients would still require lymphadenectomy (40% unilateral, 10% bilateral) if SLN mapping was used in routine practice. In addition, while the FIRES trial included women with high-risk histologies, the majority of patients had low-risk, endometrioid tumors. Further study will help to define performance of SLN biopsy in populations at higher risk for nodal metastases.

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

EXPERT COMMENTARY

The role of lymphadenectomy for endometrial cancer has evolved considerably over the last 30 years. While pathologic assessment of the nodes provides important information to tailor adjuvant therapy, 2 randomized trials both reported no survival benefit in women who underwent lymphadenectomy compared with hysterectomy alone.^1,2 Further, these trials revealed that lymphadenectomy was associated with significant short- and long-term sequelae.

SLN biopsy, a procedure in which a small number of nodes that represent the first drainage basins of a primary tumor are removed, has been proposed as an alternative to traditional lymphadenectomy. Although SLN biopsy is commonly used for other solid tumors, few large, multicenter studies have been conducted to evaluate the technique’s safety in endometrial cancer.

Related article:
2016 Update on cancer

Details of the study

The Fluorescence Imaging for Robotic Endometrial Sentinel lymph node biopsy (FIRES) trial was a prospective trial evaluating the performance characteristics of SLN biopsy in women with clinical stage 1 endometrial cancer at 10 sites in the United States. After cervical injection of indocyanine green, patients underwent robot-assisted hysterectomy with SLN biopsy followed by pelvic lymphadenectomy. Para-aortic lymphadenectomy was performed at the discretion of the attending surgeon. The study’s primary end point was sensitivity of SLN biopsy for detecting metastatic disease in women who had mapping.

Over approximately 3 years, 385 patients were enrolled. Overall, 86% of patients had mapping of at least 1 SLN and 52% had bilateral mapping. Positive nodes were found in 12% of the study population. Among women who had SLNs identified, 35 of 36 nodal metastases were identified (97% sensitivity). Negative SLNs correctly predicted the absence of metastases (negative predictive value) in 99.6% of patients.

Overall, the procedure was well tolerated. Adverse events were noted in 9% of patients, and approximately two-thirds were considered serious adverse events. The most common adverse events were neurologic complications, respiratory distress, nausea and vomiting, and bowel injury in 3 patients. One ureteral injury occurred during SLN biopsy.

Related article:
Does laparoscopic versus open abdominal surgery for stage I endometrial cancer affect oncologic outcomes?

Study strengths and weaknesses

The FIRES study provides strong evidence for the effectiveness of SLN biopsy in women with apparent early stage endometrial cancer. The procedure not only was highly accurate in identifying nodal disease but it also had acceptable adverse events. Further, many of the benefits of SLN biopsy, such as a reduction in lymphedema, will require long-term follow-up.

Consider study results in context. As oncologists consider the role of SLN biopsy in practice, this work should be interpreted in the context of the study design. The study was performed by only 18 surgeons at 10 centers. Prior to study initiation, each site and surgeon underwent formal training and observation to ensure that the technique for SLN biopsy was adequate. Clearly, there will be a learning curve for SLN biopsy, and this study’s results may not immediately be generalizable.

Despite rigorous quality control procedures, there was no nodal mapping in 48% of the hemi-pelvises. In practice, these patients require lymph node dissection. The authors estimated that 50% of patients would still require lymphadenectomy (40% unilateral, 10% bilateral) if SLN mapping was used in routine practice. In addition, while the FIRES trial included women with high-risk histologies, the majority of patients had low-risk, endometrioid tumors. Further study will help to define performance of SLN biopsy in populations at higher risk for nodal metastases.

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

EXPERT COMMENTARY

The role of lymphadenectomy for endometrial cancer has evolved considerably over the last 30 years. While pathologic assessment of the nodes provides important information to tailor adjuvant therapy, 2 randomized trials both reported no survival benefit in women who underwent lymphadenectomy compared with hysterectomy alone.^1,2 Further, these trials revealed that lymphadenectomy was associated with significant short- and long-term sequelae.

SLN biopsy, a procedure in which a small number of nodes that represent the first drainage basins of a primary tumor are removed, has been proposed as an alternative to traditional lymphadenectomy. Although SLN biopsy is commonly used for other solid tumors, few large, multicenter studies have been conducted to evaluate the technique’s safety in endometrial cancer.

Related article:
2016 Update on cancer

Details of the study

The Fluorescence Imaging for Robotic Endometrial Sentinel lymph node biopsy (FIRES) trial was a prospective trial evaluating the performance characteristics of SLN biopsy in women with clinical stage 1 endometrial cancer at 10 sites in the United States. After cervical injection of indocyanine green, patients underwent robot-assisted hysterectomy with SLN biopsy followed by pelvic lymphadenectomy. Para-aortic lymphadenectomy was performed at the discretion of the attending surgeon. The study’s primary end point was sensitivity of SLN biopsy for detecting metastatic disease in women who had mapping.

Over approximately 3 years, 385 patients were enrolled. Overall, 86% of patients had mapping of at least 1 SLN and 52% had bilateral mapping. Positive nodes were found in 12% of the study population. Among women who had SLNs identified, 35 of 36 nodal metastases were identified (97% sensitivity). Negative SLNs correctly predicted the absence of metastases (negative predictive value) in 99.6% of patients.

Overall, the procedure was well tolerated. Adverse events were noted in 9% of patients, and approximately two-thirds were considered serious adverse events. The most common adverse events were neurologic complications, respiratory distress, nausea and vomiting, and bowel injury in 3 patients. One ureteral injury occurred during SLN biopsy.

Related article:
Does laparoscopic versus open abdominal surgery for stage I endometrial cancer affect oncologic outcomes?

Study strengths and weaknesses

The FIRES study provides strong evidence for the effectiveness of SLN biopsy in women with apparent early stage endometrial cancer. The procedure not only was highly accurate in identifying nodal disease but it also had acceptable adverse events. Further, many of the benefits of SLN biopsy, such as a reduction in lymphedema, will require long-term follow-up.

Consider study results in context. As oncologists consider the role of SLN biopsy in practice, this work should be interpreted in the context of the study design. The study was performed by only 18 surgeons at 10 centers. Prior to study initiation, each site and surgeon underwent formal training and observation to ensure that the technique for SLN biopsy was adequate. Clearly, there will be a learning curve for SLN biopsy, and this study’s results may not immediately be generalizable.

Despite rigorous quality control procedures, there was no nodal mapping in 48% of the hemi-pelvises. In practice, these patients require lymph node dissection. The authors estimated that 50% of patients would still require lymphadenectomy (40% unilateral, 10% bilateral) if SLN mapping was used in routine practice. In addition, while the FIRES trial included women with high-risk histologies, the majority of patients had low-risk, endometrioid tumors. Further study will help to define performance of SLN biopsy in populations at higher risk for nodal metastases.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Blood vessels injured during trocar insertion: $8.7M verdict

PATIENT’S CLAIM:

The resident was negligent in performing trocar insertion during laparoscopic surgery by inserting the trocar too far into the abdomen. The attending ObGyn did not supervise the resident properly. There is nothing in the patient's medical records to indicate that she had abnormal anatomy. The woman's life is in turmoil after what was supposed to be a routine procedure.

DEFENDANTS' DEFENSE:

There was no negligence. The patient's anatomy was abnormal, making the risk of surgery higher. The injury is a known complication of laparoscopic surgery.

VERDICT:

An $8,718,848 Illinois verdict was returned.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Wrong fallopian tube transected: $1.8M award

A 28-year-old woman underwent an appendectomy. During the operation, the surgeon saw an abscess on the patient's right fallopian tube and called in an ObGyn to remove the abscess. While doing so, the ObGyn transected the left fallopian tube. Both fallopian tubes were removed.

PATIENT’S CLAIM:

The surgeon did not tell the ObGyn which fallopian tube was abscessed and therefore the ObGyn operated on the wrong tube. In addition, the surgeon failed to obtain informed consent for bilateral salpingectomy. The patient is now unable to conceive without assisted reproductive treatment.

PHYSICIAN’S DEFENSE:

The surgeon admitted his mistakes but disputed the informed consent claim. The patient probably would not have been able to conceive naturally due to the infection.

VERDICT:

A $1.8 million Connecticut verdict was returned.

Related article:
Elective laparoscopic appendectomy in gynecologic surgery: When, why, and how

Complications after vaginal hysterectomy

A woman underwent laparoscopic vaginal hysterectomy and bilateral salpingo-oophorectomy with anterior and posterior repair using mesh in August 2010. Shortly after surgery, the patient reported vaginal discharge with pain and bleeding. She was treated with antibiotics. Results of a CT scan identified the cause of her symptoms as vaginal cuff granulations. 

Her pain continued and in June 2011, she underwent vaginal tissue biopsy. After testing revealed the presence of fecal matter, a small-bowel vaginal fistula was identified. She underwent laparoscopic enterectomy, urethral lysis, an omental pedicle flap, and cystoscopy. The mesh had perforated several loops of the small bowel.

In August 2011, the patient reported spinal pain. Magnetic resonance imaging (MRI) revealed a new fluid abscess in a disc extending through the tract anterior to the soft tissue of the pelvis. She underwent intensive antibiotic therapy. 

PATIENT’S CLAIM:

The gynecologic surgeon fell below the standard of care in his treatment of her conditions.

PHYSICIAN’S DEFENSE:

The surgeon denied allegations.

VERDICT:

A Nevada defense verdict was returned.

Related article:
Vaginal hysterectomy with basic instrumentation

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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

Blood vessels injured during trocar insertion: $8.7M verdict

PATIENT’S CLAIM:

The resident was negligent in performing trocar insertion during laparoscopic surgery by inserting the trocar too far into the abdomen. The attending ObGyn did not supervise the resident properly. There is nothing in the patient's medical records to indicate that she had abnormal anatomy. The woman's life is in turmoil after what was supposed to be a routine procedure.

DEFENDANTS' DEFENSE:

There was no negligence. The patient's anatomy was abnormal, making the risk of surgery higher. The injury is a known complication of laparoscopic surgery.

VERDICT:

An $8,718,848 Illinois verdict was returned.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Wrong fallopian tube transected: $1.8M award

A 28-year-old woman underwent an appendectomy. During the operation, the surgeon saw an abscess on the patient's right fallopian tube and called in an ObGyn to remove the abscess. While doing so, the ObGyn transected the left fallopian tube. Both fallopian tubes were removed.

PATIENT’S CLAIM:

The surgeon did not tell the ObGyn which fallopian tube was abscessed and therefore the ObGyn operated on the wrong tube. In addition, the surgeon failed to obtain informed consent for bilateral salpingectomy. The patient is now unable to conceive without assisted reproductive treatment.

PHYSICIAN’S DEFENSE:

The surgeon admitted his mistakes but disputed the informed consent claim. The patient probably would not have been able to conceive naturally due to the infection.

VERDICT:

A $1.8 million Connecticut verdict was returned.

Related article:
Elective laparoscopic appendectomy in gynecologic surgery: When, why, and how

Complications after vaginal hysterectomy

A woman underwent laparoscopic vaginal hysterectomy and bilateral salpingo-oophorectomy with anterior and posterior repair using mesh in August 2010. Shortly after surgery, the patient reported vaginal discharge with pain and bleeding. She was treated with antibiotics. Results of a CT scan identified the cause of her symptoms as vaginal cuff granulations. 

Her pain continued and in June 2011, she underwent vaginal tissue biopsy. After testing revealed the presence of fecal matter, a small-bowel vaginal fistula was identified. She underwent laparoscopic enterectomy, urethral lysis, an omental pedicle flap, and cystoscopy. The mesh had perforated several loops of the small bowel.

In August 2011, the patient reported spinal pain. Magnetic resonance imaging (MRI) revealed a new fluid abscess in a disc extending through the tract anterior to the soft tissue of the pelvis. She underwent intensive antibiotic therapy. 

PATIENT’S CLAIM:

The gynecologic surgeon fell below the standard of care in his treatment of her conditions.

PHYSICIAN’S DEFENSE:

The surgeon denied allegations.

VERDICT:

A Nevada defense verdict was returned.

Related article:
Vaginal hysterectomy with basic instrumentation

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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

Blood vessels injured during trocar insertion: $8.7M verdict

PATIENT’S CLAIM:

The resident was negligent in performing trocar insertion during laparoscopic surgery by inserting the trocar too far into the abdomen. The attending ObGyn did not supervise the resident properly. There is nothing in the patient's medical records to indicate that she had abnormal anatomy. The woman's life is in turmoil after what was supposed to be a routine procedure.

DEFENDANTS' DEFENSE:

There was no negligence. The patient's anatomy was abnormal, making the risk of surgery higher. The injury is a known complication of laparoscopic surgery.

VERDICT:

An $8,718,848 Illinois verdict was returned.

Related article:
How to avoid major vessel injury during gynecologic laparoscopy

Wrong fallopian tube transected: $1.8M award

A 28-year-old woman underwent an appendectomy. During the operation, the surgeon saw an abscess on the patient's right fallopian tube and called in an ObGyn to remove the abscess. While doing so, the ObGyn transected the left fallopian tube. Both fallopian tubes were removed.

PATIENT’S CLAIM:

The surgeon did not tell the ObGyn which fallopian tube was abscessed and therefore the ObGyn operated on the wrong tube. In addition, the surgeon failed to obtain informed consent for bilateral salpingectomy. The patient is now unable to conceive without assisted reproductive treatment.

PHYSICIAN’S DEFENSE:

The surgeon admitted his mistakes but disputed the informed consent claim. The patient probably would not have been able to conceive naturally due to the infection.

VERDICT:

A $1.8 million Connecticut verdict was returned.

Related article:
Elective laparoscopic appendectomy in gynecologic surgery: When, why, and how

Complications after vaginal hysterectomy

A woman underwent laparoscopic vaginal hysterectomy and bilateral salpingo-oophorectomy with anterior and posterior repair using mesh in August 2010. Shortly after surgery, the patient reported vaginal discharge with pain and bleeding. She was treated with antibiotics. Results of a CT scan identified the cause of her symptoms as vaginal cuff granulations. 

Her pain continued and in June 2011, she underwent vaginal tissue biopsy. After testing revealed the presence of fecal matter, a small-bowel vaginal fistula was identified. She underwent laparoscopic enterectomy, urethral lysis, an omental pedicle flap, and cystoscopy. The mesh had perforated several loops of the small bowel.

In August 2011, the patient reported spinal pain. Magnetic resonance imaging (MRI) revealed a new fluid abscess in a disc extending through the tract anterior to the soft tissue of the pelvis. She underwent intensive antibiotic therapy. 

PATIENT’S CLAIM:

The gynecologic surgeon fell below the standard of care in his treatment of her conditions.

PHYSICIAN’S DEFENSE:

The surgeon denied allegations.

VERDICT:

A Nevada defense verdict was returned.

Related article:
Vaginal hysterectomy with basic instrumentation

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

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

Read the accompanying article by Dr. Parker: “Laparoscopic myomectomy: Tips for patient selection and technique”

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

Read the accompanying article by Dr. Parker: “Laparoscopic myomectomy: Tips for patient selection and technique”

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

Read the accompanying article by Dr. Parker: “Laparoscopic myomectomy: Tips for patient selection and technique”

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