Theodore Bosworth

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr. Adam reported no relevant financial disclosures.

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

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

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

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

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

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

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

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

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

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

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

Dr. Adam reported no relevant financial disclosures.

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

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

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

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

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

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

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

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

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

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

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

Dr. Adam reported no relevant financial disclosures.

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

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

RTEmagicC_92a47a2_Morgan_Daniel_M_MICHIGAN.jpg.jpg

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

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

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

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

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

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

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

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

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

Dr. Morgan reported no relevant financial disclosures.

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

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

RTEmagicC_92a47a2_Morgan_Daniel_M_MICHIGAN.jpg.jpg

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

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

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

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

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

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

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

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

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

Dr. Morgan reported no relevant financial disclosures.

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

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

RTEmagicC_92a47a2_Morgan_Daniel_M_MICHIGAN.jpg.jpg

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

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

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

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

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

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

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

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

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

Dr. Morgan reported no relevant financial disclosures.

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

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

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

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

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

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

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

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

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

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

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

Dr. Natalie Karp reported no relevant financial disclosures.

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

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

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

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

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

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

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

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

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

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

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

Dr. Natalie Karp reported no relevant financial disclosures.

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

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

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

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

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

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

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

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

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

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

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

Dr. Natalie Karp reported no relevant financial disclosures.

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr. Carson reported no relevant financial disclosures

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr. Carson reported no relevant financial disclosures

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

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

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

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

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

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

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

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

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

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

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

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

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

Dr. Carson reported no relevant financial disclosures

ORLANDO – Women diagnosed with a gynecologic malignancy have a strong likelihood of presenting with a coexisting pelvic floor disorder, according to data collected prospectively from a cancer survivorship cohort.

Bladder symptoms on validated questionnaires completed soon after diagnosis and prior to surgical treatment were especially common, with an overall urinary incontinence rate of 46.1% and a stress incontinence (SUI) rate of 59.5%, Dr. C. Emi Bretschneider reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“We think increased awareness of pelvic health issues will allow for more individualized and comprehensive counseling and care of these women,” said Dr. Bretschneider of the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill.

She identified pelvic floor disorders as a major potential source of diminished quality of life in women with gynecologic malignancies.

Dr. C. Bryce Bowling, a urogynecologist at the University of Tennessee, Knoxville, agreed. Although he observed that the risk of both pelvic floor disorders and gynecologic malignancies increase with age, he said the reported rates at which they coexist is “sobering.”

“These are important data for those who are not already aware of this relationship,” Dr. Bowling, a discussant invited by the Society of Gynecologic Surgeons, said in an interview.

At many institutions, including his own, screening for pelvic floor disorders in women with gynecologic malignancies is already routine.

“Screening for incontinence is a very important consideration even for those with a poor prognosis,” he said. “Control of urinary symptoms over the course of the woman’s survival will have a very positive impact on quality of life.”

The data on pelvic floor disorders was drawn from 154 women with gynecologic cancers who completed baseline evaluations of bowel and bladder symptoms using two validated questionnaires in a recent 10-month period. Most (62%) had endometrial cancer, but other cancers, such as ovarian (17%) and cervical (11%) were represented. There were no significant differences in the rates of pelvic floor disorders among the cancer types.

In addition to the substantial rates of urinary incontinence and SUI, 40.8% of patients reported urinary incontinence with urgency and 21.5% reported nocturia most or every night. The rate of enuresis was 7.2%. In addition, 3.9% reported fecal incontinence.

Complaints of abdominal pain (46.8%), constipation (42.2%), and diarrhea (20.1%) were also common, Dr. Bretschneider reported at the meeting, jointly sponsored by the American College of Surgeons.

When women older than 50 years were compared to younger women, the rates of nearly every indicator of a pelvic floor disorder were higher. Most differences, such as overall urinary incontinence (P = .009), SUI (P = .005), and abdominal pain (P = .002) had a high degree of statistical significance. However, overall urinary incontinence and SUI were not significantly associated with age when modeled as a continuous variable.

Recognizing pelvic floor disorders at the time of the diagnosis of gynecologic malignancy can be relevant to planning cancer treatment, according to Dr. Bretschnieder. The study results highlight the need for a proactive approach that includes screening at the time of diagnosis, she said.

ORLANDO – Women diagnosed with a gynecologic malignancy have a strong likelihood of presenting with a coexisting pelvic floor disorder, according to data collected prospectively from a cancer survivorship cohort.

Bladder symptoms on validated questionnaires completed soon after diagnosis and prior to surgical treatment were especially common, with an overall urinary incontinence rate of 46.1% and a stress incontinence (SUI) rate of 59.5%, Dr. C. Emi Bretschneider reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“We think increased awareness of pelvic health issues will allow for more individualized and comprehensive counseling and care of these women,” said Dr. Bretschneider of the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill.

She identified pelvic floor disorders as a major potential source of diminished quality of life in women with gynecologic malignancies.

Dr. C. Bryce Bowling, a urogynecologist at the University of Tennessee, Knoxville, agreed. Although he observed that the risk of both pelvic floor disorders and gynecologic malignancies increase with age, he said the reported rates at which they coexist is “sobering.”

“These are important data for those who are not already aware of this relationship,” Dr. Bowling, a discussant invited by the Society of Gynecologic Surgeons, said in an interview.

At many institutions, including his own, screening for pelvic floor disorders in women with gynecologic malignancies is already routine.

“Screening for incontinence is a very important consideration even for those with a poor prognosis,” he said. “Control of urinary symptoms over the course of the woman’s survival will have a very positive impact on quality of life.”

The data on pelvic floor disorders was drawn from 154 women with gynecologic cancers who completed baseline evaluations of bowel and bladder symptoms using two validated questionnaires in a recent 10-month period. Most (62%) had endometrial cancer, but other cancers, such as ovarian (17%) and cervical (11%) were represented. There were no significant differences in the rates of pelvic floor disorders among the cancer types.

In addition to the substantial rates of urinary incontinence and SUI, 40.8% of patients reported urinary incontinence with urgency and 21.5% reported nocturia most or every night. The rate of enuresis was 7.2%. In addition, 3.9% reported fecal incontinence.

Complaints of abdominal pain (46.8%), constipation (42.2%), and diarrhea (20.1%) were also common, Dr. Bretschneider reported at the meeting, jointly sponsored by the American College of Surgeons.

When women older than 50 years were compared to younger women, the rates of nearly every indicator of a pelvic floor disorder were higher. Most differences, such as overall urinary incontinence (P = .009), SUI (P = .005), and abdominal pain (P = .002) had a high degree of statistical significance. However, overall urinary incontinence and SUI were not significantly associated with age when modeled as a continuous variable.

Recognizing pelvic floor disorders at the time of the diagnosis of gynecologic malignancy can be relevant to planning cancer treatment, according to Dr. Bretschnieder. The study results highlight the need for a proactive approach that includes screening at the time of diagnosis, she said.

ORLANDO – Women diagnosed with a gynecologic malignancy have a strong likelihood of presenting with a coexisting pelvic floor disorder, according to data collected prospectively from a cancer survivorship cohort.

Bladder symptoms on validated questionnaires completed soon after diagnosis and prior to surgical treatment were especially common, with an overall urinary incontinence rate of 46.1% and a stress incontinence (SUI) rate of 59.5%, Dr. C. Emi Bretschneider reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

“We think increased awareness of pelvic health issues will allow for more individualized and comprehensive counseling and care of these women,” said Dr. Bretschneider of the department of obstetrics and gynecology at the University of North Carolina, Chapel Hill.

She identified pelvic floor disorders as a major potential source of diminished quality of life in women with gynecologic malignancies.

Dr. C. Bryce Bowling, a urogynecologist at the University of Tennessee, Knoxville, agreed. Although he observed that the risk of both pelvic floor disorders and gynecologic malignancies increase with age, he said the reported rates at which they coexist is “sobering.”

“These are important data for those who are not already aware of this relationship,” Dr. Bowling, a discussant invited by the Society of Gynecologic Surgeons, said in an interview.

At many institutions, including his own, screening for pelvic floor disorders in women with gynecologic malignancies is already routine.

“Screening for incontinence is a very important consideration even for those with a poor prognosis,” he said. “Control of urinary symptoms over the course of the woman’s survival will have a very positive impact on quality of life.”

The data on pelvic floor disorders was drawn from 154 women with gynecologic cancers who completed baseline evaluations of bowel and bladder symptoms using two validated questionnaires in a recent 10-month period. Most (62%) had endometrial cancer, but other cancers, such as ovarian (17%) and cervical (11%) were represented. There were no significant differences in the rates of pelvic floor disorders among the cancer types.

In addition to the substantial rates of urinary incontinence and SUI, 40.8% of patients reported urinary incontinence with urgency and 21.5% reported nocturia most or every night. The rate of enuresis was 7.2%. In addition, 3.9% reported fecal incontinence.

Complaints of abdominal pain (46.8%), constipation (42.2%), and diarrhea (20.1%) were also common, Dr. Bretschneider reported at the meeting, jointly sponsored by the American College of Surgeons.

When women older than 50 years were compared to younger women, the rates of nearly every indicator of a pelvic floor disorder were higher. Most differences, such as overall urinary incontinence (P = .009), SUI (P = .005), and abdominal pain (P = .002) had a high degree of statistical significance. However, overall urinary incontinence and SUI were not significantly associated with age when modeled as a continuous variable.

Recognizing pelvic floor disorders at the time of the diagnosis of gynecologic malignancy can be relevant to planning cancer treatment, according to Dr. Bretschnieder. The study results highlight the need for a proactive approach that includes screening at the time of diagnosis, she said.

ORLANDO – A proprietary self-fixating polypropylene mesh system implanted with minimally invasive surgery provides a high rate of success against refractory fecal incontinence, according to data from a multicenter prospective trial.

Whether measured at 3, 6, or 12 months, approximately 65% of patients achieved treatment success, defined as at least a 50% reduction in episodes of fecal incontinence, Dr. Dee E. Fenner reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

RTEmagicC_075418c_Fenner_Dee_MICH.jpg.jpg

The mesh system, which remains in clinical development, is called TOPAS. It was evaluated in 152 patients enrolled at 14 centers in the United States. All patients had failed at least two conservative treatments, such as pelvic floor exercises with or without biofeedback. The average duration of fecal incontinence was 110 months.

From a baseline of nine episodes per week, the median number of episodes of fecal incontinence fell to 2.5 times per week after surgery. This did not change when evaluated at 3, 6, or 12 months. The median number of episodes with urgency decreased from two at baseline to zero. In 19% of patients, fecal incontinence remained completely resolved over the 12 months of follow-up, according to Dr. Fenner, the study’s lead investigator and director of gynecology at the University of Michigan, Ann Arbor.

The mean procedure time for the minimally invasive surgery required to create the tunnel adjacent to the anus in which the mesh system is placed was 33 minutes. The average length of stay in the hospital was 11 hours.

Of the 104 adverse events recorded in the study, 98 were not considered serious. These included pelvic pain that resolved without treatment and infections treated with antibiotics. The two serious adverse events with the greatest potential to be treatment related were a deep venous thrombosis (DVT) and a case of worsening prolapse. There were no revisions, extrusions, or treatment-related deaths, Dr. Fenner said.

Quality of life analyses measured with standardized questionnaires demonstrated significant improvements in domains for lifestyle, coping, depression, and embarrassment, Dr. Fenner reported at the meeting, which was jointly sponsored by the American College of Surgeons.

In a critique invited by the SGS, Dr. Holly E. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, called the evidence of benefit after 12 months of follow-up “credible.” She agreed with Dr. Fenner’s conclusion that this a promising surgical therapy for refractory patients.

“These results are very good for a difficult population, but I think it is important to first demonstrate that patients cannot achieve an adequate reduction in symptoms with nonsurgical approaches before this approach is considered,” Dr. Richter said in an interview.

The study had no control arm because there were no proven treatments for patients with refractory incontinence at the time of its design, according to Dr. Fenner. Several options, including sacral nerve stimulation, have since become available, she said.

The TOPASsystem is currently under review by the Food and Drug Administration. Dr. Fenner said that approval, if granted, might still be a year away.

Dr. Fenner reported receiving research support from American Medical Systems, which manufactures the TOPAS system.

ORLANDO – A proprietary self-fixating polypropylene mesh system implanted with minimally invasive surgery provides a high rate of success against refractory fecal incontinence, according to data from a multicenter prospective trial.

Whether measured at 3, 6, or 12 months, approximately 65% of patients achieved treatment success, defined as at least a 50% reduction in episodes of fecal incontinence, Dr. Dee E. Fenner reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

RTEmagicC_075418c_Fenner_Dee_MICH.jpg.jpg

The mesh system, which remains in clinical development, is called TOPAS. It was evaluated in 152 patients enrolled at 14 centers in the United States. All patients had failed at least two conservative treatments, such as pelvic floor exercises with or without biofeedback. The average duration of fecal incontinence was 110 months.

From a baseline of nine episodes per week, the median number of episodes of fecal incontinence fell to 2.5 times per week after surgery. This did not change when evaluated at 3, 6, or 12 months. The median number of episodes with urgency decreased from two at baseline to zero. In 19% of patients, fecal incontinence remained completely resolved over the 12 months of follow-up, according to Dr. Fenner, the study’s lead investigator and director of gynecology at the University of Michigan, Ann Arbor.

The mean procedure time for the minimally invasive surgery required to create the tunnel adjacent to the anus in which the mesh system is placed was 33 minutes. The average length of stay in the hospital was 11 hours.

Of the 104 adverse events recorded in the study, 98 were not considered serious. These included pelvic pain that resolved without treatment and infections treated with antibiotics. The two serious adverse events with the greatest potential to be treatment related were a deep venous thrombosis (DVT) and a case of worsening prolapse. There were no revisions, extrusions, or treatment-related deaths, Dr. Fenner said.

Quality of life analyses measured with standardized questionnaires demonstrated significant improvements in domains for lifestyle, coping, depression, and embarrassment, Dr. Fenner reported at the meeting, which was jointly sponsored by the American College of Surgeons.

In a critique invited by the SGS, Dr. Holly E. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, called the evidence of benefit after 12 months of follow-up “credible.” She agreed with Dr. Fenner’s conclusion that this a promising surgical therapy for refractory patients.

“These results are very good for a difficult population, but I think it is important to first demonstrate that patients cannot achieve an adequate reduction in symptoms with nonsurgical approaches before this approach is considered,” Dr. Richter said in an interview.

The study had no control arm because there were no proven treatments for patients with refractory incontinence at the time of its design, according to Dr. Fenner. Several options, including sacral nerve stimulation, have since become available, she said.

The TOPASsystem is currently under review by the Food and Drug Administration. Dr. Fenner said that approval, if granted, might still be a year away.

Dr. Fenner reported receiving research support from American Medical Systems, which manufactures the TOPAS system.

ORLANDO – A proprietary self-fixating polypropylene mesh system implanted with minimally invasive surgery provides a high rate of success against refractory fecal incontinence, according to data from a multicenter prospective trial.

Whether measured at 3, 6, or 12 months, approximately 65% of patients achieved treatment success, defined as at least a 50% reduction in episodes of fecal incontinence, Dr. Dee E. Fenner reported at the annual scientific meeting of the Society of Gynecologic Surgeons.

RTEmagicC_075418c_Fenner_Dee_MICH.jpg.jpg

The mesh system, which remains in clinical development, is called TOPAS. It was evaluated in 152 patients enrolled at 14 centers in the United States. All patients had failed at least two conservative treatments, such as pelvic floor exercises with or without biofeedback. The average duration of fecal incontinence was 110 months.

From a baseline of nine episodes per week, the median number of episodes of fecal incontinence fell to 2.5 times per week after surgery. This did not change when evaluated at 3, 6, or 12 months. The median number of episodes with urgency decreased from two at baseline to zero. In 19% of patients, fecal incontinence remained completely resolved over the 12 months of follow-up, according to Dr. Fenner, the study’s lead investigator and director of gynecology at the University of Michigan, Ann Arbor.

The mean procedure time for the minimally invasive surgery required to create the tunnel adjacent to the anus in which the mesh system is placed was 33 minutes. The average length of stay in the hospital was 11 hours.

Of the 104 adverse events recorded in the study, 98 were not considered serious. These included pelvic pain that resolved without treatment and infections treated with antibiotics. The two serious adverse events with the greatest potential to be treatment related were a deep venous thrombosis (DVT) and a case of worsening prolapse. There were no revisions, extrusions, or treatment-related deaths, Dr. Fenner said.

Quality of life analyses measured with standardized questionnaires demonstrated significant improvements in domains for lifestyle, coping, depression, and embarrassment, Dr. Fenner reported at the meeting, which was jointly sponsored by the American College of Surgeons.

In a critique invited by the SGS, Dr. Holly E. Richter, director of the division of urogynecology and pelvic reconstructive surgery at the University of Alabama at Birmingham, called the evidence of benefit after 12 months of follow-up “credible.” She agreed with Dr. Fenner’s conclusion that this a promising surgical therapy for refractory patients.

“These results are very good for a difficult population, but I think it is important to first demonstrate that patients cannot achieve an adequate reduction in symptoms with nonsurgical approaches before this approach is considered,” Dr. Richter said in an interview.

The study had no control arm because there were no proven treatments for patients with refractory incontinence at the time of its design, according to Dr. Fenner. Several options, including sacral nerve stimulation, have since become available, she said.

The TOPASsystem is currently under review by the Food and Drug Administration. Dr. Fenner said that approval, if granted, might still be a year away.

Dr. Fenner reported receiving research support from American Medical Systems, which manufactures the TOPAS system.

PHILADELPHIA – In long-term follow-up for the treatment of inflammatory bowel disease, the novel monoclonal antibody vedolizumab continues to remain free of serious infections or other signs of major complications from altered immune function, according to pooled data presented at the annual meeting of the American College of Gastroenterology.

Over the course of follow-up, which now extends to 104 weeks in these trials, called GEMINI 1 and GEMINI 2, overall infection rates have been about the same in the vedolizumab and placebo arms even when corticosteroids or immunosuppressive agents are used concurrently, according to Dr. Edward V. Loftus Jr., professor of medicine at the Mayo Clinic, Rochester, Minn.

RTEmagicC_260342b_Loftus_Edward_V_MN2.jpg.jpg

There is particular focus on the safety of vedolizumab, because of the theoretical risks of biologics overall and vedolizumab specifically. Vedolizumab has been shown to provide sustained remissions relative to placebo in both Crohn’s disease and ulcerative colitis in the previously presented and updated GEMINI trials, but this agent, like other biologics, alters mediators of immune function.

The follow-up summarized at the ACG meeting, which evaluated risk of adverse events of vedolizumab alone or in combination with other inflammatory bowel disease (IBD) agents that affect immune function, suggests that the risk of adverse events is low, but the conclusion is not definitive.

“There was not a signal of more side effects with combination therapy, which is reassuring. However, the study is limited by the number of adverse events available to analyze,” said Dr. David T. Rubin, section chief of gastroenterology, hepatology, and nutrition at the University of Chicago. The likelihood of a high risk of adverse events is diminishing as follow-up and patient sample size increase, but Dr. Rubin suggested that clinicians should monitor any IBD patient taking an immunosuppressive agent for infectious complications.

“At the University of Chicago IBD Center, we have now treated more than 100 patients and are studying this therapy to better understand its performance in postmarket,” Dr. Rubin said in an interview. “So far, we have made similar observations to the clinical trials and to those made by Dr. Loftus here at the ACG.”

Unlike tumor necrosis factor (TNF) inhibitors, which were the first biologics to be licensed for use in IBD, vedolizumab inhibits the migration of leukocytes in the GI tract by preventing the alpha₄beta₇ subunit from binding to the adhesion molecule MAdCAM-1. It has been unclear whether or to what degree vedolizumab shares the known risk, albeit small, of inducing opportunistic infections observed with TNF inhibitors.

The most recent data continue to suggest that there is no greater risk of infection or other complications of immune function for vedolizumab than other biologics, and the risk may be lower. In the pooled GEMINI data with 1,434 patients followed during induction and maintenance phases with data in some groups out to 104 weeks, the overall percentages of infection and the individual infections rates have been “similar,” Dr. Loftus reported.

“The exception has been nasopharyngitis, which was less common in the placebo group,” said Dr. Loftus, providing relative rates of approximately 13% and 9% for vedolizumab and placebo, respectively. He noted, however, that the length of follow-up has been longer in the vedolizumab relative to the placebo groups. Rates of tuberculosis, Clostridium difficile colitis, and other serious infections have not differed significantly.

In addition, there has been no association between vedolizumab and progressive multifocal leukoencephalopathy (PML) so far. Concern about a risk for PML was raised by the relationship of vedolizumab to natalizumab, which blocks the same adhesion compounds and has been associated with PML. The absence of PML in follow-up so far is consistent with evidence that the activity of vedolizumab, unlike the activity of natalizumab, is largely or entirely confined to the GI tract.

No multicenter, randomized trials have yet to be conducted comparing either the efficacy or safety of vedolizumab, which was approved in May 2014 for the treatment of moderate to severe Crohn’s disease and ulcerative colitis, to other biologics used in IBD.

PHILADELPHIA – In long-term follow-up for the treatment of inflammatory bowel disease, the novel monoclonal antibody vedolizumab continues to remain free of serious infections or other signs of major complications from altered immune function, according to pooled data presented at the annual meeting of the American College of Gastroenterology.

Over the course of follow-up, which now extends to 104 weeks in these trials, called GEMINI 1 and GEMINI 2, overall infection rates have been about the same in the vedolizumab and placebo arms even when corticosteroids or immunosuppressive agents are used concurrently, according to Dr. Edward V. Loftus Jr., professor of medicine at the Mayo Clinic, Rochester, Minn.

RTEmagicC_260342b_Loftus_Edward_V_MN2.jpg.jpg

There is particular focus on the safety of vedolizumab, because of the theoretical risks of biologics overall and vedolizumab specifically. Vedolizumab has been shown to provide sustained remissions relative to placebo in both Crohn’s disease and ulcerative colitis in the previously presented and updated GEMINI trials, but this agent, like other biologics, alters mediators of immune function.

The follow-up summarized at the ACG meeting, which evaluated risk of adverse events of vedolizumab alone or in combination with other inflammatory bowel disease (IBD) agents that affect immune function, suggests that the risk of adverse events is low, but the conclusion is not definitive.

“There was not a signal of more side effects with combination therapy, which is reassuring. However, the study is limited by the number of adverse events available to analyze,” said Dr. David T. Rubin, section chief of gastroenterology, hepatology, and nutrition at the University of Chicago. The likelihood of a high risk of adverse events is diminishing as follow-up and patient sample size increase, but Dr. Rubin suggested that clinicians should monitor any IBD patient taking an immunosuppressive agent for infectious complications.

“At the University of Chicago IBD Center, we have now treated more than 100 patients and are studying this therapy to better understand its performance in postmarket,” Dr. Rubin said in an interview. “So far, we have made similar observations to the clinical trials and to those made by Dr. Loftus here at the ACG.”

Unlike tumor necrosis factor (TNF) inhibitors, which were the first biologics to be licensed for use in IBD, vedolizumab inhibits the migration of leukocytes in the GI tract by preventing the alpha₄beta₇ subunit from binding to the adhesion molecule MAdCAM-1. It has been unclear whether or to what degree vedolizumab shares the known risk, albeit small, of inducing opportunistic infections observed with TNF inhibitors.

The most recent data continue to suggest that there is no greater risk of infection or other complications of immune function for vedolizumab than other biologics, and the risk may be lower. In the pooled GEMINI data with 1,434 patients followed during induction and maintenance phases with data in some groups out to 104 weeks, the overall percentages of infection and the individual infections rates have been “similar,” Dr. Loftus reported.

“The exception has been nasopharyngitis, which was less common in the placebo group,” said Dr. Loftus, providing relative rates of approximately 13% and 9% for vedolizumab and placebo, respectively. He noted, however, that the length of follow-up has been longer in the vedolizumab relative to the placebo groups. Rates of tuberculosis, Clostridium difficile colitis, and other serious infections have not differed significantly.

In addition, there has been no association between vedolizumab and progressive multifocal leukoencephalopathy (PML) so far. Concern about a risk for PML was raised by the relationship of vedolizumab to natalizumab, which blocks the same adhesion compounds and has been associated with PML. The absence of PML in follow-up so far is consistent with evidence that the activity of vedolizumab, unlike the activity of natalizumab, is largely or entirely confined to the GI tract.

No multicenter, randomized trials have yet to be conducted comparing either the efficacy or safety of vedolizumab, which was approved in May 2014 for the treatment of moderate to severe Crohn’s disease and ulcerative colitis, to other biologics used in IBD.

PHILADELPHIA – In long-term follow-up for the treatment of inflammatory bowel disease, the novel monoclonal antibody vedolizumab continues to remain free of serious infections or other signs of major complications from altered immune function, according to pooled data presented at the annual meeting of the American College of Gastroenterology.

Over the course of follow-up, which now extends to 104 weeks in these trials, called GEMINI 1 and GEMINI 2, overall infection rates have been about the same in the vedolizumab and placebo arms even when corticosteroids or immunosuppressive agents are used concurrently, according to Dr. Edward V. Loftus Jr., professor of medicine at the Mayo Clinic, Rochester, Minn.

RTEmagicC_260342b_Loftus_Edward_V_MN2.jpg.jpg

There is particular focus on the safety of vedolizumab, because of the theoretical risks of biologics overall and vedolizumab specifically. Vedolizumab has been shown to provide sustained remissions relative to placebo in both Crohn’s disease and ulcerative colitis in the previously presented and updated GEMINI trials, but this agent, like other biologics, alters mediators of immune function.

The follow-up summarized at the ACG meeting, which evaluated risk of adverse events of vedolizumab alone or in combination with other inflammatory bowel disease (IBD) agents that affect immune function, suggests that the risk of adverse events is low, but the conclusion is not definitive.

“There was not a signal of more side effects with combination therapy, which is reassuring. However, the study is limited by the number of adverse events available to analyze,” said Dr. David T. Rubin, section chief of gastroenterology, hepatology, and nutrition at the University of Chicago. The likelihood of a high risk of adverse events is diminishing as follow-up and patient sample size increase, but Dr. Rubin suggested that clinicians should monitor any IBD patient taking an immunosuppressive agent for infectious complications.

“At the University of Chicago IBD Center, we have now treated more than 100 patients and are studying this therapy to better understand its performance in postmarket,” Dr. Rubin said in an interview. “So far, we have made similar observations to the clinical trials and to those made by Dr. Loftus here at the ACG.”

Unlike tumor necrosis factor (TNF) inhibitors, which were the first biologics to be licensed for use in IBD, vedolizumab inhibits the migration of leukocytes in the GI tract by preventing the alpha₄beta₇ subunit from binding to the adhesion molecule MAdCAM-1. It has been unclear whether or to what degree vedolizumab shares the known risk, albeit small, of inducing opportunistic infections observed with TNF inhibitors.

The most recent data continue to suggest that there is no greater risk of infection or other complications of immune function for vedolizumab than other biologics, and the risk may be lower. In the pooled GEMINI data with 1,434 patients followed during induction and maintenance phases with data in some groups out to 104 weeks, the overall percentages of infection and the individual infections rates have been “similar,” Dr. Loftus reported.

“The exception has been nasopharyngitis, which was less common in the placebo group,” said Dr. Loftus, providing relative rates of approximately 13% and 9% for vedolizumab and placebo, respectively. He noted, however, that the length of follow-up has been longer in the vedolizumab relative to the placebo groups. Rates of tuberculosis, Clostridium difficile colitis, and other serious infections have not differed significantly.

In addition, there has been no association between vedolizumab and progressive multifocal leukoencephalopathy (PML) so far. Concern about a risk for PML was raised by the relationship of vedolizumab to natalizumab, which blocks the same adhesion compounds and has been associated with PML. The absence of PML in follow-up so far is consistent with evidence that the activity of vedolizumab, unlike the activity of natalizumab, is largely or entirely confined to the GI tract.

No multicenter, randomized trials have yet to be conducted comparing either the efficacy or safety of vedolizumab, which was approved in May 2014 for the treatment of moderate to severe Crohn’s disease and ulcerative colitis, to other biologics used in IBD.

PHILADELPHIA – The first trial conducted in gastroesophageal reflux diseases that employed control of regurgitation as a primary endpoint found a significant advantage for transoral fundoplication over a sham procedure, according to the results presented at the American College of Gastroenterology (ACG).

On the basis of these results “TF [transoral fundoplication] should be considered in GERD [gastroesophageal reflux disease] patients with small or absent hiatal hernia who suffer from troublesome regurgitation despite PPI therapy,” reported Dr. Peter J. Kahrilas, the Gilbert H. Marquardt Professor of Medicine, a professor of medicine, gastroenterology, and hepatology, at Northwestern University, Chicago*.

RTEmagicC_95633ca_Kahrilas_Peter_J.jpg.jpg

The focus on regurgitation in this trial was partially driven by the lack of previous evidence for an effective therapy. In those trials that have included change in regurgitation among secondary endpoints, Dr. Kahrilas said control on this symptom has typically been “significantly less” than that observed with heartburn.

In this study, called RESPECT, 129 patients were randomized in a 2:1 ratio to TF performed with the Esophyx device or to a sham procedure. Both groups were initiated on a standard dose of proton pump inhibitors (PPIs), but PPIs were discontinued in the TF arm 2 weeks after the procedure. In the sham group, an increase in PPI dose was permitted at the 2-week and 12-week assessments in those not already at the maximum double the standard dose limit.

The primary endpoint was elimination of troublesome regurgitation based on the regurgitation-related fields from the Reflux Disease Questionnaire (RDQ), which is a validated tool for GERD assessment. On this basis, symptoms at the final 26-week assessment had resolved in 67% of patients randomized to TF and 25% (P = .023) randomized to the sham procedure. Early failure rates were also significantly lower in the TF group (11% vs. 36%; P = .002).

Intraesophageal acid levels assessed with 48-hour pH monitoring at the end of the study “were improved but not normalized in the TF group and unchanged in the sham group,” Dr. Kahrilas reported.

Adverse events, although more common in the TF group, were infrequent in both arms, and none were serious. Summarizing risk of adverse events, Dr. Kahrilas said, “TF appears safe without typical fundoplication side effects.”

The specific mechanism of benefit for controlling regurgitation has not been defined, but Dr. Kahrilas suggested, “We think we are restricting the volume of reflux.”

Regurgitation is “the ignored symptom of GERD,” according to Dr. Kahrilas. Although this symptom can be significant to patients, clinicians have had limited treatment options.

This point was emphasized by Dr. Nicholas Shaheen, director, Center for Esophageal Diseases and Swallowing, University of North Carolina, Chapel Hill. In an interview, Dr. Shaheen said effective therapy for regurgitation is an unmet need.

“Patients with predominant regurgitation are not uncommon and PPIs do appear to be less effective for this symptom,” Dr. Shaheen reported. “Having a treatment option with efficacy specific for this symptom could be helpful.”

Dr. Peter Kahrilas has numerous financial relationships with pharmaceutical companies including EndoGastric, the sponsor of this trial.

*Correction, 10/27/2014: An earlier version of this article misstated Dr. Kahrilas' position.

PHILADELPHIA – The first trial conducted in gastroesophageal reflux diseases that employed control of regurgitation as a primary endpoint found a significant advantage for transoral fundoplication over a sham procedure, according to the results presented at the American College of Gastroenterology (ACG).

On the basis of these results “TF [transoral fundoplication] should be considered in GERD [gastroesophageal reflux disease] patients with small or absent hiatal hernia who suffer from troublesome regurgitation despite PPI therapy,” reported Dr. Peter J. Kahrilas, the Gilbert H. Marquardt Professor of Medicine, a professor of medicine, gastroenterology, and hepatology, at Northwestern University, Chicago*.

RTEmagicC_95633ca_Kahrilas_Peter_J.jpg.jpg

The focus on regurgitation in this trial was partially driven by the lack of previous evidence for an effective therapy. In those trials that have included change in regurgitation among secondary endpoints, Dr. Kahrilas said control on this symptom has typically been “significantly less” than that observed with heartburn.

In this study, called RESPECT, 129 patients were randomized in a 2:1 ratio to TF performed with the Esophyx device or to a sham procedure. Both groups were initiated on a standard dose of proton pump inhibitors (PPIs), but PPIs were discontinued in the TF arm 2 weeks after the procedure. In the sham group, an increase in PPI dose was permitted at the 2-week and 12-week assessments in those not already at the maximum double the standard dose limit.

The primary endpoint was elimination of troublesome regurgitation based on the regurgitation-related fields from the Reflux Disease Questionnaire (RDQ), which is a validated tool for GERD assessment. On this basis, symptoms at the final 26-week assessment had resolved in 67% of patients randomized to TF and 25% (P = .023) randomized to the sham procedure. Early failure rates were also significantly lower in the TF group (11% vs. 36%; P = .002).

Intraesophageal acid levels assessed with 48-hour pH monitoring at the end of the study “were improved but not normalized in the TF group and unchanged in the sham group,” Dr. Kahrilas reported.

Adverse events, although more common in the TF group, were infrequent in both arms, and none were serious. Summarizing risk of adverse events, Dr. Kahrilas said, “TF appears safe without typical fundoplication side effects.”

The specific mechanism of benefit for controlling regurgitation has not been defined, but Dr. Kahrilas suggested, “We think we are restricting the volume of reflux.”

Regurgitation is “the ignored symptom of GERD,” according to Dr. Kahrilas. Although this symptom can be significant to patients, clinicians have had limited treatment options.

This point was emphasized by Dr. Nicholas Shaheen, director, Center for Esophageal Diseases and Swallowing, University of North Carolina, Chapel Hill. In an interview, Dr. Shaheen said effective therapy for regurgitation is an unmet need.

“Patients with predominant regurgitation are not uncommon and PPIs do appear to be less effective for this symptom,” Dr. Shaheen reported. “Having a treatment option with efficacy specific for this symptom could be helpful.”

Dr. Peter Kahrilas has numerous financial relationships with pharmaceutical companies including EndoGastric, the sponsor of this trial.

*Correction, 10/27/2014: An earlier version of this article misstated Dr. Kahrilas' position.

PHILADELPHIA – The first trial conducted in gastroesophageal reflux diseases that employed control of regurgitation as a primary endpoint found a significant advantage for transoral fundoplication over a sham procedure, according to the results presented at the American College of Gastroenterology (ACG).

On the basis of these results “TF [transoral fundoplication] should be considered in GERD [gastroesophageal reflux disease] patients with small or absent hiatal hernia who suffer from troublesome regurgitation despite PPI therapy,” reported Dr. Peter J. Kahrilas, the Gilbert H. Marquardt Professor of Medicine, a professor of medicine, gastroenterology, and hepatology, at Northwestern University, Chicago*.

RTEmagicC_95633ca_Kahrilas_Peter_J.jpg.jpg

The focus on regurgitation in this trial was partially driven by the lack of previous evidence for an effective therapy. In those trials that have included change in regurgitation among secondary endpoints, Dr. Kahrilas said control on this symptom has typically been “significantly less” than that observed with heartburn.

In this study, called RESPECT, 129 patients were randomized in a 2:1 ratio to TF performed with the Esophyx device or to a sham procedure. Both groups were initiated on a standard dose of proton pump inhibitors (PPIs), but PPIs were discontinued in the TF arm 2 weeks after the procedure. In the sham group, an increase in PPI dose was permitted at the 2-week and 12-week assessments in those not already at the maximum double the standard dose limit.

The primary endpoint was elimination of troublesome regurgitation based on the regurgitation-related fields from the Reflux Disease Questionnaire (RDQ), which is a validated tool for GERD assessment. On this basis, symptoms at the final 26-week assessment had resolved in 67% of patients randomized to TF and 25% (P = .023) randomized to the sham procedure. Early failure rates were also significantly lower in the TF group (11% vs. 36%; P = .002).

Intraesophageal acid levels assessed with 48-hour pH monitoring at the end of the study “were improved but not normalized in the TF group and unchanged in the sham group,” Dr. Kahrilas reported.

Adverse events, although more common in the TF group, were infrequent in both arms, and none were serious. Summarizing risk of adverse events, Dr. Kahrilas said, “TF appears safe without typical fundoplication side effects.”

The specific mechanism of benefit for controlling regurgitation has not been defined, but Dr. Kahrilas suggested, “We think we are restricting the volume of reflux.”

Regurgitation is “the ignored symptom of GERD,” according to Dr. Kahrilas. Although this symptom can be significant to patients, clinicians have had limited treatment options.

This point was emphasized by Dr. Nicholas Shaheen, director, Center for Esophageal Diseases and Swallowing, University of North Carolina, Chapel Hill. In an interview, Dr. Shaheen said effective therapy for regurgitation is an unmet need.

“Patients with predominant regurgitation are not uncommon and PPIs do appear to be less effective for this symptom,” Dr. Shaheen reported. “Having a treatment option with efficacy specific for this symptom could be helpful.”

Dr. Peter Kahrilas has numerous financial relationships with pharmaceutical companies including EndoGastric, the sponsor of this trial.

*Correction, 10/27/2014: An earlier version of this article misstated Dr. Kahrilas' position.

PHILADELPHIA – A registry created by the National Institutes of Health (NIH) to track idiosyncratic drug-induced liver injury (DILI) largely confirms the significant risks suggested by small studies and textbook summaries, according to newly summarized data presented at the American College of Gastroenterology (ACG).

According to the registry, antimicrobials dominate cases of DILI, a substantial minority of DILI patients die of this complication or require liver transplant, and the risks of adverse outcomes from DILI are far greater in the presence of hepatitis or another preexisting liver disease, reported Dr. Naga P. Chalasani, chief of the division of gastroenterology and hepatology, Indiana University school of medicine, Indianapolis.

RTEmagicC_f93135e_Chalasani_Naga_P_IN.jpg.jpg

Since 2004, when the Drug Induced Liver Injury Network was established by the NIH, 1,257 patients have been enrolled of which 899 were found to have probable, highly likely, or definite DILI by an adjudication committee charged with determining causality. The mortality rate overall was 6.2% with an additional 4% undergoing liver transplant.

The most commonly implicated causal agents by class were antimicrobials (45.4%), herbal and dietary supplements (16.1%), cardiovascular agents (9.7%), and CNS agents (9.1%) with a wide variety of other classes falling in at much lower representation. Nine of the top 10 individual agents implicated in DILI (amoxicillin-clavulanate led the list) were antimicrobials. The exception — and in the 10^th spot — was diclofenac.

“What may be of interest to the clinician is how long it takes on average to recover,” Dr. Chalasani observed. For those who present with jaundice, which represented about 70% of patients in the registry, the average was about 70 days. This information may be useful “if a patient asks you how long I am going to be yellow.”

Characterizing DILI as hepatocellular, cholestatic, or mixed may have value in assessing risk. According to Dr. Chalasani, the rates of DILI-related death were higher in cholestatic than hepatocellular presentations, but the risk of liver transplant was lower. In the mixed group, liver-related death was uncommon, and there were no liver transplants even though these patients more often developed chronic DILI.

The average time from exposure to DILI in drugs with a short latency was 36 days. Drugs with a long latency, defined as more than 1 year, included nitrofurantoin, statins, amiodarone, and mercaptopurine.

“The pattern of long latency is very interesting. Patients are often on a stable dose of a given drug for a length of time and doing well and then the dose is escalated and, boom, they present with DILI,” Dr. Chalasani reported.

Despite the hypothesis that there might be differences in characteristics and outcomes from long versus short latencies, none were seen.

Stevens-Johnson Syndrome (SJS) was observed in about 1% of the DILI patients in the registry. Antimicrobials were again implicated in patients who developed SJS, but the list of most common drugs in this subset also included lamotrigine and carbamazepine.

Patients with preexisting liver disease, such as a form of hepatitis or nonalcoholic fatty liver disease, represented 10% of the registry population. The causative agents were similar with the exception of azathioprine, which appeared to impose an even greater risk in those with liver disease than in those without.

“Although it has been written in the textbooks, this is the first set of data to show DILI in patients with preexisting liver disease imposes a three times higher likelihood of death than in those without liver disease,” Dr. Chalasani reported.

DILI is a rare disease, occurring in only about 20/100,000 patients. As a result, the NIH registry is considered an essential tool for gathering data on this complication in order to assess its causes and prognosis.

Dr. Chalasani reports that he and his coauthors have multiple financial relationships with industry but none that are relevant to this study.

PHILADELPHIA – A registry created by the National Institutes of Health (NIH) to track idiosyncratic drug-induced liver injury (DILI) largely confirms the significant risks suggested by small studies and textbook summaries, according to newly summarized data presented at the American College of Gastroenterology (ACG).

According to the registry, antimicrobials dominate cases of DILI, a substantial minority of DILI patients die of this complication or require liver transplant, and the risks of adverse outcomes from DILI are far greater in the presence of hepatitis or another preexisting liver disease, reported Dr. Naga P. Chalasani, chief of the division of gastroenterology and hepatology, Indiana University school of medicine, Indianapolis.

RTEmagicC_f93135e_Chalasani_Naga_P_IN.jpg.jpg

Since 2004, when the Drug Induced Liver Injury Network was established by the NIH, 1,257 patients have been enrolled of which 899 were found to have probable, highly likely, or definite DILI by an adjudication committee charged with determining causality. The mortality rate overall was 6.2% with an additional 4% undergoing liver transplant.

The most commonly implicated causal agents by class were antimicrobials (45.4%), herbal and dietary supplements (16.1%), cardiovascular agents (9.7%), and CNS agents (9.1%) with a wide variety of other classes falling in at much lower representation. Nine of the top 10 individual agents implicated in DILI (amoxicillin-clavulanate led the list) were antimicrobials. The exception — and in the 10^th spot — was diclofenac.

“What may be of interest to the clinician is how long it takes on average to recover,” Dr. Chalasani observed. For those who present with jaundice, which represented about 70% of patients in the registry, the average was about 70 days. This information may be useful “if a patient asks you how long I am going to be yellow.”

Characterizing DILI as hepatocellular, cholestatic, or mixed may have value in assessing risk. According to Dr. Chalasani, the rates of DILI-related death were higher in cholestatic than hepatocellular presentations, but the risk of liver transplant was lower. In the mixed group, liver-related death was uncommon, and there were no liver transplants even though these patients more often developed chronic DILI.

The average time from exposure to DILI in drugs with a short latency was 36 days. Drugs with a long latency, defined as more than 1 year, included nitrofurantoin, statins, amiodarone, and mercaptopurine.

“The pattern of long latency is very interesting. Patients are often on a stable dose of a given drug for a length of time and doing well and then the dose is escalated and, boom, they present with DILI,” Dr. Chalasani reported.

Despite the hypothesis that there might be differences in characteristics and outcomes from long versus short latencies, none were seen.

Stevens-Johnson Syndrome (SJS) was observed in about 1% of the DILI patients in the registry. Antimicrobials were again implicated in patients who developed SJS, but the list of most common drugs in this subset also included lamotrigine and carbamazepine.

Patients with preexisting liver disease, such as a form of hepatitis or nonalcoholic fatty liver disease, represented 10% of the registry population. The causative agents were similar with the exception of azathioprine, which appeared to impose an even greater risk in those with liver disease than in those without.

“Although it has been written in the textbooks, this is the first set of data to show DILI in patients with preexisting liver disease imposes a three times higher likelihood of death than in those without liver disease,” Dr. Chalasani reported.

DILI is a rare disease, occurring in only about 20/100,000 patients. As a result, the NIH registry is considered an essential tool for gathering data on this complication in order to assess its causes and prognosis.

Dr. Chalasani reports that he and his coauthors have multiple financial relationships with industry but none that are relevant to this study.

PHILADELPHIA – A registry created by the National Institutes of Health (NIH) to track idiosyncratic drug-induced liver injury (DILI) largely confirms the significant risks suggested by small studies and textbook summaries, according to newly summarized data presented at the American College of Gastroenterology (ACG).

According to the registry, antimicrobials dominate cases of DILI, a substantial minority of DILI patients die of this complication or require liver transplant, and the risks of adverse outcomes from DILI are far greater in the presence of hepatitis or another preexisting liver disease, reported Dr. Naga P. Chalasani, chief of the division of gastroenterology and hepatology, Indiana University school of medicine, Indianapolis.

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Since 2004, when the Drug Induced Liver Injury Network was established by the NIH, 1,257 patients have been enrolled of which 899 were found to have probable, highly likely, or definite DILI by an adjudication committee charged with determining causality. The mortality rate overall was 6.2% with an additional 4% undergoing liver transplant.

The most commonly implicated causal agents by class were antimicrobials (45.4%), herbal and dietary supplements (16.1%), cardiovascular agents (9.7%), and CNS agents (9.1%) with a wide variety of other classes falling in at much lower representation. Nine of the top 10 individual agents implicated in DILI (amoxicillin-clavulanate led the list) were antimicrobials. The exception — and in the 10^th spot — was diclofenac.

“What may be of interest to the clinician is how long it takes on average to recover,” Dr. Chalasani observed. For those who present with jaundice, which represented about 70% of patients in the registry, the average was about 70 days. This information may be useful “if a patient asks you how long I am going to be yellow.”

Characterizing DILI as hepatocellular, cholestatic, or mixed may have value in assessing risk. According to Dr. Chalasani, the rates of DILI-related death were higher in cholestatic than hepatocellular presentations, but the risk of liver transplant was lower. In the mixed group, liver-related death was uncommon, and there were no liver transplants even though these patients more often developed chronic DILI.

The average time from exposure to DILI in drugs with a short latency was 36 days. Drugs with a long latency, defined as more than 1 year, included nitrofurantoin, statins, amiodarone, and mercaptopurine.

“The pattern of long latency is very interesting. Patients are often on a stable dose of a given drug for a length of time and doing well and then the dose is escalated and, boom, they present with DILI,” Dr. Chalasani reported.

Despite the hypothesis that there might be differences in characteristics and outcomes from long versus short latencies, none were seen.

Stevens-Johnson Syndrome (SJS) was observed in about 1% of the DILI patients in the registry. Antimicrobials were again implicated in patients who developed SJS, but the list of most common drugs in this subset also included lamotrigine and carbamazepine.

Patients with preexisting liver disease, such as a form of hepatitis or nonalcoholic fatty liver disease, represented 10% of the registry population. The causative agents were similar with the exception of azathioprine, which appeared to impose an even greater risk in those with liver disease than in those without.

“Although it has been written in the textbooks, this is the first set of data to show DILI in patients with preexisting liver disease imposes a three times higher likelihood of death than in those without liver disease,” Dr. Chalasani reported.

DILI is a rare disease, occurring in only about 20/100,000 patients. As a result, the NIH registry is considered an essential tool for gathering data on this complication in order to assess its causes and prognosis.

Dr. Chalasani reports that he and his coauthors have multiple financial relationships with industry but none that are relevant to this study.