ACS Surgery News

The November issue of ACS Surgery News is available online – use the mobile app to download or view as a pdf.

This month’s issue features study results on the likely future of robot-assisted surgery, an update on the CMS 2016 fee schedule, and some unexpected outcomes from laparoscopic lavage for perforated diverticulitis.

Don’t miss part 2 of Dr. Joseph Sakran’s popular column on negotiating contracts in the medical context.

The November issue of ACS Surgery News is available online – use the mobile app to download or view as a pdf.

This month’s issue features study results on the likely future of robot-assisted surgery, an update on the CMS 2016 fee schedule, and some unexpected outcomes from laparoscopic lavage for perforated diverticulitis.

Don’t miss part 2 of Dr. Joseph Sakran’s popular column on negotiating contracts in the medical context.

The November issue of ACS Surgery News is available online – use the mobile app to download or view as a pdf.

This month’s issue features study results on the likely future of robot-assisted surgery, an update on the CMS 2016 fee schedule, and some unexpected outcomes from laparoscopic lavage for perforated diverticulitis.

Don’t miss part 2 of Dr. Joseph Sakran’s popular column on negotiating contracts in the medical context.

The rate of avoidable complications affecting patients in hospitals leveled off in 2014 after 3 years of declines, according to a federal report released Dec. 1.

Hospitals have averted many types of injuries where clear preventive steps have been identified, but they still struggle to avert complications with broader causes and less clear-cut solutions, government and hospital officials said.

There were at least 4 million infections and other potentially avoidable injuries in hospitals last year, the study estimated. That translates to about 12 of every 100 hospital stays. Among the most common complications that were measured – each occurring a quarter million times or more – were bed sores, falls, bad reactions to drugs used to treat diabetes, and kidney damage that develops after contrast dyes are injected through catheters to help radiologists take images of blood vessels.

The frequency of hospital complications last year was 17% lower than in 2010 but the same as in 2013, indicating that some patient safety improvements made by hospitals and the government are sticking. But the lack of improvement raised concerns that it is becoming harder for hospitals to further reduce the chances that a patient may be harmed during a visit.

“We are still trying to understand all the factors involved, but I think the improvements we saw from 2010 to 2013 were very likely the low-hanging fruit, the easy problems to solve,” said Dr. Richard Kronick, director of the U.S. Agency for Healthcare Research and Quality (AHRQ), which conducted the study.

The Obama administration has been focusing on lowering the rates of medical infections and injuries as it tracks a slew of patient safety initiatives created by the Affordable Care Act. Those include Medicare penalties for poor-performing hospitals, wider use of electronic records to help track patient care and prevent mistakes, and grants to collaborations of medical providers formed to improve the quality of patient care and identify the best ways of addressing each type of problem.

The AHRQ report calculated national rates for 27 specific complications by extrapolating from 30,000 medical cases that officials examined. Decreases in infections, medicine reactions, and other complications since 2010 have resulted in 2.1 million fewer incidents of harm, 87,000 fewer deaths, and $20 billion in health care savings, the report concluded.

“Those are real people that are not dying, getting infections or other adverse events in the hospital,” said Dr. Patrick Conway, chief medical officer for the Centers for Medicare & Medicaid Services.

Some of the most significant progress was made in lowering the number of infections from central lines inserted into veins – down 72% from 2010. Medical researchers have proven that these infections can be virtually eliminated if doctors and nurses follow a clear set of procedures.

Infections from urinary catheters decreased by 38% and surgical site infections dropped by 18%. In all three cases, the reductions exceeded the goals set by the administration. Dr. Conway noted that hospitals had a financial motivation to cut these infections as they are used to determine whether hospitals get Medicare bonuses and penalties each year.

However, hospitals have not made headway in trimming the numbers of falls or pneumonia cases in patients breathing through mechanical ventilators, the report found. And the rates of adverse drug reactions and complications during childbirth were higher than what the administration estimated they should be for 2014.

Dr. Conway said that complications are difficult to address because they involve tradeoffs that can cause other problems. For instance, he said, hospitals have to balance efforts to reduce falls with the need to help unstable patients improve their ability to walk. “We’ve got to work with providers to figure out what’s the sweet spot that can keep mobilization occurring but decrease the rate of falls,” he said.

Even though overall complication rates were flat, the report found that some types of injuries became less common in 2014. One was the number of blood clots that form after surgery and travel to the lung; those rates dropped by 30% in a year.

Maulik Joshi, an executive at the American Hospital Association, predicted that complications will become even rarer in future years. “Hospitals are working on projects that are just not reflected in these data points,” he said.

But a few conditions became more prevalent in 2014. Infections from methicillin-resistant Staphylococcus aureus increased by 55% to an estimated 17,000 incidents last year. The number of times a catheter punctured a femoral artery during an angiography increased by 25% to 74,000, the report estimated.

“We think we addressed a lot of the areas where there was a strong evidence base on how to improve patient safety,” Dr. Conway said. “We’ll now have to tackle that next wave that has multiple causes.”

The rate of avoidable complications affecting patients in hospitals leveled off in 2014 after 3 years of declines, according to a federal report released Dec. 1.

Hospitals have averted many types of injuries where clear preventive steps have been identified, but they still struggle to avert complications with broader causes and less clear-cut solutions, government and hospital officials said.

There were at least 4 million infections and other potentially avoidable injuries in hospitals last year, the study estimated. That translates to about 12 of every 100 hospital stays. Among the most common complications that were measured – each occurring a quarter million times or more – were bed sores, falls, bad reactions to drugs used to treat diabetes, and kidney damage that develops after contrast dyes are injected through catheters to help radiologists take images of blood vessels.

The frequency of hospital complications last year was 17% lower than in 2010 but the same as in 2013, indicating that some patient safety improvements made by hospitals and the government are sticking. But the lack of improvement raised concerns that it is becoming harder for hospitals to further reduce the chances that a patient may be harmed during a visit.

“We are still trying to understand all the factors involved, but I think the improvements we saw from 2010 to 2013 were very likely the low-hanging fruit, the easy problems to solve,” said Dr. Richard Kronick, director of the U.S. Agency for Healthcare Research and Quality (AHRQ), which conducted the study.

The Obama administration has been focusing on lowering the rates of medical infections and injuries as it tracks a slew of patient safety initiatives created by the Affordable Care Act. Those include Medicare penalties for poor-performing hospitals, wider use of electronic records to help track patient care and prevent mistakes, and grants to collaborations of medical providers formed to improve the quality of patient care and identify the best ways of addressing each type of problem.

The AHRQ report calculated national rates for 27 specific complications by extrapolating from 30,000 medical cases that officials examined. Decreases in infections, medicine reactions, and other complications since 2010 have resulted in 2.1 million fewer incidents of harm, 87,000 fewer deaths, and $20 billion in health care savings, the report concluded.

“Those are real people that are not dying, getting infections or other adverse events in the hospital,” said Dr. Patrick Conway, chief medical officer for the Centers for Medicare & Medicaid Services.

Some of the most significant progress was made in lowering the number of infections from central lines inserted into veins – down 72% from 2010. Medical researchers have proven that these infections can be virtually eliminated if doctors and nurses follow a clear set of procedures.

Infections from urinary catheters decreased by 38% and surgical site infections dropped by 18%. In all three cases, the reductions exceeded the goals set by the administration. Dr. Conway noted that hospitals had a financial motivation to cut these infections as they are used to determine whether hospitals get Medicare bonuses and penalties each year.

However, hospitals have not made headway in trimming the numbers of falls or pneumonia cases in patients breathing through mechanical ventilators, the report found. And the rates of adverse drug reactions and complications during childbirth were higher than what the administration estimated they should be for 2014.

Dr. Conway said that complications are difficult to address because they involve tradeoffs that can cause other problems. For instance, he said, hospitals have to balance efforts to reduce falls with the need to help unstable patients improve their ability to walk. “We’ve got to work with providers to figure out what’s the sweet spot that can keep mobilization occurring but decrease the rate of falls,” he said.

Even though overall complication rates were flat, the report found that some types of injuries became less common in 2014. One was the number of blood clots that form after surgery and travel to the lung; those rates dropped by 30% in a year.

Maulik Joshi, an executive at the American Hospital Association, predicted that complications will become even rarer in future years. “Hospitals are working on projects that are just not reflected in these data points,” he said.

But a few conditions became more prevalent in 2014. Infections from methicillin-resistant Staphylococcus aureus increased by 55% to an estimated 17,000 incidents last year. The number of times a catheter punctured a femoral artery during an angiography increased by 25% to 74,000, the report estimated.

“We think we addressed a lot of the areas where there was a strong evidence base on how to improve patient safety,” Dr. Conway said. “We’ll now have to tackle that next wave that has multiple causes.”

The rate of avoidable complications affecting patients in hospitals leveled off in 2014 after 3 years of declines, according to a federal report released Dec. 1.

Hospitals have averted many types of injuries where clear preventive steps have been identified, but they still struggle to avert complications with broader causes and less clear-cut solutions, government and hospital officials said.

There were at least 4 million infections and other potentially avoidable injuries in hospitals last year, the study estimated. That translates to about 12 of every 100 hospital stays. Among the most common complications that were measured – each occurring a quarter million times or more – were bed sores, falls, bad reactions to drugs used to treat diabetes, and kidney damage that develops after contrast dyes are injected through catheters to help radiologists take images of blood vessels.

The frequency of hospital complications last year was 17% lower than in 2010 but the same as in 2013, indicating that some patient safety improvements made by hospitals and the government are sticking. But the lack of improvement raised concerns that it is becoming harder for hospitals to further reduce the chances that a patient may be harmed during a visit.

“We are still trying to understand all the factors involved, but I think the improvements we saw from 2010 to 2013 were very likely the low-hanging fruit, the easy problems to solve,” said Dr. Richard Kronick, director of the U.S. Agency for Healthcare Research and Quality (AHRQ), which conducted the study.

The Obama administration has been focusing on lowering the rates of medical infections and injuries as it tracks a slew of patient safety initiatives created by the Affordable Care Act. Those include Medicare penalties for poor-performing hospitals, wider use of electronic records to help track patient care and prevent mistakes, and grants to collaborations of medical providers formed to improve the quality of patient care and identify the best ways of addressing each type of problem.

The AHRQ report calculated national rates for 27 specific complications by extrapolating from 30,000 medical cases that officials examined. Decreases in infections, medicine reactions, and other complications since 2010 have resulted in 2.1 million fewer incidents of harm, 87,000 fewer deaths, and $20 billion in health care savings, the report concluded.

“Those are real people that are not dying, getting infections or other adverse events in the hospital,” said Dr. Patrick Conway, chief medical officer for the Centers for Medicare & Medicaid Services.

Some of the most significant progress was made in lowering the number of infections from central lines inserted into veins – down 72% from 2010. Medical researchers have proven that these infections can be virtually eliminated if doctors and nurses follow a clear set of procedures.

Infections from urinary catheters decreased by 38% and surgical site infections dropped by 18%. In all three cases, the reductions exceeded the goals set by the administration. Dr. Conway noted that hospitals had a financial motivation to cut these infections as they are used to determine whether hospitals get Medicare bonuses and penalties each year.

However, hospitals have not made headway in trimming the numbers of falls or pneumonia cases in patients breathing through mechanical ventilators, the report found. And the rates of adverse drug reactions and complications during childbirth were higher than what the administration estimated they should be for 2014.

Dr. Conway said that complications are difficult to address because they involve tradeoffs that can cause other problems. For instance, he said, hospitals have to balance efforts to reduce falls with the need to help unstable patients improve their ability to walk. “We’ve got to work with providers to figure out what’s the sweet spot that can keep mobilization occurring but decrease the rate of falls,” he said.

Even though overall complication rates were flat, the report found that some types of injuries became less common in 2014. One was the number of blood clots that form after surgery and travel to the lung; those rates dropped by 30% in a year.

Maulik Joshi, an executive at the American Hospital Association, predicted that complications will become even rarer in future years. “Hospitals are working on projects that are just not reflected in these data points,” he said.

But a few conditions became more prevalent in 2014. Infections from methicillin-resistant Staphylococcus aureus increased by 55% to an estimated 17,000 incidents last year. The number of times a catheter punctured a femoral artery during an angiography increased by 25% to 74,000, the report estimated.

“We think we addressed a lot of the areas where there was a strong evidence base on how to improve patient safety,” Dr. Conway said. “We’ll now have to tackle that next wave that has multiple causes.”

Countries with a cesarean delivery rate as high as 19% have lower maternal and neonatal mortality, compared with countries that have higher c-section rates, according to a report published online Dec. 1 in JAMA.

The findings suggest that the current World Health Organization (WHO) recommendation that national rates of cesarean delivery shouldn’t exceed 10%-15% of live births may be setting the target rate too low, according to Dr. George Molina of Ariadne Labs at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, Boston, and his associates.

“The WHO recommendation that population level cesarean delivery rates should not exceed 10%-15% was a consensus opinion based on the observation that some countries with the lowest perinatal mortality rates had cesarean delivery rates that were less than 10/100 live births,” the researchers wrote. “Prior studies suggesting that lower cesarean delivery rate thresholds were optimal for maternal and neonatal mortality were incomplete because they examined data from limited sets of countries and often examined outcomes in wealthier countries.”

Martin Valigursky/Thinkstock.com

The researchers estimated that globally, the number of cesarean deliveries was 22.9 million in 2012 for a global cesarean delivery rate of 19.4/100 live births.

Cesarean delivery rates of up to 19.1/100 live births were inversely correlated with the maternal mortality ratio at the country level, and cesarean delivery rates of up to 19.4/100 live births were inversely correlated with the neonatal mortality ratio.

Dr. Molina and his colleagues analyzed the most recent information concerning modes of delivery, per capita health expenditures, life expectancy, and numerous other related factors using several multinational health databases. The goal was to estimate national rates of cesarean delivery and relate those figures to maternal and neonatal mortality for as many countries as possible, focusing on the most recent single year (2012) for which adequate data were available.

A sensitivity analysis of the 76 countries with the highest-quality cesarean delivery rate information showed that cesarean delivery rates greater than 6.9 to 20.1 per 100 live births were inversely correlated with the maternal mortality ratio. Cesarean delivery rates of 12.6 to 24.0 per 100 live births were inversely correlated with neonatal mortality (JAMA. 2015 Dec 1;314[21]:2263-70. doi: 10.1001/jama.2015.15553).

The researchers noted that they focused solely on mortality and did not assess other health outcomes. This means that they could not address the many possible benefits of cesarean delivery, such as reduced morbidity from complicated vaginal delivery or from prolonged obstructed labor.

In a separate report, a different research group found that children born by planned cesarean delivery, as compared with vaginal delivery, had a slightly increased risk of asthma requiring hospital admission, of needing a prescription for a salbutamol inhaler at age 5 years, and of all-cause mortality by age 21 years.

Dr. Mairead Blackof the University of Aberdeen (England) and her associates examined the relationship between planned cesarean delivery and chronic illness and death among the offspring. They assessed outcomes in 321,287 singleton live births to first-time mothers that occurred in Scotland in 1993-2007; the children were followed until January 2015, for a mean follow-up of 14.8 years.

In this cohort, 12,355 children (3.8%) were born by planned cesarean delivery, 56,015 (17.5%) by unscheduled cesarean, and 252,917 (78.7%) by vaginal delivery.

Children born by planned C-sections were slightly, but significantly more likely than were those born vaginally to develop asthma requiring hospital admission (3.73% vs. 3.41%; hazard ratio, 1.22).

Compared with children delivered vaginally, those delivered by planned cesarean section also were slightly, but significantly more likely to require a prescription for a salbutamol inhaler at age 5 years (10.34% vs. 9.62%; HR, 1.13) and to die before the age of 21 years(0.40% vs. 0.32%; HR, 1.41).

However, there were no significant differences between the two study groups in risk of developing inflammatory bowel disease (0.11% vs. 0.13%) or cancer (0.23% vs 0.21%), they noted (JAMA. 2015 Dec 1;314[21]:2271-9. doi: 10.1001/jama.2015.16176).

These findings “suggest that avoidance of vaginal birth may be an important early-life factor in the growing global burden of asthma, although absolute increase in risk to individuals is low,” Dr. Black and her associates wrote.

The researchers in both studies reported having no relevant financial disclosures. Dr. Black’s study was supported in part by the Wellcome Trust. 

Countries with a cesarean delivery rate as high as 19% have lower maternal and neonatal mortality, compared with countries that have higher c-section rates, according to a report published online Dec. 1 in JAMA.

The findings suggest that the current World Health Organization (WHO) recommendation that national rates of cesarean delivery shouldn’t exceed 10%-15% of live births may be setting the target rate too low, according to Dr. George Molina of Ariadne Labs at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, Boston, and his associates.

“The WHO recommendation that population level cesarean delivery rates should not exceed 10%-15% was a consensus opinion based on the observation that some countries with the lowest perinatal mortality rates had cesarean delivery rates that were less than 10/100 live births,” the researchers wrote. “Prior studies suggesting that lower cesarean delivery rate thresholds were optimal for maternal and neonatal mortality were incomplete because they examined data from limited sets of countries and often examined outcomes in wealthier countries.”

Martin Valigursky/Thinkstock.com

The researchers estimated that globally, the number of cesarean deliveries was 22.9 million in 2012 for a global cesarean delivery rate of 19.4/100 live births.

Cesarean delivery rates of up to 19.1/100 live births were inversely correlated with the maternal mortality ratio at the country level, and cesarean delivery rates of up to 19.4/100 live births were inversely correlated with the neonatal mortality ratio.

Dr. Molina and his colleagues analyzed the most recent information concerning modes of delivery, per capita health expenditures, life expectancy, and numerous other related factors using several multinational health databases. The goal was to estimate national rates of cesarean delivery and relate those figures to maternal and neonatal mortality for as many countries as possible, focusing on the most recent single year (2012) for which adequate data were available.

A sensitivity analysis of the 76 countries with the highest-quality cesarean delivery rate information showed that cesarean delivery rates greater than 6.9 to 20.1 per 100 live births were inversely correlated with the maternal mortality ratio. Cesarean delivery rates of 12.6 to 24.0 per 100 live births were inversely correlated with neonatal mortality (JAMA. 2015 Dec 1;314[21]:2263-70. doi: 10.1001/jama.2015.15553).

The researchers noted that they focused solely on mortality and did not assess other health outcomes. This means that they could not address the many possible benefits of cesarean delivery, such as reduced morbidity from complicated vaginal delivery or from prolonged obstructed labor.

In a separate report, a different research group found that children born by planned cesarean delivery, as compared with vaginal delivery, had a slightly increased risk of asthma requiring hospital admission, of needing a prescription for a salbutamol inhaler at age 5 years, and of all-cause mortality by age 21 years.

Dr. Mairead Blackof the University of Aberdeen (England) and her associates examined the relationship between planned cesarean delivery and chronic illness and death among the offspring. They assessed outcomes in 321,287 singleton live births to first-time mothers that occurred in Scotland in 1993-2007; the children were followed until January 2015, for a mean follow-up of 14.8 years.

In this cohort, 12,355 children (3.8%) were born by planned cesarean delivery, 56,015 (17.5%) by unscheduled cesarean, and 252,917 (78.7%) by vaginal delivery.

Children born by planned C-sections were slightly, but significantly more likely than were those born vaginally to develop asthma requiring hospital admission (3.73% vs. 3.41%; hazard ratio, 1.22).

Compared with children delivered vaginally, those delivered by planned cesarean section also were slightly, but significantly more likely to require a prescription for a salbutamol inhaler at age 5 years (10.34% vs. 9.62%; HR, 1.13) and to die before the age of 21 years(0.40% vs. 0.32%; HR, 1.41).

However, there were no significant differences between the two study groups in risk of developing inflammatory bowel disease (0.11% vs. 0.13%) or cancer (0.23% vs 0.21%), they noted (JAMA. 2015 Dec 1;314[21]:2271-9. doi: 10.1001/jama.2015.16176).

These findings “suggest that avoidance of vaginal birth may be an important early-life factor in the growing global burden of asthma, although absolute increase in risk to individuals is low,” Dr. Black and her associates wrote.

The researchers in both studies reported having no relevant financial disclosures. Dr. Black’s study was supported in part by the Wellcome Trust. 

Countries with a cesarean delivery rate as high as 19% have lower maternal and neonatal mortality, compared with countries that have higher c-section rates, according to a report published online Dec. 1 in JAMA.

The findings suggest that the current World Health Organization (WHO) recommendation that national rates of cesarean delivery shouldn’t exceed 10%-15% of live births may be setting the target rate too low, according to Dr. George Molina of Ariadne Labs at Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, Boston, and his associates.

“The WHO recommendation that population level cesarean delivery rates should not exceed 10%-15% was a consensus opinion based on the observation that some countries with the lowest perinatal mortality rates had cesarean delivery rates that were less than 10/100 live births,” the researchers wrote. “Prior studies suggesting that lower cesarean delivery rate thresholds were optimal for maternal and neonatal mortality were incomplete because they examined data from limited sets of countries and often examined outcomes in wealthier countries.”

Martin Valigursky/Thinkstock.com

The researchers estimated that globally, the number of cesarean deliveries was 22.9 million in 2012 for a global cesarean delivery rate of 19.4/100 live births.

Cesarean delivery rates of up to 19.1/100 live births were inversely correlated with the maternal mortality ratio at the country level, and cesarean delivery rates of up to 19.4/100 live births were inversely correlated with the neonatal mortality ratio.

Dr. Molina and his colleagues analyzed the most recent information concerning modes of delivery, per capita health expenditures, life expectancy, and numerous other related factors using several multinational health databases. The goal was to estimate national rates of cesarean delivery and relate those figures to maternal and neonatal mortality for as many countries as possible, focusing on the most recent single year (2012) for which adequate data were available.

A sensitivity analysis of the 76 countries with the highest-quality cesarean delivery rate information showed that cesarean delivery rates greater than 6.9 to 20.1 per 100 live births were inversely correlated with the maternal mortality ratio. Cesarean delivery rates of 12.6 to 24.0 per 100 live births were inversely correlated with neonatal mortality (JAMA. 2015 Dec 1;314[21]:2263-70. doi: 10.1001/jama.2015.15553).

The researchers noted that they focused solely on mortality and did not assess other health outcomes. This means that they could not address the many possible benefits of cesarean delivery, such as reduced morbidity from complicated vaginal delivery or from prolonged obstructed labor.

In a separate report, a different research group found that children born by planned cesarean delivery, as compared with vaginal delivery, had a slightly increased risk of asthma requiring hospital admission, of needing a prescription for a salbutamol inhaler at age 5 years, and of all-cause mortality by age 21 years.

Dr. Mairead Blackof the University of Aberdeen (England) and her associates examined the relationship between planned cesarean delivery and chronic illness and death among the offspring. They assessed outcomes in 321,287 singleton live births to first-time mothers that occurred in Scotland in 1993-2007; the children were followed until January 2015, for a mean follow-up of 14.8 years.

In this cohort, 12,355 children (3.8%) were born by planned cesarean delivery, 56,015 (17.5%) by unscheduled cesarean, and 252,917 (78.7%) by vaginal delivery.

Children born by planned C-sections were slightly, but significantly more likely than were those born vaginally to develop asthma requiring hospital admission (3.73% vs. 3.41%; hazard ratio, 1.22).

Compared with children delivered vaginally, those delivered by planned cesarean section also were slightly, but significantly more likely to require a prescription for a salbutamol inhaler at age 5 years (10.34% vs. 9.62%; HR, 1.13) and to die before the age of 21 years(0.40% vs. 0.32%; HR, 1.41).

However, there were no significant differences between the two study groups in risk of developing inflammatory bowel disease (0.11% vs. 0.13%) or cancer (0.23% vs 0.21%), they noted (JAMA. 2015 Dec 1;314[21]:2271-9. doi: 10.1001/jama.2015.16176).

These findings “suggest that avoidance of vaginal birth may be an important early-life factor in the growing global burden of asthma, although absolute increase in risk to individuals is low,” Dr. Black and her associates wrote.

The researchers in both studies reported having no relevant financial disclosures. Dr. Black’s study was supported in part by the Wellcome Trust. 

LAS VEGAS – Adhesion barriers may cause more problems than they prevent when employed in myomectomy and hysterectomy.

Ileus, fever, hematomas, and even small bowel obstruction occurred significantly more often when the barriers were used in conjunction with those procedures – especially when performed as open surgeries, Dr. François Closon reported at the AAGL Global Congress. And although their use remains relatively small among these patients, it’s been steadily rising since 2003, he said.

“Adhesion barriers are also being used about eight times more often in myomectomies than in hysterectomies, and this seems to be going up every year,” Dr. Closon of McGill University, Montreal, said at the meeting sponsored by AAGL.

His retrospective study drew on the U.S. Healthcare Cost and Utilization Project Nationwide Inpatient Sample, and examined the perioperative outcomes of adhesion barriers among nearly 475,000 women who underwent myomectomy or hysterectomy during 2003-2011. Of these, 9,000 (about 2%) had an adhesion barrier applied during the surgery. There were no significant baseline differences between the groups, except for age. Women in the myomectomy group were younger than those in the hysterectomy group (mean 36 years vs. 46 years). Age, however, was not associated with the use of an adhesion barrier.

Dr. Closon found a significant linear increase in the use of barriers in both procedures over the study period. In hysterectomy, barrier use rose slightly, but significantly, from 0.37% in 2003 to 2% in 2011. The increase was much greater for use in myomectomy, which rose from 3% to 7% during the same period.

Ileus was significantly more common among myomectomies that used the barrier (4% vs. 3%; OR, 1.49). The difference was more pronounced with hysterectomies (5% vs. 2.5%; OR, 1.97).

Small bowel obstruction was rare, but significantly more common in hysterectomies that employed adhesion barriers (0.2% vs. 0.4%; OR, 1.89).

Fever was also significantly more common in both procedures when the barrier was used (myomectomy 4.4% vs. 3%; OR, 1.43; hysterectomy 2.5% vs. 1.6%; OR, 1.65).

“The odds of intra-abdominal hematoma, postoperative pain, and a length of stay of 3 or more days were also significantly higher when an adhesion barrier was applied,” Dr. Closon said.

He reported having no financial disclosures.

msullivan@frontlinemedcom.com

LAS VEGAS – Adhesion barriers may cause more problems than they prevent when employed in myomectomy and hysterectomy.

Ileus, fever, hematomas, and even small bowel obstruction occurred significantly more often when the barriers were used in conjunction with those procedures – especially when performed as open surgeries, Dr. François Closon reported at the AAGL Global Congress. And although their use remains relatively small among these patients, it’s been steadily rising since 2003, he said.

“Adhesion barriers are also being used about eight times more often in myomectomies than in hysterectomies, and this seems to be going up every year,” Dr. Closon of McGill University, Montreal, said at the meeting sponsored by AAGL.

His retrospective study drew on the U.S. Healthcare Cost and Utilization Project Nationwide Inpatient Sample, and examined the perioperative outcomes of adhesion barriers among nearly 475,000 women who underwent myomectomy or hysterectomy during 2003-2011. Of these, 9,000 (about 2%) had an adhesion barrier applied during the surgery. There were no significant baseline differences between the groups, except for age. Women in the myomectomy group were younger than those in the hysterectomy group (mean 36 years vs. 46 years). Age, however, was not associated with the use of an adhesion barrier.

Dr. Closon found a significant linear increase in the use of barriers in both procedures over the study period. In hysterectomy, barrier use rose slightly, but significantly, from 0.37% in 2003 to 2% in 2011. The increase was much greater for use in myomectomy, which rose from 3% to 7% during the same period.

Ileus was significantly more common among myomectomies that used the barrier (4% vs. 3%; OR, 1.49). The difference was more pronounced with hysterectomies (5% vs. 2.5%; OR, 1.97).

Small bowel obstruction was rare, but significantly more common in hysterectomies that employed adhesion barriers (0.2% vs. 0.4%; OR, 1.89).

Fever was also significantly more common in both procedures when the barrier was used (myomectomy 4.4% vs. 3%; OR, 1.43; hysterectomy 2.5% vs. 1.6%; OR, 1.65).

“The odds of intra-abdominal hematoma, postoperative pain, and a length of stay of 3 or more days were also significantly higher when an adhesion barrier was applied,” Dr. Closon said.

He reported having no financial disclosures.

msullivan@frontlinemedcom.com

LAS VEGAS – Adhesion barriers may cause more problems than they prevent when employed in myomectomy and hysterectomy.

Ileus, fever, hematomas, and even small bowel obstruction occurred significantly more often when the barriers were used in conjunction with those procedures – especially when performed as open surgeries, Dr. François Closon reported at the AAGL Global Congress. And although their use remains relatively small among these patients, it’s been steadily rising since 2003, he said.

“Adhesion barriers are also being used about eight times more often in myomectomies than in hysterectomies, and this seems to be going up every year,” Dr. Closon of McGill University, Montreal, said at the meeting sponsored by AAGL.

His retrospective study drew on the U.S. Healthcare Cost and Utilization Project Nationwide Inpatient Sample, and examined the perioperative outcomes of adhesion barriers among nearly 475,000 women who underwent myomectomy or hysterectomy during 2003-2011. Of these, 9,000 (about 2%) had an adhesion barrier applied during the surgery. There were no significant baseline differences between the groups, except for age. Women in the myomectomy group were younger than those in the hysterectomy group (mean 36 years vs. 46 years). Age, however, was not associated with the use of an adhesion barrier.

Dr. Closon found a significant linear increase in the use of barriers in both procedures over the study period. In hysterectomy, barrier use rose slightly, but significantly, from 0.37% in 2003 to 2% in 2011. The increase was much greater for use in myomectomy, which rose from 3% to 7% during the same period.

Ileus was significantly more common among myomectomies that used the barrier (4% vs. 3%; OR, 1.49). The difference was more pronounced with hysterectomies (5% vs. 2.5%; OR, 1.97).

Small bowel obstruction was rare, but significantly more common in hysterectomies that employed adhesion barriers (0.2% vs. 0.4%; OR, 1.89).

Fever was also significantly more common in both procedures when the barrier was used (myomectomy 4.4% vs. 3%; OR, 1.43; hysterectomy 2.5% vs. 1.6%; OR, 1.65).

“The odds of intra-abdominal hematoma, postoperative pain, and a length of stay of 3 or more days were also significantly higher when an adhesion barrier was applied,” Dr. Closon said.

He reported having no financial disclosures.

msullivan@frontlinemedcom.com

ORLANDO – New evidence further strengthens the case for coronary artery bypass grafting over percutaneous coronary intervention as the preferred revascularization strategy in diabetic patients with multivessel coronary artery disease.

An analysis of 4,819 such patients in a British Columbia province-wide registry who underwent revascularization during 2007-2014 led to the conclusion that the 30-day adjusted risk of the primary composite endpoint of death, MI, or stroke was 39% lower in those who underwent coronary artery bypass grafting (CABG), Dr. Krishnan Ramanathan reported at the American Heart Association scientific sessions.

Bruce Jancin/Frontline Medical News

From day 31 through 5 years of follow-up, the relative risk reduction was 36% in favor of CABG, again after adjustment for age, sex, presentation with stable ischemic heart disease or stabilized acute coronary syndrome (ACS), urgency, renal insufficiency, liver disease, peripheral arterial disease, and left ventricular ejection fraction, added Dr. Ramanathan of the University of British Columbia in Vancouver.

These results in a broad patient population in real-world clinical practice, albeit in an observational, nonrandomized setting, mirror those in the earlier randomized FREEDOM trial sponsored by the National Heart, Lung, and Blood Institute. The 5-year rate of the composite of death, MI, or stroke in FREEDOM was 18.7% in the CABG group and 26.6% with percutaneous coronary intervention (PCI). The number needed to treat with CABG instead of PCI in FREEDOM in order to avoid one case of the composite endpoint was 12.6 (N Engl J Med. 2012 Dec 20;367[25]:2375-84).

An important difference between the British Columbia and the FREEDOM trial is that the registry contained a much higher proportion of diabetic patients with multivessel disease who presented with acute coronary syndrome. Indeed, the ratio of stabilized ACS to stable ischemic heart disease patients in the registry was 62% to 38% as compared with 36% to 64% in FREEDOM. The registry patients underwent a median of 7.8 days of stabilization from the time of initial catheterization to CABG.

The registry data really shore up the advantages of CABG over PCI in diabetics with multivessel disease and ACS, Dr. Ramanathan noted. In the registry, the 30-day composite endpoint occurred in 4.4% of CABG-treated ACS patients, compared with 8.3% with PCI. For 31 days through 5 years, the rates were 21.4% versus 34.7%. The differences favoring CABG were highly significant at both time points.

FREEDOM led to two important revisions in the 2014 guidelines on coronary revascularization, issued by the American College of Cardiology, American Heart Association, American Academy of Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiac Angiography and Interventions, and Society of Thoracic Surgeons. In a focused update issued earlier this year, a new class I recommendation was issued calling for a heart team approach to revascularization in patients with diabetes mellitus and complex multivessel coronary artery disease (CAD). And a recommendation for CABG over PCI for improving survival in diabetic patients with multivessel CAD was upgraded from class IIa to class I.

Even though FREEDOM was a major randomized trial that might be expected to be practice changing, that hasn’t happened. A report from the ACC’s National Cardiovascular Data ACTION Registry presented earlier this year at the ACC annual scientific session documented that the most common revascularization strategy for diabetic patients with multivessel CAD following a non–ST elevation ACS remains PCI, as has been the case since the registry was created. In fact, following the 2012 publication of FREEDOM, the proportion of such patients treated by PCI took a sharp uptick in 2013-2014, according to Dr. Ramanathan.

In the British Columbia registry, 64% of diabetic patients with multivessel disease and an ACS were treated by PCI, 36% by CABG.

“Overall, CABG in stabilized ACS patients is underutilized,” he said.

Discussant Dr. Marc Ruel declared, “The salient finding about the British Columbia study is not so much about the stable ischemic heart disease patients, but about the high proportion of ACS patients in the study. CABG was better than PCI for all major adverse cardiovascular events and each component of the endpoint.”

Bruce Jancin/Frontline Medical News

Dr. Ruel, professor and chair of cardiac surgery at the University of Ottawa Heart Institute, coauthored a meta-analysis of randomized controlled trials comparing CABG to PCI in diabetic patients. Half of the trials used later-generation drug-eluting stents. At 5 years of follow-up, the relative risk of all-cause mortality in diabetic patients allocated to CABG was 0.67 (Lancet Diabetes Endocrinol. 2013 Dec;1[4]:317-28).

“Remember that 0.67 because it’s a recurring number in our literature,” he advised.

For example, in the British Columbia study the relative risk of death, MI, or stroke from 31 days to 5 years was 0.64 in the CABG as compared with the PCI group. And in a patient-level meta-analysis of the FREEDOM, BARI-2D, and COURAGE trials presented by Dr. John Mancini earlier at the AHA scientific sessions in Orlando, CABG plus optimal medical therapy was associated with a 0.65 relative risk of death, MI, or stroke, compared with PCI plus optimal medical therapy, which in turn wasn’t significantly better than optimal medical therapy alone, Dr. Ruel noted.

The 2015 European Society of Cardiology guidelines on management of ACS state that a heart team discussion involving a cardiologist and cardiac surgeon does not need to take place for every patient presenting with multivessel disease and a non–ST elevation ACS. The British Columbia study, coupled with the other evidence, “gives new credence” to a call for revision of that recommendation in diabetic patients, he said.

The British Columbia study was supported by the British Columbia Provincial Health Services Authority. Dr. Ramanathan reported having no financial conflicts.

bjancin@frontlinemedcom.com

ORLANDO – New evidence further strengthens the case for coronary artery bypass grafting over percutaneous coronary intervention as the preferred revascularization strategy in diabetic patients with multivessel coronary artery disease.

An analysis of 4,819 such patients in a British Columbia province-wide registry who underwent revascularization during 2007-2014 led to the conclusion that the 30-day adjusted risk of the primary composite endpoint of death, MI, or stroke was 39% lower in those who underwent coronary artery bypass grafting (CABG), Dr. Krishnan Ramanathan reported at the American Heart Association scientific sessions.

Bruce Jancin/Frontline Medical News

From day 31 through 5 years of follow-up, the relative risk reduction was 36% in favor of CABG, again after adjustment for age, sex, presentation with stable ischemic heart disease or stabilized acute coronary syndrome (ACS), urgency, renal insufficiency, liver disease, peripheral arterial disease, and left ventricular ejection fraction, added Dr. Ramanathan of the University of British Columbia in Vancouver.

These results in a broad patient population in real-world clinical practice, albeit in an observational, nonrandomized setting, mirror those in the earlier randomized FREEDOM trial sponsored by the National Heart, Lung, and Blood Institute. The 5-year rate of the composite of death, MI, or stroke in FREEDOM was 18.7% in the CABG group and 26.6% with percutaneous coronary intervention (PCI). The number needed to treat with CABG instead of PCI in FREEDOM in order to avoid one case of the composite endpoint was 12.6 (N Engl J Med. 2012 Dec 20;367[25]:2375-84).

An important difference between the British Columbia and the FREEDOM trial is that the registry contained a much higher proportion of diabetic patients with multivessel disease who presented with acute coronary syndrome. Indeed, the ratio of stabilized ACS to stable ischemic heart disease patients in the registry was 62% to 38% as compared with 36% to 64% in FREEDOM. The registry patients underwent a median of 7.8 days of stabilization from the time of initial catheterization to CABG.

The registry data really shore up the advantages of CABG over PCI in diabetics with multivessel disease and ACS, Dr. Ramanathan noted. In the registry, the 30-day composite endpoint occurred in 4.4% of CABG-treated ACS patients, compared with 8.3% with PCI. For 31 days through 5 years, the rates were 21.4% versus 34.7%. The differences favoring CABG were highly significant at both time points.

FREEDOM led to two important revisions in the 2014 guidelines on coronary revascularization, issued by the American College of Cardiology, American Heart Association, American Academy of Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiac Angiography and Interventions, and Society of Thoracic Surgeons. In a focused update issued earlier this year, a new class I recommendation was issued calling for a heart team approach to revascularization in patients with diabetes mellitus and complex multivessel coronary artery disease (CAD). And a recommendation for CABG over PCI for improving survival in diabetic patients with multivessel CAD was upgraded from class IIa to class I.

Even though FREEDOM was a major randomized trial that might be expected to be practice changing, that hasn’t happened. A report from the ACC’s National Cardiovascular Data ACTION Registry presented earlier this year at the ACC annual scientific session documented that the most common revascularization strategy for diabetic patients with multivessel CAD following a non–ST elevation ACS remains PCI, as has been the case since the registry was created. In fact, following the 2012 publication of FREEDOM, the proportion of such patients treated by PCI took a sharp uptick in 2013-2014, according to Dr. Ramanathan.

In the British Columbia registry, 64% of diabetic patients with multivessel disease and an ACS were treated by PCI, 36% by CABG.

“Overall, CABG in stabilized ACS patients is underutilized,” he said.

Discussant Dr. Marc Ruel declared, “The salient finding about the British Columbia study is not so much about the stable ischemic heart disease patients, but about the high proportion of ACS patients in the study. CABG was better than PCI for all major adverse cardiovascular events and each component of the endpoint.”

Bruce Jancin/Frontline Medical News

Dr. Ruel, professor and chair of cardiac surgery at the University of Ottawa Heart Institute, coauthored a meta-analysis of randomized controlled trials comparing CABG to PCI in diabetic patients. Half of the trials used later-generation drug-eluting stents. At 5 years of follow-up, the relative risk of all-cause mortality in diabetic patients allocated to CABG was 0.67 (Lancet Diabetes Endocrinol. 2013 Dec;1[4]:317-28).

“Remember that 0.67 because it’s a recurring number in our literature,” he advised.

For example, in the British Columbia study the relative risk of death, MI, or stroke from 31 days to 5 years was 0.64 in the CABG as compared with the PCI group. And in a patient-level meta-analysis of the FREEDOM, BARI-2D, and COURAGE trials presented by Dr. John Mancini earlier at the AHA scientific sessions in Orlando, CABG plus optimal medical therapy was associated with a 0.65 relative risk of death, MI, or stroke, compared with PCI plus optimal medical therapy, which in turn wasn’t significantly better than optimal medical therapy alone, Dr. Ruel noted.

The 2015 European Society of Cardiology guidelines on management of ACS state that a heart team discussion involving a cardiologist and cardiac surgeon does not need to take place for every patient presenting with multivessel disease and a non–ST elevation ACS. The British Columbia study, coupled with the other evidence, “gives new credence” to a call for revision of that recommendation in diabetic patients, he said.

The British Columbia study was supported by the British Columbia Provincial Health Services Authority. Dr. Ramanathan reported having no financial conflicts.

bjancin@frontlinemedcom.com

ORLANDO – New evidence further strengthens the case for coronary artery bypass grafting over percutaneous coronary intervention as the preferred revascularization strategy in diabetic patients with multivessel coronary artery disease.

An analysis of 4,819 such patients in a British Columbia province-wide registry who underwent revascularization during 2007-2014 led to the conclusion that the 30-day adjusted risk of the primary composite endpoint of death, MI, or stroke was 39% lower in those who underwent coronary artery bypass grafting (CABG), Dr. Krishnan Ramanathan reported at the American Heart Association scientific sessions.

Bruce Jancin/Frontline Medical News

From day 31 through 5 years of follow-up, the relative risk reduction was 36% in favor of CABG, again after adjustment for age, sex, presentation with stable ischemic heart disease or stabilized acute coronary syndrome (ACS), urgency, renal insufficiency, liver disease, peripheral arterial disease, and left ventricular ejection fraction, added Dr. Ramanathan of the University of British Columbia in Vancouver.

These results in a broad patient population in real-world clinical practice, albeit in an observational, nonrandomized setting, mirror those in the earlier randomized FREEDOM trial sponsored by the National Heart, Lung, and Blood Institute. The 5-year rate of the composite of death, MI, or stroke in FREEDOM was 18.7% in the CABG group and 26.6% with percutaneous coronary intervention (PCI). The number needed to treat with CABG instead of PCI in FREEDOM in order to avoid one case of the composite endpoint was 12.6 (N Engl J Med. 2012 Dec 20;367[25]:2375-84).

An important difference between the British Columbia and the FREEDOM trial is that the registry contained a much higher proportion of diabetic patients with multivessel disease who presented with acute coronary syndrome. Indeed, the ratio of stabilized ACS to stable ischemic heart disease patients in the registry was 62% to 38% as compared with 36% to 64% in FREEDOM. The registry patients underwent a median of 7.8 days of stabilization from the time of initial catheterization to CABG.

The registry data really shore up the advantages of CABG over PCI in diabetics with multivessel disease and ACS, Dr. Ramanathan noted. In the registry, the 30-day composite endpoint occurred in 4.4% of CABG-treated ACS patients, compared with 8.3% with PCI. For 31 days through 5 years, the rates were 21.4% versus 34.7%. The differences favoring CABG were highly significant at both time points.

FREEDOM led to two important revisions in the 2014 guidelines on coronary revascularization, issued by the American College of Cardiology, American Heart Association, American Academy of Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiac Angiography and Interventions, and Society of Thoracic Surgeons. In a focused update issued earlier this year, a new class I recommendation was issued calling for a heart team approach to revascularization in patients with diabetes mellitus and complex multivessel coronary artery disease (CAD). And a recommendation for CABG over PCI for improving survival in diabetic patients with multivessel CAD was upgraded from class IIa to class I.

Even though FREEDOM was a major randomized trial that might be expected to be practice changing, that hasn’t happened. A report from the ACC’s National Cardiovascular Data ACTION Registry presented earlier this year at the ACC annual scientific session documented that the most common revascularization strategy for diabetic patients with multivessel CAD following a non–ST elevation ACS remains PCI, as has been the case since the registry was created. In fact, following the 2012 publication of FREEDOM, the proportion of such patients treated by PCI took a sharp uptick in 2013-2014, according to Dr. Ramanathan.

In the British Columbia registry, 64% of diabetic patients with multivessel disease and an ACS were treated by PCI, 36% by CABG.

“Overall, CABG in stabilized ACS patients is underutilized,” he said.

Discussant Dr. Marc Ruel declared, “The salient finding about the British Columbia study is not so much about the stable ischemic heart disease patients, but about the high proportion of ACS patients in the study. CABG was better than PCI for all major adverse cardiovascular events and each component of the endpoint.”

Bruce Jancin/Frontline Medical News

Dr. Ruel, professor and chair of cardiac surgery at the University of Ottawa Heart Institute, coauthored a meta-analysis of randomized controlled trials comparing CABG to PCI in diabetic patients. Half of the trials used later-generation drug-eluting stents. At 5 years of follow-up, the relative risk of all-cause mortality in diabetic patients allocated to CABG was 0.67 (Lancet Diabetes Endocrinol. 2013 Dec;1[4]:317-28).

“Remember that 0.67 because it’s a recurring number in our literature,” he advised.

For example, in the British Columbia study the relative risk of death, MI, or stroke from 31 days to 5 years was 0.64 in the CABG as compared with the PCI group. And in a patient-level meta-analysis of the FREEDOM, BARI-2D, and COURAGE trials presented by Dr. John Mancini earlier at the AHA scientific sessions in Orlando, CABG plus optimal medical therapy was associated with a 0.65 relative risk of death, MI, or stroke, compared with PCI plus optimal medical therapy, which in turn wasn’t significantly better than optimal medical therapy alone, Dr. Ruel noted.

The 2015 European Society of Cardiology guidelines on management of ACS state that a heart team discussion involving a cardiologist and cardiac surgeon does not need to take place for every patient presenting with multivessel disease and a non–ST elevation ACS. The British Columbia study, coupled with the other evidence, “gives new credence” to a call for revision of that recommendation in diabetic patients, he said.

The British Columbia study was supported by the British Columbia Provincial Health Services Authority. Dr. Ramanathan reported having no financial conflicts.

bjancin@frontlinemedcom.com

Minimally invasive myomectomies dropped nearly 20% following the Food and Drug Administration’s warning to avoid power morcellation in the treatment of uterine fibroids, and minimally invasive hysterectomies fell nearly 6%, according to a time-series analysis of a Florida health system.

But the decline in the use of these techniques varied by subspecialty, with ob.gyns. and minimally invasive gynecologic specialists being more likely to shy away from minimally invasive hysterectomy, while reproductive endocrinologists and minimally invasive gynecologists were the subspecialists most likely not to perform minimally invasive myomectomy after the FDA warning, according to the researchers (Obstet Gynecol. 2015;126:1174-80).

On April 17, 2014, the FDA issued a warning against the use of power morcellators in the surgical treatment of uterine leiomyomas because of the risk of iatrogenic dissemination of malignant tissue in the event of an unsuspected sarcoma. In the aftermath of that warning, many hospitals have banned the use of power morcellators for myoma surgery.

Dr. Kenneth I. Barron of Florida Hospital Medical Group, Orlando, and his colleagues performed a time-series, retrospective analysis of 3,573 patients who underwent a hysterectomy or myomectomy between Aug. 1, 2013, and Dec. 31, 2014, to gauge the impact of the warning on gynecologic practice. They compared surgical interventions performed during the 8 months before the FDA announcement with surgical interventions performed during the 8 months after the announcement, quantifying the proportion of minimally invasive vaginal, laparoscopic, or robotic-assisted surgery cases for each study period.

In the pre-FDA warning arm, 1,694 hysterectomies and 102 myomectomies met inclusion criteria; in the post-FDA warning cohort, 1,690 hysterectomies and 87 myomectomies met inclusion criteria. Subjects were drawn from the surgical case logs of the operating room documentation system of the Florida Hospital System, where the use of power morcellation was suspended immediately following the FDA warning. The analysis included six hospitals and 98 surgeons.

During the study period, minimally invasive myomectomies decreased by 19%. The percentage of myomectomies performed with minimally invasive techniques fell from 62.7% before the FDA warning to 43.7% after (P = .009).

Minimally invasive hysterectomies decreased by 5.8%, dropping from 85.7% to 79.9% (P less than .001) following the FDA warning statement. The drop in minimally invasive hysterectomies were due largely to a 60% drop in laparoscopic supracervical hysterectomies, according to the study.

The findings were subspecialty specific. For instance, the researchers observed that there was an 8.7% decrease in minimally invasive hysterectomies when gynecologic oncology cases were excluded from the sample (P less than .001). Ob.gyns. and minimally invasive gynecologic specialists had the greatest decreases in minimally invasive hysterectomies. Significant decreases were not observed with urogynecologists or oncologists.

In terms of minimally invasive myomectomies, there was a drop among reproductive endocrinologists (P = .006) and minimally invasive gynecologic specialists (P = .01), but not among ob.gyns.

“Caution should be taken in interpreting this data to mean there has been an irreversible backslide toward open surgery,” the researchers wrote. “Our results reflect the immediate change in surgical practice after a policy change, and this might be neutralized once newer techniques for removing myomas and myomatous uteri by minimally invasive measures are adopted more broadly.”

Minimally invasive myomectomies dropped nearly 20% following the Food and Drug Administration’s warning to avoid power morcellation in the treatment of uterine fibroids, and minimally invasive hysterectomies fell nearly 6%, according to a time-series analysis of a Florida health system.

But the decline in the use of these techniques varied by subspecialty, with ob.gyns. and minimally invasive gynecologic specialists being more likely to shy away from minimally invasive hysterectomy, while reproductive endocrinologists and minimally invasive gynecologists were the subspecialists most likely not to perform minimally invasive myomectomy after the FDA warning, according to the researchers (Obstet Gynecol. 2015;126:1174-80).

On April 17, 2014, the FDA issued a warning against the use of power morcellators in the surgical treatment of uterine leiomyomas because of the risk of iatrogenic dissemination of malignant tissue in the event of an unsuspected sarcoma. In the aftermath of that warning, many hospitals have banned the use of power morcellators for myoma surgery.

Dr. Kenneth I. Barron of Florida Hospital Medical Group, Orlando, and his colleagues performed a time-series, retrospective analysis of 3,573 patients who underwent a hysterectomy or myomectomy between Aug. 1, 2013, and Dec. 31, 2014, to gauge the impact of the warning on gynecologic practice. They compared surgical interventions performed during the 8 months before the FDA announcement with surgical interventions performed during the 8 months after the announcement, quantifying the proportion of minimally invasive vaginal, laparoscopic, or robotic-assisted surgery cases for each study period.

In the pre-FDA warning arm, 1,694 hysterectomies and 102 myomectomies met inclusion criteria; in the post-FDA warning cohort, 1,690 hysterectomies and 87 myomectomies met inclusion criteria. Subjects were drawn from the surgical case logs of the operating room documentation system of the Florida Hospital System, where the use of power morcellation was suspended immediately following the FDA warning. The analysis included six hospitals and 98 surgeons.

During the study period, minimally invasive myomectomies decreased by 19%. The percentage of myomectomies performed with minimally invasive techniques fell from 62.7% before the FDA warning to 43.7% after (P = .009).

Minimally invasive hysterectomies decreased by 5.8%, dropping from 85.7% to 79.9% (P less than .001) following the FDA warning statement. The drop in minimally invasive hysterectomies were due largely to a 60% drop in laparoscopic supracervical hysterectomies, according to the study.

The findings were subspecialty specific. For instance, the researchers observed that there was an 8.7% decrease in minimally invasive hysterectomies when gynecologic oncology cases were excluded from the sample (P less than .001). Ob.gyns. and minimally invasive gynecologic specialists had the greatest decreases in minimally invasive hysterectomies. Significant decreases were not observed with urogynecologists or oncologists.

In terms of minimally invasive myomectomies, there was a drop among reproductive endocrinologists (P = .006) and minimally invasive gynecologic specialists (P = .01), but not among ob.gyns.

“Caution should be taken in interpreting this data to mean there has been an irreversible backslide toward open surgery,” the researchers wrote. “Our results reflect the immediate change in surgical practice after a policy change, and this might be neutralized once newer techniques for removing myomas and myomatous uteri by minimally invasive measures are adopted more broadly.”

Minimally invasive myomectomies dropped nearly 20% following the Food and Drug Administration’s warning to avoid power morcellation in the treatment of uterine fibroids, and minimally invasive hysterectomies fell nearly 6%, according to a time-series analysis of a Florida health system.

But the decline in the use of these techniques varied by subspecialty, with ob.gyns. and minimally invasive gynecologic specialists being more likely to shy away from minimally invasive hysterectomy, while reproductive endocrinologists and minimally invasive gynecologists were the subspecialists most likely not to perform minimally invasive myomectomy after the FDA warning, according to the researchers (Obstet Gynecol. 2015;126:1174-80).

On April 17, 2014, the FDA issued a warning against the use of power morcellators in the surgical treatment of uterine leiomyomas because of the risk of iatrogenic dissemination of malignant tissue in the event of an unsuspected sarcoma. In the aftermath of that warning, many hospitals have banned the use of power morcellators for myoma surgery.

Dr. Kenneth I. Barron of Florida Hospital Medical Group, Orlando, and his colleagues performed a time-series, retrospective analysis of 3,573 patients who underwent a hysterectomy or myomectomy between Aug. 1, 2013, and Dec. 31, 2014, to gauge the impact of the warning on gynecologic practice. They compared surgical interventions performed during the 8 months before the FDA announcement with surgical interventions performed during the 8 months after the announcement, quantifying the proportion of minimally invasive vaginal, laparoscopic, or robotic-assisted surgery cases for each study period.

In the pre-FDA warning arm, 1,694 hysterectomies and 102 myomectomies met inclusion criteria; in the post-FDA warning cohort, 1,690 hysterectomies and 87 myomectomies met inclusion criteria. Subjects were drawn from the surgical case logs of the operating room documentation system of the Florida Hospital System, where the use of power morcellation was suspended immediately following the FDA warning. The analysis included six hospitals and 98 surgeons.

During the study period, minimally invasive myomectomies decreased by 19%. The percentage of myomectomies performed with minimally invasive techniques fell from 62.7% before the FDA warning to 43.7% after (P = .009).

Minimally invasive hysterectomies decreased by 5.8%, dropping from 85.7% to 79.9% (P less than .001) following the FDA warning statement. The drop in minimally invasive hysterectomies were due largely to a 60% drop in laparoscopic supracervical hysterectomies, according to the study.

The findings were subspecialty specific. For instance, the researchers observed that there was an 8.7% decrease in minimally invasive hysterectomies when gynecologic oncology cases were excluded from the sample (P less than .001). Ob.gyns. and minimally invasive gynecologic specialists had the greatest decreases in minimally invasive hysterectomies. Significant decreases were not observed with urogynecologists or oncologists.

In terms of minimally invasive myomectomies, there was a drop among reproductive endocrinologists (P = .006) and minimally invasive gynecologic specialists (P = .01), but not among ob.gyns.

“Caution should be taken in interpreting this data to mean there has been an irreversible backslide toward open surgery,” the researchers wrote. “Our results reflect the immediate change in surgical practice after a policy change, and this might be neutralized once newer techniques for removing myomas and myomatous uteri by minimally invasive measures are adopted more broadly.”

Medicare has relaxed some requirements of the Stark Law through its 2016 fee schedule and created new exceptions for compensation arrangements under the statute. The changes make it easier to recruit nonphysician employees, share rental space, and operate on expired contracts without fear of violating the law.

“These rules show the government was seeking to give some flexibility in the area of Stark procedure or technical issues,” said Julie E. Kass, a Washington area health law attorney who specializes in Stark and antikickback laws. “I think what [the Centers for Medicare & Medicaid Services] was seeing, and the kinds of issues being disclosed, weren’t things that were going to raise the risk of fraud or abuse to the program. Recognizing that, they wanted to make sure there weren’t unnecessary concerns about these, or unnecessary [efforts].”

What should you know about the Stark Law modifications? Ms. Kass and Philadelphia-based health law attorney Karl A. Thallner Jr. discussed the latest changes in a recent interview.

Nonphysician recruitment

Starting in 2016, hospitals can assist in the recruitment of nonphysician health professionals for physician practices. In the past, hospitals could not because remuneration could be considered a compensation relationship between the hospital and the practice.

In the fee schedule final rule, CMS expands its definition of nonphysician provider to mean physician assistant, nurse practitioner, clinical nurse specialist, certified nurse-midwife, clinical psychologist, or clinical social worker. Hospitals, rural health clinics, and federally qualified health centers can provide recruitment assistance and retention payments to physician practices to employ nonphysician providers. CMS also loosened its original proposal that said the nonphysician provider would have to be a bona fide employee of the physician practice. Instead, they can be independent contractors as long as they contract directly with the practice, according to the final rule. Third-party companies do not qualify.

While the change is primarily positive, it does have limitations, Mr. Thallner said. The subsidy amount from the hospital for example, can be only 50% of employment costs and can last just 2 years.

“At some point, the practice is going to have to assume the full risk of the person,” he said. “But one might envision some scenarios where this might be helpful to physician practice in a community where there’s some need for start-up support.”

Holdover extension

Physicians who have compensation arrangements that fall under a Stark Law exception no longer need to panic if their agreement expires and they neglect to redraft a new contract. The 2016 rule releases doctors from potential violations if such an agreement expires, but the arrangement continues under the same terms.

In the past, doctors had a 6-month grace period to renew an arrangement agreement once the contract expired. CMS noted it receives numerous disclosures of actual or potential violations relating to writing requirements of compensation exceptions through the self-referral disclosure protocol, which allows providers and suppliers to disclose actual or potential violations of the physician self-referral law to CMS and authorizes the Health & Human Services department to reduce the amount potentially owed for disclosed violations. However, arrangements that continue beyond the 6-month period do not necessarily pose a risk of program or patient abuse, provided that the arrangement continues to satisfy the specific requirements of the applicable exception, the agency stated.

The agency has eliminated the time limitation on contract holdovers if the agreements meet requirements related to fair market value and so long as the compensation does not take into account the volume or value of referrals or other business generated between the parties.

“This one [is] helpful if you find you have an agreement that has slipped through the cracks,” Mr. Thallner said.

Practices should still be monitoring agreements after they expire to ensure that compensation levels remain appropriate and take efforts to redraft if changes are identified, he stressed.

Timeshare reprieve

Timeshare arrangements for office space, equipment, personnel, supplies, and other services are allowed starting in 2016.

Previously, physicians who did not require traditional office spaces could only lease from sources who could pose a referral relationship on a part-time basis and those rentals had to me meet specific rental criteria. The renter was required to have exclusive use of the space and 1-year contract.

CMS now acknowledges that in some cases – such as in rural or underserved areas – there may be a community need for short-term specialty services in which exclusive use of an office is not necessary. Under a timeshare arrangement, a hospital or local practice may ask a specialist from a neighboring community to use space owned by the hospital or practice on a limited or as-needed basis. Often, the specialist does not establish an additional office, but instead creates a timeshare-like arrangement for the space, equipment, and services necessary to treat patients.

To timeshare, doctors must meet the following requirements:

• The arrangement is set out in writing, signed by the parties, and specifies the premises, equipment, personnel, items, supplies, and services covered by the arrangement.

• The arrangement is between a physician and a hospital or a physician organization of which the physician is not an owner, employee, or contractor.

• The arrangement is not conditioned on the licensee’s referral of patients to the licensor.

• The compensation over the term of the arrangement is set in advance, consistent with fair market value.

The timeshare exception reduces hassles and makes it easier for doctors to share work spaces for short durations of time, Ms. Kass said.

“Physicians are able to either license or be the licensor or licensee of a timeshare arrangement rather than having a lease on a part-time basis,” she said. “You can still create a lease on a part-time basis using the old rental of space rules, but if you’re leasing a whole office, complete with all of the equipment and personnel and the space, you are able to do that for a day, for a week, in periods of time. Now one single exception can help you with that.”

agallegos@frontlinemedcom.com

On Twitter @legal_med

Medicare has relaxed some requirements of the Stark Law through its 2016 fee schedule and created new exceptions for compensation arrangements under the statute. The changes make it easier to recruit nonphysician employees, share rental space, and operate on expired contracts without fear of violating the law.

“These rules show the government was seeking to give some flexibility in the area of Stark procedure or technical issues,” said Julie E. Kass, a Washington area health law attorney who specializes in Stark and antikickback laws. “I think what [the Centers for Medicare & Medicaid Services] was seeing, and the kinds of issues being disclosed, weren’t things that were going to raise the risk of fraud or abuse to the program. Recognizing that, they wanted to make sure there weren’t unnecessary concerns about these, or unnecessary [efforts].”

What should you know about the Stark Law modifications? Ms. Kass and Philadelphia-based health law attorney Karl A. Thallner Jr. discussed the latest changes in a recent interview.

Nonphysician recruitment

Starting in 2016, hospitals can assist in the recruitment of nonphysician health professionals for physician practices. In the past, hospitals could not because remuneration could be considered a compensation relationship between the hospital and the practice.

In the fee schedule final rule, CMS expands its definition of nonphysician provider to mean physician assistant, nurse practitioner, clinical nurse specialist, certified nurse-midwife, clinical psychologist, or clinical social worker. Hospitals, rural health clinics, and federally qualified health centers can provide recruitment assistance and retention payments to physician practices to employ nonphysician providers. CMS also loosened its original proposal that said the nonphysician provider would have to be a bona fide employee of the physician practice. Instead, they can be independent contractors as long as they contract directly with the practice, according to the final rule. Third-party companies do not qualify.

While the change is primarily positive, it does have limitations, Mr. Thallner said. The subsidy amount from the hospital for example, can be only 50% of employment costs and can last just 2 years.

“At some point, the practice is going to have to assume the full risk of the person,” he said. “But one might envision some scenarios where this might be helpful to physician practice in a community where there’s some need for start-up support.”

Holdover extension

Physicians who have compensation arrangements that fall under a Stark Law exception no longer need to panic if their agreement expires and they neglect to redraft a new contract. The 2016 rule releases doctors from potential violations if such an agreement expires, but the arrangement continues under the same terms.

In the past, doctors had a 6-month grace period to renew an arrangement agreement once the contract expired. CMS noted it receives numerous disclosures of actual or potential violations relating to writing requirements of compensation exceptions through the self-referral disclosure protocol, which allows providers and suppliers to disclose actual or potential violations of the physician self-referral law to CMS and authorizes the Health & Human Services department to reduce the amount potentially owed for disclosed violations. However, arrangements that continue beyond the 6-month period do not necessarily pose a risk of program or patient abuse, provided that the arrangement continues to satisfy the specific requirements of the applicable exception, the agency stated.

The agency has eliminated the time limitation on contract holdovers if the agreements meet requirements related to fair market value and so long as the compensation does not take into account the volume or value of referrals or other business generated between the parties.

“This one [is] helpful if you find you have an agreement that has slipped through the cracks,” Mr. Thallner said.

Practices should still be monitoring agreements after they expire to ensure that compensation levels remain appropriate and take efforts to redraft if changes are identified, he stressed.

Timeshare reprieve

Timeshare arrangements for office space, equipment, personnel, supplies, and other services are allowed starting in 2016.

Previously, physicians who did not require traditional office spaces could only lease from sources who could pose a referral relationship on a part-time basis and those rentals had to me meet specific rental criteria. The renter was required to have exclusive use of the space and 1-year contract.

CMS now acknowledges that in some cases – such as in rural or underserved areas – there may be a community need for short-term specialty services in which exclusive use of an office is not necessary. Under a timeshare arrangement, a hospital or local practice may ask a specialist from a neighboring community to use space owned by the hospital or practice on a limited or as-needed basis. Often, the specialist does not establish an additional office, but instead creates a timeshare-like arrangement for the space, equipment, and services necessary to treat patients.

To timeshare, doctors must meet the following requirements:

• The arrangement is set out in writing, signed by the parties, and specifies the premises, equipment, personnel, items, supplies, and services covered by the arrangement.

• The arrangement is between a physician and a hospital or a physician organization of which the physician is not an owner, employee, or contractor.

• The arrangement is not conditioned on the licensee’s referral of patients to the licensor.

• The compensation over the term of the arrangement is set in advance, consistent with fair market value.

The timeshare exception reduces hassles and makes it easier for doctors to share work spaces for short durations of time, Ms. Kass said.

“Physicians are able to either license or be the licensor or licensee of a timeshare arrangement rather than having a lease on a part-time basis,” she said. “You can still create a lease on a part-time basis using the old rental of space rules, but if you’re leasing a whole office, complete with all of the equipment and personnel and the space, you are able to do that for a day, for a week, in periods of time. Now one single exception can help you with that.”

agallegos@frontlinemedcom.com

On Twitter @legal_med

Medicare has relaxed some requirements of the Stark Law through its 2016 fee schedule and created new exceptions for compensation arrangements under the statute. The changes make it easier to recruit nonphysician employees, share rental space, and operate on expired contracts without fear of violating the law.

“These rules show the government was seeking to give some flexibility in the area of Stark procedure or technical issues,” said Julie E. Kass, a Washington area health law attorney who specializes in Stark and antikickback laws. “I think what [the Centers for Medicare & Medicaid Services] was seeing, and the kinds of issues being disclosed, weren’t things that were going to raise the risk of fraud or abuse to the program. Recognizing that, they wanted to make sure there weren’t unnecessary concerns about these, or unnecessary [efforts].”

What should you know about the Stark Law modifications? Ms. Kass and Philadelphia-based health law attorney Karl A. Thallner Jr. discussed the latest changes in a recent interview.

Nonphysician recruitment

Starting in 2016, hospitals can assist in the recruitment of nonphysician health professionals for physician practices. In the past, hospitals could not because remuneration could be considered a compensation relationship between the hospital and the practice.

In the fee schedule final rule, CMS expands its definition of nonphysician provider to mean physician assistant, nurse practitioner, clinical nurse specialist, certified nurse-midwife, clinical psychologist, or clinical social worker. Hospitals, rural health clinics, and federally qualified health centers can provide recruitment assistance and retention payments to physician practices to employ nonphysician providers. CMS also loosened its original proposal that said the nonphysician provider would have to be a bona fide employee of the physician practice. Instead, they can be independent contractors as long as they contract directly with the practice, according to the final rule. Third-party companies do not qualify.

While the change is primarily positive, it does have limitations, Mr. Thallner said. The subsidy amount from the hospital for example, can be only 50% of employment costs and can last just 2 years.

“At some point, the practice is going to have to assume the full risk of the person,” he said. “But one might envision some scenarios where this might be helpful to physician practice in a community where there’s some need for start-up support.”

Holdover extension

Physicians who have compensation arrangements that fall under a Stark Law exception no longer need to panic if their agreement expires and they neglect to redraft a new contract. The 2016 rule releases doctors from potential violations if such an agreement expires, but the arrangement continues under the same terms.

In the past, doctors had a 6-month grace period to renew an arrangement agreement once the contract expired. CMS noted it receives numerous disclosures of actual or potential violations relating to writing requirements of compensation exceptions through the self-referral disclosure protocol, which allows providers and suppliers to disclose actual or potential violations of the physician self-referral law to CMS and authorizes the Health & Human Services department to reduce the amount potentially owed for disclosed violations. However, arrangements that continue beyond the 6-month period do not necessarily pose a risk of program or patient abuse, provided that the arrangement continues to satisfy the specific requirements of the applicable exception, the agency stated.

The agency has eliminated the time limitation on contract holdovers if the agreements meet requirements related to fair market value and so long as the compensation does not take into account the volume or value of referrals or other business generated between the parties.

“This one [is] helpful if you find you have an agreement that has slipped through the cracks,” Mr. Thallner said.

Practices should still be monitoring agreements after they expire to ensure that compensation levels remain appropriate and take efforts to redraft if changes are identified, he stressed.

Timeshare reprieve

Timeshare arrangements for office space, equipment, personnel, supplies, and other services are allowed starting in 2016.

Previously, physicians who did not require traditional office spaces could only lease from sources who could pose a referral relationship on a part-time basis and those rentals had to me meet specific rental criteria. The renter was required to have exclusive use of the space and 1-year contract.

CMS now acknowledges that in some cases – such as in rural or underserved areas – there may be a community need for short-term specialty services in which exclusive use of an office is not necessary. Under a timeshare arrangement, a hospital or local practice may ask a specialist from a neighboring community to use space owned by the hospital or practice on a limited or as-needed basis. Often, the specialist does not establish an additional office, but instead creates a timeshare-like arrangement for the space, equipment, and services necessary to treat patients.

To timeshare, doctors must meet the following requirements:

• The arrangement is set out in writing, signed by the parties, and specifies the premises, equipment, personnel, items, supplies, and services covered by the arrangement.

• The arrangement is between a physician and a hospital or a physician organization of which the physician is not an owner, employee, or contractor.

• The arrangement is not conditioned on the licensee’s referral of patients to the licensor.

• The compensation over the term of the arrangement is set in advance, consistent with fair market value.

The timeshare exception reduces hassles and makes it easier for doctors to share work spaces for short durations of time, Ms. Kass said.

“Physicians are able to either license or be the licensor or licensee of a timeshare arrangement rather than having a lease on a part-time basis,” she said. “You can still create a lease on a part-time basis using the old rental of space rules, but if you’re leasing a whole office, complete with all of the equipment and personnel and the space, you are able to do that for a day, for a week, in periods of time. Now one single exception can help you with that.”

agallegos@frontlinemedcom.com

On Twitter @legal_med