Bariatric Surgery

NEW ORLEANS – A significant reduction in 30-day all-cause hospital readmissions after sleeve gastrectomy was accomplished through the first-ever joint national quality improvement collaboration between the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery, John M. Morton, MD, reported at Obesity Week 2016.

The quality improvement program, known as DROP, for Decreasing Readmissions through Opportunities Provided, was developed by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). It was put to the test in a year-long study conducted in 128 nationally representative U.S. hospitals. The study involved a comparison of the participating hospitals’ 30-day all-cause readmission rates following bariatric surgery in the year prior to vs. the year after launch of the DROP project.

Bruce Jancin/Frontline Medical News

Of particular interest was the finding that the readmission rate following laparoscopic sleeve gastrectomy decreased from 4.02% to 3.54%, a 12% reduction. That’s an important finding, because sleeve gastrectomy is now by far the most frequently performed type of bariatric surgery in the United States. Indeed, it accounted for 54% of the estimated 196,000 bariatric surgery procedures performed in the country in 2015. Roux-en-Y gastric bypass was a distant second at 23%, followed by surgical revisions at 13.6%.

Moreover, the impact of the DROP initiative appeared to accelerate over time. The initiative as tested consisted of a comprehensive bundle of numerous components addressing preoperative, in-hospital, and postoperative care, and it took a while for hospitals to implement. The 30-day readmission rate following laparoscopic sleeve gastrectomy actually increased by 9.2% in the first 3 months following launch of the DROP initiative. But the readmission rate then took a U-turn, declining by 13.2% in the second quarter compared to the year-before rate, by 16.9% in the third quarter, and falling by 27.1% in the final 3 months of the study.

Mean length of stay for patients undergoing laparoscopic sleeve gastrectomy fell significantly, from 1.9 days pre-DROP to 1.79 days. The DROP intervention also achieved a significant decrease in length of stay for laparoscopic adjustable gastric banding, from 0.5 to 0.42 days.

The rate of readmission within 24 hours post discharge in laparoscopic sleeve gastrectomy patients decreased significantly by 19% after introduction of the DROP program. The trend was favorable, albeit not statistically significant, for the other two bariatric procedures studied.

Of note, hospitals in the two quartiles with the lowest preintervention 30-day all-cause readmission rates post bariatric surgery, with rates of 1.34% and 3.15%, respectively, didn’t derive any further reduction by participating in the DROP program. They already were performing many of the elements included in the intervention. But hospitals in the third quartile significantly improved their 30-day readmission rate from 4.84% to 4.13%, and those in the fourth quartile improved from 7.31% preintervention to 4.47% under the DROP program.

The program had no impact on postoperative leak rates or other surgical complications. However, patient satisfaction scores improved after introduction of the DROP intervention.

The preoperative components of the DROP readmission prevention bundle included a standardized 5-minute educational video featuring a surgeon, nutritionist, pharmacist, and psychologist or psychiatrist, with advice on key issues related to the upcoming operation. That’s also when the visits with the surgeon and a nutritionist were to be scheduled for within 30 days post surgery, and when the patient received phone numbers for the clinic and on-call surgeon in case questions arose later.

The in-hospital elements of the DROP intervention included provision of a clinical roadmap to guide patient expectations, as well as a nutritional consultation. The postoperative components included a day-after-discharge phone call from a nurse or physician assistant, a letter sent to the referring physician containing a discharge summary and recommendations, and a system to make sure that the scheduled follow-up appointments with the surgeon and nutritionist actually take place.

Since adherence to the various components of the DROP bundle varied from hospital to hospital, it was possible for Dr. Morton and his coinvestigators to determine which elements made the most difference in improving 30-day readmission rates. They found that the key difference makers were the nurse’s phone call on the day following discharge and the postoperative visits with the surgeon and nutritionist within the first several weeks.

Asked whether the study findings mean that hospitals that already have a 30-day all-cause readmission rate in the lower half of the national average don’t need to adopt the DROP program, Dr. Morton replied: “One size does not fit all. Maybe some centers don’t need to do all this.”

Thirty-day all-cause readmissions were selected for the first quality improvement project by the MBSAQIP in part because the Centers for Medicare & Medicaid Services has identified it as a priority area for surgery in general. Also, Dr. Morton was a coinvestigator in a study that found many readmissions after bariatric surgery are tied to preventable causes, including dietary indiscretions resulting in nausea and vomiting or dehydration, medication side effects, and inappropriate patient expectations (J Gastrointest Surg. 2016 Nov;20[11]:1797-1801).

“I think readmissions are a good outcome to study, because they incorporate many different elements of the patient experience, including patient safety and satisfaction. No surgeon wants to have a patient come back to the ER and be readmitted. And finally, there’s the cost,” Dr. Morton observed.

He noted that members of the MBSAQIP developed the DROP project in a highly efficient and cost-effective manner through a series of webinars and conference calls without the need for face-to-face meetings. The group plans to follow the same approach to its future quality improvement programs.

The DROP study was funded without industry support. Dr. Morton reported serving on advisory boards for Allurion and Novo Nordisk.

[email protected]

NEW ORLEANS – A significant reduction in 30-day all-cause hospital readmissions after sleeve gastrectomy was accomplished through the first-ever joint national quality improvement collaboration between the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery, John M. Morton, MD, reported at Obesity Week 2016.

The quality improvement program, known as DROP, for Decreasing Readmissions through Opportunities Provided, was developed by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). It was put to the test in a year-long study conducted in 128 nationally representative U.S. hospitals. The study involved a comparison of the participating hospitals’ 30-day all-cause readmission rates following bariatric surgery in the year prior to vs. the year after launch of the DROP project.

Bruce Jancin/Frontline Medical News

Of particular interest was the finding that the readmission rate following laparoscopic sleeve gastrectomy decreased from 4.02% to 3.54%, a 12% reduction. That’s an important finding, because sleeve gastrectomy is now by far the most frequently performed type of bariatric surgery in the United States. Indeed, it accounted for 54% of the estimated 196,000 bariatric surgery procedures performed in the country in 2015. Roux-en-Y gastric bypass was a distant second at 23%, followed by surgical revisions at 13.6%.

Moreover, the impact of the DROP initiative appeared to accelerate over time. The initiative as tested consisted of a comprehensive bundle of numerous components addressing preoperative, in-hospital, and postoperative care, and it took a while for hospitals to implement. The 30-day readmission rate following laparoscopic sleeve gastrectomy actually increased by 9.2% in the first 3 months following launch of the DROP initiative. But the readmission rate then took a U-turn, declining by 13.2% in the second quarter compared to the year-before rate, by 16.9% in the third quarter, and falling by 27.1% in the final 3 months of the study.

Mean length of stay for patients undergoing laparoscopic sleeve gastrectomy fell significantly, from 1.9 days pre-DROP to 1.79 days. The DROP intervention also achieved a significant decrease in length of stay for laparoscopic adjustable gastric banding, from 0.5 to 0.42 days.

The rate of readmission within 24 hours post discharge in laparoscopic sleeve gastrectomy patients decreased significantly by 19% after introduction of the DROP program. The trend was favorable, albeit not statistically significant, for the other two bariatric procedures studied.

Of note, hospitals in the two quartiles with the lowest preintervention 30-day all-cause readmission rates post bariatric surgery, with rates of 1.34% and 3.15%, respectively, didn’t derive any further reduction by participating in the DROP program. They already were performing many of the elements included in the intervention. But hospitals in the third quartile significantly improved their 30-day readmission rate from 4.84% to 4.13%, and those in the fourth quartile improved from 7.31% preintervention to 4.47% under the DROP program.

The program had no impact on postoperative leak rates or other surgical complications. However, patient satisfaction scores improved after introduction of the DROP intervention.

The preoperative components of the DROP readmission prevention bundle included a standardized 5-minute educational video featuring a surgeon, nutritionist, pharmacist, and psychologist or psychiatrist, with advice on key issues related to the upcoming operation. That’s also when the visits with the surgeon and a nutritionist were to be scheduled for within 30 days post surgery, and when the patient received phone numbers for the clinic and on-call surgeon in case questions arose later.

The in-hospital elements of the DROP intervention included provision of a clinical roadmap to guide patient expectations, as well as a nutritional consultation. The postoperative components included a day-after-discharge phone call from a nurse or physician assistant, a letter sent to the referring physician containing a discharge summary and recommendations, and a system to make sure that the scheduled follow-up appointments with the surgeon and nutritionist actually take place.

Since adherence to the various components of the DROP bundle varied from hospital to hospital, it was possible for Dr. Morton and his coinvestigators to determine which elements made the most difference in improving 30-day readmission rates. They found that the key difference makers were the nurse’s phone call on the day following discharge and the postoperative visits with the surgeon and nutritionist within the first several weeks.

Asked whether the study findings mean that hospitals that already have a 30-day all-cause readmission rate in the lower half of the national average don’t need to adopt the DROP program, Dr. Morton replied: “One size does not fit all. Maybe some centers don’t need to do all this.”

Thirty-day all-cause readmissions were selected for the first quality improvement project by the MBSAQIP in part because the Centers for Medicare & Medicaid Services has identified it as a priority area for surgery in general. Also, Dr. Morton was a coinvestigator in a study that found many readmissions after bariatric surgery are tied to preventable causes, including dietary indiscretions resulting in nausea and vomiting or dehydration, medication side effects, and inappropriate patient expectations (J Gastrointest Surg. 2016 Nov;20[11]:1797-1801).

“I think readmissions are a good outcome to study, because they incorporate many different elements of the patient experience, including patient safety and satisfaction. No surgeon wants to have a patient come back to the ER and be readmitted. And finally, there’s the cost,” Dr. Morton observed.

He noted that members of the MBSAQIP developed the DROP project in a highly efficient and cost-effective manner through a series of webinars and conference calls without the need for face-to-face meetings. The group plans to follow the same approach to its future quality improvement programs.

The DROP study was funded without industry support. Dr. Morton reported serving on advisory boards for Allurion and Novo Nordisk.

[email protected]

NEW ORLEANS – A significant reduction in 30-day all-cause hospital readmissions after sleeve gastrectomy was accomplished through the first-ever joint national quality improvement collaboration between the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery, John M. Morton, MD, reported at Obesity Week 2016.

The quality improvement program, known as DROP, for Decreasing Readmissions through Opportunities Provided, was developed by the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). It was put to the test in a year-long study conducted in 128 nationally representative U.S. hospitals. The study involved a comparison of the participating hospitals’ 30-day all-cause readmission rates following bariatric surgery in the year prior to vs. the year after launch of the DROP project.

Bruce Jancin/Frontline Medical News

Of particular interest was the finding that the readmission rate following laparoscopic sleeve gastrectomy decreased from 4.02% to 3.54%, a 12% reduction. That’s an important finding, because sleeve gastrectomy is now by far the most frequently performed type of bariatric surgery in the United States. Indeed, it accounted for 54% of the estimated 196,000 bariatric surgery procedures performed in the country in 2015. Roux-en-Y gastric bypass was a distant second at 23%, followed by surgical revisions at 13.6%.

Moreover, the impact of the DROP initiative appeared to accelerate over time. The initiative as tested consisted of a comprehensive bundle of numerous components addressing preoperative, in-hospital, and postoperative care, and it took a while for hospitals to implement. The 30-day readmission rate following laparoscopic sleeve gastrectomy actually increased by 9.2% in the first 3 months following launch of the DROP initiative. But the readmission rate then took a U-turn, declining by 13.2% in the second quarter compared to the year-before rate, by 16.9% in the third quarter, and falling by 27.1% in the final 3 months of the study.

Mean length of stay for patients undergoing laparoscopic sleeve gastrectomy fell significantly, from 1.9 days pre-DROP to 1.79 days. The DROP intervention also achieved a significant decrease in length of stay for laparoscopic adjustable gastric banding, from 0.5 to 0.42 days.

The rate of readmission within 24 hours post discharge in laparoscopic sleeve gastrectomy patients decreased significantly by 19% after introduction of the DROP program. The trend was favorable, albeit not statistically significant, for the other two bariatric procedures studied.

Of note, hospitals in the two quartiles with the lowest preintervention 30-day all-cause readmission rates post bariatric surgery, with rates of 1.34% and 3.15%, respectively, didn’t derive any further reduction by participating in the DROP program. They already were performing many of the elements included in the intervention. But hospitals in the third quartile significantly improved their 30-day readmission rate from 4.84% to 4.13%, and those in the fourth quartile improved from 7.31% preintervention to 4.47% under the DROP program.

The program had no impact on postoperative leak rates or other surgical complications. However, patient satisfaction scores improved after introduction of the DROP intervention.

The preoperative components of the DROP readmission prevention bundle included a standardized 5-minute educational video featuring a surgeon, nutritionist, pharmacist, and psychologist or psychiatrist, with advice on key issues related to the upcoming operation. That’s also when the visits with the surgeon and a nutritionist were to be scheduled for within 30 days post surgery, and when the patient received phone numbers for the clinic and on-call surgeon in case questions arose later.

The in-hospital elements of the DROP intervention included provision of a clinical roadmap to guide patient expectations, as well as a nutritional consultation. The postoperative components included a day-after-discharge phone call from a nurse or physician assistant, a letter sent to the referring physician containing a discharge summary and recommendations, and a system to make sure that the scheduled follow-up appointments with the surgeon and nutritionist actually take place.

Since adherence to the various components of the DROP bundle varied from hospital to hospital, it was possible for Dr. Morton and his coinvestigators to determine which elements made the most difference in improving 30-day readmission rates. They found that the key difference makers were the nurse’s phone call on the day following discharge and the postoperative visits with the surgeon and nutritionist within the first several weeks.

Asked whether the study findings mean that hospitals that already have a 30-day all-cause readmission rate in the lower half of the national average don’t need to adopt the DROP program, Dr. Morton replied: “One size does not fit all. Maybe some centers don’t need to do all this.”

Thirty-day all-cause readmissions were selected for the first quality improvement project by the MBSAQIP in part because the Centers for Medicare & Medicaid Services has identified it as a priority area for surgery in general. Also, Dr. Morton was a coinvestigator in a study that found many readmissions after bariatric surgery are tied to preventable causes, including dietary indiscretions resulting in nausea and vomiting or dehydration, medication side effects, and inappropriate patient expectations (J Gastrointest Surg. 2016 Nov;20[11]:1797-1801).

“I think readmissions are a good outcome to study, because they incorporate many different elements of the patient experience, including patient safety and satisfaction. No surgeon wants to have a patient come back to the ER and be readmitted. And finally, there’s the cost,” Dr. Morton observed.

He noted that members of the MBSAQIP developed the DROP project in a highly efficient and cost-effective manner through a series of webinars and conference calls without the need for face-to-face meetings. The group plans to follow the same approach to its future quality improvement programs.

The DROP study was funded without industry support. Dr. Morton reported serving on advisory boards for Allurion and Novo Nordisk.

[email protected]

NEW ORLEANS – The first-ever analysis of medical malpractice closed claims involving bariatric surgeons spotlights key opportunities for improvement for the surgical specialty, Eric J. DeMaria, MD, declared at Obesity Week 2016.

Four of the nation’s largest medical malpractice insurance companies agreed to allow members of an American Society for Metabolic and Bariatric Surgery task force to make site visits to their corporate offices, where the surgeons sat in closed rooms to read and take notes on a total of 175 cases closed during 2010-2015. Those case notes were later shared with the full task force, which sifted through the details in order to identify common causal themes and opportunities for improvement, explained Dr. DeMaria, a bariatric surgeon in Suffolk, Va.

Bruce Jancin/Frontline Medical News

• The defense prevailed in 63% of cases. The mean expense for defending a lawsuit was $91,836.

• In the 37% of cases involving monetary awards, the mean figure was $293,500, ranging from $20,000 to $8 million.

• Mortality was involved in 35% of cases. Other notable complications resulting in lawsuits included leak in 18% of cases, bowel obstruction in 10%, bleeding in 5.3%, retained foreign body in 5.3%, and vascular injury from access in 4.4%.

• Preoperative issues such as informed consent and disclosure of information were rare.

• The defendant surgeon was a foreign medical graduate in 27.5% of cases, board certified in 75.9%, and only 43% of the hospitals where the surgery took place were accredited. All those figures are at odds with national norms.

• The panel determined that the cause of the complication was provider-related in 50% of cases, system-related in 29%, and intrinsic to the patient’s disease in 21%.

• In the panel’s view, the complication was preventable by the surgeon in nearly 60% of cases and not preventable by the surgeon in 20%, with the remainder of cases deemed impossible to judge.

• Better preoperative care would have prevented the complication in 20% of cases, in the panel’s view. Better postoperative care would have prevented the complication in 45%.

• Just over 5% of the malpractice claims involved nonstandard malabsorptive operations. “Some of them I’d never heard of before,” according to Dr. DeMaria.

• Care was deemed by the panel to be appropriate in roughly 21% of the malpractice cases and grossly negligent or incompetent in 8%. Twenty-three percent of lawsuits involved preventable error of such magnitude that significant coaching and instruction would be required in order to prevent a recurrence.

Dr. DeMaria observed that this analysis of closed claims suggests that in order to reduce future malpractice claims against bariatric surgeons, it makes sense to focus on a few key areas of practice where most of the serious problems occur.

“We found the same themes repeated over and over; for example, delays in diagnosis and treatment of leaks,” he said.

A substantial number of the lawsuits could have been prevented through the use of preinsufflation and optical trocars, or access away from the midline, he added.

But the number one theme to emerge from the lawsuit analysis was poor communication with the health care team and/or family. The experts on the task force considered the communication performance to be appropriate in only 20% of cases.

“I would emphasize the strong contribution of communication issues, and the strong contribution of coverage and handoff issues,” Dr. DeMaria said. “One example of an intervention that might be introduced would be to standardize the language used in the operating room just before you start to staple the stomach, very similar to what airplane pilots do in their communication. We saw cases over and over again where the anesthesia person was asked to take out the [nasogastric] tube didn’t realize that meant the esophageal stethoscope, too.

“We need to do a better job of not just making sure a coverage person has been identified, but actually communicating with that person and doing a standardized handoff procedure,” Dr. DeMaria continued. “Management of postoperative phone calls is another important area: Who answers the phone? What are they supposed to do with that information? How do you get patients to appropriate care?”

Discussant Ramsey M. Dallal, MD, congratulated Dr. DeMaria and his fellow ASMBS task force members on “the massive amount of work” entailed in this project. And he urged his colleagues to take to heart the lessons learned.

“People hear the word ‘malpractice’ and they get fearful. They think of lawyers and of being attacked. The reality is this is not a malpractice study; this is a patient safety study. A study like this is an excellent way to improve patient safety. The problem with registry data is we don’t get the details – and it’s the case details that point out problems and potential solutions,” said Dr. Dallal, director of bariatrics and vice chair of the department of surgery at the Einstein Healthcare Network in the Philadelphia area.

The closed claims analysis was conducted free of commercial support. Dr. DeMaria reported serving as a consultant to Covidien and Ethicon.

[email protected]
 

NEW ORLEANS – The first-ever analysis of medical malpractice closed claims involving bariatric surgeons spotlights key opportunities for improvement for the surgical specialty, Eric J. DeMaria, MD, declared at Obesity Week 2016.

Four of the nation’s largest medical malpractice insurance companies agreed to allow members of an American Society for Metabolic and Bariatric Surgery task force to make site visits to their corporate offices, where the surgeons sat in closed rooms to read and take notes on a total of 175 cases closed during 2010-2015. Those case notes were later shared with the full task force, which sifted through the details in order to identify common causal themes and opportunities for improvement, explained Dr. DeMaria, a bariatric surgeon in Suffolk, Va.

Bruce Jancin/Frontline Medical News

• The defense prevailed in 63% of cases. The mean expense for defending a lawsuit was $91,836.

• In the 37% of cases involving monetary awards, the mean figure was $293,500, ranging from $20,000 to $8 million.

• Mortality was involved in 35% of cases. Other notable complications resulting in lawsuits included leak in 18% of cases, bowel obstruction in 10%, bleeding in 5.3%, retained foreign body in 5.3%, and vascular injury from access in 4.4%.

• Preoperative issues such as informed consent and disclosure of information were rare.

• The defendant surgeon was a foreign medical graduate in 27.5% of cases, board certified in 75.9%, and only 43% of the hospitals where the surgery took place were accredited. All those figures are at odds with national norms.

• The panel determined that the cause of the complication was provider-related in 50% of cases, system-related in 29%, and intrinsic to the patient’s disease in 21%.

• In the panel’s view, the complication was preventable by the surgeon in nearly 60% of cases and not preventable by the surgeon in 20%, with the remainder of cases deemed impossible to judge.

• Better preoperative care would have prevented the complication in 20% of cases, in the panel’s view. Better postoperative care would have prevented the complication in 45%.

• Just over 5% of the malpractice claims involved nonstandard malabsorptive operations. “Some of them I’d never heard of before,” according to Dr. DeMaria.

• Care was deemed by the panel to be appropriate in roughly 21% of the malpractice cases and grossly negligent or incompetent in 8%. Twenty-three percent of lawsuits involved preventable error of such magnitude that significant coaching and instruction would be required in order to prevent a recurrence.

Dr. DeMaria observed that this analysis of closed claims suggests that in order to reduce future malpractice claims against bariatric surgeons, it makes sense to focus on a few key areas of practice where most of the serious problems occur.

“We found the same themes repeated over and over; for example, delays in diagnosis and treatment of leaks,” he said.

A substantial number of the lawsuits could have been prevented through the use of preinsufflation and optical trocars, or access away from the midline, he added.

But the number one theme to emerge from the lawsuit analysis was poor communication with the health care team and/or family. The experts on the task force considered the communication performance to be appropriate in only 20% of cases.

“I would emphasize the strong contribution of communication issues, and the strong contribution of coverage and handoff issues,” Dr. DeMaria said. “One example of an intervention that might be introduced would be to standardize the language used in the operating room just before you start to staple the stomach, very similar to what airplane pilots do in their communication. We saw cases over and over again where the anesthesia person was asked to take out the [nasogastric] tube didn’t realize that meant the esophageal stethoscope, too.

“We need to do a better job of not just making sure a coverage person has been identified, but actually communicating with that person and doing a standardized handoff procedure,” Dr. DeMaria continued. “Management of postoperative phone calls is another important area: Who answers the phone? What are they supposed to do with that information? How do you get patients to appropriate care?”

Discussant Ramsey M. Dallal, MD, congratulated Dr. DeMaria and his fellow ASMBS task force members on “the massive amount of work” entailed in this project. And he urged his colleagues to take to heart the lessons learned.

“People hear the word ‘malpractice’ and they get fearful. They think of lawyers and of being attacked. The reality is this is not a malpractice study; this is a patient safety study. A study like this is an excellent way to improve patient safety. The problem with registry data is we don’t get the details – and it’s the case details that point out problems and potential solutions,” said Dr. Dallal, director of bariatrics and vice chair of the department of surgery at the Einstein Healthcare Network in the Philadelphia area.

The closed claims analysis was conducted free of commercial support. Dr. DeMaria reported serving as a consultant to Covidien and Ethicon.

[email protected]
 

NEW ORLEANS – The first-ever analysis of medical malpractice closed claims involving bariatric surgeons spotlights key opportunities for improvement for the surgical specialty, Eric J. DeMaria, MD, declared at Obesity Week 2016.

Four of the nation’s largest medical malpractice insurance companies agreed to allow members of an American Society for Metabolic and Bariatric Surgery task force to make site visits to their corporate offices, where the surgeons sat in closed rooms to read and take notes on a total of 175 cases closed during 2010-2015. Those case notes were later shared with the full task force, which sifted through the details in order to identify common causal themes and opportunities for improvement, explained Dr. DeMaria, a bariatric surgeon in Suffolk, Va.

Bruce Jancin/Frontline Medical News

• The defense prevailed in 63% of cases. The mean expense for defending a lawsuit was $91,836.

• In the 37% of cases involving monetary awards, the mean figure was $293,500, ranging from $20,000 to $8 million.

• Mortality was involved in 35% of cases. Other notable complications resulting in lawsuits included leak in 18% of cases, bowel obstruction in 10%, bleeding in 5.3%, retained foreign body in 5.3%, and vascular injury from access in 4.4%.

• Preoperative issues such as informed consent and disclosure of information were rare.

• The defendant surgeon was a foreign medical graduate in 27.5% of cases, board certified in 75.9%, and only 43% of the hospitals where the surgery took place were accredited. All those figures are at odds with national norms.

• The panel determined that the cause of the complication was provider-related in 50% of cases, system-related in 29%, and intrinsic to the patient’s disease in 21%.

• In the panel’s view, the complication was preventable by the surgeon in nearly 60% of cases and not preventable by the surgeon in 20%, with the remainder of cases deemed impossible to judge.

• Better preoperative care would have prevented the complication in 20% of cases, in the panel’s view. Better postoperative care would have prevented the complication in 45%.

• Just over 5% of the malpractice claims involved nonstandard malabsorptive operations. “Some of them I’d never heard of before,” according to Dr. DeMaria.

• Care was deemed by the panel to be appropriate in roughly 21% of the malpractice cases and grossly negligent or incompetent in 8%. Twenty-three percent of lawsuits involved preventable error of such magnitude that significant coaching and instruction would be required in order to prevent a recurrence.

Dr. DeMaria observed that this analysis of closed claims suggests that in order to reduce future malpractice claims against bariatric surgeons, it makes sense to focus on a few key areas of practice where most of the serious problems occur.

“We found the same themes repeated over and over; for example, delays in diagnosis and treatment of leaks,” he said.

A substantial number of the lawsuits could have been prevented through the use of preinsufflation and optical trocars, or access away from the midline, he added.

But the number one theme to emerge from the lawsuit analysis was poor communication with the health care team and/or family. The experts on the task force considered the communication performance to be appropriate in only 20% of cases.

“I would emphasize the strong contribution of communication issues, and the strong contribution of coverage and handoff issues,” Dr. DeMaria said. “One example of an intervention that might be introduced would be to standardize the language used in the operating room just before you start to staple the stomach, very similar to what airplane pilots do in their communication. We saw cases over and over again where the anesthesia person was asked to take out the [nasogastric] tube didn’t realize that meant the esophageal stethoscope, too.

“We need to do a better job of not just making sure a coverage person has been identified, but actually communicating with that person and doing a standardized handoff procedure,” Dr. DeMaria continued. “Management of postoperative phone calls is another important area: Who answers the phone? What are they supposed to do with that information? How do you get patients to appropriate care?”

Discussant Ramsey M. Dallal, MD, congratulated Dr. DeMaria and his fellow ASMBS task force members on “the massive amount of work” entailed in this project. And he urged his colleagues to take to heart the lessons learned.

“People hear the word ‘malpractice’ and they get fearful. They think of lawyers and of being attacked. The reality is this is not a malpractice study; this is a patient safety study. A study like this is an excellent way to improve patient safety. The problem with registry data is we don’t get the details – and it’s the case details that point out problems and potential solutions,” said Dr. Dallal, director of bariatrics and vice chair of the department of surgery at the Einstein Healthcare Network in the Philadelphia area.

The closed claims analysis was conducted free of commercial support. Dr. DeMaria reported serving as a consultant to Covidien and Ethicon.

[email protected]
 

NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.

“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.

Bruce Jancin/Frontline Medical News

[email protected]


 

NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.

“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.

Bruce Jancin/Frontline Medical News

[email protected]


 

NEW ORLEANS – The widespread health insurance industry practice of requiring obese patients to spend months on a physician-supervised strict weight-loss diet prior to approving coverage of bariatric surgery accomplishes nothing constructive, Charles J. Keith Jr., MD, reported at Obesity Week 2016.

“We found that insurance-mandated preoperative diets were associated with a significant delay in treatment, no improvement in postoperative complication rates, and also no improvement in weight loss outcomes. If anything, after adjusting for potential confounding variables, the outcomes were inferior to the group that wasn’t required to diet,” said Dr. Keith of the University of Alabama at Birmingham.

Bruce Jancin/Frontline Medical News

[email protected]


 

NEW ORLEANS – Performing bariatric surgery prior to total knee or hip replacement instead of vice versa resulted in significantly shorter orthopedic surgical operating time and length of stay in an observational study, Emanuel E. Nearing II, MD, reported at Obesity Week 2016.

“We propose that strong consideration be given to bariatric surgery as a means of weight loss and BMI [body mass index] reduction in patients with obesity prior to total joint replacement,” he said at the meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

Bruce Jancin/Frontline Medical News

[email protected]
 

NEW ORLEANS – Performing bariatric surgery prior to total knee or hip replacement instead of vice versa resulted in significantly shorter orthopedic surgical operating time and length of stay in an observational study, Emanuel E. Nearing II, MD, reported at Obesity Week 2016.

“We propose that strong consideration be given to bariatric surgery as a means of weight loss and BMI [body mass index] reduction in patients with obesity prior to total joint replacement,” he said at the meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

Bruce Jancin/Frontline Medical News

[email protected]
 

NEW ORLEANS – Performing bariatric surgery prior to total knee or hip replacement instead of vice versa resulted in significantly shorter orthopedic surgical operating time and length of stay in an observational study, Emanuel E. Nearing II, MD, reported at Obesity Week 2016.

“We propose that strong consideration be given to bariatric surgery as a means of weight loss and BMI [body mass index] reduction in patients with obesity prior to total joint replacement,” he said at the meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

Bruce Jancin/Frontline Medical News

[email protected]
 

NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m² at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m² or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m² or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m² 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m². And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m² 1 year post surgery had a preoperative BMI of 40 kg/m² or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m² or below.

Among patients with a preoperative BMI of 50-59 kg/m², only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m², only 0.4% had a BMI of less than 30 kg/m² at 1 year.

“Patients with a BMI of 50 kg/m² or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m² such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m² or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m² at 1 year and those who did not.
 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m² in 2006 and 46.9 kg/m² in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m², respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m² before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

[email protected]

NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m² at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m² or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m² or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m² 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m². And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m² 1 year post surgery had a preoperative BMI of 40 kg/m² or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m² or below.

Among patients with a preoperative BMI of 50-59 kg/m², only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m², only 0.4% had a BMI of less than 30 kg/m² at 1 year.

“Patients with a BMI of 50 kg/m² or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m² such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m² or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m² at 1 year and those who did not.
 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m² in 2006 and 46.9 kg/m² in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m², respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m² before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

[email protected]

NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m² at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m² or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.

Indeed, patients with a baseline BMI of 40 kg/m² or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m² 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.

“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m². And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m² 1 year post surgery had a preoperative BMI of 40 kg/m² or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m² or below.

Among patients with a preoperative BMI of 50-59 kg/m², only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m², only 0.4% had a BMI of less than 30 kg/m² at 1 year.

“Patients with a BMI of 50 kg/m² or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.

Why is a postsurgical BMI below 30 kg/m² such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m² or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.

In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.

The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.

Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.

Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m² at 1 year and those who did not.
 

Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.

Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m² in 2006 and 46.9 kg/m² in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m², respectively, in those years.

Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m² before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.

Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.

“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.

Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
 

[email protected]

NEW ORLEANS – Results of a new 40,000-patient Swedish observational study provide the strongest evidence to date suggesting a causal relationship between bariatric surgery and reduced risk of heart failure, according to Johan Sundström, MD.

The study, which included patients drawn from two large Swedish national registries, demonstrated that bariatric surgery was associated with a 46% reduction in the incidence of heart failure during a median 4.1 years of follow-up, compared with an intensive lifestyle modification program for weight loss.

“These are observational data, but it’s a very large study population – and probably there will never be a large randomized trial of bariatric surgery versus weight loss through intensive lifestyle modification as a means of reducing the risk of heart failure,” Dr. Sundström, professor of epidemiology and a cardiologist at Uppsala (Sweden) University, said at the American Heart Association scientific sessions.

The study included 25,804 bariatric surgery patients in SOReg, the Scandinavian Obesity Surgery Registry, and a matched comparator group of 13,701 participants in a Swedish national registry of obese participants in a commercial Sweden-based intensive structural lifestyle modification program for weight loss called Itrim. The two groups were matched for baseline body mass index, which was a mean of 41.5 kg, and numerous other demographic factors and comorbid conditions. Participants weighed an average of 119 kg at baseline. None of the subjects had a history of heart failure.

The bariatric surgery group lost substantially more weight than did the lifestyle modification group: an average loss of about 35 kg after 1 year, which was 18.8 kg more than in the lifestyle modification group. After 2 years, the bariatric surgery group had an average of 22.6 kg more weight loss than did the comparison group.

The primary outcome was hospitalization for new-onset heart failure during a median 4.1 years of follow-up. Subjects were well below the age range when the incidence of heart failure accelerates – they averaged 41 years of age – but 73 of them did develop heart failure during follow-up. The incidence was 46% lower in the bariatric surgery patients. This supports the study hypothesis that bariatric surgery leads to a low incidence of new-onset heart failure, compared with intensive lifestyle modification because of its larger weight loss effect.

When Dr. Sundström and his coinvestigators combined the two study groups, they found that a 10-kg weight loss at 1 year was associated with a 23% reduction in the risk of heart failure during follow-up, irrespective of whether the weight loss was achieved surgically or through the lifestyle program.

“A great way of studying causality is to take away the exposure and note what happens to the outcome. If there’s a causal link, then if you take away the risk factor – in this case, obesity – the disease should go away,” he explained in a video interview.

The reduced risk of heart failure in the bariatric surgery patients wasn’t because of fewer acute MIs. Indeed, their acute MI rate during follow-up was similar to that of the lifestyle modification group. But bariatric surgery was associated with relative risk reductions of 35%-37% for atrial fibrillation or need for diabetes or blood pressure–lowering medications at 1 year – and atrial fibrillation, diabetes, and hypertension are all established risk factors for heart failure, Dr. Sundström noted.

The Itrim intensive lifestyle modification program entailed an initial very-low-energy diet for the first 3 months in order to achieve massive weight loss, followed by a 9-month maintenance program involving motivational counseling, exercise, behavioral therapy, and a restricted diet.

Dr. Sundström said he and his coinvestigators plan to continue the study and expand it to look at differences in additional cardiovascular endpoints as patients age.

The study was funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, Uppsala University, the Karolinska Institute, and the Swedish Research Council. Dr. Sundström reported serving as a scientific advisor to Itrim.

[email protected]

NEW ORLEANS – Results of a new 40,000-patient Swedish observational study provide the strongest evidence to date suggesting a causal relationship between bariatric surgery and reduced risk of heart failure, according to Johan Sundström, MD.

The study, which included patients drawn from two large Swedish national registries, demonstrated that bariatric surgery was associated with a 46% reduction in the incidence of heart failure during a median 4.1 years of follow-up, compared with an intensive lifestyle modification program for weight loss.

“These are observational data, but it’s a very large study population – and probably there will never be a large randomized trial of bariatric surgery versus weight loss through intensive lifestyle modification as a means of reducing the risk of heart failure,” Dr. Sundström, professor of epidemiology and a cardiologist at Uppsala (Sweden) University, said at the American Heart Association scientific sessions.

The study included 25,804 bariatric surgery patients in SOReg, the Scandinavian Obesity Surgery Registry, and a matched comparator group of 13,701 participants in a Swedish national registry of obese participants in a commercial Sweden-based intensive structural lifestyle modification program for weight loss called Itrim. The two groups were matched for baseline body mass index, which was a mean of 41.5 kg, and numerous other demographic factors and comorbid conditions. Participants weighed an average of 119 kg at baseline. None of the subjects had a history of heart failure.

The bariatric surgery group lost substantially more weight than did the lifestyle modification group: an average loss of about 35 kg after 1 year, which was 18.8 kg more than in the lifestyle modification group. After 2 years, the bariatric surgery group had an average of 22.6 kg more weight loss than did the comparison group.

The primary outcome was hospitalization for new-onset heart failure during a median 4.1 years of follow-up. Subjects were well below the age range when the incidence of heart failure accelerates – they averaged 41 years of age – but 73 of them did develop heart failure during follow-up. The incidence was 46% lower in the bariatric surgery patients. This supports the study hypothesis that bariatric surgery leads to a low incidence of new-onset heart failure, compared with intensive lifestyle modification because of its larger weight loss effect.

When Dr. Sundström and his coinvestigators combined the two study groups, they found that a 10-kg weight loss at 1 year was associated with a 23% reduction in the risk of heart failure during follow-up, irrespective of whether the weight loss was achieved surgically or through the lifestyle program.

“A great way of studying causality is to take away the exposure and note what happens to the outcome. If there’s a causal link, then if you take away the risk factor – in this case, obesity – the disease should go away,” he explained in a video interview.

The reduced risk of heart failure in the bariatric surgery patients wasn’t because of fewer acute MIs. Indeed, their acute MI rate during follow-up was similar to that of the lifestyle modification group. But bariatric surgery was associated with relative risk reductions of 35%-37% for atrial fibrillation or need for diabetes or blood pressure–lowering medications at 1 year – and atrial fibrillation, diabetes, and hypertension are all established risk factors for heart failure, Dr. Sundström noted.

The Itrim intensive lifestyle modification program entailed an initial very-low-energy diet for the first 3 months in order to achieve massive weight loss, followed by a 9-month maintenance program involving motivational counseling, exercise, behavioral therapy, and a restricted diet.

Dr. Sundström said he and his coinvestigators plan to continue the study and expand it to look at differences in additional cardiovascular endpoints as patients age.

The study was funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, Uppsala University, the Karolinska Institute, and the Swedish Research Council. Dr. Sundström reported serving as a scientific advisor to Itrim.

[email protected]

NEW ORLEANS – Results of a new 40,000-patient Swedish observational study provide the strongest evidence to date suggesting a causal relationship between bariatric surgery and reduced risk of heart failure, according to Johan Sundström, MD.

The study, which included patients drawn from two large Swedish national registries, demonstrated that bariatric surgery was associated with a 46% reduction in the incidence of heart failure during a median 4.1 years of follow-up, compared with an intensive lifestyle modification program for weight loss.

“These are observational data, but it’s a very large study population – and probably there will never be a large randomized trial of bariatric surgery versus weight loss through intensive lifestyle modification as a means of reducing the risk of heart failure,” Dr. Sundström, professor of epidemiology and a cardiologist at Uppsala (Sweden) University, said at the American Heart Association scientific sessions.

The study included 25,804 bariatric surgery patients in SOReg, the Scandinavian Obesity Surgery Registry, and a matched comparator group of 13,701 participants in a Swedish national registry of obese participants in a commercial Sweden-based intensive structural lifestyle modification program for weight loss called Itrim. The two groups were matched for baseline body mass index, which was a mean of 41.5 kg, and numerous other demographic factors and comorbid conditions. Participants weighed an average of 119 kg at baseline. None of the subjects had a history of heart failure.

The bariatric surgery group lost substantially more weight than did the lifestyle modification group: an average loss of about 35 kg after 1 year, which was 18.8 kg more than in the lifestyle modification group. After 2 years, the bariatric surgery group had an average of 22.6 kg more weight loss than did the comparison group.

The primary outcome was hospitalization for new-onset heart failure during a median 4.1 years of follow-up. Subjects were well below the age range when the incidence of heart failure accelerates – they averaged 41 years of age – but 73 of them did develop heart failure during follow-up. The incidence was 46% lower in the bariatric surgery patients. This supports the study hypothesis that bariatric surgery leads to a low incidence of new-onset heart failure, compared with intensive lifestyle modification because of its larger weight loss effect.

When Dr. Sundström and his coinvestigators combined the two study groups, they found that a 10-kg weight loss at 1 year was associated with a 23% reduction in the risk of heart failure during follow-up, irrespective of whether the weight loss was achieved surgically or through the lifestyle program.

“A great way of studying causality is to take away the exposure and note what happens to the outcome. If there’s a causal link, then if you take away the risk factor – in this case, obesity – the disease should go away,” he explained in a video interview.

The reduced risk of heart failure in the bariatric surgery patients wasn’t because of fewer acute MIs. Indeed, their acute MI rate during follow-up was similar to that of the lifestyle modification group. But bariatric surgery was associated with relative risk reductions of 35%-37% for atrial fibrillation or need for diabetes or blood pressure–lowering medications at 1 year – and atrial fibrillation, diabetes, and hypertension are all established risk factors for heart failure, Dr. Sundström noted.

The Itrim intensive lifestyle modification program entailed an initial very-low-energy diet for the first 3 months in order to achieve massive weight loss, followed by a 9-month maintenance program involving motivational counseling, exercise, behavioral therapy, and a restricted diet.

Dr. Sundström said he and his coinvestigators plan to continue the study and expand it to look at differences in additional cardiovascular endpoints as patients age.

The study was funded by the U.S. National Institute of Diabetes and Digestive and Kidney Diseases, Uppsala University, the Karolinska Institute, and the Swedish Research Council. Dr. Sundström reported serving as a scientific advisor to Itrim.

[email protected]

WASHINGTON – Readmissions after bariatric surgery are significantly higher among black patients than among whites.

The reasons aren’t entirely clear, but since long-term morbidity and mortality are equivalent, they are probably more related to socioeconomics than clinical factors, Matthew Whealon, MD, said at the annual clinical congress of the American College of Surgeons.

“I think they are multifactorial,” said Dr. Whealon of the University of California, Irvine. “Some of it may be related to comorbidities, but other factors could be socioeconomic status, insurance status, access to primary care and follow-up care, even home support systems and patient expectations after surgery. I think it’s incumbent upon us to try and identify some of these risk factors and address them before surgery to reduce this disparity in readmissions.”

Michele G. Sullivan/Frontline Medical News

[email protected]

On Twitter @Alz_Gal

WASHINGTON – Readmissions after bariatric surgery are significantly higher among black patients than among whites.

The reasons aren’t entirely clear, but since long-term morbidity and mortality are equivalent, they are probably more related to socioeconomics than clinical factors, Matthew Whealon, MD, said at the annual clinical congress of the American College of Surgeons.

“I think they are multifactorial,” said Dr. Whealon of the University of California, Irvine. “Some of it may be related to comorbidities, but other factors could be socioeconomic status, insurance status, access to primary care and follow-up care, even home support systems and patient expectations after surgery. I think it’s incumbent upon us to try and identify some of these risk factors and address them before surgery to reduce this disparity in readmissions.”

Michele G. Sullivan/Frontline Medical News

[email protected]

On Twitter @Alz_Gal

WASHINGTON – Readmissions after bariatric surgery are significantly higher among black patients than among whites.

The reasons aren’t entirely clear, but since long-term morbidity and mortality are equivalent, they are probably more related to socioeconomics than clinical factors, Matthew Whealon, MD, said at the annual clinical congress of the American College of Surgeons.

“I think they are multifactorial,” said Dr. Whealon of the University of California, Irvine. “Some of it may be related to comorbidities, but other factors could be socioeconomic status, insurance status, access to primary care and follow-up care, even home support systems and patient expectations after surgery. I think it’s incumbent upon us to try and identify some of these risk factors and address them before surgery to reduce this disparity in readmissions.”

Michele G. Sullivan/Frontline Medical News

[email protected]

On Twitter @Alz_Gal

NEW ORLEANS – Severely obese patients who undergo Roux-en-Y gastric bypass surgery are subsequently at sharply increased risk for new-onset alcohol use disorder as well as for treatment of substance use disorder, compared with others who opt for a laparoscopic adjustable banding procedure for weight loss, Wendy C. King, PhD, reported at a meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

This new finding from the NIH-sponsored Longitudinal Assessment of Bariatric Surgery–2 study (LABS-2) has important implications for clinical practice.

“Patients considering bariatric surgery really should be informed of this surgery-specific risk. Also, alcohol use disorder screening, evaluation, intervention, and referral should be incorporated as part of regular presurgical and definitely also postoperative care. And because many patients don’t return to their surgeon for long-term postoperative care, it’s important that clinicians in primary care and other specialties are really looking for this problem in long-term follow-up,” said Dr. King, an epidemiologist at the University of Pittsburgh.

LABS-2 is an observational cohort study of patients undergoing first-time bariatric surgery at 10 participating U.S. hospitals, all of which have academic ties and are rated as bariatric surgery centers of excellence. Dr. King presented 5-year postsurgical follow-up data on 1,481 patients who had Roux-en-Y gastric bypass (RYGB) and 522 with laparoscopic adjustable gastric banding (LAGB). Independently of their regular clinical care visits, participants were assessed annually for their alcohol use and its consequences using the Alcohol Use Disorders Identification Test (AUDIT), use of illicit drugs within the past year, and whether they had undergone hospitalization or counseling for alcohol or drug problems. A score of 8 or more points on the AUDIT was deemed an indication of symptoms of alcohol use disorder (AUD),

After eliminating from consideration the 7% of patients with AUD symptoms at baseline, the cumulative incidence of AUD symptoms in the RYGB patients climbed from zero to 20.8% by the end of the fifth year of follow-up. Treatment for a substance use disorder occurred in 3.5% of RYGB patients during their first 5 years postsurgery, and 7.5% admitted to illicit drug use, said Dr. King.

In contrast, the cumulative incidence of AUD symptoms through 5 years in the LAGB patients was only 11.3%, less than 1% underwent treatment for a substance use disorder, and 4.9% said they had used illicit drugs.

But LABS-2 is not a randomized trial. Patients chose their bariatric procedure together with their surgeon. For this reason, it was important to perform a multivariate regression analysis adjusted for sociodemographics, social support, psychiatric treatment, lifetime history of psychiatric hospitalization, baseline smoking and alcohol consumption, and other potential confounders.

After performing this statistical exercise, the RYGB patients remained at an adjusted 2.05-fold increased risk of AUD symptoms, compared with the LAGB patients, as well as at 3.83-fold greater risk of treatment for a substance use disorder.

The 1.6-fold increased rate of illicit drug use in the RYGB group didn’t achieve statistical significance. Moreover, on closer examination, most of this illicit drug use involved marijuana, and its use in the post–bariatric surgery population appeared to mirror secular trends in the United States as a whole, according to Dr. King.

With her coinvestigators, Dr. King searched for presurgical risk factors that might predict postsurgical substance misuse. Perhaps the most interesting finding concerned the factors that weren’t predictive, including education, unemployment, score on the Beck Depression Inventory, SF-36 mental component summary score, race, marital status, binge eating, loss of control eating, and body mass index.

Lower social support prior to surgery was associated with increased risk for developing AUD symptoms during the first 5 years after bariatric surgery. Younger age and smoking at baseline were associated with increased rates of postoperative AUD symptoms, substance use disorder treatment, and illicit drug use. A history of psychiatric treatment was associated with increased rates of substance use disorder treatment and illicit drug use.

“That could indicate greater medical surveillance among those patients or greater willingness to get treatment, since they’d had treatment for other psychiatric issues in the past,” Dr. King speculated.

She described the study’s strengths as its large size, geographically diverse patient population, unusually high retention over time, compared with other bariatric surgery studies, and the use of AUDIT, a validated and reliable screening tool. The major limitations are that investigators didn’t inquire about illicit use of opioids and benzodiazepines, and recipients of gastric sleeve procedures weren’t included in the long-term follow-up analysis because LABS-2 began before the gastric sleeve boomed in popularity.

John M. Morton, MD, a former president of the American Society for Metabolic and Bariatric Surgery, predicted that a similar study that included gastric sleeve patients would show them to have the same unremarkable postoperative rates of substance misuse as the LAGB group.

“I want to emphasize that this increased incidence of alcohol problems in the Roux-en-Y gastric bypass patients is maybe not so much a psychological issue as it is a physiologic one,” added Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) School of Medicine.

Dr. King agreed. “Just in the last year and a half there have been some great pharmacokinetic studies showing that the Roux-en-Y affects alcohol metabolism and absorption, as well as studies in rodent models that suggest alcohol produces increased neurobiologic reward,” she noted.

The LABS-2 study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. King reported having no relevant financial interests.
 

[email protected]
 

NEW ORLEANS – Severely obese patients who undergo Roux-en-Y gastric bypass surgery are subsequently at sharply increased risk for new-onset alcohol use disorder as well as for treatment of substance use disorder, compared with others who opt for a laparoscopic adjustable banding procedure for weight loss, Wendy C. King, PhD, reported at a meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

This new finding from the NIH-sponsored Longitudinal Assessment of Bariatric Surgery–2 study (LABS-2) has important implications for clinical practice.

“Patients considering bariatric surgery really should be informed of this surgery-specific risk. Also, alcohol use disorder screening, evaluation, intervention, and referral should be incorporated as part of regular presurgical and definitely also postoperative care. And because many patients don’t return to their surgeon for long-term postoperative care, it’s important that clinicians in primary care and other specialties are really looking for this problem in long-term follow-up,” said Dr. King, an epidemiologist at the University of Pittsburgh.

LABS-2 is an observational cohort study of patients undergoing first-time bariatric surgery at 10 participating U.S. hospitals, all of which have academic ties and are rated as bariatric surgery centers of excellence. Dr. King presented 5-year postsurgical follow-up data on 1,481 patients who had Roux-en-Y gastric bypass (RYGB) and 522 with laparoscopic adjustable gastric banding (LAGB). Independently of their regular clinical care visits, participants were assessed annually for their alcohol use and its consequences using the Alcohol Use Disorders Identification Test (AUDIT), use of illicit drugs within the past year, and whether they had undergone hospitalization or counseling for alcohol or drug problems. A score of 8 or more points on the AUDIT was deemed an indication of symptoms of alcohol use disorder (AUD),

After eliminating from consideration the 7% of patients with AUD symptoms at baseline, the cumulative incidence of AUD symptoms in the RYGB patients climbed from zero to 20.8% by the end of the fifth year of follow-up. Treatment for a substance use disorder occurred in 3.5% of RYGB patients during their first 5 years postsurgery, and 7.5% admitted to illicit drug use, said Dr. King.

In contrast, the cumulative incidence of AUD symptoms through 5 years in the LAGB patients was only 11.3%, less than 1% underwent treatment for a substance use disorder, and 4.9% said they had used illicit drugs.

But LABS-2 is not a randomized trial. Patients chose their bariatric procedure together with their surgeon. For this reason, it was important to perform a multivariate regression analysis adjusted for sociodemographics, social support, psychiatric treatment, lifetime history of psychiatric hospitalization, baseline smoking and alcohol consumption, and other potential confounders.

After performing this statistical exercise, the RYGB patients remained at an adjusted 2.05-fold increased risk of AUD symptoms, compared with the LAGB patients, as well as at 3.83-fold greater risk of treatment for a substance use disorder.

The 1.6-fold increased rate of illicit drug use in the RYGB group didn’t achieve statistical significance. Moreover, on closer examination, most of this illicit drug use involved marijuana, and its use in the post–bariatric surgery population appeared to mirror secular trends in the United States as a whole, according to Dr. King.

With her coinvestigators, Dr. King searched for presurgical risk factors that might predict postsurgical substance misuse. Perhaps the most interesting finding concerned the factors that weren’t predictive, including education, unemployment, score on the Beck Depression Inventory, SF-36 mental component summary score, race, marital status, binge eating, loss of control eating, and body mass index.

Lower social support prior to surgery was associated with increased risk for developing AUD symptoms during the first 5 years after bariatric surgery. Younger age and smoking at baseline were associated with increased rates of postoperative AUD symptoms, substance use disorder treatment, and illicit drug use. A history of psychiatric treatment was associated with increased rates of substance use disorder treatment and illicit drug use.

“That could indicate greater medical surveillance among those patients or greater willingness to get treatment, since they’d had treatment for other psychiatric issues in the past,” Dr. King speculated.

She described the study’s strengths as its large size, geographically diverse patient population, unusually high retention over time, compared with other bariatric surgery studies, and the use of AUDIT, a validated and reliable screening tool. The major limitations are that investigators didn’t inquire about illicit use of opioids and benzodiazepines, and recipients of gastric sleeve procedures weren’t included in the long-term follow-up analysis because LABS-2 began before the gastric sleeve boomed in popularity.

John M. Morton, MD, a former president of the American Society for Metabolic and Bariatric Surgery, predicted that a similar study that included gastric sleeve patients would show them to have the same unremarkable postoperative rates of substance misuse as the LAGB group.

“I want to emphasize that this increased incidence of alcohol problems in the Roux-en-Y gastric bypass patients is maybe not so much a psychological issue as it is a physiologic one,” added Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) School of Medicine.

Dr. King agreed. “Just in the last year and a half there have been some great pharmacokinetic studies showing that the Roux-en-Y affects alcohol metabolism and absorption, as well as studies in rodent models that suggest alcohol produces increased neurobiologic reward,” she noted.

The LABS-2 study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. King reported having no relevant financial interests.
 

[email protected]
 

NEW ORLEANS – Severely obese patients who undergo Roux-en-Y gastric bypass surgery are subsequently at sharply increased risk for new-onset alcohol use disorder as well as for treatment of substance use disorder, compared with others who opt for a laparoscopic adjustable banding procedure for weight loss, Wendy C. King, PhD, reported at a meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.

This new finding from the NIH-sponsored Longitudinal Assessment of Bariatric Surgery–2 study (LABS-2) has important implications for clinical practice.

“Patients considering bariatric surgery really should be informed of this surgery-specific risk. Also, alcohol use disorder screening, evaluation, intervention, and referral should be incorporated as part of regular presurgical and definitely also postoperative care. And because many patients don’t return to their surgeon for long-term postoperative care, it’s important that clinicians in primary care and other specialties are really looking for this problem in long-term follow-up,” said Dr. King, an epidemiologist at the University of Pittsburgh.

LABS-2 is an observational cohort study of patients undergoing first-time bariatric surgery at 10 participating U.S. hospitals, all of which have academic ties and are rated as bariatric surgery centers of excellence. Dr. King presented 5-year postsurgical follow-up data on 1,481 patients who had Roux-en-Y gastric bypass (RYGB) and 522 with laparoscopic adjustable gastric banding (LAGB). Independently of their regular clinical care visits, participants were assessed annually for their alcohol use and its consequences using the Alcohol Use Disorders Identification Test (AUDIT), use of illicit drugs within the past year, and whether they had undergone hospitalization or counseling for alcohol or drug problems. A score of 8 or more points on the AUDIT was deemed an indication of symptoms of alcohol use disorder (AUD),

After eliminating from consideration the 7% of patients with AUD symptoms at baseline, the cumulative incidence of AUD symptoms in the RYGB patients climbed from zero to 20.8% by the end of the fifth year of follow-up. Treatment for a substance use disorder occurred in 3.5% of RYGB patients during their first 5 years postsurgery, and 7.5% admitted to illicit drug use, said Dr. King.

In contrast, the cumulative incidence of AUD symptoms through 5 years in the LAGB patients was only 11.3%, less than 1% underwent treatment for a substance use disorder, and 4.9% said they had used illicit drugs.

But LABS-2 is not a randomized trial. Patients chose their bariatric procedure together with their surgeon. For this reason, it was important to perform a multivariate regression analysis adjusted for sociodemographics, social support, psychiatric treatment, lifetime history of psychiatric hospitalization, baseline smoking and alcohol consumption, and other potential confounders.

After performing this statistical exercise, the RYGB patients remained at an adjusted 2.05-fold increased risk of AUD symptoms, compared with the LAGB patients, as well as at 3.83-fold greater risk of treatment for a substance use disorder.

The 1.6-fold increased rate of illicit drug use in the RYGB group didn’t achieve statistical significance. Moreover, on closer examination, most of this illicit drug use involved marijuana, and its use in the post–bariatric surgery population appeared to mirror secular trends in the United States as a whole, according to Dr. King.

With her coinvestigators, Dr. King searched for presurgical risk factors that might predict postsurgical substance misuse. Perhaps the most interesting finding concerned the factors that weren’t predictive, including education, unemployment, score on the Beck Depression Inventory, SF-36 mental component summary score, race, marital status, binge eating, loss of control eating, and body mass index.

Lower social support prior to surgery was associated with increased risk for developing AUD symptoms during the first 5 years after bariatric surgery. Younger age and smoking at baseline were associated with increased rates of postoperative AUD symptoms, substance use disorder treatment, and illicit drug use. A history of psychiatric treatment was associated with increased rates of substance use disorder treatment and illicit drug use.

“That could indicate greater medical surveillance among those patients or greater willingness to get treatment, since they’d had treatment for other psychiatric issues in the past,” Dr. King speculated.

She described the study’s strengths as its large size, geographically diverse patient population, unusually high retention over time, compared with other bariatric surgery studies, and the use of AUDIT, a validated and reliable screening tool. The major limitations are that investigators didn’t inquire about illicit use of opioids and benzodiazepines, and recipients of gastric sleeve procedures weren’t included in the long-term follow-up analysis because LABS-2 began before the gastric sleeve boomed in popularity.

John M. Morton, MD, a former president of the American Society for Metabolic and Bariatric Surgery, predicted that a similar study that included gastric sleeve patients would show them to have the same unremarkable postoperative rates of substance misuse as the LAGB group.

“I want to emphasize that this increased incidence of alcohol problems in the Roux-en-Y gastric bypass patients is maybe not so much a psychological issue as it is a physiologic one,” added Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) School of Medicine.

Dr. King agreed. “Just in the last year and a half there have been some great pharmacokinetic studies showing that the Roux-en-Y affects alcohol metabolism and absorption, as well as studies in rodent models that suggest alcohol produces increased neurobiologic reward,” she noted.

The LABS-2 study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. King reported having no relevant financial interests.
 

[email protected]
 

Laparoscopic sleeve gastrectomy is safe and effective overall, but staple line reinforcement appears to increase the rate of postsurgical leaks – which were associated with readmissions and, in some cases, reoperations.

A large review of quality improvement data found that staple line reinforcement – an extremely common technique – was associated with a 60% increased risk of leak, compared with closures without staple line reinforcement, Elizabeth R. Berger, MD, and her colleagues reported in the October issue of the Annals of Surgery (2016;264:464-73).

“This study also demonstrates that leaks were significantly more morbid than bleeding with higher readmission and reoperation rates in patients with a leak vs. a bleed,” wrote Dr. Berger of Loyola University, Chicago, and her coauthors. “Therefore, a surgeon should consider the benefits, risks, and costs of each surgical technique in performing a laparoscopic sleeve gastrectomy and selectively utilize those that, in their hands, minimize morbidity while maximizing clinical effectiveness.”

The team examined outcomes in 189,477 laparoscopic sleeve gastrectomies performed by 1,634 surgeons at 720 centers from 2012 to 2014. All of the data were extracted from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, created in 2012 by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery.

They examined the impact of staple line reinforcement, oversewing the staple line, bougie size, and distance of the staple line from the pylorus on 30-day outcomes, and their effect on weight loss and weight-related comorbidities at 1 year. Outcomes included morbidity, leak rates, and bleeding, which were examined at both the patient and surgeon levels.

Most patients (126,904; 67%) patients had some type of staple line reinforcement (SLR); the rest had only oversewn staple lines (OSL) or no reinforcement. Leaks occurred in 1,703 patients and bleeds in 1,436 patients. Leaks were more serious than bleeds: Patients with a leak were almost 28% more likely to readmitted and 11% more likely to need a reoperation than were patients who had only a bleed.

At the patient level, those with SLR with or without OSL were 20%-46% more likely to experience a leak than were those who had neither. Bleeding rates were about 70% lower in the SLR groups.

Most surgeons in the analysis (80%) used some type of SLR; almost 20% routinely used only OSL, and 30% routinely used only SLR. At the surgeon level, SLR was associated with a 60% increased risk of a postoperative leak, compared with no reinforcement. There was no association between SLR and bleeding risk, however.

Oversewing had an effect on 1-year weight loss. Patients with oversewn staple lines lost an additional 1.3 points on the body mass index (BMI) scale, compared with patients with no type of reinforcement.

“The reason for increased leaks from SLR is relatively unclear,” the authors wrote. “The two layers of material that are placed within the staple line could increase ischemia or decrease the relative staple heights. At the notches, where one staple firing ends and the next one begins, there is sandwiching of the two layers of staples and a combined four layers of SLR. This bulk may predispose to leaks.”

Larger bougie sizes (BS) seemed more beneficial than did smaller ones, in both the surgeon- and patient-level analyses. A BS of at least 38 French was associated with a 28% decreased risk of a leak (odds ratio 0.72) at the patient level and a 10% decreased risk at the surgeon level (OR 0.90). There were no associations with bleeding.

“Our findings support literature that describes narrower BSs leads to increased ischemia secondary to increased intraluminal pressure, causing more leaks,” the authors wrote.

A BS of at least 40 French had a significant impact on weight loss. At 1 year, patients with the larger BS had lost 2.45 points more on the BMI scale than did those with smaller sizes.

This finding is in accord with other studies, including one that found the best weight-loss outcomes associated with a BS of more than 60 French. “Perhaps the sleeve works because of more rapid emptying, which is favored by a relatively larger BS, rather than because of restriction,” they said.

The distance to the pylorus (DP) from the staple line initiation point was divided into four sections: less than 4 cm; 4-5 cm; 5-6 cm; and 6 cm or more.

On a patient level, there was no association between DP and leak rates. There was, however, an association with bleeding. A DP of 4-4.99 cm had the highest rate, 90%, while a DP of 5-5.99 cm had the lowest (71%). DP was also associated with weight loss on this level, with a distance of more than 6 cm being associated with the biggest BMI decrease (3.7 points).

“Our data show significantly increased excess weight loss in a stepwise fashion as the DP increases,” the authors said. “Our data suggest that as DP increased, there was an increased excess weight loss, possibly explained by preserving the ‘antral mill.’ Stapling further from the pylorus perhaps keeps the antrum’s functional component intact and allows food to enter the distal gut more quickly, leading to earlier satiety and increased weight loss.”

Only 114 surgeons (8%) used a DP of less than 4 cm. There were no significant associations with any 30-day outcomes and DP after adjustment.

The authors had no financial disclosures.

Laparoscopic sleeve gastrectomy is safe and effective overall, but staple line reinforcement appears to increase the rate of postsurgical leaks – which were associated with readmissions and, in some cases, reoperations.

A large review of quality improvement data found that staple line reinforcement – an extremely common technique – was associated with a 60% increased risk of leak, compared with closures without staple line reinforcement, Elizabeth R. Berger, MD, and her colleagues reported in the October issue of the Annals of Surgery (2016;264:464-73).

“This study also demonstrates that leaks were significantly more morbid than bleeding with higher readmission and reoperation rates in patients with a leak vs. a bleed,” wrote Dr. Berger of Loyola University, Chicago, and her coauthors. “Therefore, a surgeon should consider the benefits, risks, and costs of each surgical technique in performing a laparoscopic sleeve gastrectomy and selectively utilize those that, in their hands, minimize morbidity while maximizing clinical effectiveness.”

The team examined outcomes in 189,477 laparoscopic sleeve gastrectomies performed by 1,634 surgeons at 720 centers from 2012 to 2014. All of the data were extracted from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, created in 2012 by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery.

They examined the impact of staple line reinforcement, oversewing the staple line, bougie size, and distance of the staple line from the pylorus on 30-day outcomes, and their effect on weight loss and weight-related comorbidities at 1 year. Outcomes included morbidity, leak rates, and bleeding, which were examined at both the patient and surgeon levels.

Most patients (126,904; 67%) patients had some type of staple line reinforcement (SLR); the rest had only oversewn staple lines (OSL) or no reinforcement. Leaks occurred in 1,703 patients and bleeds in 1,436 patients. Leaks were more serious than bleeds: Patients with a leak were almost 28% more likely to readmitted and 11% more likely to need a reoperation than were patients who had only a bleed.

At the patient level, those with SLR with or without OSL were 20%-46% more likely to experience a leak than were those who had neither. Bleeding rates were about 70% lower in the SLR groups.

Most surgeons in the analysis (80%) used some type of SLR; almost 20% routinely used only OSL, and 30% routinely used only SLR. At the surgeon level, SLR was associated with a 60% increased risk of a postoperative leak, compared with no reinforcement. There was no association between SLR and bleeding risk, however.

Oversewing had an effect on 1-year weight loss. Patients with oversewn staple lines lost an additional 1.3 points on the body mass index (BMI) scale, compared with patients with no type of reinforcement.

“The reason for increased leaks from SLR is relatively unclear,” the authors wrote. “The two layers of material that are placed within the staple line could increase ischemia or decrease the relative staple heights. At the notches, where one staple firing ends and the next one begins, there is sandwiching of the two layers of staples and a combined four layers of SLR. This bulk may predispose to leaks.”

Larger bougie sizes (BS) seemed more beneficial than did smaller ones, in both the surgeon- and patient-level analyses. A BS of at least 38 French was associated with a 28% decreased risk of a leak (odds ratio 0.72) at the patient level and a 10% decreased risk at the surgeon level (OR 0.90). There were no associations with bleeding.

“Our findings support literature that describes narrower BSs leads to increased ischemia secondary to increased intraluminal pressure, causing more leaks,” the authors wrote.

A BS of at least 40 French had a significant impact on weight loss. At 1 year, patients with the larger BS had lost 2.45 points more on the BMI scale than did those with smaller sizes.

This finding is in accord with other studies, including one that found the best weight-loss outcomes associated with a BS of more than 60 French. “Perhaps the sleeve works because of more rapid emptying, which is favored by a relatively larger BS, rather than because of restriction,” they said.

The distance to the pylorus (DP) from the staple line initiation point was divided into four sections: less than 4 cm; 4-5 cm; 5-6 cm; and 6 cm or more.

On a patient level, there was no association between DP and leak rates. There was, however, an association with bleeding. A DP of 4-4.99 cm had the highest rate, 90%, while a DP of 5-5.99 cm had the lowest (71%). DP was also associated with weight loss on this level, with a distance of more than 6 cm being associated with the biggest BMI decrease (3.7 points).

“Our data show significantly increased excess weight loss in a stepwise fashion as the DP increases,” the authors said. “Our data suggest that as DP increased, there was an increased excess weight loss, possibly explained by preserving the ‘antral mill.’ Stapling further from the pylorus perhaps keeps the antrum’s functional component intact and allows food to enter the distal gut more quickly, leading to earlier satiety and increased weight loss.”

Only 114 surgeons (8%) used a DP of less than 4 cm. There were no significant associations with any 30-day outcomes and DP after adjustment.

The authors had no financial disclosures.

Laparoscopic sleeve gastrectomy is safe and effective overall, but staple line reinforcement appears to increase the rate of postsurgical leaks – which were associated with readmissions and, in some cases, reoperations.

A large review of quality improvement data found that staple line reinforcement – an extremely common technique – was associated with a 60% increased risk of leak, compared with closures without staple line reinforcement, Elizabeth R. Berger, MD, and her colleagues reported in the October issue of the Annals of Surgery (2016;264:464-73).

“This study also demonstrates that leaks were significantly more morbid than bleeding with higher readmission and reoperation rates in patients with a leak vs. a bleed,” wrote Dr. Berger of Loyola University, Chicago, and her coauthors. “Therefore, a surgeon should consider the benefits, risks, and costs of each surgical technique in performing a laparoscopic sleeve gastrectomy and selectively utilize those that, in their hands, minimize morbidity while maximizing clinical effectiveness.”

The team examined outcomes in 189,477 laparoscopic sleeve gastrectomies performed by 1,634 surgeons at 720 centers from 2012 to 2014. All of the data were extracted from the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program, created in 2012 by the American College of Surgeons and the American Society for Metabolic and Bariatric Surgery.

They examined the impact of staple line reinforcement, oversewing the staple line, bougie size, and distance of the staple line from the pylorus on 30-day outcomes, and their effect on weight loss and weight-related comorbidities at 1 year. Outcomes included morbidity, leak rates, and bleeding, which were examined at both the patient and surgeon levels.

Most patients (126,904; 67%) patients had some type of staple line reinforcement (SLR); the rest had only oversewn staple lines (OSL) or no reinforcement. Leaks occurred in 1,703 patients and bleeds in 1,436 patients. Leaks were more serious than bleeds: Patients with a leak were almost 28% more likely to readmitted and 11% more likely to need a reoperation than were patients who had only a bleed.

At the patient level, those with SLR with or without OSL were 20%-46% more likely to experience a leak than were those who had neither. Bleeding rates were about 70% lower in the SLR groups.

Most surgeons in the analysis (80%) used some type of SLR; almost 20% routinely used only OSL, and 30% routinely used only SLR. At the surgeon level, SLR was associated with a 60% increased risk of a postoperative leak, compared with no reinforcement. There was no association between SLR and bleeding risk, however.

Oversewing had an effect on 1-year weight loss. Patients with oversewn staple lines lost an additional 1.3 points on the body mass index (BMI) scale, compared with patients with no type of reinforcement.

“The reason for increased leaks from SLR is relatively unclear,” the authors wrote. “The two layers of material that are placed within the staple line could increase ischemia or decrease the relative staple heights. At the notches, where one staple firing ends and the next one begins, there is sandwiching of the two layers of staples and a combined four layers of SLR. This bulk may predispose to leaks.”

Larger bougie sizes (BS) seemed more beneficial than did smaller ones, in both the surgeon- and patient-level analyses. A BS of at least 38 French was associated with a 28% decreased risk of a leak (odds ratio 0.72) at the patient level and a 10% decreased risk at the surgeon level (OR 0.90). There were no associations with bleeding.

“Our findings support literature that describes narrower BSs leads to increased ischemia secondary to increased intraluminal pressure, causing more leaks,” the authors wrote.

A BS of at least 40 French had a significant impact on weight loss. At 1 year, patients with the larger BS had lost 2.45 points more on the BMI scale than did those with smaller sizes.

This finding is in accord with other studies, including one that found the best weight-loss outcomes associated with a BS of more than 60 French. “Perhaps the sleeve works because of more rapid emptying, which is favored by a relatively larger BS, rather than because of restriction,” they said.

The distance to the pylorus (DP) from the staple line initiation point was divided into four sections: less than 4 cm; 4-5 cm; 5-6 cm; and 6 cm or more.

On a patient level, there was no association between DP and leak rates. There was, however, an association with bleeding. A DP of 4-4.99 cm had the highest rate, 90%, while a DP of 5-5.99 cm had the lowest (71%). DP was also associated with weight loss on this level, with a distance of more than 6 cm being associated with the biggest BMI decrease (3.7 points).

“Our data show significantly increased excess weight loss in a stepwise fashion as the DP increases,” the authors said. “Our data suggest that as DP increased, there was an increased excess weight loss, possibly explained by preserving the ‘antral mill.’ Stapling further from the pylorus perhaps keeps the antrum’s functional component intact and allows food to enter the distal gut more quickly, leading to earlier satiety and increased weight loss.”

Only 114 surgeons (8%) used a DP of less than 4 cm. There were no significant associations with any 30-day outcomes and DP after adjustment.

The authors had no financial disclosures.