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Insurance-mandated diet pre–bariatric surgery deemed harmful
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.
Dr. Keith presented a retrospective review from the prospectively collected Alabama University bariatric surgery database, which included all 284 patients who underwent laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy during 2009-2013. A total of 79% of the patients had private health insurance that required their participation in a preoperative physician-guided diet program, typically for 6 months. The other 21% did not have a mandatory preoperative diet requirement; the great majority of this group were covered under Medicare, which doesn’t require a diet program before bariatric surgery. The two groups weren’t significantly different in initial or immediately preoperative weight or body mass index, obesity-related comorbid conditions, type of bariatric surgery, or socioeconomic status.
The mean time from initial clinic visit to bariatric surgery was significantly shorter in the group with no mandated preoperative diet, at 154 vs. 218 days. In a multivariate analysis adjusted for age, sex, race, operation type, and comorbidities, the no-mandatory-diet group had a significantly greater reduction in BMI 6 months post surgery: a mean loss of 12.2 kg/m2, compared with 10.9 kg/m2 in the group required to participate in a preoperative diet. The difference was even greater at 2 years follow-up: a mean decrease of 14.9 kg/m2 in the no-diet group, vs. 10.7 kg/m2 in the mandatory diet group. The no-diet group experienced a mean 33% weight loss at 2 years, significantly better than the 25% weight loss in the mandatory diet group, Dr. Keith reported at the meeting, presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
Audience discussion showed that the insurance-mandated preoperative diet requirement is a hot button issue in the bariatric surgical community.
“I think these insurance programs are specifically designed to delay care,” one surgeon asserted.
Another bariatric surgeon commented that while Dr. Keith’s study will be helpful in advocating for removal of the mandatory preoperative diet requirement, what’s really needed are studies that demonstrate just how often this requirement results in drop out from bariatric programs by patients who’ve grown discouraged by yet-another unsuccessful attempt at nonsurgical weight loss.
Dr. Keith reported having no financial conflicts of interest regarding his study.
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.
Dr. Keith presented a retrospective review from the prospectively collected Alabama University bariatric surgery database, which included all 284 patients who underwent laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy during 2009-2013. A total of 79% of the patients had private health insurance that required their participation in a preoperative physician-guided diet program, typically for 6 months. The other 21% did not have a mandatory preoperative diet requirement; the great majority of this group were covered under Medicare, which doesn’t require a diet program before bariatric surgery. The two groups weren’t significantly different in initial or immediately preoperative weight or body mass index, obesity-related comorbid conditions, type of bariatric surgery, or socioeconomic status.
The mean time from initial clinic visit to bariatric surgery was significantly shorter in the group with no mandated preoperative diet, at 154 vs. 218 days. In a multivariate analysis adjusted for age, sex, race, operation type, and comorbidities, the no-mandatory-diet group had a significantly greater reduction in BMI 6 months post surgery: a mean loss of 12.2 kg/m2, compared with 10.9 kg/m2 in the group required to participate in a preoperative diet. The difference was even greater at 2 years follow-up: a mean decrease of 14.9 kg/m2 in the no-diet group, vs. 10.7 kg/m2 in the mandatory diet group. The no-diet group experienced a mean 33% weight loss at 2 years, significantly better than the 25% weight loss in the mandatory diet group, Dr. Keith reported at the meeting, presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
Audience discussion showed that the insurance-mandated preoperative diet requirement is a hot button issue in the bariatric surgical community.
“I think these insurance programs are specifically designed to delay care,” one surgeon asserted.
Another bariatric surgeon commented that while Dr. Keith’s study will be helpful in advocating for removal of the mandatory preoperative diet requirement, what’s really needed are studies that demonstrate just how often this requirement results in drop out from bariatric programs by patients who’ve grown discouraged by yet-another unsuccessful attempt at nonsurgical weight loss.
Dr. Keith reported having no financial conflicts of interest regarding his study.
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.
Dr. Keith presented a retrospective review from the prospectively collected Alabama University bariatric surgery database, which included all 284 patients who underwent laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy during 2009-2013. A total of 79% of the patients had private health insurance that required their participation in a preoperative physician-guided diet program, typically for 6 months. The other 21% did not have a mandatory preoperative diet requirement; the great majority of this group were covered under Medicare, which doesn’t require a diet program before bariatric surgery. The two groups weren’t significantly different in initial or immediately preoperative weight or body mass index, obesity-related comorbid conditions, type of bariatric surgery, or socioeconomic status.
The mean time from initial clinic visit to bariatric surgery was significantly shorter in the group with no mandated preoperative diet, at 154 vs. 218 days. In a multivariate analysis adjusted for age, sex, race, operation type, and comorbidities, the no-mandatory-diet group had a significantly greater reduction in BMI 6 months post surgery: a mean loss of 12.2 kg/m2, compared with 10.9 kg/m2 in the group required to participate in a preoperative diet. The difference was even greater at 2 years follow-up: a mean decrease of 14.9 kg/m2 in the no-diet group, vs. 10.7 kg/m2 in the mandatory diet group. The no-diet group experienced a mean 33% weight loss at 2 years, significantly better than the 25% weight loss in the mandatory diet group, Dr. Keith reported at the meeting, presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
Audience discussion showed that the insurance-mandated preoperative diet requirement is a hot button issue in the bariatric surgical community.
“I think these insurance programs are specifically designed to delay care,” one surgeon asserted.
Another bariatric surgeon commented that while Dr. Keith’s study will be helpful in advocating for removal of the mandatory preoperative diet requirement, what’s really needed are studies that demonstrate just how often this requirement results in drop out from bariatric programs by patients who’ve grown discouraged by yet-another unsuccessful attempt at nonsurgical weight loss.
Dr. Keith reported having no financial conflicts of interest regarding his study.
Key clinical point:
Major finding: At follow-up 2 years after bariatric surgery, patients who were required by their insurance company to participate in a physician-supervised preoperative diet program had an adjusted mean 25% weight loss, a significantly worse outcome than the mean 33% weight loss among patients with no such requirement.
Data source: This was a retrospective analysis of 284 patients in a prospectively collected university bariatric surgery database.
Disclosures: The study presenter reported having no relevant financial interests.
Bariatric surgery or total joint replacement: which first?
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.
“A common complaint of patients presenting with obesity is that their osteoarthritis has limited their mobility and that their weight gain is secondary to that reduced mobility. They believe that a new joint will help them regain their mobility and then lose weight. Interestingly, this does not appear to be the case. In fact, the majority of patients in our study actually gained weight following joint replacement. Given that, these patients need to be weight-optimized prior to total joint replacement. Bariatric surgery is a durable way to facilitate this,” he continued.
Dr. Nearing presented a retrospective observational study of 102 patients who underwent either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy plus a total knee or hip replacement in the Gundersen system. Sixty-six patients had their bariatric surgery first, by a mean of 4.3 years, while the other 36 had arthroplasty a mean of 4.9 years before their bariatric surgery. The two groups were similar in terms of demographics and baseline comorbid conditions.
Patients who had their total joint replacement first had a mean preoperative BMI of 43.7 kg/m2 and a mean pre–bariatric surgery BMI of 46.3 kg/m2. The patients who had bariatric surgery first had a preoperative BMI of 49.6 kg/m2 and a mean pre–orthopedic surgery BMI of 37.6 kgm2. One year after joint replacement surgery, patients who had that operation first had a mean BMI of 43.9 kg/m2, compared with 37.8 kg/m2 for those who waited until after they underwent bariatric surgery.
Mean operative time for total joint replacement when it was the first operation was 113.5 minutes and substantially less at 71 minutes when it was done after bariatric surgery. Mean hospital length of stay for total joint replacement when it followed bariatric surgery was 2.9 days, a full day less than when joint replacement came first.
Rates of complications including skin or soft tissue infection, venous thromboembolism, hematoma, need for transfusion, and periprosthetic infection at 30 and 90 days didn’t differ between the two groups. Neither did the need for late reinterventions.
Dr. Nearing noted that a working group of the American Association of Hip and Knee Surgeons has conducted a review of the orthopedic surgery literature and concluded that all patients with a BMI of 30 kg/m2 or more undergoing total knee or hip arthroplasty are at increased risk for perioperative respiratory complications, thromboembolic events, delayed wound healing, infection, and need for joint revision surgery (J Arthroplasty. 2013 May;28[5]:714-21).
He observed that a retrospective study such as his cannot shed light on the optimal time interval for total joint replacement following bariatric surgery. That key question is being addressed by the ongoing prospective SWIFT (Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty) trial. The study hypothesis is that bariatric surgery prior to the knee replacement surgery will reduce risk and improve long-term outcomes and physical function.
Several audience member commented that, based upon their experience, they would have anticipated that complication rates would have been significantly lower in total joint replacement patients when that operation followed bariatric surgery.
“We were surprised, too,” Dr. Nearing replied. “I think the explanation is that at Gundersen we have three bariatric surgeons and only a handful of orthopedic surgeons, and we use protocols and pathways. We just routinely do our operations the same way each and every time.”
John M. Morton, MD, a former American Society for Metabolic and Bariatric Surgery president, commented that the Gundersen study findings sound a call for more cross-specialty collaboration in steering obese patients with severe knee or hip osteoarthritis to bariatric surgery first in order to maximize the results of the joint replacement surgery.
“I think we’re all seeing weight loss as another form of prehabilitation for other specialties. Our orthopedic colleagues are kind of like us – surgeons – so this seems to be a great place for us to partner with them,” said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Dr. Nearing reported having no financial interests relevant to his study.
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.
“A common complaint of patients presenting with obesity is that their osteoarthritis has limited their mobility and that their weight gain is secondary to that reduced mobility. They believe that a new joint will help them regain their mobility and then lose weight. Interestingly, this does not appear to be the case. In fact, the majority of patients in our study actually gained weight following joint replacement. Given that, these patients need to be weight-optimized prior to total joint replacement. Bariatric surgery is a durable way to facilitate this,” he continued.
Dr. Nearing presented a retrospective observational study of 102 patients who underwent either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy plus a total knee or hip replacement in the Gundersen system. Sixty-six patients had their bariatric surgery first, by a mean of 4.3 years, while the other 36 had arthroplasty a mean of 4.9 years before their bariatric surgery. The two groups were similar in terms of demographics and baseline comorbid conditions.
Patients who had their total joint replacement first had a mean preoperative BMI of 43.7 kg/m2 and a mean pre–bariatric surgery BMI of 46.3 kg/m2. The patients who had bariatric surgery first had a preoperative BMI of 49.6 kg/m2 and a mean pre–orthopedic surgery BMI of 37.6 kgm2. One year after joint replacement surgery, patients who had that operation first had a mean BMI of 43.9 kg/m2, compared with 37.8 kg/m2 for those who waited until after they underwent bariatric surgery.
Mean operative time for total joint replacement when it was the first operation was 113.5 minutes and substantially less at 71 minutes when it was done after bariatric surgery. Mean hospital length of stay for total joint replacement when it followed bariatric surgery was 2.9 days, a full day less than when joint replacement came first.
Rates of complications including skin or soft tissue infection, venous thromboembolism, hematoma, need for transfusion, and periprosthetic infection at 30 and 90 days didn’t differ between the two groups. Neither did the need for late reinterventions.
Dr. Nearing noted that a working group of the American Association of Hip and Knee Surgeons has conducted a review of the orthopedic surgery literature and concluded that all patients with a BMI of 30 kg/m2 or more undergoing total knee or hip arthroplasty are at increased risk for perioperative respiratory complications, thromboembolic events, delayed wound healing, infection, and need for joint revision surgery (J Arthroplasty. 2013 May;28[5]:714-21).
He observed that a retrospective study such as his cannot shed light on the optimal time interval for total joint replacement following bariatric surgery. That key question is being addressed by the ongoing prospective SWIFT (Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty) trial. The study hypothesis is that bariatric surgery prior to the knee replacement surgery will reduce risk and improve long-term outcomes and physical function.
Several audience member commented that, based upon their experience, they would have anticipated that complication rates would have been significantly lower in total joint replacement patients when that operation followed bariatric surgery.
“We were surprised, too,” Dr. Nearing replied. “I think the explanation is that at Gundersen we have three bariatric surgeons and only a handful of orthopedic surgeons, and we use protocols and pathways. We just routinely do our operations the same way each and every time.”
John M. Morton, MD, a former American Society for Metabolic and Bariatric Surgery president, commented that the Gundersen study findings sound a call for more cross-specialty collaboration in steering obese patients with severe knee or hip osteoarthritis to bariatric surgery first in order to maximize the results of the joint replacement surgery.
“I think we’re all seeing weight loss as another form of prehabilitation for other specialties. Our orthopedic colleagues are kind of like us – surgeons – so this seems to be a great place for us to partner with them,” said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Dr. Nearing reported having no financial interests relevant to his study.
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.
“A common complaint of patients presenting with obesity is that their osteoarthritis has limited their mobility and that their weight gain is secondary to that reduced mobility. They believe that a new joint will help them regain their mobility and then lose weight. Interestingly, this does not appear to be the case. In fact, the majority of patients in our study actually gained weight following joint replacement. Given that, these patients need to be weight-optimized prior to total joint replacement. Bariatric surgery is a durable way to facilitate this,” he continued.
Dr. Nearing presented a retrospective observational study of 102 patients who underwent either laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy plus a total knee or hip replacement in the Gundersen system. Sixty-six patients had their bariatric surgery first, by a mean of 4.3 years, while the other 36 had arthroplasty a mean of 4.9 years before their bariatric surgery. The two groups were similar in terms of demographics and baseline comorbid conditions.
Patients who had their total joint replacement first had a mean preoperative BMI of 43.7 kg/m2 and a mean pre–bariatric surgery BMI of 46.3 kg/m2. The patients who had bariatric surgery first had a preoperative BMI of 49.6 kg/m2 and a mean pre–orthopedic surgery BMI of 37.6 kgm2. One year after joint replacement surgery, patients who had that operation first had a mean BMI of 43.9 kg/m2, compared with 37.8 kg/m2 for those who waited until after they underwent bariatric surgery.
Mean operative time for total joint replacement when it was the first operation was 113.5 minutes and substantially less at 71 minutes when it was done after bariatric surgery. Mean hospital length of stay for total joint replacement when it followed bariatric surgery was 2.9 days, a full day less than when joint replacement came first.
Rates of complications including skin or soft tissue infection, venous thromboembolism, hematoma, need for transfusion, and periprosthetic infection at 30 and 90 days didn’t differ between the two groups. Neither did the need for late reinterventions.
Dr. Nearing noted that a working group of the American Association of Hip and Knee Surgeons has conducted a review of the orthopedic surgery literature and concluded that all patients with a BMI of 30 kg/m2 or more undergoing total knee or hip arthroplasty are at increased risk for perioperative respiratory complications, thromboembolic events, delayed wound healing, infection, and need for joint revision surgery (J Arthroplasty. 2013 May;28[5]:714-21).
He observed that a retrospective study such as his cannot shed light on the optimal time interval for total joint replacement following bariatric surgery. That key question is being addressed by the ongoing prospective SWIFT (Surgical Weight-Loss to Improve Functional Status Trajectories Following Total Knee Arthroplasty) trial. The study hypothesis is that bariatric surgery prior to the knee replacement surgery will reduce risk and improve long-term outcomes and physical function.
Several audience member commented that, based upon their experience, they would have anticipated that complication rates would have been significantly lower in total joint replacement patients when that operation followed bariatric surgery.
“We were surprised, too,” Dr. Nearing replied. “I think the explanation is that at Gundersen we have three bariatric surgeons and only a handful of orthopedic surgeons, and we use protocols and pathways. We just routinely do our operations the same way each and every time.”
John M. Morton, MD, a former American Society for Metabolic and Bariatric Surgery president, commented that the Gundersen study findings sound a call for more cross-specialty collaboration in steering obese patients with severe knee or hip osteoarthritis to bariatric surgery first in order to maximize the results of the joint replacement surgery.
“I think we’re all seeing weight loss as another form of prehabilitation for other specialties. Our orthopedic colleagues are kind of like us – surgeons – so this seems to be a great place for us to partner with them,” said Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.
Dr. Nearing reported having no financial interests relevant to his study.
AT OBESITY WEEK 2016
Key clinical point:
Major finding: When total joint replacement in obese patients was performed after bariatric surgery, mean hospital length of stay was a full day less than when the orthopedic surgery preceded the bariatric surgery.
Data source: This retrospective observational study included 102 obese patients who underwent bariatric surgery and total knee or hip replacement.
Disclosures: The study presenter reported having no financial conflicts of interest.
What referring physicians need to know about bariatric surgery success rates
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.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
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.
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.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
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.
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.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
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.
OBESITY WEEK 2016
Key clinical point:
Major finding: Patients who underwent bariatric surgery when their BMI was 40 kg/m2 or below were 13.3-fold more likely to have a BMI below 30 kg/m2 1 year later.
Data source: A study of 1-year outcomes in nearly 20,000 patients in the Michigan Bariatric Surgery Collaborative database.
Disclosures: The study presenter reported receiving research funding from Blue Cross Blue Shield of Michigan.
VIDEO: Bariatric surgery may protect against heart failure
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.
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.
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.
AT THE AHA SCIENTIFIC SESSIONS 2016
Key clinical point:
Major finding: The incidence of new-onset heart failure was 46% lower during follow-up after bariatric surgery than among participants in an intensive lifestyle modification program for weight loss.
Data source: This observational registry study followed nearly 26,000 Swedish bariatric surgery patients and 14,000 matched participants in a commercial intensive lifestyle modification program for a median of 4.1 years.
Disclosures: The study was funded by the U.S. National Institutes of Diabetes and Digestive and Kidney Diseases, Uppsala University, the Karolinska Institute, and the Swedish Research Council. The presenter reported serving as a scientific advisor to Itrim.
Readmissions after bariatric surgery more common among black patients
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.”
Black patients undergoing Roux-en-Y bypass were significantly younger (43 vs. 45 years), and more often women (86% vs. 78%). They also had significantly higher body mass index than did white patients (48 vs. 46 kg/m2). More black individuals had a BMI of 50 kg/m2 or higher.
There were no significant differences in the severity of comorbidities. About 70% of each group had severe comorbidities as classified by the American Anesthesiologists Society risk assessment profile.
However, those comorbidities were different. Among black patients, steroid use, heart failure, hypertension, and end-stage renal disease were significantly more common. Among white patients, chronic obstructive pulmonary disease and bleeding disorders were more common.
There were no differences in 30-day mortality (less than 1% of each group); serious morbidity (3%) or any morbidity (5%); length of stay (2.4 days); or reoperation (2.6%).
However, readmissions were significantly more likely among black patients (8% vs. 5.6%). This translated to a 29% increased risk of readmission (OR 1.29).
Compared to whites, blacks who had a laparoscopic vertical sleeve gastrectomy were also significantly younger (42 vs. 45 years); more often women (87% vs. 76%); and heavier (BMI 47 vs. 45 kg/m2). Again, they were more likely to have a BMI of more than 50 kg/m2 (28% vs. 21%).
Significantly more were in the ASA class 3 of severe comorbidities (70% vs.66%). There were also differences in the comorbidities, with blacks more likely to have heart failure, hypertension, and end-stage renal disease, and whites more likely to have diabetes, smoking, dyspnea, and chronic obstructive pulmonary disease.
Among these patients, 30-day mortality was not different (less than 1%). Serious morbidity was also similar (about 2%), as was any morbidity (about 3%). The reoperation rate was the same (1.2%).
Length of stay was longer among black patients but this was not clinically significant, Dr. Whealon said: It still hovered right around 2 days.
But readmissions were significantly more common among blacks (5% vs. 3%). This difference translated to a 35% increased risk of readmission (odds ratio 1.35).
The nature of the NSQIP data makes it impossible to tease out any other factors that might have contributed to this finding. However, Dr. Whealon said, the equivalent findings on morbidity and mortality are very encouraging and represent a big improvement.
“We have done very well in driving down morbidity and mortality among these patients. Mortality rates are one tenth of what we were seeing a decade ago.”
This change hasn’t been well documented yet because many of the large studies showing racial and ethnic mortality disparities include data drawn from open bariatric surgery, which has been almost completely abandoned in favor of the much safer laparoscopic approaches.
Dr. Whealon had no financial disclosures.
msullivan@frontlinemedcom.com
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.”
Black patients undergoing Roux-en-Y bypass were significantly younger (43 vs. 45 years), and more often women (86% vs. 78%). They also had significantly higher body mass index than did white patients (48 vs. 46 kg/m2). More black individuals had a BMI of 50 kg/m2 or higher.
There were no significant differences in the severity of comorbidities. About 70% of each group had severe comorbidities as classified by the American Anesthesiologists Society risk assessment profile.
However, those comorbidities were different. Among black patients, steroid use, heart failure, hypertension, and end-stage renal disease were significantly more common. Among white patients, chronic obstructive pulmonary disease and bleeding disorders were more common.
There were no differences in 30-day mortality (less than 1% of each group); serious morbidity (3%) or any morbidity (5%); length of stay (2.4 days); or reoperation (2.6%).
However, readmissions were significantly more likely among black patients (8% vs. 5.6%). This translated to a 29% increased risk of readmission (OR 1.29).
Compared to whites, blacks who had a laparoscopic vertical sleeve gastrectomy were also significantly younger (42 vs. 45 years); more often women (87% vs. 76%); and heavier (BMI 47 vs. 45 kg/m2). Again, they were more likely to have a BMI of more than 50 kg/m2 (28% vs. 21%).
Significantly more were in the ASA class 3 of severe comorbidities (70% vs.66%). There were also differences in the comorbidities, with blacks more likely to have heart failure, hypertension, and end-stage renal disease, and whites more likely to have diabetes, smoking, dyspnea, and chronic obstructive pulmonary disease.
Among these patients, 30-day mortality was not different (less than 1%). Serious morbidity was also similar (about 2%), as was any morbidity (about 3%). The reoperation rate was the same (1.2%).
Length of stay was longer among black patients but this was not clinically significant, Dr. Whealon said: It still hovered right around 2 days.
But readmissions were significantly more common among blacks (5% vs. 3%). This difference translated to a 35% increased risk of readmission (odds ratio 1.35).
The nature of the NSQIP data makes it impossible to tease out any other factors that might have contributed to this finding. However, Dr. Whealon said, the equivalent findings on morbidity and mortality are very encouraging and represent a big improvement.
“We have done very well in driving down morbidity and mortality among these patients. Mortality rates are one tenth of what we were seeing a decade ago.”
This change hasn’t been well documented yet because many of the large studies showing racial and ethnic mortality disparities include data drawn from open bariatric surgery, which has been almost completely abandoned in favor of the much safer laparoscopic approaches.
Dr. Whealon had no financial disclosures.
msullivan@frontlinemedcom.com
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.”
Black patients undergoing Roux-en-Y bypass were significantly younger (43 vs. 45 years), and more often women (86% vs. 78%). They also had significantly higher body mass index than did white patients (48 vs. 46 kg/m2). More black individuals had a BMI of 50 kg/m2 or higher.
There were no significant differences in the severity of comorbidities. About 70% of each group had severe comorbidities as classified by the American Anesthesiologists Society risk assessment profile.
However, those comorbidities were different. Among black patients, steroid use, heart failure, hypertension, and end-stage renal disease were significantly more common. Among white patients, chronic obstructive pulmonary disease and bleeding disorders were more common.
There were no differences in 30-day mortality (less than 1% of each group); serious morbidity (3%) or any morbidity (5%); length of stay (2.4 days); or reoperation (2.6%).
However, readmissions were significantly more likely among black patients (8% vs. 5.6%). This translated to a 29% increased risk of readmission (OR 1.29).
Compared to whites, blacks who had a laparoscopic vertical sleeve gastrectomy were also significantly younger (42 vs. 45 years); more often women (87% vs. 76%); and heavier (BMI 47 vs. 45 kg/m2). Again, they were more likely to have a BMI of more than 50 kg/m2 (28% vs. 21%).
Significantly more were in the ASA class 3 of severe comorbidities (70% vs.66%). There were also differences in the comorbidities, with blacks more likely to have heart failure, hypertension, and end-stage renal disease, and whites more likely to have diabetes, smoking, dyspnea, and chronic obstructive pulmonary disease.
Among these patients, 30-day mortality was not different (less than 1%). Serious morbidity was also similar (about 2%), as was any morbidity (about 3%). The reoperation rate was the same (1.2%).
Length of stay was longer among black patients but this was not clinically significant, Dr. Whealon said: It still hovered right around 2 days.
But readmissions were significantly more common among blacks (5% vs. 3%). This difference translated to a 35% increased risk of readmission (odds ratio 1.35).
The nature of the NSQIP data makes it impossible to tease out any other factors that might have contributed to this finding. However, Dr. Whealon said, the equivalent findings on morbidity and mortality are very encouraging and represent a big improvement.
“We have done very well in driving down morbidity and mortality among these patients. Mortality rates are one tenth of what we were seeing a decade ago.”
This change hasn’t been well documented yet because many of the large studies showing racial and ethnic mortality disparities include data drawn from open bariatric surgery, which has been almost completely abandoned in favor of the much safer laparoscopic approaches.
Dr. Whealon had no financial disclosures.
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
AT THE ACS CLINICAL CONGRESS
Key clinical point:
Major finding: Black patients were 29% more likely to be readmitted after Roux-en-Y and 35% more likely to be readmitted after sleeve gastrectomy.
Data source: The NSQIP database review comprised about 62,000 surgeries.
Disclosures: Dr. Whealon had no financial disclosures.
Weight loss procedure is linked to subsequent substance misuse
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.
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.
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.
AT OBESITY WEEK 2016
Key clinical point:
Major finding: In the first 5 years following bariatric surgery, patients who underwent Roux-en-Y gastric bypass were twice as likely to develop new-onset alcohol use disorder and nearly four times more likely to be treated for substance use disorder, compared with recipients of laparoscopic gastric banding.
Data source: The LABS-2 study is an observational cohort study involving more than 2,000 patients in long-term follow-up after undergoing Roux-en-Y gastric bypass or laparoscopic adjustable banding.
Disclosures: LABS-2 is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The presenter reported having no relevant financial interests.
Staple line reinforcement linked to increased leak risk in bariatric surgery
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.
Before drawing overarching conclusions and implementing recommendations based on this study, there are several limitations that must be borne in mind when considering data-mining exercises such as this one:
• It should be taken into account that there was significant intraoperative variation in technique and experience among the surgeons that was not captured through the data acquisition.
• Similarly, the true distance between the stapler and the selected bougie is also variable, adding an inherent lack of accuracy of the true real diameter of the completed gastric tube.
• There is a lack of granular information, including the type of SLR or staplers used, thereby also limiting any reliable conclusions that could be drawn.
• There are additional techniques, such as omental buttressing, and the use of clips, sutures, or hemostatic agents that are not reported, yet may have an impact on leak and bleeding rates.
• The reported follow-up rate of 39.4% at 1 year is typically considered to be suboptimal.
• SLR techniques may also include oversewing, and these are also subject to wide variation, including the type of suture material used, and the actual suturing technique that was implemented.
• Only those patients whose bleeding was severe enough to warrant transfusions were included, such that lower level bleeding would have not been represented in this report.
• There were also deficiencies in correlating leaks or bleeding rates with staple height selection, or the experience and learning curve of the surgeon.
Samer Mattar, MD, is a bariatric surgeon and professor of surgery at Oregon Health and Science University, Portland. Dr. Mattar has no disclosures.
Before drawing overarching conclusions and implementing recommendations based on this study, there are several limitations that must be borne in mind when considering data-mining exercises such as this one:
• It should be taken into account that there was significant intraoperative variation in technique and experience among the surgeons that was not captured through the data acquisition.
• Similarly, the true distance between the stapler and the selected bougie is also variable, adding an inherent lack of accuracy of the true real diameter of the completed gastric tube.
• There is a lack of granular information, including the type of SLR or staplers used, thereby also limiting any reliable conclusions that could be drawn.
• There are additional techniques, such as omental buttressing, and the use of clips, sutures, or hemostatic agents that are not reported, yet may have an impact on leak and bleeding rates.
• The reported follow-up rate of 39.4% at 1 year is typically considered to be suboptimal.
• SLR techniques may also include oversewing, and these are also subject to wide variation, including the type of suture material used, and the actual suturing technique that was implemented.
• Only those patients whose bleeding was severe enough to warrant transfusions were included, such that lower level bleeding would have not been represented in this report.
• There were also deficiencies in correlating leaks or bleeding rates with staple height selection, or the experience and learning curve of the surgeon.
Samer Mattar, MD, is a bariatric surgeon and professor of surgery at Oregon Health and Science University, Portland. Dr. Mattar has no disclosures.
Before drawing overarching conclusions and implementing recommendations based on this study, there are several limitations that must be borne in mind when considering data-mining exercises such as this one:
• It should be taken into account that there was significant intraoperative variation in technique and experience among the surgeons that was not captured through the data acquisition.
• Similarly, the true distance between the stapler and the selected bougie is also variable, adding an inherent lack of accuracy of the true real diameter of the completed gastric tube.
• There is a lack of granular information, including the type of SLR or staplers used, thereby also limiting any reliable conclusions that could be drawn.
• There are additional techniques, such as omental buttressing, and the use of clips, sutures, or hemostatic agents that are not reported, yet may have an impact on leak and bleeding rates.
• The reported follow-up rate of 39.4% at 1 year is typically considered to be suboptimal.
• SLR techniques may also include oversewing, and these are also subject to wide variation, including the type of suture material used, and the actual suturing technique that was implemented.
• Only those patients whose bleeding was severe enough to warrant transfusions were included, such that lower level bleeding would have not been represented in this report.
• There were also deficiencies in correlating leaks or bleeding rates with staple height selection, or the experience and learning curve of the surgeon.
Samer Mattar, MD, is a bariatric surgeon and professor of surgery at Oregon Health and Science University, Portland. Dr. Mattar has no 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.
FROM THE ANNALS OF SURGERY
Key clinical point:
Major finding: Compared to not reinforcing the staple line, doing sow as associated with up to a 60% increase in the risk of a postsurgical leak.
Data source: The database review contained outcomes on 189,477 laparoscopic sleeve gastrectomies.
Disclosures: None of the study authors had any financial disclosures.
VIDEO: Pre–gastric bypass antibiotics alter gut microbiome
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
WASHINGTON – Antibiotics given in advance of gastric bypass surgery preferentially alter the microbiome, nudging it toward a more “lean” physiologic profile.
Given before a sleeve gastrectomy, vancomycin, which has little gut penetration, barely shifted the high ratio of Firmicutes to Bacteroidetes, a profile typically associated with obesity and insulin resistance. But cefazolin, which has much higher gut penetration, suppressed the presence of Firmicutes, which metabolize fat, and allowed the expansion of carbohydrate-loving Bacteroidetes – a profile generally seen in lean people.
Cyrus Jahansouz, MD, of the University of Minnesota, Minneapolis, and his colleagues wanted to examine whether a shift in preoperative antibiotics might affect the way the microbiome re-establishes itself in the wake of vertical sleeve gastrectomy. They enrolled 32 patients who were candidates for the procedure. None had undergone prior gastrointestinal surgery, and none had been exposed to antibiotics in the 3 months prior to bariatric surgery. They were similar in age, weight, body mass index, and fasting glucose. The mean HbA1c was about 6%.
Patients were randomized to three groups: maximal diet therapy (800 calories per day) without surgery; vertical sleeve gastrectomy with the usual preoperative antibiotic cefazolin and the postsurgical diet; and vertical sleeve gastrectomy with preoperative vancomycin and the postsurgical diet. All patients gave a fecal sample immediately before surgery and another one 6 days after surgery.
Preoperative cluster analysis of bacterial DNA showed that all of the samples had a similar composition, predominated by Firmicutes species (60%-70%). Bacteroidetes species made up about 20%-30%, with Proteobacteriae, Actinobacteriae, Verrucomicrobia, and other phyla comprising the remainder of the microbiome.
At the second sampling, the diet-only group showed no microbiome changes at all. The vancomycin group showed a very small but not significant expansion of Bacteroidetes and reduction of Firmicutes.
Patients in the cefazolin group showed a significant shift in the ratio – and it was quite striking, Dr. Jahansouz said. Among these patients, Firmicutes had decreased from 70% to 40% of the community. Bacteroidetes showed a corresponding shift, increasing from 20% of the community to 45%. The findings are quite surprising, he noted, considering that only one dose of antibiotic was associated with the changes and that they were evident within just a few days.
Although “a little hard to interpret” because of its small size and short follow-up, the study suggests that antibiotic choice might contribute to the success of weight-loss surgery, Dr. Jahansouz said at the annual clinical congress of the American College of Surgeons.
“There are still several factors in the perioperative period that we have to study to be able to identify what other things might have also influenced the shift,” he said in an interview. “But I do think that, in the future, these changes can be manipulated to benefit metabolic outcomes.”
Two phyla – Bacteroidetes and Firmicutes – dominate the human gut microbiome in a dynamic ratio that is highly associated with the way energy is extracted from food. Bacteroidetes species specialize in carbohydrate digestion and Firmicutes in fat digestion. “In a lean, insulin-sensitive state, Bacteroidetes dominates the human gut microbiome,” Dr. Jahansouz said. “With the progression of obesity and insulin resistance, there is a subsequent shift in the microbiome phenotype, favoring the growth of Firmicutes at the expense and reduction of Bacteroidetes. This is a significant change, because this obesity-associated phenotype has an increased capacity to harvest energy. It’s not the same for a lean person to consume 1,000 calories as it is for an obese person to consume them.”
Bariatric surgery has been shown to alter the gut microbiome, shifting it toward this more “lean” profile (Cell Metab. 2015 Aug 4;22[2]:228-38). This shift may be an important component of the still not fully elucidated mechanisms by which bariatric surgery causes weight loss and normalizes insulin signaling, Dr. Jahansouz said.
Dr. Jahansouz is following this group of patients to explore whether there are differences in weight loss and insulin signaling. He also will track whether the microbiome stabilizes at its early postsurgical profile, or continues to shift, either toward an even higher Bacteroidetes to Firmicutes ratio, or back to a more “obese” profile.
He and his colleagues are also investigating the effect of antibiotics and gastric bypass surgery in mouse models. “I can say that antibiotics seem to have a remarkable impact on the effect of mouse sleeve gastrectomy. We’re not quite there yet with humans,” but the data are compelling.
Dr. Jahansouz said that he had no financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
msullivan@frontlinemedcom.com
On Twitter @Alz_Gal
EXPERT ANALYSIS FROM THE ACS CLINICAL CONGRESS
Patient-reported outcomes tied to long-term outcomes in bariatric surgery
Clinical outcomes of surgery and patient-reported outcomes of function, disability, and health status are two different measures of surgical success.
A large study of patients who had bariatric surgery showed that patient-reported outcomes were correlated with long-term weight loss but not with short-term complication rates. In addition, obesity-specific patient-reported quality of life scores were associated with a reduction in medications required for the treatment of obesity-related conditions.
“Clinical outcomes, such as perioperative morbidity and mortality, are commonly used to benchmark hospital performance,” reported Jennifer F. Waljee, MD, and her associates at the University of Michigan, Ann Arbor (Ann Surg. 2016. doi: 10.1097/SLA.0000000000001852).
“However, for many surgical procedures, such as bariatric surgery ... complications may be rare, and may not entirely reflect treatment effectiveness. Alternatively, patient-reported measures of function, disability, and health status may offer a unique and more reliable assessment of provider quality and performance,” she explained. Yet despite growing interest in using patient-reported measures, many important questions regarding their accuracy, applicability, and clinical utility remain. The purpose of this study was, therefore, to evaluate how patient-reported quality of life measures compared to short-term and long-term clinical outcomes in patients who underwent bariatric surgery.
The majority of the study’s 11,420 participants were female (79.8%), were white (84.1%), and underwent Roux-en-Y laparoscopic gastric bypass (56.8%). For each study participant, both short-term and long-term clinical outcome measures were obtained from medical board review. Short-term clinical outcomes were defined as the rate of perioperative complications within 30 days of bariatric surgery. Percent excess weight loss at 1 year post surgery was used as a long-term clinical outcome.
In addition, two patient-reported outcomes were collected: an overall health-related quality of life score called the Health and Activities Limitations Index (HALex) and an obesity-specific quality of life score, the Bariatric Quality of Life (BQL) index, which measures well-being, social and physical functioning, and obesity-related symptoms.
Multivariate and linear regression models demonstrated that short-term complication rates were not correlated to the overall patient-reported quality of life score (P = .32) or to the obesity-specific BQL score (P = .74).
However, the long-term measure of excess weight loss at 1 year post surgery was significantly associated with both overall and obesity-specific patient-reported measures of health-related quality of life (P less than .002 and P less than .001 respectively).
Moreover, scores indicating improved quality of life were associated with greater weight loss.
Finally, comorbidity resolution, estimated by the reduction in the use of medications taken to treat conditions related to obesity, was significantly associated with the obesity-specific measure, BQL, but not the overall quality of life measure, HALex.
“In conclusion, [patient-reported outcomes] are distinct from clinical outcomes,” investigators wrote. Patient-reported outcomes “provide an opportunity for improved population-based cost-effectiveness analyses using outcomes germane to procedures performed for symptomatology and improving QOL,” they added.
The Agency for Healthcare Research and Quality supported the research. The investigators reported having no disclosures.
On Twitter @jessnicolecraig
Clinical outcomes of surgery and patient-reported outcomes of function, disability, and health status are two different measures of surgical success.
A large study of patients who had bariatric surgery showed that patient-reported outcomes were correlated with long-term weight loss but not with short-term complication rates. In addition, obesity-specific patient-reported quality of life scores were associated with a reduction in medications required for the treatment of obesity-related conditions.
“Clinical outcomes, such as perioperative morbidity and mortality, are commonly used to benchmark hospital performance,” reported Jennifer F. Waljee, MD, and her associates at the University of Michigan, Ann Arbor (Ann Surg. 2016. doi: 10.1097/SLA.0000000000001852).
“However, for many surgical procedures, such as bariatric surgery ... complications may be rare, and may not entirely reflect treatment effectiveness. Alternatively, patient-reported measures of function, disability, and health status may offer a unique and more reliable assessment of provider quality and performance,” she explained. Yet despite growing interest in using patient-reported measures, many important questions regarding their accuracy, applicability, and clinical utility remain. The purpose of this study was, therefore, to evaluate how patient-reported quality of life measures compared to short-term and long-term clinical outcomes in patients who underwent bariatric surgery.
The majority of the study’s 11,420 participants were female (79.8%), were white (84.1%), and underwent Roux-en-Y laparoscopic gastric bypass (56.8%). For each study participant, both short-term and long-term clinical outcome measures were obtained from medical board review. Short-term clinical outcomes were defined as the rate of perioperative complications within 30 days of bariatric surgery. Percent excess weight loss at 1 year post surgery was used as a long-term clinical outcome.
In addition, two patient-reported outcomes were collected: an overall health-related quality of life score called the Health and Activities Limitations Index (HALex) and an obesity-specific quality of life score, the Bariatric Quality of Life (BQL) index, which measures well-being, social and physical functioning, and obesity-related symptoms.
Multivariate and linear regression models demonstrated that short-term complication rates were not correlated to the overall patient-reported quality of life score (P = .32) or to the obesity-specific BQL score (P = .74).
However, the long-term measure of excess weight loss at 1 year post surgery was significantly associated with both overall and obesity-specific patient-reported measures of health-related quality of life (P less than .002 and P less than .001 respectively).
Moreover, scores indicating improved quality of life were associated with greater weight loss.
Finally, comorbidity resolution, estimated by the reduction in the use of medications taken to treat conditions related to obesity, was significantly associated with the obesity-specific measure, BQL, but not the overall quality of life measure, HALex.
“In conclusion, [patient-reported outcomes] are distinct from clinical outcomes,” investigators wrote. Patient-reported outcomes “provide an opportunity for improved population-based cost-effectiveness analyses using outcomes germane to procedures performed for symptomatology and improving QOL,” they added.
The Agency for Healthcare Research and Quality supported the research. The investigators reported having no disclosures.
On Twitter @jessnicolecraig
Clinical outcomes of surgery and patient-reported outcomes of function, disability, and health status are two different measures of surgical success.
A large study of patients who had bariatric surgery showed that patient-reported outcomes were correlated with long-term weight loss but not with short-term complication rates. In addition, obesity-specific patient-reported quality of life scores were associated with a reduction in medications required for the treatment of obesity-related conditions.
“Clinical outcomes, such as perioperative morbidity and mortality, are commonly used to benchmark hospital performance,” reported Jennifer F. Waljee, MD, and her associates at the University of Michigan, Ann Arbor (Ann Surg. 2016. doi: 10.1097/SLA.0000000000001852).
“However, for many surgical procedures, such as bariatric surgery ... complications may be rare, and may not entirely reflect treatment effectiveness. Alternatively, patient-reported measures of function, disability, and health status may offer a unique and more reliable assessment of provider quality and performance,” she explained. Yet despite growing interest in using patient-reported measures, many important questions regarding their accuracy, applicability, and clinical utility remain. The purpose of this study was, therefore, to evaluate how patient-reported quality of life measures compared to short-term and long-term clinical outcomes in patients who underwent bariatric surgery.
The majority of the study’s 11,420 participants were female (79.8%), were white (84.1%), and underwent Roux-en-Y laparoscopic gastric bypass (56.8%). For each study participant, both short-term and long-term clinical outcome measures were obtained from medical board review. Short-term clinical outcomes were defined as the rate of perioperative complications within 30 days of bariatric surgery. Percent excess weight loss at 1 year post surgery was used as a long-term clinical outcome.
In addition, two patient-reported outcomes were collected: an overall health-related quality of life score called the Health and Activities Limitations Index (HALex) and an obesity-specific quality of life score, the Bariatric Quality of Life (BQL) index, which measures well-being, social and physical functioning, and obesity-related symptoms.
Multivariate and linear regression models demonstrated that short-term complication rates were not correlated to the overall patient-reported quality of life score (P = .32) or to the obesity-specific BQL score (P = .74).
However, the long-term measure of excess weight loss at 1 year post surgery was significantly associated with both overall and obesity-specific patient-reported measures of health-related quality of life (P less than .002 and P less than .001 respectively).
Moreover, scores indicating improved quality of life were associated with greater weight loss.
Finally, comorbidity resolution, estimated by the reduction in the use of medications taken to treat conditions related to obesity, was significantly associated with the obesity-specific measure, BQL, but not the overall quality of life measure, HALex.
“In conclusion, [patient-reported outcomes] are distinct from clinical outcomes,” investigators wrote. Patient-reported outcomes “provide an opportunity for improved population-based cost-effectiveness analyses using outcomes germane to procedures performed for symptomatology and improving QOL,” they added.
The Agency for Healthcare Research and Quality supported the research. The investigators reported having no disclosures.
On Twitter @jessnicolecraig
FROM ANNALS OF SURGERY
Key clinical point: Patient-reported quality of life measures were associated with long-term but not short-term clinical outcomes.
Major finding: Overall and obesity-specific patient-reported quality of life scores were associated with long-term excess weight loss (P less than .002 and P less than .001 respectively).
Data source: A retrospective study of 11,420 patients who underwent bariatric surgery.
Disclosures: The Agency for Healthcare Research and Quality supported the study. The investigators reported having no disclosures.
Endobariatrics: Coming to a clinic near you
SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.
The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.
“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.
Dr. Edmundowicz reviewed the latest developments presented at DDW.
Self-assembling magnets for dual-path enteral anastomoses
The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.
In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.
“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.
Duodenal mucosal resurfacing
The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.
Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.
There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.
Gastric balloons
Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.
The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.
“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.
Aspiration therapy
With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.
One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.
“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.
SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.
The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.
“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.
Dr. Edmundowicz reviewed the latest developments presented at DDW.
Self-assembling magnets for dual-path enteral anastomoses
The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.
In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.
“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.
Duodenal mucosal resurfacing
The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.
Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.
There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.
Gastric balloons
Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.
The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.
“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.
Aspiration therapy
With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.
One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.
“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.
SAN DIEGO – Device companies are working hard to bring obesity management to the endoscopy suite.
The field is called endobariatrics, and its goal is to fill the gap between surgery and pharmacotherapy. Drugs and lifestyle counseling don’t work too well, but a lot of people don’t want to go under the knife, so something is needed in the middle. Endobariatrics has the potential to be a boon for both obese patients and gastroenterology practices.
Several new investigational devices and approaches were showcased at the annual Digestive Disease Week; some “are beginning to approach the kind of results we see with surgical techniques,” said Steven Edmundowicz, MD, medical director of the University of Colorado Digestive Health Center, Aurora.
“We are seeing a tremendous amount of development in this space, but it’s early, and we have to be cautious,” he said. There have already been a few disappointments, including the EndoBarrier, a fluoropolymer liner anchored in the duodenal bulb and unfurled down the duodenum to block food absorption. A key U.S. trial was recently halted due to liver abscesses.
Dr. Edmundowicz reviewed the latest developments presented at DDW.
Self-assembling magnets for dual-path enteral anastomoses
The goal of the GI Windows system is to create a partial jejunoileal, side to side bypass without surgery. A 28-mm magnet ring is introduced to the ileum by colonoscopy, and a second ring to the jejunum by endoscopy. The rings snap together and tissue caught between them dies from pressure necrosis, leaving patients with a jejunoileal communication. Once food reaches that point, it either diverts through the anastomosis or continues past it down the digestive track. The magnets pass after the anastomosis forms in a week or so.
In a 6-month feasibility study from the Czech Republic, 10 obese patients lost 28.3% of their excess weight without diet restrictions. Those with diabetes had a mean hemoglobin A1c drop of 1.8%, and normalization of fasting blood glucose levels. The procedure took just over an hour and a half after the first five cases.
“I am very excited about [this]; I really want to see where the data are going,” Dr. Edmundowicz said.
Duodenal mucosal resurfacing
The idea of the Revita System (Fractyl) is to ablate “diabetic mucosa” in the duodenum so that normal mucosa can replace it. Saline is injected endoscopically under a portion of the duodenal mucosa to lift it off the muscularis; once isolated, the mucosa is destroyed – some in the audience thought “cooked” was a better word – by exposure to a hot water balloon catheter threaded into the lumen.
Thirty-nine overweight or obese type 2 diabetics had a 1.2% improvement at 6 months from a baseline hemoglobin A1c of 9.6% in a series from Santiago, Chile. Weight loss was modest in the trial; the system is being developed for type 2 diabetics.
There is some histologic support for the notion of a diabetic mucosa with both structural and hormonal aberrations, but it’s unclear if it’s a sign or cause of sickness. Even so, “the mucosa regenerates” and won’t be diabetic “for a while” after the procedure, said investigator Manoel Galvao Neto, MD, of the Gastro Obeso Center, São Paulo.
Gastric balloons
Inflating a balloon in the stomach to make people feel full isn’t new, but the notion of putting the balloon into a capsule that patients can swallow and inflating it through a tether is a more recent notion.
The Obalon (Obalon Therapeutics) is one such device. In an unblinded, sham-controlled trial with 336 obese patients, subjects who got the 250-mL, nitrogen-filled Obalons – most received three – lost about 3% more of their total body weight at 24 weeks than those who did not. Although swallowed, Obalon is removed endoscopically. Meanwhile, 34 obese patients who swallowed the 550-mL, fluid-filled Elipse balloon (Allurion) had a total body weight loss of 9.5% and mean excess weight loss of 37.2% at 4 months, by which time Elipse deflates on its own and passes without endoscopic retrieval.
“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.
Aspiration therapy
With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.
One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.
“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.
AT DDW® 2016
