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GBS in T2DM patients: Study highlights pros and cons, need for better patient selection

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Gastric bypass surgery lowers the risk of all-cause mortality and cardiovascular disease and also has beneficial effects on severe kidney disease in obese patients with type 2 diabetes mellitus (T2DM), but the risk for a number of short-term complications is high, according to a nationwide, matched, observational cohort study in Sweden.

After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.


Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.

“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.

Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.

However, numerous adverse events occurred more often in case patients, he said.

For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.


Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.

The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.

This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.

“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.

“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.

Dr. Liakopoulos reported having no disclosures.

[email protected]

SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.

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Gastric bypass surgery lowers the risk of all-cause mortality and cardiovascular disease and also has beneficial effects on severe kidney disease in obese patients with type 2 diabetes mellitus (T2DM), but the risk for a number of short-term complications is high, according to a nationwide, matched, observational cohort study in Sweden.

After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.


Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.

“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.

Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.

However, numerous adverse events occurred more often in case patients, he said.

For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.


Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.

The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.

This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.

“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.

“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.

Dr. Liakopoulos reported having no disclosures.

[email protected]

SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.

 

Gastric bypass surgery lowers the risk of all-cause mortality and cardiovascular disease and also has beneficial effects on severe kidney disease in obese patients with type 2 diabetes mellitus (T2DM), but the risk for a number of short-term complications is high, according to a nationwide, matched, observational cohort study in Sweden.

After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.


Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.

“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.

Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.

However, numerous adverse events occurred more often in case patients, he said.

For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.


Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.

The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.

This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.

“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.

“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.

Dr. Liakopoulos reported having no disclosures.

[email protected]

SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.

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Key clinical point: Bariatric surgery lowers mortality, CVD, and renal and other risks in obese T2DM patients but also has high complication rates.

Major finding: All-cause mortality, CVD, and renal disease risks were 49%, 34%, and 42% lower, respectively, in cases vs. controls.

Study details: A matched observational cohort study of 5,321 cases and 5,321 controls.

Disclosures: Dr. Liakopoulos reported having no disclosures.

Source: Liakopoulos V et al. ADA 2018, Abstract 131-OR.

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Enhanced recovery initiative improved bariatric length of stay

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Wed, 01/02/2019 - 10:12

– Adopting a 28-point enhanced recovery protocol for bariatric surgery significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.

Dr. Stacy A. Brethauer

Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).

The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.

“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.

Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.

ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.

The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.

Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.

The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.

Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.

Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.

Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.

Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.

Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.

The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.

ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.

“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “

Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.

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– Adopting a 28-point enhanced recovery protocol for bariatric surgery significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.

Dr. Stacy A. Brethauer

Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).

The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.

“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.

Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.

ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.

The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.

Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.

The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.

Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.

Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.

Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.

Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.

Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.

The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.

ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.

“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “

Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.

– Adopting a 28-point enhanced recovery protocol for bariatric surgery significantly reduced length of stay without significant effects on complications or readmissions, according to interim results of a large, nationwide surgical quality initiative.

Dr. Stacy A. Brethauer

Thirty-six centers participated in this pilot initiative, making it one of the largest national projects focused on enhanced recovery to date, according to Stacy A. Brethauer, MD, FACS, cochair of the Quality and Data Committee of the Metabolic and Bariatric Surgery Accreditation Quality Improvement Program (MBSAQIP).

The initiative, known as Employing New Enhanced Recovery Goals for Bariatric Surgery (ENERGY), was developed in light of “huge gaps in literature and knowledge” about what best practices of enhanced recovery should look like for bariatric surgery, Dr. Brethauer said in a podium presentation at the American College of Surgeons Quality and Safety Conference.

“Bariatric surgery is very pathway driven, but the pathway can be very cumbersome and very antiquated if you don’t keep it up to date and evidence based,” said Dr. Brethauer, associate professor of surgery at the Cleveland Clinic.

Invitations to join in the ENERGY pilot were targeted to the 80 or so MBSAQIP-accredited centers in the top decile of programs for length of stay. “That’s the needle that we want to move,” Dr. Brethauer said.

ENERGY includes interventions in the preoperative, perioperative, and postoperative setting for each patient who undergoes a primary band, lap sleeve, or lap bypass procedure.

The 36 participating centers were asked to document 28 discrete process measures, starting with “did the patient stop smoking before surgery?” and ending with “did the patient have a follow-up clinic appointment scheduled?” Each one was entered by a trained clinical reviewer. The program included monthly audits for each participating center.

Data collection started on July 1, 2017, and continued to June 30, 2018, following a 6-month run-up period to allow centers to incorporate the measures.

The interim analysis presented included 4,700 patients who underwent procedures in the first 6 months of the data collection period. Nearly 60% (2,790 patients) had a laparoscopic sleeve gastrectomy, while about 40% (1,896 patients) underwent laparoscopic gastric bypass, and 0.1% (6 patients) had a band procedure.

Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers (P less than .001), Dr. Brethauer reported.

Similarly, the rate of extended length of stay was 4.4% in the first 6 months of the pilot, down from 8.2% in 2016. Extended length of stay decreased with increasing adherence to the protocol, Dr. Brethauer and his colleagues found in their analysis.

Those length-of-stay reductions were accomplished with no increase in bleeding rates, all-cause reoperation rates, or readmissions. “We’re not doing this at the expense of other complications,” Dr. Brethauer said in a comment on the results.

Adherence to the 28 ENERGY measures increased from 26% in the first month of the pilot to 80.2% in March 2017, the latest month included in the interim analysis.

Opioid-sparing pain management strategies are incorporated into ENERGY. Over the first six months of the pilot, the average proportion of patients receiving no opioids postoperatively was 26.8%.

The ultimate goal of ENERGY is a large-scale rollout of enhanced recovery strategies, according to Dr. Brethauer.

ENERGY is the second national quality improvement project of the MBSAQIP. In the first, known as Decreasing Readmissions through Opportunities Provided (DROP), 128 U.S. hospitals implemented a set of standard processes organized into preoperative, inpatient, and postoperative care bundles. Results of a yearlong study of the DROP intervention demonstrated a significant reduction in 30-day all-cause hospital readmissions following sleeve gastrectomy.

“If you look at what’s happened in our specialty, and all the changes and all the work that’s been done, it’s really quite impressive,” Dr. Brethauer told attendees at the meeting. “It’s something that we’re very proud of. “

Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.

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Key clinical point: An evidence-based enhanced recovery protocol reduced length of stay for bariatric surgery patients.

Major finding: Average length of stay was 1.76 days in the first 6 months of the pilot, down from 2.24 days in 2016 for those same participating centers.

Study details: Data on 36 bariatric surgery centers and 4,700 patients who underwent procedures in the first 6 months of the data collection period.

Disclosures: Dr. Brethauer reported disclosures related to Medtronic and Ethicon outside of the scope of this presentation.

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What underlies post–bariatric surgery bone fragility?

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Fri, 01/18/2019 - 17:44

 

– Charting a healthy path for patients after bariatric surgery can be complicated and addressing bone health is an important part of the endocrinologist’s role in keeping patients safe from postsurgical fractures, according to John Bilezikian, MD.

“Abnormal bone metabolism is a feature of both obesity and gastric bypass surgery,” said Dr. Bilezikian, speaking during a bariatric surgery–focused session at the annual scientific & clinical congress of the American Academy of Clinical Endocrinologists.

It’s not easy to assess bone health, even before surgery, said Dr. Bilezikian. Even objective measures of bone density, such as dual-energy x-ray absorptiometry (DXA), may be skewed: very high fat mass causes artifact that interferes with accurate measurement of bone density, and DXA can’t distinguish between cortical and trabecular bone. The latter is a particular issue in high body mass index patients, since obesity is known to be associated with a more fragile bone microarchitecture, said Dr. Bilezikian, the Dorothy L. and Daniel H. Silberberg Professor of Medicine and director of the metabolic bone diseases unit at Columbia University, New York.

With these caveats in mind, Dr. Bilezikian said, there are some lessons to be learned from existing research to better manage bone health in bariatric patients.

After Roux-en-Y gastric bypass surgery (RYGB), bone turnover soon increases, with bone resorption markers increasing by up to 200% in the first 12-18 months after surgery. Bone formation markers also are elevated but to a lesser extent, said Dr. Bilezikian. Over time, the weight loss from RYGB is associated with a significant drop in bone mineral density (BMD) at weight-bearing sites. Weight loss was associated with bone loss at the total hip (r = 0.70; P less than .0003) and femoral neck (r = 0.47; P = .03 (J Clin Endocrinol Metab. 2013 Feb;98[2] 541-9).

A newer-technology, high-resolution peripheral quantitative CT (HR-pQCT) offers a noninvasive look not just at bone size and density but also at microarchitecture, including cortical thickness and details of trabecular structure. This technology “can help elucidate the structural basis for fragility,” said Dr. Bilezikian.

HR-pQCT was used in a recent study (J Bone Min Res. 2017 Dec. 27. doi: 10.1002/jbmr.3371) that followed 48 patients for 1 year after RYGB. Using HR-pQCT, DXA, and serum markers of bone turnover, the researchers found significant decrease in BMD and estimated decrease in bone strength after RYGB. Bone cortex became increasingly porous as well. Taken together, these changes may indicate an increased fracture risk, concluded the investigators.

A longer study that followed RYGB recipients for 2 years and used similar imaging and serum parameters also found that participants had decreased BMD. Tellingly, these investigators saw more marked increase in cortical porosity in the second year after bypass. Estimated bone strength continued to decline during the study period, even after weight loss had stopped.

All of these findings, said Dr. Bilezikian, point to a pathogenetic process other than weight loss that promotes the deteriorating bone microarchitecture seen years after RYGB. “Loss of bone mass and skeletal deterioration after gastric bypass surgery cannot be explained by weight loss alone,” said Dr. Bilezikian.

Another recent study was able to follow a small cohort of patients for a full 5 years, using DXA, lumbar CT, and Hr-pQCT. Though weight loss stabilized after 2 years and 25-OH D and calcium levels were unchanged from presurgical baseline, bone density continued to drop, and bone microarchitecture further deteriorated, said Dr. Bilezikian (Greenblatt L et al. ASBMR 2017, Abstract 1125).

Initially, post–bariatric surgery weight loss may induce bone changes because of skeletal unloading; further down the road, estrogen production by adipose tissue is decreased with ongoing fat loss, and sarcopenia may have an adverse effect on bone microarchitecture. Postsurgical malabsorption may also be an early mechanism of bone loss.

Other hormonal changes can include secondary hyperparathyroidism. Leptin, adiponectin, and peptide YY levels also may be altered.

Do these changes in BMD and bone architecture result in increased fracture risk? This question is difficult to answer, for the same reasons that other bariatric surgery research can be challenging, said Dr. Bilezikian. There is heterogeneity of procedures and supplement regimens, sample sizes can be small, follow-up times short, and adherence often is not tracked.

However, there are some clues that RYGB may be associated with an increased risk of all fractures and of fragility fractures, with appendicular fractures seen most frequently (Osteoporos Int. 2014 Jan; 25[1]:151-8). A larger study that tracked 12,676 patients receiving bariatric surgery, 38,028 patients with obesity, and 126,760 nonobese participants found that the bariatric patients had a 4.1% risk of fracture at 4 years post surgery, compared with 2.7% and 2.4% fracture rates in the participants with and without obesity, respectively (BMJ. 2016;354:i3794).

Other retrospective studies have found “a time-dependent increase in nonvertebral fractures with Roux-en-Y gastric bypass compared to gastric banding,” said Dr. Bilezikian.

How can these risks be managed after gastric bypass surgery? “Strive for nutritional adequacy” as the first step, said Dr. Bilezikian, meaning that calcium and vitamin D should be prescribed – and adherence encouraged – as indicated. Levels of 25-OH D should be checked regularly, with supplementation managed to keep levels over 30 ng/mL, he said.

All patients should be encouraged to develop and maintain an appropriate exercise regimen, and BMD should be followed over time. Those caring for post–gastric bypass patients can still use a bisphosphonate or other bone-health medication, if indicated using standard parameters. However, “You probably shouldn’t use an oral bisphosphonate in this population,” said Dr. Bilezikian.

Dr. Bilezikian reported that he has consulting or advisory relationships with Amgen, Radius Pharmaceuticals, Shire Pharmaceuticals, and Ultragenyx, and serves on a data safety monitoring board for Regeneron.

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– Charting a healthy path for patients after bariatric surgery can be complicated and addressing bone health is an important part of the endocrinologist’s role in keeping patients safe from postsurgical fractures, according to John Bilezikian, MD.

“Abnormal bone metabolism is a feature of both obesity and gastric bypass surgery,” said Dr. Bilezikian, speaking during a bariatric surgery–focused session at the annual scientific & clinical congress of the American Academy of Clinical Endocrinologists.

It’s not easy to assess bone health, even before surgery, said Dr. Bilezikian. Even objective measures of bone density, such as dual-energy x-ray absorptiometry (DXA), may be skewed: very high fat mass causes artifact that interferes with accurate measurement of bone density, and DXA can’t distinguish between cortical and trabecular bone. The latter is a particular issue in high body mass index patients, since obesity is known to be associated with a more fragile bone microarchitecture, said Dr. Bilezikian, the Dorothy L. and Daniel H. Silberberg Professor of Medicine and director of the metabolic bone diseases unit at Columbia University, New York.

With these caveats in mind, Dr. Bilezikian said, there are some lessons to be learned from existing research to better manage bone health in bariatric patients.

After Roux-en-Y gastric bypass surgery (RYGB), bone turnover soon increases, with bone resorption markers increasing by up to 200% in the first 12-18 months after surgery. Bone formation markers also are elevated but to a lesser extent, said Dr. Bilezikian. Over time, the weight loss from RYGB is associated with a significant drop in bone mineral density (BMD) at weight-bearing sites. Weight loss was associated with bone loss at the total hip (r = 0.70; P less than .0003) and femoral neck (r = 0.47; P = .03 (J Clin Endocrinol Metab. 2013 Feb;98[2] 541-9).

A newer-technology, high-resolution peripheral quantitative CT (HR-pQCT) offers a noninvasive look not just at bone size and density but also at microarchitecture, including cortical thickness and details of trabecular structure. This technology “can help elucidate the structural basis for fragility,” said Dr. Bilezikian.

HR-pQCT was used in a recent study (J Bone Min Res. 2017 Dec. 27. doi: 10.1002/jbmr.3371) that followed 48 patients for 1 year after RYGB. Using HR-pQCT, DXA, and serum markers of bone turnover, the researchers found significant decrease in BMD and estimated decrease in bone strength after RYGB. Bone cortex became increasingly porous as well. Taken together, these changes may indicate an increased fracture risk, concluded the investigators.

A longer study that followed RYGB recipients for 2 years and used similar imaging and serum parameters also found that participants had decreased BMD. Tellingly, these investigators saw more marked increase in cortical porosity in the second year after bypass. Estimated bone strength continued to decline during the study period, even after weight loss had stopped.

All of these findings, said Dr. Bilezikian, point to a pathogenetic process other than weight loss that promotes the deteriorating bone microarchitecture seen years after RYGB. “Loss of bone mass and skeletal deterioration after gastric bypass surgery cannot be explained by weight loss alone,” said Dr. Bilezikian.

Another recent study was able to follow a small cohort of patients for a full 5 years, using DXA, lumbar CT, and Hr-pQCT. Though weight loss stabilized after 2 years and 25-OH D and calcium levels were unchanged from presurgical baseline, bone density continued to drop, and bone microarchitecture further deteriorated, said Dr. Bilezikian (Greenblatt L et al. ASBMR 2017, Abstract 1125).

Initially, post–bariatric surgery weight loss may induce bone changes because of skeletal unloading; further down the road, estrogen production by adipose tissue is decreased with ongoing fat loss, and sarcopenia may have an adverse effect on bone microarchitecture. Postsurgical malabsorption may also be an early mechanism of bone loss.

Other hormonal changes can include secondary hyperparathyroidism. Leptin, adiponectin, and peptide YY levels also may be altered.

Do these changes in BMD and bone architecture result in increased fracture risk? This question is difficult to answer, for the same reasons that other bariatric surgery research can be challenging, said Dr. Bilezikian. There is heterogeneity of procedures and supplement regimens, sample sizes can be small, follow-up times short, and adherence often is not tracked.

However, there are some clues that RYGB may be associated with an increased risk of all fractures and of fragility fractures, with appendicular fractures seen most frequently (Osteoporos Int. 2014 Jan; 25[1]:151-8). A larger study that tracked 12,676 patients receiving bariatric surgery, 38,028 patients with obesity, and 126,760 nonobese participants found that the bariatric patients had a 4.1% risk of fracture at 4 years post surgery, compared with 2.7% and 2.4% fracture rates in the participants with and without obesity, respectively (BMJ. 2016;354:i3794).

Other retrospective studies have found “a time-dependent increase in nonvertebral fractures with Roux-en-Y gastric bypass compared to gastric banding,” said Dr. Bilezikian.

How can these risks be managed after gastric bypass surgery? “Strive for nutritional adequacy” as the first step, said Dr. Bilezikian, meaning that calcium and vitamin D should be prescribed – and adherence encouraged – as indicated. Levels of 25-OH D should be checked regularly, with supplementation managed to keep levels over 30 ng/mL, he said.

All patients should be encouraged to develop and maintain an appropriate exercise regimen, and BMD should be followed over time. Those caring for post–gastric bypass patients can still use a bisphosphonate or other bone-health medication, if indicated using standard parameters. However, “You probably shouldn’t use an oral bisphosphonate in this population,” said Dr. Bilezikian.

Dr. Bilezikian reported that he has consulting or advisory relationships with Amgen, Radius Pharmaceuticals, Shire Pharmaceuticals, and Ultragenyx, and serves on a data safety monitoring board for Regeneron.

 

– Charting a healthy path for patients after bariatric surgery can be complicated and addressing bone health is an important part of the endocrinologist’s role in keeping patients safe from postsurgical fractures, according to John Bilezikian, MD.

“Abnormal bone metabolism is a feature of both obesity and gastric bypass surgery,” said Dr. Bilezikian, speaking during a bariatric surgery–focused session at the annual scientific & clinical congress of the American Academy of Clinical Endocrinologists.

It’s not easy to assess bone health, even before surgery, said Dr. Bilezikian. Even objective measures of bone density, such as dual-energy x-ray absorptiometry (DXA), may be skewed: very high fat mass causes artifact that interferes with accurate measurement of bone density, and DXA can’t distinguish between cortical and trabecular bone. The latter is a particular issue in high body mass index patients, since obesity is known to be associated with a more fragile bone microarchitecture, said Dr. Bilezikian, the Dorothy L. and Daniel H. Silberberg Professor of Medicine and director of the metabolic bone diseases unit at Columbia University, New York.

With these caveats in mind, Dr. Bilezikian said, there are some lessons to be learned from existing research to better manage bone health in bariatric patients.

After Roux-en-Y gastric bypass surgery (RYGB), bone turnover soon increases, with bone resorption markers increasing by up to 200% in the first 12-18 months after surgery. Bone formation markers also are elevated but to a lesser extent, said Dr. Bilezikian. Over time, the weight loss from RYGB is associated with a significant drop in bone mineral density (BMD) at weight-bearing sites. Weight loss was associated with bone loss at the total hip (r = 0.70; P less than .0003) and femoral neck (r = 0.47; P = .03 (J Clin Endocrinol Metab. 2013 Feb;98[2] 541-9).

A newer-technology, high-resolution peripheral quantitative CT (HR-pQCT) offers a noninvasive look not just at bone size and density but also at microarchitecture, including cortical thickness and details of trabecular structure. This technology “can help elucidate the structural basis for fragility,” said Dr. Bilezikian.

HR-pQCT was used in a recent study (J Bone Min Res. 2017 Dec. 27. doi: 10.1002/jbmr.3371) that followed 48 patients for 1 year after RYGB. Using HR-pQCT, DXA, and serum markers of bone turnover, the researchers found significant decrease in BMD and estimated decrease in bone strength after RYGB. Bone cortex became increasingly porous as well. Taken together, these changes may indicate an increased fracture risk, concluded the investigators.

A longer study that followed RYGB recipients for 2 years and used similar imaging and serum parameters also found that participants had decreased BMD. Tellingly, these investigators saw more marked increase in cortical porosity in the second year after bypass. Estimated bone strength continued to decline during the study period, even after weight loss had stopped.

All of these findings, said Dr. Bilezikian, point to a pathogenetic process other than weight loss that promotes the deteriorating bone microarchitecture seen years after RYGB. “Loss of bone mass and skeletal deterioration after gastric bypass surgery cannot be explained by weight loss alone,” said Dr. Bilezikian.

Another recent study was able to follow a small cohort of patients for a full 5 years, using DXA, lumbar CT, and Hr-pQCT. Though weight loss stabilized after 2 years and 25-OH D and calcium levels were unchanged from presurgical baseline, bone density continued to drop, and bone microarchitecture further deteriorated, said Dr. Bilezikian (Greenblatt L et al. ASBMR 2017, Abstract 1125).

Initially, post–bariatric surgery weight loss may induce bone changes because of skeletal unloading; further down the road, estrogen production by adipose tissue is decreased with ongoing fat loss, and sarcopenia may have an adverse effect on bone microarchitecture. Postsurgical malabsorption may also be an early mechanism of bone loss.

Other hormonal changes can include secondary hyperparathyroidism. Leptin, adiponectin, and peptide YY levels also may be altered.

Do these changes in BMD and bone architecture result in increased fracture risk? This question is difficult to answer, for the same reasons that other bariatric surgery research can be challenging, said Dr. Bilezikian. There is heterogeneity of procedures and supplement regimens, sample sizes can be small, follow-up times short, and adherence often is not tracked.

However, there are some clues that RYGB may be associated with an increased risk of all fractures and of fragility fractures, with appendicular fractures seen most frequently (Osteoporos Int. 2014 Jan; 25[1]:151-8). A larger study that tracked 12,676 patients receiving bariatric surgery, 38,028 patients with obesity, and 126,760 nonobese participants found that the bariatric patients had a 4.1% risk of fracture at 4 years post surgery, compared with 2.7% and 2.4% fracture rates in the participants with and without obesity, respectively (BMJ. 2016;354:i3794).

Other retrospective studies have found “a time-dependent increase in nonvertebral fractures with Roux-en-Y gastric bypass compared to gastric banding,” said Dr. Bilezikian.

How can these risks be managed after gastric bypass surgery? “Strive for nutritional adequacy” as the first step, said Dr. Bilezikian, meaning that calcium and vitamin D should be prescribed – and adherence encouraged – as indicated. Levels of 25-OH D should be checked regularly, with supplementation managed to keep levels over 30 ng/mL, he said.

All patients should be encouraged to develop and maintain an appropriate exercise regimen, and BMD should be followed over time. Those caring for post–gastric bypass patients can still use a bisphosphonate or other bone-health medication, if indicated using standard parameters. However, “You probably shouldn’t use an oral bisphosphonate in this population,” said Dr. Bilezikian.

Dr. Bilezikian reported that he has consulting or advisory relationships with Amgen, Radius Pharmaceuticals, Shire Pharmaceuticals, and Ultragenyx, and serves on a data safety monitoring board for Regeneron.

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Bariatric revision mortality linked to age, comorbidities

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Mortality after revisional bariatric procedures remains rare but may be more common than the literature suggests, and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.

Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.

In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).

Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.

The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.

The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.

On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.

 

 


In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.

The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.

She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.

Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.

[email protected]

SOURCE: Popov VB et al. DDW 2018, Abstract 324.

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Mortality after revisional bariatric procedures remains rare but may be more common than the literature suggests, and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.

Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.

In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).

Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.

The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.

The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.

On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.

 

 


In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.

The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.

She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.

Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.

[email protected]

SOURCE: Popov VB et al. DDW 2018, Abstract 324.

Mortality after revisional bariatric procedures remains rare but may be more common than the literature suggests, and appears to be rising in recent years, according to two studies presented at the annual Digestive Disease Week®.

Violeta B. Popov, MD, of New York University, and a team of researchers used the Nationwide Inpatient Sample (NIS) to look at mortality risk, costs, and risk factors for complications in revisional bariatric procedures.

In one presentation, Dr. Popov noted that revision after bariatric surgery occurred in approximately 8% of cases for a variety of reasons including lap band adjustment, weight regain, gastric reflux problems, and rarely, because of staple-line leaks. Referring to findings based on the Bariatric Outcomes Longitudinal Database (BOLD), Dr. Popov said that mortality after primary bariatric surgery is estimated at around 0.2% and revisional procedures carry nearly the same low level of mortality risk. BOLD was developed by the American Society of Metabolic and Bariatric Surgery and reflects outcomes from certified Bariatric Centers of Excellence from 2007 to 2012. However, Dr. Popov noted, the outcomes derived from BOLD may well be better than those from noncertified centers (Gastrointest Surg. 2015 Jan;19[1]:171-8).

Dr. Popov reported that the number of revisional procedures has doubled over recent years, from 6% of all bariatric procedures in 2011 to 13% in 2015. The reasons behind the increase could be related to the number of patients switching to a different bariatric approach, the removal of lap bands, and possibly the increase in the number of primary bariatric surgeries performed by less-skilled operators, Dr. Popov said.

The investigators aimed to determine the mortality trends for these procedures in addition to evaluating costs and risk factors for complications. They conducted a retrospective cohort study using the 2014 NIS, comprising 14,280 patients who underwent revisional bariatric surgery. The primary outcome was postoperative in-hospital mortality, with secondary outcomes of cost, length of hospital stay (LOS), and ICU stay. The variables included a variety of comorbidities, alcohol use, smoking, income, and insurance status.

The mean age of this sample was 68 years and 58.8% were female. Outcomes for revisional bariatric surgery were worse in several categories than were found in the BOLD study in terms of LOS, costs, and mortality, and postoperative in-hospital mortality was unexpectedly high at 2.1% (290 patients). A total of 3.3% of the patients had an ICU stay, one-quarter of whom died.

On univariate analysis, comorbidities (age, coagulopathy, chronic kidney disease, anemia, and chronic heart failure) and the combined number of chronic conditions were all significant predictors of mortality. Multivariate analysis identified age (odds ratio, 1.08; 95% confidence interval, 1.04-1.20; P less than .001), alcohol use (OR, 4.0; 95% CI, 1.3-11.7; P = .01), coagulopathy (OR, 5.4; 95% CI, 2.2-13.3; P less than .001), and insurance status (Medicaid vs. private; OR, 4.0; 95% CI, 1.7-9.9; P = .002) as the most significant predictors of mortality after a revisional bariatric procedure.

 

 


In a poster, Dr. Popov and her colleagues presented data from the NIS database looking at 10-year mortality and outcome trends for revisional surgery versus primary Roux-en-Y gastric bypass (RYGB) surgery. Inpatient mortality for RYGB decreased from 2.54% in 2003 to 1.80% in 2014, but was still substantially higher than the BOLD findings. But mortality for revisional surgery increased: 1.90% versus 2.03%. LOS for RYGB decreased from 5.9 days to 5.4 but increased for revisional surgery from 4.6 to 5.4 days. Cost for both procedures, adjusted for inflation, more than doubled between 2003 and 2014. And patients requiring ICU admission for both procedures went from 1% in 2003 to 3% in 2014.

The limitations of both analyses are their retrospective design, the NIS bias inferred by the inclusion of only inpatient procedures, and the lack of laboratory data or data on body mass index. In addition, during the study period, primary bariatric surgery began to be performed as an outpatient procedure. “Low-risk procedures performed in outpatient facilities will not be captured in the database and thus the higher mortality for these higher risk patients is expected,” Dr. Popov said. These patients are likely to be sicker and have more comorbidities. Revisional procedures are typically done in the hospital, but there are some low-risk revisional procedures such as lap band removal that could be done as outpatient procedures. Dr. Popov had confidence that the NIS database reflects real-world outcomes for revisional bariatric procedures.

She concluded that the explanation for the increase in mortality risk for revisional bariatric surgery may be because of more of these procedures being done outside centers of excellence and more, older patients with comorbidities having the surgery, and that nonsurgical alternatives should be explored for the older sicker patients.

Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.

[email protected]

SOURCE: Popov VB et al. DDW 2018, Abstract 324.

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Key clinical point: Revisional bariatric procedures may carry a greater mortality risk than previous studies have suggested.

Major finding: The mortality rate in the sample was 2.1%.

Study details: The 2014 Nationwide Inpatient Sample database, comprising 14,280 patients who underwent revisional bariatric surgery.

Disclosures: Dr. Popova disclosed ownership of shares in Embarcadero Technologies but no conflicts of interest.

Source: Popov VB et al. DDW 2018, Abstract 324.

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Beyond the sleeve and RYGB: The frontier of bariatric procedures

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– Though sleeve gastrectomy and Roux-en-Y gastric bypass are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.

A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.

One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.

In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.

The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”

A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.

In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.

 

 


Parsing safety and efficacy of this procedure isn’t easy, given the studies at hand, said Dr. McKenzie: “The data are plagued by short follow-up, low numbers, and inconsistent quality.” Of the 14 case series following 1,045 patients, none include randomized controlled data, he said.

The data that are available show total body weight loss in the 34%-39% range, with little difference between losses seen at 1 year and 2 years.

However, said Dr. McKenzie, one 100-patient case series showed that SADI-S patients averaged 2.5 bowel movements daily after the procedure, and two patients needed surgical revision because they were experiencing malnutrition. Anemia, vitamin B12 and D deficiencies, and folate deficiency are all commonly seen two years after SADI-S procedures, he said.

“The OADS procedure is very effective, although better data are needed before drawing conclusions,” said Dr. McKenzie.

A gastric bypass variation known as the “mini” bypass, or the one anastomosis gastric bypass (OAGB), is another less common bariatric technique. In this procedure, a small gastric pouch is created that forms the working stomach, which is then connected to the duodenum with bypassing of a significant portion (up to 200 cm) of the small intestine. This procedure causes both restrictive and malabsorptive weight loss, and is usually performed using minimally invasive surgery.

Four randomized controlled trials exist, said Dr. McKenzie, that compare OAGB variously to Roux-en-Y gastric bypass (RYGB) and to sleeve gastrectomy. In an 80-patient study that compared OAGB with RYGB at two years post-procedure, excess weight loss was similar, at 60% for OAGB versus 64% for RYGB ( Ann Surg. 2005;24[1]20-8). However, morbidity was less for OAGB recipients (8% vs 20%, P less than .05).

Another study looked at OAGB and sleeve gastrectomy in 60 patients, following them for 5 years. Total body weight loss was similar between groups at 20%-23%, said Dr. McKenzie (Obes Surg. 2014;24[9]1552-62).

“But what about bile reflux?” asked Dr. McKenzie. He pointed out that in OAGB, digestive juices enter the digestive path very close to the outlet of the new, surgically created stomach, affording the potential for significant reflux. Calling for further study of the frequency of bile reflux and potential long-term sequelae, he advised caution with this otherwise attractive procedure.

Those caring for bariatric patients may also see the consequences of “rogue” procedures on occasion: “Interest in metabolic surgery has led to some ‘original’ procedures, many of which are not based on firm science,” said Dr. McKenzie. An exemplar of an understudied procedure is the sleeve gastrectomy with a loop bipartition, with results that have been published in case reports, but whose longer-term outcomes are unknown.

“Caution is advised regarding operations that are devised outside of study protocols,” said Dr. McKenzie.

Dr. McKenzie reported that he had no relevant financial disclosures.
 

SOURCE: McKenzie, T. AACE 2018, presentation SGS4.

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– Though sleeve gastrectomy and Roux-en-Y gastric bypass are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.

A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.

One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.

In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.

The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”

A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.

In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.

 

 


Parsing safety and efficacy of this procedure isn’t easy, given the studies at hand, said Dr. McKenzie: “The data are plagued by short follow-up, low numbers, and inconsistent quality.” Of the 14 case series following 1,045 patients, none include randomized controlled data, he said.

The data that are available show total body weight loss in the 34%-39% range, with little difference between losses seen at 1 year and 2 years.

However, said Dr. McKenzie, one 100-patient case series showed that SADI-S patients averaged 2.5 bowel movements daily after the procedure, and two patients needed surgical revision because they were experiencing malnutrition. Anemia, vitamin B12 and D deficiencies, and folate deficiency are all commonly seen two years after SADI-S procedures, he said.

“The OADS procedure is very effective, although better data are needed before drawing conclusions,” said Dr. McKenzie.

A gastric bypass variation known as the “mini” bypass, or the one anastomosis gastric bypass (OAGB), is another less common bariatric technique. In this procedure, a small gastric pouch is created that forms the working stomach, which is then connected to the duodenum with bypassing of a significant portion (up to 200 cm) of the small intestine. This procedure causes both restrictive and malabsorptive weight loss, and is usually performed using minimally invasive surgery.

Four randomized controlled trials exist, said Dr. McKenzie, that compare OAGB variously to Roux-en-Y gastric bypass (RYGB) and to sleeve gastrectomy. In an 80-patient study that compared OAGB with RYGB at two years post-procedure, excess weight loss was similar, at 60% for OAGB versus 64% for RYGB ( Ann Surg. 2005;24[1]20-8). However, morbidity was less for OAGB recipients (8% vs 20%, P less than .05).

Another study looked at OAGB and sleeve gastrectomy in 60 patients, following them for 5 years. Total body weight loss was similar between groups at 20%-23%, said Dr. McKenzie (Obes Surg. 2014;24[9]1552-62).

“But what about bile reflux?” asked Dr. McKenzie. He pointed out that in OAGB, digestive juices enter the digestive path very close to the outlet of the new, surgically created stomach, affording the potential for significant reflux. Calling for further study of the frequency of bile reflux and potential long-term sequelae, he advised caution with this otherwise attractive procedure.

Those caring for bariatric patients may also see the consequences of “rogue” procedures on occasion: “Interest in metabolic surgery has led to some ‘original’ procedures, many of which are not based on firm science,” said Dr. McKenzie. An exemplar of an understudied procedure is the sleeve gastrectomy with a loop bipartition, with results that have been published in case reports, but whose longer-term outcomes are unknown.

“Caution is advised regarding operations that are devised outside of study protocols,” said Dr. McKenzie.

Dr. McKenzie reported that he had no relevant financial disclosures.
 

SOURCE: McKenzie, T. AACE 2018, presentation SGS4.

 

– Though sleeve gastrectomy and Roux-en-Y gastric bypass are the bariatric procedures most patients will receive, other surgical approaches to weight loss are occasionally performed. Knowing these various techniques and their likely efficacy and safety can help physicians who care for patients with obesity, whether a patient is considering a less common option, or whether a post-vagal blockade patient shows up on the schedule with long-term issues.

A common theme among many of these procedures is that overall numbers are low, long-term follow-up may be lacking, and research quality is variable, said Travis McKenzie, MD, speaking at a bariatric surgery-focused session of the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists.

One minimally invasive approach targets stomach functions and the appetite and satiety signaling system. In vagal blockade via an electronic implant (vBloc), an indwelling, removable device produces electronically-induced intermittent blockade of the vagal nerve.

In one randomized controlled trial, excess weight loss in patients receiving this procedure was 24%, significantly more than the 16% seen in the group that received a sham procedure (P = .002); both groups received regular follow-up and counseling, according to the study protocol. Overall, at 1 year, 52% of those in the treatment group had seen at least 20% reduction in excess weight; just 3.7% of vBloc recipients had adverse events, mostly some dyspepsia and pain at the implant site, said Dr. McKenzie, an endocrine surgeon at the Mayo Clinic, Rochester, Minn.

The vBloc procedure, said Dr. McKenzie, “demonstrated modest weight loss at 2 years, with a reasonable risk profile.”

A variation of the duodenal switch is known as single anastomosis duodeno-ileal bypass with sleeve gastrectomy, or SADI-S. This procedure both resects the greater curve of the stomach to create a gastric sleeve, and uses a single intestinal anastomosis to create a common channel of 200, 250 or 300 cm, bypassing most of the small intestine.

In this procedure, also known as the one-anastomosis duodenal switch (OADS), weight loss occurs both because of intestinal malabsorption and because of the reduced stomach volume.

 

 


Parsing safety and efficacy of this procedure isn’t easy, given the studies at hand, said Dr. McKenzie: “The data are plagued by short follow-up, low numbers, and inconsistent quality.” Of the 14 case series following 1,045 patients, none include randomized controlled data, he said.

The data that are available show total body weight loss in the 34%-39% range, with little difference between losses seen at 1 year and 2 years.

However, said Dr. McKenzie, one 100-patient case series showed that SADI-S patients averaged 2.5 bowel movements daily after the procedure, and two patients needed surgical revision because they were experiencing malnutrition. Anemia, vitamin B12 and D deficiencies, and folate deficiency are all commonly seen two years after SADI-S procedures, he said.

“The OADS procedure is very effective, although better data are needed before drawing conclusions,” said Dr. McKenzie.

A gastric bypass variation known as the “mini” bypass, or the one anastomosis gastric bypass (OAGB), is another less common bariatric technique. In this procedure, a small gastric pouch is created that forms the working stomach, which is then connected to the duodenum with bypassing of a significant portion (up to 200 cm) of the small intestine. This procedure causes both restrictive and malabsorptive weight loss, and is usually performed using minimally invasive surgery.

Four randomized controlled trials exist, said Dr. McKenzie, that compare OAGB variously to Roux-en-Y gastric bypass (RYGB) and to sleeve gastrectomy. In an 80-patient study that compared OAGB with RYGB at two years post-procedure, excess weight loss was similar, at 60% for OAGB versus 64% for RYGB ( Ann Surg. 2005;24[1]20-8). However, morbidity was less for OAGB recipients (8% vs 20%, P less than .05).

Another study looked at OAGB and sleeve gastrectomy in 60 patients, following them for 5 years. Total body weight loss was similar between groups at 20%-23%, said Dr. McKenzie (Obes Surg. 2014;24[9]1552-62).

“But what about bile reflux?” asked Dr. McKenzie. He pointed out that in OAGB, digestive juices enter the digestive path very close to the outlet of the new, surgically created stomach, affording the potential for significant reflux. Calling for further study of the frequency of bile reflux and potential long-term sequelae, he advised caution with this otherwise attractive procedure.

Those caring for bariatric patients may also see the consequences of “rogue” procedures on occasion: “Interest in metabolic surgery has led to some ‘original’ procedures, many of which are not based on firm science,” said Dr. McKenzie. An exemplar of an understudied procedure is the sleeve gastrectomy with a loop bipartition, with results that have been published in case reports, but whose longer-term outcomes are unknown.

“Caution is advised regarding operations that are devised outside of study protocols,” said Dr. McKenzie.

Dr. McKenzie reported that he had no relevant financial disclosures.
 

SOURCE: McKenzie, T. AACE 2018, presentation SGS4.

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The case for bariatric surgery to manage CV risk in diabetes

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– For patients with obesity and metabolic syndrome or type 2 diabetes (T2D), it may be hard to best bariatric surgery for optimizing cardiovascular and metabolic health over the lifespan.

“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.

At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.

Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).

Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.

From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.

The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m2 and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m2 is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.

 

 


The body of data that support long-term metabolic and cardiovascular benefits of bariatric surgery as obesity therapy is growing, said Dr. Hurley. A large prospective observational study by the American College of Surgeons’ Bariatric Surgery Center Network followed 28,616 patients, finding that Roux-en-Y gastric bypass (RYGB) was most effective in improving or resolving CVD comorbidities. At 1 year post surgery, 83% of RYGB patients saw improvement or resolution of T2D; the figure was 79% for hypertension and 66% for dyslipidemia (Ann Surg. 2011;254[3]:410-20).

Weight loss for patients receiving bariatric procedures has generally been durable: for laparoscopic RYGB patients tracked to 7 years after surgery, 75% had maintained at least a 20% weight loss (JAMA Surg. 2018;153[5]427-34).

Longer-term clinical follow-up points toward favorable metabolic and cardiovascular outcomes, said Dr. Hurley, citing data from the Swedish Obese Subjects (SOS) trial. This study followed over 4,000 patients with high BMIs (at least 34 kg/m2 for men and 38 kg/m2 for women) over 10 years. At that point, 36% of gastric bypass patients, compared with 13% of non-surgical high BMI patients, saw resolution of T2D, a significant difference. Triglyceride levels also fell significantly more for the bypass recipients. Hypertension was resolved in just 19% of patients at 10 years, a non-significant difference from the 11% of control patients. Data from the same patient set also showed a significant reduction in total cardiovascular events in the surgical versus non-surgical patients (n = 49 vs. 28, hazard ratio 0.83, log-rank P = .05). Fatal cardiovascular events were significantly lower for patients who had received bariatric surgery, with a 24% decline in mortality for bariatric surgery patients at about 11 years post surgery.

Canadian data showed even greater reductions in mortality, with an 89% decrease in mortality after RYGB, compared with non-surgical patients at the 5-year mark (Ann Surg 2004;240:416-24).
 

 


In trials that afforded a direct comparison of medical therapy and bariatric surgery obesity and diabetes, Dr. Hurley said that randomized trials generally show no change to modest change in HbA1c levels with medical management. By contrast, patients in the surgical arms showed a range of improvement ranging from a reduction of just under 1% to reductions of over 5%, with an average reduction of more than 2% across the trials.

Separating out data from the randomized controlled trials with patient BMIs averaging 35 kg/m2 or less, odds ratios still favored bariatric surgery over medication therapy for diabetes-related outcomes in this lower-BMI population, said Dr. Hurley (Diabetes Care 2016;39:924-33).

More data come from a recently reported randomized trial that assigned patients with T2D and a mean BMI of 37 kg/m2 (range, 27-43) to intensive medical therapy, or either sleeve gastrectomy (SG) or RYGB. The study, which had a 90% completion rate at the 5-year mark, found that both surgical procedures were significantly more effective at reducing HbA1c to 6% or less 12 months into the study (P less than .001).

At the 60-month mark, 45% of the RYGB and 25% of the SG patients were on no diabetes medications, while just 2% of the medical therapy arm had stopped all medications, and 40% of this group remained on insulin 5 years into the study, said Dr. Hurley (N Engl J Med. 2017;376:641-651).
 

 


“For treatment of type 2 diabetes and cardiovascular co-morbidities, long-term goals often are met following bariatric surgery versus behavior change,” said Dr. Hurley.

Dr. Hurley reported that he had no financial disclosures.

SOURCE: Hurley, D. AACE 2018, Session SGS-4.

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– For patients with obesity and metabolic syndrome or type 2 diabetes (T2D), it may be hard to best bariatric surgery for optimizing cardiovascular and metabolic health over the lifespan.

“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.

At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.

Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).

Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.

From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.

The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m2 and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m2 is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.

 

 


The body of data that support long-term metabolic and cardiovascular benefits of bariatric surgery as obesity therapy is growing, said Dr. Hurley. A large prospective observational study by the American College of Surgeons’ Bariatric Surgery Center Network followed 28,616 patients, finding that Roux-en-Y gastric bypass (RYGB) was most effective in improving or resolving CVD comorbidities. At 1 year post surgery, 83% of RYGB patients saw improvement or resolution of T2D; the figure was 79% for hypertension and 66% for dyslipidemia (Ann Surg. 2011;254[3]:410-20).

Weight loss for patients receiving bariatric procedures has generally been durable: for laparoscopic RYGB patients tracked to 7 years after surgery, 75% had maintained at least a 20% weight loss (JAMA Surg. 2018;153[5]427-34).

Longer-term clinical follow-up points toward favorable metabolic and cardiovascular outcomes, said Dr. Hurley, citing data from the Swedish Obese Subjects (SOS) trial. This study followed over 4,000 patients with high BMIs (at least 34 kg/m2 for men and 38 kg/m2 for women) over 10 years. At that point, 36% of gastric bypass patients, compared with 13% of non-surgical high BMI patients, saw resolution of T2D, a significant difference. Triglyceride levels also fell significantly more for the bypass recipients. Hypertension was resolved in just 19% of patients at 10 years, a non-significant difference from the 11% of control patients. Data from the same patient set also showed a significant reduction in total cardiovascular events in the surgical versus non-surgical patients (n = 49 vs. 28, hazard ratio 0.83, log-rank P = .05). Fatal cardiovascular events were significantly lower for patients who had received bariatric surgery, with a 24% decline in mortality for bariatric surgery patients at about 11 years post surgery.

Canadian data showed even greater reductions in mortality, with an 89% decrease in mortality after RYGB, compared with non-surgical patients at the 5-year mark (Ann Surg 2004;240:416-24).
 

 


In trials that afforded a direct comparison of medical therapy and bariatric surgery obesity and diabetes, Dr. Hurley said that randomized trials generally show no change to modest change in HbA1c levels with medical management. By contrast, patients in the surgical arms showed a range of improvement ranging from a reduction of just under 1% to reductions of over 5%, with an average reduction of more than 2% across the trials.

Separating out data from the randomized controlled trials with patient BMIs averaging 35 kg/m2 or less, odds ratios still favored bariatric surgery over medication therapy for diabetes-related outcomes in this lower-BMI population, said Dr. Hurley (Diabetes Care 2016;39:924-33).

More data come from a recently reported randomized trial that assigned patients with T2D and a mean BMI of 37 kg/m2 (range, 27-43) to intensive medical therapy, or either sleeve gastrectomy (SG) or RYGB. The study, which had a 90% completion rate at the 5-year mark, found that both surgical procedures were significantly more effective at reducing HbA1c to 6% or less 12 months into the study (P less than .001).

At the 60-month mark, 45% of the RYGB and 25% of the SG patients were on no diabetes medications, while just 2% of the medical therapy arm had stopped all medications, and 40% of this group remained on insulin 5 years into the study, said Dr. Hurley (N Engl J Med. 2017;376:641-651).
 

 


“For treatment of type 2 diabetes and cardiovascular co-morbidities, long-term goals often are met following bariatric surgery versus behavior change,” said Dr. Hurley.

Dr. Hurley reported that he had no financial disclosures.

SOURCE: Hurley, D. AACE 2018, Session SGS-4.

 

– For patients with obesity and metabolic syndrome or type 2 diabetes (T2D), it may be hard to best bariatric surgery for optimizing cardiovascular and metabolic health over the lifespan.

“Behavioral changes in diet and activity may be effective over the short term, but they are often ineffective over the long term,” said Daniel L. Hurley, MD. By contrast, “Bariatric surgery is very effective long-term,” he said.

At the annual clinical and scientific meeting of the American Association of Clinical Endocrinologists, Dr. Hurley made the case for bariatric surgery in effective and durable management of type 2 diabetes and cardiovascular risk, weighing risks and benefits for those with higher and lower levels of obesity.

Speaking during a morning session focused on bariatric surgery, Dr. Hurley, an endocrionologist at the Mayo Clinic, Rochester, Minn., noted that bariatric surgery reduces not just weight, but also visceral adiposity. This, he said, is important when thinking about type 2 diabetes (T2D), because diabetes prevalence has climbed in the United States as obesity has also increased, according to examination of data from the National Health and Nutrition Examination Survey (NHANES).

Additionally, increased abdominal adiposity is associated with increased risk for cardiovascular-related deaths, myocardial infarctions, and all-cause deaths. Some of this relationship is mediated by T2D, which itself “is a major cause of cardiovascular-related morbidity and mortality,” said Dr. Hurley.

From a population health perspective, the increased prevalence of T2D – expected to reach 10% in the United States by 2030 – will also boost cardiovascular morbidity and mortality, said Dr. Hurley. Those with T2D die 5 to 10 years earlier, and have double the risk for heart attack and stroke of their peers without diabetes. The risk of lower limb amputation can be as much as 40 times greater for an individual with T2D across the lifespan, he said.

The National Institutes of Health recognizes bariatric surgery as an appropriate weight loss therapy for individuals with a body mass index (BMI) of at least 35 kg/m2 and comorbidity. Whether bariatric surgery might be appropriate for individuals with T2D and BMIs of less than 35 kg/m2 is less settled, though at least some RCTs support the surgical approach, said Dr. Hurley.

 

 


The body of data that support long-term metabolic and cardiovascular benefits of bariatric surgery as obesity therapy is growing, said Dr. Hurley. A large prospective observational study by the American College of Surgeons’ Bariatric Surgery Center Network followed 28,616 patients, finding that Roux-en-Y gastric bypass (RYGB) was most effective in improving or resolving CVD comorbidities. At 1 year post surgery, 83% of RYGB patients saw improvement or resolution of T2D; the figure was 79% for hypertension and 66% for dyslipidemia (Ann Surg. 2011;254[3]:410-20).

Weight loss for patients receiving bariatric procedures has generally been durable: for laparoscopic RYGB patients tracked to 7 years after surgery, 75% had maintained at least a 20% weight loss (JAMA Surg. 2018;153[5]427-34).

Longer-term clinical follow-up points toward favorable metabolic and cardiovascular outcomes, said Dr. Hurley, citing data from the Swedish Obese Subjects (SOS) trial. This study followed over 4,000 patients with high BMIs (at least 34 kg/m2 for men and 38 kg/m2 for women) over 10 years. At that point, 36% of gastric bypass patients, compared with 13% of non-surgical high BMI patients, saw resolution of T2D, a significant difference. Triglyceride levels also fell significantly more for the bypass recipients. Hypertension was resolved in just 19% of patients at 10 years, a non-significant difference from the 11% of control patients. Data from the same patient set also showed a significant reduction in total cardiovascular events in the surgical versus non-surgical patients (n = 49 vs. 28, hazard ratio 0.83, log-rank P = .05). Fatal cardiovascular events were significantly lower for patients who had received bariatric surgery, with a 24% decline in mortality for bariatric surgery patients at about 11 years post surgery.

Canadian data showed even greater reductions in mortality, with an 89% decrease in mortality after RYGB, compared with non-surgical patients at the 5-year mark (Ann Surg 2004;240:416-24).
 

 


In trials that afforded a direct comparison of medical therapy and bariatric surgery obesity and diabetes, Dr. Hurley said that randomized trials generally show no change to modest change in HbA1c levels with medical management. By contrast, patients in the surgical arms showed a range of improvement ranging from a reduction of just under 1% to reductions of over 5%, with an average reduction of more than 2% across the trials.

Separating out data from the randomized controlled trials with patient BMIs averaging 35 kg/m2 or less, odds ratios still favored bariatric surgery over medication therapy for diabetes-related outcomes in this lower-BMI population, said Dr. Hurley (Diabetes Care 2016;39:924-33).

More data come from a recently reported randomized trial that assigned patients with T2D and a mean BMI of 37 kg/m2 (range, 27-43) to intensive medical therapy, or either sleeve gastrectomy (SG) or RYGB. The study, which had a 90% completion rate at the 5-year mark, found that both surgical procedures were significantly more effective at reducing HbA1c to 6% or less 12 months into the study (P less than .001).

At the 60-month mark, 45% of the RYGB and 25% of the SG patients were on no diabetes medications, while just 2% of the medical therapy arm had stopped all medications, and 40% of this group remained on insulin 5 years into the study, said Dr. Hurley (N Engl J Med. 2017;376:641-651).
 

 


“For treatment of type 2 diabetes and cardiovascular co-morbidities, long-term goals often are met following bariatric surgery versus behavior change,” said Dr. Hurley.

Dr. Hurley reported that he had no financial disclosures.

SOURCE: Hurley, D. AACE 2018, Session SGS-4.

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FDA alerts clinicians to gastric balloon deaths

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A total of 12 deaths over the past 2 years have been linked to the use of liquid-filled intragastric balloon devices for the treatment of obesity, according to an alert from the Food and Drug Administration issued on June 4.

Seven of these deaths occurred in patients in the United States; four involved the ORBERA Intragastric Balloon System, and three involved the ReShape Integrated Dual Balloon System.

Four of the deaths reported worldwide since 2016 occurred following gastric perforation within a month of surgery (three with the ORBERA system and one with the ReShape system), according to the FDA. A fifth death involving the Orbera system remains under investigation by the manufacturer.

The FDA has approved updated labeling for the ORBERA and ReShape balloon systems in the United States. The labels contain more information about possible death associated with the use of these devices in the United States. The manufacturers’ sites, Apollo Endosurgery and ReShape Lifesciences, provide more details about the new labeling.

In a letter to health care providers, the FDA advised clinicians to educate bariatric surgery patients about the symptoms of complications from balloon procedures, including not only gastric perforation but also esophageal perforation, balloon deflation, gastrointestinal obstruction, and ulceration. In addition, the FDA reminded clinicians to monitor patients during the entire course of treatment for additional complications, including acute pancreatitis and spontaneous hyperinflation.

Any adverse events involving intragastric balloon systems should be reported to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

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A total of 12 deaths over the past 2 years have been linked to the use of liquid-filled intragastric balloon devices for the treatment of obesity, according to an alert from the Food and Drug Administration issued on June 4.

Seven of these deaths occurred in patients in the United States; four involved the ORBERA Intragastric Balloon System, and three involved the ReShape Integrated Dual Balloon System.

Four of the deaths reported worldwide since 2016 occurred following gastric perforation within a month of surgery (three with the ORBERA system and one with the ReShape system), according to the FDA. A fifth death involving the Orbera system remains under investigation by the manufacturer.

The FDA has approved updated labeling for the ORBERA and ReShape balloon systems in the United States. The labels contain more information about possible death associated with the use of these devices in the United States. The manufacturers’ sites, Apollo Endosurgery and ReShape Lifesciences, provide more details about the new labeling.

In a letter to health care providers, the FDA advised clinicians to educate bariatric surgery patients about the symptoms of complications from balloon procedures, including not only gastric perforation but also esophageal perforation, balloon deflation, gastrointestinal obstruction, and ulceration. In addition, the FDA reminded clinicians to monitor patients during the entire course of treatment for additional complications, including acute pancreatitis and spontaneous hyperinflation.

Any adverse events involving intragastric balloon systems should be reported to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

 

A total of 12 deaths over the past 2 years have been linked to the use of liquid-filled intragastric balloon devices for the treatment of obesity, according to an alert from the Food and Drug Administration issued on June 4.

Seven of these deaths occurred in patients in the United States; four involved the ORBERA Intragastric Balloon System, and three involved the ReShape Integrated Dual Balloon System.

Four of the deaths reported worldwide since 2016 occurred following gastric perforation within a month of surgery (three with the ORBERA system and one with the ReShape system), according to the FDA. A fifth death involving the Orbera system remains under investigation by the manufacturer.

The FDA has approved updated labeling for the ORBERA and ReShape balloon systems in the United States. The labels contain more information about possible death associated with the use of these devices in the United States. The manufacturers’ sites, Apollo Endosurgery and ReShape Lifesciences, provide more details about the new labeling.

In a letter to health care providers, the FDA advised clinicians to educate bariatric surgery patients about the symptoms of complications from balloon procedures, including not only gastric perforation but also esophageal perforation, balloon deflation, gastrointestinal obstruction, and ulceration. In addition, the FDA reminded clinicians to monitor patients during the entire course of treatment for additional complications, including acute pancreatitis and spontaneous hyperinflation.

Any adverse events involving intragastric balloon systems should be reported to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

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Bismuth subgallate cuts stool smell after duodenal switch

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– Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.

Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.

Dr. Walter Medlin
Loop duodenal switch (LDS) generally causes fat and starch malabsorption, which is good for weight loss but can result in odor problems that can “give rise to social and family conflicts” and be disabling.

“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.

Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.

Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.

Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.

 

 


Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.

“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.

Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.

Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.

 

 


The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.

Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.

The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.

The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.

SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.

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– Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.

Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.

Dr. Walter Medlin
Loop duodenal switch (LDS) generally causes fat and starch malabsorption, which is good for weight loss but can result in odor problems that can “give rise to social and family conflicts” and be disabling.

“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.

Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.

Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.

Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.

 

 


Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.

“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.

Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.

Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.

 

 


The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.

Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.

The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.

The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.

SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.

 

– Bismuth subgallate (Devrom) is a big help with an embarrassing and underappreciated problem after loop duodenal switch: smelly flatulence and stool.

Bismuth subgallate, an over the counter product that’s been on the market for decades, has been primarily studied to eliminate the odor of flatulence and bowel movements in ostomates, according to Walter Medlin, MD, a surgeon at the Bariatric Medicine Institute in Salt Lake City.

Dr. Walter Medlin
Loop duodenal switch (LDS) generally causes fat and starch malabsorption, which is good for weight loss but can result in odor problems that can “give rise to social and family conflicts” and be disabling.

“A lot of patients have this complaint, but they tend not to talk to their physicians about it,” Dr. Medlin said at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS.

Enter bismuth subgallate. Dr. Medlin and his team randomized 36 LDS patients to 200-mg capsules, two per meal, or to placebo for a week. Patients then underwent a one-week washout period, then crossed over to bismuth subgallate or placebo for another week. Patients and surgeons were blinded to treatment groups.

Subjects were at least 6 months out from LDS to give their gut a chance to adapt to the surgery. Patients with GI infections and those on confounding medications were among those excluded from the study. The mean age of the patients was 48 years, and there were slightly more women than men.

Subjects filled out the Gastrointestinal Quality of Life Index questionnaire at baseline and after both treatment periods. The index assesses digestive symptoms, physical status, emotional status, social performance, and treatment effects. Additional measures were added: Patients rated stool smell, flatulence smell, and concerns about each on a 4-point scale.

 

 


Twenty-nine patients completed the study; five were lost to follow-up, and two withdrew. With bismuth subgallate, scores improved by about 1.5 points on all four questions about stool and flatulence odor.

“Most of these patients had complaints of ‘all the time’ or ‘very frequent’ odor issues, and this really takes [those complaints] down to ‘occasional’ or ‘rare.’ It’s a pretty big change,” Dr. Medlin said.

Total Gastrointestinal Quality of Life Index scores improved as well, from a mean at baseline of 93 points up to 109 points out of a possible score of 160 points. Scores on the digestive portion improved from 49 to 60 points. Bismuth subgallate outperformed placebo significantly on both measures. There were trends toward improvement in other domains as well.

Stools darkened in one patient, and the tongue darkened in another; both are well-known side effects. There were no drug toxicities.

 

 


The study “is an important contribution. Duodenal switch is the most effective [bariatric] operation we do, but a lot of patients aren’t utilizing it because of this concern [about flatulence smell],” said the moderator of Dr. Medlin’s presentation, John Morton, MD, chief of bariatric and minimally invasive surgery at Stanford (Calif.) University.

Perhaps the biggest problem with bismuth subgallate is getting a hold of it, as Dr. Medlin and others noted. It’s not sold in stores but can be purchased online, including from its maker Parthenon at about $14 for a hundred capsules. The product is also available as a chewable.

The product probably helps by blocking bacterial breakdown of food residues in the colon, among other actions. “It really is an intestinal deodorant. I find patients are interested in having access to this tool” and might not need as much as in the trial, said Dr. Medlin, who stocks it in his office.

The study was funded by an unrestricted education grant from Parthenon. The investigators had no relevant disclosures.

SOURCE: Zaveri H et al. SAGES 2018, Abstract S028.

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Key clinical point: Bismuth subgallate (Devrom) is a big help for an embarrassing and underappreciated problem after loop duodenal switch: stool odor.

Major finding: Patients reported about a 1.5-point improvement on 4-point scales rating stool and flatulence odor and their concerns about them.

Study details: Randomized, placebo-controlled trial with 36 patients

Disclosures: The investigators reported an unrestricted educational grant from Parthenon, the makers of the tested product.

Source: Zaveri H et al. SAGES 2018, Abstract S028.

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VIDEO: First year after bariatric surgery critical for HbA1c improvement

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– Acute weight loss during the first year after bariatric surgery has a significant effect on hemoglobin A1c level improvement at 5 years’ follow-up, according to a study presented at the annual meeting of the American Association of Clinical Endocrinologists.

The data presented could help clinicians understand when and where to focus their efforts to help patients optimize weight loss in order to see the best long-term benefits of the procedure, according to presenter Keren Zhou, MD, an endocrinology fellow at the Cleveland Clinic.

“Clinicians need to really focus on that first year weight loss after bariatric surgery to try and optimize 5-year A1c outcomes,” said Dr. Zhou. “It also answers another question people have been having, which is how much does weight regain after bariatric surgery really matter? What we’ve been able to show here is that weight regain didn’t look very correlated at all.”

Dr. Zhou and her colleagues developed the ancillary study using data from the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial, specifically looking at 96 patients: 49 who underwent bariatric surgery and 47 who had a sleeve gastrectomy.

Patients were majority female, on average 48 years old, with a mean body mass index of 36.5 and HbA1c level of 9.4.

Overall, bariatric surgery patients lost an average of 27.2% in the first year, and regained around 8.2% from the first to fifth year, while sleeve gastrectomy lost and regained 25.1% and 9.4% respectively.

When comparing weight loss in the first year and HbA1c levels, Dr. Zhou and her colleagues found a significant correlation for both bariatric surgery and sleeve gastrectomy patients (r +.34; P = .0006).

 

 


“It was interesting because when we graphically represented the weight changes in addition to the A1c over time, we found that they actually correlated quite closely, but it was only when we did the statistical analysis on the numbers that we found that [in both groups] people who lost less weight had a higher A1c at the 5-year mark,” said Dr. Zhou.

In the non–multivariable analysis, however, investigators found a more significant correlation between weight regain and HbA1c levels in gastrectomy patients, however these findings changed when Dr. Zhou and her fellow investigators controlled for insulin use and baseline C-peptide.

In continuing studies, Dr. Zhou and her team will dive deeper into why these correlations exist, as right now they can only speculate.

Dr. Zhou reported no relevant financial disclosures.

SOURCE: Zhou K et al. AACE 18. Abstract 240-F.

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– Acute weight loss during the first year after bariatric surgery has a significant effect on hemoglobin A1c level improvement at 5 years’ follow-up, according to a study presented at the annual meeting of the American Association of Clinical Endocrinologists.

The data presented could help clinicians understand when and where to focus their efforts to help patients optimize weight loss in order to see the best long-term benefits of the procedure, according to presenter Keren Zhou, MD, an endocrinology fellow at the Cleveland Clinic.

“Clinicians need to really focus on that first year weight loss after bariatric surgery to try and optimize 5-year A1c outcomes,” said Dr. Zhou. “It also answers another question people have been having, which is how much does weight regain after bariatric surgery really matter? What we’ve been able to show here is that weight regain didn’t look very correlated at all.”

Dr. Zhou and her colleagues developed the ancillary study using data from the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial, specifically looking at 96 patients: 49 who underwent bariatric surgery and 47 who had a sleeve gastrectomy.

Patients were majority female, on average 48 years old, with a mean body mass index of 36.5 and HbA1c level of 9.4.

Overall, bariatric surgery patients lost an average of 27.2% in the first year, and regained around 8.2% from the first to fifth year, while sleeve gastrectomy lost and regained 25.1% and 9.4% respectively.

When comparing weight loss in the first year and HbA1c levels, Dr. Zhou and her colleagues found a significant correlation for both bariatric surgery and sleeve gastrectomy patients (r +.34; P = .0006).

 

 


“It was interesting because when we graphically represented the weight changes in addition to the A1c over time, we found that they actually correlated quite closely, but it was only when we did the statistical analysis on the numbers that we found that [in both groups] people who lost less weight had a higher A1c at the 5-year mark,” said Dr. Zhou.

In the non–multivariable analysis, however, investigators found a more significant correlation between weight regain and HbA1c levels in gastrectomy patients, however these findings changed when Dr. Zhou and her fellow investigators controlled for insulin use and baseline C-peptide.

In continuing studies, Dr. Zhou and her team will dive deeper into why these correlations exist, as right now they can only speculate.

Dr. Zhou reported no relevant financial disclosures.

SOURCE: Zhou K et al. AACE 18. Abstract 240-F.

– Acute weight loss during the first year after bariatric surgery has a significant effect on hemoglobin A1c level improvement at 5 years’ follow-up, according to a study presented at the annual meeting of the American Association of Clinical Endocrinologists.

The data presented could help clinicians understand when and where to focus their efforts to help patients optimize weight loss in order to see the best long-term benefits of the procedure, according to presenter Keren Zhou, MD, an endocrinology fellow at the Cleveland Clinic.

“Clinicians need to really focus on that first year weight loss after bariatric surgery to try and optimize 5-year A1c outcomes,” said Dr. Zhou. “It also answers another question people have been having, which is how much does weight regain after bariatric surgery really matter? What we’ve been able to show here is that weight regain didn’t look very correlated at all.”

Dr. Zhou and her colleagues developed the ancillary study using data from the STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) trial, specifically looking at 96 patients: 49 who underwent bariatric surgery and 47 who had a sleeve gastrectomy.

Patients were majority female, on average 48 years old, with a mean body mass index of 36.5 and HbA1c level of 9.4.

Overall, bariatric surgery patients lost an average of 27.2% in the first year, and regained around 8.2% from the first to fifth year, while sleeve gastrectomy lost and regained 25.1% and 9.4% respectively.

When comparing weight loss in the first year and HbA1c levels, Dr. Zhou and her colleagues found a significant correlation for both bariatric surgery and sleeve gastrectomy patients (r +.34; P = .0006).

 

 


“It was interesting because when we graphically represented the weight changes in addition to the A1c over time, we found that they actually correlated quite closely, but it was only when we did the statistical analysis on the numbers that we found that [in both groups] people who lost less weight had a higher A1c at the 5-year mark,” said Dr. Zhou.

In the non–multivariable analysis, however, investigators found a more significant correlation between weight regain and HbA1c levels in gastrectomy patients, however these findings changed when Dr. Zhou and her fellow investigators controlled for insulin use and baseline C-peptide.

In continuing studies, Dr. Zhou and her team will dive deeper into why these correlations exist, as right now they can only speculate.

Dr. Zhou reported no relevant financial disclosures.

SOURCE: Zhou K et al. AACE 18. Abstract 240-F.

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Key clinical point: Weight loss in the first year is correlated with long-term HbA1c improvement.

Major finding: Change in weight within the first year was significantly correlated with lower HbA1c levels at 5 years (P = .0003).

Study details: Ancillary study of 96 patients who underwent either bariatric surgery or sleeve gastrectomy and participated in the STAMPEDE study.

Disclosures: Presenter reported no relevant financial disclosures.

Source: Zhou K et al. AACE 18. Abstract 240-F.

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Figure-of-eight overstitch keeps endoscopic stents in place

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– Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.

Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.

Dr. Varun Krishnan
The approach has been around for over a decade, but migration remains a significant concern; many surgeons don’t fix endothelial stents in place.

Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.

Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).

The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,

The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.

 

 


“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.

Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.

Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.

Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
 

 


Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.

Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.

Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.

In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.

The investigators did not report any relevant disclosures, and there was no outside funding.
 
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– Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.

Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.

Dr. Varun Krishnan
The approach has been around for over a decade, but migration remains a significant concern; many surgeons don’t fix endothelial stents in place.

Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.

Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).

The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,

The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.

 

 


“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.

Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.

Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.

Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
 

 


Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.

Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.

Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.

In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.

The investigators did not report any relevant disclosures, and there was no outside funding.
 

 

– Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.

Anastomotic leaks are a major and potentially fatal complication of bariatric surgery. Stents are one of the fix options: An expanding tube is rolled down over the wound to take the pressure off and give it time to heal. The stent is removed after the leak closes, which can take a few weeks or longer.

Dr. Varun Krishnan
The approach has been around for over a decade, but migration remains a significant concern; many surgeons don’t fix endothelial stents in place.

Stents designed specifically for the procedure will likely address the problem in the near future, but for now, the overstitch helps at Lenox Hill. Meanwhile, “it’s important to [realize] that stent migration did not adversely impact [bariatric surgery] failure rates, nor was migration associated with the incidence of revision surgery,” said surgery resident Varun Krishnan, MD.

Dr. Krishnan was the lead investigator on a review of 37 leak cases at Lenox Hill from 2005 to 2017, 17 before overstitch was begun in 2012, and 20 afterwards, with follow-up out to 71 months. The results were presented at the World Congress of Endoscopic Surgery hosted by SAGES & CAGS. The senior investigator was Lenox Hill surgeon Julio Teixeira, MD, FACS, associate professor of medicine at Hofstra University, Hempstead, N.Y. He reported the first use of stents for bariatric leaks in 2007 (Surg Obes Relat Dis. 2007 Jan-Feb;3[1]:68-71).

The goal of the review was to address lingering concerns about long-term effects of stents on weight loss and other issues. In the end, “our experience with stenting has been very positive. It’s a very good [option] for treating leaks after bariatric surgery,” Dr. Krishnan said,

The overall success rate was 95%. The 2 failures were both in the sleeve gastrectomy patient group, which made up 43% of the 37 leak cases. The leaks were fixed in one sleeve patient with conversion to a Roux-en-Y gastric bypass, and the other with a stent redo. Both were in the overstitch group.

 

 


“We had better success with gastric bypass [patients], probably due to anatomy,” Dr. Krishnan noted. Sleeves leave patients with higher intraluminal pressures, which complicate leak healing.

Stents didn’t have any impact on weight loss. Patients lost a mean of 57% of their excess body weight over an average of 21 months.

Out of 20 patients with available data, 5 were readmitted for oral intolerance, another major concern with endoscopic stents; 3 had their stents removed because of it. None required total parenteral nutrition.

Among 17 patients with available data, 7 (41.7%) had poststent reflux; all of them reported proton-pump inhibitor histories.
 

 


Of the 37 total cases, 15 patients (41%) had Roux-en-Y bypasses. The remaining six bypass patients received either duodenal switches or foregut procedures.

Two sleeve and four bypass patients (16%) had revisions. One was the conversion to bypass after stent failure, but the others were for intussusception, strictures, reflux, and other problems that didn’t seem related to stents. About six patients were restented, the one case for stent failure plus five or so for migration.

Patients were an average of about 40 years old, and 70% were women. Average preop body mass index was over 40 kg/m2. The one death in the series was from fungal sepsis a year after stent removal.

In response to an audience question, Dr. Krishnan noted that the distal tip of the stent was placed just after the gastrojejunal anastomosis in bypass cases. Also, bariatric surgeons do the endoscopy at Lenox Hill and place the stents.

The investigators did not report any relevant disclosures, and there was no outside funding.
 
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REPORTING FROM SAGES 2018

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Key clinical point: Consider fixation when endoscopic stents are used for bariatric surgery leaks.

Major finding: Endoscopic stent migration fell from 41% of stent cases to 15% after surgeons at Lenox Hill Hospital, New York, started to secure stents with a single, proximal figure-of-eight overstitch.

Study details: A review of 37 leak cases

Disclosures: The investigators did not report any relevant disclosures, and there was no outside funding.

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