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Beyond the sleeve and RYGB: The frontier of bariatric procedures
BOSTON – Though 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.
BOSTON – Though 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.
BOSTON – Though 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.
EXPERT ANALYSIS FROM AACE 2018
The case for bariatric surgery to manage CV risk in diabetes
BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes ( 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.
koakes@mdedge.com
SOURCE: Hurley, D. AACE 2018, Session SGS-4.
BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes ( 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.
koakes@mdedge.com
SOURCE: Hurley, D. AACE 2018, Session SGS-4.
BOSTON – For patients with obesity and metabolic syndrome or type 2 diabetes ( 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.
koakes@mdedge.com
SOURCE: Hurley, D. AACE 2018, Session SGS-4.
EXPERT ANALYSIS FROM AACE 2018
FDA alerts clinicians to gastric balloon deaths
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.
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.
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.
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.
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.
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.
Genes, not adiposity, may be driving appetite differences in obesity
BOSTON – Evidence from a twin study points to genes, rather than just adiposity, as the underlying factor in differences in appetite and satiety that have been observed in obesity.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The work adds a new dimension – and some questions – to previous research, which suggested individuals with obesity show heightened brain activation to food cues, especially calorically dense food.
“We thought it was fat mass…but when we controlled for everything that monozygotic pairs have in common, that relationship went away, implicating something that the monozygotic twins have in common, i.e., genetics,” said first author Jennifer Rosenbaum, MD, in a video interview at the annual meeting of the American Academy of Clinical Endocrinologists.
Dr. Rosenbaum, a fellow in the department of metabolism, endocrinology, and nutrition at the University of Washington, Seattle, and her collaborators made use of a statewide twin registry to conduct an extensive investigation of subjective and objective measures of appetite and satiety in the 42 twin pairs.
Twins had a mean age of 31 years; 27 of the twin pairs were monozygotic, Dr. Rosenbaum said. At least one member of each twin pair met criteria for obesity, and participants had a mean body mass index of 32.8 kg/m2.
On the study day, participants arrived in fasting state, and had a fixed-calorie breakfast equivalent to 10% of their daily caloric needs. They then underwent dual-energy x-ray absorptiometry scanning to determine adiposity, and also filled out a behavioral questionnaire.
Then, participants received the first of two functional MRI scans; during the scan, they were shown images of high calorie foods, low calorie foods, and nonfood objects, completing ratings of how appealing they found each image. After consuming another standardized meal equivalent to 20% of daily caloric needs, the fMRI scan was repeated.
Finally, participants were given access to a buffet meal and allowed to eat as much as they chose; consumption was measured. Before and after each meal and scan, and at various points during the day, the investigators also obtained blood samples and asked participants to rate their hunger on a visual analog scale.
“When compared with how much fat mass they had, there was no relationship between how hungry or full they were when they were fasting, how hungry or full they were with a snack, or when they ate the buffet. It just didn’t matter how much fat mass they had” for subjective reporting of hunger and fullness, said Dr. Rosenbaum.
However, there was a direct correlation between fat mass and amount consumed at the ad libitum buffet. Additionally, the fMRI analysis showed that “the brain activation that we would expect to go down, didn’t seem to go down as much if you had more adiposity,” she said.
As fat mass went up, areas of the brain implicated in appetite and reward showed more activity when participants were presented with the tempting images of high calorie foods, regardless of the calories consumed. These areas include the ventral and dorsal striata, the amygdala, the insula, the ventral tegmental area, and the medial orbitofrontal cortex.
Next, the researchers looked for differences within the monozygotic twin pairs, who essentially share a genome. They compared the brain activation of the twin with the higher fat mass with that of the twin with lower fat mass. Instead of seeing the same correlation between higher adiposity and greater brain activation with tempting stimuli, “Suddenly, we lost that relationship between how many calories they would eat and how their brain activated with the food,” said Dr. Rosenbaum. This is a clue, she said, that genetics, rather than simple adiposity, is driving the different responses to food cues.
The study was funded by the National Institutes of Health. Dr. Rosenbaum reported no financial disclosures.
BOSTON – Evidence from a twin study points to genes, rather than just adiposity, as the underlying factor in differences in appetite and satiety that have been observed in obesity.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The work adds a new dimension – and some questions – to previous research, which suggested individuals with obesity show heightened brain activation to food cues, especially calorically dense food.
“We thought it was fat mass…but when we controlled for everything that monozygotic pairs have in common, that relationship went away, implicating something that the monozygotic twins have in common, i.e., genetics,” said first author Jennifer Rosenbaum, MD, in a video interview at the annual meeting of the American Academy of Clinical Endocrinologists.
Dr. Rosenbaum, a fellow in the department of metabolism, endocrinology, and nutrition at the University of Washington, Seattle, and her collaborators made use of a statewide twin registry to conduct an extensive investigation of subjective and objective measures of appetite and satiety in the 42 twin pairs.
Twins had a mean age of 31 years; 27 of the twin pairs were monozygotic, Dr. Rosenbaum said. At least one member of each twin pair met criteria for obesity, and participants had a mean body mass index of 32.8 kg/m2.
On the study day, participants arrived in fasting state, and had a fixed-calorie breakfast equivalent to 10% of their daily caloric needs. They then underwent dual-energy x-ray absorptiometry scanning to determine adiposity, and also filled out a behavioral questionnaire.
Then, participants received the first of two functional MRI scans; during the scan, they were shown images of high calorie foods, low calorie foods, and nonfood objects, completing ratings of how appealing they found each image. After consuming another standardized meal equivalent to 20% of daily caloric needs, the fMRI scan was repeated.
Finally, participants were given access to a buffet meal and allowed to eat as much as they chose; consumption was measured. Before and after each meal and scan, and at various points during the day, the investigators also obtained blood samples and asked participants to rate their hunger on a visual analog scale.
“When compared with how much fat mass they had, there was no relationship between how hungry or full they were when they were fasting, how hungry or full they were with a snack, or when they ate the buffet. It just didn’t matter how much fat mass they had” for subjective reporting of hunger and fullness, said Dr. Rosenbaum.
However, there was a direct correlation between fat mass and amount consumed at the ad libitum buffet. Additionally, the fMRI analysis showed that “the brain activation that we would expect to go down, didn’t seem to go down as much if you had more adiposity,” she said.
As fat mass went up, areas of the brain implicated in appetite and reward showed more activity when participants were presented with the tempting images of high calorie foods, regardless of the calories consumed. These areas include the ventral and dorsal striata, the amygdala, the insula, the ventral tegmental area, and the medial orbitofrontal cortex.
Next, the researchers looked for differences within the monozygotic twin pairs, who essentially share a genome. They compared the brain activation of the twin with the higher fat mass with that of the twin with lower fat mass. Instead of seeing the same correlation between higher adiposity and greater brain activation with tempting stimuli, “Suddenly, we lost that relationship between how many calories they would eat and how their brain activated with the food,” said Dr. Rosenbaum. This is a clue, she said, that genetics, rather than simple adiposity, is driving the different responses to food cues.
The study was funded by the National Institutes of Health. Dr. Rosenbaum reported no financial disclosures.
BOSTON – Evidence from a twin study points to genes, rather than just adiposity, as the underlying factor in differences in appetite and satiety that have been observed in obesity.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The work adds a new dimension – and some questions – to previous research, which suggested individuals with obesity show heightened brain activation to food cues, especially calorically dense food.
“We thought it was fat mass…but when we controlled for everything that monozygotic pairs have in common, that relationship went away, implicating something that the monozygotic twins have in common, i.e., genetics,” said first author Jennifer Rosenbaum, MD, in a video interview at the annual meeting of the American Academy of Clinical Endocrinologists.
Dr. Rosenbaum, a fellow in the department of metabolism, endocrinology, and nutrition at the University of Washington, Seattle, and her collaborators made use of a statewide twin registry to conduct an extensive investigation of subjective and objective measures of appetite and satiety in the 42 twin pairs.
Twins had a mean age of 31 years; 27 of the twin pairs were monozygotic, Dr. Rosenbaum said. At least one member of each twin pair met criteria for obesity, and participants had a mean body mass index of 32.8 kg/m2.
On the study day, participants arrived in fasting state, and had a fixed-calorie breakfast equivalent to 10% of their daily caloric needs. They then underwent dual-energy x-ray absorptiometry scanning to determine adiposity, and also filled out a behavioral questionnaire.
Then, participants received the first of two functional MRI scans; during the scan, they were shown images of high calorie foods, low calorie foods, and nonfood objects, completing ratings of how appealing they found each image. After consuming another standardized meal equivalent to 20% of daily caloric needs, the fMRI scan was repeated.
Finally, participants were given access to a buffet meal and allowed to eat as much as they chose; consumption was measured. Before and after each meal and scan, and at various points during the day, the investigators also obtained blood samples and asked participants to rate their hunger on a visual analog scale.
“When compared with how much fat mass they had, there was no relationship between how hungry or full they were when they were fasting, how hungry or full they were with a snack, or when they ate the buffet. It just didn’t matter how much fat mass they had” for subjective reporting of hunger and fullness, said Dr. Rosenbaum.
However, there was a direct correlation between fat mass and amount consumed at the ad libitum buffet. Additionally, the fMRI analysis showed that “the brain activation that we would expect to go down, didn’t seem to go down as much if you had more adiposity,” she said.
As fat mass went up, areas of the brain implicated in appetite and reward showed more activity when participants were presented with the tempting images of high calorie foods, regardless of the calories consumed. These areas include the ventral and dorsal striata, the amygdala, the insula, the ventral tegmental area, and the medial orbitofrontal cortex.
Next, the researchers looked for differences within the monozygotic twin pairs, who essentially share a genome. They compared the brain activation of the twin with the higher fat mass with that of the twin with lower fat mass. Instead of seeing the same correlation between higher adiposity and greater brain activation with tempting stimuli, “Suddenly, we lost that relationship between how many calories they would eat and how their brain activated with the food,” said Dr. Rosenbaum. This is a clue, she said, that genetics, rather than simple adiposity, is driving the different responses to food cues.
The study was funded by the National Institutes of Health. Dr. Rosenbaum reported no financial disclosures.
REPORTING FROM AACE 2018
Bismuth subgallate cuts stool smell after duodenal switch
SEATTLE – 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.
“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.
SEATTLE – 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.
“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.
SEATTLE – 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.
“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.
REPORTING FROM SAGES 2018
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.
VIDEO: Move beyond BMI to see obesity as a disease
BOSTON – , W. Timothy Garvey, MD, said.
“The term ‘obesity’ means so many things to different people,” Dr. Garvey explained in a video interview at the annual meeting of the American Association of Clinical Endocrinologists. “It doesn’t tell you what the impact is of excess adiposity on health.”
In fact, obesity meets the criteria needed to be defined as a disease, said Dr. Garvey, who coauthored a 2017 AACE position statement recommending a new diagnostic term for obesity: adiposity-based chronic disease, or ABCD.
“It’s not going to replace the general use of the term ‘obesity,’ of course; but for medical diagnosis, this term does tell you what we’re treating, and why we’re treating it,” noted Dr. Garvey, of the University of Alabama at Birmingham.
Instead of relying on BMI [body mass index], the ABCD model emphasizes a “complications-centric” approach that drives therapeutic decisions, which may include medication.
“A structured lifestyle intervention is the key to therapy, but if we add medications on to any lifestyle intervention, we’re going to get more bang for the buck,” Dr. Garvey explained.
“We’re going to get more weight loss and be able to keep it off for a longer period of time,” he added. “We want that in situations in particular where the patient really has complications. This could be diabetes, it could be prediabetes, it could be obstructive sleep apnea, symptomatic osteoarthritis in the knees, stress incontinence, hypertension – any one of a number of weight-related complications that are really impairing health.”
The five medications approved for chronic management of obesity all have been shown to be safe and effective in clinical trials. But they have different mechanisms of action, different side effect profiles, and different warnings and precautions, Dr. Garvey noted.
Understanding the pharmacology of all five drugs is important to help a specific patient achieve the best outcomes.
“There’s no drug that can be recommended, in a hierarchical sense, as being better than any others across the board in all patients,” Dr. Garvey explained. “We really need to individualize therapy based on their side effect profile and their types of complications that present with the patient.”
Endocrinologists can be particularly helpful in incorporating weight loss therapy into the overall therapeutic plan for refractory cases, he said, or in patients significantly burdened with metabolic complications, including dysglycemia, diabetes, hypertriglyceridemia, and nonalcoholic fatty liver disease.
Primary care physicians, advanced practice clinicians, dietitians, and others are needed on the team to engineer a successful lifestyle intervention for the obese patient. However, Dr. Garvey emphasized that the endocrinology subspecialty encompasses not only endocrinology and diabetes, but also metabolism.
“We need to take the lead here,” Dr. Garvey said. “Obesity is the most common metabolic disease on the planet.”
Dr. Garvey reported disclosures related to Janssen, Novo Nordisk, and Sanofi.
BOSTON – , W. Timothy Garvey, MD, said.
“The term ‘obesity’ means so many things to different people,” Dr. Garvey explained in a video interview at the annual meeting of the American Association of Clinical Endocrinologists. “It doesn’t tell you what the impact is of excess adiposity on health.”
In fact, obesity meets the criteria needed to be defined as a disease, said Dr. Garvey, who coauthored a 2017 AACE position statement recommending a new diagnostic term for obesity: adiposity-based chronic disease, or ABCD.
“It’s not going to replace the general use of the term ‘obesity,’ of course; but for medical diagnosis, this term does tell you what we’re treating, and why we’re treating it,” noted Dr. Garvey, of the University of Alabama at Birmingham.
Instead of relying on BMI [body mass index], the ABCD model emphasizes a “complications-centric” approach that drives therapeutic decisions, which may include medication.
“A structured lifestyle intervention is the key to therapy, but if we add medications on to any lifestyle intervention, we’re going to get more bang for the buck,” Dr. Garvey explained.
“We’re going to get more weight loss and be able to keep it off for a longer period of time,” he added. “We want that in situations in particular where the patient really has complications. This could be diabetes, it could be prediabetes, it could be obstructive sleep apnea, symptomatic osteoarthritis in the knees, stress incontinence, hypertension – any one of a number of weight-related complications that are really impairing health.”
The five medications approved for chronic management of obesity all have been shown to be safe and effective in clinical trials. But they have different mechanisms of action, different side effect profiles, and different warnings and precautions, Dr. Garvey noted.
Understanding the pharmacology of all five drugs is important to help a specific patient achieve the best outcomes.
“There’s no drug that can be recommended, in a hierarchical sense, as being better than any others across the board in all patients,” Dr. Garvey explained. “We really need to individualize therapy based on their side effect profile and their types of complications that present with the patient.”
Endocrinologists can be particularly helpful in incorporating weight loss therapy into the overall therapeutic plan for refractory cases, he said, or in patients significantly burdened with metabolic complications, including dysglycemia, diabetes, hypertriglyceridemia, and nonalcoholic fatty liver disease.
Primary care physicians, advanced practice clinicians, dietitians, and others are needed on the team to engineer a successful lifestyle intervention for the obese patient. However, Dr. Garvey emphasized that the endocrinology subspecialty encompasses not only endocrinology and diabetes, but also metabolism.
“We need to take the lead here,” Dr. Garvey said. “Obesity is the most common metabolic disease on the planet.”
Dr. Garvey reported disclosures related to Janssen, Novo Nordisk, and Sanofi.
BOSTON – , W. Timothy Garvey, MD, said.
“The term ‘obesity’ means so many things to different people,” Dr. Garvey explained in a video interview at the annual meeting of the American Association of Clinical Endocrinologists. “It doesn’t tell you what the impact is of excess adiposity on health.”
In fact, obesity meets the criteria needed to be defined as a disease, said Dr. Garvey, who coauthored a 2017 AACE position statement recommending a new diagnostic term for obesity: adiposity-based chronic disease, or ABCD.
“It’s not going to replace the general use of the term ‘obesity,’ of course; but for medical diagnosis, this term does tell you what we’re treating, and why we’re treating it,” noted Dr. Garvey, of the University of Alabama at Birmingham.
Instead of relying on BMI [body mass index], the ABCD model emphasizes a “complications-centric” approach that drives therapeutic decisions, which may include medication.
“A structured lifestyle intervention is the key to therapy, but if we add medications on to any lifestyle intervention, we’re going to get more bang for the buck,” Dr. Garvey explained.
“We’re going to get more weight loss and be able to keep it off for a longer period of time,” he added. “We want that in situations in particular where the patient really has complications. This could be diabetes, it could be prediabetes, it could be obstructive sleep apnea, symptomatic osteoarthritis in the knees, stress incontinence, hypertension – any one of a number of weight-related complications that are really impairing health.”
The five medications approved for chronic management of obesity all have been shown to be safe and effective in clinical trials. But they have different mechanisms of action, different side effect profiles, and different warnings and precautions, Dr. Garvey noted.
Understanding the pharmacology of all five drugs is important to help a specific patient achieve the best outcomes.
“There’s no drug that can be recommended, in a hierarchical sense, as being better than any others across the board in all patients,” Dr. Garvey explained. “We really need to individualize therapy based on their side effect profile and their types of complications that present with the patient.”
Endocrinologists can be particularly helpful in incorporating weight loss therapy into the overall therapeutic plan for refractory cases, he said, or in patients significantly burdened with metabolic complications, including dysglycemia, diabetes, hypertriglyceridemia, and nonalcoholic fatty liver disease.
Primary care physicians, advanced practice clinicians, dietitians, and others are needed on the team to engineer a successful lifestyle intervention for the obese patient. However, Dr. Garvey emphasized that the endocrinology subspecialty encompasses not only endocrinology and diabetes, but also metabolism.
“We need to take the lead here,” Dr. Garvey said. “Obesity is the most common metabolic disease on the planet.”
Dr. Garvey reported disclosures related to Janssen, Novo Nordisk, and Sanofi.
REPORTING FROM AACE 2018
Trends in teen consumption of sports drinks are up and down
Although daily consumption of sports drinks decreased from 2010 to 2015 among teenagers, sugar-sweetened sports drinks still are popular, with numerous high school students drinking them at least weekly, said Kyla Cordery of the Steven and Alexandra Cohen Children’s Medical Center of New York, Lake Success, N.Y., and her associates.
Yet sports drink consumption in the previous week increased from 58% in 2010 to 60% in 2015 (P = .0002). And daily consumption of sports drinks also increased among teenagers watching television for more than 2 hours per day and among obese teens.
Boys were more than twice as likely as girls to drink one of more sports drinks daily (19% vs. 9%), as were more athletic/active children than those weren’t very athletic/active (18% vs. 10%).
“ Like many sugar-sweetened beverages, the excessive consumption of sports drinks is associated with weight gain, dental erosion, obesity, poor nutrition, and diabetes,” Ms. Cordery and her associates wrote. “The America Academy of Pediatrics’ Committee on Nutrition and Council on Sports Medicine and Fitness stated that the level of physical activity of the average child does not require the electrolyte replenishment offered by sports drinks.” Rehydration with water should be encouraged for most sports-related activities.
SOURCE: Cordery K et al. doi: 10.1542/peds.2017-2784.
Although daily consumption of sports drinks decreased from 2010 to 2015 among teenagers, sugar-sweetened sports drinks still are popular, with numerous high school students drinking them at least weekly, said Kyla Cordery of the Steven and Alexandra Cohen Children’s Medical Center of New York, Lake Success, N.Y., and her associates.
Yet sports drink consumption in the previous week increased from 58% in 2010 to 60% in 2015 (P = .0002). And daily consumption of sports drinks also increased among teenagers watching television for more than 2 hours per day and among obese teens.
Boys were more than twice as likely as girls to drink one of more sports drinks daily (19% vs. 9%), as were more athletic/active children than those weren’t very athletic/active (18% vs. 10%).
“ Like many sugar-sweetened beverages, the excessive consumption of sports drinks is associated with weight gain, dental erosion, obesity, poor nutrition, and diabetes,” Ms. Cordery and her associates wrote. “The America Academy of Pediatrics’ Committee on Nutrition and Council on Sports Medicine and Fitness stated that the level of physical activity of the average child does not require the electrolyte replenishment offered by sports drinks.” Rehydration with water should be encouraged for most sports-related activities.
SOURCE: Cordery K et al. doi: 10.1542/peds.2017-2784.
Although daily consumption of sports drinks decreased from 2010 to 2015 among teenagers, sugar-sweetened sports drinks still are popular, with numerous high school students drinking them at least weekly, said Kyla Cordery of the Steven and Alexandra Cohen Children’s Medical Center of New York, Lake Success, N.Y., and her associates.
Yet sports drink consumption in the previous week increased from 58% in 2010 to 60% in 2015 (P = .0002). And daily consumption of sports drinks also increased among teenagers watching television for more than 2 hours per day and among obese teens.
Boys were more than twice as likely as girls to drink one of more sports drinks daily (19% vs. 9%), as were more athletic/active children than those weren’t very athletic/active (18% vs. 10%).
“ Like many sugar-sweetened beverages, the excessive consumption of sports drinks is associated with weight gain, dental erosion, obesity, poor nutrition, and diabetes,” Ms. Cordery and her associates wrote. “The America Academy of Pediatrics’ Committee on Nutrition and Council on Sports Medicine and Fitness stated that the level of physical activity of the average child does not require the electrolyte replenishment offered by sports drinks.” Rehydration with water should be encouraged for most sports-related activities.
SOURCE: Cordery K et al. doi: 10.1542/peds.2017-2784.
FROM PEDIATRICS
VIDEO: BMI helps predict bone fragility in obese patients
BOSTON – An index that takes into account the ratio between body mass index (BMI) and bone mineral density (BMD) correlated well with trabecular bone scores, a newer assessment of bone fragility. The index may help predict risk for fragility fractures in individuals with obesity when trabecular bone scores are not available.
“Obesity is traditionally thought to be protective against bone fractures,” said Mikiko Watanabe, MD, an endocrinologist at Sapienza University of Rome. “But recent evidence suggests that this is not entirely true, especially in morbidly obese patients.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Lumbar spine BMD alone may not accurately capture bone fragility in patients with obesity, said Dr. Watanabe in an interview at the annual meeting of the American Association of Clinical Endocrinologists.
Adding the trabecular bone score (TBS) to BMD gives additional information about bone microarchitecture, refining risk assessment for fragility fractures. This newer technology, however, may not be readily available and may be associated with extra cost.
Accordingly, said Dr. Watanabe, the study’s senior investigator, Sapienza University’s Carla Lubrano, MD, had the idea to index bone density to BMI, and then see how well the ratio correlated to TBS; obesity is known to be associated with lower TBS scores, indicating increased bone fragility.
Living in Italy, with relatively fewer medical resources available, “We were trying to find some readily available index that could predict the risk of fracture as well as the indexes that are around right now,” said Dr. Watanabe.
“We did find some very interesting data in our population of over 2,000 obese patients living in Rome,” she said. “We do confirm something from the literature, where BMD tends to go high with increasing BMI.” Further, the relatively weak correlation between TBS and BMI was confirmed in the investigators’ work (r = 0.3).
“If you correct the BMD by BMI – so if you use our index – then the correlation becomes more stringent, and definitely so much better,” she said (r = 0.54).
Dr. Watanabe and her colleagues also conducted an analysis to see if there were differences between participants with and without metabolic syndrome. The 45.7% of participants who had metabolic syndrome had similar lumbar spine BMD scores to the rest of the cohort (1.067 versus 1.063 g/cm2, P = .50754).
However, both the TBS and BMD/BMI ratio were significantly lower for those with metabolic syndrome than for the metabolically healthy participants. The TBS, as expected, was 1.21 in patients with metabolic syndrome, and 1.31 in patients without metabolic syndrome; the BMD/BMI ratio followed the same pattern, with ratios of 0.28 for those with, and 0.30 for those without, metabolic syndrome (P less than .00001 for both).
Dr. Watanabe said that she and her associates are continuing research “to see whether our ratio is actually able to predict the risk of fractures." The hope, she said, is to use the BMD/BMI index together with or instead of TBS to better assess bone strength in patients with obesity.
Dr. Watanabe reported that she had no relevant conflicts of interest.
BOSTON – An index that takes into account the ratio between body mass index (BMI) and bone mineral density (BMD) correlated well with trabecular bone scores, a newer assessment of bone fragility. The index may help predict risk for fragility fractures in individuals with obesity when trabecular bone scores are not available.
“Obesity is traditionally thought to be protective against bone fractures,” said Mikiko Watanabe, MD, an endocrinologist at Sapienza University of Rome. “But recent evidence suggests that this is not entirely true, especially in morbidly obese patients.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Lumbar spine BMD alone may not accurately capture bone fragility in patients with obesity, said Dr. Watanabe in an interview at the annual meeting of the American Association of Clinical Endocrinologists.
Adding the trabecular bone score (TBS) to BMD gives additional information about bone microarchitecture, refining risk assessment for fragility fractures. This newer technology, however, may not be readily available and may be associated with extra cost.
Accordingly, said Dr. Watanabe, the study’s senior investigator, Sapienza University’s Carla Lubrano, MD, had the idea to index bone density to BMI, and then see how well the ratio correlated to TBS; obesity is known to be associated with lower TBS scores, indicating increased bone fragility.
Living in Italy, with relatively fewer medical resources available, “We were trying to find some readily available index that could predict the risk of fracture as well as the indexes that are around right now,” said Dr. Watanabe.
“We did find some very interesting data in our population of over 2,000 obese patients living in Rome,” she said. “We do confirm something from the literature, where BMD tends to go high with increasing BMI.” Further, the relatively weak correlation between TBS and BMI was confirmed in the investigators’ work (r = 0.3).
“If you correct the BMD by BMI – so if you use our index – then the correlation becomes more stringent, and definitely so much better,” she said (r = 0.54).
Dr. Watanabe and her colleagues also conducted an analysis to see if there were differences between participants with and without metabolic syndrome. The 45.7% of participants who had metabolic syndrome had similar lumbar spine BMD scores to the rest of the cohort (1.067 versus 1.063 g/cm2, P = .50754).
However, both the TBS and BMD/BMI ratio were significantly lower for those with metabolic syndrome than for the metabolically healthy participants. The TBS, as expected, was 1.21 in patients with metabolic syndrome, and 1.31 in patients without metabolic syndrome; the BMD/BMI ratio followed the same pattern, with ratios of 0.28 for those with, and 0.30 for those without, metabolic syndrome (P less than .00001 for both).
Dr. Watanabe said that she and her associates are continuing research “to see whether our ratio is actually able to predict the risk of fractures." The hope, she said, is to use the BMD/BMI index together with or instead of TBS to better assess bone strength in patients with obesity.
Dr. Watanabe reported that she had no relevant conflicts of interest.
BOSTON – An index that takes into account the ratio between body mass index (BMI) and bone mineral density (BMD) correlated well with trabecular bone scores, a newer assessment of bone fragility. The index may help predict risk for fragility fractures in individuals with obesity when trabecular bone scores are not available.
“Obesity is traditionally thought to be protective against bone fractures,” said Mikiko Watanabe, MD, an endocrinologist at Sapienza University of Rome. “But recent evidence suggests that this is not entirely true, especially in morbidly obese patients.”
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Lumbar spine BMD alone may not accurately capture bone fragility in patients with obesity, said Dr. Watanabe in an interview at the annual meeting of the American Association of Clinical Endocrinologists.
Adding the trabecular bone score (TBS) to BMD gives additional information about bone microarchitecture, refining risk assessment for fragility fractures. This newer technology, however, may not be readily available and may be associated with extra cost.
Accordingly, said Dr. Watanabe, the study’s senior investigator, Sapienza University’s Carla Lubrano, MD, had the idea to index bone density to BMI, and then see how well the ratio correlated to TBS; obesity is known to be associated with lower TBS scores, indicating increased bone fragility.
Living in Italy, with relatively fewer medical resources available, “We were trying to find some readily available index that could predict the risk of fracture as well as the indexes that are around right now,” said Dr. Watanabe.
“We did find some very interesting data in our population of over 2,000 obese patients living in Rome,” she said. “We do confirm something from the literature, where BMD tends to go high with increasing BMI.” Further, the relatively weak correlation between TBS and BMI was confirmed in the investigators’ work (r = 0.3).
“If you correct the BMD by BMI – so if you use our index – then the correlation becomes more stringent, and definitely so much better,” she said (r = 0.54).
Dr. Watanabe and her colleagues also conducted an analysis to see if there were differences between participants with and without metabolic syndrome. The 45.7% of participants who had metabolic syndrome had similar lumbar spine BMD scores to the rest of the cohort (1.067 versus 1.063 g/cm2, P = .50754).
However, both the TBS and BMD/BMI ratio were significantly lower for those with metabolic syndrome than for the metabolically healthy participants. The TBS, as expected, was 1.21 in patients with metabolic syndrome, and 1.31 in patients without metabolic syndrome; the BMD/BMI ratio followed the same pattern, with ratios of 0.28 for those with, and 0.30 for those without, metabolic syndrome (P less than .00001 for both).
Dr. Watanabe said that she and her associates are continuing research “to see whether our ratio is actually able to predict the risk of fractures." The hope, she said, is to use the BMD/BMI index together with or instead of TBS to better assess bone strength in patients with obesity.
Dr. Watanabe reported that she had no relevant conflicts of interest.
REPORTING FROM AACE 2018
Figure-of-eight overstitch keeps endoscopic stents in place
SEATTLE – 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.
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.
SEATTLE – 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.
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.
SEATTLE – 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.
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.
REPORTING FROM SAGES 2018
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.
Responsive parenting intervention slows weight gain in infancy
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
REPORTING FROM PAS 2018
Key clinical point:
Major finding: For the primary outcome of body mass index z score at 3 years, a significant difference favoring the responsive parenting intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04).
Study details: A randomized clinical trial including 279 mother-newborn dyads.
Disclosures: Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.