Bariatric Surgery

The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.

The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.

“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.

The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.

The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.

Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.

TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.

The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.

“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.

The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.

The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.

Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.

TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.

The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, said in a news release.

“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” Mr. McKhann added.

The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.

The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.

Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20%-30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.

TORe is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.

A version of this article first appeared on Medscape.com.

Pediatric obesity is a serious problem, not only in the United States but worldwide. Unfortunately, the ongoing COVID-19 pandemic has worsened the epidemic of childhood obesity. Solutions for treating the millions of children and adolescents with obesity are desperately needed because prevention efforts over the past several decades have not been sufficient in slowing the steady rise in obesity prevalence.

Lifestyle modification, including dietary changes, increases in activity, and behavioral modification, are the cornerstone of any obesity treatment, but they alone are not powerful enough to treat obesity by itself in the vast majority of children and adolescents. This is because obesity is not a lifestyle choice; rather, it is a disease, and a disease that has a tremendous amount of biology driving individuals toward weight gain and the propensity toward weight regain if weight is lost.

Fortunately, the tools to treat the underlying biology driving obesity are becoming safer, more effective, and more widely used every year. The two most effective biology-based treatments for pediatric obesity are antiobesity medications and bariatric surgery. These two treatments, when accompanied by lifestyle modification, have the potential to reduce not only body weight but also treat many other risk factors, such as prediabetes, diabetes, high blood pressure, poor cholesterol, liver disease, and sleep apnea, as well as others.
 

Rise in antiobesity medications

Antiobesity medications are developing at a rapid pace. Seven medications have been approved by the Food and Drug Administration for adults, and three medications (phentermine, orlistat, and liraglutide) are now approved for children and adolescents.

The number of antiobesity medications for use in children and adolescents is expected to expand to five, with semaglutide and phentermine-topiramate (Qsymia) both completing trials in adolescents in 2022. Each of these medications works by treating the biology that drives weight gain, whether it is decreasing impulsivity, reducing hunger and appetite hormone pathways, or improving energy regulation pathways. Weight loss at 1 year for currently FDA-approved medications in adolescents ranges from 3% to 6% on average, depending on the medications. The newer medications already FDA approved in adults that will soon, hopefully, be available in pediatrics result in 10%-16% weight loss on average.

A common parent and patient question regarding antiobesity medications is: “If I start an antiobesity medication, how long will I need to be on it?” The simple answer is: “Probably for the rest of your life.”

This can be a shock to hear, but obesity treatment is very similar to that of hypertension or diabetes. Using high blood pressure as an example: If a patient has high blood pressure (for example, 160/90 mm Hg), they will be prescribed a medication to treat it. Once blood pressure comes down to near-normal levels (for example, 120/80 mm Hg), a dose will be maintained, not removed, because that is the biological mediator keeping the blood pressure low. Removal of the medication would result in blood pressure going back to homeostasis (160/90 mm Hg in our example) in a short period of time).

The same can be said for obesity. For example, if a 16-year-old girl is prescribed liraglutide, a glucagonlike peptide–1 receptor agonist, and loses 10% of her body weight at 1 year, that is great success. Why would we remove the medication that is treating the underlying biology causing successful weight loss?

In short, we would not want to do that. Even if our example patient only maintained that 10% initial weight loss, that would be very successful, just like someone maintaining their low blood pressure. As medications begin to develop at a rapid pace and become more available to pediatric patients, the messaging and conversation around anti-obesity medications must continue to focus on obesity being a biological disease and not a behavior for treatment to be effective and not stigmatized.
 

Bariatric surgery most effective treatment for pediatric obesity

Currently, the most effective treatment for pediatric obesity is bariatric surgery. The two most commonly used surgical procedures today are the sleeve gastrectomy and gastric bypass. Sleeve gastrectomy works by removing 75%-85% of the stomach and creating a new stomach, called a “sleeve.” Gastric bypass works by separating the stomach into two parts and connecting one part of the new stomach into the intestine.

Both surgeries are very effective at treating obesity in adolescents, with an average weight loss of 30%-35%. Surgery is not just a restrictive means of controlling body weight; it also changes key hormones for appetite and satiety that signal the brain. In fact, many of the same biological signals that are changed by surgery are the same signals being targeted by antiobesity medications. Long-term outcome of bariatric surgery in adolescents, provided by Teen-LABS, show it to be safe and maybe even more effective than in adults for treating diabetes and hypertension, with similar weight loss.
 

Does treatment outweigh the potential risks?

Although obesity surgery and antiobesity medications are more successful at treating obesity in children and adolescents than lifestyle medications, they do have some risks. Surgery, depending on the type of surgery, can cause nutritional deficiencies, reduce body mineral density, and is a life-changing medical procedure. Antiobesity medications, depending on the type, can cause nausea and vomiting and increase heart rate – and because they are relatively new, we do not fully understand the long-term impact of continued use past 1 year.

However, an important question to ask is: “Do the risks of obesity surgery and antiobesity medications outweigh the risk of having lifelong obesity?” The answer to me and many of my colleagues is: “Yes!” Although there are risks associated with the two best treatments for pediatric obesity, those risks under proper supervision of a medical professional far outweigh the risks of not properly treating obesity and allowing it to persist and get worse over many years to come. Obesity is a disease deeply rooted in biology, and we must use biology-based treatments to tackle this problem in children and adolescents, who deserve the best care and treatments possible.

Dr. Ryder is assistant professor of pediatrics and associate director of research, Center for Pediatric Obesity Medicine, at the University of Minnesota, Minneapolis. She reported receiving donations for clinical trials from Boehringer Ingelheim. A version of this article first appeared on Medscape.com.

Pediatric obesity is a serious problem, not only in the United States but worldwide. Unfortunately, the ongoing COVID-19 pandemic has worsened the epidemic of childhood obesity. Solutions for treating the millions of children and adolescents with obesity are desperately needed because prevention efforts over the past several decades have not been sufficient in slowing the steady rise in obesity prevalence.

Lifestyle modification, including dietary changes, increases in activity, and behavioral modification, are the cornerstone of any obesity treatment, but they alone are not powerful enough to treat obesity by itself in the vast majority of children and adolescents. This is because obesity is not a lifestyle choice; rather, it is a disease, and a disease that has a tremendous amount of biology driving individuals toward weight gain and the propensity toward weight regain if weight is lost.

Fortunately, the tools to treat the underlying biology driving obesity are becoming safer, more effective, and more widely used every year. The two most effective biology-based treatments for pediatric obesity are antiobesity medications and bariatric surgery. These two treatments, when accompanied by lifestyle modification, have the potential to reduce not only body weight but also treat many other risk factors, such as prediabetes, diabetes, high blood pressure, poor cholesterol, liver disease, and sleep apnea, as well as others.
 

Rise in antiobesity medications

Antiobesity medications are developing at a rapid pace. Seven medications have been approved by the Food and Drug Administration for adults, and three medications (phentermine, orlistat, and liraglutide) are now approved for children and adolescents.

The number of antiobesity medications for use in children and adolescents is expected to expand to five, with semaglutide and phentermine-topiramate (Qsymia) both completing trials in adolescents in 2022. Each of these medications works by treating the biology that drives weight gain, whether it is decreasing impulsivity, reducing hunger and appetite hormone pathways, or improving energy regulation pathways. Weight loss at 1 year for currently FDA-approved medications in adolescents ranges from 3% to 6% on average, depending on the medications. The newer medications already FDA approved in adults that will soon, hopefully, be available in pediatrics result in 10%-16% weight loss on average.

A common parent and patient question regarding antiobesity medications is: “If I start an antiobesity medication, how long will I need to be on it?” The simple answer is: “Probably for the rest of your life.”

This can be a shock to hear, but obesity treatment is very similar to that of hypertension or diabetes. Using high blood pressure as an example: If a patient has high blood pressure (for example, 160/90 mm Hg), they will be prescribed a medication to treat it. Once blood pressure comes down to near-normal levels (for example, 120/80 mm Hg), a dose will be maintained, not removed, because that is the biological mediator keeping the blood pressure low. Removal of the medication would result in blood pressure going back to homeostasis (160/90 mm Hg in our example) in a short period of time).

The same can be said for obesity. For example, if a 16-year-old girl is prescribed liraglutide, a glucagonlike peptide–1 receptor agonist, and loses 10% of her body weight at 1 year, that is great success. Why would we remove the medication that is treating the underlying biology causing successful weight loss?

In short, we would not want to do that. Even if our example patient only maintained that 10% initial weight loss, that would be very successful, just like someone maintaining their low blood pressure. As medications begin to develop at a rapid pace and become more available to pediatric patients, the messaging and conversation around anti-obesity medications must continue to focus on obesity being a biological disease and not a behavior for treatment to be effective and not stigmatized.
 

Bariatric surgery most effective treatment for pediatric obesity

Currently, the most effective treatment for pediatric obesity is bariatric surgery. The two most commonly used surgical procedures today are the sleeve gastrectomy and gastric bypass. Sleeve gastrectomy works by removing 75%-85% of the stomach and creating a new stomach, called a “sleeve.” Gastric bypass works by separating the stomach into two parts and connecting one part of the new stomach into the intestine.

Both surgeries are very effective at treating obesity in adolescents, with an average weight loss of 30%-35%. Surgery is not just a restrictive means of controlling body weight; it also changes key hormones for appetite and satiety that signal the brain. In fact, many of the same biological signals that are changed by surgery are the same signals being targeted by antiobesity medications. Long-term outcome of bariatric surgery in adolescents, provided by Teen-LABS, show it to be safe and maybe even more effective than in adults for treating diabetes and hypertension, with similar weight loss.
 

Does treatment outweigh the potential risks?

Although obesity surgery and antiobesity medications are more successful at treating obesity in children and adolescents than lifestyle medications, they do have some risks. Surgery, depending on the type of surgery, can cause nutritional deficiencies, reduce body mineral density, and is a life-changing medical procedure. Antiobesity medications, depending on the type, can cause nausea and vomiting and increase heart rate – and because they are relatively new, we do not fully understand the long-term impact of continued use past 1 year.

However, an important question to ask is: “Do the risks of obesity surgery and antiobesity medications outweigh the risk of having lifelong obesity?” The answer to me and many of my colleagues is: “Yes!” Although there are risks associated with the two best treatments for pediatric obesity, those risks under proper supervision of a medical professional far outweigh the risks of not properly treating obesity and allowing it to persist and get worse over many years to come. Obesity is a disease deeply rooted in biology, and we must use biology-based treatments to tackle this problem in children and adolescents, who deserve the best care and treatments possible.

Dr. Ryder is assistant professor of pediatrics and associate director of research, Center for Pediatric Obesity Medicine, at the University of Minnesota, Minneapolis. She reported receiving donations for clinical trials from Boehringer Ingelheim. A version of this article first appeared on Medscape.com.

Pediatric obesity is a serious problem, not only in the United States but worldwide. Unfortunately, the ongoing COVID-19 pandemic has worsened the epidemic of childhood obesity. Solutions for treating the millions of children and adolescents with obesity are desperately needed because prevention efforts over the past several decades have not been sufficient in slowing the steady rise in obesity prevalence.

Lifestyle modification, including dietary changes, increases in activity, and behavioral modification, are the cornerstone of any obesity treatment, but they alone are not powerful enough to treat obesity by itself in the vast majority of children and adolescents. This is because obesity is not a lifestyle choice; rather, it is a disease, and a disease that has a tremendous amount of biology driving individuals toward weight gain and the propensity toward weight regain if weight is lost.

Fortunately, the tools to treat the underlying biology driving obesity are becoming safer, more effective, and more widely used every year. The two most effective biology-based treatments for pediatric obesity are antiobesity medications and bariatric surgery. These two treatments, when accompanied by lifestyle modification, have the potential to reduce not only body weight but also treat many other risk factors, such as prediabetes, diabetes, high blood pressure, poor cholesterol, liver disease, and sleep apnea, as well as others.
 

Rise in antiobesity medications

Antiobesity medications are developing at a rapid pace. Seven medications have been approved by the Food and Drug Administration for adults, and three medications (phentermine, orlistat, and liraglutide) are now approved for children and adolescents.

The number of antiobesity medications for use in children and adolescents is expected to expand to five, with semaglutide and phentermine-topiramate (Qsymia) both completing trials in adolescents in 2022. Each of these medications works by treating the biology that drives weight gain, whether it is decreasing impulsivity, reducing hunger and appetite hormone pathways, or improving energy regulation pathways. Weight loss at 1 year for currently FDA-approved medications in adolescents ranges from 3% to 6% on average, depending on the medications. The newer medications already FDA approved in adults that will soon, hopefully, be available in pediatrics result in 10%-16% weight loss on average.

A common parent and patient question regarding antiobesity medications is: “If I start an antiobesity medication, how long will I need to be on it?” The simple answer is: “Probably for the rest of your life.”

This can be a shock to hear, but obesity treatment is very similar to that of hypertension or diabetes. Using high blood pressure as an example: If a patient has high blood pressure (for example, 160/90 mm Hg), they will be prescribed a medication to treat it. Once blood pressure comes down to near-normal levels (for example, 120/80 mm Hg), a dose will be maintained, not removed, because that is the biological mediator keeping the blood pressure low. Removal of the medication would result in blood pressure going back to homeostasis (160/90 mm Hg in our example) in a short period of time).

The same can be said for obesity. For example, if a 16-year-old girl is prescribed liraglutide, a glucagonlike peptide–1 receptor agonist, and loses 10% of her body weight at 1 year, that is great success. Why would we remove the medication that is treating the underlying biology causing successful weight loss?

In short, we would not want to do that. Even if our example patient only maintained that 10% initial weight loss, that would be very successful, just like someone maintaining their low blood pressure. As medications begin to develop at a rapid pace and become more available to pediatric patients, the messaging and conversation around anti-obesity medications must continue to focus on obesity being a biological disease and not a behavior for treatment to be effective and not stigmatized.
 

Bariatric surgery most effective treatment for pediatric obesity

Currently, the most effective treatment for pediatric obesity is bariatric surgery. The two most commonly used surgical procedures today are the sleeve gastrectomy and gastric bypass. Sleeve gastrectomy works by removing 75%-85% of the stomach and creating a new stomach, called a “sleeve.” Gastric bypass works by separating the stomach into two parts and connecting one part of the new stomach into the intestine.

Both surgeries are very effective at treating obesity in adolescents, with an average weight loss of 30%-35%. Surgery is not just a restrictive means of controlling body weight; it also changes key hormones for appetite and satiety that signal the brain. In fact, many of the same biological signals that are changed by surgery are the same signals being targeted by antiobesity medications. Long-term outcome of bariatric surgery in adolescents, provided by Teen-LABS, show it to be safe and maybe even more effective than in adults for treating diabetes and hypertension, with similar weight loss.
 

Does treatment outweigh the potential risks?

Although obesity surgery and antiobesity medications are more successful at treating obesity in children and adolescents than lifestyle medications, they do have some risks. Surgery, depending on the type of surgery, can cause nutritional deficiencies, reduce body mineral density, and is a life-changing medical procedure. Antiobesity medications, depending on the type, can cause nausea and vomiting and increase heart rate – and because they are relatively new, we do not fully understand the long-term impact of continued use past 1 year.

However, an important question to ask is: “Do the risks of obesity surgery and antiobesity medications outweigh the risk of having lifelong obesity?” The answer to me and many of my colleagues is: “Yes!” Although there are risks associated with the two best treatments for pediatric obesity, those risks under proper supervision of a medical professional far outweigh the risks of not properly treating obesity and allowing it to persist and get worse over many years to come. Obesity is a disease deeply rooted in biology, and we must use biology-based treatments to tackle this problem in children and adolescents, who deserve the best care and treatments possible.

Dr. Ryder is assistant professor of pediatrics and associate director of research, Center for Pediatric Obesity Medicine, at the University of Minnesota, Minneapolis. She reported receiving donations for clinical trials from Boehringer Ingelheim. A version of this article first appeared on Medscape.com.

Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) each led to good and sustainable weight loss 10 years later, although reflux was more prevalent after SG, according to the Sleeve vs. Bypass (SLEEVEPASS) randomized clinical trial.

At 10 years, there were no statistically significant between-procedure differences in type 2 diabetes remission, dyslipidemia, or obstructive sleep apnea, but hypertension remission was greater with RYGB.

However, importantly, the cumulative incidence of Barrett’s esophagus was similar after both procedures (4%) and markedly lower than reported in previous trials (14%-17%).

To their knowledge, this is the largest randomized controlled trial with the longest follow-up comparing these two laparoscopic bariatric surgeries, Paulina Salminen, MD, PhD, and colleagues write in their study published online in JAMA Surgery.

They aimed to clarify the “controversial issues” of long-term gastroesophageal reflux disease (GERD) symptoms, endoscopic esophagitis, and Barrett’s esophagus after SG vs. RYGB.    

The findings showed that “there was no difference in the prevalence of Barrett’s esophagus, contrary to previous reports of alarming rates of Barrett’s [esophagus] after sleeve gastrectomy,” Dr. Salminen from Turku (Finland) University Hospital, told this news organization in an email.

“However, our results also show that esophagitis and GERD symptoms are significantly more prevalent after sleeve [gastrectomy], and GERD is an important factor to be considered in the preoperative assessment of bariatric surgery and procedure choice,” she said.

The takeaway is that “we have two good procedures providing good and sustainable 10-year results for both weight loss and remission of comorbidities” for severe obesity, a major health risk, Dr. Salminen summarized.
 

10-year data analysis

Long-term outcomes from randomized clinical trials of laparoscopic SG vs. RYGB are limited, and recent studies have shown a high incidence of worsening of de novo GERD, esophagitis, and Barrett’s esophagus, after laparoscopic SG, Dr. Salminen and colleagues write.

To investigate, they analyzed 10-year data from SLEEVEPASS, which had randomized 240 adult patients with severe obesity to either SG or RYGB at three hospitals in Finland during 2008-2010.

At baseline, 121 patients were randomized to SG and 119 to RYGB. They had a mean age of 48 years, a mean body mass index of 45.9 kg/m², and 70% were women.

Two patients never had the surgery, and at 10 years, 10 patients had died of causes unrelated to bariatric surgery.

At 10 years, 193 of the 288 remaining patients (85%) completed the follow-up for weight loss and other comorbidity outcomes, and 176 of 228 (77%) underwent gastroscopy.

The primary study endpoint of the trial was percent excess weight loss (%EWL). At 10 years, the median %EWL was 43.5% after SG vs. 50.7% after RYGB, with a wide range for both procedures (roughly 2%-110% excess weight loss). Mean estimate %EWL was not equivalent, with it being 8.4% in favor of RYGB.

After SG and RYGB, there were no statistically significant differences in type 2 diabetes remission (26% and 33%, respectively), dyslipidemia (19% and 35%, respectively), or obstructive sleep apnea (16% and 31%, respectively).

Hypertension remission was superior after RYGB (8% vs. 24%; P = .04).

Esophagitis was more prevalent after SG (31% vs. 7%; P < .001).
 

‘Very important study’

“This is a very important study, the first to report 10-year results of a randomized controlled trial comparing the two most frequently used bariatric operations, SG and RYGB,” Beat Peter Müller, MD, MBA, and Adrian Billeter, MD, PhD, who were not involved with this research, told this news organization in an email.

“The results will have a major impact on the future of bariatric surgery,” according to Dr. Müller and Dr. Billeter, from Heidelberg (Germany) University.

The most relevant findings are the GERD outcomes, they said. Because of the high rate of upper endoscopies at 10 years (73%), the study allowed a good assessment of this.

“While this study confirms that SG is a GERD-prone procedure, it clearly demonstrates that GERD after SG does not induce severe esophagitis and Barrett’s esophagus,” they said.

Most importantly, the rate of Barrett’s esophagus, the precursor lesion of adenocarcinomas of the esophago-gastric junction is similar (4%) after both operations and there was no dysplasia in either group, they stressed.

“The main problem after SG remains new-onset GERD, for which still no predictive parameter exists,” according to Dr. Müller and Dr. Billeter.

“The take home message … is that GERD after SG is generally mild and the risk of Barrett’s esophagus is equally higher after SG and RYGB,” they said. “Therefore, all patients after any bariatric operations should undergo regular upper endoscopies.” 

However, “RYGB still leads to an increase in proton-pump inhibitor use, despite RYGB being one of the most effective antireflux procedures,” they said. “This finding needs further investigation.”

Furthermore, “a 4% Barrett esophagus rate 10 years after RYGB is troublesome, and the reasons should be investigated,” they added.

“Another relevant finding is that after 10 years, RYGB has a statistically better weight loss, which reaches the primary endpoint of the SLEEVEPASS trial for the first time,” they noted, yet the clinical relevance of this is not clear, since there was no difference in resolution of comorbidities, except for hypertension. 

Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, who was not involved with this research, agreed that “the study shows durable and good weight loss for either type of laparoscopic surgery with important metabolic effects and confirms the long-term benefits of weight-loss surgery.”

“What is somewhat new is the lower levels of Barrett’s esophagus after sleeve gastrectomy compared with several earlier studies,” he told this news organization in an email.

“This is somewhat incongruent with the relatively high incidence of postsleeve esophagitis noted in the study, which is an accepted risk factor for Barrett’s esophagus,” he continued. “Thus, I believe concern will still remain about GERD-related complications, including Barrett’s [esophagus], after sleeve gastrectomy.”    

“This paper highlights the need for larger prospective studies, especially those that include diverse, older populations with multiple risk factors for Barrett’s esophagus,” Dr. Ketwaroo said.
 

Looking ahead

Using a large data set, such as that from SLEEVEPASS and possibly with data from the SM-BOSS trial and the BariSurg trial, with machine learning and other sophisticated analyses might identify parameters that could be used to choose the best operation for an individual patient, Dr. Salminen speculated. 

“I think what we have learned from these long-term follow-up results is that GERD assessment should be a part of the preoperative assessment, and for patients who have preoperative GERD symptoms and GERD-related endoscopic findings (e.g., hiatal hernia), gastric bypass would be a more optimal procedure choice, if there are no contraindications for it,” she said.

Patient discussions should also cover “long-term symptoms, for example, abdominal pain after RYGB,” she added.

“I am looking forward to our future 20-year follow-up results,” Dr. Salminen said, “which will shed more light on this topic of postoperative [endoscopic] surveillance.

In the meantime, “preoperative gastroscopy is necessary and beneficial, at least when considering sleeve gastrectomy,” she said.

The SLEEVEPASS trial was supported by the Mary and Georg C. Ehrnrooth Foundation, the Government Research Foundation (in a grant awarded to Turku University Hospital), the Orion Research Foundation, the Paulo Foundation, and the Gastroenterological Research Foundation. Dr. Salminen reported receiving grants from the Government Research Foundation awarded to Turku University Hospital and the Mary and Georg C. Ehrnrooth Foundation. Another coauthor received grants from the Orion Research Foundation, the Paulo Foundation, and the Gastroenterological Research Foundation during the study. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) each led to good and sustainable weight loss 10 years later, although reflux was more prevalent after SG, according to the Sleeve vs. Bypass (SLEEVEPASS) randomized clinical trial.

At 10 years, there were no statistically significant between-procedure differences in type 2 diabetes remission, dyslipidemia, or obstructive sleep apnea, but hypertension remission was greater with RYGB.

However, importantly, the cumulative incidence of Barrett’s esophagus was similar after both procedures (4%) and markedly lower than reported in previous trials (14%-17%).

To their knowledge, this is the largest randomized controlled trial with the longest follow-up comparing these two laparoscopic bariatric surgeries, Paulina Salminen, MD, PhD, and colleagues write in their study published online in JAMA Surgery.

They aimed to clarify the “controversial issues” of long-term gastroesophageal reflux disease (GERD) symptoms, endoscopic esophagitis, and Barrett’s esophagus after SG vs. RYGB.    

The findings showed that “there was no difference in the prevalence of Barrett’s esophagus, contrary to previous reports of alarming rates of Barrett’s [esophagus] after sleeve gastrectomy,” Dr. Salminen from Turku (Finland) University Hospital, told this news organization in an email.

“However, our results also show that esophagitis and GERD symptoms are significantly more prevalent after sleeve [gastrectomy], and GERD is an important factor to be considered in the preoperative assessment of bariatric surgery and procedure choice,” she said.

The takeaway is that “we have two good procedures providing good and sustainable 10-year results for both weight loss and remission of comorbidities” for severe obesity, a major health risk, Dr. Salminen summarized.
 

10-year data analysis

Long-term outcomes from randomized clinical trials of laparoscopic SG vs. RYGB are limited, and recent studies have shown a high incidence of worsening of de novo GERD, esophagitis, and Barrett’s esophagus, after laparoscopic SG, Dr. Salminen and colleagues write.

To investigate, they analyzed 10-year data from SLEEVEPASS, which had randomized 240 adult patients with severe obesity to either SG or RYGB at three hospitals in Finland during 2008-2010.

At baseline, 121 patients were randomized to SG and 119 to RYGB. They had a mean age of 48 years, a mean body mass index of 45.9 kg/m², and 70% were women.

Two patients never had the surgery, and at 10 years, 10 patients had died of causes unrelated to bariatric surgery.

At 10 years, 193 of the 288 remaining patients (85%) completed the follow-up for weight loss and other comorbidity outcomes, and 176 of 228 (77%) underwent gastroscopy.

The primary study endpoint of the trial was percent excess weight loss (%EWL). At 10 years, the median %EWL was 43.5% after SG vs. 50.7% after RYGB, with a wide range for both procedures (roughly 2%-110% excess weight loss). Mean estimate %EWL was not equivalent, with it being 8.4% in favor of RYGB.

After SG and RYGB, there were no statistically significant differences in type 2 diabetes remission (26% and 33%, respectively), dyslipidemia (19% and 35%, respectively), or obstructive sleep apnea (16% and 31%, respectively).

Hypertension remission was superior after RYGB (8% vs. 24%; P = .04).

Esophagitis was more prevalent after SG (31% vs. 7%; P < .001).
 

‘Very important study’

“This is a very important study, the first to report 10-year results of a randomized controlled trial comparing the two most frequently used bariatric operations, SG and RYGB,” Beat Peter Müller, MD, MBA, and Adrian Billeter, MD, PhD, who were not involved with this research, told this news organization in an email.

“The results will have a major impact on the future of bariatric surgery,” according to Dr. Müller and Dr. Billeter, from Heidelberg (Germany) University.

The most relevant findings are the GERD outcomes, they said. Because of the high rate of upper endoscopies at 10 years (73%), the study allowed a good assessment of this.

“While this study confirms that SG is a GERD-prone procedure, it clearly demonstrates that GERD after SG does not induce severe esophagitis and Barrett’s esophagus,” they said.

Most importantly, the rate of Barrett’s esophagus, the precursor lesion of adenocarcinomas of the esophago-gastric junction is similar (4%) after both operations and there was no dysplasia in either group, they stressed.

“The main problem after SG remains new-onset GERD, for which still no predictive parameter exists,” according to Dr. Müller and Dr. Billeter.

“The take home message … is that GERD after SG is generally mild and the risk of Barrett’s esophagus is equally higher after SG and RYGB,” they said. “Therefore, all patients after any bariatric operations should undergo regular upper endoscopies.” 

However, “RYGB still leads to an increase in proton-pump inhibitor use, despite RYGB being one of the most effective antireflux procedures,” they said. “This finding needs further investigation.”

Furthermore, “a 4% Barrett esophagus rate 10 years after RYGB is troublesome, and the reasons should be investigated,” they added.

“Another relevant finding is that after 10 years, RYGB has a statistically better weight loss, which reaches the primary endpoint of the SLEEVEPASS trial for the first time,” they noted, yet the clinical relevance of this is not clear, since there was no difference in resolution of comorbidities, except for hypertension. 

Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, who was not involved with this research, agreed that “the study shows durable and good weight loss for either type of laparoscopic surgery with important metabolic effects and confirms the long-term benefits of weight-loss surgery.”

“What is somewhat new is the lower levels of Barrett’s esophagus after sleeve gastrectomy compared with several earlier studies,” he told this news organization in an email.

“This is somewhat incongruent with the relatively high incidence of postsleeve esophagitis noted in the study, which is an accepted risk factor for Barrett’s esophagus,” he continued. “Thus, I believe concern will still remain about GERD-related complications, including Barrett’s [esophagus], after sleeve gastrectomy.”    

“This paper highlights the need for larger prospective studies, especially those that include diverse, older populations with multiple risk factors for Barrett’s esophagus,” Dr. Ketwaroo said.
 

Looking ahead

Using a large data set, such as that from SLEEVEPASS and possibly with data from the SM-BOSS trial and the BariSurg trial, with machine learning and other sophisticated analyses might identify parameters that could be used to choose the best operation for an individual patient, Dr. Salminen speculated. 

“I think what we have learned from these long-term follow-up results is that GERD assessment should be a part of the preoperative assessment, and for patients who have preoperative GERD symptoms and GERD-related endoscopic findings (e.g., hiatal hernia), gastric bypass would be a more optimal procedure choice, if there are no contraindications for it,” she said.

Patient discussions should also cover “long-term symptoms, for example, abdominal pain after RYGB,” she added.

“I am looking forward to our future 20-year follow-up results,” Dr. Salminen said, “which will shed more light on this topic of postoperative [endoscopic] surveillance.

In the meantime, “preoperative gastroscopy is necessary and beneficial, at least when considering sleeve gastrectomy,” she said.

The SLEEVEPASS trial was supported by the Mary and Georg C. Ehrnrooth Foundation, the Government Research Foundation (in a grant awarded to Turku University Hospital), the Orion Research Foundation, the Paulo Foundation, and the Gastroenterological Research Foundation. Dr. Salminen reported receiving grants from the Government Research Foundation awarded to Turku University Hospital and the Mary and Georg C. Ehrnrooth Foundation. Another coauthor received grants from the Orion Research Foundation, the Paulo Foundation, and the Gastroenterological Research Foundation during the study. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

Sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) each led to good and sustainable weight loss 10 years later, although reflux was more prevalent after SG, according to the Sleeve vs. Bypass (SLEEVEPASS) randomized clinical trial.

At 10 years, there were no statistically significant between-procedure differences in type 2 diabetes remission, dyslipidemia, or obstructive sleep apnea, but hypertension remission was greater with RYGB.

However, importantly, the cumulative incidence of Barrett’s esophagus was similar after both procedures (4%) and markedly lower than reported in previous trials (14%-17%).

To their knowledge, this is the largest randomized controlled trial with the longest follow-up comparing these two laparoscopic bariatric surgeries, Paulina Salminen, MD, PhD, and colleagues write in their study published online in JAMA Surgery.

They aimed to clarify the “controversial issues” of long-term gastroesophageal reflux disease (GERD) symptoms, endoscopic esophagitis, and Barrett’s esophagus after SG vs. RYGB.    

The findings showed that “there was no difference in the prevalence of Barrett’s esophagus, contrary to previous reports of alarming rates of Barrett’s [esophagus] after sleeve gastrectomy,” Dr. Salminen from Turku (Finland) University Hospital, told this news organization in an email.

“However, our results also show that esophagitis and GERD symptoms are significantly more prevalent after sleeve [gastrectomy], and GERD is an important factor to be considered in the preoperative assessment of bariatric surgery and procedure choice,” she said.

The takeaway is that “we have two good procedures providing good and sustainable 10-year results for both weight loss and remission of comorbidities” for severe obesity, a major health risk, Dr. Salminen summarized.
 

10-year data analysis

Long-term outcomes from randomized clinical trials of laparoscopic SG vs. RYGB are limited, and recent studies have shown a high incidence of worsening of de novo GERD, esophagitis, and Barrett’s esophagus, after laparoscopic SG, Dr. Salminen and colleagues write.

To investigate, they analyzed 10-year data from SLEEVEPASS, which had randomized 240 adult patients with severe obesity to either SG or RYGB at three hospitals in Finland during 2008-2010.

At baseline, 121 patients were randomized to SG and 119 to RYGB. They had a mean age of 48 years, a mean body mass index of 45.9 kg/m², and 70% were women.

Two patients never had the surgery, and at 10 years, 10 patients had died of causes unrelated to bariatric surgery.

At 10 years, 193 of the 288 remaining patients (85%) completed the follow-up for weight loss and other comorbidity outcomes, and 176 of 228 (77%) underwent gastroscopy.

The primary study endpoint of the trial was percent excess weight loss (%EWL). At 10 years, the median %EWL was 43.5% after SG vs. 50.7% after RYGB, with a wide range for both procedures (roughly 2%-110% excess weight loss). Mean estimate %EWL was not equivalent, with it being 8.4% in favor of RYGB.

After SG and RYGB, there were no statistically significant differences in type 2 diabetes remission (26% and 33%, respectively), dyslipidemia (19% and 35%, respectively), or obstructive sleep apnea (16% and 31%, respectively).

Hypertension remission was superior after RYGB (8% vs. 24%; P = .04).

Esophagitis was more prevalent after SG (31% vs. 7%; P < .001).
 

‘Very important study’

“This is a very important study, the first to report 10-year results of a randomized controlled trial comparing the two most frequently used bariatric operations, SG and RYGB,” Beat Peter Müller, MD, MBA, and Adrian Billeter, MD, PhD, who were not involved with this research, told this news organization in an email.

“The results will have a major impact on the future of bariatric surgery,” according to Dr. Müller and Dr. Billeter, from Heidelberg (Germany) University.

The most relevant findings are the GERD outcomes, they said. Because of the high rate of upper endoscopies at 10 years (73%), the study allowed a good assessment of this.

“While this study confirms that SG is a GERD-prone procedure, it clearly demonstrates that GERD after SG does not induce severe esophagitis and Barrett’s esophagus,” they said.

Most importantly, the rate of Barrett’s esophagus, the precursor lesion of adenocarcinomas of the esophago-gastric junction is similar (4%) after both operations and there was no dysplasia in either group, they stressed.

“The main problem after SG remains new-onset GERD, for which still no predictive parameter exists,” according to Dr. Müller and Dr. Billeter.

“The take home message … is that GERD after SG is generally mild and the risk of Barrett’s esophagus is equally higher after SG and RYGB,” they said. “Therefore, all patients after any bariatric operations should undergo regular upper endoscopies.” 

However, “RYGB still leads to an increase in proton-pump inhibitor use, despite RYGB being one of the most effective antireflux procedures,” they said. “This finding needs further investigation.”

Furthermore, “a 4% Barrett esophagus rate 10 years after RYGB is troublesome, and the reasons should be investigated,” they added.

“Another relevant finding is that after 10 years, RYGB has a statistically better weight loss, which reaches the primary endpoint of the SLEEVEPASS trial for the first time,” they noted, yet the clinical relevance of this is not clear, since there was no difference in resolution of comorbidities, except for hypertension. 

Gyanprakash A. Ketwaroo, MD, of Baylor College of Medicine, Houston, who was not involved with this research, agreed that “the study shows durable and good weight loss for either type of laparoscopic surgery with important metabolic effects and confirms the long-term benefits of weight-loss surgery.”

“What is somewhat new is the lower levels of Barrett’s esophagus after sleeve gastrectomy compared with several earlier studies,” he told this news organization in an email.

“This is somewhat incongruent with the relatively high incidence of postsleeve esophagitis noted in the study, which is an accepted risk factor for Barrett’s esophagus,” he continued. “Thus, I believe concern will still remain about GERD-related complications, including Barrett’s [esophagus], after sleeve gastrectomy.”    

“This paper highlights the need for larger prospective studies, especially those that include diverse, older populations with multiple risk factors for Barrett’s esophagus,” Dr. Ketwaroo said.
 

Looking ahead

Using a large data set, such as that from SLEEVEPASS and possibly with data from the SM-BOSS trial and the BariSurg trial, with machine learning and other sophisticated analyses might identify parameters that could be used to choose the best operation for an individual patient, Dr. Salminen speculated. 

“I think what we have learned from these long-term follow-up results is that GERD assessment should be a part of the preoperative assessment, and for patients who have preoperative GERD symptoms and GERD-related endoscopic findings (e.g., hiatal hernia), gastric bypass would be a more optimal procedure choice, if there are no contraindications for it,” she said.

Patient discussions should also cover “long-term symptoms, for example, abdominal pain after RYGB,” she added.

“I am looking forward to our future 20-year follow-up results,” Dr. Salminen said, “which will shed more light on this topic of postoperative [endoscopic] surveillance.

In the meantime, “preoperative gastroscopy is necessary and beneficial, at least when considering sleeve gastrectomy,” she said.

The SLEEVEPASS trial was supported by the Mary and Georg C. Ehrnrooth Foundation, the Government Research Foundation (in a grant awarded to Turku University Hospital), the Orion Research Foundation, the Paulo Foundation, and the Gastroenterological Research Foundation. Dr. Salminen reported receiving grants from the Government Research Foundation awarded to Turku University Hospital and the Mary and Georg C. Ehrnrooth Foundation. Another coauthor received grants from the Orion Research Foundation, the Paulo Foundation, and the Gastroenterological Research Foundation during the study. No other disclosures were reported.

A version of this article first appeared on Medscape.com.

Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images

• 1.31 (95% CI, 1.30-1.33) for heart failure
• 1.40 (95% CI, 1.37-1.43) for stroke
• 1.59 (95% CI, 1.43-1.75) for systemic embolism
• 1.14 (95% CI, 1.13-1.16) for major bleeding  
• 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images

• 1.31 (95% CI, 1.30-1.33) for heart failure
• 1.40 (95% CI, 1.37-1.43) for stroke
• 1.59 (95% CI, 1.43-1.75) for systemic embolism
• 1.14 (95% CI, 1.13-1.16) for major bleeding  
• 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images

• 1.31 (95% CI, 1.30-1.33) for heart failure
• 1.40 (95% CI, 1.37-1.43) for stroke
• 1.59 (95% CI, 1.43-1.75) for systemic embolism
• 1.14 (95% CI, 1.13-1.16) for major bleeding  
• 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Avexitide (Eiger Biopharmaceuticals), a first-in-class glucagonlike peptide (GLP)–1 receptor blocker, significantly reduced hypoglycemia in patients with refractory postbariatric hypoglycemia, new research finds.  

Postbariatric hypoglycemia is a complication of bariatric surgery that is estimated to occur in about 29%-34% of people who undergo Roux-en-Y gastric bypass and in 11%-23% of those who undergo vertical sleeve gastrectomy. It typically manifests about 1-3 hours after meals and can lead to severe neuroglycopenic symptoms including blurred vision, confusion, drowsiness, and incoordination.

In addition, more than one-third (37%) with the condition have hypoglycemic unawareness. This can lead to seizures in about 59%, loss of consciousness and hospitalization in 50%, motor vehicle accidents, and even death. More than 90% with the condition consider themselves disabled, and 41% report being unable to work.

There are no currently approved medical treatments for postbariatric hypoglycemia. The standard of care is medical nutrition therapy involving a low-carbohydrate diet with carb restriction and small, frequent mixed meals. If this doesn’t work, off-label stepped pharmacotherapy has been tried, including acarbose (Precose), octreotide (Sandostatin), and diazoxide (Proglycem).

But “these are limited by efficacy and tolerability,” said Marilyn Tan, MD, who presented the findings from the phase 2 trial of avexitide at the annual meeting of the Endocrine Society.

In very severe cases, gastrostomy tubes or bypass reversal are options but those lead to weight regain and incomplete efficacy. “Safe, effective, and targeted therapies are needed urgently for postbariatric hypoglycemia,” said Dr. Tan, of the department of endocrinology at Stanford (Calif.) University.

The pathophysiology isn’t fully understood, but there appears to be an exaggerated GLP-1 response that leads to abnormal insulin secretion and symptomatic hyperinsulinemic hypoglycemia. Avexitide (formerly exendin 9-39), blocks the GLP-1 receptor and mitigates the excessive GLP-1 response, she explained.

Asked to comment, session moderator Michelle Van Name, MD, told this news organization, “This is a problem and it’s important for us to understand more about it and to identify different treatment options so these patients can continue to live their full, healthy lives post bariatric surgery.”

And, avexitide also holds potential for treating congenital hyperinsulinism, “which is a very challenging disease to treat in babies,” noted Dr. Van Name, a pediatric endocrinologist at Yale University, New Haven, Conn.
 

Drug reduced all levels of hypoglycemia, across surgery types

The study enrolled 14 women and 2 men with severe refractory postbariatric surgery hypoglycemia despite medical nutrition therapy. A majority (9) had undergone Roux-en-Y gastric bypass, 4 had vertical sleeve gastrectomy, 2 gastrectomy, and 1 had Nissen fundoplication. Seven patients (43.7%) had experienced loss of consciousness from hyperinsulinemic hypoglycemia. None had diabetes.

They were randomly assigned to either subcutaneous 45 mg of avexitide twice daily or 90 mg once daily for 14 days each, with a 2-day washout period followed by a switch to the other dose.

Both doses resulted in significant reductions in hypoglycemia as measured by self–blood glucose monitoring. The once-daily dose reduced level 1 hypoglycemia (glucose < 70 mg/dL) by 67.5% and it reduced level 2 (< 54 mg/dL) by 53.3% (P = .0043).

Even greater reductions were seen in severe hypoglycemia (that is, altered mental status/requiring assistance) – by 67.5% for the twice-daily dose (P = .0003) and by 66.1% with the once-daily dose (P = .0003). 

“This is consistent with what we’ve seen in prior avexitide trials,” Dr. Tan noted.

More hypoglycemic events were captured using blinded continuous glucose monitoring (CGM), since it picked up episodes of which the patient was unaware. There were significant reductions in percentage time spent in level 1 and level 2 hypoglycemia, as well as in absolute number of hypoglycemic events over 14 days.

Here, the effect was greater with the once-daily 90 mg dose, with reductions of up to 65% in time spent and number of events, but results for the twice-daily dose were also significant, Dr. Tan said.

The drug was effective across all surgical subtypes. Patients who underwent vertical sleeve gastrectomy/gastrectomy had greater rates of hypoglycemia at baseline and “robust responses to avexitide subcutaneous injections. This supports the critical role of GLP-1,” Dr. Tan said.

There were no severe adverse events. The most commonly reported adverse events were diarrhea, headache, bloating, and injection-site reaction/bruising. All were mild and self-limited and resolved without treatment. No participants withdrew from the study.

Eiger Biopharmaceuticals is currently working with the U.S. Food and Drug Administration and the European Medicines Agency to design a phase 3 trial.

The study is an investor-initiated trial with funding from Eiger Biopharmaceuticals. Dr. Tan receives research support from Eiger Biopharmaceuticals as a site investigator. Dr. Van Name is an investigator for a trial sponsored by Provention Bio.

A version of this article first appeared on Medscape.com.

Avexitide (Eiger Biopharmaceuticals), a first-in-class glucagonlike peptide (GLP)–1 receptor blocker, significantly reduced hypoglycemia in patients with refractory postbariatric hypoglycemia, new research finds.  

Postbariatric hypoglycemia is a complication of bariatric surgery that is estimated to occur in about 29%-34% of people who undergo Roux-en-Y gastric bypass and in 11%-23% of those who undergo vertical sleeve gastrectomy. It typically manifests about 1-3 hours after meals and can lead to severe neuroglycopenic symptoms including blurred vision, confusion, drowsiness, and incoordination.

In addition, more than one-third (37%) with the condition have hypoglycemic unawareness. This can lead to seizures in about 59%, loss of consciousness and hospitalization in 50%, motor vehicle accidents, and even death. More than 90% with the condition consider themselves disabled, and 41% report being unable to work.

There are no currently approved medical treatments for postbariatric hypoglycemia. The standard of care is medical nutrition therapy involving a low-carbohydrate diet with carb restriction and small, frequent mixed meals. If this doesn’t work, off-label stepped pharmacotherapy has been tried, including acarbose (Precose), octreotide (Sandostatin), and diazoxide (Proglycem).

But “these are limited by efficacy and tolerability,” said Marilyn Tan, MD, who presented the findings from the phase 2 trial of avexitide at the annual meeting of the Endocrine Society.

In very severe cases, gastrostomy tubes or bypass reversal are options but those lead to weight regain and incomplete efficacy. “Safe, effective, and targeted therapies are needed urgently for postbariatric hypoglycemia,” said Dr. Tan, of the department of endocrinology at Stanford (Calif.) University.

The pathophysiology isn’t fully understood, but there appears to be an exaggerated GLP-1 response that leads to abnormal insulin secretion and symptomatic hyperinsulinemic hypoglycemia. Avexitide (formerly exendin 9-39), blocks the GLP-1 receptor and mitigates the excessive GLP-1 response, she explained.

Asked to comment, session moderator Michelle Van Name, MD, told this news organization, “This is a problem and it’s important for us to understand more about it and to identify different treatment options so these patients can continue to live their full, healthy lives post bariatric surgery.”

And, avexitide also holds potential for treating congenital hyperinsulinism, “which is a very challenging disease to treat in babies,” noted Dr. Van Name, a pediatric endocrinologist at Yale University, New Haven, Conn.
 

Drug reduced all levels of hypoglycemia, across surgery types

The study enrolled 14 women and 2 men with severe refractory postbariatric surgery hypoglycemia despite medical nutrition therapy. A majority (9) had undergone Roux-en-Y gastric bypass, 4 had vertical sleeve gastrectomy, 2 gastrectomy, and 1 had Nissen fundoplication. Seven patients (43.7%) had experienced loss of consciousness from hyperinsulinemic hypoglycemia. None had diabetes.

They were randomly assigned to either subcutaneous 45 mg of avexitide twice daily or 90 mg once daily for 14 days each, with a 2-day washout period followed by a switch to the other dose.

Both doses resulted in significant reductions in hypoglycemia as measured by self–blood glucose monitoring. The once-daily dose reduced level 1 hypoglycemia (glucose < 70 mg/dL) by 67.5% and it reduced level 2 (< 54 mg/dL) by 53.3% (P = .0043).

Even greater reductions were seen in severe hypoglycemia (that is, altered mental status/requiring assistance) – by 67.5% for the twice-daily dose (P = .0003) and by 66.1% with the once-daily dose (P = .0003). 

“This is consistent with what we’ve seen in prior avexitide trials,” Dr. Tan noted.

More hypoglycemic events were captured using blinded continuous glucose monitoring (CGM), since it picked up episodes of which the patient was unaware. There were significant reductions in percentage time spent in level 1 and level 2 hypoglycemia, as well as in absolute number of hypoglycemic events over 14 days.

Here, the effect was greater with the once-daily 90 mg dose, with reductions of up to 65% in time spent and number of events, but results for the twice-daily dose were also significant, Dr. Tan said.

The drug was effective across all surgical subtypes. Patients who underwent vertical sleeve gastrectomy/gastrectomy had greater rates of hypoglycemia at baseline and “robust responses to avexitide subcutaneous injections. This supports the critical role of GLP-1,” Dr. Tan said.

There were no severe adverse events. The most commonly reported adverse events were diarrhea, headache, bloating, and injection-site reaction/bruising. All were mild and self-limited and resolved without treatment. No participants withdrew from the study.

Eiger Biopharmaceuticals is currently working with the U.S. Food and Drug Administration and the European Medicines Agency to design a phase 3 trial.

The study is an investor-initiated trial with funding from Eiger Biopharmaceuticals. Dr. Tan receives research support from Eiger Biopharmaceuticals as a site investigator. Dr. Van Name is an investigator for a trial sponsored by Provention Bio.

A version of this article first appeared on Medscape.com.

Avexitide (Eiger Biopharmaceuticals), a first-in-class glucagonlike peptide (GLP)–1 receptor blocker, significantly reduced hypoglycemia in patients with refractory postbariatric hypoglycemia, new research finds.  

Postbariatric hypoglycemia is a complication of bariatric surgery that is estimated to occur in about 29%-34% of people who undergo Roux-en-Y gastric bypass and in 11%-23% of those who undergo vertical sleeve gastrectomy. It typically manifests about 1-3 hours after meals and can lead to severe neuroglycopenic symptoms including blurred vision, confusion, drowsiness, and incoordination.

In addition, more than one-third (37%) with the condition have hypoglycemic unawareness. This can lead to seizures in about 59%, loss of consciousness and hospitalization in 50%, motor vehicle accidents, and even death. More than 90% with the condition consider themselves disabled, and 41% report being unable to work.

There are no currently approved medical treatments for postbariatric hypoglycemia. The standard of care is medical nutrition therapy involving a low-carbohydrate diet with carb restriction and small, frequent mixed meals. If this doesn’t work, off-label stepped pharmacotherapy has been tried, including acarbose (Precose), octreotide (Sandostatin), and diazoxide (Proglycem).

But “these are limited by efficacy and tolerability,” said Marilyn Tan, MD, who presented the findings from the phase 2 trial of avexitide at the annual meeting of the Endocrine Society.

In very severe cases, gastrostomy tubes or bypass reversal are options but those lead to weight regain and incomplete efficacy. “Safe, effective, and targeted therapies are needed urgently for postbariatric hypoglycemia,” said Dr. Tan, of the department of endocrinology at Stanford (Calif.) University.

The pathophysiology isn’t fully understood, but there appears to be an exaggerated GLP-1 response that leads to abnormal insulin secretion and symptomatic hyperinsulinemic hypoglycemia. Avexitide (formerly exendin 9-39), blocks the GLP-1 receptor and mitigates the excessive GLP-1 response, she explained.

Asked to comment, session moderator Michelle Van Name, MD, told this news organization, “This is a problem and it’s important for us to understand more about it and to identify different treatment options so these patients can continue to live their full, healthy lives post bariatric surgery.”

And, avexitide also holds potential for treating congenital hyperinsulinism, “which is a very challenging disease to treat in babies,” noted Dr. Van Name, a pediatric endocrinologist at Yale University, New Haven, Conn.
 

Drug reduced all levels of hypoglycemia, across surgery types

The study enrolled 14 women and 2 men with severe refractory postbariatric surgery hypoglycemia despite medical nutrition therapy. A majority (9) had undergone Roux-en-Y gastric bypass, 4 had vertical sleeve gastrectomy, 2 gastrectomy, and 1 had Nissen fundoplication. Seven patients (43.7%) had experienced loss of consciousness from hyperinsulinemic hypoglycemia. None had diabetes.

They were randomly assigned to either subcutaneous 45 mg of avexitide twice daily or 90 mg once daily for 14 days each, with a 2-day washout period followed by a switch to the other dose.

Both doses resulted in significant reductions in hypoglycemia as measured by self–blood glucose monitoring. The once-daily dose reduced level 1 hypoglycemia (glucose < 70 mg/dL) by 67.5% and it reduced level 2 (< 54 mg/dL) by 53.3% (P = .0043).

Even greater reductions were seen in severe hypoglycemia (that is, altered mental status/requiring assistance) – by 67.5% for the twice-daily dose (P = .0003) and by 66.1% with the once-daily dose (P = .0003). 

“This is consistent with what we’ve seen in prior avexitide trials,” Dr. Tan noted.

More hypoglycemic events were captured using blinded continuous glucose monitoring (CGM), since it picked up episodes of which the patient was unaware. There were significant reductions in percentage time spent in level 1 and level 2 hypoglycemia, as well as in absolute number of hypoglycemic events over 14 days.

Here, the effect was greater with the once-daily 90 mg dose, with reductions of up to 65% in time spent and number of events, but results for the twice-daily dose were also significant, Dr. Tan said.

The drug was effective across all surgical subtypes. Patients who underwent vertical sleeve gastrectomy/gastrectomy had greater rates of hypoglycemia at baseline and “robust responses to avexitide subcutaneous injections. This supports the critical role of GLP-1,” Dr. Tan said.

There were no severe adverse events. The most commonly reported adverse events were diarrhea, headache, bloating, and injection-site reaction/bruising. All were mild and self-limited and resolved without treatment. No participants withdrew from the study.

Eiger Biopharmaceuticals is currently working with the U.S. Food and Drug Administration and the European Medicines Agency to design a phase 3 trial.

The study is an investor-initiated trial with funding from Eiger Biopharmaceuticals. Dr. Tan receives research support from Eiger Biopharmaceuticals as a site investigator. Dr. Van Name is an investigator for a trial sponsored by Provention Bio.

A version of this article first appeared on Medscape.com.

A new study provides more evidence that the substantial weight loss achieved with bariatric surgery offers long-term protection against cancer.

The study found that adults with obesity who had bariatric surgery had a 32% lower risk of developing cancer and a 48% lower risk of dying from cancer, compared with peers who did not have the surgery.

“The magnitude of the benefit was very large and dose-dependent, with more weight loss associated with greater reduction in cancer risk,” lead investigator Ali Aminian, MD, director of the Bariatric & Metabolic Institute, Cleveland Clinic, told this news organization.

The study was published online in the Journal of the American Medical Association.
 

Best evidence to date

“We know that obesity is strongly linked with different types of cancers, but we didn’t know if losing a significant amount of weight can significantly decrease the risk of cancer,” Dr. Aminian explained.

The SPLENDID study involved 30,318 adults with obesity (median age, 46 years; 77% women; median body mass index, 45 kg/m²). 

The 5,053 patients who underwent Roux-en-Y gastric bypass (66%) or sleeve gastrectomy (34%) were matched (1:5) to 25,265 patients who did not undergo bariatric surgery (nonsurgical control group).

At 10 years, patients who had bariatric surgery had lost 27.5 kg (60 pounds) compared with 2.7 kg (6 pounds) for peers who didn’t have the surgery, a difference of 19.2%. 

During a median follow-up of 6.1 years, 96 patients in the bariatric surgery group and 780 patients in the nonsurgical control group developed an obesity-associated cancer (incidence rate of 3.0 vs. 4.6 events per 1,000 person-years).

At 10 years, the cumulative incidence of obesity-associated cancer was significantly lower in the bariatric surgery group (2.9% vs. 4.9%; absolute risk difference, 2.0%; 95% confidence interval [CI], 1.2%-2.7%; adjusted hazard ratio [HR], 0.68; 95% CI, 0.53-0.87; P = .002).

Most cancer types were less common in the bariatric surgery group. However, a comprehensive analysis of the impact of bariatric surgery on individual cancer types was not possible.

In the fully-adjusted Cox models, the association between bariatric surgery and individual cancer types was significant only for endometrial cancer (adjusted HR, 0.47; 95% CI, 0.27-0.83). 

For the other individual cancers, there was a “trend or signal toward a reduction in their risk after the surgery,” Dr. Aminian said.

He noted that endometrial cancer has the strongest association with obesity, and patients who seek bariatric surgery are typically obese, middle-aged women.

“So, it was not surprising that we had more cases of endometrial cancer than other types of cancer,” he said.

The SPLENDID study also showed a significant reduction in cancer-related mortality at 10 years in patients with vs. without bariatric surgery (0.8% vs. 1.4%; adjusted HR, 0.52; 95% CI, 0.31-0.88; P = .01).

The benefits of bariatric surgery were evident in both women and men, younger and older patients, and Black and White patients, and were similarly observed after both gastric bypass and sleeve gastrectomy.

For the cancer protective effect, patients need to lose at least 20%-25% of their body weight, which is almost impossible with diet alone, Dr. Aminian said.

Obesity is “second only to tobacco” as a preventable cause of cancer in the United States, senior author Steven Nissen, MD, chief academic officer of the Heart, Vascular, and Thoracic Institute at Cleveland Clinic, said in a news release.

“This study provides the best possible evidence on the value of intentional weight loss to reduce cancer risk and mortality,” Dr. Nissen said.
 

Questions remain

In an accompanying editorial, Anita P. Courcoulas, MD, of the University of Pittsburgh Medical Center, said future studies should look at potential factors that influence the association between bariatric surgery and reduced cancer risk, with an eye toward individualizing treatment and figuring out who will benefit the most.

“It is likely that cancer risk reduction after bariatric surgery varies by sex, age, race and ethnicity, type of bariatric surgery, alcohol and smoking status, cancer site, diabetes status, body mass index, and other factors,” Dr. Courcoulas pointed out.

“In addition, there is a need to understand the specific biological mechanisms of effect responsible for the observed change in cancer risk because these mechanisms have not been clearly investigated and elucidated in humans,” she said.

“If this association is further validated, it would extend the benefits of bariatric surgery to another important area of long-term health and prevention. This additional information could then further guide for whom bariatric surgery is most beneficial,” Dr. Courcoulas concluded.

The study had no specific funding. Dr. Aminian reported receiving grants and speaking honoraria from Medtronic. Dr. Nissen reported receiving grants from Novartis, Eli Lilly, AbbVie, Silence Therapeutics, AstraZeneca, Esperion Therapeutics, Amgen, and Bristol Myers Squibb. A complete list of author disclosures is available with the original article.  Dr. Courcoulas had no relevant disclosures.

A version of this article first appeared on Medscape.com.

A new study provides more evidence that the substantial weight loss achieved with bariatric surgery offers long-term protection against cancer.

The study found that adults with obesity who had bariatric surgery had a 32% lower risk of developing cancer and a 48% lower risk of dying from cancer, compared with peers who did not have the surgery.

“The magnitude of the benefit was very large and dose-dependent, with more weight loss associated with greater reduction in cancer risk,” lead investigator Ali Aminian, MD, director of the Bariatric & Metabolic Institute, Cleveland Clinic, told this news organization.

The study was published online in the Journal of the American Medical Association.
 

Best evidence to date

“We know that obesity is strongly linked with different types of cancers, but we didn’t know if losing a significant amount of weight can significantly decrease the risk of cancer,” Dr. Aminian explained.

The SPLENDID study involved 30,318 adults with obesity (median age, 46 years; 77% women; median body mass index, 45 kg/m²). 

The 5,053 patients who underwent Roux-en-Y gastric bypass (66%) or sleeve gastrectomy (34%) were matched (1:5) to 25,265 patients who did not undergo bariatric surgery (nonsurgical control group).

At 10 years, patients who had bariatric surgery had lost 27.5 kg (60 pounds) compared with 2.7 kg (6 pounds) for peers who didn’t have the surgery, a difference of 19.2%. 

During a median follow-up of 6.1 years, 96 patients in the bariatric surgery group and 780 patients in the nonsurgical control group developed an obesity-associated cancer (incidence rate of 3.0 vs. 4.6 events per 1,000 person-years).

At 10 years, the cumulative incidence of obesity-associated cancer was significantly lower in the bariatric surgery group (2.9% vs. 4.9%; absolute risk difference, 2.0%; 95% confidence interval [CI], 1.2%-2.7%; adjusted hazard ratio [HR], 0.68; 95% CI, 0.53-0.87; P = .002).

Most cancer types were less common in the bariatric surgery group. However, a comprehensive analysis of the impact of bariatric surgery on individual cancer types was not possible.

In the fully-adjusted Cox models, the association between bariatric surgery and individual cancer types was significant only for endometrial cancer (adjusted HR, 0.47; 95% CI, 0.27-0.83). 

For the other individual cancers, there was a “trend or signal toward a reduction in their risk after the surgery,” Dr. Aminian said.

He noted that endometrial cancer has the strongest association with obesity, and patients who seek bariatric surgery are typically obese, middle-aged women.

“So, it was not surprising that we had more cases of endometrial cancer than other types of cancer,” he said.

The SPLENDID study also showed a significant reduction in cancer-related mortality at 10 years in patients with vs. without bariatric surgery (0.8% vs. 1.4%; adjusted HR, 0.52; 95% CI, 0.31-0.88; P = .01).

The benefits of bariatric surgery were evident in both women and men, younger and older patients, and Black and White patients, and were similarly observed after both gastric bypass and sleeve gastrectomy.

For the cancer protective effect, patients need to lose at least 20%-25% of their body weight, which is almost impossible with diet alone, Dr. Aminian said.

Obesity is “second only to tobacco” as a preventable cause of cancer in the United States, senior author Steven Nissen, MD, chief academic officer of the Heart, Vascular, and Thoracic Institute at Cleveland Clinic, said in a news release.

“This study provides the best possible evidence on the value of intentional weight loss to reduce cancer risk and mortality,” Dr. Nissen said.
 

Questions remain

In an accompanying editorial, Anita P. Courcoulas, MD, of the University of Pittsburgh Medical Center, said future studies should look at potential factors that influence the association between bariatric surgery and reduced cancer risk, with an eye toward individualizing treatment and figuring out who will benefit the most.

“It is likely that cancer risk reduction after bariatric surgery varies by sex, age, race and ethnicity, type of bariatric surgery, alcohol and smoking status, cancer site, diabetes status, body mass index, and other factors,” Dr. Courcoulas pointed out.

“In addition, there is a need to understand the specific biological mechanisms of effect responsible for the observed change in cancer risk because these mechanisms have not been clearly investigated and elucidated in humans,” she said.

“If this association is further validated, it would extend the benefits of bariatric surgery to another important area of long-term health and prevention. This additional information could then further guide for whom bariatric surgery is most beneficial,” Dr. Courcoulas concluded.

The study had no specific funding. Dr. Aminian reported receiving grants and speaking honoraria from Medtronic. Dr. Nissen reported receiving grants from Novartis, Eli Lilly, AbbVie, Silence Therapeutics, AstraZeneca, Esperion Therapeutics, Amgen, and Bristol Myers Squibb. A complete list of author disclosures is available with the original article.  Dr. Courcoulas had no relevant disclosures.

A version of this article first appeared on Medscape.com.

A new study provides more evidence that the substantial weight loss achieved with bariatric surgery offers long-term protection against cancer.

The study found that adults with obesity who had bariatric surgery had a 32% lower risk of developing cancer and a 48% lower risk of dying from cancer, compared with peers who did not have the surgery.

“The magnitude of the benefit was very large and dose-dependent, with more weight loss associated with greater reduction in cancer risk,” lead investigator Ali Aminian, MD, director of the Bariatric & Metabolic Institute, Cleveland Clinic, told this news organization.

The study was published online in the Journal of the American Medical Association.
 

Best evidence to date

“We know that obesity is strongly linked with different types of cancers, but we didn’t know if losing a significant amount of weight can significantly decrease the risk of cancer,” Dr. Aminian explained.

The SPLENDID study involved 30,318 adults with obesity (median age, 46 years; 77% women; median body mass index, 45 kg/m²). 

The 5,053 patients who underwent Roux-en-Y gastric bypass (66%) or sleeve gastrectomy (34%) were matched (1:5) to 25,265 patients who did not undergo bariatric surgery (nonsurgical control group).

At 10 years, patients who had bariatric surgery had lost 27.5 kg (60 pounds) compared with 2.7 kg (6 pounds) for peers who didn’t have the surgery, a difference of 19.2%. 

During a median follow-up of 6.1 years, 96 patients in the bariatric surgery group and 780 patients in the nonsurgical control group developed an obesity-associated cancer (incidence rate of 3.0 vs. 4.6 events per 1,000 person-years).

At 10 years, the cumulative incidence of obesity-associated cancer was significantly lower in the bariatric surgery group (2.9% vs. 4.9%; absolute risk difference, 2.0%; 95% confidence interval [CI], 1.2%-2.7%; adjusted hazard ratio [HR], 0.68; 95% CI, 0.53-0.87; P = .002).

Most cancer types were less common in the bariatric surgery group. However, a comprehensive analysis of the impact of bariatric surgery on individual cancer types was not possible.

In the fully-adjusted Cox models, the association between bariatric surgery and individual cancer types was significant only for endometrial cancer (adjusted HR, 0.47; 95% CI, 0.27-0.83). 

For the other individual cancers, there was a “trend or signal toward a reduction in their risk after the surgery,” Dr. Aminian said.

He noted that endometrial cancer has the strongest association with obesity, and patients who seek bariatric surgery are typically obese, middle-aged women.

“So, it was not surprising that we had more cases of endometrial cancer than other types of cancer,” he said.

The SPLENDID study also showed a significant reduction in cancer-related mortality at 10 years in patients with vs. without bariatric surgery (0.8% vs. 1.4%; adjusted HR, 0.52; 95% CI, 0.31-0.88; P = .01).

The benefits of bariatric surgery were evident in both women and men, younger and older patients, and Black and White patients, and were similarly observed after both gastric bypass and sleeve gastrectomy.

For the cancer protective effect, patients need to lose at least 20%-25% of their body weight, which is almost impossible with diet alone, Dr. Aminian said.

Obesity is “second only to tobacco” as a preventable cause of cancer in the United States, senior author Steven Nissen, MD, chief academic officer of the Heart, Vascular, and Thoracic Institute at Cleveland Clinic, said in a news release.

“This study provides the best possible evidence on the value of intentional weight loss to reduce cancer risk and mortality,” Dr. Nissen said.
 

Questions remain

In an accompanying editorial, Anita P. Courcoulas, MD, of the University of Pittsburgh Medical Center, said future studies should look at potential factors that influence the association between bariatric surgery and reduced cancer risk, with an eye toward individualizing treatment and figuring out who will benefit the most.

“It is likely that cancer risk reduction after bariatric surgery varies by sex, age, race and ethnicity, type of bariatric surgery, alcohol and smoking status, cancer site, diabetes status, body mass index, and other factors,” Dr. Courcoulas pointed out.

“In addition, there is a need to understand the specific biological mechanisms of effect responsible for the observed change in cancer risk because these mechanisms have not been clearly investigated and elucidated in humans,” she said.

“If this association is further validated, it would extend the benefits of bariatric surgery to another important area of long-term health and prevention. This additional information could then further guide for whom bariatric surgery is most beneficial,” Dr. Courcoulas concluded.

The study had no specific funding. Dr. Aminian reported receiving grants and speaking honoraria from Medtronic. Dr. Nissen reported receiving grants from Novartis, Eli Lilly, AbbVie, Silence Therapeutics, AstraZeneca, Esperion Therapeutics, Amgen, and Bristol Myers Squibb. A complete list of author disclosures is available with the original article.  Dr. Courcoulas had no relevant disclosures.

A version of this article first appeared on Medscape.com.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

A version of this article first appeared on Medscape.com.

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

A version of this article first appeared on Medscape.com.

Bariatric surgery can reduce the risk of long-term cardiovascular outcomes in older Medicare beneficiaries with obesity, a large new observational study in which a third of the patients were over age 65 years suggests.

Overall, patients who underwent bariatric surgery had 37% lower all-cause mortality and were significantly less likely to have admissions for new-onset heart failure (64% risk reduction), myocardial infarction (37% risk reduction), and ischemic stroke (29% risk reduction), compared with similar patients who received more conservative treatment, after a median of 4 years of follow-up, report Amgad Mentias, MD, MS, a clinical cardiologist at the Cleveland Clinic Foundation, Ohio, and colleagues.

The results were published in the Journal of the American College of Cardiology.

Previous studies on bariatric surgery outcomes have primarily focused on individuals from select health care networks or medical facilities with restricted coverage in the United States or on patients with diabetes, noted Tiffany M. Powell-Wiley, MD, MPH, of the National Institutes of Health’s National Heart, Lung, and Blood Institute, Bethesda, Maryland, and colleagues in an accompanying editorial.

Contemporary cohort of patients

“A lot of the studies showed long-term outcomes outside of the U.S., specifically in Europe,” Dr. Mentias added.

The aim of this study was to evaluate the long-term association between bariatric surgery and risk of adverse cardiovascular outcomes in a contemporary large cohort from the United States.

Older patients (> 65 years) and those without diabetes were looked at as specific subgroups.

The researchers assessed 189,770 patients. There were 94,885 matched patients in each cohort. Mean age was 62.33 years. Female patients comprised 70% of the cohort. The study group had an average BMI of 44.7 kg/m2.

The study cohort was matched 1:1. Participants were either part of a control group with obesity or a group of Medicare beneficiaries who had bariatric surgery between 2013 and 2019. Sex, propensity score matching on 87 clinical variables, age, and BMI were used to match patients.

Myocardial infarction, new-onset heart failure, ischemic stroke, and all-cause mortality were all study outcomes. As a sensitivity analysis, the study team conducted an instrumental variable assessment.

More specifically, the findings showed that bariatric surgery was linked with the following after a median follow-up of 4.0 years:

• Myocardial infarction (hazard ratio, 0.63; 95% confidence interval, 0.59-0.68)
• Stroke (HR, 0.71; 95% CI, 0.65-0.79)
• New-onset heart failure (HR, 0.46; 95% CI, 0.44-0.49)
• Reduced risk of death (9.2 vs. 14.7 per 1000 person-years; HR, 0.63; 95% CI, 0.60-0.66)

Findings for those over the age of 65 were similar – lower risks of all-cause mortality (HR, 0.64), new-onset heart failure (HR, 0.52), myocardial infarction (HR, 0.70), and stroke (HR, 0.76; all P < .001). Similar findings were shown in subgroup analyses in men and women and in patients with and without diabetes.

The study cohort primarily consisted of Medicare patients, which limits the generalizability of the data. Lack of data on medications taken for cardiovascular and weight loss purposes and potential coding errors because the information was gathered from an administrative database were all limitations of the study, the researchers note.

An additional limitation was that residual unmeasured confounders, particularly patient-focused physical, social, and mental support factors, could play a role in whether a patient opted to have bariatric surgery, the study authors note.

“Additional studies are needed to compare cardiovascular outcomes after bariatric surgery with weight loss medications like glucagon-like peptide-1 (GLP-1) analogues,” the researchers add.

This study was partially funded by philanthropic contributions by the Khouri family, Bailey family, and Haslam family to the Cleveland Clinic for co-author Dr. Milind Y. Desai’s research. Dr. Mentias has disclosed no relevant financial relationships. Dr. Powell-Wiley disclosed relationships with the National Institute on Minority Health and Health Disparities and the Division of Intramural Research of the National, Heart, Lung, and Blood Institute of the National Institutes of Health.

A version of this article first appeared on Medscape.com.

Jessica Furby struggled with weight most of her life, constantly dieting and exercising to shed pounds. But nothing seemed to help. By her 22nd birthday, she tipped the scales at more than 300 pounds.

So, in 2011, while a college student in Pittsburgh, she decided to have gastric band surgery. Doctors placed a synthetic belt around her stomach to limit what she could eat. It seemed like a good option at the time and, after her surgery, she lost about 60 pounds.

But the benefits didn’t last. In the months that followed, she had pain and other complications. Worst of all, she eventually regained all the weight she’d lost – and then some. By 2016, she weighed 350 pounds and was becoming prediabetic.

That’s when she decided to have the band removed and, on her doctor’s recommendation, had gastric sleeve surgery.

Studies have found the sleeve surgeries carry fewer complications and a much higher success rate than gastric band procedures, which Ms. Furby’s experience has confirmed.

Today, at age 32, she’s down to 288 pounds and says she is on her way to hitting her ultimate goal of 200 pounds.

“The surgery has been a godsend,” she said. “I have not had any complications with it at all. The sleeve was life-changing for me.”

Ms. Furby’s experience has become more common as the risks, complications, and failures of gastric band surgeries have been rising over the past decade.

More band patients are choosing to have conversion surgery to gastric sleeve and gastric bypass. At the same time, fewer doctors are doing gastric band procedures, because of problems like Ms. Furby’s.

According to the latest figures from the American Society for Metabolic and Bariatric Surgery, gastric band procedures account for fewer than 1% of the 256,000 bariatric operations done in the United States each year, while gastric sleeves add up to nearly 60%. That makes sleeve surgeries the most commonly performed bariatric operation today.

By comparison, 35% of bariatric surgeries were gastric band procedures in 2011, while sleeve operations accounted for under 18%.

Ms. Furby’s surgeon, Anita P. Courcoulas, MD, said the trend is being driven by many of the things Ms.Furby experienced firsthand.

Dr. Courcoulas, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh, said there are two main reasons for the decline in gastric band procedures.

“It has been shown to be less effective for weight loss [than] other bariatric surgical procedures, and band intolerance often results in band removal,” she noted.

Gastric sleeve, followed by gastric bypass, are the two most commonly performed operations in the United States and worldwide, she said.

Dr. Courcoulas said the shift from gastric bypass to gastric sleeve procedures “is likely driven by the decline in the band usage, patient preferences for a less invasive operation, such as the sleeve compared to bypass, and surgeon preferences about which operation(s) to offer a given patient.”

Ali Aminian, MD, director of the Bariatric and Metabolic Institute at the Cleveland Clinic, agrees that gastric band complications and failures, in addition to ineffective weight loss, are behind the trend, driving patients and doctors to choose safer and more effective procedures.

He said the Cleveland Clinic no longer does band operations, and he has done a lot of conversions.

“Around 50%-60% of [gastric band] patients require reoperation to take care of the complications,” he says. “So, when you have a surgery where more than half of the time the patients require reoperation, we cannot claim that’s a safe operation.”
 

Evolution in bariatric surgery

Bariatric surgeries for weight loss date back to the 1950s and 1960s, when surgeons at the University of Minnesota first did experimental bypass operations. Adjustable gastric banding appeared in the late 1970s and early 1980s.

But these procedures didn’t gain widespread mainstream use until gastric band procedures gained full Food and Drug Administration approval in 2001. Clinical trials have found people who have bariatric surgery have a significantly lower risk of heart disease and other obesity-related health problems.

In the decade that followed the FDA’s approval of gastric band surgery, it became a popular weight loss procedure, accounting for more than a third of all bariatric surgeries by 2011.

“Fifteen to 20 years ago, [gastric] band was the most commonly performed procedure for bariatric surgery worldwide and in the United States,” Dr. Aminian said. “It was very easy to do, it was quick – it takes 20 minutes to do the procedure – recovery was short, and initially patients had great outcomes. They would lose weight and were healthy.”

But over the past decade, surgeons found that patients often regained the weight they’d lost, and complication and failure rates rose.

“Because the [gastric] band is a foreign body that we place inside the body, many patients had complications related to that foreign body,” Dr. Aminian said.

The band can sometimes move or be displaced, causing blockage of the stomach, experts noted. Other common complications include nausea, vomiting, acid reflux, and esophageal issues (such as a hard time swallowing). Some patients feel pain, constant food cravings, or that they can’t eat or drink anything. And painful infections and other problems can develop with the tubing or the port placed under the skin that is connected to the band, which doctors use to make adjustments after surgery.

“Scar tissue can also form around the [gastric] band that can cause a blockage in the stomach,” Dr. Aminian said. “Then if the band is too tight, it can erode into the stomach tissue or even go inside the stomach and cause perforation or bleeding.”

By contrast, gastric sleeve and bypass procedures have been found to be safer, result in longer-lasting weight loss, carry fewer complications, and require fewer patient reoperations. Dr. Aminian estimates that 2%-3% of patients need second operations.

Another key factor: Metabolic ‘reset’

Sleeve and bypass procedures offer another critical advantage over band operations: They help reset the body’s metabolism better, changing appetite- and weight-related hormones in the body.

Those hormones can affect food cravings, help people feel full after eating, or boost weight gain in ways that can trump willpower, experts say.

“The [gastric] band doesn’t change the hormones in the body, it’s just a restrictive band around the esophagus or the upper part of the stomach, so it limits the patient’s ability to eat too much,” Dr. Aminian said. “That’s why it doesn’t have the metabolic effects.”

But other procedures, like the gastric sleeve, change the hormones in the body. Removing the source of those hormones means the patient won’t have the same appetite, Dr. Aminian said.

“And that’s why it’s very effective. The problem with the [gastric] band is the patient always has the feeling and desire to eat – they’re always hungry. That’s why in the long run, they fail,” he said.

“They change the setpoints,” Dr. Aminian said. “When the hormones in your body change, the [metabolic] setpoint in the brain also changes.”

He likens the metabolic setpoint to a thermostat in your home that regulates temperature inside.

“When a patient goes on a diet or goes on the [gastric] band, the thermostat doesn’t change,” he says. “They may lose some weight, but they’re going to regain it because the thermostat is the same. But when the hormones in your body change, then the thermostat will change and you’re not going to regain the weight that you have lost.”

Sachin Kukreja, MD, a surgeon and CEO at DFW Bariatrics and General Surgery in Dallas, said he believes these metabolic changes are the biggest things behind successful surgeries.

“People synonymize bariatric surgery with weight loss surgery, but really the metrics we should be using are more related to metabolic measures,” said Dr. Kukreja, who hasn’t done a band surgery since 2013. “And so, the metabolic parameters that change with bariatric surgery are much more significant in the setting with sleeve and gastric sleeve, and much less significant with [gastric] band.”

David Arterburn, MD, agrees that resetting metabolism is important but said the issue is “controversial and challenging” among bariatric surgeons.

“The metabolic setpoint is the idea that we have a biologically controlled set body weight that we will always return to. Clearly, this is not the case for everyone, as some people lose and maintain long-term weight loss,” said Dr. Arterburn, a general internist and bariatric surgery researcher at Kaiser Permanente Washington Health Research Institute in Seattle.
 

Postop lifestyle changes critical to success

Bariatric surgeons and patients alike also say that no surgical procedure is a magic-bullet solution for weight loss. Patients who have any type of bariatric surgery must embrace postop lifestyle changes – adopting healthier diets, getting more exercise, cutting out unhealthy habits – to lose weight and maintain weight loss.

Jan Lasecki, 54, a health care specialist in Akron, Ohio, who had band-to-sleeve conversion surgery in 2020, said the postop follow-up was at least as important as the surgery itself in helping her shed pounds.

She said at first, she chose gastric band surgery several years ago because it was “less invasive” than gastric sleeve or bypass. But while she lost about 50 pounds, she regained it after about 6 years and had other complications.

So, 2 years ago, Ms. Lasecki had two surgeries 6 months apart – one to remove her band, and a second to create a gastric sleeve. And the results, she said, have been very successful, in part because of the changes she made after surgery, with the help of her doctor’s staff.

“I have now lost about 90 pounds and have kept if off since surgery,” she says. “I would tell anyone considering any bariatric surgery, it was definitely worth it [and] having the sleeve resulted in greater weight loss.”

The follow-up was key to the success, she said.

The staff “have the tools and support to help you when you tend to fall back on old behaviors and start to regain weight,” Ms. Lasecki said. “They can help you before it gets out of control. I had no issues following either procedure from a surgery perspective.”

Sally and Robert Cordova – who had gastric bypass and sleeve surgeries, respectively, 3 years ago – agreed that the postop lifestyle changes are critical to success.

“When we agreed to have this surgery, we agreed that this will be a lifestyle change for the rest of our lives,” said Sally, 48, an accounting specialist who’s lost 150 pounds – half her body weight – since her surgery. “You can’t just get to your ideal weight and then stop.”

Robert, 47, a federal border control agent whose workmates nicknamed him “Big Rob” when he tipped the scales at 336 pounds, said it’s a mistake to think of the surgery as a “magic-bullet” solution to obesity. There’s more to it than that, he said.

“One of the things I like about the process I’ve taken is, in my opinion, they set you up for success,” he said. “Because it’s not just having the surgery and you’re done; it’s all the classes educating you about all the lifestyle changes you have to do, and starting them before the surgery. The only people that I know personally who haven’t been successful with the surgery are those who haven’t made the lifestyle changes.”

Today, at 230 pounds, Robert says he’s never felt better.

“I feel great,” he says. “I have become more active, obviously doing everything is a lot easier. It got to the point where it was a task to just tying up my shoes!”
 

Should band patients convert to sleeve or bypass?

Bariatric surgeons interviewed for this article were reluctant to say that all people who had gastric band procedures should convert to gastric sleeve or bypass. But they made it clear that sleeve and bypass procedures are safer and more effective than gastric band surgery, which is why it is rarely done today.

“If a patient experiences poor weight loss or complications from a band, they can consider conversion/revision to a sleeve or bypass,” said Dr. Courcoulas, echoing the views of other doctors.

“The choice of revision procedure should be based on patient factors, including diabetes and total weight. Converting a band to a sleeve is a technically easier operation, and some studies show that there are fewer complications, compared to conversion to a bypass. These considerations need to be balanced with data that show that both weight loss and metabolic improvements such as diabetes are greater after bypass, compared to sleeve.”

Doctors and experts also say it’s important for patients who are considering a gastric band conversion to gastric sleeve or bypass to understand the differences among these three primary procedures, all endorsed by the American Society for Metabolic and Bariatric Surgery.

Here’s a primer, including the pros and cons of each procedure:
 

Gastric band

In gastric band surgery, an adjustable gastric band made of silicone is placed around the top part of the stomach, creating a small pouch above it, to limit the amount of food a person can eat. The size of the opening between the pouch and the stomach can be adjusted with fluid injections through a port placed underneath the skin.

Food goes through the stomach but is limited by the smaller opening of the band.

Advantages:

• Lowest rate of complications right after surgery.
• No division of the stomach or intestines.
• Patients go home on the day of surgery, and recovery is quick.
• The band can be removed, if necessary.

Disadvantages:

• The band may need to be adjusted from time to time, and patients must make monthly office visits during the first year.
• There’s less weight loss than with other surgical procedures.
• It comes with the risk of band movement (slippage) or damage to the stomach over time (erosion).
• The surgery means that a foreign implant has to remain in the body.
• It has a high rate of reoperation.
• The surgery can bring swallowing problems, enlargement of the esophagus, and other complications.

Gastric sleeve

For laparoscopic sleeve gastrectomy – often called gastric sleeve – surgeons remove about 80% of the stomach, so the remaining stomach is the size and shape of a banana.

The new, smaller stomach holds less food and liquid, reducing how much food (and how many calories) the patient can get. By removing the portion of the stomach that produces hunger and appetite hormones, the surgery also helps reset the body’s metabolism – decreasing hunger, increasing feelings of fullness, and allowing the body to reach and maintain a healthy weight as well as control blood sugar.

Advantages:

• It’s technically simple and has a short surgery time.
• It can be done in certain patients with high-risk medical conditions.
• It may be the first step for patients with severe obesity or as a bridge to gastric bypass.
• The surgery brings effective weight loss and improvement of obesity-related conditions (typically 50%-60%, by Mayo Clinic estimates), with a low complication rate (2%-3%).

Disadvantages:

• Nonreversible procedure.
• May worsen or cause new reflux and heartburn.
• Less impact on metabolism, compared to bypass procedures.

Gastric bypass

Gastric bypass, also known as the Roux-en-Y gastric bypass (French for “in the form of a Y”) is another effective procedure used to treat obesity and obesity-related diseases (done laparoscopically since the 1990s).

For the operation, surgeons divide the stomach into a smaller top portion (pouch) about the size of an egg, then the larger part of the stomach is bypassed and no longer stores or digests food.

The small intestine is divided and connected to the new egg-sized stomach pouch to allow food to pass.

Gastric bypass works by limiting the amount of food and calories a patient can consume. It also decreases hunger and increases fullness, allowing the patient to reach and maintain a healthy weight. The impact on hormones and metabolic health often results in improvement of diabetes and helps patients with reflux.

Advantages:

• Reliable and long-lasting weight loss.
• Effective for remission of obesity-associated conditions.
• Effective weight loss (60%-70%, by Mayo Clinic estimates).

Disadvantages:

• Technically more complex when compared to gastric sleeve or band.
• More vitamin and mineral deficiencies than with gastric sleeve or band.
• Risk for small bowel complications and obstruction, as well as ulcers, especially with NSAID or tobacco use.
• May cause “dumping syndrome,” a feeling of sickness after eating or drinking, especially sweets.

A version of this article first appeared on WebMD.com.

Editor’s Note: This story has been updated to properly identify a product referenced in the story.

Jessica Furby struggled with weight most of her life, constantly dieting and exercising to shed pounds. But nothing seemed to help. By her 22nd birthday, she tipped the scales at more than 300 pounds.

So, in 2011, while a college student in Pittsburgh, she decided to have gastric band surgery. Doctors placed a synthetic belt around her stomach to limit what she could eat. It seemed like a good option at the time and, after her surgery, she lost about 60 pounds.

But the benefits didn’t last. In the months that followed, she had pain and other complications. Worst of all, she eventually regained all the weight she’d lost – and then some. By 2016, she weighed 350 pounds and was becoming prediabetic.

That’s when she decided to have the band removed and, on her doctor’s recommendation, had gastric sleeve surgery.

Studies have found the sleeve surgeries carry fewer complications and a much higher success rate than gastric band procedures, which Ms. Furby’s experience has confirmed.

Today, at age 32, she’s down to 288 pounds and says she is on her way to hitting her ultimate goal of 200 pounds.

“The surgery has been a godsend,” she said. “I have not had any complications with it at all. The sleeve was life-changing for me.”

Ms. Furby’s experience has become more common as the risks, complications, and failures of gastric band surgeries have been rising over the past decade.

More band patients are choosing to have conversion surgery to gastric sleeve and gastric bypass. At the same time, fewer doctors are doing gastric band procedures, because of problems like Ms. Furby’s.

According to the latest figures from the American Society for Metabolic and Bariatric Surgery, gastric band procedures account for fewer than 1% of the 256,000 bariatric operations done in the United States each year, while gastric sleeves add up to nearly 60%. That makes sleeve surgeries the most commonly performed bariatric operation today.

By comparison, 35% of bariatric surgeries were gastric band procedures in 2011, while sleeve operations accounted for under 18%.

Ms. Furby’s surgeon, Anita P. Courcoulas, MD, said the trend is being driven by many of the things Ms.Furby experienced firsthand.

Dr. Courcoulas, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh, said there are two main reasons for the decline in gastric band procedures.

“It has been shown to be less effective for weight loss [than] other bariatric surgical procedures, and band intolerance often results in band removal,” she noted.

Gastric sleeve, followed by gastric bypass, are the two most commonly performed operations in the United States and worldwide, she said.

Dr. Courcoulas said the shift from gastric bypass to gastric sleeve procedures “is likely driven by the decline in the band usage, patient preferences for a less invasive operation, such as the sleeve compared to bypass, and surgeon preferences about which operation(s) to offer a given patient.”

Ali Aminian, MD, director of the Bariatric and Metabolic Institute at the Cleveland Clinic, agrees that gastric band complications and failures, in addition to ineffective weight loss, are behind the trend, driving patients and doctors to choose safer and more effective procedures.

He said the Cleveland Clinic no longer does band operations, and he has done a lot of conversions.

“Around 50%-60% of [gastric band] patients require reoperation to take care of the complications,” he says. “So, when you have a surgery where more than half of the time the patients require reoperation, we cannot claim that’s a safe operation.”
 

Evolution in bariatric surgery

Bariatric surgeries for weight loss date back to the 1950s and 1960s, when surgeons at the University of Minnesota first did experimental bypass operations. Adjustable gastric banding appeared in the late 1970s and early 1980s.

But these procedures didn’t gain widespread mainstream use until gastric band procedures gained full Food and Drug Administration approval in 2001. Clinical trials have found people who have bariatric surgery have a significantly lower risk of heart disease and other obesity-related health problems.

In the decade that followed the FDA’s approval of gastric band surgery, it became a popular weight loss procedure, accounting for more than a third of all bariatric surgeries by 2011.

“Fifteen to 20 years ago, [gastric] band was the most commonly performed procedure for bariatric surgery worldwide and in the United States,” Dr. Aminian said. “It was very easy to do, it was quick – it takes 20 minutes to do the procedure – recovery was short, and initially patients had great outcomes. They would lose weight and were healthy.”

But over the past decade, surgeons found that patients often regained the weight they’d lost, and complication and failure rates rose.

“Because the [gastric] band is a foreign body that we place inside the body, many patients had complications related to that foreign body,” Dr. Aminian said.

The band can sometimes move or be displaced, causing blockage of the stomach, experts noted. Other common complications include nausea, vomiting, acid reflux, and esophageal issues (such as a hard time swallowing). Some patients feel pain, constant food cravings, or that they can’t eat or drink anything. And painful infections and other problems can develop with the tubing or the port placed under the skin that is connected to the band, which doctors use to make adjustments after surgery.

“Scar tissue can also form around the [gastric] band that can cause a blockage in the stomach,” Dr. Aminian said. “Then if the band is too tight, it can erode into the stomach tissue or even go inside the stomach and cause perforation or bleeding.”

By contrast, gastric sleeve and bypass procedures have been found to be safer, result in longer-lasting weight loss, carry fewer complications, and require fewer patient reoperations. Dr. Aminian estimates that 2%-3% of patients need second operations.

Another key factor: Metabolic ‘reset’

Sleeve and bypass procedures offer another critical advantage over band operations: They help reset the body’s metabolism better, changing appetite- and weight-related hormones in the body.

Those hormones can affect food cravings, help people feel full after eating, or boost weight gain in ways that can trump willpower, experts say.

“The [gastric] band doesn’t change the hormones in the body, it’s just a restrictive band around the esophagus or the upper part of the stomach, so it limits the patient’s ability to eat too much,” Dr. Aminian said. “That’s why it doesn’t have the metabolic effects.”

But other procedures, like the gastric sleeve, change the hormones in the body. Removing the source of those hormones means the patient won’t have the same appetite, Dr. Aminian said.

“And that’s why it’s very effective. The problem with the [gastric] band is the patient always has the feeling and desire to eat – they’re always hungry. That’s why in the long run, they fail,” he said.

“They change the setpoints,” Dr. Aminian said. “When the hormones in your body change, the [metabolic] setpoint in the brain also changes.”

He likens the metabolic setpoint to a thermostat in your home that regulates temperature inside.

“When a patient goes on a diet or goes on the [gastric] band, the thermostat doesn’t change,” he says. “They may lose some weight, but they’re going to regain it because the thermostat is the same. But when the hormones in your body change, then the thermostat will change and you’re not going to regain the weight that you have lost.”

Sachin Kukreja, MD, a surgeon and CEO at DFW Bariatrics and General Surgery in Dallas, said he believes these metabolic changes are the biggest things behind successful surgeries.

“People synonymize bariatric surgery with weight loss surgery, but really the metrics we should be using are more related to metabolic measures,” said Dr. Kukreja, who hasn’t done a band surgery since 2013. “And so, the metabolic parameters that change with bariatric surgery are much more significant in the setting with sleeve and gastric sleeve, and much less significant with [gastric] band.”

David Arterburn, MD, agrees that resetting metabolism is important but said the issue is “controversial and challenging” among bariatric surgeons.

“The metabolic setpoint is the idea that we have a biologically controlled set body weight that we will always return to. Clearly, this is not the case for everyone, as some people lose and maintain long-term weight loss,” said Dr. Arterburn, a general internist and bariatric surgery researcher at Kaiser Permanente Washington Health Research Institute in Seattle.
 

Postop lifestyle changes critical to success

Bariatric surgeons and patients alike also say that no surgical procedure is a magic-bullet solution for weight loss. Patients who have any type of bariatric surgery must embrace postop lifestyle changes – adopting healthier diets, getting more exercise, cutting out unhealthy habits – to lose weight and maintain weight loss.

Jan Lasecki, 54, a health care specialist in Akron, Ohio, who had band-to-sleeve conversion surgery in 2020, said the postop follow-up was at least as important as the surgery itself in helping her shed pounds.

She said at first, she chose gastric band surgery several years ago because it was “less invasive” than gastric sleeve or bypass. But while she lost about 50 pounds, she regained it after about 6 years and had other complications.

So, 2 years ago, Ms. Lasecki had two surgeries 6 months apart – one to remove her band, and a second to create a gastric sleeve. And the results, she said, have been very successful, in part because of the changes she made after surgery, with the help of her doctor’s staff.

“I have now lost about 90 pounds and have kept if off since surgery,” she says. “I would tell anyone considering any bariatric surgery, it was definitely worth it [and] having the sleeve resulted in greater weight loss.”

The follow-up was key to the success, she said.

The staff “have the tools and support to help you when you tend to fall back on old behaviors and start to regain weight,” Ms. Lasecki said. “They can help you before it gets out of control. I had no issues following either procedure from a surgery perspective.”

Sally and Robert Cordova – who had gastric bypass and sleeve surgeries, respectively, 3 years ago – agreed that the postop lifestyle changes are critical to success.

“When we agreed to have this surgery, we agreed that this will be a lifestyle change for the rest of our lives,” said Sally, 48, an accounting specialist who’s lost 150 pounds – half her body weight – since her surgery. “You can’t just get to your ideal weight and then stop.”

Robert, 47, a federal border control agent whose workmates nicknamed him “Big Rob” when he tipped the scales at 336 pounds, said it’s a mistake to think of the surgery as a “magic-bullet” solution to obesity. There’s more to it than that, he said.

“One of the things I like about the process I’ve taken is, in my opinion, they set you up for success,” he said. “Because it’s not just having the surgery and you’re done; it’s all the classes educating you about all the lifestyle changes you have to do, and starting them before the surgery. The only people that I know personally who haven’t been successful with the surgery are those who haven’t made the lifestyle changes.”

Today, at 230 pounds, Robert says he’s never felt better.

“I feel great,” he says. “I have become more active, obviously doing everything is a lot easier. It got to the point where it was a task to just tying up my shoes!”
 

Should band patients convert to sleeve or bypass?

Bariatric surgeons interviewed for this article were reluctant to say that all people who had gastric band procedures should convert to gastric sleeve or bypass. But they made it clear that sleeve and bypass procedures are safer and more effective than gastric band surgery, which is why it is rarely done today.

“If a patient experiences poor weight loss or complications from a band, they can consider conversion/revision to a sleeve or bypass,” said Dr. Courcoulas, echoing the views of other doctors.

“The choice of revision procedure should be based on patient factors, including diabetes and total weight. Converting a band to a sleeve is a technically easier operation, and some studies show that there are fewer complications, compared to conversion to a bypass. These considerations need to be balanced with data that show that both weight loss and metabolic improvements such as diabetes are greater after bypass, compared to sleeve.”

Doctors and experts also say it’s important for patients who are considering a gastric band conversion to gastric sleeve or bypass to understand the differences among these three primary procedures, all endorsed by the American Society for Metabolic and Bariatric Surgery.

Here’s a primer, including the pros and cons of each procedure:
 

Gastric band

In gastric band surgery, an adjustable gastric band made of silicone is placed around the top part of the stomach, creating a small pouch above it, to limit the amount of food a person can eat. The size of the opening between the pouch and the stomach can be adjusted with fluid injections through a port placed underneath the skin.

Food goes through the stomach but is limited by the smaller opening of the band.

Advantages:

• Lowest rate of complications right after surgery.
• No division of the stomach or intestines.
• Patients go home on the day of surgery, and recovery is quick.
• The band can be removed, if necessary.

Disadvantages:

• The band may need to be adjusted from time to time, and patients must make monthly office visits during the first year.
• There’s less weight loss than with other surgical procedures.
• It comes with the risk of band movement (slippage) or damage to the stomach over time (erosion).
• The surgery means that a foreign implant has to remain in the body.
• It has a high rate of reoperation.
• The surgery can bring swallowing problems, enlargement of the esophagus, and other complications.

Gastric sleeve

For laparoscopic sleeve gastrectomy – often called gastric sleeve – surgeons remove about 80% of the stomach, so the remaining stomach is the size and shape of a banana.

The new, smaller stomach holds less food and liquid, reducing how much food (and how many calories) the patient can get. By removing the portion of the stomach that produces hunger and appetite hormones, the surgery also helps reset the body’s metabolism – decreasing hunger, increasing feelings of fullness, and allowing the body to reach and maintain a healthy weight as well as control blood sugar.

Advantages:

• It’s technically simple and has a short surgery time.
• It can be done in certain patients with high-risk medical conditions.
• It may be the first step for patients with severe obesity or as a bridge to gastric bypass.
• The surgery brings effective weight loss and improvement of obesity-related conditions (typically 50%-60%, by Mayo Clinic estimates), with a low complication rate (2%-3%).

Disadvantages:

• Nonreversible procedure.
• May worsen or cause new reflux and heartburn.
• Less impact on metabolism, compared to bypass procedures.

Gastric bypass

Gastric bypass, also known as the Roux-en-Y gastric bypass (French for “in the form of a Y”) is another effective procedure used to treat obesity and obesity-related diseases (done laparoscopically since the 1990s).

For the operation, surgeons divide the stomach into a smaller top portion (pouch) about the size of an egg, then the larger part of the stomach is bypassed and no longer stores or digests food.

The small intestine is divided and connected to the new egg-sized stomach pouch to allow food to pass.

Gastric bypass works by limiting the amount of food and calories a patient can consume. It also decreases hunger and increases fullness, allowing the patient to reach and maintain a healthy weight. The impact on hormones and metabolic health often results in improvement of diabetes and helps patients with reflux.

Advantages:

• Reliable and long-lasting weight loss.
• Effective for remission of obesity-associated conditions.
• Effective weight loss (60%-70%, by Mayo Clinic estimates).

Disadvantages:

• Technically more complex when compared to gastric sleeve or band.
• More vitamin and mineral deficiencies than with gastric sleeve or band.
• Risk for small bowel complications and obstruction, as well as ulcers, especially with NSAID or tobacco use.
• May cause “dumping syndrome,” a feeling of sickness after eating or drinking, especially sweets.

A version of this article first appeared on WebMD.com.

Editor’s Note: This story has been updated to properly identify a product referenced in the story.

Jessica Furby struggled with weight most of her life, constantly dieting and exercising to shed pounds. But nothing seemed to help. By her 22nd birthday, she tipped the scales at more than 300 pounds.

So, in 2011, while a college student in Pittsburgh, she decided to have gastric band surgery. Doctors placed a synthetic belt around her stomach to limit what she could eat. It seemed like a good option at the time and, after her surgery, she lost about 60 pounds.

But the benefits didn’t last. In the months that followed, she had pain and other complications. Worst of all, she eventually regained all the weight she’d lost – and then some. By 2016, she weighed 350 pounds and was becoming prediabetic.

That’s when she decided to have the band removed and, on her doctor’s recommendation, had gastric sleeve surgery.

Studies have found the sleeve surgeries carry fewer complications and a much higher success rate than gastric band procedures, which Ms. Furby’s experience has confirmed.

Today, at age 32, she’s down to 288 pounds and says she is on her way to hitting her ultimate goal of 200 pounds.

“The surgery has been a godsend,” she said. “I have not had any complications with it at all. The sleeve was life-changing for me.”

Ms. Furby’s experience has become more common as the risks, complications, and failures of gastric band surgeries have been rising over the past decade.

More band patients are choosing to have conversion surgery to gastric sleeve and gastric bypass. At the same time, fewer doctors are doing gastric band procedures, because of problems like Ms. Furby’s.

According to the latest figures from the American Society for Metabolic and Bariatric Surgery, gastric band procedures account for fewer than 1% of the 256,000 bariatric operations done in the United States each year, while gastric sleeves add up to nearly 60%. That makes sleeve surgeries the most commonly performed bariatric operation today.

By comparison, 35% of bariatric surgeries were gastric band procedures in 2011, while sleeve operations accounted for under 18%.

Ms. Furby’s surgeon, Anita P. Courcoulas, MD, said the trend is being driven by many of the things Ms.Furby experienced firsthand.

Dr. Courcoulas, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh, said there are two main reasons for the decline in gastric band procedures.

“It has been shown to be less effective for weight loss [than] other bariatric surgical procedures, and band intolerance often results in band removal,” she noted.

Gastric sleeve, followed by gastric bypass, are the two most commonly performed operations in the United States and worldwide, she said.

Dr. Courcoulas said the shift from gastric bypass to gastric sleeve procedures “is likely driven by the decline in the band usage, patient preferences for a less invasive operation, such as the sleeve compared to bypass, and surgeon preferences about which operation(s) to offer a given patient.”

Ali Aminian, MD, director of the Bariatric and Metabolic Institute at the Cleveland Clinic, agrees that gastric band complications and failures, in addition to ineffective weight loss, are behind the trend, driving patients and doctors to choose safer and more effective procedures.

He said the Cleveland Clinic no longer does band operations, and he has done a lot of conversions.

“Around 50%-60% of [gastric band] patients require reoperation to take care of the complications,” he says. “So, when you have a surgery where more than half of the time the patients require reoperation, we cannot claim that’s a safe operation.”
 

Evolution in bariatric surgery

Bariatric surgeries for weight loss date back to the 1950s and 1960s, when surgeons at the University of Minnesota first did experimental bypass operations. Adjustable gastric banding appeared in the late 1970s and early 1980s.

But these procedures didn’t gain widespread mainstream use until gastric band procedures gained full Food and Drug Administration approval in 2001. Clinical trials have found people who have bariatric surgery have a significantly lower risk of heart disease and other obesity-related health problems.

In the decade that followed the FDA’s approval of gastric band surgery, it became a popular weight loss procedure, accounting for more than a third of all bariatric surgeries by 2011.

“Fifteen to 20 years ago, [gastric] band was the most commonly performed procedure for bariatric surgery worldwide and in the United States,” Dr. Aminian said. “It was very easy to do, it was quick – it takes 20 minutes to do the procedure – recovery was short, and initially patients had great outcomes. They would lose weight and were healthy.”

But over the past decade, surgeons found that patients often regained the weight they’d lost, and complication and failure rates rose.

“Because the [gastric] band is a foreign body that we place inside the body, many patients had complications related to that foreign body,” Dr. Aminian said.

The band can sometimes move or be displaced, causing blockage of the stomach, experts noted. Other common complications include nausea, vomiting, acid reflux, and esophageal issues (such as a hard time swallowing). Some patients feel pain, constant food cravings, or that they can’t eat or drink anything. And painful infections and other problems can develop with the tubing or the port placed under the skin that is connected to the band, which doctors use to make adjustments after surgery.

“Scar tissue can also form around the [gastric] band that can cause a blockage in the stomach,” Dr. Aminian said. “Then if the band is too tight, it can erode into the stomach tissue or even go inside the stomach and cause perforation or bleeding.”

By contrast, gastric sleeve and bypass procedures have been found to be safer, result in longer-lasting weight loss, carry fewer complications, and require fewer patient reoperations. Dr. Aminian estimates that 2%-3% of patients need second operations.

Another key factor: Metabolic ‘reset’

Sleeve and bypass procedures offer another critical advantage over band operations: They help reset the body’s metabolism better, changing appetite- and weight-related hormones in the body.

Those hormones can affect food cravings, help people feel full after eating, or boost weight gain in ways that can trump willpower, experts say.

“The [gastric] band doesn’t change the hormones in the body, it’s just a restrictive band around the esophagus or the upper part of the stomach, so it limits the patient’s ability to eat too much,” Dr. Aminian said. “That’s why it doesn’t have the metabolic effects.”

But other procedures, like the gastric sleeve, change the hormones in the body. Removing the source of those hormones means the patient won’t have the same appetite, Dr. Aminian said.

“And that’s why it’s very effective. The problem with the [gastric] band is the patient always has the feeling and desire to eat – they’re always hungry. That’s why in the long run, they fail,” he said.

“They change the setpoints,” Dr. Aminian said. “When the hormones in your body change, the [metabolic] setpoint in the brain also changes.”

He likens the metabolic setpoint to a thermostat in your home that regulates temperature inside.

“When a patient goes on a diet or goes on the [gastric] band, the thermostat doesn’t change,” he says. “They may lose some weight, but they’re going to regain it because the thermostat is the same. But when the hormones in your body change, then the thermostat will change and you’re not going to regain the weight that you have lost.”

Sachin Kukreja, MD, a surgeon and CEO at DFW Bariatrics and General Surgery in Dallas, said he believes these metabolic changes are the biggest things behind successful surgeries.

“People synonymize bariatric surgery with weight loss surgery, but really the metrics we should be using are more related to metabolic measures,” said Dr. Kukreja, who hasn’t done a band surgery since 2013. “And so, the metabolic parameters that change with bariatric surgery are much more significant in the setting with sleeve and gastric sleeve, and much less significant with [gastric] band.”

David Arterburn, MD, agrees that resetting metabolism is important but said the issue is “controversial and challenging” among bariatric surgeons.

“The metabolic setpoint is the idea that we have a biologically controlled set body weight that we will always return to. Clearly, this is not the case for everyone, as some people lose and maintain long-term weight loss,” said Dr. Arterburn, a general internist and bariatric surgery researcher at Kaiser Permanente Washington Health Research Institute in Seattle.
 

Postop lifestyle changes critical to success

Bariatric surgeons and patients alike also say that no surgical procedure is a magic-bullet solution for weight loss. Patients who have any type of bariatric surgery must embrace postop lifestyle changes – adopting healthier diets, getting more exercise, cutting out unhealthy habits – to lose weight and maintain weight loss.

Jan Lasecki, 54, a health care specialist in Akron, Ohio, who had band-to-sleeve conversion surgery in 2020, said the postop follow-up was at least as important as the surgery itself in helping her shed pounds.

She said at first, she chose gastric band surgery several years ago because it was “less invasive” than gastric sleeve or bypass. But while she lost about 50 pounds, she regained it after about 6 years and had other complications.

So, 2 years ago, Ms. Lasecki had two surgeries 6 months apart – one to remove her band, and a second to create a gastric sleeve. And the results, she said, have been very successful, in part because of the changes she made after surgery, with the help of her doctor’s staff.

“I have now lost about 90 pounds and have kept if off since surgery,” she says. “I would tell anyone considering any bariatric surgery, it was definitely worth it [and] having the sleeve resulted in greater weight loss.”

The follow-up was key to the success, she said.

The staff “have the tools and support to help you when you tend to fall back on old behaviors and start to regain weight,” Ms. Lasecki said. “They can help you before it gets out of control. I had no issues following either procedure from a surgery perspective.”

Sally and Robert Cordova – who had gastric bypass and sleeve surgeries, respectively, 3 years ago – agreed that the postop lifestyle changes are critical to success.

“When we agreed to have this surgery, we agreed that this will be a lifestyle change for the rest of our lives,” said Sally, 48, an accounting specialist who’s lost 150 pounds – half her body weight – since her surgery. “You can’t just get to your ideal weight and then stop.”

Robert, 47, a federal border control agent whose workmates nicknamed him “Big Rob” when he tipped the scales at 336 pounds, said it’s a mistake to think of the surgery as a “magic-bullet” solution to obesity. There’s more to it than that, he said.

“One of the things I like about the process I’ve taken is, in my opinion, they set you up for success,” he said. “Because it’s not just having the surgery and you’re done; it’s all the classes educating you about all the lifestyle changes you have to do, and starting them before the surgery. The only people that I know personally who haven’t been successful with the surgery are those who haven’t made the lifestyle changes.”

Today, at 230 pounds, Robert says he’s never felt better.

“I feel great,” he says. “I have become more active, obviously doing everything is a lot easier. It got to the point where it was a task to just tying up my shoes!”
 

Should band patients convert to sleeve or bypass?

Bariatric surgeons interviewed for this article were reluctant to say that all people who had gastric band procedures should convert to gastric sleeve or bypass. But they made it clear that sleeve and bypass procedures are safer and more effective than gastric band surgery, which is why it is rarely done today.

“If a patient experiences poor weight loss or complications from a band, they can consider conversion/revision to a sleeve or bypass,” said Dr. Courcoulas, echoing the views of other doctors.

“The choice of revision procedure should be based on patient factors, including diabetes and total weight. Converting a band to a sleeve is a technically easier operation, and some studies show that there are fewer complications, compared to conversion to a bypass. These considerations need to be balanced with data that show that both weight loss and metabolic improvements such as diabetes are greater after bypass, compared to sleeve.”

Doctors and experts also say it’s important for patients who are considering a gastric band conversion to gastric sleeve or bypass to understand the differences among these three primary procedures, all endorsed by the American Society for Metabolic and Bariatric Surgery.

Here’s a primer, including the pros and cons of each procedure:
 

Gastric band

In gastric band surgery, an adjustable gastric band made of silicone is placed around the top part of the stomach, creating a small pouch above it, to limit the amount of food a person can eat. The size of the opening between the pouch and the stomach can be adjusted with fluid injections through a port placed underneath the skin.

Food goes through the stomach but is limited by the smaller opening of the band.

Advantages:

• Lowest rate of complications right after surgery.
• No division of the stomach or intestines.
• Patients go home on the day of surgery, and recovery is quick.
• The band can be removed, if necessary.

Disadvantages:

• The band may need to be adjusted from time to time, and patients must make monthly office visits during the first year.
• There’s less weight loss than with other surgical procedures.
• It comes with the risk of band movement (slippage) or damage to the stomach over time (erosion).
• The surgery means that a foreign implant has to remain in the body.
• It has a high rate of reoperation.
• The surgery can bring swallowing problems, enlargement of the esophagus, and other complications.

Gastric sleeve

For laparoscopic sleeve gastrectomy – often called gastric sleeve – surgeons remove about 80% of the stomach, so the remaining stomach is the size and shape of a banana.

The new, smaller stomach holds less food and liquid, reducing how much food (and how many calories) the patient can get. By removing the portion of the stomach that produces hunger and appetite hormones, the surgery also helps reset the body’s metabolism – decreasing hunger, increasing feelings of fullness, and allowing the body to reach and maintain a healthy weight as well as control blood sugar.

Advantages:

• It’s technically simple and has a short surgery time.
• It can be done in certain patients with high-risk medical conditions.
• It may be the first step for patients with severe obesity or as a bridge to gastric bypass.
• The surgery brings effective weight loss and improvement of obesity-related conditions (typically 50%-60%, by Mayo Clinic estimates), with a low complication rate (2%-3%).

Disadvantages:

• Nonreversible procedure.
• May worsen or cause new reflux and heartburn.
• Less impact on metabolism, compared to bypass procedures.

Gastric bypass

Gastric bypass, also known as the Roux-en-Y gastric bypass (French for “in the form of a Y”) is another effective procedure used to treat obesity and obesity-related diseases (done laparoscopically since the 1990s).

For the operation, surgeons divide the stomach into a smaller top portion (pouch) about the size of an egg, then the larger part of the stomach is bypassed and no longer stores or digests food.

The small intestine is divided and connected to the new egg-sized stomach pouch to allow food to pass.

Gastric bypass works by limiting the amount of food and calories a patient can consume. It also decreases hunger and increases fullness, allowing the patient to reach and maintain a healthy weight. The impact on hormones and metabolic health often results in improvement of diabetes and helps patients with reflux.

Advantages:

• Reliable and long-lasting weight loss.
• Effective for remission of obesity-associated conditions.
• Effective weight loss (60%-70%, by Mayo Clinic estimates).

Disadvantages:

• Technically more complex when compared to gastric sleeve or band.
• More vitamin and mineral deficiencies than with gastric sleeve or band.
• Risk for small bowel complications and obstruction, as well as ulcers, especially with NSAID or tobacco use.
• May cause “dumping syndrome,” a feeling of sickness after eating or drinking, especially sweets.

A version of this article first appeared on WebMD.com.

Editor’s Note: This story has been updated to properly identify a product referenced in the story.

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Saxenda, Novo Nordisk) was safe and effective for treating weight regain after Roux-en-Y gastric bypass (RYGB), in a randomized controlled trial.

That is, 132 patients who had lost at least 25% of their initial weight after RYGB and then gained at least 10% back were randomized 2:1 to receive liraglutide plus frequent lifestyle advice from a registered dietitian or lifestyle advice alone.

After a year, 69%, 48%, and 24% of patients who had received liraglutide lost at least 5%, 10%, and 15% of their study entry weight, respectively. In contrast, only 5% of patients in the control group lost at least 5% of their weight and none lost at least 10% of their weight.

“Liraglutide 3.0 mg/day, with lifestyle modification, was significantly more effective than placebo in treating weight regain after RYGB without increased risk of serious adverse events,” Holly F. Lofton, MD, summarized this week in an oral session at ObesityWeek®, the annual meeting of The Obesity Society.

Dr. Lofton, a clinical associate professor of surgery and medicine, and director, weight management program, NYU, Langone Health, explained to this news organization that she initiated the study after attending a “packed” session about post bariatric surgery weight regain at a prior American Society of Metabolic and Bariatric Surgery conference.

“The lecturers recommended conservative measures (such as reiterating the diet recommendations, exercise, [and] counseling), and revisional surgeries,” she said in an email, but at the time “there was no literature that provided direction on which pharmacotherapies are best for this population.”

It was known that decreases in endogenous GLP-1 levels coincide with weight regain, and liraglutide (Saxenda) was the only GLP-1 agonist approved for chronic weight management at the time, so she devised the current study protocol.

The findings are especially helpful for patients who are not candidates for bariatric surgery revisions, she noted. Further research is needed to investigate the effect of newer GLP-1 agonists, such as semaglutide (Wegovy), on weight regain following different types of bariatric surgery.

Asked to comment, Wendy C. King, PhD, who was not involved with this research, said that more than two-thirds of patients treated with 3 mg/day subcutaneous liraglutide injections in the current study lost at least 5% of their initial weight a year later, and 20% of them attained a weight as low as, or lower than, their lowest weight after bariatric surgery (nadir weight).

“The fact that both groups received lifestyle counseling from registered dietitians for just over a year, but only patients in the liraglutide group lost weight, on average, speaks to the difficulty of losing weight following weight regain post–bariatric surgery,” added Dr. King, an associate professor of epidemiology at the University of Pittsburgh, Pennsylvania.

This study “provides data that may help clinicians and patients understand the potential effect of adding liraglutide 3.0 mg/day to their weight loss efforts,” she told this news organization in an email.

However, “given that 42% of those on liraglutide reported gastrointestinal-related side effects, patients should also be counseled on this potential outcome and given suggestions for how to minimize such side effects,” Dr. King suggested.
 

Weight regain common, repeat surgery entails risk

Weight regain is common even years after bariatric surgery. Repeat surgery entails some risk, and lifestyle approaches alone are rarely successful in reversing weight regain, Dr. Lofton told the audience.

The researchers enrolled 132 adults who had a mean weight of 134 kg (295 pounds) when they underwent RYGB, and who lost at least 25% of their initial weight (mean weight loss of 38%) after the surgery, but who also regained at least 10% of their initial weight.

At enrollment of the current study (baseline), the patients had had RYGB 18 months to 10 years earlier (mean 5.7 years earlier) and now had a mean weight of 99 kg (218 pounds) and a mean BMI of 35.6 kg/m². None of the patients had diabetes.  

The patients were randomized to receive liraglutide (n = 89, 84% women) or placebo (n = 43, 88% women) for 56 weeks.

They were a mean age of 48 years, and about 59% were White and 25% were Black.

All patients had clinic visits every 3 months where they received lifestyle counseling from a registered dietitian.

At 12 months, patients in the liraglutide group had lost a mean of 8.8% of their baseline weight, whereas those in the placebo group had gained a mean of 1.48% of their baseline weight.

There were no significant between-group differences in cardiometabolic variables.

None of the patients in the control group attained a weight that was as low as their nadir weight after RYGB.

The rates of nausea (25%), constipation (16%), and abdominal pain (10%) in the liraglutide group were higher than in the placebo group (7%, 14%, and 5%, respectively) but similar to rates of gastrointestinal side effects in other trials of this agent.

Dr. Lofton has disclosed receiving consulting fees and being on a speaker bureau for Novo Nordisk and receiving research funds from Boehringer Ingelheim, Eli Lilly, and Novo Nordisk. Dr. King has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.