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Dear colleagues,
Treating obesity easily falls under our purview as gastroenterologists. But like the mouse who would bell the cat, our direct involvement has been limited. However, over the past decade, advances in endobariatrics and medical management have given us many options. But how do we choose from this growing armamentarium of minimally invasive procedures and weight loss medicines? What combination is best? And what about the standard “diet and exercise”?
In this issue of perspectives, Carolyn Newberry, MD, director of GI nutrition at Innovation Center for Health and Nutrition in Gastroenterology, Weill Cornell Medicine, New York, will emphasize the benefits of medical and lifestyle management. Pichamol Jirapinyo, MD, MPH, ABOM, director of bariatric endoscopy fellowship at Brigham and Women’s Hospital/Harvard Medical School, Boston, responds with robust data for endoscopic therapies. We hope that their expert perspectives will help guide you in your own approach to obesity management – certainly no one size fits all. I welcome your thoughts on this growing field in gastroenterology – share with us on Twitter @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.
Exciting time for endoscopic bariatric and metabolic therapies (EBMTs)
BY PICHAMOL JIRAPINYO, MD, MPH, ABOM
2022 was an exciting year for our field of endoscopic bariatric and metabolic therapy (EBMT). Not only did it mark the 10th year anniversary since the very first-in-human endoscopic sleeve gastroplasty (ESG) performed by Christopher Thompson and Robert Hawes in India, but also the MERIT trial (a randomized-controlled trial on ESG) was published.1 This decade of work led to the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, Tex.) being granted de novo authorization from the Food and Drug Administration for the treatment of obesity and weight regain following bariatric surgery.
Currently, at our institution, we offer four primary EBMTs for patients who are seeking endoscopic weight loss therapy and have not yet undergone prior bariatric surgery. These include the Orbera intragastric balloon (IGB) (Apollo Endosurgery), ESG (Apollo Endosurgery), primary obesity surgery endoluminal (POSE: USGI Medical, San Clemente, Calif.), and a gastric plication procedure using Endomina (Endo Tools Therapeutics, Gosselies, Belgium). While the former two have FDA approval, the latter two devices have FDA clearance for tissue approximation. The indication for primary EBMTs includes having a body mass index of at least 30 kg/m2.
From our experience, patients who present to our bariatric endoscopy clinic consist of three groups. First are those who have tried several anti-obesity medications (AOMs), but are unable to tolerate the side effects or their BMI remains greater than 30 kg/m2. Second are those who have heard about EBMTs and are interested in the procedures. Usually, these patients are either too light to qualify for bariatric surgery (BMI 30-35 kg/m2 or 35-40 kg/m2 without an obesity-related comorbidity) or are not interested in bariatric surgery for a variety of reasons, including its perceived invasiveness. The last group are those whose BMI falls within the “super obese” category, defined as a BMI ≥ 50 kg/m2, who are deemed too high risk to undergo medically necessary procedures, such as an orthopedic, colorectal, or transplant surgery.
During the initial consultation, I always discuss pros and cons of all treatment modalities for obesity with the patients, ranging from lifestyle modification to AOMs, EBMTs, and bariatric surgeries. While the data on AOMs are promising, especially with the most recent FDA-approved semaglutide (Wegovy: Novo Nordisk, Bagsvaerd, Denmark) yielding 14.9% total weight loss (TWL) at 1 year, in reality, the starting doses of this medication have been out of stock for over a year.2 Other AOMs, on the other hand, are associated with 6%-8% TWL and are frequently associated with intolerance due to side effects. In comparison, meta-analyses demonstrate that an IGB is associated with 11.3% TWL and ESG with 16.5% TWL at 1 year. Our recent publication describing a new technique for POSE, also known as a distal POSE procedure with a double-helix technique, demonstrates a 20.3% TWL at 1 year.3 The rate of serious adverse events for EBMTs is low with 0.1% for IGB and 1%-2% for ESG/POSE.
The question regarding a comparison between AOMs and EBMTs comes up quite frequently in clinical practice. In reality, I often encourage my patients to consider combination therapy where I prescribe an AOM at 3-6 months following EBMTs to augment the amount of weight loss. However, since this is a debate, I will highlight a few advantages of EBMTs. First, the amount of weight loss following EBMTs, especially with ESG/POSE (which is currently the most commonly-requested procedure in our practice), tends to be higher than that of most AOMs. Second, while we are eagerly awaiting the long-term safety and efficacy data for semaglutide, ESG has been shown to be durable with the patients maintaining 15.9% TWL at 5 years.4 Third, an EBMT is a one-time procedure. In contrast, AOMs rely on patients’ compliance with taking the medication(s) reliably and indefinitely. A study based on HMO pharmacy data of over a million patients who were prescribed AOMs showed that fewer than 2% completed 12 months of weight loss medication therapy.5 The long-term use of AOMs also has cost implications. Specifically, a month supply of semaglutide costs about $1,400, which translates to $16,800 in 1 year and $84,000 in 5 years, which clearly outweighs the cost of ESG/POSE that has been demonstrated to be durable up to at least 5 years. IGBs have limitations similar to those of AOMs upon removal. Nevertheless, with the average cost of an IGB being $8,000, placing one every year would still be less costly, although this would likely be unnecessary considering the weight loss trend after IGB.
There are a few hurdles that need to be overcome before EBMTs are widely adopted. Reimbursement remains a major issue at most centers in the United States. Currently, most EBMTs are offered as a self-pay procedure, making the majority of patients who are otherwise eligible and interested not able to afford the procedure. With the recently published MERIT trial, long-term data on ESG as well as several upcoming society guidelines on EBMTs, we are hopeful that insurance coverage for EBMTs is nearing. Another important aspect is training. While IGB placement and removal are simple procedures, performing a high-quality ESG/POSE requires rigorous training to ensure safety and optimal outcomes. Several professional societies are working hard to develop curriculums on EBMTs with a focus on hands-on training to ensure endoscopists are properly trained prior to starting their bariatric endoscopy program. At our institution, we have a dedicated training program focusing on bariatric endoscopy (i.e. separate from the traditional advanced endoscopy fellowship), where fellows learn advanced bariatric suturing and plication as well as multidisciplinary care for this patient population. I am hopeful that this kind of training will become more prevalent in the near future.
With mounting evidence supporting the benefits of EBMTs, bariatric endoscopy has revolutionized the care of patients suffering from obesity and its related comorbidities. Moving forward, the field will continue to evolve, and EBMT procedures will only become simpler, safer, and more effective. It is an exciting time for gastroenterologists to get involved.
Dr. Jirapinyo is the director of bariatric endoscopy fellowship at Brigham and Women’s Hospital/Harvard Medical School, Boston. She is board certified in internal medicine, gastroenterology, and obesity medicine and completed her bariatric endoscopy and advanced endoscopy fellowships at Brigham and Women’s Hospital. She serves as a consultant for Apollo Endosurgery, Spatz Medical, and ERBE, and she receives research support from USGI Medical, GI Dynamics, and Fractyl.
References
1. Abu Dayyeh BK et al. Lancet. 2022;400(10350):441-51.
2. Wilding JPH et al. N Engl J Med. 2021;384:989-1002.
3. Jirapinyo P and Thompson CC. Gastrointest Endosc. 2022;96(3):479-86.
4. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021;19(5):1051-57.
5. Hemo B et al. Diabetes Res Clin Pract. 2011;94(2):269-75.
A new frontier for weight management: Assess your options carefully
BY CAROLYN NEWBERRY, MD
Considering the continued rise in obesity rates in this country coupled with an increase in associated digestive disease burden from conditions such as nonalcoholic fatty liver disease (NAFLD), gastroesophageal reflux disease (GERD), and select gastrointestinal malignancies, I believe it is now more important than ever for gastroenterologists to familiarize themselves with weight management principles and incorporation into clinical practice. A growing arsenal of tools is available for addressing excess weight, including medications and novel endobariatric techniques. Although the latter is an important consideration in patients with obesity, lifestyle counseling with or without weight loss medications sets the stage for sustainable weight loss success and may eliminate the need for procedural intervention. As such, current guidelines set forth by multiple societies, including the American Gastroenterological Association (AGA), emphasize the importance of lifestyle counseling targeting caloric restriction and increased physical activity along with medical augmentation via pharmacological agents in eligible patients.1,2 These guidelines underline the importance of medical weight management prior to consideration of procedural options, including both endobariatrics and more classic bariatric surgeries. This ensures patients understand approaches to weight loss via noninvasive means, reduces risk of weight regain by building foundational habits, and enhances overall success of procedures long term if they are pursued. In addition, newer pharmacological agents are now approaching total body weight loss percentages of currently available endobariatric techniques while still showing high tolerance rates and long-term efficacy, indicating some patients who previously would require procedures to meet weight loss goals may no longer need them.3 Alternatively, these medications may augment efforts prior to procedures, enhancing overall total body weight loss achieved. If patients are not introduced to such options initially and as a part of comprehensive care management planning, they may not achieve the same degree of weight loss success and metabolic optimization.
As a gastroenterologist co-leading a multidisciplinary weight management and lifestyle clinic, I have witnessed firsthand the enhanced outcomes in patients who pursue endobariatric procedures after establishing care with a clinical team and attempting (and succeeding) in weight loss via changes in diet, physical activity, and medication use. Patients should be encouraged to gain understanding of one’s own “personal relationship” with food and/or address medical and social barriers to weight loss maintenance prior to procedural intervention, which requires some lead time and ideally professional expertise from multiple team members, including a dietitian. Weight regain after anti-obesity surgery is common, with significant gain occurring in up to half of patients. Several factors have been associated with weight regain, including lack of consistent follow-up, excess calorie and simple carbohydrate intake, and inconsistent physical activity.4 As such, most insurance companies mandate a trial of at least 6 months of lifestyle and/or medical weight management prior to considering procedural reimbursement. Although robust longitudinal data for endobariatric outcomes is not yet available, it is reasonable to believe similar concepts may be in play. In fact, since endobariatric procedures are less invasive but also therefore more temporal (as in the case of endoscopic balloon placement, which is only approved for 6 months of continuous use), behavioral modification and medical management to reduce risk of significant weight regain is even more imperative. Even in the case of more durable procedures, such as endoscopic gastroplasty, lack of compliance with recommended dietary protocols can reduce efficacy by loosening and even ripping sutures prior to establishment of bridging fibrotic mucosal changes, which enhance longevity of the procedure and support continued gastric restriction and reduction in motility. Some patients who undergo endoscopic gastroplasty end up seeking out revision and repeat procedure later due to lack of results, which may be avoided with alternative dietary and lifestyle decisions in the postprocedural state.
The landscape of non-procedural weight management tools has changed in the last 1-2 years with the approval of newer injectable medications that disrupt insulin and hormonal pathways and produce sustainable weight loss similar to reported outcomes achieved with endobariatric procedures. These medications are becoming increasingly accessible and of interest to patients, with continued destigmatization of the use of weight loss drugs in practice, which had previous negative connotations and concerns regarding safety. New guidelines put forth by the AGA recommend adding pharmacological agents to lifestyle interventions over continuing lifestyle interventions alone if adequate weight loss has not been achieved with the latter.3 This further exemplifies the importance of a multifaceted approach to optimize medical weight management as first-line therapy for obesity and associated comorbidities.
In summary, although endobariatric procedures are an important tool for gastroenterologists to incorporate into their weight management plans, they must be implemented with care and only after lifestyle and medical interventions have failed to produce desired results. Shared decision making among providers and patients enhances weight loss efforts and augments sustainability of outcomes. Considering the rapidly evolving landscape of obesity medicine, gastroenterologists need to continue to stay up to date on best practices to improve patient care, reduce associated morbidity, and enhance outcomes of novel endobariatric procedures.
Dr. Newberry is with the Innovative Center for Health and Nutrition in Gastroenterology (ICHANGE), division of gastroenterology, Weill Cornell Medical Center, New York. She disclosed receiving speaker honorariums from Baxter International and InBody USA.
References
1. Acosta et al. Clin Gastroenterol Hepatol. 2017 May;15(5):631-49.
2. Jensen et al. Circulation. 2014;129:S102-38.
3. Grunvald et al. Gastroenterology. 2022;163(5):1198-225.
4. Athansiadis et al. Surg Endosc. 2021 Aug;35(8):4069-84.
Dear colleagues,
Treating obesity easily falls under our purview as gastroenterologists. But like the mouse who would bell the cat, our direct involvement has been limited. However, over the past decade, advances in endobariatrics and medical management have given us many options. But how do we choose from this growing armamentarium of minimally invasive procedures and weight loss medicines? What combination is best? And what about the standard “diet and exercise”?
In this issue of perspectives, Carolyn Newberry, MD, director of GI nutrition at Innovation Center for Health and Nutrition in Gastroenterology, Weill Cornell Medicine, New York, will emphasize the benefits of medical and lifestyle management. Pichamol Jirapinyo, MD, MPH, ABOM, director of bariatric endoscopy fellowship at Brigham and Women’s Hospital/Harvard Medical School, Boston, responds with robust data for endoscopic therapies. We hope that their expert perspectives will help guide you in your own approach to obesity management – certainly no one size fits all. I welcome your thoughts on this growing field in gastroenterology – share with us on Twitter @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.
Exciting time for endoscopic bariatric and metabolic therapies (EBMTs)
BY PICHAMOL JIRAPINYO, MD, MPH, ABOM
2022 was an exciting year for our field of endoscopic bariatric and metabolic therapy (EBMT). Not only did it mark the 10th year anniversary since the very first-in-human endoscopic sleeve gastroplasty (ESG) performed by Christopher Thompson and Robert Hawes in India, but also the MERIT trial (a randomized-controlled trial on ESG) was published.1 This decade of work led to the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, Tex.) being granted de novo authorization from the Food and Drug Administration for the treatment of obesity and weight regain following bariatric surgery.
Currently, at our institution, we offer four primary EBMTs for patients who are seeking endoscopic weight loss therapy and have not yet undergone prior bariatric surgery. These include the Orbera intragastric balloon (IGB) (Apollo Endosurgery), ESG (Apollo Endosurgery), primary obesity surgery endoluminal (POSE: USGI Medical, San Clemente, Calif.), and a gastric plication procedure using Endomina (Endo Tools Therapeutics, Gosselies, Belgium). While the former two have FDA approval, the latter two devices have FDA clearance for tissue approximation. The indication for primary EBMTs includes having a body mass index of at least 30 kg/m2.
From our experience, patients who present to our bariatric endoscopy clinic consist of three groups. First are those who have tried several anti-obesity medications (AOMs), but are unable to tolerate the side effects or their BMI remains greater than 30 kg/m2. Second are those who have heard about EBMTs and are interested in the procedures. Usually, these patients are either too light to qualify for bariatric surgery (BMI 30-35 kg/m2 or 35-40 kg/m2 without an obesity-related comorbidity) or are not interested in bariatric surgery for a variety of reasons, including its perceived invasiveness. The last group are those whose BMI falls within the “super obese” category, defined as a BMI ≥ 50 kg/m2, who are deemed too high risk to undergo medically necessary procedures, such as an orthopedic, colorectal, or transplant surgery.
During the initial consultation, I always discuss pros and cons of all treatment modalities for obesity with the patients, ranging from lifestyle modification to AOMs, EBMTs, and bariatric surgeries. While the data on AOMs are promising, especially with the most recent FDA-approved semaglutide (Wegovy: Novo Nordisk, Bagsvaerd, Denmark) yielding 14.9% total weight loss (TWL) at 1 year, in reality, the starting doses of this medication have been out of stock for over a year.2 Other AOMs, on the other hand, are associated with 6%-8% TWL and are frequently associated with intolerance due to side effects. In comparison, meta-analyses demonstrate that an IGB is associated with 11.3% TWL and ESG with 16.5% TWL at 1 year. Our recent publication describing a new technique for POSE, also known as a distal POSE procedure with a double-helix technique, demonstrates a 20.3% TWL at 1 year.3 The rate of serious adverse events for EBMTs is low with 0.1% for IGB and 1%-2% for ESG/POSE.
The question regarding a comparison between AOMs and EBMTs comes up quite frequently in clinical practice. In reality, I often encourage my patients to consider combination therapy where I prescribe an AOM at 3-6 months following EBMTs to augment the amount of weight loss. However, since this is a debate, I will highlight a few advantages of EBMTs. First, the amount of weight loss following EBMTs, especially with ESG/POSE (which is currently the most commonly-requested procedure in our practice), tends to be higher than that of most AOMs. Second, while we are eagerly awaiting the long-term safety and efficacy data for semaglutide, ESG has been shown to be durable with the patients maintaining 15.9% TWL at 5 years.4 Third, an EBMT is a one-time procedure. In contrast, AOMs rely on patients’ compliance with taking the medication(s) reliably and indefinitely. A study based on HMO pharmacy data of over a million patients who were prescribed AOMs showed that fewer than 2% completed 12 months of weight loss medication therapy.5 The long-term use of AOMs also has cost implications. Specifically, a month supply of semaglutide costs about $1,400, which translates to $16,800 in 1 year and $84,000 in 5 years, which clearly outweighs the cost of ESG/POSE that has been demonstrated to be durable up to at least 5 years. IGBs have limitations similar to those of AOMs upon removal. Nevertheless, with the average cost of an IGB being $8,000, placing one every year would still be less costly, although this would likely be unnecessary considering the weight loss trend after IGB.
There are a few hurdles that need to be overcome before EBMTs are widely adopted. Reimbursement remains a major issue at most centers in the United States. Currently, most EBMTs are offered as a self-pay procedure, making the majority of patients who are otherwise eligible and interested not able to afford the procedure. With the recently published MERIT trial, long-term data on ESG as well as several upcoming society guidelines on EBMTs, we are hopeful that insurance coverage for EBMTs is nearing. Another important aspect is training. While IGB placement and removal are simple procedures, performing a high-quality ESG/POSE requires rigorous training to ensure safety and optimal outcomes. Several professional societies are working hard to develop curriculums on EBMTs with a focus on hands-on training to ensure endoscopists are properly trained prior to starting their bariatric endoscopy program. At our institution, we have a dedicated training program focusing on bariatric endoscopy (i.e. separate from the traditional advanced endoscopy fellowship), where fellows learn advanced bariatric suturing and plication as well as multidisciplinary care for this patient population. I am hopeful that this kind of training will become more prevalent in the near future.
With mounting evidence supporting the benefits of EBMTs, bariatric endoscopy has revolutionized the care of patients suffering from obesity and its related comorbidities. Moving forward, the field will continue to evolve, and EBMT procedures will only become simpler, safer, and more effective. It is an exciting time for gastroenterologists to get involved.
Dr. Jirapinyo is the director of bariatric endoscopy fellowship at Brigham and Women’s Hospital/Harvard Medical School, Boston. She is board certified in internal medicine, gastroenterology, and obesity medicine and completed her bariatric endoscopy and advanced endoscopy fellowships at Brigham and Women’s Hospital. She serves as a consultant for Apollo Endosurgery, Spatz Medical, and ERBE, and she receives research support from USGI Medical, GI Dynamics, and Fractyl.
References
1. Abu Dayyeh BK et al. Lancet. 2022;400(10350):441-51.
2. Wilding JPH et al. N Engl J Med. 2021;384:989-1002.
3. Jirapinyo P and Thompson CC. Gastrointest Endosc. 2022;96(3):479-86.
4. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021;19(5):1051-57.
5. Hemo B et al. Diabetes Res Clin Pract. 2011;94(2):269-75.
A new frontier for weight management: Assess your options carefully
BY CAROLYN NEWBERRY, MD
Considering the continued rise in obesity rates in this country coupled with an increase in associated digestive disease burden from conditions such as nonalcoholic fatty liver disease (NAFLD), gastroesophageal reflux disease (GERD), and select gastrointestinal malignancies, I believe it is now more important than ever for gastroenterologists to familiarize themselves with weight management principles and incorporation into clinical practice. A growing arsenal of tools is available for addressing excess weight, including medications and novel endobariatric techniques. Although the latter is an important consideration in patients with obesity, lifestyle counseling with or without weight loss medications sets the stage for sustainable weight loss success and may eliminate the need for procedural intervention. As such, current guidelines set forth by multiple societies, including the American Gastroenterological Association (AGA), emphasize the importance of lifestyle counseling targeting caloric restriction and increased physical activity along with medical augmentation via pharmacological agents in eligible patients.1,2 These guidelines underline the importance of medical weight management prior to consideration of procedural options, including both endobariatrics and more classic bariatric surgeries. This ensures patients understand approaches to weight loss via noninvasive means, reduces risk of weight regain by building foundational habits, and enhances overall success of procedures long term if they are pursued. In addition, newer pharmacological agents are now approaching total body weight loss percentages of currently available endobariatric techniques while still showing high tolerance rates and long-term efficacy, indicating some patients who previously would require procedures to meet weight loss goals may no longer need them.3 Alternatively, these medications may augment efforts prior to procedures, enhancing overall total body weight loss achieved. If patients are not introduced to such options initially and as a part of comprehensive care management planning, they may not achieve the same degree of weight loss success and metabolic optimization.
As a gastroenterologist co-leading a multidisciplinary weight management and lifestyle clinic, I have witnessed firsthand the enhanced outcomes in patients who pursue endobariatric procedures after establishing care with a clinical team and attempting (and succeeding) in weight loss via changes in diet, physical activity, and medication use. Patients should be encouraged to gain understanding of one’s own “personal relationship” with food and/or address medical and social barriers to weight loss maintenance prior to procedural intervention, which requires some lead time and ideally professional expertise from multiple team members, including a dietitian. Weight regain after anti-obesity surgery is common, with significant gain occurring in up to half of patients. Several factors have been associated with weight regain, including lack of consistent follow-up, excess calorie and simple carbohydrate intake, and inconsistent physical activity.4 As such, most insurance companies mandate a trial of at least 6 months of lifestyle and/or medical weight management prior to considering procedural reimbursement. Although robust longitudinal data for endobariatric outcomes is not yet available, it is reasonable to believe similar concepts may be in play. In fact, since endobariatric procedures are less invasive but also therefore more temporal (as in the case of endoscopic balloon placement, which is only approved for 6 months of continuous use), behavioral modification and medical management to reduce risk of significant weight regain is even more imperative. Even in the case of more durable procedures, such as endoscopic gastroplasty, lack of compliance with recommended dietary protocols can reduce efficacy by loosening and even ripping sutures prior to establishment of bridging fibrotic mucosal changes, which enhance longevity of the procedure and support continued gastric restriction and reduction in motility. Some patients who undergo endoscopic gastroplasty end up seeking out revision and repeat procedure later due to lack of results, which may be avoided with alternative dietary and lifestyle decisions in the postprocedural state.
The landscape of non-procedural weight management tools has changed in the last 1-2 years with the approval of newer injectable medications that disrupt insulin and hormonal pathways and produce sustainable weight loss similar to reported outcomes achieved with endobariatric procedures. These medications are becoming increasingly accessible and of interest to patients, with continued destigmatization of the use of weight loss drugs in practice, which had previous negative connotations and concerns regarding safety. New guidelines put forth by the AGA recommend adding pharmacological agents to lifestyle interventions over continuing lifestyle interventions alone if adequate weight loss has not been achieved with the latter.3 This further exemplifies the importance of a multifaceted approach to optimize medical weight management as first-line therapy for obesity and associated comorbidities.
In summary, although endobariatric procedures are an important tool for gastroenterologists to incorporate into their weight management plans, they must be implemented with care and only after lifestyle and medical interventions have failed to produce desired results. Shared decision making among providers and patients enhances weight loss efforts and augments sustainability of outcomes. Considering the rapidly evolving landscape of obesity medicine, gastroenterologists need to continue to stay up to date on best practices to improve patient care, reduce associated morbidity, and enhance outcomes of novel endobariatric procedures.
Dr. Newberry is with the Innovative Center for Health and Nutrition in Gastroenterology (ICHANGE), division of gastroenterology, Weill Cornell Medical Center, New York. She disclosed receiving speaker honorariums from Baxter International and InBody USA.
References
1. Acosta et al. Clin Gastroenterol Hepatol. 2017 May;15(5):631-49.
2. Jensen et al. Circulation. 2014;129:S102-38.
3. Grunvald et al. Gastroenterology. 2022;163(5):1198-225.
4. Athansiadis et al. Surg Endosc. 2021 Aug;35(8):4069-84.
Dear colleagues,
Treating obesity easily falls under our purview as gastroenterologists. But like the mouse who would bell the cat, our direct involvement has been limited. However, over the past decade, advances in endobariatrics and medical management have given us many options. But how do we choose from this growing armamentarium of minimally invasive procedures and weight loss medicines? What combination is best? And what about the standard “diet and exercise”?
In this issue of perspectives, Carolyn Newberry, MD, director of GI nutrition at Innovation Center for Health and Nutrition in Gastroenterology, Weill Cornell Medicine, New York, will emphasize the benefits of medical and lifestyle management. Pichamol Jirapinyo, MD, MPH, ABOM, director of bariatric endoscopy fellowship at Brigham and Women’s Hospital/Harvard Medical School, Boston, responds with robust data for endoscopic therapies. We hope that their expert perspectives will help guide you in your own approach to obesity management – certainly no one size fits all. I welcome your thoughts on this growing field in gastroenterology – share with us on Twitter @AGA_GIHN.
Gyanprakash A. Ketwaroo, MD, MSc, is associate professor of medicine, Yale University, New Haven, Conn., and chief of endoscopy at West Haven (Conn.) VA Medical Center. He is an associate editor for GI & Hepatology News.
Exciting time for endoscopic bariatric and metabolic therapies (EBMTs)
BY PICHAMOL JIRAPINYO, MD, MPH, ABOM
2022 was an exciting year for our field of endoscopic bariatric and metabolic therapy (EBMT). Not only did it mark the 10th year anniversary since the very first-in-human endoscopic sleeve gastroplasty (ESG) performed by Christopher Thompson and Robert Hawes in India, but also the MERIT trial (a randomized-controlled trial on ESG) was published.1 This decade of work led to the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, Tex.) being granted de novo authorization from the Food and Drug Administration for the treatment of obesity and weight regain following bariatric surgery.
Currently, at our institution, we offer four primary EBMTs for patients who are seeking endoscopic weight loss therapy and have not yet undergone prior bariatric surgery. These include the Orbera intragastric balloon (IGB) (Apollo Endosurgery), ESG (Apollo Endosurgery), primary obesity surgery endoluminal (POSE: USGI Medical, San Clemente, Calif.), and a gastric plication procedure using Endomina (Endo Tools Therapeutics, Gosselies, Belgium). While the former two have FDA approval, the latter two devices have FDA clearance for tissue approximation. The indication for primary EBMTs includes having a body mass index of at least 30 kg/m2.
From our experience, patients who present to our bariatric endoscopy clinic consist of three groups. First are those who have tried several anti-obesity medications (AOMs), but are unable to tolerate the side effects or their BMI remains greater than 30 kg/m2. Second are those who have heard about EBMTs and are interested in the procedures. Usually, these patients are either too light to qualify for bariatric surgery (BMI 30-35 kg/m2 or 35-40 kg/m2 without an obesity-related comorbidity) or are not interested in bariatric surgery for a variety of reasons, including its perceived invasiveness. The last group are those whose BMI falls within the “super obese” category, defined as a BMI ≥ 50 kg/m2, who are deemed too high risk to undergo medically necessary procedures, such as an orthopedic, colorectal, or transplant surgery.
During the initial consultation, I always discuss pros and cons of all treatment modalities for obesity with the patients, ranging from lifestyle modification to AOMs, EBMTs, and bariatric surgeries. While the data on AOMs are promising, especially with the most recent FDA-approved semaglutide (Wegovy: Novo Nordisk, Bagsvaerd, Denmark) yielding 14.9% total weight loss (TWL) at 1 year, in reality, the starting doses of this medication have been out of stock for over a year.2 Other AOMs, on the other hand, are associated with 6%-8% TWL and are frequently associated with intolerance due to side effects. In comparison, meta-analyses demonstrate that an IGB is associated with 11.3% TWL and ESG with 16.5% TWL at 1 year. Our recent publication describing a new technique for POSE, also known as a distal POSE procedure with a double-helix technique, demonstrates a 20.3% TWL at 1 year.3 The rate of serious adverse events for EBMTs is low with 0.1% for IGB and 1%-2% for ESG/POSE.
The question regarding a comparison between AOMs and EBMTs comes up quite frequently in clinical practice. In reality, I often encourage my patients to consider combination therapy where I prescribe an AOM at 3-6 months following EBMTs to augment the amount of weight loss. However, since this is a debate, I will highlight a few advantages of EBMTs. First, the amount of weight loss following EBMTs, especially with ESG/POSE (which is currently the most commonly-requested procedure in our practice), tends to be higher than that of most AOMs. Second, while we are eagerly awaiting the long-term safety and efficacy data for semaglutide, ESG has been shown to be durable with the patients maintaining 15.9% TWL at 5 years.4 Third, an EBMT is a one-time procedure. In contrast, AOMs rely on patients’ compliance with taking the medication(s) reliably and indefinitely. A study based on HMO pharmacy data of over a million patients who were prescribed AOMs showed that fewer than 2% completed 12 months of weight loss medication therapy.5 The long-term use of AOMs also has cost implications. Specifically, a month supply of semaglutide costs about $1,400, which translates to $16,800 in 1 year and $84,000 in 5 years, which clearly outweighs the cost of ESG/POSE that has been demonstrated to be durable up to at least 5 years. IGBs have limitations similar to those of AOMs upon removal. Nevertheless, with the average cost of an IGB being $8,000, placing one every year would still be less costly, although this would likely be unnecessary considering the weight loss trend after IGB.
There are a few hurdles that need to be overcome before EBMTs are widely adopted. Reimbursement remains a major issue at most centers in the United States. Currently, most EBMTs are offered as a self-pay procedure, making the majority of patients who are otherwise eligible and interested not able to afford the procedure. With the recently published MERIT trial, long-term data on ESG as well as several upcoming society guidelines on EBMTs, we are hopeful that insurance coverage for EBMTs is nearing. Another important aspect is training. While IGB placement and removal are simple procedures, performing a high-quality ESG/POSE requires rigorous training to ensure safety and optimal outcomes. Several professional societies are working hard to develop curriculums on EBMTs with a focus on hands-on training to ensure endoscopists are properly trained prior to starting their bariatric endoscopy program. At our institution, we have a dedicated training program focusing on bariatric endoscopy (i.e. separate from the traditional advanced endoscopy fellowship), where fellows learn advanced bariatric suturing and plication as well as multidisciplinary care for this patient population. I am hopeful that this kind of training will become more prevalent in the near future.
With mounting evidence supporting the benefits of EBMTs, bariatric endoscopy has revolutionized the care of patients suffering from obesity and its related comorbidities. Moving forward, the field will continue to evolve, and EBMT procedures will only become simpler, safer, and more effective. It is an exciting time for gastroenterologists to get involved.
Dr. Jirapinyo is the director of bariatric endoscopy fellowship at Brigham and Women’s Hospital/Harvard Medical School, Boston. She is board certified in internal medicine, gastroenterology, and obesity medicine and completed her bariatric endoscopy and advanced endoscopy fellowships at Brigham and Women’s Hospital. She serves as a consultant for Apollo Endosurgery, Spatz Medical, and ERBE, and she receives research support from USGI Medical, GI Dynamics, and Fractyl.
References
1. Abu Dayyeh BK et al. Lancet. 2022;400(10350):441-51.
2. Wilding JPH et al. N Engl J Med. 2021;384:989-1002.
3. Jirapinyo P and Thompson CC. Gastrointest Endosc. 2022;96(3):479-86.
4. Sharaiha RZ et al. Clin Gastroenterol Hepatol. 2021;19(5):1051-57.
5. Hemo B et al. Diabetes Res Clin Pract. 2011;94(2):269-75.
A new frontier for weight management: Assess your options carefully
BY CAROLYN NEWBERRY, MD
Considering the continued rise in obesity rates in this country coupled with an increase in associated digestive disease burden from conditions such as nonalcoholic fatty liver disease (NAFLD), gastroesophageal reflux disease (GERD), and select gastrointestinal malignancies, I believe it is now more important than ever for gastroenterologists to familiarize themselves with weight management principles and incorporation into clinical practice. A growing arsenal of tools is available for addressing excess weight, including medications and novel endobariatric techniques. Although the latter is an important consideration in patients with obesity, lifestyle counseling with or without weight loss medications sets the stage for sustainable weight loss success and may eliminate the need for procedural intervention. As such, current guidelines set forth by multiple societies, including the American Gastroenterological Association (AGA), emphasize the importance of lifestyle counseling targeting caloric restriction and increased physical activity along with medical augmentation via pharmacological agents in eligible patients.1,2 These guidelines underline the importance of medical weight management prior to consideration of procedural options, including both endobariatrics and more classic bariatric surgeries. This ensures patients understand approaches to weight loss via noninvasive means, reduces risk of weight regain by building foundational habits, and enhances overall success of procedures long term if they are pursued. In addition, newer pharmacological agents are now approaching total body weight loss percentages of currently available endobariatric techniques while still showing high tolerance rates and long-term efficacy, indicating some patients who previously would require procedures to meet weight loss goals may no longer need them.3 Alternatively, these medications may augment efforts prior to procedures, enhancing overall total body weight loss achieved. If patients are not introduced to such options initially and as a part of comprehensive care management planning, they may not achieve the same degree of weight loss success and metabolic optimization.
As a gastroenterologist co-leading a multidisciplinary weight management and lifestyle clinic, I have witnessed firsthand the enhanced outcomes in patients who pursue endobariatric procedures after establishing care with a clinical team and attempting (and succeeding) in weight loss via changes in diet, physical activity, and medication use. Patients should be encouraged to gain understanding of one’s own “personal relationship” with food and/or address medical and social barriers to weight loss maintenance prior to procedural intervention, which requires some lead time and ideally professional expertise from multiple team members, including a dietitian. Weight regain after anti-obesity surgery is common, with significant gain occurring in up to half of patients. Several factors have been associated with weight regain, including lack of consistent follow-up, excess calorie and simple carbohydrate intake, and inconsistent physical activity.4 As such, most insurance companies mandate a trial of at least 6 months of lifestyle and/or medical weight management prior to considering procedural reimbursement. Although robust longitudinal data for endobariatric outcomes is not yet available, it is reasonable to believe similar concepts may be in play. In fact, since endobariatric procedures are less invasive but also therefore more temporal (as in the case of endoscopic balloon placement, which is only approved for 6 months of continuous use), behavioral modification and medical management to reduce risk of significant weight regain is even more imperative. Even in the case of more durable procedures, such as endoscopic gastroplasty, lack of compliance with recommended dietary protocols can reduce efficacy by loosening and even ripping sutures prior to establishment of bridging fibrotic mucosal changes, which enhance longevity of the procedure and support continued gastric restriction and reduction in motility. Some patients who undergo endoscopic gastroplasty end up seeking out revision and repeat procedure later due to lack of results, which may be avoided with alternative dietary and lifestyle decisions in the postprocedural state.
The landscape of non-procedural weight management tools has changed in the last 1-2 years with the approval of newer injectable medications that disrupt insulin and hormonal pathways and produce sustainable weight loss similar to reported outcomes achieved with endobariatric procedures. These medications are becoming increasingly accessible and of interest to patients, with continued destigmatization of the use of weight loss drugs in practice, which had previous negative connotations and concerns regarding safety. New guidelines put forth by the AGA recommend adding pharmacological agents to lifestyle interventions over continuing lifestyle interventions alone if adequate weight loss has not been achieved with the latter.3 This further exemplifies the importance of a multifaceted approach to optimize medical weight management as first-line therapy for obesity and associated comorbidities.
In summary, although endobariatric procedures are an important tool for gastroenterologists to incorporate into their weight management plans, they must be implemented with care and only after lifestyle and medical interventions have failed to produce desired results. Shared decision making among providers and patients enhances weight loss efforts and augments sustainability of outcomes. Considering the rapidly evolving landscape of obesity medicine, gastroenterologists need to continue to stay up to date on best practices to improve patient care, reduce associated morbidity, and enhance outcomes of novel endobariatric procedures.
Dr. Newberry is with the Innovative Center for Health and Nutrition in Gastroenterology (ICHANGE), division of gastroenterology, Weill Cornell Medical Center, New York. She disclosed receiving speaker honorariums from Baxter International and InBody USA.
References
1. Acosta et al. Clin Gastroenterol Hepatol. 2017 May;15(5):631-49.
2. Jensen et al. Circulation. 2014;129:S102-38.
3. Grunvald et al. Gastroenterology. 2022;163(5):1198-225.
4. Athansiadis et al. Surg Endosc. 2021 Aug;35(8):4069-84.