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.
Dr. Pichamol Jirapinyo
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.
