Abbas, Abu Dayyeh, Jirapinyo and Simons-Linares report no relevant financial disclosures. Chiang reports a financial relationship with Medtronic.
The obesity epidemic is one of today’s most blatantly visible — yet actively neglected — public health concerns, affecting more than 1 billion people globally, according to WHO.
The CDC has reported that U.S. obesity prevalence climbed from 30.5% in 1999 to 41.9% by 2020, while the prevalence of severe obesity went from 4.7% to 9.2% during that time. With this rise in prevalence, the obesity epidemic has brought about considerable socioeconomic and health care-associated cost burden: The estimated annual health care utilization cost of caring for patients with obesity was $173 billion in 2019.
Historically, obesity management has fallen in the realm of other specialties. Although gastroenterologists have dealt with common comorbidities such as fatty liver disease and GERD, they have not always been in the position to guide remission. With the help of emerging research and FDA approvals, gastroenterologists are now better positioned to assist in the management of this epidemic.
“In gastroenterology, we have not focused on the fact that this is a gastrointestinal disease; our curriculums and our societies have not previously endorsed that fact and now we are playing catch up as far as educating gastroenterologists,” Barham K. Abu Dayyeh, MD, MPH, director of advanced endoscopy and professor of medicine in the department of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minnesota, told Healio Gastroenterology. “We need to take the disease of obesity seriously, and we need to be an active player in management.”
Traditionally, obesity management has involved intensive lifestyle modification and pharmacologic intervention, which has been associated with approximately 3.1% to 6.6% of total weight loss (Tawadros A, et al.), or bariatric surgery — for patients with a BMI greater than 40 or greater than 35 with clinical comorbidity — which has been associated with approximately 20% to 33.3% of total weight loss. However, only 1% of eligible patients opt to undergo surgery.
A gap exists in this care continuum among those who have had little luck with lifestyle changes or pharmacologic intervention, those who are eligible but elect not to undergo surgery and those with a BMI between 30 and 40 who are not even given the option for effective intervention.
“There’s a wide range of medical problems that come with obesity, and when you look at the surgical guidelines they only focus on the severest ones and highest BMIs. We see a lot of people who are ticking time bombs — many patients with obesity are not qualified for surgery,” Ali M. Abbas, MD, MPH, assistant professor of medicine and surgery and director of bariatric endoscopy at the University of South Florida, said. “If you’re unable to intervene early enough to prevent worsened disease outcomes, you’re not giving them very good options. And that’s the whole idea of the gap in care: If you are able to give a viable option, it can push patients to reclaim their health and prevent them from slipping deeper into obesity comorbidities.”
“The vast majority of disease is unmet,” Abu Dayyeh added. “We need more tools in the toolbox to address this heterogenous disease. … The more appealing gastric interventions that we’re seeing are propelling the field into pushing the boundary closer to bariatric surgery. Gastric remodeling techniques, like those seen with bariatric endoscopy, change the shape of the stomach while preserving its vascular and nervous supply.”
Healio Gastroenterology spoke with experts across the field about bariatric endoscopy: what it entails, its approved strategies and its potential to bridge the medical-surgical gap in obesity management.
Bariatric Endoscopy: The Basics
The basis of bariatric endoscopy is utilizing the GI tract to induce weight loss and metabolic improvement.
“Bariatric endoscopy is a nonsurgical approach to help patients with primary weight loss as well as treat complications of bariatric surgery, including weight regain after previous surgery,” Austin Chiang, MD, MPH, director of the endoscopic bariatric program at Thomas Jefferson University Hospital and assistant professor of medicine at Sidney Kimmel Medical College, said. “For primary weight loss, the main modalities are endoscopic suturing techniques to reduce the volume of the stomach as well as space-occupying intragastric balloons. However, dietary guidance and lifestyle modifications must serve as the basis of any weight loss plan.”
For years it has been widely accepted that the solution to body weight recalibration lay within the GI tract. This has been exemplified by surgeries like gastric bypass, where rearrangement of the GI tract (stomach size reduction and rerouting the small intestine) induced remission or improvement of obesity along with most comorbidities. Though often successful, the fact remains that approximately 98% of patients with obesity who are eligible for bariatric surgery do not elect to undergo this invasive procedure.
“Given the invasiveness of surgery, its permanent alteration to the anatomy and given that this disease goes into remission but is not cured, we can conclude that surgery is part of the solution but is not enough to be the solution for a disease like obesity. We’re faced with a chasm where the vast majority of disease is being unchecked with serious consequences,” Abu Dayyeh said. “Bariatric endoscopy, at its essence, is utilizing the power of the GI tract to develop anatomy-preserving tools that effectively treat obesity and metabolic consequences.”
Today, the two bariatric endoscopy procedures approved in the U.S. are intragastric balloons (IGB) and endoscopy sleeve gastroplasty (ESG).
With its first FDA approval in 2015 for patients with a BMI between 30 and 40, IGB is an adjustable, fluid- or gas-filled balloon designed to limit the amount of space in the stomach. The balloon is either placed via endoscopy or is swallowed and induces an approximate 10% loss of starting body weight.
“Currently, the balloon that is commercially available in the U.S. is only approved for 6 months. No matter how much a patient likes it, we have to eventually remove the balloon,” Sigh Pichamol Jirapinyo, MD, MPH, associate director of bariatric endoscopy and director of bariatric endoscopy fellowship at Brigham and Women’s Hospital, said. “Following balloon removal, there’s a slight risk for weight regain. I usually add a weight loss medication a few months prior to or at the time of removal to minimize regain and help maintain the weight loss that has already been achieved.”
In a 2015 systematic review and meta-analysis of 17 studies by the ASGE Bariatric Endoscopy Task Force, Abu Dayyeh and colleagues reported an 11% total body weight loss as well as a 25% excess weight loss at 12 months among 1,683 patients who underwent balloon placement. They further reported frequent side effects of pain and nausea among 33.7% of patients and early balloon removal among 7%; serious side effects of balloon migration and gastric perforation were rare and occurred in 1.4% and 0.1% of patients, respectively.
Coupled with this data and FDA approval, the AGA was the first society to endorse IGB as a therapeutic option in its 2021 guidelines (Muniraj T, et al.).
“Usually, I would explain both pros and cons of various endoscopic bariatric therapies to help patients come up with a treatment based on their preference,” Jirapinyo said. “The intragastric balloon tends to be less invasive than endoscopic sleeve gastroplasty, because we do not sew or alter the shape of the stomach at all. However, the amount of weight loss is slightly lower for an intragastric balloon compared to endoscopic sleeve: approximately 10% vs. 15% to 20% of baseline weight.”
In his presentation at the ACG/FCG Annual Spring Symposium 2022, Abbas noted that in addition to being less invasive, IGB is easy to place and currently the least expensive option. However, limited insurance coverage, weight gain following removal and risk for early removal may make this option less appealing.
Endoscopic Sleeve Gastroplasty
“ESG is an outpatient procedure where we go through the mouth of the patient with a device that allows us to suture the stomach which then reduces its volume into a tubular or ‘banana’ shape,” Roberto Simons-Linares, MD, director of bariatric endoscopy at Cleveland Clinic, said. “This procedure is my favorite because it is a very safe and effective bariatric endoscopy procedure for weight loss.”
According to meta-analysis data from eight cohort studies (1,815 patients who underwent ESG), Babu P. Mohan, MD, and colleagues found ESG induced a 17.1% total weight loss as well as 63% excess weight loss at 12 months following the procedure. They reported minimal adverse events with 1.1% of patients experiencing bleeding, 0.4% of patients experiencing GERD and 2.9% of patients experiencing both.
Further long-term data showed ESG yielded a 14.5% (95% CI, 8.2-20.9) total body weight loss at 5 years among 203 patients (89% follow-up) with 69% of patients achieving greater than 10% total body weight loss (Sharaiha RZ, et al.).
“For endoscopic sleeve gastroplasty, pros would be the efficacy and durability. Depending on the device and suturing or plication pattern, the amount of weight loss shown in studies is 15% to 20% of their starting weight so you get more weight loss compared with the balloon and our study [Jirapinyo P, et al.] showed that this weight loss may last up to at least 5 years,” Jirapinyo said. “Cons is this procedure is slightly more invasive because the endoscopist has to use a needle to sew and change the stomach shape.”
Additional benefits of ESG include its rapid recovery time and ability to be performed as an outpatient procedure. However, insurance approval is not available.
Bridging the Gap: When to Recommend Endoscopy vs. Surgery
According to the experts, there are clear indications for bariatric surgery: While bariatric endoscopy is meant to help patients who do not qualify for more invasive measures, the indications for endoscopy are determined on more of a case-by-case and patient preference basis.
“Bariatric endoscopy should be recommended for patients with a BMI between 30 and 40 after they have attempted lifestyle modification, since most of them are too light to qualify for bariatric surgery,” Jirapinyo said. “The second group is for patients with a BMI greater than 40 who are ‘eligible’ for surgery but do not elect to undergo surgery.” Jirapinyo added that additional populations that would benefit from endoscopy include patients with a BMI above 40 who are deemed too high risk or patients who require a minimally invasive intervention as a bridge to another procedure, such as organ transplantation.
“Depending on BMI cutoffs, bariatric endoscopy may not even be an option,” Chiang said. “For those who fulfill BMI requirements for either endoscopy or surgery, a further discussion is required with their physicians. Ultimately, it can be a very personal decision for the patient and this needs to be respected.”
Existing Barriers to Care
Though bariatric endoscopy has the potential to change the face of obesity management and remission, several barriers to patient care remain, the largest of which are lack of education, awareness and insurance coverage.
“Every time I do something clinically, I like to also do something in terms of advocacy to try and educate patients, providers and insurance,” Simons-Linares said. “Endoscopy right now needs more support from insurance to really see that this minimally-invasive procedure is actually saving money and lives.”
Another hurdle is a lack of multidisciplinary skilled teams. Obesity is a chronic condition that requires follow-up with a support system of nutritionists and clinicians to ensure patients maintain their weight loss.
“Additionally, training is important. These procedures represent a unique skill set with significant cognitive elements. It’s relatively hard to train people once they have left fellowship. As such, we should focus on incorporating bariatric endoscopy into fellowship,” Jirapinyo said.
On the Horizon
Managing obesity is an ongoing process that requires the introduction of more options, in addition to what is already available, with the aim of providing patients with a more comprehensive care continuum.
“There’s a lot of focus on these modular systems that hybrid between endoscopy and laparoscopy in order to preserve the anatomy while having the efficacy of bariatric surgery,” Abu Dayyeh said.
“The number of people dying from [metabolic] diseases dwarf the deaths of COVID-19; most of these go unchecked and we need a call to action by governments, regulators and private insurance societies for more interventions,” he continued. “We’re facing a bigger epidemic that we need to respond to with vigor, because the numbers are not getting better. It’s only getting worse.”
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