The obesity epidemic is upon us. The most recent data from the Behavioral Risk Factors Surveillance System on self-reported rates of obesity show that, even in the “fittest” states in the country, obesity is reported in one in five individuals.1 The obesity epidemic has overwhelmed our practices, bariatric surgeons and health care systems. The direct and indirect costs of obesity and the metabolic complications of type 2 diabetes mellitus and nonalcoholic fatty liver disease continue to grow. The less visible costs of the epidemic that include cardiovascular disease and the increased incidence of cancers, joint disease and other comorbidities also continue to grow. Despite this, payors are largely unwilling to provide uniform coverage of obesity care. Many patients find that their insurance will not cover lifestyle modification therapy, dietary visits related to obesity, medications for obesity, endoscopic bariatric therapy (EBT) or bariatric surgery. These factors in turn cause us as clinicians to miss opportunities to intervene before the complications of obesity are prominent, harmful and expensive to treat.
It has been two years since the U.S. Food and Drug Administration (FDA) approved modern EBT. Currently available EBT has been recently reviewed.2 Its impact on the obesity epidemic has been, quite frankly, minimal. Patients wishing to undergo endoscopic therapy often pay out of pocket for the procedure, and, if complications arise, they also assume all the risk (and cost). Although centers across the U.S. have begun programs that incorporate EBT, the number of patients evaluated and treated remains small and likely will not significantly change until payors recognize EBT as a viable option for these patients.
Current offerings for patients interested in EBT include fluid- and gas-filled intragastric balloons, aspiration therapy and gastric restriction with approved tissue apposition devices — mainly endoscopic sleeve gastroplasty with an endoscopic suturing system. Many centers offering these techniques have incorporated them into a multidisciplinary approach to allow patients the ability to explore all options, from lifestyle modification therapy to bariatric surgery. EBT is the most effective when it is incorporated into a multidisciplinary approach that offers patients lifestyle modification therapy, which can include dietary counseling, supportive services from a navigator/life coach, physician follow-up and psychology resources. In addition to being trained in the procedural aspects of EBT, physicians using EBT to treat obesity and its related comorbidities must be well educated and trained in all aspects of obesity management. This can be accomplished through participation in either the AGA POWER3 program or in the pursuit of formal certification in obesity medicine by participating in continuing medical education and passing a board certification examination.
These data suggest that the long-term use of this device by patients who adhere to treatment will result in significant weight loss and continued maintenance of that loss within two to four years.
Several types of EBT are approved for use in the U.S. The FDA has approved gas- and saline-filled intragastric balloons for implantation for a period of six months. Weight loss can persist after balloon removal. Additional studies are ongoing to demonstrate the amount of weight loss we can expect to see in clinical use. Gas-filled balloons continue to be better tolerated than those filled with saline, and additional efficacy data for gas-filled balloons is forthcoming. Reports of significant adverse events (AEs) due to saline-filled balloons have been reported to the FDA’s Manufacturer and User Facility Device Experience database, although these numbers are small. These reports are not filtered, and, in some cases, the AEs may be difficult to attribute to EBT. Additional updates are anticipated from the FDA regarding the incidence of these AEs by the end of 2018.
Aspiration therapy continues to be offered at select centers, and additional longer-term data are now becoming available. These data suggest that the long-term use of this device by patients who adhere to treatment will result in significant weight loss and continued maintenance of that loss within two to four years.
Endoscopic sleeve gastroplasty has become more widely available both in the U.S. and abroad. A three-center study followed patients for more than 18 months and has demonstrated some durability of the weight loss seen with this technique as well. The results of other trials have demonstrated rates of efficacy and safety similar to these observed with the laparoscopic gastric band. A randomized trial comparing endoscopic with laparoscopic sleeve gastrectomy is currently underway. More single- and multi-center series with safety and efficacy data are expected to be released soon.
Several new devices and approaches are also moving through or toward FDA pivotal trial status. I hope that in my next article I will be able to highlight improved insurance coverage for obesity management, including EBT, as well as an expanded armamentarium of FDA-approved devices that we can use to help treat our patients.
Dr. Edmundowicz is on the medical advisory board for Olympus, consults for Elsevier, Medtronic, Allurion, and has received research support from Medtronic and Spironetics. Dr. Edmundowicz is the ASGE president.
1. Kushner, R.F., Kahan, S. The state of obesity in 2017. Med Clin. 2018;102:1-11.
2. Abu Dayyeh, B.K, Edmundowicz, S., Thompson, C.C. Clinical practice update: expert review on endoscopic bariatric therapies. Gastroenterology. 2017;152:716-729.
3. Acosta, A., Streett, S., Kroh, M.D., et al, POWER — practice guide on obesity and weight management, education, and resources. Clin Gastroenterol Hepatol. 2017;15:631-649.