“This is a very promising approach. I am very excited about digested balloons,” said Dr. Edmundowicz, an investigator in the Obalon study.
Endoscopic sleeve gastroplasty
Endoscopic sleeve gastroplasty duplicates sleeve gastrectomy with stitches placed endoscopically to seal off the greater curvature of the stomach; functionally, patients are left with a narrow sleeve of a stomach. In a multicenter series presented at DDW, 242 patients had a mean total body weight loss of 19.8% at 18 months, with a low incidence of complications. “Weight loss appears to be continuing,” Dr. Edmundowicz said. Investigators used the Apollo OverStitch (Apollo Endosurgery) to place the sutures.
Aspiration therapy
With Food and Drug Administration approval on June 14, AspireAssist (Aspire Bariatrics) is probably the best known of the newer approaches. Patients drain a portion of their meals through an endoscopically placed percutaneous gastrostomy tube a half hour or so after eating. It takes 5-10 minutes. The agency is eager to keep it out of the hands of bulimics.
One-year data were reported at DDW; 111 obese AspireAssist subjects lost a mean of 37.2% of their excess weight versus 13% in 60 patients randomized to lifestyle counseling alone.
“It may not be aesthetically pleasing, but it certainly works. It’s a viable technology,” said Dr. Edmundowicz, who was an investigator.
The studies were funded by companies developing the devices and techniques. Dr. Edmundowicz has stock options, or is a consultant or researcher, Aspire, Obalon, GI Dynamics, Elira, and other firms.
Caveat emptor, all over again
Although many of these innovations will eventually achieve acceptable clinical results in trials and be adopted by both gastroenterologists and surgeons, a note of caution is in order, argues Tyler G. Hughes, MD, FACS, is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, coeditor of ACS Surgery News.
“The recent uptick in ‘non-surgical’ obesity treatment reverberates as history gets ready to repeat itself. If surgeons don’t take the lead, two things are likely to happen. First, ‘interventionists,’ ignorant of the lessons of yesterday will introduce foreign bodies into the soft GI tract only to see these ‘safe’ devices create surgical havoc or malabsorptive disasters. Second, instead of doing a complete spectrum of obesity procedures, surgeons will be left with the worst cases and fixing complications while the ‘interventionist’ (and I do not limit that to gastroenterologists) do the easy cases at prices three times the cost of the old way. Will this really benefit the patients?
Rather than permitting a race to the newest unproven device to satisfy public clamor, while conveniently making a tidy profit for anyone able to claim the title ‘interventionist,’ bariatric surgeons need to grab the endoscope with both hands and do the research and reporting for these new procedures. It starts with the need for every surgical resident to be proficient with the GI endoscopes and ends with surgeons seeing surgery in a wider view than through an incision,” Dr. Hughes said.