Minimally invasive endoscopic sleeve gastroplasty added to lifestyle modifications was effective for inducing significant weight loss, according to the randomized MERIT trial.
Among patients with class I or II obesity, the average percentage of excess weight loss at week 52 was significantly greater for those who underwent sleeve gastroplasty, at 49.2% versus 3.2% for the control group, reported Barham Abu Dayyeh, MD, of the Mayo Clinic in Rochester, Minnesota, and colleagues.
On top of that, 77% of sleeve gastroplasty patients were able to achieve a 25% or greater drop in excess weight (defined as weight over a BMI of 25) by the first year versus only 12% of the control group, the team wrote in The Lancet.
As for total weight loss, sleeve gastroplasty patients saw a decline of 13.6% over the first postoperative year compared with only 0.8% for the control group.
Beyond weight loss, 80% of patients who underwent surgery also saw improvement in at least one metabolic comorbidity versus 45% of the controls. Only 12% of sleeve gastroplasty patients saw a worsening in one or more metabolic comorbidities versus 50% of the controls.
Among the patients with diabetes prior to surgery, 93% had a clinical improvement in disease after surgery versus only 15% of the control participants. None of the surgery patients saw a worsening in their diabetes by the end of follow-up compared with 44% of the control group.
By 104 weeks after undergoing surgery, 68% of sleeve gastroplasty patients were able to maintain this achievement of 25% or greater excess weight loss. This included the original sleeve gastroplasty group, plus any participants from the initial control group who crossed over to receive surgery at the 52-week mark.
The rate of serious adverse events was low throughout follow-up, occurring in only 2% (3 of 131) of patients. No patients died or needed intensive care or surgery after sleeve gastroplasty. The most common adverse events reported were gastrointestinal-related — such as pain, heartburn, nausea, and vomiting — but most resolved within 1 week after surgery.
First described by Abu Dayyeh himself in 2013, this type of procedure is performed slightly differently than the most common forms of bariatric surgeries, like sleeve gastrectomy or Roux-en-Y gastric bypass. Instead, sleeve gastroplasty is a reversible, incision-less, endoluminal organ-sparing procedure that imbricates most of the stomach by serial interrupted sutures placed from the incisura to the cardia performed with a full-thickness endoscopic suturing device. Weight loss is subsequently achieved by the procedure delaying gastric emptying and increasing satiation.
“ESG [endoscopic sleeve gastroplasty] is a minimally invasive alternative to laparoscopic sleeve gastrectomy that can be done at a lower BMI, offering a safe and effective option for individuals wishing to avoid surgery,” Abu Dayyeh’s group suggested.
Writing in an accompanying commentary, Vitor Ottoboni Brunaldi, MD, MSc, of the University of São Paulo Medical School in Brazil, and Christine Stier, MD, of the University Hospital Würzburg in Germany, said that while the results are “impressive,” longer-term data — particularly 5 and 10 years out — are really needed.
“Above all, longer-term data are mandatory to support the sustainability of the results, and thus the viability of the procedure itself,” they said. The commentators also suggested head-to-head trials comparing this procedure with the other popular bariatric procedures, like sleeve gastrectomy, in order to “better define the spectrum of indications and patient selection criteria for endoscopic suturing procedures.”
The multicenter U.S.-based trial included 209 adults with class I or class II obesity: i.e., a BMI between 30 and 40. All participants were ages 21 to 65 and had a history of failed non-surgical weight loss methods.
A total of 85 participants were randomly assigned to receive surgery, who were compared with 124 controls. As expected with a bariatric surgery cohort, the vast majority were female (84% of the control group and 88% of the surgery group). A third of the control group and 23% of the surgical group had diabetes.
Both groups were also instructed to adhere to lifestyle modifications, comprised of a low-calorie diet plus exercise.
Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and nephrology news. Based out of the New York City office, she’s worked at the company since 2015.
The trial was supported by Apollo Endosurgery and the Mayo Clinic.
Abu Dayyeh reported relationships with Endogenex, Endo-TAGSS, Metamodix, BFKW, USGI, Spatz Medical Boston Scientific, Olympus, Johnson & Johnson, Medtronic, EndoGastric Solutions, Apollo Endosurgery, Cairn Diagnostics, and Aspire Bariatrics. Other co-authors also reported disclosures.
Brunaldi reported having no competing interests; Stier reported relationships with Johnson & Johnson, Novo Nordisk, Apollo Endosurgery, the German Obesity Alliance, and IFSO Bariatric Endoscopy Committee.