Background

Background: Sleeve gastrectomy (SG) procedures have become the highest volume procedure worldwide for treatment of obesity. Patients have reported insufficient weight-loss or weight-regain leading to the need for an effective and safe revisional surgery to address their obesity. Objective: A study to determine the technical feasibility and safety of a minimally invasive, duodenal-ileal side-to-side anastomosis using a Sutureless Neodymium Anastomosis Procedure (SNAP) for patients with weight-regain or inadequate weight-loss following SG.

Methods

Our study is a prospective, single-arm, open label pilot study that enrolled patients with obesity to assist in weight-reduction following a SG performed >12 months prior. For SNAP, self-assembling magnets are deployed into the ileum (laparoscopically) and duodenum (per-oral endoscopy) respectively. Magnets were coupled together under laparoscopic and fluoroscopic guidance, creating a compression anastomosis. Primary endpoints: technical feasibility, effect on weight loss, and safety.

Results

Successful duodenal-ileal diversions were created with SNAP in 27 subjects (mean age: 50.6±9.1, mean BMI: 38.1±4.6 kg/m2) with no device-related serious adverse events. All magnets were naturally expelled in patients’ fecal stream. Upper endoscopy at 3M follow-up (FU) confirmed patent, healthy anastomosis in all patients. Patients with ≥9M FU experienced %TBWL of 13.7±8.3%, 17.0±11.2%, and 21.4±13.5% at 3, 6, and 9 months respectively compared to baseline.

Conclusions

Successful duodenal-ileal diversion was created in all patients with the SNAP procedure, demonstrating feasibility and safety in these patients. Weight reduction is clinically meaningful at reported FU periods with patient reporting very high satisfaction. Early results are encouraging but further study is required.