Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results.

INTRODUCTION: Gastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution. METHODS: In patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0- ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC). RESULTS: Between November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality. CONCLUSION: In a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.

First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System.

PURPOSES: Classical gastrointestinal anastomoses are formed with sutures and/or metal staples, resulting in significant bleeding and leak rates. This study evaluated the feasibility and safety of the novel magnet anastomosis system (MS) to create a side-to-side duodeno-ileal (DI) diversion for weight loss and type 2 diabetes (T2D) resolution. MATERIALS AND METHODS: Patients with severe obesity (body mass index (BMI) ≥ 35 kg/m2 with/without T2D (HbA1C ≥ 6.5%)) underwent the study procedure, a side-to-side MS DI diversion, with a standard sleeve gastrectomy (SG). A linear magnet was delivered by flexible endoscopy to a point 250 cm proximal to the ileocecal valve; a second magnet was positioned in the first part of the duodenum; the bowel segments containing magnets were apposed, initiating gradual anastomosis formation. Laparoscopic assistance was used to obtain bowel measurements, obviate tissue interposition, and close mesenteric defects. RESULTS: Between November 22 and 26, 2021, 5 female patients (mean weight 117.6 ± 7.1 kg, BMI (kg/m2) 44.4 ± 2.2) underwent side-to-side MS DI + SG. All magnets were successfully placed, expelled without re-intervention, and formed patent durable anastomoses. Total weight loss at 12 months was 34.0 ± 1.4% (SEM); excess weight loss, 80.2 ± 6.6%; and BMI reduction, 15.1. Mean HbA1C (%) dropped from 6.8 ± 0.8 to 4.8 ± 0.2; and glucose (mg/dL), from 134.3 ± 17.9 to 87.3 ± 6.3 (mean reduction, 47.0 mg/dL). There was no anastomotic bleeding, leakage, obstruction, or infection and no mortality. CONCLUSIONS: Creation of a side-to-side magnetic compression anastomosis to achieve duodeno-ileostomy diversion in adults with severe obesity was feasible and safe, achieved excellent weight loss, and resolved type 2 diabetes at 1-year follow-up. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05322122.