Creation of Side-to-Side Compression Anastomosis Using the GT Metabolic Solutions™ Magnet System, DI Biofragmentable (MagDI™ System) to Achieve Duodeno-Ileal Diversion in Patients with Obesity: Preliminary Italian Multi-Center Results

BackgroundLinear magnetic compression is a novel technique to perform gastrointestinal anastomosis.ObjectiveThis Italian multi-center clinical investigation aimed to evaluate the feasibility, safety and efficacy of the creation of a side-to-side compression anastomosis using the GT Metabolic Solutions (TM) Magnet System, DI Biofragmentable (MagDI (TM) System) to achieve duodeno-ileal diversion.MethodsPatients with a body mass index (BMI) of >= 30 to 50 kg/m2 and weight regain and/or type 2 diabetes mellitus (T2DM) after sleeve gastrectomy (SG) and patients with a BMI of >= 30 to 35 kg/m2 and T2DM underwent a side-to-side duodeno-ileal diversion using the GT Metabolic (TM) DI Magnet (linear, 39 mm).Results28 patients (19 F) underwent surgery in 4 centers in the time between 09/24 and 02/25. Mean age and BMI were 44 years and 36.7 +/- 4.4 kg/m2. Mean operative time and hospital stay were 73.2 min and 1.6 days. Paired magnets were expelled in all patients in a mean of 37.3 days. There were three procedure-related serious adverse events (Clavien Dindo III, one ileal perforation on POD 1, one liver insufficiency leading to reversal on POD 144 and one trocar site hernia on POD 203). Mean BMI, %EWL and %TWL at 90 days (n = 23) were 32.7 +/- 0.8 kg/m2, 36.6 +/- 4.6% and 10.4 +/- 1.1%. Mean HbA1c decreased from 6% at baseline to 5.7% at 30 days and to 5.5% at 90 days.ConclusionPreliminary data shows that side-to-side magnet compression duodeno-ileal anastomosis was feasible, safe and effective. Future follow-up data is necessary.