Background
Magnetic digestive anastomosis has the potential to reduce anastomotic complications and complexity. We report the 1-year results of a new surgical technique using Self-forming Nitinol magnet Anastomosis Procedure with Sleeve gastrectomy (SNAP-S, GI-Windows).
Methods
Prospective non-randomized multicenter trial. Surgery consisted in creating a side-to-side duodeno-ileal anastomosis at 300cm from IC valve, using circular magnetic anastomosis. The proximal magnet was deployed by endoscopy and the distal one by laparoscopy. A sleeve gastrectomy was performed at the same time. Data is reported as Mean+-Standard Deviation for continuous variable or percentage for non-continuous ones.
Results
A total of 19 participants were recruited, with a mean age of 45 (28-59) years, sex-ratio (%F) of 74% and initial BMI of 42.6+-4.9kg/m2. All patients had T2D with an initial Hemoglobin A1c (HbA1C) of 7.3+-1.3%. All procedures were performed using a combination of endoscopy and laparoscopy. There was no conversion or peri-operative mortality. A total of 41 procedure related adverse events were recorded during the 12-month follow-up. Seven events in 4 subjects were considered serious. Total Weight Loss at 3, 6 and 12 months was 22+-19%, 28+-19% and 35+-19%, respectively. All patients had an HbA1c<=6.0% at 12 months with a mean HbA1C of 5.1+-0.5% and a mean absolute drop of 2.2%.
Conclusions
Data at 12-months suggest that SNAP-S procedure is feasible and safe and provides significant weight loss and improvement of comorbidities. Additional prospective data is required.