Discussion
inflammation, T2D, weight loss, duodenal and ileal bowel
TYPE 2 DIABETES, VASCULARIZATION, INFLAMMATION, SECONDARY, COMPLICATIONS
Surgical magnets have been applied to gain exposure, dissect tissue planes, achieve hemostasis, and recently, to create an anastomosis. This first-in-human study was aimed at evaluating the 30-day feasibility and safety of the magnet system in creating a side-to-side duodeno-ileal diversion and at observing preliminary 360-day weight loss and T2D resolution. Our predicate study of the MS device in swine successfully demonstrated that the insertion technique was technically straightforward and that the compressive force of linear magnets mated through duodenal and ileal bowel walls would form a patent anastomosis with an internal diameter of > 20.0 mm. At 6-week postprocedure, gross and histologic examination confirmed well-healed anastomoses with minimal inflammation and good vascularization compared to sutured enterotomy sites. The current human study corroborated these preclinical findings.All 5 patients (100.0%) met the primary endpoint: magnets were successfully placed and subsequently expelled without surgical re-intervention, and magnetic formation of patent anastomoses comprised of healthy mucosal tissue was attained. There was no mortality nor device-related AEs or SAEs at 30 and 360 days. All secondary endpoints trended toward MBS efficacy objectives. Patients had significant marked weight and BMI loss, > 5.0% TWL, and functional improvement of HbA1At this time, MS 30-day feasibility and safety outcomes can only be compared directly to one other report. Schlottmann et al. described 4 females/4 males with a median BMI of 38.8 who underwent side-to-side DI using the self-forming magnets (SFM) device [Contemporary non-magnetic CA devices have been shown comparably effective to conventional suturing and stapling [In terms of 30-day morbidity, early registry and systematic review data suggest that SADI-S may be as safe as duodenal switch (DS) with a potentially higher incidence of complications than SG and Roux-en-Y gastric bypass (RYGB) [SADI-S weight loss efficacy is considerable, with mean 12-month TWL ranging from 21.5 to 41.2% and EWL from 61.6 to 102.0% [Type 2 diabetes resolution of 60.0–80.0% after SADI-S has been reported, similar to that of BPD/DS which results in the highest rate of T2D resolution among MBS procedures [