First-in-Human Side-to-Side Duodeno-Ileal Bipartition for Weight Loss and Type 2 Diabetes with the Swallowable Biofragmentable Magnetic Anastomosis System.

IF 3.8 2区医学 Q1 SURGERY Journal of the American College of Surgeons Pub Date : 2025-03-10 DOI:10.1097/XCS.0000000000001384

Michel Gagner, David Abuladze, J N Buchwald, Levan Koiava, Lamees Almutlaq

{"title":"First-in-Human Side-to-Side Duodeno-Ileal Bipartition for Weight Loss and Type 2 Diabetes with the Swallowable Biofragmentable Magnetic Anastomosis System.","authors":"Michel Gagner, David Abuladze, J N Buchwald, Levan Koiava, Lamees Almutlaq","doi":"10.1097/XCS.0000000000001384","DOIUrl":null,"url":null,"abstract":"Background: Anastomosis creation using a novel magnetic compression technique may provide an alternative minimally invasive approach to gastrointestinal surgery. The biofragmentable magnetic anastomosis system (BMAS) is endo-laparoscopically placed to effect magnetic duodeno-ileostomy (MagDI) bipartition for reduction of weight and type 2 diabetes (T2D). MagDI obviates major risks associated with enterotomy, stapling/suturing, and retained foreign materials.Study design: A first-in-human prospective investigation of feasibility, safety, and efficacy in adults with body mass index (BMI) ≥30.0 to ≤35.0 kg/m2. An initial BMAS magnet, swallowed by the patient or delivered under anesthesia by endoscopy, was guided laparoscopically to the distal ileum; a second magnet was endoscopically positioned in the post-pyloric duodenum; magnets were aligned to fuse over 7-21 days forming the duodeno-ileostomy. Primary endpoints: feasibility and severe adverse event (SAEs) incidence by Clavien-Dindo (CD) grade. Secondary endpoints: weight and T2D reduction.Results: Between 12-20-2022 and 5-21-2024, 15 patients (mean BMI 33.0±0.4 kg/m2), all with T2D (HbA1C 8.2±0.4%, glucose 187.9±15.5 mg/dL, on T2D medications) underwent MagDI. Mean operative time, 51.3±5.3 minutes. Feasibility at 90 days was confirmed in 100.0% with 0.0% leakage, bleeding, infection, stricture, mortality. 89.4% of AEs were mild; 3 CD-III SAEs were resolved. At 1 year, 100.0% of anastomoses were patent; BMI (n=8) 30.1±0.9; excess weight loss 38.8%; HbA1C 6.6±0.1%; glucose 142.8±9.5 mg/dL.Conclusions: The novel swallowable, biofragmentable magnetic anastomosis system was feasible, safe, and effective in achieving incisionless, suture/staple-free magnetic duodeno-ileostomy. The device and procedure provide a promising minimally invasive option for moderate, clinically meaningful weight loss and T2D mitigation.","PeriodicalId":17140,"journal":{"name":"Journal of the American College of Surgeons","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the American College of Surgeons","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/XCS.0000000000001384","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"SURGERY","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Anastomosis creation using a novel magnetic compression technique may provide an alternative minimally invasive approach to gastrointestinal surgery. The biofragmentable magnetic anastomosis system (BMAS) is endo-laparoscopically placed to effect magnetic duodeno-ileostomy (MagDI) bipartition for reduction of weight and type 2 diabetes (T2D). MagDI obviates major risks associated with enterotomy, stapling/suturing, and retained foreign materials.

Study design: A first-in-human prospective investigation of feasibility, safety, and efficacy in adults with body mass index (BMI) ≥30.0 to ≤35.0 kg/m2. An initial BMAS magnet, swallowed by the patient or delivered under anesthesia by endoscopy, was guided laparoscopically to the distal ileum; a second magnet was endoscopically positioned in the post-pyloric duodenum; magnets were aligned to fuse over 7-21 days forming the duodeno-ileostomy. Primary endpoints: feasibility and severe adverse event (SAEs) incidence by Clavien-Dindo (CD) grade. Secondary endpoints: weight and T2D reduction.

Results: Between 12-20-2022 and 5-21-2024, 15 patients (mean BMI 33.0±0.4 kg/m2), all with T2D (HbA1C 8.2±0.4%, glucose 187.9±15.5 mg/dL, on T2D medications) underwent MagDI. Mean operative time, 51.3±5.3 minutes. Feasibility at 90 days was confirmed in 100.0% with 0.0% leakage, bleeding, infection, stricture, mortality. 89.4% of AEs were mild; 3 CD-III SAEs were resolved. At 1 year, 100.0% of anastomoses were patent; BMI (n=8) 30.1±0.9; excess weight loss 38.8%; HbA1C 6.6±0.1%; glucose 142.8±9.5 mg/dL.

Conclusions: The novel swallowable, biofragmentable magnetic anastomosis system was feasible, safe, and effective in achieving incisionless, suture/staple-free magnetic duodeno-ileostomy. The device and procedure provide a promising minimally invasive option for moderate, clinically meaningful weight loss and T2D mitigation.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

求助全文

约1分钟内获得全文去求助

来源期刊

Journal of the American College of Surgeons 医学-外科

CiteScore

6.90

自引率

5.80%

发文量

1515

审稿时长

3-6 weeks

期刊介绍： The Journal of the American College of Surgeons (JACS) is a monthly journal publishing peer-reviewed original contributions on all aspects of surgery. These contributions include, but are not limited to, original clinical studies, review articles, and experimental investigations with clear clinical relevance. In general, case reports are not considered for publication. As the official scientific journal of the American College of Surgeons, JACS has the goal of providing its readership the highest quality rapid retrieval of information relevant to surgeons.