title: Endoscopic intestinal bypass creation by using self-assembling magnets in a porcine model.
abstract: OBJECTIVE
  A purely endoluminal method of GI bypass would be desirable for the treatment of obstruction, obesity, or metabolic syndrome. We have developed a technology based on miniature self-assembling magnets that create large-caliber anastomoses (Incisionless Anastomosis System [IAS]). The aim of this study was to evaluate procedural characteristics of IAS deployment and long-term anastomotic integrity and patency.
  
  
  METHODS
  We performed a 3-month survival study of Yorkshire pigs (5 interventions, 3 controls). Intervention pigs underwent simultaneous enteroscopy/colonoscopy performed with the animals under intravenous sedation. The IAS magnets were deployed and coupled with reciprocal magnets under fluoroscopy. Every 3 to 6 days pigs underwent endoscopy until jejunocolonic anastomosis (dual-path bypass) creation and magnet expulsion. Necropsies and histological evaluation were performed. The primary endpoints were technical success; secondary endpoints of anastomosis integrity, patency, and histological characteristics were weight trends.
  
  
  RESULTS
  Under intravenous sedation, endoscopic bypass creation by using IAS magnets was successfully performed in 5 of 5 pigs (100%). Given porcine anatomy, the easiest dual-path bypass to create was between the proximal jejunum and colon. The mean procedure time was 14.7 minutes. Patent, leak-free anastomoses formed by day 4. All IAS magnets were expelled by day 12. All anastomoses were fully patent at 3 months with a mean diameter of 3.5 cm. The mean 3-month weight was 45 kg in bypass pigs and 78 kg in controls (P = .01). At necropsy, adhesions were absent. Histology showed full re-epithelialization across the anastomosis without fibrosis or inflammation.
  
  
  CONCLUSIONS
  Large-caliber, leak-free, foreign body-free endoscopic intestinal bypass by using IAS magnets can be safely and rapidly performed in the porcine by model using only intravenous sedation.
authors.affiliation: Division of Gastroenterology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Marvin
authors.initials: M
authors.lastname: Ryou
authors.affiliation: Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: A Tony
authors.initials: AT
authors.lastname: Agoston
authors.affiliation: Division of Gastroenterology, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Thompson
mesh_terms: D000714:Anastomosis, Surgical / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D000818:Animals; D001835:Body Weight; D003106:Colon / Q000601:surgery*; D016099:Endoscopy, Gastrointestinal / Q000295:instrumentation / Q000379:methods*; D007583:Jejunum / Q000601:surgery*; D059346:Magnets; D011312:Pressure; D062326:Re-Epithelialization; D013552:Swine; D013997:Time Factors