Small bowel magnetic compression anastomosis creation for bypass procedures in a porcine model.

Abstract

Background: Stapled and hand-sewn techniques dominate gastrointestinal anastomotic procedures. These techniques are effective but not without flaws. Retained foreign bodies, pathways from mucosa to serosa, and increased scar tissue are some of the drawbacks, and can lead to postoperative complications. The GI Windows Flexagon™ system utilizes self-forming magnets (SFM's) to create anastomoses by compression, sealing serosa to serosa, leaving no foreign bodies. Combining the Flexagon™ SFM with the OTOLoc™ device (implant with a central lumen which provides radial support to the enterotomies), enables immediate flow through the anastomosis and facilitates creation of enteral bypass procedures unique to this technology. We sought to compare the safety and efficacy of the GI Windows Flexagon™ and OTOLoc™ technologies against conventional stapling.

Methods: A preclinical study was conducted on 14 Yorkshire swine to compare laparoscopic magnetic and stapled duodenoileostomies and jejunojejunostomies. Study endpoints included: adverse or serious adverse events, anastomotic burst pressure, adhesions, histopathology, and bacterial ingress. A Likert scale was used to assess the usability of the devices.

Results: All procedures were successfully completed via laparoscopic approach; no adverse or serious adverse events were observed at the 42-day endpoint. All SFM's were expelled in less than 20 days. Average anastomotic burst pressure was 129.2 mmHg for SFM compared to 79.4 mmHg in stapled controls. Adhesion scores were similar between groups. Histopathology revealed that magnetic anastomoses have less intestinal wall distortion, fewer signs of chronic inflammation, and no bacterial ingress. The usability of all devices was reported as "Easy" or "Very Easy."

Conclusion: GI Windows magnetic compression anastomoses creation in this porcine model revealed an overall ease of use, all while demonstrating procedural feasibility, safety, and clinical effectiveness. Surprisingly, in nearly all results assessed, SFM anastomoses were found to be comparable to the control stapled anastomoses in regard to structural, physiological, and histological endpoints.