Side-to-side duodeno-ileal magnetic compression anastomosis: design and feasibility of a novel device in a porcine model.

Abstract

Minimally invasive metabolic/bariatric surgery (MBS) may be further advanced by magnetic compression anastomosis (MCA) technology. The study aimed to develop a magnet sized to create a patent duodeno-ileostomy (DI) and verify its effectiveness in a porcine model. Developmental study phase: magnets with 4 different flange-offset dimensions were tested to identify a design that would successfully form a compression anastomosis. Verification phase: evaluation of the selected design's efficacy. In each 6-week phase (4 pigs/phase), one magnet was inserted laparoscopically in the jejunum, one placed gastroscopically in the duodenum. Magnets were aligned, gradually fused, formed an anastomosis, and then detached and were expelled. At necropsy, MCA sites and sutured enterotomy sites were collected and compared. Developmental phase: the linear BC42 magnet with a 2.3-mm flange offset design was selected. Verification phase: in 4 swine magnets were mated at the target location, confirmed radiographically. Mean time to magnet detachment 16.0days (12-22), to expulsion 24.5days (17-33). MCA was achieved in all animals at time of sacrifice. Animals gained a mean 9.5kg (3.9-11.8). Specimens revealed patent anastomoses of ≥ 20mm with smooth mucosa and minimal inflammation and fibrosis compared to sutured enterotomies. One pig underwent corrective surgery for a mesenteric hernia without sequelae. In a large-animal model, gross and histopathologic examination confirmed that the linear MCA device created a patent, well-vascularized, duodeno-ileal anastomosis. The novel MCA device may be appropriate for use in human MBS procedures.