Immediately-Patent Magnetic Duodeno-Ileal Anastomosis (IMPA-DI): The First-in-Human Study.
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BACKGROUND: Duodeno-ileal anastomoses are technically challenging and associated with high complication rates, limiting their adoption in bariatric surgery despite their efficacy in weight loss. Magnetic compression anastomoses (MCAs) have emerged as a promising technique, promoting tissue fusion and reducing risks of bleeding and leakage. However, delayed patency limits their application. The OTOLoc™ system, combined with Flexagon self-forming magnets (SFMs), addresses this limitation by enabling immediate patency during healing. This study reports the first-in-human experience of immediately patent magnetic duodeno-ileal anastomosis (IMPA-DI) using these novel devices during single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). METHODS: This single-center, observational study evaluated the feasibility and short-term safety of IMPA-DI. Seven adult patients with moderate to severe obesity were included. The SFM assembly, coupled with the OTOLoc™ system, was laparoscopically deployed to create an immediately patent duodeno-ileal anastomosis. Primary endpoints were technical success and freedom from anastomosis-related adverse events (AEs) within 30 days. Secondary outcomes included procedural metrics and overall safety. RESULTS: All seven procedures were successfully completed, with a median overall duration of 58 min and magnet placement duration of 12 min. Three intraoperative AEs (serosal and liver injuries, staple line bleeding) were unrelated to IMPA and resolved without complications. All patients resumed liquid diets within 2 days, and no anastomosis-related AEs were observed within 30 days. All devices were naturally expelled without complications. CONCLUSIONS: This first-in-human study demonstrates the feasibility, safety, and efficiency of the IMPA-DI approach using Flexagon SFMs and the OTOLoc™ system. The immediate patency and straightforward deployment highlight the potential for broader application in challenging anastomotic sites. While limited by the small sample size and single-center design, the results underscore the promise of magnetic compression anastomoses. Further studies are warranted to validate these findings and explore long-term outcomes.
