First-in-human side-to-side linear magnetic compression gastroileostomy: feasibility and early outcomes in adults with obesity.

BACKGROUND

Conventional surgical stapling/suturing requires tissue fixation with retained potentially inflammatory materials. A novel minimally invasive magnetic compression anastomosis system that requires no fixation, enterotomy closure, or permanent implant seems to mitigate major complications associated with stapling/suturing. As an option for revision of clinically suboptimal sleeve gastrectomy (SG), the technical feasibility, safety, and preliminary efficacy of magnetic gastroileostomy bipartition (MagGI procedure) were evaluated in a first-in-human case series.

METHODS

In this prospective single-center study, adults with a body mass index (BMI) of ≥30.0 to ≤50.0 kg/m who were candidates for SG revision underwent the MagGI procedure. A distal magnet was delivered endoscopically with laparoscopic assistance to the ileum. A proximal magnet was positioned endoscopically in the gastric antrum. The magnets were aligned to gradually fuse, forming a gastroileal bipartition. The primary safety endpoint was minimal incidence of device- and procedure-related severe adverse events (SAEs) (Clavien-Dindo [CD] classification). The primary efficacy endpoint was technical feasibility. The secondary endpoints were reduction of weight and metabolic parameters.

RESULTS

Between November 27, 2023, and May 27, 2024, 7 patients (mean BMI of 38.8 ± 0.9 kg/m) underwent revisional MagGI. Feasibility was demonstrated, and patent gastroileal anastomoses were confirmed in 100.0% of cases, with no device-related events and 1 SAE with a CD III mild rating. There was no anastomotic leakage, bleeding, obstruction, infection, or stricture. Total weight loss and excess weight loss were 18.9% ± 3.9% and 52.4% ± 11.0%, respectively. A BMI reduction of 7.4 kg/m was observed (P <.05). Mild nutritional concerns were treated.

CONCLUSION

At the 6-month interim evaluation, the MagGI procedure was performed to revise clinically suboptimal SG. In addition, the procedure was technically straightforward, incurred no major complications, and renewed clinically meaningful weight loss in a small cohort.