Efficacy and safety of novel VAC-Stent in management of upper gastrointestinal post-surgical leaks: results from a large multicenter study in tertiary referral centers.

BACKGROUND AND AIM: Self-expandable metal stents (SEMS) and endoscopic vacuum therapy (EVT) represent the mainstay of endoscopic treatment for leaks of the upper gastrointestinal (UGI) tract. The VAC-Stent GIᵀᴹ (MicroTech, Düsseldorf, Germany) is a novel device that combines the principles of both SEMS and EVT. In this study, we evaluate the efficacy and safety of VAC-Stent in the management of post-surgical UGI wall defects. METHODS: A retrospective multicenter study was performed in seven Italian endoscopic centers between June 2023 and January 2025. A total of 81 patients with evidence of UGIpost-surgical leak were enrolled (71.6% male; age range 32 - 83 yrs; mean age 63.5 ± 11.8 yrs). VAC-Stent removal or substitution was scheduled within 7 days from the deployment; continuous suction with negative pressure of - 125 mmHg was applied; leak closure was radiologically and/or endoscopically confirmed. RESULTS: A total of 156 VAC-Stents GIᵀᴹ was implanted in 81 patients (range 1-7; mean stent per patient 2.0 ± 1.0), with a mean treatment duration of 12.7 ± 6.3 days (range 7 - 41 days). Six out 81 patients were excluded because of premature death unrelated to stent failure. Deployment was successful in 100% of cases (150/150). Mean diameter of the wall defect was 19.6 ± 18.2 mm and complete healing was achieved in 85.3% of patients (64/75). Enteral nutrition was provided in 53.3% of the cases. One case of late bleeding occurred after stent deployment and was managed conservatively; no cases of recurrence were recorded during follow-up. CONCLUSIONS: VAC-stent GIᵀᴹ represents a safe and effective approach in treating anastomotic leaks following upper GI surgery.