Mid-Term Outcomes of the Viabahn Balloon-Expandable Endoprosthesis as Bridging Stent Graft for Fenestrated and Branched Endovascular Aortic Repair.

Abstract

Purpose: Bridging stent grafts (BSG) implanted during fenestrated and branched endovascular aortic repair (F/B-EVAR) are crucial for the successful exclusion of thoracoabdominal and complex abdominal aortic aneurysms (AAA). The aim of this study was to analyze the outcomes of the Gore Viabahn VBX stent graft as BSG for renal and visceral target vessels during F/B-EVAR.

Materials and methods: All consecutive patients undergoing F/B-EVAR for thoracoabdominal or complex AAAs from January 2019 to May 2023 who were treated with at least 1 VBX stent graft as BSG were included. Procedural, radiological, and follow-up data of the included patients were retrospectively reviewed. Primary outcome of the study was technical success of VBX stent graft implantation. Secondary endpoints were VBX-related adverse events, target vessel instability, endoleaks, and overall survival.

Results: A total of 273 VBX stent grafts were implanted in 263 target vessels in 38 FEVAR, 46 BEVAR, and 3 F/B-EVAR (combined design) stent grafts in 87 patients (74.7% male; mean age, 73.6 ± 7.0 years). Technical success of VBX stent graft implantation was 97.5% with 273 successful implantations in 280 attempts. The VBX-related secondary endpoints were evaluated for 269 VBX stent grafts in 259 target vessels. Target vessel designs included 107 fenestrations (41.3%), 82 outer-branches (31.7%), and 70 inner-branches (27.0%). Freedom from VBX-related adverse events at 12 months postoperatively was 96.6% (95% CI: 92.9%-100%) for target vessels with a fenestration and 93.6% (95% CI: 89.4%-98.0%) for target vessels with a branch. Freedom from target vessel instability at 12 months postoperatively for fenestrations and branches was 98.1% (95% CI: 94.4%-100%) and 97.6% (95% CI: 94.9%-100%) respectively. A total of 9 (3.5%) VBX-related endoleaks were detected during follow-up. Overall survival of all treated patients was 86.7% (95% CI: 79.1%-94.9%) at a median follow-up of 14 months.

Conclusion: The VBX stent graft shows an excellent performance as a BSG in F/B-EVAR. The VBX stent graft has a high technical implantation success and shows a high mid-term freedom from stent graft-related adverse events and target vessel instability for both target vessels with a fenestration and a branch. Long-term follow-up data of the performance of the VBX stent graft are to be awaited.

Clinical impact: This study evaluated the outcomes of the Gore Viabahn VBX stent graft as a bridging stent graft (BSG) for renal and visceral target vessels. It is important to evaluate the performance of such recently introduced stent grafts as these are essentially used in procedures outside of the Instructions for Use. This comprehensive analysis of the VBX stent graft as a BSG adds to the evidence of the performance of this stent graft as a BSG.