A 1-year follow-up analysis of a post-market surveillance study of a self-expanding endoprosthesis for stenosis or occlusion at the arteriovenous access

Purpose: To assess 1-year safety and efficacy of the Gore ® Viabahn ® Endoprosthesis self-expanding (SX) stent graft when used to treat stenosis or thrombosis at the venous anastomosis of synthetic arteriovenous access graft (AVG). Material and methods: This prospective, multicenter, post-market surveillance study evaluated the SX stent graft when used to treat stenotic or thrombosed vascular access circuits at the venous anastomosis of synthetic AVGs. Safety outcomes of adverse and serious adverse events were assessed. Efficacy outcomes of Kaplan-Meier (KM) estimates of primary patency and secondary patency of both the target lesion and the vascular access circuit, were evaluated through 1 year. Results: In 103 patients, the stent graft was implanted with placement at the venous anastomosis of stenotic and thrombosed AVGs; 28 patients (27.2%) had elephant trunk placements. In 12 (11.7%) patients, devices were placed across the elbow. Through 1-year, KM estimates of primary patency for the target lesion were 52.7% (95% CI: 41.9, 62.3) and for the vascular access circuit 35.9% (95% CI: 26.2, 45.7). Secondary patency for both the target lesion and the vascular access circuit was 91.5% (95% CI: 83.8, 95.7). Mean cumulative number of reinterventions at 12 months was 0.69 (95% CI: 0.48, 0.90). The rate of device-related adverse events was 36.2%. There were two procedure-related events, and no device defects reported. Conclusions: This 1-year surveillance study of stent grafting at the venous anastomosis with the GORE ® VIABAHN ® SX stent graft, for treatment of stenotic or thrombosed synthetic AVGs, demonstrated acceptable safety outcomes.