Treatment with a self-expanding endoprosthesis in patients with stenosis or occlusion at the arteriovenous graft: 6-Month outcomes of a post-marketing surveillance study.

Purpose: To assess 6-month safety and efficacy of a self-expanding stent graft placement to treat stenotic or thrombosed synthetic arteriovenous access graft at the venous anastomoses.

Material And Methods: This prospective, multicenter, post-market surveillance study assessed the GORE VIABAHN Endoprosthesis (stent graft) in Japanese patients with stenotic or thrombosed vascular access grafts. Key efficacy and safety outcomes were primary patency (PP) and secondary patency (SP) of the target lesion and the vascular access circuit, repeat interventions, technical and clinical success, incidence of adverse and serious adverse events, and device deficiencies through 6 months.

Results: The 103 enrolled patients (mean age 71.8 years; 57.3% female) had stent grafts placed in the venous anastomosis of arteriovenous access grafts (on-label). The majority of lesions were stenotic (77.1%) and located in the upper arm (91.4%). Mean lesion length was 42.9 ± 23.6 mm and diameter was 6.7 ± 1.9 mm; 28 patients (27.2%) had elephant trunk placements. Technical and clinical success rates were 100%. At 6 months, Kaplan-Meier estimates of target lesion and circuit PP were 75.1% (95% CI: 65.2, 82.6) and 66.8% (95% CI: 56.4, 75.3), and SP rates were 93.8% (95% CI: 86.7, 97.2) and 93.8% (95% CI: 86.7, 97.2), respectively. Mean cumulative number of reinterventions (0.36; 95% CI: 0.20, 0.51) and incidence of device- or procedure-related adverse events were low (⩽3%). No device deficiencies were reported.

Conclusions: The 6-month outcomes of the self-expanding stent graft to treat thrombosed venous anastomoses of synthetic hemodialysis vascular access grafts with stenosis demonstrated safety and effectiveness.