Safety and efficacy of a new covered stent in hemodialysis vascular access outflow stenosis: a brazilian multicenter retrospective study

Abstract

Objective: Vascular stenosis commonly leads to dysfunction in hemodialysis vascular access. Although percutaneous transluminal angioplasty is an established treatment, stent utilization has increased in the last decade as an alternative solution to extend the access function. This study evaluated the safety and initial results of a new impermeable covered stent for treating vascular access outflow stenosis.

Methods: Investigators retrospectively analyzed 114 hemodialysis patients treated with polytetrafluorethylene-covered stents from September 2018 to September 2022 across four centers. Lesions treated were de novo or restenotic and located in the venous graft anastomosis, outflow segment, cephalic arch, and basilic swing point. Patients were followed by in-person physical examination at 1, 3, and 6months, and Duplex ultrasound was performed to evaluate the vascular access circuit and in-stent restenosis. The primary efficacy endpoint was target lesion primary patency at 1, 3, and 6months. Secondary endpoints included access circuit primary patency and secondary patency at 1, 3, and 6months. The primary safety endpoint was freedom from local or systemic serious adverse events through 30days post-procedure.

Results: Forty-four patients had thrombosed access at the initial presentation, and 41 patients presented with recurrent stenosis. The target lesion primary patency rates at 1, 3, and 6months were 100%, 89.4%, and 74%, respectively. The access circuit primary patency rates were 100% at 1month, 85% at 3months, and 62.7% at 6months. The secondary patency rates at 1, 3, and 6months were 100%, 96.4%, and 94.6%, respectively. In the adjusted multivariate Cox regression analysis, only recurrent lesions and female gender were associated with reduced primary patency rates. No serious adverse event was observed through the first 30days post-procedure.

Conclusion: In this retrospective analysis, a new covered stent was shown to be safe and effective for treating peripheral outflow stenosis in vascular access.