Safety and Performance of a Cell-Impermeable Endoprosthesis for Hemodialysis Vascular Access Outflow Stenosis: A Brazilian Multicenter Retrospective Study.

Abstract

To evaluate the safety and performance of Wrapsody™, a cell-impermeable endoprosthesis (CIE), for treating hemodialysis vascular access outflow stenosis. Investigators retrospectively analyzed 113 hemodialysis patients treated with a CIE (11/2021-12/2022) across four centers in Brazil. Denovo or restenotic lesions were treated. The primary efficacy outcome measure was target lesion primary patency (TLPP) at 1, 3, 6, and 12months; the primary safety outcome measure was the absence of serious local or systemic adverse events within the first 30days post-procedure. Secondary outcome measures included technical and procedural success, access circuit primary patency (ACPP), and secondary patency at 1, 3, 6, and 12months post-procedure. Thirty-nine patients (34.5%) had thrombosed access at the initial presentation, and 38 patients (33.6%) presented with recurrent stenosis. TLPP rates at 1, 3, 6, and 12months were 100%, 96.4%, 86.4%, and 69.7%, respectively. ACPP rates were 100% at 1month, 89.2% at 3months, 70.9% at 6months, and 56.0% at 12months. The target lesion secondary patency rates at 1, 3, 6, and 12months were 100%, 97.3%, 93.6%, and 91.7%, respectively. In the adjusted multivariate Cox regression analysis, male sex and endoprosthesis with diameters of 10, 12, 14, and 16mm were associated with improved primary patency rates. No localized or systemic serious adverse event was observed through the first 30days post-procedure. The CIE evaluated in this study is safe and effective for treating peripheral and central outflow stenoses in hemodialysis vascular access. Level 2b, cohort study.