Final 3-year study outcomes from the evaluation of the Zilver Vena Venous Stent for the treatment of symptomatic iliofemoral venous outflow obstruction (VIVO clinical study).

Abstract

PURPOSE: To report 3-year outcomes from a prospective, multicenter, non-randomized, single-arm study designed to assess the safety and effectiveness of the BLIND TEXT for the treatment of symptomatic iliofemoral venous outflow obstruction.MATERIALS AND METHODS: The BLIND study included patients with symptomatic obstruction of one iliofemoral venous segment (i.e., one limb), characterized by a CEAP clinical classification of = 3 or a VCSS pain score = 2. Patients were retrospectively grouped, based on baseline clinical presentation, as: post-thrombotic (PTS), non-thrombotic (NIVL), or acute DVT (aDVT). Clinical improvement was assessed by change in VCSS, VDS, CIVIQ-20 scores, and CEAP "C" classification. Stent performance was evaluated by rates of patency by ultrasound, freedom from clinically driven reintervention, and freedom from stent fracture.RESULTS: The 3-year results for the 243 patients in the BLIND cohort included a 90.3% rate of patency by ultrasound and a 92.6% rate of freedom from clinically driven reintervention. The 3-year rate of patency by ultrasound for the NIVL, aDVT, and PTS groups were 100%, 84.0%, and 86.1%, respectively. Sustained clinical improvement through 3 years was demonstrated by changes in VCSS, VDS, CIVIQ-20, and CEAP "C" classification. No stent fractures were observed.CONCLUSION: The BLIND study demonstrated sustained high rates of patency and freedom from clinically driven reintervention and improvements in venous clinical symptoms through 3 years. Each patient group (NIVL, aDVT, PTS) showed clinical improvement and sustained patency through 3 years; some variation existed among groups (e.g., only the NIVL group had a 100% patency rate).

View details for DOI 10.1016/j.jvir.2024.02.025

View details for PubMedID 38484910