Real-world outcomes of Zilver Vena® Venous Self Expanding Stent placement for thrombotic and non-thrombotic indications in Spain.

Abstract

PurposeTo evaluate longer term outcomes of the Zilver Vena Venous Stent in patients undergoing venous stenting.Materials and MethodsPatients with iliofemoral obstructive venous disease and treated with venous stents were retrospectively enrolled in a physician-led real-world data collection effort. Results were analyzed by etiologies: post-thrombotic syndrome (PTS), non-thrombotic iliac vein lesion (NIVL), and iliocaval acute deep vein thrombosis (aDVT). Patency outcomes (primary, assisted-primary, secondary), reinterventions (in-stent and all), adverse events, and venous clinical outcome measures (VCSS, CEAP, Villalta Score) were reported using Kaplan-Meier estimates and summary statistics.ResultsA total of 219 patients (89.5% women, mean age 45.3 ± 11.9 years) were identified: 56 PTS, 153 NIVL, and 10 aDVT patients. Devices were placed across the inguinal ligament in 80.4%, 0%, and 70.0% of patients in the PTS, NIVL, and aDVT groups, respectively. Through 1-year, Kaplan-Meier estimated primary patency rate was 96.4% for PTS, 99.3% for NIVL, and 100% for aDVT patients, respectively, and followed the same trend through 3 years. Freedom from (FF) all and within stent reinterventions estimated by Kaplan-Meier was 87.9% and 90.1% for PTS, 98.2% and 98.2% for NIVL through 3 years. No reinterventions were reported for the aDVT group. Improved venous clinical outcome measures were seen in all groups at the last follow-up visit. Stent fractures occurred in 2 PTS patients without related reintervention or clinical sequelae. No stent migrations were reported.ConclusionReal-world use showed high patency rates and improved venous clinical outcome measures (VCSS, Villalta, and CEAP) after venous stent placement.