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

Purpose: To evaluate longer term outcomes of the Zilver Vena Venous Stent in patients undergoing venous stenting.

Materials and methods: Patients 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.

Results: A 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.

Conclusion: Real-world use showed high patency rates and improved venous clinical outcome measures (VCSS, Villalta, and CEAP) after venous stent placement.