One Year Outcomes of the VIVO-EU Study of Treatment of Symptomatic Iliofemoral Outflow Obstruction with the Zilver Vena Venous Self-Expanding Stent

OBJECTIVE To evaluate the performance of the Zilver® Vena™ Venous Stent in the treatment of patients with symptomatic iliofemoral outflow obstruction. METHODS Between August 2012 and January 2015, 35 patients (mean age of 45.1 ± 15.5 years; 77.1% female) with symptomatic iliofemoral venous outflow obstruction were treated with the Zilver Vena Venous Stent (Cook Ireland, Ltd.) as part of this prospective, single arm, multicenter study. Study assessments included procedural success, major adverse events (MAEs), freedom from occlusion and qualitative patency at 6 and 12 month post-procedure, clinical symptoms of venous insufficiency, and reintervention with the treated venous segment. RESULTS The rate of freedom from occlusion at 6 month and 12 month was 88.2%. The rate of qualitative patency was 88.2% at 6 month and 85.2% at 12 month. Three MAEs were reported: one symptomatic pulmonary embolism and two clinically-driven reinterventions. Following stenting, clinical symptoms of venous insufficiency improved significantly from baseline at each follow-up, as measured by VDS (p < 0.0001), CEAP C (p ≤ 0.0001), VCSS (p < 0.0001), and CIVIQ (p < 0.0001). CONCLUSION Clinical results with the Zilver Vena Venous Stent were favorable through 12 month, with high patency rates, reduction of venous insufficiency symptoms, and low morbidity.