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)

Anthony J Comerota; Paul Gagne; Jennifer A Brown; Edem Segbefia; Lawrence V Hofmann; VIVO Clinical Study Investigators

doi:10.1016/j.jvir.2024.02.025

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)

J Vasc Interv Radiol. 2024 Mar 12:S1051-0443(24)00209-4. doi: 10.1016/j.jvir.2024.02.025. Online ahead of print.

Authors

Anthony J Comerota¹, Paul Gagne², Jennifer A Brown³, Edem Segbefia³, Lawrence V Hofmann⁴; VIVO Clinical Study Investigators

Affiliations

¹ Heart and Vascular Institute, Inova Hospital, Alexandria, Virginia. Electronic address: anthonyjcomerota@gmail.com.
² Vascular Surgery, Vascular Care Connecticut, Darien, Connecticut.
³ Cook Research, West Lafayette, Indiana.
⁴ Interventional Radiology, Stanford Health Care, Stanford, California.

PMID: 38484910
DOI: 10.1016/j.jvir.2024.02.025

Abstract

Purpose: To report 3-year outcomes from a prospective, multicenter, nonrandomized, single-arm study designed to assess the safety and effectiveness of the Zilver Vena Venous Stent for the treatment of symptomatic iliofemoral venous outflow obstruction.

Materials and methods: The VIVO study included patients with symptomatic obstruction of 1 iliofemoral venous segment (ie, 1 limb), characterized by a Clinical, Etiological, Anatomic, Pathophysiology (CEAP) clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) for pain of ≥2. Patients were retrospectively grouped based on baseline clinical presentation as postthrombotic syndrome (PTS), nonthrombotic iliac vein (NIVL) obstruction, or acute deep vein thrombosis (aDVT). Clinical improvement was assessed by change in VCSS, Venous Disability Score, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) scores, and CEAP C classification. Stent performance was evaluated by rates of patency by ultrasound (US), freedom from clinically driven reintervention, and freedom from stent fracture.

Results: The 3-year results for the 243 patients in the VIVO cohort included a 90.3% rate of patency by US and a 92.6% rate of freedom from clinically driven reintervention. The 3-year rates of patency by US 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, Venous Disability Score, CIVIQ-20, and CEAP C classification. No stent fractures were observed.

Conclusions: The VIVO 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, and PTS) showed clinical improvement and sustained patency through 3 years; some variation existed among groups (eg, only the NIVL group had a 100% patency rate).