Cook Medical’s Zilver Vena Stent for Treating Symptomatic Iliofemoral Venous Outflow Obstruction Supported by 3-Year VIVO Outcomes

October 5, 2021—The continued safety and effectiveness of the Zilver Vena venous stent (Cook Medical) in the treatment of symptomatic iliofemoral venous outflow obstruction were supported by the 3-year results of the VIVO clinical study. Paul Gagne, MD, presented the findings during a late-breaking clinical trials session at the VIVA 2021, the annual Vascular InterVentional Advances meeting held October 4-7 in Las Vegas, Nevada.

According to the VIVA press release, the VIVO study was composed of patients with symptomatic obstruction of one iliofemoral venous segment, (ie, clinical, etiology, anatomy, pathophysiology [CEAP] clinical classification ≥ 3 or Venous Clinical Severity Score [VCSS] pain score ≥ 2).

Follow-up through 3 years included measures of patency, reintervention, clinical outcomes (measured by VCSS, vascular duplex scan [VDS], CEAP “C”, and Chronic Venous Insufficiency Questionnaire [CIVIQ]), and device integrity measures of fracture and migration.

The investigators enrolled 243 patients (70% women; mean age, 53 ± 15 years; 67.5% with current or past deep vein thrombosis).

As summarized in the VIVA press release, the investigators reported the following:

• The 30-day primary safety endpoint and 12-month primary effectiveness endpoint were met, exceeding the corresponding performance goals (P < .0001), and improvement in clinical outcome measures was demonstrated at 12 months (P < .0001).
• The investigators advised that follow-up through 3 years is complete, and results observed at 12 months were maintained.
• Specifically, 3-year outcomes include high rates of patency by ultrasound (90.3% ± 2.2%), freedom from clinically driven reinterventions (92.6% ± 2.0%), and freedom from reinterventions (82.9% ± 2.6%).
• Clinical improvement, as measured by VCSS, VDS, CEAP “C”, and CIVIQ, was sustained through 3 years (P < .0001).

Importantly, there were no core laboratory–reported stent fractures, and only one core laboratory–reported migration (adjudicated as technique-related caused by device undersizing) through 3 years, as noted in the VIVA announcement.