Abstract

INTRODUCTION: To evaluate the safety and effectiveness of the Zilver Vena Venous Stent in the treatment of patients with symptomatic iliofemoral outflow obstruction.METHODS: The VIVO clinical study was a prospective, nonrandomized, multicenter study, that enrolled patients with symptomatic obstruction of one iliofemoral venous segment. Included were patients with Clinical, Etiological, Anatomic, Pathophysiology (CEAP) clinical classification of =3 or a Venous Clinical Severity Score (VCSS) pain score =2. All patients received a self-expanding venous stent (Zilver Vena Venous Stent, Cook Ireland, Ltd.). The primary safety endpoint was 30-day freedom from major adverse events (MAE). The primary effectiveness endpoint was 12-month rate of primary quantitative patency by venography as determined by the core laboratory. The secondary endpoint was the change in VCSS from baseline to 1 month and 12 months. Additional measures included freedom from clinically-driven reinterventions, change in CEAP "C" classification, Venous Disability Score (VDS), and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores from baseline to 12 months, and stent durability measures.RESULTS: Between December 2013 and October 2016, 243 patients (70% female; mean age of 53 ± 15 years; 67.5% with current or past DVT) were enrolled at 30 institutions. Iliac vein compression by the iliac artery (n=191; 78.6%) was the primary indication for stent placement. The mean lesion length was 98.6±69.8 mm. The 30-day freedom from MAE rate was 96.7%, greater than the literature-defined performance goal (PG) of 87% (95% CI: 93.5%-98.6%, p<0.0001). The 12-month primary quantitative patency rate was 89.9%, greater than the literature-defined PG of 76% (95% CI: 85.1%-93.4%, p<0.0001). The change in VCSS from baseline was -3.0 (95% CI: -3.5 to -2.6, p<0.0001) at 1 month and -4.2 (95% CI: -4.7 to -3.7, p<0.0001) at 12 months, demonstrating clinical improvement. Similarly, significantly (p<0.0001) fewer symptoms over time (from pre-procedure through 12 months) were measured by the clinical scores of VDS, CEAP "C" classification, and CIVIQ. The 12-month rate of freedom from clinically-driven reintervention was 95.8% ± 1.3%. Through 12 months, there were no stent fractures and one clinical migration (Clinical Events Committee adjudicated as technique-related due to device undersizing at placement).CONCLUSION: Twelve-month results of the VIVO study demonstrate the safety and effectiveness of the Zilver Vena Venous Stent for the treatment of symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared to baseline.

View details for DOI 10.1016/j.jvsv.2022.12.066

View details for PubMedID 36646383