Braided nitinol stent for chronic iliofemoral venous disease – the real-world BLUEFLOW registry

Abstract

Summary: Background: In patients with iliofemoral chronic venous disease (CVD) secondary to post-thrombotic or non-thrombotic obstruction, venous outflow obstruction after adequate anticoagulation alone is still frequent and post-thrombotic syndrome is a common complication. Thus, we aimed to evaluate mid-term effectiveness and safety of a novel braided venous stent for venous outflow obstruction treatment. Patients and methods: Consecutive patients who underwent venous recanalization with a new braided, closed cell, venous stent for non- or post-thrombotic CVD were eligible for inclusion in our retrospective, observational study. Effectiveness outcomes were primary patency and change in the revised venous clinical severity score (rVCSS) and the clinical score of the comprehensive classification system for chronic venous disease (CEAP) at 6- and 12-month follow-up. Safety outcomes were recurrent DVT, clinically driven target vein revascularization, index limb major amputation, or death. Results: A total of 67 participants (50.7% female, aged 46.7±18.1 years) who underwent blueflow Venous Stent implantation between February 2018 and March 2019 were enrolled. Primary patency of the target segment was present in 91.7% (95%CI: 76.8–97.7) of participants at the 6-month examination and in 79.8% (95%CI: 66.4–93.2) at the 12-month examination. Twelve-month primary patency was 91.7% (95%CI: 76.0–100) in non-thrombotic, and 72.6% (95%CI: 53.9–91.3) in postthrombotic disease (log-rank p=0.14). Median rVCSS improved from 8 (interquartile range [IQR]: 9–7) at baseline to 4 (IQR: 6.3–2.8) at 12 months (p<0.001) with a substantial clinical improvement of ≥2 points in 86.1% (31 of 36 participants). No significant association of rVCSS improvement with thrombotic pathogenesis could be found. Median clinical CEAP score improved from 3 (IQR: 3–3) to 2 (IQR: 3–2), p>0.001. No safety signal occurred. Conclusions: blueflow Venous Stent implantation for the treatment of iliofemoral CVD was associated with promising patency and favorable clinical improvement over the mid-term.