Endovascular treatment of iliofemoral vein obstruction below the inguinal ligament using a new-dedicated stent: early experience from a single center.

BACKGROUND The aim of this study was to assess our experience with a new commercially available venous stent as an extension below the inguinal ligament in patients with iliofemoral venous outflow obstruction involving the common femoral vein. METHODS We treated 16 patients with iliofemoral venous outflow occlusion and postthrombotic syndrome (PTS) (mean age: 52.5±20.2; female: 87.5%) with the Blueflow Venous Stent between 2019 and 2020. All patients had unilateral venous disease with > 50% stenosis in the iliofemoral veins. The primary endpoints assessed were technical success, primary and secondary patency rate at 1 year of follow-up, respectively. Clinical improvement was assessed with the Villalta scale, revised venous clinical severity score (rVCSS) classification and visual analog-scale (VAS) respectively. RESULTS The technical success rate was 100%. No intraoperative and 30-days post-operative complications were documented. The primary and secondary patency rates were 80.2% and 100% respectively, at 1 year of follow-up. One in-stent occlusion and two in-stent restenosis were detected during follow-up. Stent fracture and/or migration were not observed during follow-up. A significant improvement in the Villalta scale and rVCSS score was documented with a median score of 3 (IQR: 2-6) and 2.5 (IQR: 1-5) versus baseline at the last follow-up. A pain reduction of 18 mm on the VAS scale was documented at 1-year follow-up. CONCLUSIONS In this cohort of patients, the Blueflow Venous Stent across the inguinal ligament was safe and effective for the treatment of symptomatic iliofemoral venous disease, with a high primary patency rate at 1-year of follow-up. However, longer follow-up and larger cohorts are still needed.