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 post-thrombotic syndrome (PTS) (mean age: 52.5±20.2; female: 87.5%) with the Blueflow Venous Stent (plusmedica GmbH & Co. KG, Düsseldorf, Germany) 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 postoperative 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.