Patency and Clinical Outcomes of a Dedicated, Self-Expanding, Hybrid Oblique Stent Used in the Treatment of Common Iliac Vein Compression.

ABSTRACT

PURPOSE: To investigate the clinical outcomes of a dedicated hybrid oblique nitinol stent that has been specifically designed to treat common iliac vein compression. METHODS: The Bern Venous Stent Registry database was interrogated to identify all patients who had at least 6-month follow-up after treatment with the sinus-Obliquus hybrid stent for common iliac vein compression. The search identified 24 patients (mean age 39±18 years; 20 women) who matched the search criteria. Ten patients had postthrombotic syndrome (PTS), another 10 patients had acute iliofemoral thrombosis after catheter-directed therapy, and 4 patients had nonthrombotic iliac vein compression. Primary treatment success was defined as antegrade flow and stenosis <30% on venography and evidence of a spontaneous Doppler signal in the treated segment. Stent patency was assessed using duplex ultrasound. Clinical outcomes were evaluated using a clinical symptom score (Villalta) and the revised venous clinical severity score (rVCSS) at 3, 6, and 12 months in follow-up. RESULTS: Primary treatment success was achieved in all patients. Mean follow-up was 10±3 months. Primary patency estimates by Kaplan-Meier analysis were 92% at 6 months [95% confidence interval (CI) 71% to 98%] and 83% (95% CI 54% to 95%) at 10 months. Three symptomatic patients underwent reintervention for early and late stent thromboses and the third for in-stent restenosis, resulting in secondary patency of 100%. Overall, all patients had clinical improvement at the latest follow-up; 50% reported complete resolution of symptoms. In patients with PTS, the Villalta score decreased by 6±6 points (p=0.02) and the rVCSS score by 3±1 points (p=0.05). Among deep vein thrombosis patients, none developed PTS. CONCLUSION: In patients with common iliac vein compression, the oblique hybrid nitinol stent appears to provide excellent early patency and clinical outcomes.