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

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.