Newly Designed, Self-Expanding Large-Bore Nitinol Stents for Symptomatic Central Venous Stenosis: Technical and Long-Term Clinical Outcome.

Abstract

Purpose: To retrospectively analyze the technical and long-term clinical outcome of angioplasty and stenting using the Venovo™ venous stent for the treatment of malignant and benign superior vena cava (SVC) occlusive disease.

Materials and methods: Consecutive patients treated with the Venovo™ venous stent for SVC occlusive disease were included. SVC obstruction symptoms were classified according to the Kishi score. The Wilcoxon signed-rank test was used for testing significance of changes. Technical success, defined as correct placement of the stent, completely covering and re-expanding the obstruction, between groups was tested using the Fisher exact test. Overall survival was calculated using the Kaplan-Meier method.

Results: Fifty-five patients underwent stent insertion for symptomatic benign (n = 13; 24%) or malignant (n = 42; 76%) SVC occlusive disease. A significant drop in Kishi score, mean 3.91 before versus mean 1.02 after the procedure (P < 0.0001), was observed. In one patient (1.8%), an additional balloon-expandable stent was needed to manage incomplete expansion of the nitinol stent. In one patient, a procedure-related lung embolic complication was noted. Early thrombotic occlusion of the stent occurred in one patient. Late symptomatic restenosis occurred in 3 patients. Overall primary stent patency and primary-assisted stent patency were 86% (95% CI 66-95) and 97% (95% CI 83-100) at 1-year follow-up and 98% (95% CI 87-100), 98% (87-100) at 2-year follow-up, respectively.

Conclusion: In this retrospective analysis, angioplasty and stent placement using the Venovo™ venous stent is safe and clinically effective for the treatment of both benign and malignant SVC occlusive disease. Reintervention for symptomatic restenosis is rare.