Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein(®) device: one-year results of a prospective series.

Boersma, D; van Eekeren, R R J P; Werson, D A B; van der Waal, R I F; Reijnen, M M J P; de Vries, J-P P M · Eur J Vasc Endovasc Surg · 2013

prospective_cohort · Level II

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Abstract

This study evaluated the feasibility, safety and 1-year results of mechanochemical endovenous ablation (MOCA™) of small saphenous vein (SSV) insufficiency. Prospective cohort study. Fifty consecutive patients were treated for primary SSV insufficiency with MOCA™ using the ClariVein(®) device and polidocanol. Initial technical success, complications, patient satisfaction and visual analogue scale (VAS) pain score were assessed. Anatomic and clinical success was assessed at 6 weeks and at 1 year. Initial technical success of MOCA™ was 100%. At the 6-week assessment, all treated veins were occluded. The 1-year follow-up duplex showed anatomic success in 94% (95% confidence interval, 0.87-1). Venous clinical severity score (VCSS) decreased significantly from 3.0 (interquartile range (IQR) 2-5) before treatment to 1.0 (IQR 1-3, P < 0.001) at 6 weeks and to 1.0 (IQR 1-2, P < 0.001) at 1 year. Median procedural VAS score for pain was 2 (IQR 2-4). No major complications were observed, especially no nerve injury. MOCA™ is a safe, feasible and efficacious technique for treatment of SSV insufficiency. One-year follow-up shows a 94% anatomic success rate and no major complications.

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