Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial

Abstract

Objective The purpose of this study was to assess the safety and efficacy of the ClariVein® system that employs mechanochemical ablation of the great saphenous vein (GSV). Method Patients eligible for ablation of the GSV underwent micropuncture access with only local anaesthesia to insert a 4 or 5 Fr sheath. The ClariVein® catheter was placed through the sheath, the wire was extruded, and the distal tip of the wire positioned 2 cm from the saphenofemoral junction under ultrasound guidance. Catheter wire rotation was then activated for 2–3 seconds at approximately 3500 rpm. With the wire rotating, infusion of the sclerosant was started simultaneously with catheter pullback. The sclerosant used was 1.5% liquid sodium tetradecyl sulphate (Sotradecol©, Bioniche Pharma Group, Geneva, Switzerland). Results Thirty GSVs in 29 patients were treated. All patients have reached six-month follow-up; the average number of postoperative days is 260. No adverse events have been reported. The Primary Closure Rate is 96.7%. Conclusion Mechanochemical ablation appears to be safe and efficacious. The ClariVein® technique eliminates the need for tumescent anaesthesia. The great majority of incompetent GSVs can be treated with this technique.