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

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.