Comment to: Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial by Elias S, Raines JK. Phlebology 2012;27:67-72.

Abstract

A new mechanochemical device, (ClariVein_w, Madison, CT, USA), that does not require a generator or the use of tumescent anesthesia, was developed to achieve venous occlusion utilizing a wire rotating within the lumen of the vein at 3500 rpm that abrades the intima to allow for improve the efficacy of the sclerosant. A liquid sclerosant (sodium tetradecyl sulphate) is concomitantly infused through an opening close to the distal end of the catheter near the rotating wire. The wire tip is positioned 2 cm from the saphenofemoral junction under ultrasound guidance. With the wire rotating and during sclerosant infusion, the catheter is pulled down the vein at a rate of approximately 1–2 mm per second. Catheter wire rotation is first activated for 2–3 s at the highest speed setting to create venospasm which minimizes forward flow into the common femoral vein. This is a single-use device that can be inserted through a 4 or 5 French guiding catheter with local insertion site anesthesia only, without the need for tumescence anesthesia. The system includes an infusion catheter, motor drive, stopcock and syringe.
Our series included 30 veins in 29 patients: 77% were in Class 2 (varicose veins), 7% in Class 3 (varicose veins and edema), and 16% in Class 4a (varicose veins with skin changes). The sclerosant used was 1.5% liquid sodium tetradecyl sulphate (Sotradecol®). For this study, all treated veins received 12 cc of 1.5% sclerosant. The average diameter of the treated GSV was 8.1 mm (range 5.5-13 mm). Average treatment length was 37.5 cm (range 24-47 cm). Average total procedure time was 14 min. No other concomitant procedures were performed. A compression bandage was applied to the treated limb from the foot to the groin remaining in place for 24 h. The patients then applied a 15-20 mmHg thigh-high compression stocking continuously for the next 48 h, except whilst showering. During the procedure, no patient complained of pain. Three minor thigh ecchymoses were observed at levels where the rotating wire may have caught on a valve cusp or vein wall. Average follow up is 260 days with only one vein recanalized, corresponding to a primary closure rate of 96.7%. No adverse events of any grade were recorded. In conclusion, mechanochemical ablation utilizing the ClariVein® device has a good safety profile and appears to have good efficacy. These two modalities, mechanical and chemical, achieve venous occlusion results equal to those from endothermal methods.