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

Abstract

ObjectiveThe 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).MethodPatients 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).ResultsThirty 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%.ConclusionMechanochemical 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.

Chronic Venous Insufficiency

“…In a small trial of 29 patients with GSV insufficiency, the primary occlusion rate at 6 months was 96.7%, with no adverse events reported. 108 Further studies with long-term follow-up in a variety of CEAP clinical classes are necessary to assess the equivalency of these tumescentless methods compared with other ablative methods.…”

Varicose Veins of Lower Extremities, Hemodynamics and Treatment Methods.

“…The number of studies assessing this method is small. In one of them, the effectiveness was estimated at 97% of all great saphenous vein occlusions within 6 months [34].…”

What is popular may no longer be popular: Cyanoacrylate and other alternatives in surgical treatment of chronic venous insufficiency

“…The main strategy is to cause mechanical damage in the endothelium and also increase shear stress. [7] It does not require TA. The main drawback is the possibility of the wire to get stuck on vein wall or even cause perforation which is not very hardly resolved by pulling back the catheter, but may cause substantial postoperative pain and discomfort.…”

“…[4] Those two methods defined as endovenous thermal ablation (EVTA) have become the treatment of choice as first line therapy recommended by American Venous Forum and United Kingdom recommendations. [5,6] However, a search for a better technique has continued with mechanicochemical ablation (MOCA) first reported by Elias and Raines in 2012 [7] and finally cyanoacrylate ablation (CAA) by Almeida in 2013. [8] What is the current state of surgical treatment strategies and why do we need alternatives?…”