Currently most forms of endothermal ablation of the great (GSV) and small saphenous veins (SSV) require instillation of tumescent anesthesia and an exogenous energy source (radiofrequency or laser). These two requirements involve: some patient discomfort, additional procedure time, an operator learning curve and increased cost. A new endovenous device, ClariVein was evaluated that does not require tumescent anesthesia or an exogenous energy source (generator).

The ClariVein catheter combines two modalities: endovenous mechanical vein destruction with a rotating wire and the simultaneous infusion of a FDA approved liquid sclerosant, sodium tetradecyl sulfate to enhance venous occlusion. This mechanical-chemical ablative modality is unique. An IRB sanctioned study was conducted to evaluate the safety and efficacy of this technique.

Thirty patients with GSV incompetence were treated. CEAP class was C2(24), C3(2) and C4(4). All procedures were performed in office with local anesthesia at the access site only. No tumescent anesthesia or oral sedation was used. Ultrasound guided access and post procedure evaluation was similar to existing endothermal techniques. Post procedure, patients resumed normal activity. No concomitant treatments (phlebectomy, sclerotherapy, PAPS) were performed. Post treatment compression was utilized for 14-days. Patients were studied one week, one month, three months and six months post treatment.

Total procedure time averaged 14 minutes with catheter ablative treatment time of 5 minutes. GSV size 2cm from SFJ was 8.1mm (5.5-12mm) with an average treatment length of 36cm.

At one month and three months, 29 of 30 patients are occluded. Ten patients have been followed for six months, nine of 10 occluded. Full study six-month results for the remaining 20 patients will be complete by December 2009. The only GSV patent is the first subject of the trial, all others are successfully ablated.

Complications consisted of thigh ecchymoses (3). No DVT, nerve, skin or deep vessel injury occurred. All patients resumed full activity the day of the procedure.

The endomechanical ablative aspect of ClariVein coupled with an approved liquid sclerosant accomplishes GSV occlusion without tumescent anesthesia. The elimination of this step in endovenous ablation represents a further simplification for patient and physician. Pain, discomfort and bruising are minimal.

Short-term occlusion rates are comparable to existing endothermal methods. Symptom improvement also parallels these methods. Longer follow up will continue to evaluate the durability of this technique.

Theoretical advantages include: the treatment of GSV from ankle to groin and SSV without concern for endothermal nerve, skin, or vessel injury. The ClariVein catheter appears to be a viable treatment option for most incompetent great saphenous veins.

Steve Elias, MD FACS FACPh, is associate professor of surgery at Mount Sinai Hospital in New York and the director of The Centers for Vein Disease at Mount Sinai and Englewood Hospitals. He is the principal investigator of the trial, which was conducted at Englewood Hospital and Medical Center in New Jersey.