Powered Phlebectomy (TriVexTM) in Treatment of Varicose Veins

Abstract

This study assesses the operation of transilluminated powered phlebectomy for removal of varicose veins. It was a prospective, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of the powered varicose vein extractor for ablation of primary varicose veins. A total of 114 patients (117 limbs) were recruited from four centers in Europe and four centers in the United States. Safety of the varicose vein extractor was evaluated by recording nature and severity of all adverse events and complications. Efficacy was assessed by the patient, an independent study nurse, and the surgeon. Operations were performed under general, spinal, or epidural anesthesia and tumescent anesthesia was added with infusions of dilute lidocaine with epinephrine. Transillumination was achieved with a specially designed cannula, and the vein extraction was done using a vein resector with a rotating tubular inner cannula encased in a stationary outer sheath dissector. Demographic information regarding the 28 men and 89 women included in the study are detailed. Eighty-four percent of the limbs were CEAP class 2 with only 16% being in classes 3 and 4. Accompanying greater saphenous vein stripping was done in 67% of the limbs in the United States and 88% in those in Europe. Proximal ligation only was used in one limb in the United States and eight in Europe. The study showed that transilluminated powered phlebectomy used in varicose vein removal is swift and efficacious with a conservation of operating time and the results being satisfactory to the patient and clinician alike.