Initial Phase III clinical studies with polidocanol endovenous microfoam (PEM) have demonstrated safety and efficacy in the treatment of superficial venous reflux. In those studies, the primary outcome requirement was to assess improvement in symptoms related to superficial venous disease. The goal of this study was to evaluate the efficacy of PEM technology in routine clinical practice, specifically closure rates following treatment.
This was an observational study during which data were prospectively collected from two vein centers using an electronic database. Patients with CEAP Class 2 or higher and symptomatic superficial axial reflux (great saphenous vein, anterior accessory saphenous vein and small saphenous vein) were included and followed prospectively. PEM was used to treat the saphenous vein and the varicosities. CEAP classification was used to classify chronic venous disease, and the venous clinical severity score (VCSS) was applied to measure the severity of disease. Pain and discomfort were assessed with a visual analogue scale and residual veins by physical examination.
PEM was used to treat superficial reflux in 60 patients. CEAP distribution was C2 in 32 patients, C3 in 14, C4 in 10 and C5 in 4 patients. The average pre-treatment VCSS was 7.3. Saphenous vein diameter was 6.5 mm and the average length was 31 cm. The average volume of PEM used to treat the saphenous veins was 9.3 cc. Closure rate at 3 months was 93% (54/58) and 93% (51/55) at 6 months. VCSS improved from 7.3 to 1.4. Complications included one deep vein thrombosis (1.7%), 5 patients (8.3%) with thrombophlebitis and 4 patients (6.6%) with skin pigmentation.
PEM is safe and effective for the treatment of saphenous reflux and varicosities. Early closure rates using PEM are maintained at 6 months and are comparable to results reported with non-thermal non-tumescent and thermal tumescent technologies.
Copyright © 2020. Published by Elsevier Inc.