Results of polidocanol endovenous microfoam in clinical practice

Background: Initial phase III clinical studies with polidocanol endovenous microfoam (PEM) demonstrated its safety and efficacy in the treatment of superficial venous reflux. In those studies, the primary outcome requirement was to assess the improvement in symptoms related to superficial venous disease. The goal of the present study was to evaluate the efficacy of PEM technology in routine clinical practice—specifically, the closure rates after treatment. Methods: We performed an observational study during which data were prospectively collected from 2 vein centers using an electronic database. Patients with CEAP (clinical, etiologic, anatomic, pathophysiologic) class ≥2 and symptomatic superficial axial reflux (great saphenous vein, anterior accessory saphenous vein, and small saphenous vein) were included and followed up prospectively. PEM was used to treat the saphenous vein and varicosities. The CEAP classification was used to classify chronic venous disease, and the venous clinical severity score (VCSS) was applied to measure the disease severity. Pain and discomfort were assessed using a visual analog scale, and the residual veins were assessed by physical examination. Results: PEM was used to treat superficial reflux in 60 patients. The CEAP classification was C2 for 32 patients, C3 for 14, C4 for 10, and C5 for 4 patients. The average pretreatment VCSS was 7.3. The 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 mL. The closure rate at 3 and 6 months was 93% (54 of 58) and 93% (51 of 55), respectively. The VCSS had improved from 7.3 to 1.4. Complications included 1 case of deep vein thrombosis (1.7%), 5 patients (8.3%) with thrombophlebitis, and 4 patients (6.6%) with skin pigmentation. Conclusions: PEM is safe and effective for the treatment of saphenous reflux and varicosities. The early closure rates using PEM were maintained at 6 months and are comparable to the results reported with nonthermal, nontumescent technologies and thermal tumescent technologies.