Abstract

Background: Great saphenous vein (GSV) reflux is the most frequent form of venous insufficiency in symptomatic patients and is commonly responsible for varicose veins of the lower extremity. This non-randomized prospective controlled study was designed to test the hypothesis that 1) endovenous laser treatment is more effective than foam sclerotherapy in the closure of the refluxing GSV (as measured by degree of great saphenous vein reflux and venous clinical severity score changes) and 2) to record the associated complications of echo-guided endovenous chemical ablation with foam and endovenous laser therapy for the treatment of great saphenous vein reflux and to further identify risk factors associated with treatment failure. Methods: Between January 1, 2006 and June 25, 2006, patients seeking treatment of varicose veins at a private practice of vascular medicine were assessed for the study. Inclusion criteria were: 1) presence of great saphenous vein reflux and 2) C2-6, Epr, A s, according to the CEAP classification. The selected patients consented into the study and were allowed to choose between foam (53 patients) or laser (45 patients) treatment. Duplex examinations were performed prior to treatment and at seven and 14 days, four weeks, six months, and one year after treatment. Venous clinical severity score was assessed pre-treatment and at one year post-procedure. Results: The cohorts showed no statistically significant differences in age, sex, clinical and anatomical presentation, great saphenous vein diameter, and venous clinical severity score before the treatments. After one year follow up, occlusion of the great saphenous vein was confirmed in 93.4% (42/45) of limbs studied in the laser group and 77.4% (41/53) of limbs in the foam group (P < .0465). Venous clinical severity score significantly improved in both groups (P < .0001). Procedure associated pain was higher in the laser group (P < .0082). Induration, phlebitis, and ecchymosis were the most common complications. Logistical regression and subgroups analysis shown that a larger great saphenous vein diameter measured before treatment was associated with treatment failure in the foam (odds ratio 1.68, 95% CI 1.24-2.27, P < .0008) and in the laser group (odds ratio 1.91, 95% CI 1.02-3.59, P < .0428). A 90% treatment success is predicted for veins <6.5 mm in the foam group versus veins <12 mm in the laser group. Conclusions: Overall, endovenous laser ablation achieved higher occlusion rates than echo-guided chemical ablation with foam after one year follow-up. Matching the patient to the technique based on great saphenous vein diameter measured before treatment may assist in boosting the treatment success rate to >90%. A larger patient cohort followed and compared over a longer period of time would be required to confirm these findings. © 2008 The Society for Vascular Surgery.