BACKGROUND: Despite adequate treatment of varicose veins, recurrences and primary failures still occur. This article hypothesizes that increasing the dose of radiofrequency ablation (RFA) could improve efficacy through inducing a greater shrinkage of the treated vein. METHODS: A comparative clinical study of 67 extremities with varicose veins caused by great saphenous vein (GSV) reflux treated with RFA ClosureFAST was conducted. Group 1 (n = 22) received 1 treatment cycle (20 sec) and group 2 (n = 45) received 2 cycles (40 sec) along the GSV trunk. Clinical and duplex follow-up were performed at day 4, and at 1, 3, and 6 months. The main outcomes measured were GSV diameters, occlusion rate, and secondary effects. Statistical analysis was performed using the Student's t test, linear mixed model, Bland-Altman plot, Lin's concordance correlation coefficient, and intraclass correlation coefficient. RESULTS: Both groups were comparable for demographic and specific study variables with a very low intraobserver variability. The immediate occlusion rate was 100% for both groups. Group 2 showed a quicker and greater reduction in medium diameter along the period of the study (P = 0.0074). Beyond the 6-month period of study, 1 partial GSV recanalization in group 1 and 1 complete GSV recanalization in an obese patient in group 2 were detected. No skin burns, paresthesia, or deep vein thromboses appeared. CONCLUSIONS: Two cycles of RFA treatment in all segments of the GSV achieves quicker and greater vein shrinkage of the medium diameter without an increase in side effects. Further studies are needed to evaluate the implications in terms of intermediate and long-term clinical efficacy.
BACKGROUND: Despite adequate treatment of varicose veins, recurrences and primary failures still occur. This article hypothesizes that increasing the dose of radiofrequency ablation (RFA) could improve efficacy through inducing a greater shrinkage of the treated vein. METHODS: A comparative clinical study of 67 extremities with varicose veins caused by great saphenous vein (GSV) reflux treated with RFA ClosureFAST was conducted. Group 1 (n = 22) received 1 treatment cycle (20 sec) and group 2 (n = 45) received 2 cycles (40 sec) along the GSV trunk. Clinical and duplex follow-up were performed at day 4, and at 1, 3, and 6 months. The main outcomes measured were GSV diameters, occlusion rate, and secondary effects. Statistical analysis was performed using the Student's t test, linear mixed model, Bland-Altman plot, Lin's concordance correlation coefficient, and intraclass correlation coefficient. RESULTS: Both groups were comparable for demographic and specific study variables with a very low intraobserver variability. The immediate occlusion rate was 100% for both groups. Group 2 showed a quicker and greater reduction in medium diameter along the period of the study (P = 0.0074). Beyond the 6-month period of study, 1 partial GSV recanalization in group 1 and 1 complete GSV recanalization in an obesepatient in group 2 were detected. No skin burns, paresthesia, or deep vein thromboses appeared. CONCLUSIONS: Two cycles of RFA treatment in all segments of the GSV achieves quicker and greater vein shrinkage of the medium diameter without an increase in side effects. Further studies are needed to evaluate the implications in terms of intermediate and long-term clinical efficacy.