Randomized Clinical Trial of VNUS® ClosureFAST™ Radiofrequency Ablation versus Laser for Varicose Veins

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Conclusion: Radiofrequency ablation (RFA) using VNUS ClosureFAST (VNUS Medical Technologies, San Jose, Calif) is associated with less postprocedural pain than endovenous laser ablation (EVLA). Clinical and quality of life improvements for the two procedures are similar at 6 weeks. Summary: Endovenous ablative procedures have largely replaced standard saphenous stripping for treatment of saphenous reflux in patients with primary varicose veins. At the time of publication of this article, only one small randomized trial has compared VNUS ClosureFAST and EVLA (Almeida JI et al, J Vasc Interv Radiol 2009;20:752-9). This current study compares the most utilized technique for EVLA in Great Britain (980-nm wavelength and bare fiber) vs the most popular RFA system in Great Britain (VNUS ClosureFAST). Consecutive patients with primary great saphenous vein reflux were randomized to EVLA or RFA at a single center. The primary outcome measure was postprocedural pain at 3 days. Secondary outcome measures were quality of life at 6 weeks, as determined by the Aberdeen Varicose Vein Questionnaire (AVVQ) and Short Form 12 (SF-12), and clinical improvement using the Venous Clinical Severity Score (VCSS). Analysis was on an intention-to-treat basis. There were 64 patients randomized to EVLA and 67 to RFA. At 3 days, mean (SD) pain scores were 26.4 (22.1) mm for RFA and 36.8 (22.5) mm for EVLA (P = .010). Over 10 days, mean (SD) pain scores were 22.0 (19.8) mm for RFA vs 34.3 (21.1) mm for EVLA respectively (P = .001). Mean number of analgesic tablets used over 3 days and over 10 days was lower for RFA (P = .003) than EVLA (P = .001). There were no differences in AVVQ, SF-12, and VCSS scores at 6 weeks between the two groups (P = .887, P = .076, P = .449, respectively). Comment: The study demonstrated that VNUS ClosureFAST results in significantly less pain than 980-nm EVLA for ablation of the great saphenous veins in treatment of patients with varicose veins. The study supports previous publications that demonstrate less postprocedural pain after RFA but failed to show differences in outcomes after 1 month (Morrisson N, Semin Vasc Surg 2005;18:15-8 and Almeida J, et al, J Vasc Interv Radiol 2009;20:752-9). However, EVLA is continuing to be refined. There are newer fibers with longer wave lengths and jacketed laser fibers that appear to be associated with lower postintervention pain scores (Almeida J, et al. Vasc Endovasc Surg 2009;43:467-72). Data comparing these new devices with VNUS closure system will also eventually be required.