Prospective study of safety and effectiveness in the use of radiofrequency ablation for incompetent great saphenous vein ≥12 mm

Objective: The objective of this study was to assess the outcomes of radiofrequency ablation (RFA) in incompetent great saphenous vein (GSV) according to its diameter. Methods: This was a prospective single-center study including all patients treated with RFA from September 2014 to December 2015. The sample was divided according to the maximum GSV diameter measured on duplex ultrasound scan (A, <12 mm; B, >= 12 mm). Second-generation catheters (ClosureFast; Covidien, Mansfield, Mass) and tumescent anesthesia were used. Clinical stage (according to Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] classification), quality of life (measured by the 14-item Chronic Venous Insufficiency Questionnaire), and pain on visual analog scale were recorded before the procedure and during follow-up. Technical success was defined as GSV occlusion on duplex ultrasound scan. Safety was defined as incidence and type of adverse events at 10 days, 1 month, 6 months, and 12 months. Results: There were 257 patients included, 183 (71%) with GSV diameter <12 mm and 74 (29%) with GSV diameter >= 12 mm. Mean GSV diameter was 8 +/- 2 mm (4-11 mm) and 14 +/- 2 mm (12-21 mm), respectively. Before the procedure, although a tendency toward greater clinical severity was observed in group B, no significant differences were found in the percentage of patients in C4 and C5 categories (A, 10%; B, 22%), median pain perception (A, 40; B, 39), or median quality of life value on the 14-item Chronic Venous Insufficiency Questionnaire scale (A, 27; B, 27). The rate of GSV occlusion at 1 month (n = 221) was 97% in group A and 100% in group B (P = .325); at 6 months (n = 158), it was 97% and 98%, respectively (P > .999); and at 12 months (n = 90), it was 99% and 96% (P = .481). There was a significant improvement in pain and quality of life in both groups, without differences between them. Finally, no differences between groups were found in terms of adverse events. Paresthesias were the most frequent event (A, 4%; B, 5%; P = NS), which disappeared during follow-up in half of the cases. Regarding major adverse events, there was only one case of deep venous thrombosis in group B. Conclusions: RFA is safe and effective for the treatment of GSV >= 12 mm at midterm.