Treatment of Superficial Venous Reflux in CEAP 6 Patients: A Comparison of Cyanoacrylate Glue and Radiofrequency Ablation Techniques

Abstract

Abstract Objective Venous leg ulcers (CEAP [clinical, etiologic, anatomic, pathophysiologic] class 6) represent the most severe form of chronic venous insufficiency. As closure techniques for superficial venous reflux evolve, direct outcome comparisons of treatments are integral, because many studies have already demonstrated that early endovenous intervention improves wound healing. The present study compared the rates of venous wound healing between two techniques of superficial vein closure: ClosureFast radiofrequency ablation (RFA) and adhesive closure (VenaSeal; both Medtronic, Inc, Minneapolis, Minn). Methods We performed a multi-institutional retrospective review of all patients with CEAP class 6 who had undergone closure of their truncal veins from 2015 to 2020. Patients undergoing ClosureFast RFA were compared with those undergoing VenaSeal adhesive closure. The primary endpoint was the interval to wound healing from initial vein closure. The secondary endpoints included ulcer recurrence and infection rates. Bivariate analysis involved the χ2, Fisher exact, t, and Wilcoxon rank sum tests. Multivariate linear regression analysis was used to examine the factors affecting the time to wound healing in the most predictive model. Statistical significance was defined as P Results A total of 119 patients with CEAP 6 were included, with a median follow-up of 105 days (interquartile range, 44-208 days). Of the 119 limbs, 68 were treated with RFA and 51 with VenaSeal. Significantly more patients undergoing RFA had had a history of deep vein thrombosis (29% vs 10%; P = .01) and deep venous reflux (82% vs 51%; P = .003). The VenaSeal patients were older (72 years vs 65 years; P = .02) with a greater rate of coronary artery disease (16% vs 37%; P = .01). The median time to wound healing after the procedure was significantly shorter for VenaSeal than for RFA (43 vs 104 days; P = .001). Two RFA patients developed a postprocedure infection. The ulcer recurrence rate was 19.3% (22.1% for RFA vs 13.7% for VenaSeal; P = .25). On multivariate analysis, the treatment modality was the only significant predictor of the time to wound healing. When stratified by ulcer size as small ( 3 cm2), VenaSeal closure healed the wounds significantly faster for all ulcers. Conclusion ClosureFast and VenaSeal are both safe and effective treatments to eliminate truncal venous insufficiency. VenaSeal showed a superior time to wound healing compared with ClosureFast in both large and small ulcers.