One-year Results With a New Endovenous Radiofrequency Ablation Catheter, Venclose

Abstract

Chronic venous Insufficiency is a common problem, and radio-frequency ablation (RFA) of incompetent veins is a common and effective treatment. In 2018, the Venclose device and catheter were approved for use in the United States. Given the lack of literature on this new devicem we previously published initial results and now are following-up with 1-year data from our patients. We performed a retrospective analysis of patients who had previously received endovenous RFA with Venclose, looking at their follow-up duplexes at 3 months, 6 months, 9 months, and 1 year. Procedure success was coded as the target veins remaining obliterated on lower-extremity ultrasound. We followed 405 patients who had 846 procedures. Our patients were 69.3% female (281/405) and were aged 18 to 93 years (mean, 54.02 ± 12.4 years). Under the clinical manifestations portion of the CEAP classification system, the majority of our limbs were class C3 (543; 64.1%). Follow-up ranged from 28 to 604 days. We treated 19 anterior accessory saphenous veins, 491 great saphenous vein (GSV) above-knee segments, 149 GSV below-knee segments, 1 GSV duplicate, and 186 small saphenous veins. At 3 months, there were 846 procedures followed-up, with 15 recanalizations; at 6 months, there were 651 procedures with follow-up, with 9 additional recanalizations, and there were no recanalizations at 9 months (n = 397 procedures) and at 1 year (n = 246 procedures). We observed 24 recanalizations in total, four of which required reintervention. Of the 24 recanalizations, 13 were in GSV above-knee segments, three were in GSV below-knee segments, and the remaining eight were in small saphenous veins, and all reinterventions were in GSV above-knee segments. Kaplan-Meier analysis showed successful closure of 97% of the patient population at 1 year. Cox regression analysis accounting for laterality, sex, age, and CEAP showed no significant hazard ratio. The Venclose device and catheter have good results at 1 year. All identified recanalizations occurred within 6 months of follow-up; none were noted at 9 months or 1 year. Recanalization rates for the procedure are comparable to other RFA catheters.