Prospective comparative study of different endovenous thermal ablation systems for treatment of great saphenous vein reflux

Abstract

ObjectiveThe aim of our study was to compare three different endovenous thermal ablation (EVTA) modalities in the treatment of great saphenous vein (GSV) incompetence. MethodsWe performed a single-center, prospective, comparative cohort study that included consecutive patients undergoing EVTA of the GSV. Patients were treated with either segmental radiofrequency ablation (sRFA) or endovenous laser ablation (EVLA) with a 1470-nm dual radial fiber or with a 1470-nm jacket-tip fiber. The clinical classification CEAP (clinical, etiologic, anatomic, pathophysiologic), 10-cm visual analog scale scores for pain, Venous Clinical Severity Scores (VCSSs), and chronic venous insufficiency quality-of-life questionnaire (CIVIQ-20) scores were recorded. The primary outcome was clinical success, which was defined as the absence of reflux or recanalization of the GSV and procedure-related complications, assessed at 7 and 30 days and 1 year postoperatively. The secondary outcomes were the assessment of postoperative pain using the VAS and improvement in the VCSSs and CIVIQ-20 scores. ResultsA total of 153 patients (160 limbs) had undergone sRFA (sRFA group; n = 53 limbs), 1470-nm radial fiber EVLA (EVLA-R group; n = 55 limbs), or 1470-nm jacket-tip fiber EVLA (EVLA-J group; n = 52 limbs). The patient demographics, CEAP clinical class, and intraoperative details were comparable among the three groups. The GSV occlusion rate at 1 year was 93% in the sRFA group, 93% in the EVLA-R group, and 95% in the EVLA-J group. No major complications were observed postoperatively. Endothermal heat-induced thrombosis was observed in 2 (4.4%), 1 (2.2%), and 2 (4.4%) patients in the sRFA, EVLA-R, and EVLA-J groups, respectively (P > .5). The VCSS showed greater improvement in the EVLA-R group at 1 week compared with that in the sRFA (P = .05) and EVLA-J (P = .002) groups. Changes in the CIVIQ-20 score were in favor of the EVLA-R group at 7 days (−14.3 ± 10.3 vs −7.9 ± 5.9; adjusted difference, 6.06; 95% confidence interval [CI], 1.57-10.55; P = .01) and 30 days (−12 ± 8 vs −11.2 ± 7; adjusted difference, 5.5; 95% CI, 1.21-9.81; P = .02) postoperatively compared with the sRFA group and at 7 days compared with the EVLA-J group (−14.3 ± 10.3 vs −9.6 ± 7.9; adjusted difference, −4.4; 95% CI, −9.06 to 0.22; P = .05). Analyzing the different components of the CIVIQ-20, pain, and physical scores showed a greater reduction in the EVLA-R group in the early postoperative period compared with that in the sRFA and EVLA-J groups. ConclusionsAll three EVTA modalities showed equal effectiveness and safety for the treatment of GSV reflux. EVLA with the 1470-nm radial fiber showed better outcomes in terms of early postoperative VCSSs and pain and physical CIVIQ scores. The clinical and quality of life benefits were similar for all modalities at 1 year postoperatively.