Abstract
BACKGROUND: Chronic venous insufficiency is a common vascular disorder that can lead to significant morbidity if left untreated. Endovenous thermal ablation, particularly radiofrequency ablation (RFA), has become a first-line therapy owing to its high efficacy and favorable safety profile. We sought to evaluate the technical success, safety, and clinical outcomes of the ThermoBlock RFA system in patients with reflux grade 4 great saphenous vein (GSV) insufficiency. METHODS: This single-center retrospective study included 910 patients (444 males, 466 females; mean age, 45.4 ± 11.5 years) who underwent ThermoBlock RFA between March 2019 and June 2023. Clinical severity was assessed using the Venous Clinical Severity Score, and quality of life (QoL) was measured with the VEINES-QOL/Sym questionnaire. Duplex ultrasound examinations were performed at baseline and at 3, 6, 12, and 24 months. Statistical analyses used paired t tests for continuous variables and Wilcoxon signed-rank tests for ordinal variables, with effect sizes reported. RESULTS: Technical success at 3 months was 97.6%. The Venous Clinical Severity Score improved from 10.9 ± 2.4 to 3.6 ± 0.9 (P < .001; Cohen's d = 3.7), and VEINES-QOL/Sym scores increased from 60.5 ± 7.71 to 84.6 ± 8.52 (P < .001; Cohen's d = 3.0). The mean GSV diameter decreased from 7.33 ± 1.13 mm before the procedure to 5.39 ± 0.60 mm at 3 months and 2.94 ± 0.66 mm at 24 months (P < .001). No mortality or pulmonary embolism occurred; deep vein thrombosis was observed in 0.7% of patients. Minor complications included thrombophlebitis (10.3%), hyperpigmentation (11.9%), ecchymosis (10.9%), and numbness (24.7%). CONCLUSIONS: ThermoBlock RFA is a safe and effective treatment for chronic GSV insufficiency, achieving high vein closure rates, substantial symptom relief, and improved QoL with minimal major complications. Its integrated laser guidance system may enhance procedural precision and support durable long-term outcomes. CLINICAL RELEVANCE: Chronic venous insufficiency is a prevalent condition that significantly impairs QoL and imposes a substantial socioeconomic burden. Endovenous thermal ablation techniques have largely replaced conventional surgery owing to their high efficacy and lower complication rates. The ThermoBlock RFA system integrates precise thermal control with laser-guided catheter positioning, potentially enhancing procedural accuracy and outcomes. In this large, single-center study of 910 patients with advanced saphenous vein insufficiency, ThermoBlock RFA achieved a 97.6% closure rate at 3 months, with marked improvements in Venous Clinical Severity Score and VEINES-QOL/Sym scores, and a low incidence of major complications. These findings support ThermoBlock RFA as a safe, effective, and reproducible first-line option for the treatment of chronic venous insufficiency, even in patients with large-diameter great saphenous veins.