Early outcomes of the Third-generation of ClosureFast radiofrequency ablation for great saphenous vein reflux.

Abstract

Background: This study aimed to assess the safety of the third-generation ClosureFast catheter for radiofrequency ablation (RFA) in the treatment of great saphenous vein (GSV) reflux in patients presenting to a dedicated vein center. Materials and methods: All consecutive patients with incompetent GSV who underwent RFA between December 2023 and May 2024 were retrospectively analyzed. The primary study endpoints were technical success and postoperative complication rate at 30 days. Secondary study endpoints were freedom from GSV recanalization and recurrent varicose vein (RVV) rate over the follow-up. The improvement in symptoms (measured by the Venous Clinical Severity Score [VCSS]) was evaluated. Results: During the study period, 50 limbs were treated in 50 consecutive patients (mean age 55.8±13.4 years; 56% women; CEAP 2-4; VCSS >5). The technical success rate was achieved in 100% of cases. There was no significant incidence of 30-day complications. There were no instances of deep venous thrombosis or puncture site thermal injury. One patient (2%) had hyperpigmentation; two patients (4%) had ecchymosis; 4 patients (8%) had pain. At a mean follow-up of 2.9±1.4 months, GSV occlusion and freedom from reintervention rates were both 100% within 1 week and 30 days respectively. No patients had RVV over the follow-up. The VCSS score had decreased a median of 3.5 (IQR: 2.4-5) points from baseline (p<0.01). The mean CEAP class had decreased to 1.59 points from baseline, reflecting a shift towards milder disease categories (C0-C2). Conclusions: The third generation of RFA is safe and effective to ablate the GSV with a low complication rate in the perioperative period. However, durability over the follow-up and further studies with larger cohorts of patients are still needed to confirm these outcomes.