Baccellieri Domenico, Ardita Vincenzo, Galati Nicola, Anselmi Claudia, Mangili Benedetta, Chiesa Roberto
Vascular Surgery, Vita-Salute University School of Medicine, San Raffaele Scientific Institute, Milan, Italy.
Vasa. 2025 Jul;54(4):280-286. doi: 10.1024/0301-1526/a001195. Epub 2025 Mar 31.
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. 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. 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). 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.
本研究旨在评估第三代ClosureFast导管用于射频消融（RFA）治疗就诊于专业静脉中心的患者大隐静脉（GSV）反流的安全性。对2023年12月至2024年5月期间所有连续接受RFA治疗的GSV功能不全患者进行回顾性分析。主要研究终点为技术成功率和30天时的术后并发症发生率。次要研究终点为随访期间GSV再通率和复发性静脉曲张（RVV）发生率。评估症状改善情况（通过静脉临床严重程度评分[VCSS]测量）。在研究期间，50例连续患者的50条肢体接受了治疗（平均年龄55.8±13.4岁；56%为女性；CEAP 2-4级；VCSS>5）。所有病例的技术成功率均达到100%。30天并发症发生率无显著差异。未发生深静脉血栓形成或穿刺部位热损伤。1例患者（2%）出现色素沉着；2例患者（4%）出现瘀斑；4例患者（8%）出现疼痛。平均随访2.9±1.4个月时，GSV闭塞率和无需再次干预率在1周和30天时分别均为100%。随访期间无患者发生RVV。VCSS评分较基线水平中位数下降了3.5（IQR：2.4-5）分（p<0.01）。平均CEAP分级较基线水平降至1.59级，表明病情向较轻类别（C0-C2）转变。第三代RFA消融GSV安全有效，围手术期并发症发生率低。然而，仍需要进行随访期的耐久性研究以及更大患者队列的进一步研究来证实这些结果。
