Safety and efficacy of endovenous microwave ablation for treatment of varicose veins of the lower limbs in China: A prospective registered clinical trial

Abstract

Objective This study aimed to investigate the safety and efficacy of a new Chinese device using microwave ablation for treating symptomatic great saphenous vein (GSV) varicose veins (VVs). Methods This prospective, single-arm, single-center, cohort study investigated the safety and efficacy of endovenous microwave ablation for the treatment of symptomatic VVs. A total of 50 patients with lower limb varicose veins were enrolled from the Hospital of Chengdu University of Traditional Chinese Medicine. The clinical outcomes and complications were assessed at 1, 6, and 12 months after the procedure. The primary outcome was the occlusion rate of GSV immediately and at 1, 6, and 12 months after the treatment. The secondary outcomes included the venous clinical severity score (VCSS), the chronic venous insufficiency questionnaire 14 items (CIVIQ-14) score, the Aberdeen varicose vein questionnaire (AVVQ) score, and the pain visual analog scale (VAS) score. This study protocol was registered at ClinicalTrials.gov (ID: NCT04645771). Results In total, 50 limbs from 50 patients (26 female; mean age: 53.45 ± 9.78 years) were treated. A technical success rate of 100% was achieved and no serious adverse events were recorded. During the follow-up period, the occlusion rate of the major/minor saphenous vein trunk remained 100% at 1, 6, and 12 months after surgery except one patient fell off. The median 24-h VAS value was 2 (2,3). The VCSS score, CIVIQ-14 score, and AVVQ score ( p < .05) at 1, 6, and 12 months improved significantly compared with the value preoperative ( p < .05). Conclusion EMA was safe and effective for treating varicose veins in the lower limbs, with a high rate of venous trunk occlusion and few complications, thus improving patients’ postoperative quality of life.