Karnabatidis Dimitris, Papageorgiou Christos, Kitrou Panagiotis, Spiliopoulos Stavros
Department of Interventional Radiology, School of Medicine, Patras University Hospital, Greece.
Department of Radiology, Interventional Radiology Unit, School of Medicine, National and Kapodistrian University of Athens, Greece.
Vascular. 2023 Oct;31(5):1011-1016. doi: 10.1177/17085381221099115. Epub 2022 May 12.
This study aims to investigate the safety and efficacy of a new device using microwave technology for the endovenous ablation of the great saphenous vein (GSV) causing symptomatic lower limb varicose veins (LLVV).
This prospective, single-arm, single-center, cohort study investigated the safety and effectiveness of endovenous microwave ablation for the treatment of symptomatic LLVV. Enrollment period was set between January and December 2020. Primary safety endpoint was the occurrence of procedure-related complications and primary efficacy endpoint was anatomical success defined as the duplex ultrasound (DUS)-proven GSV occlusion at 1 year follow-up. Secondary endpoints included 1-year clinical success (CEAP classification improvement), repeat procedures rate due to GSV recanalization, and pain assessment at 24 h post treatment.
In total, 50 patients (42 female; mean age: 62 ± 12 years) with 64 limbs were treated. No procedure-related complications were noted. Technical success was 95.3% (61/64 GSVs), as three cases of GSV recanalization were detected. Clinical success was 100%, as in all cases symptoms improvement by at least one grade according to CEAP classification, was achieved. Mean CEAP grade significantly improved from 3.3 ± 0.72 (median: 3) at baseline to 1.8 ± 0.85 (median: 2) at 1-year ( < 0.0001). There were no repeat procedures due to GSC recanalization. The median 24-h VAS value was 2 (mean: 1.9 ± 1.4).
Endovenous microwave ablation was safe and effective for the treatment of varicose veins, achieving high 1-year GSV occlusion rates.
本研究旨在探讨一种采用微波技术的新设备用于大隐静脉（GSV）腔内消融治疗引起症状性下肢静脉曲张（LLVV）的安全性和有效性。
这项前瞻性、单臂、单中心队列研究调查了腔内微波消融治疗症状性LLVV的安全性和有效性。入组期设定为2020年1月至12月。主要安全终点是与手术相关并发症的发生，主要疗效终点是解剖学成功，定义为在1年随访时经双功超声（DUS）证实的GSV闭塞。次要终点包括1年临床成功（CEAP分级改善）、因GSV再通导致的重复手术率以及治疗后24小时的疼痛评估。
总共治疗了50例患者（42例女性；平均年龄：62±12岁）的64条肢体。未观察到与手术相关的并发症。技术成功率为95.3%（64条GSV中的61条），因为检测到3例GSV再通。临床成功率为100%，因为在所有病例中，根据CEAP分级症状至少改善了一个等级。平均CEAP分级从基线时的3.3±0.72（中位数：3）显著改善至1年时的1.8±0.85（中位数：2）（<0.0001）。没有因GSC再通而进行重复手术。24小时VAS值中位数为2（平均值：1.9±1.4）。
腔内微波消融治疗静脉曲张安全有效，1年GSV闭塞率高。
