Izquierdo Lamoca Luis Miguel, Postigo Teresa Reyero, Morán Escalona Sonia, Giráldez Arranz Juan Francisco, Aguinaco Acosta Ana
Angiology, Vascular and Endovascular Surgery Service, Instituto Vascular Internacional, Hospital Universitario Madrid Montepríncipe, Madrid, Spain; Universidad CEU-San Pablo School of Medicine, Madrid, Spain.
Angiology, Vascular and Endovascular Surgery Service, Instituto Vascular Internacional, Hospital Universitario Madrid Montepríncipe, Madrid, Spain.
J Vasc Surg Venous Lymphat Disord. 2025 Mar 19;13(4):102233. doi: 10.1016/j.jvsv.2025.102233.
Chronic venous disease management has significantly advanced with minimally invasive techniques like endovenous thermal ablation. High-intensity focused ultrasound (HIFU) is a noninvasive alternative thermal ablation method enabling targeted vein closure without percutaneous access. This study evaluates the efficacy of HIFU treatment, combined with the Cure Conservatrice et Hémodynamique de l'Insuffisance Veineuse en Ambulatoire (CHIVA) strategy, in occluding leak points in patients with superficial venous reflux.
This retrospective study included patients treated for chronic venous disease using the SONOVEIN device from March 2020 to February 2024. Inclusion criteria were symptomatic patients (CEAP ≥C2) with ultrasound-confirmed truncal reflux. Patients under 18 years, with <12 months life expectancy, or isolated venous flow obstruction were excluded. Treatments followed CHIVA principles, targeting leak points and proximal vein segments for occlusion. Primary endpoints were leak point occlusion rates and procedural safety. In this study, primary efficacy was defined as vein closure with one treatment, whereas secondary efficacy was defined as the need for more.
A total of 204 limbs in 183 patients (131 females, 52 males; mean age, 55.2 years) underwent HIFU treatment. Primary leak point occlusion rate at 1 week, and 1, 6, 12, and 24 months were 85.1 %, 91.8%, 93.7%, 94.3%, and 95.5%, respectively. Secondary closure rates at 1 week, and 1, 6, 12, and 24 months were 89.6 %, 95.4%, 95.0%, 95.4%, and 95.7%, respectively. Overall primary and secondary cumulative closure rates at 24 months were 88.1% (95% confidence interval, 77.7%-98.4%), and 92.1% (95% confidence interval, 83.3%-100%), respectively. No major complications were observed.
HIFU achieves high leak point occlusion rates when applied under CHIVA principles, supporting its role as an effective and safe noninvasive alternative for chronic venous disease treatment. The technique minimizes risks associated with thermal ablation, such as skin burns and nerve damage, while addressing limitations of conventional methods. These results highlight the potential of HIFU as a disruptive technology in venous disease management. Further studies should assess its long-term efficacy and safety.
随着诸如静脉内热消融等微创技术的出现，慢性静脉疾病的管理有了显著进展。高强度聚焦超声（HIFU）是一种非侵入性的热消融替代方法，能够在无需经皮穿刺的情况下实现靶向静脉闭合。本研究评估了HIFU治疗联合门诊静脉功能不全保守治疗与血液动力学（CHIVA）策略在闭塞浅静脉反流患者漏点方面的疗效。
这项回顾性研究纳入了2020年3月至2024年2月期间使用SONOVEIN设备治疗慢性静脉疾病的患者。纳入标准为有症状的患者（CEAP≥C2）且经超声确认存在主干反流。排除18岁以下、预期寿命小于12个月或单纯静脉血流阻塞的患者。治疗遵循CHIVA原则，针对漏点和近端静脉段进行闭塞。主要终点为漏点闭塞率和手术安全性。在本研究中，主要疗效定义为一次治疗后静脉闭合，而次要疗效定义为需要更多治疗。
183例患者（131例女性，52例男性；平均年龄55.2岁）的204条肢体接受了HIFU治疗。1周、1个月、6个月、12个月和24个月时的主要漏点闭塞率分别为85.1%、91.8%、93.7%、94.3%和95.5%。1周、1个月、6个月、12个月和24个月时的次要闭合率分别为89.6%、95.4%、95.0%、95.4%和95.7%。24个月时总的主要和次要累积闭合率分别为88.1%（95%置信区间，77.7%-98.4%）和92.1%（95%置信区间，83.3%-100%）。未观察到重大并发症。
在CHIVA原则下应用时，HIFU可实现较高的漏点闭塞率，支持其作为慢性静脉疾病治疗有效且安全的非侵入性替代方法的作用。该技术将与热消融相关的风险（如皮肤烧伤和神经损伤）降至最低，同时解决了传统方法的局限性。这些结果凸显了HIFU作为静脉疾病管理中颠覆性技术的潜力。进一步的研究应评估其长期疗效和安全性。
