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蒸汽消融作为治疗隐静脉曲张的新型热疗方法的原理验证研究。

Proof-of-principle study of steam ablation as novel thermal therapy for saphenous varicose veins.

机构信息

Department of Dermatology, Erasmus MC, Rotterdam, The Netherlands.

出版信息

J Vasc Surg. 2011 Jan;53(1):181-6. doi: 10.1016/j.jvs.2010.06.171.

DOI:10.1016/j.jvs.2010.06.171
PMID:20801604
Abstract

INTRODUCTION

During the last decade, thermal ablation techniques such as endovenous laser ablation have been challenging the position of traditional surgery for the treatment of saphenous varicose veins. The newest method of thermal ablation is pulsated steam, which works by heating the vein with steam at 120°C. This study assessed the effectiveness of steam ablation of varicose veins in sheep and in humans.

METHODS

The safety of the procedure in sheep was assessed by cardiovascular monitoring during treatment. We used ultrasound imaging to examine occlusion of the veins. Changes in treated veins were examined microscopically. In a pilot study, 20 veins in 19 patients with insufficiency of the great or the small saphenous vein were treated with pulsated steam ablation. Anatomic success, patient satisfaction, and complications were investigated for 6 months after the procedure.

RESULTS

All veins in the sheep were occluded. No cardiovascular changes occurred during treatment. Histologic examination of treated veins showed typical changes of the vein wall, such as disappearance of the endothelial layer, fibrotic thrombosis, and major alterations in collagen fibers in the media. Steam ablation was effective in the 19 patients: 13 of 20 veins were completely closed, and 7 showed a very small segment of recanalization after 6 months of follow-up that did not seem to be clinically relevant. Nine patients had some ecchymoses at the puncture site, and one patient had a transient superficial phlebitis. A median maximal pain score of 1 (range, 0-10) was reported. No serious side effects, such as deep vein thrombosis, nerve injury, skin burns, or infections, were reported. Patients were very satisfied with the treatment, with a median satisfaction score of 9.25 (range, 0-10).

CONCLUSIONS

In this proof-of-principle study, pulsated steam ablation was an effective treatment for saphenous varicose veins.

摘要

简介

在过去的十年中,热消融技术(如静脉内激光消融)已对传统手术治疗大隐静脉曲张的地位提出挑战。最新的热消融方法是脉冲蒸汽,其通过将 120°C 的蒸汽加热静脉来工作。本研究评估了蒸汽消融在羊和人类中大隐静脉曲张的有效性。

方法

通过治疗过程中的心血管监测评估该程序在羊身上的安全性。我们使用超声成像来检查静脉阻塞情况。用显微镜检查处理过的静脉的变化。在一项初步研究中,对 19 例大隐静脉或小隐静脉功能不全的患者的 20 条静脉进行了脉冲蒸汽消融治疗。术后 6 个月,调查解剖成功率、患者满意度和并发症。

结果

羊的所有静脉均被阻塞。治疗过程中未发生心血管变化。对处理过的静脉进行组织学检查显示出静脉壁的典型变化,例如内皮层消失、纤维性血栓形成以及中膜胶原纤维的重大改变。蒸汽消融在 19 例患者中有效:20 条静脉中有 13 条完全闭塞,在 6 个月的随访中有 7 条显示非常小的再通段,但似乎无临床意义。9 例患者穿刺部位有瘀斑,1 例患者出现短暂性浅表静脉炎。报告的最大疼痛评分中位数为 1(范围,0-10)。未报告任何严重的副作用,如深静脉血栓形成、神经损伤、皮肤烧伤或感染。患者对治疗非常满意,满意度中位数为 9.25(范围,0-10)。

结论

在这项原理验证研究中,脉冲蒸汽消融是治疗大隐静脉曲张的有效方法。

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