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采用F-care与Closurefast静脉内射频治疗对大隐静脉进行消融:双盲前瞻性研究。

Ablation of the great saphenous vein with F-care versus Closurefast endovenous radiofrequency therapy: Double-blinded prospective study.

作者信息

Bitargil Macit, Kılıç Helin E

机构信息

Department of Cardiovascular Surgery, Şişli Hamidiye Etfal Research and Training Hospital, Istanbul, Turkey.

出版信息

Phlebology. 2020 Sep;35(8):561-565. doi: 10.1177/0268355520913389. Epub 2020 Mar 19.

Abstract

OBJECTIVES

F-care (endovenous radiofrequency, F Care Systems, Antwerp, Belgium) is a relatively new radiofrequency ablation technique for the treatment of venous insufficiency. There is a lack of published data about F-care in literature. This study aimed to prospectively compare the F-care method with conventional endovenous radiofrequency ablation Closurefast method for the management of incompetent great saphenous veins.

METHODS

Between June 2015 and December 2018, 114 patients with incompetent varicose veins were treated either with the F-care or Closurefast. The pre-, intra-, postprocedural, and follow-up data of the patients were collected and prospectively compared.

RESULTS

The average ablated vein length was 23.1 ± 4 cm in the F-care group and 26.6 ± 4 cm in the Closurefast group (=0.01). The average procedure time was 17.4 ± 4 min (range: 10-30 min) in the F-care group, and 17.1 ± 3 min (range: 11-27 min) in the Closurefast group (=0.77). The one-month total occlusion rates in the F-care and Closurefast groups were 96.2% and 98.1%, respectively (=0.5). The one-year full occlusion rates in the F-care and Closurefast groups were 71.7% and 90.6%, respectively (=0.013). In both the F-care and Closurefast groups, the venous clinical severity scores declined significantly with no difference between groups. There was no significant difference between adverse events following F-care treatment compared with Closurefast treatment (≤0.05).

CONCLUSIONS

The F-care system was as safe and fast, but the one-year closure rate was significantly lower when compared to the other method. There was no significant difference between the adverse effects of both approaches. Further large-scale, multi-center prospective studies with long-term outcomes are required to identify the effectiveness of F-care treatment modality for patients with saphenous vein insufficiency.

摘要

目的

F-care(静脉内射频,F Care Systems,比利时安特卫普)是一种用于治疗静脉功能不全的相对较新的射频消融技术。文献中缺乏关于F-care的已发表数据。本研究旨在前瞻性地比较F-care方法与传统静脉内射频消融Closurefast方法治疗大隐静脉功能不全的效果。

方法

2015年6月至2018年12月期间,114例静脉曲张功能不全患者接受了F-care或Closurefast治疗。收集患者术前、术中、术后及随访数据并进行前瞻性比较。

结果

F-care组平均消融静脉长度为23.1±4cm,Closurefast组为26.6±4cm(P = 0.01)。F-care组平均手术时间为17.4±4分钟(范围:10 - 30分钟),Closurefast组为17.1±3分钟(范围:11 - 27分钟)(P = 0.77)。F-care组和Closurefast组的1个月总闭塞率分别为96.2%和98.1%(P = 0.5)。F-care组和Closurefast组的1年完全闭塞率分别为71.7%和90.6%(P = 0.013)。在F-care组和Closurefast组中,静脉临床严重程度评分均显著下降,两组之间无差异。F-care治疗后的不良事件与Closurefast治疗相比无显著差异(P≤0.05)。

结论

F-care系统同样安全快捷,但与另一种方法相比,其1年闭合率显著较低。两种方法的不良反应之间无显著差异。需要进一步开展大规模、多中心的长期前瞻性研究,以确定F-care治疗方式对大隐静脉功能不全患者的有效性。

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