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一项关于新型含应用导向光的正丁基-2-氰基丙烯酸酯胶水消融导管治疗静脉功能不全的回顾性研究:十二个月的结果。

A retrospective study of a new n-butyl-2-cyanoacrylate glue ablation catheter incorporated with application guiding light for the treatment of venous insufficiency: Twelve-month results.

作者信息

Yavuz Turhan, Acar Altay Nihat, Aydın Huseyin, Ekingen Evren

机构信息

1 Department of Cardiovascular Surgery, 64076 Süleyman Demirel University Faculty of Medicine , Isparta, Turkey.

3 Batman Regional State Hospital, Batman, Turkey.

出版信息

Vascular. 2018 Oct;26(5):547-555. doi: 10.1177/1708538118770548. Epub 2018 Apr 11.

Abstract

Objective This study aims to present the early results of a retrospective study of the use of novel n-butyl-2-cyanoacrylate (VenaBlock)-based nontumescent endovenous ablation with a guiding light for the treatment of patients with varicose veins. Methods Patients with lower limb venous insufficiency were treated with n-butyl-2-cyanoacrylate (VenaBlock Venous Closure System) between April 2016 and July 2016. The study enrolled adults aged 21-70 years with symptomatic moderate to severe varicosities (C2-C4b) and great saphenous vein reflux lasting longer than 0.5 s with great saphenous vein diameter between 5.5 and 15 mm assessed in the standing position. No compression stockings were used after the procedure. Duplex ultrasound imaging and clinical follow-up were performed on the third day, first month, sixth month, and 12th month. Clinical, etiological, anatomical, pathophysiological classification; venous clinical severity score; and completed Aberdeen varicose vein questionnaire were recorded. Results Five hundred thirty-eight patients with great saphenous vein incompetency underwent n-butyl-2-cyanoacrylate ablation. The mean ablation length was 25.69 ± 4.8 cm, and the average amount of n-butyl-2-cyanoacrylate delivered was 0.87 ± 0.15 ml. The mean procedure time was 11.7 ± 4.9 min. Procedural success was 100%, and complete occlusion was observed after treatment and at the third-day follow-up. We observed ecchymosis in five patients (1.00%) at the entry site at the third-day follow-up. Phlebitis was encountered with six (1.20%) patients. No skin pigmentation, hematoma, paresthesia, deep vein thrombosis, or pulmonary embolism was observed. Kaplan-Meier analysis yielded an occlusion rate of 99.4% at the 12-month follow-up. All patients had significant improvement in venous clinical severity score and Aberdeen varicose vein questionnaire scores postoperatively ( p <0.0001). Venous clinical severity score scores decreased from 5.43 ± 0.87 to 0.6 ± 0.75. Aberdeen varicose vein questionnaire scores decreased from 18.32 ± 5.24 to 4.61 ± 1.42. Conclusions The procedure appears to be feasible, safe, and efficient in treating the great majority of incompetent great saphenous veins with this technique.

摘要

目的 本研究旨在呈现一项回顾性研究的早期结果,该研究采用基于新型正丁基 - 2 - 氰基丙烯酸酯(VenaBlock)的非肿胀性静脉内激光消融术治疗静脉曲张患者。方法 2016年4月至2016年7月期间,对下肢静脉功能不全患者采用正丁基 - 2 - 氰基丙烯酸酯(VenaBlock静脉闭合系统)进行治疗。该研究纳入年龄在21 - 70岁之间、有症状的中度至重度静脉曲张(C2 - C4b)且大隐静脉反流持续时间超过0.5秒、站立位时大隐静脉直径在5.5至15毫米之间的成年人。术后未使用弹力袜。在术后第三天、第一个月、第六个月和第十二个月进行双功超声成像和临床随访。记录临床、病因、解剖、病理生理分类;静脉临床严重程度评分;以及完成的阿伯丁静脉曲张问卷。结果 538例大隐静脉功能不全患者接受了正丁基 - 2 - 氰基丙烯酸酯消融术。平均消融长度为25.69±4.8厘米,正丁基 - 2 - 氰基丙烯酸酯的平均用量为0.87±0.15毫升。平均手术时间为11.7±4.9分钟。手术成功率为100%,治疗后及第三天随访时观察到完全闭塞。在第三天随访时,我们在5例患者(1.00%)的穿刺部位观察到瘀斑。6例(1.20%)患者出现静脉炎。未观察到皮肤色素沉着、血肿、感觉异常、深静脉血栓形成或肺栓塞。Kaplan - Meier分析显示,在12个月随访时闭塞率为99.4%。所有患者术后静脉临床严重程度评分和阿伯丁静脉曲张问卷评分均有显著改善(p<0.0001)。静脉临床严重程度评分从5.43±0.87降至0.6±0.75。阿伯丁静脉曲张问卷评分从18.32±5.24降至4.61±1.42。结论 采用该技术治疗绝大多数功能不全的大隐静脉,该手术似乎可行、安全且有效。

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