Durability and efficacy of the ELVeS® Radial® 2ring slim fiber for multiple ablations.

IF 1.6 4区医学 Q3 PERIPHERAL VASCULAR DISEASE Phlebology Pub Date : 2023-12-01 Epub Date: 2023-08-06 DOI:10.1177/02683555231193883

Jürgen Verbist, Veerle Laeremans, Fien Gryffroy, Wouter Van den Eynde, Caroline Heerinckx, Dorien Haesen

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引用次数: 0

Abstract

Objectives: To prove that the ELVeS® Radial® 2ring slim fiber (Biolitec AG, Wien, Austria) is safe and effective, with a reliable fiber durability.

Methods: This prospective, non-randomized, registry recruited patients with venous incompetence of the great saphenous vein, with or without concomitant incompetence of the small, anterior accessory and posterior accessory saphenous veins. Anatomic success, clinical success and pain were assessed.

Results: 150 patients (410 veins) underwent endovenous laser ablation (EVLA). Mean number of veins treated was 2.7 (1-7) with a mean total length of 80.7 cm. 98.3% occlusions were observed after 12 months. Clinical improvement was significant with reduced venous clinical severity scores at 1 month (1.7 ±1.9; p < .0001) and 12 months (0.7 ±1.3; p < .0001) versus pre-operation (4.4 ± 2.2). Mean pain level after 1-week was 5.8/100. No major surgery- or device-related complications occurred.

Conclusions: 1470-nm EVLA with the 2ring slim fiber is a highly effective treatment option well tolerated by patients. Despite intensive use, fiber integrity was preserved.

Clinical registration: The study protocol was registered in clinicaltrials.gov (NCT03810677).

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耐用性和功效的精灵®径向®2ring纤薄纤维多次消融。

目的:证明elf®Radial®2ring纤薄纤维(Biolitec AG, Wien, Austria)是安全有效的，具有可靠的纤维耐久性。方法:这项前瞻性、非随机、登记的研究招募了大隐静脉静脉功能不全、伴或不伴小隐静脉、前副隐静脉和后副隐静脉功能不全的患者。对解剖成功、临床成功和疼痛进行评估。结果:150例患者(410条静脉)行静脉内激光消融(EVLA)。平均治疗静脉2.7条(1 ~ 7条)，平均总长度80.7 cm。12个月后出现98.3%的闭塞。临床改善显著，1个月静脉临床严重程度评分降低(1.7±1.9;P < 0.0001)和12个月(0.7±1.3;P < 0.0001)与术前相比(4.4±2.2)。术后1周平均疼痛程度为5.8/100。没有发生与手术或器械相关的并发症。结论:1470 nm EVLA与2ring纤薄纤维是一种非常有效的治疗选择，患者耐受性良好。尽管大量使用，纤维的完整性仍得以保存。临床注册:研究方案已在clinicaltrials.gov (NCT03810677)上注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Phlebology 医学-外周血管病

CiteScore

3.30

自引率

11.80%

发文量

审稿时长

6-12 weeks

期刊介绍： The leading scientific journal devoted entirely to venous disease, Phlebology is the official journal of several international societies devoted to the subject. It publishes the results of high quality studies and reviews on any factor that may influence the outcome of patients with venous disease. This journal provides authoritative information about all aspects of diseases of the veins including up to the minute reviews, original articles, and short reports on the latest treatment procedures and patient outcomes to help medical practitioners, allied health professionals and scientists stay up-to-date on developments. Print ISSN: 0268-3555