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经 Ellipsys 血管通路系统行经皮动静脉瘘创建的中期结果、技术建议和维护算法。

Midterm results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System, technical recommendations, and an algorithm for maintenance.

机构信息

Department of Vascular Surgery, Institut Mutualiste Montsouris, Paris, France.

Department of Angioaccess Surgery, Clinique Jouvenet, Paris, France.

出版信息

J Vasc Surg. 2020 Dec;72(6):2097-2106. doi: 10.1016/j.jvs.2020.02.048. Epub 2020 Apr 8.

Abstract

OBJECTIVE

The aim of this study was to report our midterm results of percutaneous arteriovenous fistula (pAVF) creation using the Ellipsys (Avenu Medical, San Juan Capistrano, Calif) device and to present technical recommendations and our algorithm of pAVF maintenance.

METHODS

A single-center comprehensive database of all consecutive predialysis and end-stage renal disease patients who had a pAVF creation with the Ellipsys device was reviewed retrospectively. Study end points included technical success, maturation, functional patency, and required interventions.

RESULTS

Between May 2017 and July 2019, there were 234 patients (mean age, 64 years; 148 male [63%]) who had a pAVF created. Technical success was achieved in 232 individuals (99%), and average duration of the procedure was 15 minutes (7-35 minutes). Average follow-up was 252 days (range, 83-696 days). The 1-year primary, primary assisted, and secondary patency rates were 54%, 85%, and 96%, respectively. Average pAVF flow was 923 mL/min (range, 425-1440 mL/min). There were no significant adverse events related to the procedure. Only three patients (1%) required a later conversion of the pAVF anastomosis to a surgical fistula. Twenty-four (10%) patients required superficialization of deep outflow veins because of difficult cannulation. Average maturation time was 4 weeks (range, 1-12 weeks). Fourteen patients (6%) had early (<2 weeks after creation) cannulation of the pAVF.

CONCLUSIONS

The Ellipsys pAVF device allows the rapid and safe creation of a reliable autogenous access. Rates of technical success, patency, and maturation were excellent. For patients unsuited for a distal radiocephalic arteriovenous fistula, it should be considered the next preferred access option.

摘要

目的

本研究旨在报告使用 Ellipsys(Avenu Medical,加利福尼亚州圣胡安卡皮斯特拉诺)设备进行经皮动静脉瘘(pAVF)创建的中期结果,并介绍技术建议和我们的 pAVF 维护算法。

方法

回顾性分析了 2017 年 5 月至 2019 年 7 月期间在单中心接受 Ellipsys 设备行 pAVF 治疗的所有透析前和终末期肾病患者的综合数据库。研究终点包括技术成功率、成熟度、功能通畅性和所需干预措施。

结果

在 234 例患者(平均年龄 64 岁;148 例男性[63%])中,有 232 例(99%)获得了技术成功,手术平均时间为 15 分钟(7-35 分钟)。平均随访时间为 252 天(83-696 天)。1 年原发性、原发性辅助和继发性通畅率分别为 54%、85%和 96%。平均 pAVF 流量为 923ml/min(425-1440ml/min)。无与手术相关的重大不良事件。仅 3 例患者(1%)需要将 pAVF 吻合口后期转换为手术瘘。24 例(10%)患者由于难以穿刺而需要浅表化深部流出静脉。平均成熟时间为 4 周(1-12 周)。14 例患者(6%)在创建后 2 周内(<2 周)早期对 pAVF 进行了穿刺。

结论

Ellipsys pAVF 设备可快速、安全地创建可靠的自体通路。技术成功率、通畅率和成熟度均非常出色。对于不适合远端头静脉桡动脉动静脉瘘的患者,应考虑将其作为下一个首选的通路选择。

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