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用于创建血液透析动静脉内瘘的植入式血管外部支撑装置(VasQ™):单中心经验。

Implanted blood vessel external support device (VasQ™) for creation of hemodialysis arteriovenous fistula: A single-center experience.

作者信息

Leonardi Gianluca, Campagna Marco, Pellicanò Vincenzo, Guarena Cesare, Bergamo Daniela, Lavacca Antonio, Fop Fabrizio, Biancone Luigi

机构信息

S.C. Nefrologia, Dialisi e Trapianto A.O.U. Città della Salute e della Scienza, Turin, Italy.

出版信息

J Vasc Access. 2021 Jul;22(4):658-665. doi: 10.1177/1129729820971533. Epub 2020 Nov 12.

DOI:10.1177/1129729820971533
PMID:33183181
Abstract

INTRODUCTION

the external support device VasQ is intended to promote arteriovenous fistula (AVF) maturation by maintaining the optimal anastomotic angle in order to minimize blood flow disturbances around the anastomotic area. The aim of the study is to assess efficacy and safety of the VasQ device both in brachiocephalic and radiocephalic fistulae.

METHODS

a single institution prospective study was conducted with implantation of the VasQ device during AVF creation. Clinical and Doppler ultrasounds evaluations were performed at day-1, 1, 6, and 12 months for assessment of device-related adverse events, AVF maturation and patency. Moreover, volume flow rate and diameter of outflow vein were measured. A total of 16 patients were enrolled. Ten brachiocephalic and 6 radiocephalic AVFs were created with VasQ. Preoperatively cephalic vein diameter was 3.6 ± 0.9 mm.

RESULTS

our population included 13 male and 3 females patients, 9 end stage kidney disease in conservative therapy, 4 dialysis treated patients, and 3 transplanted patients; mean age was 74.0 ± 8.1 years; no severe device-related adverse events were observed. Primary patency at 1, 6, and 12 months was 100%, 87.5%, and 67.7%, respectively, while secondary patency was 100%, 100%, and 78.3%, respectively. Comparing brachiocephalic to radiocephalic AVFs no significant differences in patency rates were seen. Overall maturation rate was 94% (15/16). Mean vein diameter measured with Doppler ultrasound at postoperative day-1 and at 1, 6, and 12 months was 5.0 ± 1.0, 5.9 ± 0.9, 7.2 ± 1.6, and 7.9 ± 1.4 mm, respectively, with a mean flow rate at the brachial artery of 841 ± 176, 1052 ± 224, 1261 ± 490, and 1348 ± 477 ml/min, respectively.

CONCLUSIONS

in our limited experience VasQ was safe, with high maturation and patency rates. Positive results suggest a potential benefit for VasQ in AVF.

摘要

引言

外部支撑装置VasQ旨在通过维持最佳吻合角度来促进动静脉内瘘(AVF)成熟,从而最大程度减少吻合区域周围的血流干扰。本研究的目的是评估VasQ装置在头臂动静脉内瘘和桡动脉-头静脉内瘘中的有效性和安全性。

方法

进行了一项单机构前瞻性研究,在创建AVF期间植入VasQ装置。在第1天、1个月、6个月和12个月进行临床和多普勒超声评估,以评估与装置相关的不良事件、AVF成熟度和通畅性。此外,还测量了流出静脉的体积流速和直径。共纳入16例患者。使用VasQ创建了10个头臂动静脉内瘘和6个桡动脉-头静脉内瘘。术前头静脉直径为3.6±0.9毫米。

结果

我们的研究对象包括13例男性和3例女性患者,9例处于保守治疗的终末期肾病患者,4例接受透析治疗的患者和3例移植患者;平均年龄为74.0±8.1岁;未观察到严重的与装置相关的不良事件。1个月、6个月和12个月时的初次通畅率分别为100%、87.5%和67.7%,而二次通畅率分别为100%、100%和78.3%。比较头臂动静脉内瘘和桡动脉-头静脉内瘘,通畅率无显著差异。总体成熟率为94%(15/16)。术后第1天、1个月、6个月和12个月用多普勒超声测量的平均静脉直径分别为5.0±1.0、5.9±0.9、7.2±1.6和7.9±1.4毫米,肱动脉的平均流速分别为841±176、1052±224、1261±490和1348±477毫升/分钟。

结论

根据我们有限的经验,VasQ是安全的,具有较高的成熟率和通畅率。阳性结果表明VasQ在AVF中具有潜在益处。

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