Longitudinal micro-incision creation prior to balloon angioplasty for treatment of arteriovenous access dysfunction in a real-world patient population: 6-month cohort analysis

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2023-08-17 DOI:10.1111/hdi.13111

John Aruny, Jeffrey E. Hull, Alexander Yevzlin, Alejandro C. Alvarez, Jason D. Beaver, Robert W. Heidepriem III, Michael T. Serle

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Abstract

Introduction

Routine hemodialysis depends on well-functioning vascular access. In the event of vascular access dysfunction, percutaneous transluminal balloon angioplasty (PTA) is conducted to restore patency. Although an angioplasty procedure can provide an excellent immediate result by opening the access to allow dialysis to continue, the long-term patency rates are less than satisfactory. The goal of this study was to assess the outcomes of patients who underwent a novel vessel preparation via longitudinal, controlled-depth micro-incisions prior to PTA.

Methods

This multicenter, prospective, observational registry enrolled hemodialysis patients scheduled to undergo PTA of their arteriovenous fistula or graft due to clinical or hemodynamic abnormalities. A primary endpoint was anatomic success, defined as angiographic confirmation of <30% residual stenosis post-procedure without an adverse event. Additional assessments included device technical success, clinical success, freedom from target lesion revascularization, target lesion primary patency, and circuit primary patency at 6 months.

Findings

A total of 148 lesions were treated with the FLEX Vessel Prep™ System (FLEX VP) prior to PTA in 114 subjects at eight clinical sites. Target lesions were 21 ± 25 mm in length with mean pre-procedure stenosis of 75.2% ± 4.7%. Five procedural complications were recorded without serious adverse events. Two subjects did not complete the follow-up evaluation. Target lesion primary patency across all subjects at 6-months was 62.2% with mean freedom from target lesion revascularization of 202.7 days. Target lesion primary patency and freedom from target lesion revascularization for AVF cases (n = 72) were 67.5% and 212.9 days, respectively. Target lesion primary patency and freedom from target lesion revascularization for AVGs (n = 42) were 52.4% and 183.3 days, respectively. In cases treating AVF cephalic arch stenosis (n = 25), 6-month target lesion primary patency was 70.6% and freedom from target lesion revascularization was 213.4 days.

Discussion

This FLEX-AV registry demonstrates safety and effectiveness, notably in the cephalic arch and AVGs, when FLEX VP is used prior to PTA for treatment of vascular access dysfunction in a population of end-stage renal disease subjects.

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球囊血管成形术治疗真实世界患者群动静脉通路功能障碍前的纵向微切口创建：6个月的队列分析。

简介：常规血液透析依赖于功能良好的血管通路。在血管通路功能障碍的情况下，进行经皮腔内球囊血管成形术（PTA）以恢复通畅性。尽管血管成形术可以通过打开通道以允许透析继续来提供极好的即时结果，但长期通畅率并不令人满意。本研究的目的是评估PTA前通过纵向、控制深度的微切口进行新型血管制备的患者的结果。方法：这项多中心、前瞻性、观察性的登记纳入了因临床或血液动力学异常而计划对其动静脉瘘或移植物进行PTA的血液透析患者。主要终点是解剖成功，定义为血管造影结果的确认：共有148个病变接受了FLEX血管预备治疗™ 在八个临床部位的114名受试者中进行PTA前的系统（FLEX-VP）。目标病变为21 ± 25 长度为mm，术前平均狭窄率为75.2% ± 4.7%。记录了5例手术并发症，无严重不良事件。两名受试者未完成随访评估。所有受试者在6个月时的靶病变原发性通畅率为62.2%，靶病变血运重建的平均自由度为202.7 天。AVF病例的靶病变原发性通畅性和无靶病变血运重建的自由度（n = 72）分别为67.5%和212.9 天。AVG的靶病变原发性通畅性和无靶病变血运重建的自由度（n = 42）分别为52.4%和183.3 天。在治疗AVF头弓狭窄的病例中（n = 25），6个月的靶病变原发性通畅率为70.6%，无靶病变血运重建率为213.4 天。讨论：在终末期肾病受试者群体中，当在PTA之前使用FLEX-VP治疗血管通路功能障碍时，该FLEX-AV登记证明了安全性和有效性，尤其是在头弓和AVG中。

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

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.