Comparing surgical and endovascular arteriovenous fistula creation

项目摘要/摘要 终末期肾病是一个严重的公共卫生问题，2017年影响了≥80万美国人。这个 在美国，ESKD最常见的治疗方法是血液透析(医疗保险支出为每人/年91,795美元)。 每个依赖血液透析的患者都需要血管通路，最常见的类型是 动静脉瘘(AVF)。使用血管内技术创建动静脉动静脉瘘的首批2个设备 (EndAVF)与传统手术技术(SurgAVF)相比，于2018年获得FDA批准。由于它们的新颖性， 关于最近批准的endAVF设备结果的现有数据主要来自行业赞助的试验 旨在展示设备的安全性和有效性。没有可用于比较以下结果的预期数据 EndAVF与SurgAVF的比较，但需要一项试验来产生这样的数据，以便为患者和临床医生的决策提供信息。 因此，拟议研究的总体目标是比较Surgage AVF和EndoAVF的手术结果， 从而获得设计和执行全面随机试验所需的数据，该试验将比较 Surgage AVF与EndoAVF的治疗结果比较。 两种可用于EndoAVF创建的设备都有其使用的特定解剖要求。早些时候 小规模研究表明，约50%-60%的筛查患者有资格仅基于EndoAVF创建 在这样的解剖学标准上。到目前为止，还没有数据表明有多少患者是解剖学候选人 一个或两个endAVF装置和SurgAVF，以及他们是否愿意参与endAVF的随机试验 或者SurgAVF。这个小型R01项目的结果将为设计和实施一个全面、多用途的 制度性随机试验比较外科和血管内动静脉瘘的临床结果。 目的1：确定接受瘘管形成评估的患者符合解剖学要求的比例 使用两个批准的装置中的一个和上臂外科AVF创建endAVF的标准。在2点 参与部位，我们将评估所有患者对endAVF装置和SurgalAVF装置的解剖适合性。 通过超声筛查评估瘘管的形成。 目的2：确定endAVF与SurgAVF创建术的临床和患者报告的结果，为设计 全面随机试验。符合这两种解剖标准且同意的患者将被随机分组。 到endAVF或SurgAVF，那些不同意的人将被提供参加预期结果 注册表。 目的3：确定患者是否愿意参加外科AVF与EndoAVF的随机试验 Surgage AVF与EndoAVF的前瞻性登记，以及各自的障碍和克服障碍的策略。 我们将与美国肾脏患者协会合作进行一项调查，并进行深入采访 以评估患者对参与研究的偏好。此外，我们还将进行调查和采访 我们各自机构的患者了解参与研究的障碍和促进者。

Project Summary/Abstract End-stage kidney disease (ESKD) is a grave public health problem, affecting ≥ 800,000 Americans in 2017. The most common treatment for ESKD in the US is hemodialysis (Medicare spending rate $91,795 per-person/year). Each hemodialysis-dependent patient requires vascular access, the most common type of which is arteriovenous fistula (AVF). The first 2 devices designed to create AVFs using endovascular techniques (endoAVF), vs. traditional surgical techniques (surgAVF), were FDA-approved in 2018. Due to their novel nature, existing data on outcomes of recently-approved endoAVF devices largely arose from industry-sponsored trials aimed at demonstrating device safety and efficacy. No prospective data are available comparing results of endoAVF vs. surgAVF, but a trial to yield such data is needed to inform patient and clinician decision-making. The overall goal of the proposed research is thus to compare procedural outcomes of surgAVF vs. endoAVF, and thus acquire the data needed to inform design and execution of a full-scale randomized trial that will compare the outcomes of surgAVF vs. endoAVF. Each of the 2 available devices for endoAVF creation have specific anatomic requirements for its use. Early small-scale studies showed that ~50-60% of patients screened were eligible for endoAVF creation based solely on such anatomic criteria. No data to date indicate the incidence of patients who are anatomic candidates for one or both endoAVF devices and surgAVF, nor their willingness to participate in a randomized trial of endoAVF or surgAVF. The results of this small-R01 project will inform the design and execution of a full-scale, multi- institutional randomized trial to compare clinical outcomes of surgical vs. endovascular arteriovenous fistula. Aim 1: Determine the proportion of patients who are being evaluated for fistula creation who meet the anatomic criteria for endoAVF creation with one of the two approved devices and an upper arm surgAVF. At the 2 participating sites, we will assess anatomic suitability for both endoAVF devices and for surgAVF in all patients evaluated for fistula creation, by ultrasound screening. Aim 2: Determine clinical and patient-reported outcomes of endoAVF vs surgAVF creation to inform design of a full- scale randomized trial. Patients who are anatomic candidates for both, and who consent, will be randomized to endoAVF or surgAVF, and those who do not consent will be offered enrollment in a prospective outcomes registry. Aim 3: Determine patients' willingness to participate in a randomized trial of surgAVF vs. endoAVF or in a prospective registry of surgAVF vs. endoAVF, and the barriers to each and strategies to overcome the barriers. We will partner with the American Association of Kidney Patients to conduct a survey, with in-depth interviews of a subgroup, to assess patient preferences about study participation. In addition, we will survey and interview patients at our respective institutions about barriers and facilitators to participating in the study.