Comparing surgical and endovascular arteriovenous fistula creation

手术与血管内动静脉内瘘创建的比较

• 批准号: 10586937
• 负责人: Karen Woo
• 金额: $ 32.04万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-25 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586937
• 关键词: Affect; American; Anatomy; Arteriovenous fistula; Blood Vessels; Caliber; Characteristics; Clinical; Consent; Data; Decision Making; Device Designs; Device Safety; Devices; Disadvantaged; End stage renal failure; Enrollment; FDA approved; Face; Fistula; Goals; Gold; Guidelines; Hemodialysis; Hospitalization; Incidence; Industry; Institution; Intervention; Interview; Intravenous; Kidney; Local anesthesia; Longevity; Medicare; Minor Surgical Procedures; Nature; Nerve; Operating Rooms; Operative Surgical Procedures; Outcome; Patient Outcomes Assessments; Patient Preferences; Patients; Persons; Pilot Projects; Procedures; Public Health; Quality of life; Randomized; Recommendation; Registries; Research; Sedation procedure; Site; Subgroup; Surveys; Techniques; Thick; Update; Upper arm; base; common treatment; design; novel; operation; patient screening; prospective; randomized trial; screening; surgery outcome; ultrasound; virtual; willingness

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.

项目总结/摘要 终末期肾病（ESKD）是一个严重的公共卫生问题，2017年影响了≥ 80万美国人。的 在美国，ESKD最常见的治疗是血液透析（医疗保险费用为每人/年91，795美元）。 每个血液透析依赖患者都需要血管通路，最常见的类型是 动静脉瘘（AVF）。前2种器械设计用于使用血管内技术创建AVF （endoAVF）与传统手术技术（EAVF）相比，于2018年获得FDA批准。由于其新颖的性质， 关于最近批准的endoAVF器械结局的现有数据主要来自行业申办的试验 旨在证明器械的安全性和有效性。没有前瞻性数据可用于比较 endoAVF vs. endoAVF，但需要进行试验以获得此类数据，以便为患者和临床医生决策提供信息。 因此，拟议研究的总体目标是比较EMAAVF与endoAVF的手术结局， 从而获得所需的数据，为设计和执行一项全面的随机试验提供信息， AVF与endoAVF的结局。 用于创建endoAVF的2种可用器械均具有特定的解剖结构要求。早期 小规模研究显示，约50-60%的筛选患者有资格仅基于 在这样的解剖学标准上。到目前为止，没有数据表明解剖学候选者的患者发生率， 一种或两种endoAVF器械和EAVF，也不愿意参加endoAVF的随机试验 或者说是一种这个小型R 01项目的结果将为一个全尺寸、多功能、 比较手术与血管内动静脉瘘临床结局的机构随机试验。 目的1：确定接受瘘管创建评估的符合解剖学要求的患者比例 使用两种获批器械中的一种器械和上臂AVF创建endoAVF的标准。在2 参与临床试验机构，我们将评估所有患者的endoAVF器械和endoAVF的解剖学适用性 通过超声筛查评价瘘管形成。 目的2：确定endoAVF与endoAVF创建的临床和患者报告结局，以告知设计 全面随机试验。两种手术的解剖学候选人且同意的患者将被随机化 endoAVF或endoAVF，不同意的患者将被纳入前瞻性结局研究 注册表 目的3：确定患者是否愿意参加一项比较血管内动静脉瘘与血管内动静脉瘘的随机试验， AAVF与endoAVF的前瞻性登记研究，以及各自的障碍和克服障碍的策略。 我们将与美国肾脏病患者协会合作进行一项调查，并进行深入访谈 评估患者对研究参与的偏好。此外，我们还将调查和采访 患者在我们各自的机构的障碍和促进参与研究。