Comparing surgical and endovascular arteriovenous fistula creation

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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.