Trial of Fistula Versus Graft in Elderly Patients

End-stage renal disease requiring dialysis affects approximately 400,000 patients in the
United States with 100,000 new patients starting dialysis annually. The vast majority of
those patients utilize hemodialysis (HD), and of that group, approximately 80% start with a
tunneled dialysis catheter (TDC). Current guidelines discourage TDC, due to the risk of
serious complications like bloodstream infections, central venous stenosis, and an associated
increased mortality risk. The preferred alternative is an arteriovenous (AV) access, either
native arteriovenous fistulas (AVF) or prosthetic arteriovenous grafts (AVG). AVF are
considered the ideal long-term vascular access due to longer patency, lower costs, and an
association with longer survival as compared to AVG when they successfully mature. However,
AVF frequently require many months to mature after being constructed and have high primary
failure rates (i.e., inability to be used without revision); AVG typically perform better
short term, enabling early TDC removal and reduction in catheter related harms, but higher
rates of failure and complications long term.

In older populations, multiple studies have suggested that the elderly population may not
benefit from AVF as opposed to AVG, due to high AVF primary failure rates and overall
abbreviated life expectancy that minimizes any possible long-term benefit with AVF.

METHODS AND ANALYSIS: This open-label pilot randomized controlled trial will test the
feasibility and safety of randomizing patients over 65 years old who start hemodialysis with
a TDC (the most common initial type of HD access), and are eligible to receive either AVF or
AVG, to an AVF strategy (comparator) or to an AVG strategy (intervention). We will enroll 50
patients. Participants will provide informed consent, and they will be assigned to the AVF or
AVG arms. The primary outcome is feasibility, which we will assess by measuring: (1) the
annual rate of enrollment in the study, accounting for the number of surgeons who
participate; and (2) the proportion of randomized participants who receive the assigned AV
access. Secondary outcomes will include perioperative morbidity and mortality, catheter
removal rates, additional procedures performed, and the reasons a patient may not receive the
assigned AV access after randomization.

Inclusion Criteria:

- Age greater than 65 years old.

- On hemodialysis through a tunneled dialysis catheter.

- In the surgeon's opinion, both a fistula and a graft can be reasonably attempted,
based on the patient's anatomy.

Exclusion Criteria:

- Unable to provide informed consent.

- Unable to be medically cleared for surgery

- Does not wish to have surgery.

- Does not wish to be randomized.