A randomized pilot study to evaluate graft versus fistula vascular access strategy in older patients with advanced kidney disease: results of a feasibility study.

BACKGROUND: Although older adults encompass almost half of patients with advanced chronic kidney disease, it remains unclear which long-term hemodialysis vascular access type, arteriovenous fistula or arteriovenous graft, is optimal with respect to effectiveness and patient satisfaction. Clinical outcomes based on the initial AV access type have not been evaluated in randomized controlled trials. This pilot study tested the feasibility of randomizing older adults with advanced kidney disease to initial arteriovenous fistula versus graft vascular access surgery. METHODS: Patients 65 years or older with pre-dialysis chronic kidney disease or incident end-stage kidney disease and no prior arteriovenous vascular access intervention were randomized in a 1:1 ratio to undergo surgical placement of a fistula or a graft after providing informed consent. Trial feasibility was evaluated as (i) recruitment of ≥ 70% of eligible participants, (ii) ≥ 50 to 70% of participants undergo placement of index arteriovenous access within 90 to 180 days of enrollment, respectively, (iii) ≥ 80% adherence to study-related assessments, and (iv) ≥ 70% of participants who underwent index arteriovenous access placement will have a follow-up duration of ≥ 12 months after index surgery date. RESULTS: Between September 2018 and October 2019, 81% (44/54) of eligible participants consented and were enrolled in the study; 11 had pre-dialysis chronic kidney disease, and 33 had incident or prevalent end-stage kidney disease. After randomization, 100% (21/21) assigned to arteriovenous fistula surgery and 78% (18/23) assigned to arteriovenous graft surgery underwent index arteriovenous access placement within a median (1st, 3rd quartile) of 5.0 (1.0, 14.0) days and 13.0 (5.0, 44.3) days, respectively, after referral to vascular surgery. The completion rates for study-specific assessments ranged between 40.0 and 88.6%. At median follow-up of 215.0 days, 5 participants expired, 7 completed 12 months of follow-up, and 29 are actively being followed. Assessments of grip strength, functional independence, and vascular access satisfaction were completed by > 85% of patients who reached pre-specified post-operative assessment time point. CONCLUSIONS: Results from this study reveal it is feasible to enroll and randomize older adults with advanced kidney disease to one of two different arteriovenous vascular access placement surgeries. The study can progress with minor protocol adjustments to a multisite clinical trial. TRIAL REGISTRATION: Clinical Trials ID, NCT03545113.

A randomized pilot study comparing graft-first to fistula-first strategies in older patients with incident end-stage kidney disease: Clinical rationale and study design.

Timely placement of an arteriovenous (AV) vascular access (native AV fistula [AVF] or prosthetic AV graft [AVG]) is necessary to limit the use of tunneled central venous catheters (TCVC) in patients with end-stage kidney disease (ESKD) treated with hemodialysis (HD). National guidelines recommend placement of AVF as the AV access of first choice in all patients to improve patient survival. The benefits of AVF over AVG are less certain in the older adults, as age-related biological changes independently modulate patient outcomes. This manuscript describes the rationale, study design and protocol for a randomized controlled pilot study of the feasibility and effects of AVG-first access placement in older adults with no prior AV access surgery. Fifty patients age ≥65 years, with incident ESKD on HD via TCVC or advanced kidney disease facing imminent HD initiation, and suitable upper extremity vasculature for initial placement of an AVF or AVG, will be randomly assigned to receive either an upper extremity AVG-first (intervention) or AVF-first (comparator) access. The study will establish feasibility of randomizing older adults to the two types of AV access surgery, evaluate relationships between measurements of preoperative physical function and vascular access development, compare vascular access outcomes between groups, and gather longitudinal assessments of upper extremity muscle strength, gait speed, performance of activities of daily living, and patient satisfaction with their vascular access and quality of life. Results will assist with the planning of a larger, multicenter trial assessing patient-centered outcomes.

Long-term outcomes of transposed basilic vein arteriovenous fistulae.

The need for reliable, long-term hemodialysis vascular access remains critical. To determine the long-term outcomes of transposed basilic vein arteriovenous fistulae (BVT) and their comparability with other vascular accesses, we determined retrospectively the primary and secondary patency rates in 58 BVT and in a total of 58 arteriovenous fistulae (AVF) and arteriovenous grafts (AVG) at a single center. Fifty-eight BVT were placed in 57 individuals, 69% after prior vascular access failure. Ten BVT failed before initial use and 2 patients expired with functioning accesses before dialysis initiation. In all 58 BVT, 46.8+/-10.8% functioned at 3 years, with median survival 30.8 months. Limiting analyses to the 46 BVT that were ultimately accessed, 3-year primary and secondary patency rates were 38.3+/-7.7% and 56.5+/-12.6%, respectively. Lower ejection fraction (p=0.054) and greater numbers of prior permanent dialysis catheters (p=0.005) were present in those with failed BVT. Compared with AVF, BVT had similar 3-year primary and secondary patency rates. The secondary patency rate was significantly better for BVT vs. AVG over the observation period; at 3 years, the rates were 56.5+/-12.6% vs. 9.1+/-6.0% (p=0.002), respectively. Basilic vein arteriovenous fistulae are valuable hemodialysis accesses. Although nearly 20% of newly placed BVT will not function before first use, those that are functional have median survivals exceeding 6 years, and 38% will not require intervention within 3 years of initial use.

Non-surgical salvage of thrombosed arterio-venous fistulae: a case series and review of the literature.

Attempts to salvage thrombosed hemodialysis arterio-venous fistulae (AVF) using interventional techniques are not universally performed. Patients often require temporary dialysis catheters pending creation of a new vascular access. We determined the long-term outcome of interventional (non-surgical) repair of completely thrombosed AVF in 49 consecutive accesses (22 radio-cephalic, 1 radio-basilic, 19 brachio-cephalic, and 7 brachio-basilic) referred for an intervention within 48 hours of thrombosis. Subjects were 65% male (32), with mean +/- SD age 63.7 +/- 13.5 years (range 33-91), 51% African-American (25), 47% Caucasian (23) and 65% had diabetes (32). Overall, 96% (47/49) of thrombosed AVF were salvaged with complications observed in four cases (two extravasations of contrast; two radial artery emboli), with no serious long-term sequelae. Interventional procedures included 34 venous angioplasties, 11 venous angioplasties with stenting and two combined venous and arterial angioplasties. The primary and secondary patency rates for all salvaged AVF were 50.5 +/- 8.7%, 72.5 +/- 7.8% at 1 year, and 43.3 +/- 10%, 55.4 +/- 12.7% at 2 years, respectively. The median estimate to first intervention after the declot procedure was 14.7 months. The median estimate for continued function exceeded 23.1 months. There was no significant statistical difference in the primary (p = 0.73) and secondary patency rates (p = 0.057) for forearm vs. upper arm AVF. We conclude that interventional repairs should routinely be employed to salvage newly thrombosed AVF. The vast majority of these individuals can avoid receiving dialysis catheters or placement of a new dialysis vascular access.