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 studyspecific 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. 4 The study can progress with minor protocol adjustments to a multisite clinical trial. Trial registration: Clinical Trials ID: NCT03545113. Registered June 4, 2018. Key Messages Regarding Feasibility 1) What uncertainties existed regarding the feasibility? No trial has objectively evaluated clinical outcomes in patients with advanced kidney disease based on the type of first hemodialysis arteriovenous vascular access placed. Hence, the feasibility of randomly assigning these patients to different surgical interventions for dialysis vascular access are unknown. Because this study focused on older patients with chronic disease, uncertaint...

SummaryBackground and objectives Comparisons of fistulas and grafts often overlook the high primary failure rate of fistulas. This study compared cumulative patency (time from access creation to permanent failure) of fistulas and grafts.Design, setting, participants, & measurements Vascular accesses of 1140 hemodialysis patients from two centers (Toronto and London, Ontario, Canada, 200022010) were analyzed. Cumulative patency was compared between groups using Kaplan-Meier survival curves and log-rank tests. Hazard ratios (HRs) for fistula failure relative to grafts and 95% confidence intervals (95% CIs) are reported.Results There were 1012 (88.8%) fistulas and 128 (11.2%) grafts. The primary failure rate was two times greater for fistulas than for grafts: 40% versus 19% (P,0.001). Cumulative patency did not differ between fistulas and grafts for the patients' first access (median, 7.4 versus 15.0 months, respectively [HR, 0.99; 95% CI, 0.7921.23; P=0.85]) or for 600 with a subsequent access (7.0 versus 9.0 months [HR, 0.93; 95% CI, 0.7721.13; P=0.39]). However, when primary failures were excluded, cumulative patency became significantly longer for fistulas than for grafts for both first and subsequent accesses (61.9 versus 23.8 months [HR, 0.56; 95% CI, 0.4320.74; P,0.001] and 42.8 versus 15.9 months [HR, 0.56; 95% CI, 0.4420.72; P,0.001]). Results were similar for forearm and upper-arm accesses. Compared with functioning fistulas, grafts necessitated twice as many angioplasties (1.4 versus 3.2/ 1000 days, respectively; P,0.001) and significantly more thrombolysis interventions (0.06 versus 0.98/1000 days; P,0.001) to maintain patency once matured and successfully used for dialysis.Conclusions Cumulative patency did not differ between fistulas and grafts; however, grafts necessitated more interventions to maintain functional patency.

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