Balloon-assisted maturation of autogenous arteriovenous fistulae: A randomized controlled prospective study

Background: Current guidelines recommend referral of patient with renal failure for access creation 6 months before planned dialysis. There is a growing cohort of patients that require long-term hemodialysis without adequate preparation. Temporary dialysis catheters and rapid access arteriovenous grafts (AVG) are far from being an ideal solution in this scenario. In an effort to expedite maturation of autogenous arteriovenous fistulae (AVF), balloon-assisted maturation (BAM) was advised by some authors. This technique still lacks the support of high-level evidence studies. We investigated the ability of intra-operative BAM to induce early functional maturation of AVFs. Methods: This is a prospective randomized controlled study conducted in a tertiary referral center, with a catchment area of more than 15 million population. Cases were divided into two groups; Group (A), where BAM technique was performed, while in the control group (B), the standard technique was used (NO BAM) for creation of AVFs. Results: Between June 2017 and May 2019, 300 cases were recruited from a total of 648 primary AVF creation instances. Patients’ age ranged from 19 to 89 (mean 51.17 ±SD 15.5) years. Group A (BAM) included 52.3% (n = 157) AVFs, while Group B included 47.7% (n = 143) AVFs. The average maturation time was 3.7 weeks (SD ± 1.3, 95% CI 3.55–3.95) and 5.91 weeks (SD ± 2.2, 95% CI 5.55–6.26) for both groups, respectively (p = 0.0001). 78.3% of the AVFs that underwent BAM showed early maturation within 2–4 weeks vs 32.2% only in the NO BAM group (p = 0.002). Successful functional maturation was higher among cases of the BAM group (93%), compared to the NO BAM group (77%) (p = 0.001). Complication rates were 9.6% and 4.9% in the two groups, respectively (p = 0.042). Conclusion: BAM can play a pivotal role in helping the dialysis society meet the goals of the Fistula First Initiative, keeping in mind that this comes with an increased risk of complications. BAM should be considered only when unplanned early access to long-term dialysis is required.