Percutaneous fistulas can be alternatives to surgery for access creation in ESKD
Due to successful and durable access for hemodialysis through 5 years, percutaneous fistulas can be an alternative to surgery for access creation in patients with end-stage kidney disease, according to a speaker at ASN Kidney Week.
Following the Pivotal Multicenter Trial of Ultrasound Guided Percutaneous Arteriovenous Fistula (pAVF) Creation for Hemodialysis (Ellipsys Pivotal Trial), which showed “the early safety and efficacy in a two-stage procedure with creation followed by maturation of proximal radial artery fistula for hemodialysis,” Jeffrey E. Hull, MD, radiologist at Richmond Vascular Center in Virginia, and colleagues observed the long-term outcomes through 5 years.
Researchers combined prospective data from the Ellipsys Pivotal Trial with chart review to determine a median follow-up of 50 months. The review focused on fistula use, secondary procedures and complications. Both the initial procedures and follow-up took place in an office-based lab (OBL). There were 107 participants in the Ellipsys U.S. Pivotal Trial, most of which were male, 50% were obese with the average BMI of 31 kg/m2, about 61% were on cancer dialysis at the time of their placement and 74% had the cephalic vein as the target vein for dialysis.
“What we want to see [in ideal patient candidates] is they have a 2-mm artery in a 2-mm vein that are in direct contact at the proximal radial artery, and that they have suitable outflow veins [of] about 2 mm in diameter minimum,” Hull said. “There’s a fairly robust percentage of patients who qualify for this.
Follow-up revealed the percutaneous fistula (pAVF) was successfully used in 92.2% (83/90) of patients undergoing hemodialysis, and the non-use of pAVF occurred in 22.4% (24/107) patients (five pAVF not created, five abandoned, eight deaths, one transplant, one “pre-dialysis,” two lost to follow-up, one catheter and one peritoneal dialysis).
As for procedures, 0.93 were performed per patient per year in 5 years with 2.63 in the first year, then tapering to 0.25, 0.57, 0.18, 0.24 in years 2 to 5.
“Another important aspect of this trial was that we see in the first year that the results in terms of procedures per patient per year was similar to surgery, it was 2.66. But what we see in years 2 through 5 is that it varies between 0.18 and 0.57. So, there's a drastic reduction in secondary procedures and complications in these patients,” Hull said. “We attribute that to the low to moderate flow, it averaged 1,000 mL per minute, plus the multi-outflow feature of the fistula where if there's an injury to it, the blood flow would flow around it, keeping the overall fistula operational until it could be repaired.”
Researchers found secondary patency of 89.5%, 88.4%, 88.4%, 85.6% and 82% at years 1 to 5, and functional patency of 97.5%, 97.5%, 97.5% and 91.8% at years 1 to 4 after two-needle cannulation.
“This follow-up study has shown several important things. One: High-quality fistulas can be performed by interventional nephrology. Number two: We've increased the places where fistulas can be created. [These are] not just [in] the hospital, but now in the OBL and the ambulatory surgery center. The fistula data shows that we have high use, we have long good functional potency, we have low complications and good overall potency for 5 years,” Hull said. “So, the ongoing and future evaluation of these fistulas as includes comparing these against surgical fistulas.”
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Hull J, et al. Long-term results of the ellipsis percutaneous fistula for hemodialysis. Presented at: ASN Kidney Week; Nov. 4-7, 2021 (virtual meeting).
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