Comparison of surgical versus percutaneously created arteriovenous hemodialysis fistulas.

OBJECTIVE: The aim of the present study was to compare the results between percutaneous arteriovenous fistulas (p-AVFs) created with the Ellipsys device (Ellipsys Vascular Access System; Avenu Medical, San Juan Capistrano, Calif) and surgical arteriovenous fistulas (s-AVFs). METHODS: A single-center retrospective comparative study of the first 107 patients who had undergone p-AVF creation with the Ellipsys system from May 2017 to May 2018 with an equal number of consecutive patients who had undergone s-AVF creation in our center during the same period. The primary endpoints included the maturation and patency rates. The secondary endpoints were reintervention, risk of infection, and the incidence of steal syndrome and aneurysm formation. RESULTS: The demographic, hypertension, and diabetes data were similar for both groups. The only difference between the two groups was that more p-AVF patients had already been receiving hemodialysis (61% vs 47%; P < .05). The p-AVFs showed superior maturation rates at 6 weeks (65% vs 50%; P = .01). The primary patency rates were greater for the s-AVFs at 12 months (86% vs 61%; P < .01). However, primary patency was comparable between the two groups at 24 months (52% vs 55%; P = .48). No significant difference was found in the secondary patency rates at 12 (90% vs 91%) and 24 (88% vs 91%) months. At the 2-year follow-up point, the rate of percutaneous reintervention was similar; however, the s-AVFs had required more frequent surgical revision (36% vs 17%; P = .01). Issues with wound healing and infection were also more frequent with s-AVFs (9% vs 0.9%; P < .01). CONCLUSIONS: Fistulas created percutaneously with the Ellipsys system showed superior maturation rates and similar patency with s-AVFs created in an experienced high-volume vascular surgery practice. p-AVFs had a lower risk of wound healing issues, infection, and surgical revision. Larger, prospective, randomized multicenter studies are needed to confirm these findings.

Percutaneous creation of proximal radio-radial arteriovenous hemodialysis fistula before secondary brachial vein elevation.

OBJECTIVE: We evaluate the creation of a percutaneous proximal radial artery-radial vein arteriovenous fistula with Ellipsys® instead of the usual first-stage brachial artery fistula prior to a second-stage brachial vein elevation, in patients with inadequate cephalic and basilic veins. METHODS: Single center study of eight patients (six males, mean = 54 years) who underwent a two-stage brachial vein elevation procedure between May 2017 and October 2019. Inclusion criteria were life expectancy > 6 months, patent brachial and proximal radial artery (>2 mm in diameter) absent/inadequate cephalic and basilic veins, existence of a brachial vein >3 mm in diameter, and in continuity with a proximal radial vein > 2 mm in diameter. RESULTS: Technical success was 100%. Four patients required angioplasty of a juxta-anastomotic stenosis, accounting for a 6-month primary and secondary patency rates were 68% and 100%, respectively. Access flow averaged 982 mL/min (range 768-1586) at final follow-up evaluation. There were no significant adverse events related to the procedures. All fistulae were elevated at 4-12 (mean: 8) weeks post creation and were successfully cannulated with two needles after healing was completed (2-4 weeks after elevation). No patients developed hand ischemia or arm edema. CONCLUSIONS: Percutaneous creation of a proximal radial artery-radial vein fistula followed by brachial vein elevation is a safe and reliable option for autogenous access creation in patients with inadequate cephalic or basilic veins. Minimally invasive radial artery inflow and longer available length of the targeted brachial vein available for elevation are the main advantages in skilled hands.

Midterm results of percutaneous arteriovenous fistula creation with the Ellipsys Vascular Access System, technical recommendations, and an algorithm for maintenance.

OBJECTIVE: The aim of this study was to report our midterm results of percutaneous arteriovenous fistula (pAVF) creation using the Ellipsys (Avenu Medical, San Juan Capistrano, Calif) device and to present technical recommendations and our algorithm of pAVF maintenance. METHODS: A single-center comprehensive database of all consecutive predialysis and end-stage renal disease patients who had a pAVF creation with the Ellipsys device was reviewed retrospectively. Study end points included technical success, maturation, functional patency, and required interventions. RESULTS: Between May 2017 and July 2019, there were 234 patients (mean age, 64 years; 148 male [63%]) who had a pAVF created. Technical success was achieved in 232 individuals (99%), and average duration of the procedure was 15 minutes (7-35 minutes). Average follow-up was 252 days (range, 83-696 days). The 1-year primary, primary assisted, and secondary patency rates were 54%, 85%, and 96%, respectively. Average pAVF flow was 923 mL/min (range, 425-1440 mL/min). There were no significant adverse events related to the procedure. Only three patients (1%) required a later conversion of the pAVF anastomosis to a surgical fistula. Twenty-four (10%) patients required superficialization of deep outflow veins because of difficult cannulation. Average maturation time was 4 weeks (range, 1-12 weeks). Fourteen patients (6%) had early (<2 weeks after creation) cannulation of the pAVF. CONCLUSIONS: The Ellipsys pAVF device allows the rapid and safe creation of a reliable autogenous access. Rates of technical success, patency, and maturation were excellent. For patients unsuited for a distal radiocephalic arteriovenous fistula, it should be considered the next preferred access option.