Abstract: SA-OR125

The Pivotal Multicenter Trial of Ultrasound Guided Percutaneous Arteriovenous Fistulae for Hemodialysis Access

Session Information

Category: Dialysis

  • 603 Hemodialysis: Vascular Access

Authors

  • Hull, Jeffrey E, Richmond Vascular Center, North Chesterfield, Virginia, United States
  • Jennings, William C, Univ OK Med Col, Tulsa OK, Tulsa, Oklahoma, United States
  • Cooper, Randy I., Southwest Kidney Institute, PLC, Tempe, Arizona, United States
  • Waheed, Umar, Southwest Kidney Institute, PLC, Tempe, Arizona, United States
  • Schaefer, Matthew E., San Antonio Kidney Disease Center, San Antonio, Texas, United States
  • Narayan, Rajeev, San Antonio Kidney Disease Center, San Antonio, Texas, United States
Background

Arteriovenous fistulae for hemodialysis are usually created by a surgical procedure. Percutaneous creation of an arteriovenous fistulae with a thermal resistance anastomosis device (TRAD) in an office based vascular center is emerging as an alternative to surgery.

Methods

One hundred seven patients were enrolled in a prospective, non-inferiority trial at 5 sites. Patients underwent ultrasound guided anastomosis creation between the proximal radial artery and perforating vein with the Ellipsys® Vascular Access System followed by seperate maturation procedures. All procedures were performed in outpatient vascular centers. The primary endpoints were brachial artery flow volume ≥ 500 mL/min and vein diameter ≥ 4 mm in > 49% of patients, and absence of device related complications at 90 days.

Results

Arteriovenous fistulae with fused anastomoses were created in 95% (102/107) patients. Maturation procedures included anastomotic balloon dilation in 72% (77/107), brachial vein embolization in 32% (34/107), cubital vein ligation in 27% (29/107), and surgical transposition in 26% (28/107). The primary flow and diameter endpoints were achieved in 86.0% (92/107) of the patients exceeding the performance goal of 49% (p < 0.0001). There were no major adverse events attributed to the device. Cumulative patency was 96.1%, 93.7%, 91.0 % at 90, 180, and 360 days, respectively. The target dialysis vein was the cephalic, basilic, and brachial veins in 74% (73/99), 24% (24/99), 2% (2/99), respectively. 2-needle dialysis was achieved in 88% (71/81) of patients on hemodialysis at a mean 113.1 ± 72.0 days. Functional patency was 98.4%, 98.4%, and 92.3% at 90, 180, and 360 days, respectively.

Conclusion

The Ellipsys® Vascular Access System met the primary safety, and efficacy endpoint goals in the United States pivotal trial.

Funding

  • Commercial Support