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Abstract: FR-OR65

Long-Term Results of the Ellipsys Percutaneous Fistula for Hemodialysis

Session Information

Category: Dialysis

  • 703 Dialysis: Vascular Access


  • Hull, Jeffrey E., Richmond Vascular Center, Richmond, Virginia, United States
  • Jennings, William C., The University of Oklahoma - Tulsa, Tulsa, Oklahoma, United States
  • Cooper, Randy I., Southwest Kidney Institute Central Phoenix, Phoenix, Arizona, United States
  • Narayan, Rajeev, San Antonio Kidney Disease Center, San Antonio, Texas, United States
  • Mawla, Neghae, Dallas Nephrology, Dallas, Texas, United States

The Pivotal Multicenter Trial of Ultrasound Guided Percutaneous Arteriorvenous Fistula (pAVF) Creation for Hemodialysis (Ellipsys Pivotal Trial) demonstrated the early safety and efficacy in a two-stage procedure with creation followed by maturation of proximal radial artery fistula for hemodialysis. The long-term outcomes through 5 years were evaluated to demonstrate fistula use, durability, and complications.


Prospective data from Ellipsys Pivotal Trial was combined with chart review to obtain a median follow-up of 50 (12 to 60) months. Review included fistula use, secondary procedures, and complications. The initial procedures and follow-up were performed in the office based lab (OBL).


The percutaneous fistula (pAVF) was successfully used in 92.2% (83/90) of patients undergoing hemodialysis. Non-use of pAVF occurred in 22.4% (24/107) patients: 5 pAVF not created, 5 abandoned, 8 deaths, 1 transplant, 1 pre dialysis, 2 lost to follow-up, 1 catheter, 1 peritoneal dialysis. Procedures performed per patient per year (PPPY) to maintain function and patency was 0.93 (362/391) over 5 years with 2.63 in the first year, and then declining to 0.25, 0.57, 0.18, 0.24 in years 2-5. Access complications the location and treatment are listed in Table 1. Kaplan-Meier (KM) analysis demonstrated secondary patency of 89.5%, 88.4%, 88.4%, 85.6%, and 82.0% at years 1-5. Functional patency was 97.5%, 97.5%, 97.5%, and 91.8% at years 1-4 after two-needle cannulation.


Percutaneous fistulae created by interventionalist in the office based lab have provided durable access for hemodialysis through 5 years with a high rate of fistula use, and low rates of secondary procedures and complications.

Table 1: Access Complications and Treatment


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