Abstract: FR-OR65
Long-Term Results of the Ellipsys Percutaneous Fistula for Hemodialysis
Session Information
- High-Impact Clinical Trials
November 05, 2021 | Location: Live-Stream, Virtual Only
Abstract Time: 11:30 AM - 11:45 AM
Category: Dialysis
- 703 Dialysis: Vascular Access
Authors
- 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
Background
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.
Methods
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).
Results
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.
Conclusion
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
Funding
- Commercial Support –