Abstract: TH-PO759

Percutaneous AV Fistula Creation for Vascular Access

Session Information

Category: Dialysis

  • 603 Hemodialysis: Vascular Access

Authors

  • Cooper, Randy I., Southwest Kidney Institute, PLC, Phoenix, Arizona, United States
  • Narayan, Rajeev, San Antonio Kidney Disease Center, San Antonio, Texas, United States
  • Schaefer, Matthew E., San Antonio Kidney Disease Center, San Antonio, Texas, United States
  • Waheed, Umar, Southwest Kidney Institute, PLC, Phoenix, Arizona, United States
Background

In the era of Fistula First, nephrologists are well versed on the pitfalls of arterio-venous fistula (AVF) failure rates and surgical issues related to AVF creation. USRDS 2016 reports a primary fistula failure rate of 35.9%. Few innovations have evolved in AVF creation but recently several novel devices have been developed that can create AVF percutaneously.

Methods

Two nephrology groups with vascular centers were among 5 centers in a U.S. IDE pivotal study using a percutaneous device (Ellipsys; Avenu Medical, San Juan Capistrano, CA) to create AVF. Patients were selected based upon suitable anatomy as determined by ultrasound mapping. All procedures were performed in the physician’s centers. The primary outcome is maturation rate, defined as percentage of fistula suitable to allow successful cannulation for dialysis within 90 days including vein size and flow. The device is a single catheter that engages the walls of a perforating vein and proximal radial artery in the forearm. The AVF is created using thermal energy to “heat weld” the vessels together and cut the anastomosis.

Results

The Interventional Nephrologists (INs) in the study reported an average procedure time of 23 minutes. In addition, available 12 month follow-up data indicate a high patency rate of 96% and no significant clinical sequelae such as mega-fistulas or steal syndrome have been reported. One year data will be provided at the meeting.

Conclusion

Despite the advances from Fistula First, 80% of incident patients still initiate HD without a functioning AV access and 30% are still dialyzing with a catheter at 1 year. Our study demonstrates that PAVF offers a minimally invasive option for AVF creation that can be safely performed in an office-based setting by INs. The 90 day and 1 year data demonstrate technical and clinical success as well as a reduction in the maturation period in comparison to surgically created AVF. It is estimated, with the process under the control of the nephrologist, that catheter contact time (CCT) can be reduced by 90 days or more.

RESULTS
Fistula TypeTechnical SuccessTime to Maturation*Serious Adverse Events
Ellipsys pAVF n=6991.3%68 days1 (related to anesthesia)
Surgical creation64.1%136 daysRanges 2%-11%

*Access had flow suitable for dialysis (>4 mm vein/ >500 ml flow) Ave. Flow @ 90 days-1092 ml/min (cephalic) 1269 ml/min (basilic) Ave. Vessel diameter @ 90 days- 6.7 mm (cephalic) 6.2 mm (basilic)

Funding

  • Commercial Support