Endovascular Proximal Forearm Arteriovenous Fistula for Hemodialysis Access: Results of the Prospective, Multicenter Novel Endovascular Access Trial (NEAT)

Charmaine E. Lok, Dheeraj K. Rajan, Jason Clement, Mercedeh Kiaii, Ravi Sidhu, Ken Thomson, George Buldo, Christine Dipchand, Louise Moist, Joanna Sasal, on behalf of the NEAT Investigators

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Abstract

Background Hemodialysis arteriovenous fistulas (AVFs) are suboptimally used primarily due to problems with maturation, early thrombosis, and patient nonacceptance. An endovascular approach to fistula creation without open surgery offers another hemodialysis vascular access option. Study Design Prospective, single-arm, multicenter study (Novel Endovascular Access Trial [NEAT]). Settings & Participants Consecutive adult non−dialysis-dependent and dialysis-dependent patients referred for vascular access creation at 9 centers in Canada, Australia, and New Zealand. Intervention Using catheter-based endovascular technology and radiofrequency energy, an anastomosis was created between target vessels, resulting in an endovascular AVF (endoAVF). Outcomes Safety, efficacy, functional usability, and patency end points. Measurements Safety as percentage of device-related serious adverse events; efficacy as percentage of endoAVFs physiologically suitable (brachial artery flow ≥ 500 mL/min, vein diameter ≥ 4 mm) for dialysis within 3 months; functional usability of endoAVFs to provide prescribed dialysis via 2-needle cannulation; primary and cumulative endoAVF patencies per standardized definitions. Results 80 patients were enrolled (20 roll-in and 60 participants in the full analysis set; the latter are reported). EndoAVFs were created in 98% of participants; 8% had a serious procedure-related adverse event (2% device related). 87% were physiologically suitable for dialysis (eg, mean brachial artery flow, 918 mL/min; endoAVF vein diameter, 5.2 mm [cephalic vein]). EndoAVF functional usability was 64% in participants who received dialysis. 12-month primary and cumulative patencies were 69% and 84%, respectively. Limitations Due to the unique anatomy and vessels used to create endoAVFs, this was a single-arm study without a surgical comparator. Conclusions An endoAVF can be reliably created using a radiofrequency magnetic catheter-based system, without open surgery and with minimal complications. The endoAVF can be successfully used for hemodialysis and demonstrated high 12-month cumulative patencies. It may be a viable alternative option for achieving AVFs for hemodialysis patients in need of vascular access.

Original languageEnglish
Pages (from-to)486-497
Number of pages12
JournalAmerican Journal of Kidney Diseases
Volume70
Issue number4
DOIs
Publication statusPublished - 1 Oct 2017
Externally publishedYes

Keywords

  • access creation
  • Arteriovenous fistula (AVF)
  • blood flow rate
  • cannulation
  • end-stage renal disease (ESRD)
  • endoAVF
  • endovascular
  • endovascular fistula
  • ESRD
  • fistula failure
  • fistula maturation
  • hemodialysis
  • magnetic
  • patency
  • radiofrequency
  • vascular access

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