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

2017; Elsevier BV; Volume: 70; Issue: 4 Linguagem: Inglês

10.1053/j.ajkd.2017.03.026

1523-6838

Charmaine E. Lok, Dheeraj K. Rajan, Jason Clement, Mercedeh Kiaii, Ravi Sidhu, Ken Thomson, George P. Buldo, Christine Dipchand, Louise Moist, Joanna Sasal, Charmaine E. Lok, Dheeraj K. Rajan, Kenneth W. Sniderman, Jeff Jaskolka, Kong Teng Tan, Joanna Sasal, Mercedeh Kiaii, Jason Clement, Ravi Sidhu, George P. Buldo, Murray Asch, Gilles Soulez, Jean Éthier, A. Granger-Vallee, Patrick Gilbert, Louise Moist, Amol Mujoomdar, Christine Dipchand, Robert E. Berry, Robert J. Abraham, Karthik Tennankor, Mark T. Walsh, Ken Thomson, Scott G. Wilson, Tom Snow, Gerard S. Goh, Rowan G. Walker, Mathew Claydon, Jim Koukounaras, Andrew Holden, Andrew G. Hill, David Semple, David W. Mudge, John Harper, Magid Fahim, Gilbert Pavilion, Ross S. Francis, Nicole M. Isbel, Carmel M. Hawley, David W. Johnson, Scott B. Campbell,

Vascular anomalies and interventions

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.Prospective, single-arm, multicenter study (Novel Endovascular Access Trial [NEAT]).Consecutive adult non-dialysis-dependent and dialysis-dependent patients referred for vascular access creation at 9 centers in Canada, Australia, and New Zealand.Using catheter-based endovascular technology and radiofrequency energy, an anastomosis was created between target vessels, resulting in an endovascular AVF (endoAVF).Safety, efficacy, functional usability, and patency end points.Safety as percentage of device-related serious adverse events; efficacy as percentage of endoAVFs physiologically suitable (brachial artery flow ≥ 500mL/min, vein diameter ≥ 4mm) 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.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, 918mL/min; endoAVF vein diameter, 5.2mm [cephalic vein]). EndoAVF functional usability was 64% in participants who received dialysis. 12-month primary and cumulative patencies were 69% and 84%, respectively.Due to the unique anatomy and vessels used to create endoAVFs, this was a single-arm study without a surgical comparator.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.