Charmaine E Lok1, Dheeraj K Rajan2, Jason Clement3, Mercedeh Kiaii4, Ravi Sidhu5, Ken Thomson6, George Buldo7, Christine Dipchand8, Louise Moist9, Joanna Sasal10. 1. Division of Nephrology, Department of Medicine, University Health Network, Toronto, Ontario; University of Toronto, Toronto, Ontario. Electronic address: charmaine.lok@uhn.ca. 2. University of Toronto, Toronto, Ontario; Division of Vascular & Interventional Radiology, Department of Medical Imaging, Peter Munk Cardiac Center, University Health Network, Toronto, Ontario. 3. Department of Radiology, St. Paul's Hospital, Vancouver, BC, Canada. 4. Division of Nephrology, Department of Medicine, St. Paul's Hospital, Vancouver, BC, Canada. 5. Division of Vascular Surgery, St. Paul's Hospital, Vancouver, BC, Canada. 6. Department of Radiology, Alfred Hospital, Melbourne, Australia. 7. Division of Nephrology, Department of Medicine, Lakeridge Health, Oshawa, ON. 8. Division of Nephrology, Department of Medicine, Dalhousie University, Halifax, NS. 9. Division of Nephrology, Department of Medicine, London Health Sciences Centre, London. 10. St. Joseph's Hospital, Toronto, ON, Canada.
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 ≥ 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. 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, 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. 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.
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 ≥ 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. 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, 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. 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.