Clinical StudyThermal Resistance Anastomosis Device for the Percutaneous Creation of Arteriovenous Fistulae for Hemodialysis

PurposeTo evaluate the safety and efficacy of arteriovenous fistula (AVF) creation with a thermal resistance anastomosis device (TRAD).Materials and MethodsFrom January 2014 to March 2015, 26 patients underwent ultrasound (US)-guided percutaneous creation of proximal radial artery-to-perforating vein AVFs with a TRAD that uses heat and pressure to create a fused anastomosis. Primary endpoints were fistula creation, patent fistula by Doppler US, two-needle dialysis at the prescribed rate, and device-related complications.ResultsTechnical success rate of fistula creation was 88% (23 of 26). Procedure time averaged 18.4 minutes (range, 5-34 min), and 96% of anastomoses (22 of 23) were fused. At 6 weeks, 87% of AVFs (20 of 23) were patent, 61% (14 of 23) had 400-mL/min brachial artery flow, 1 patient was receiving dialysis, 2 fistulae had thrombosed, and 1 patient had died unrelated to the procedure. Eighty percent (16 of 20), 70% (14 of 20), and 60% (12 of 20) of patients were receiving dialysis at 3, 6, and 12 months; 4 patients died, 3 fistulae failed, and one patient was lost to follow-up. Overall, 87% of AVFs (20 of 23) had an additional procedure at a mean of 56 days (range, 0-239 d), including balloon dilation in 43% (n = 10), brachial vein embolization in 26% (n = 6), basilic vein ligation in 17% (n = 4), venous transposition in 30% (n = 7), and valvulotomy in 4% (n = 1). There were no major complications related to the device.ConclusionsPercutaneous AVFs created with a TRAD met the safety endpoints of this study. Midterm follow-up demonstrated intact anastomoses and fistulae suitable for dialysis.