Prospective, randomized evaluation of a cuffed expanded polytetrafluoroethylene graft for hemodialysis vascular access

Background. A cuffed expanded polytetrafluoroethylene (ePTFE) hemodialysis graft was developed to address the problem of recurrent stenosis at the graft-vein anastomosis. The purpose of this study was to compare graft patency and blood flow rates of cuffed and noncuffed (standard) ePTFE grafts placed for hemodialysis access. Methods. Forty-eight patients were prospectively randomized and followed for up to 24 months after placement of a cuffed or standard ePTFE graft for hemodialysis access. Study end points included time to graft failure and blood flow rates on hemodialysis. Results. Risk factors for graft failure were similar in both groups. However, the overall incidence of graft failure was significantly lower in the cuffed ePTFE graft group (P=.039). Graft patency rates in the cuffed versus standard groups were 64% versus 32% at 12 months (P = .037) and 58% versus 21% at 24 months (P = .0213). No cuffed ePTFE graft failed as a result of venous outflow stenosis. Average graft flow rates were similar when first measured 3 months postoperatively (845 mL/min, cuffed vs 715 mL/min, standard; P = .51) but declined more rapidly in the standard group (12 months, 623 vs 253 mL/min [P = .037]; 24 months, 531 vs 121 mL/min [P = .012]). Conclusions. The cuffed ePTFE graft was associated with increased blood flow rates during hemodialysis and improved graft patency compared with a standard ePTFE graft. Our results suggest a beneficial effect of the cuffed venous geometry for hemodialysis vascular access.