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.