A comparison of cryopreserved vein allografts and prosthetic grafts for hemodialysis access.

In hemodialysis patients with insufficient vasculature for creation of a native arteriovenous fistula (AVF), a polytetrafluoroethylene (PTFE) graft is commonly utilized. Because of PTFE complications, our group and others have used cryopreserved cadaver femoral vein allografts (Synergraft [SYN], CryoLife, Marietta, GA) in selected patients. Based on our experience with these allografts, we hypothesized that they were more resistant to thrombosis than PTFE grafts. The purpose of this study was to compare the thrombosis rates of SYN and PTFE grafts in a prospective, randomized fashion. Our study was interrupted when the FDA ordered CryoLife, Inc. to retain certain vascular tissue products, and patient accrual stopped in 2003. Most patients referred for hemodialysis access are evaluated with bilateral, upper extremity Doppler ultrasound. Starting in 2001, those with insufficient vasculature for native AVF were offered randomization into the PTFE or SYN groups. All accesses were placed in the upper extremity, above the elbow. Access patency and complications were recorded, and failure was defined as access removal, abandonment, or replacement of > 50% with a new conduit. Prior to FDA interruption of the study, 27 patients were randomized into each group. Patient characteristics were similar, but there were significantly more males and African-Americans in the SYN group. No significant differences were seen in primary or secondary patency, number of thrombectomies, revisions, or total interventions. Significantly more fistulagrams were performed in the SYN group (p < 0.05). No infections were seen in either group, but 2 aneurysms occurred in the SYN group. Nine (33%) patients in each group died with functioning access. Access failures: In the SYN group, 8 of 27 (30%) failed, with 5 failing from multiple access stenoses unresponsive to balloon angioplasty; in the PTFE group 4 of 27 (18%) failed, with 2 failing from multiple stenoses. In conclusion, for initial hemodialysis access in patients without sufficient vasculature for native AVF, our results do not support the routine use of SYN allografts in the general dialysis population.

RCT Entities:   Population Interventions Outcomes