A prospective evaluation of plasma-TFE and expanded PTFE grafts for routine and early use as vascular access during hemodialysis.

The use of prosthetic grafts as vascular access for chronic hemodialysis is frequently necessary in patients with end-stage renal disease. Most commonly, expanded polytetrafluoroethylene (e-PTFE) has been employed because of ease of handling, tissue inertness, and acceptable long-term patency. Delay in use to allow for tissue ingrowth, however, has often required placement of temporary access devices. The authors have undertaken evaluation of a new material, plasma polymerized woven dacron Plasma-TFE, in a prospective randomized trial (Plasma-TFE VA) to compare clinical behavior against e-PTFE grafts, and we have used the Plasma-TFE grafts in an additional group of patients (Plasma-TFE AVA) as early access (within 1 week of implantation). Twenty-one Plasma-TFE grafts were implanted in 19 patients and 19 e-PTFE grafts were implanted in 17 patients in a prospective randomized fashion. Additionally, 31 Plasma-TFE grafts were implanted in 31 nonrandomized patients for early access. Primary patency rates in Plasma-TFE VA and e-PTFE grafts were equivalent at 12 months (0.471 and 0.556). When Plasma-TFE AVA primary patency was included (0.621), comparisons were not statistically significant (p = 0.50). Similarly, secondary patency rates among the three groups did not differ (cumulative proportion patent at 12 months: Plasma-TFE VA 0.403, e-PTFE 0.658, Plasma-TFE AVA 0.510). In considering after-revision patency after graft thrombosis, however, the Plasma-TFE grafts (both VA and AVA) performed significantly more poorly (p = 0.027) than e-PTFE grafts. Incidence of graft infection, wound infection, arm edema, hematoma from use, and occurrence of distal limb ischemia between Plasma-TFE (VA and AVA) and e-PTFE did not differ statistically. The authors conclude that Plasma-TFE compares favorably to e-PTFE with respect to primary and secondary patency and nonthrombotic complications, even with early use. Plasma-TFE does not perform as well as e-PTFE, however, after graft thrombosis.

RCT Entities:   Population Interventions Outcomes