A prospective comparison of two expanded polytetrafluoroethylene grafts for linear forearm hemodialysis access: does the manufacturer matter?

ABSTRACT

BACKGROUND: The function and patency of standard 6-mm Goretex (W.L. Gore and Associates, Flagstaff, AZ) and Impra (Impra, Inc., Tempe, AZ) expanded polytetrafluoroethylene (e-PTFE) grafts for hemodialysis as radial-antecubital linear arteriovenous fistulae for dialysis are compared. STUDY DESIGN: A randomized clinical trial was conducted in two community dialysis centers and in one hospital-based center serviced by one vascular surgical practice, that performed the access surgery. Selection of linear forearm access, as opposed to other hemodialysis graft configurations, was at the discretion of the surgeon. Candidates for linear grafts had palpable radial pulses with a normal Allen test and normal digital Doppler flow in the hand. Linear grafts were placed using end-to-side anastomoses to the artery and vein, and the graft type was determined by randomization. Primary patency was determined by first episode of thrombosis, first revision, or angioplasty of the graft. Secondary patency after thrombectomy, revision, or angioplasty was determined when the graft was no longer clinically usable, and a new graft needed to be placed as a parallel conduit in the forearm or in another site. Statistical analysis was by actuarial life-table methods. RESULTS: There were 131 linear forearm grafts in 117 patients. The Impra and Goretex groups were equally matched for gender and major risk factors, except for smoking, which was more common in the Goretex group. Minimum followup was 24 months. Life table primary patencies at 1 year (Impra 43%, Goretex 47%) and at 2 years (Impra 30%, Goretex 26%) were not statistically different (p = 0.78); secondary patency was also equal at 1 year (Impra 49%, Goretex 69%) and at 2 years (Impra 33%, Goretex 41%) (p = 0.15). Discontinuance of use of a patent graft, complications, episodes of thrombosis, and the need to replace the original graft occurred in the two groups without a statistically significant difference. CONCLUSIONS: In the linear forearm position from the radial artery to an antecubital vein, there is no difference in the performance of 6-mm standard e-PTFE grafts on the basis of manufacturer, whether Goretex or Impra. On the basis of performance, linear forearm dialysis grafts are an acceptable method for hemodialysis access.