A PROSPECTIVE COMPARISON OF 2 EXPANDED POLYTETRAFLUOROETHYLENE GRAFTSFOR LINEAR FOREARM HEMODIALYSIS ACCESS - DOES THE MANUFACTURER MATTER

Background: The function and patency of standard 6-mm Goretex (W.L. Go re and Associates, Flagstaff, AZ) and Impra (Impra, Inc., Tempe, AZ) e xpanded polytetrafluoroethylene (e-PTFE) grafts for hemodialysis as ra dial-antecubital linear arteriovenous fistulae for dialysis are compar ed. Study Design: A randomized clinical trial was conducted in two com munity dialysis centers and in one hospital-based center serviced by o ne vascular surgical practice, that performed the access surgery. Sele ction 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 Alien test and normal digital Doppler flow in the hand. Linear grafts were placed usi ng end-to-side anastomoses to the artery and vein, and the graft type was determined by randomization. Primary patency was determined by fir st episode of thrombosis, first revision, or angioplasty of the graft. Secondary patency after thrombectomy, revision, or angioplasty was de termined when the graft was no longer clinically usable, and a new gra ft needed to be placed as a parallel conduit in the forearm or in anot her site. Statistical analysis was by actuarial life-table methods. Re sults: There were 131 linear forearm grafts in 117 patients. The Impra and Goretex groups were equally matched for gender and major risk fac tors, except for smoking which was more common in the Goretex group. M inimum 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 equ al at 1 year (Impra 49%, Goretex 69%) and at 2 years (Impra 33%, Goret ex 41%) (p = 0.15). Discontinuance of use of a patent graft, complicat ions, episodes of thrombosis, and the need to replace the original gra ft occurred in the two groups without a statistically significant diff erence. Conclusions: In the linear forearm position from the radial ar tery to an antecubital vein, there is no difference in the performance of 6-mm standard e-PTFE grafts on the bask of manufacturer, whether G oretex or Impra. On the basis of performance, linear forearm dialysis grafts are an acceptable method for hemodialysis access. (C) 1997 by t he American College of Surgeons.