After years of in vitro studies and non human primate implantations, the authors commenced their clinical program of autologous in vitro endothelialization of polytetrafluoroethylene (ePTFE) grafts in 1989. Based on the successful 3 year results of a pilot study (Phase I) with 49 patients (1:2 randomization, assigning 33 patients to the endothelialized group and 16 to the control group), the authors offered in vitro endothelialized grafts to all patients who did not have a suitable saphenous vein available from June 1993 onward (Phase II). Another 72 patients received 81 successfully endothelialized ePTFE grafts in this second phase of the transplantation program. In the Phase I randomized trial, the Kaplan-Meier survivorship analysis showed a primary 3 year patency rate of 84.7% for endothelialized grafts and 55.4% for control grafts. After 5 years, it was 73.8% for the endothelialized group and 20.8% for the controls. At the end of the 7 year follow-up period, the primary patency rate for endothelialized grafts remained high at 73.8%, whereas that for the control grafts dropped to zero (log-rank test; p = 0.001 and Wilcoxon test; p = 0.003). The subsequent Phase II routine clinical implantation of endothelialized ePTFE grafts showed a 3 1/2 year primary patency rate of 72.9% for all femoropopliteal reconstructions. The authors' overall 7 year follow-up with endothelialized femoropopliteal ePTFE grafts (n = 108) shows a patency of 66.0%. When pretreated with fibronectin (n = 43), the 7 year patency was 72.1%. In the above-knee group, the 7 year patency for fibronectin treated grafts was as high as 75.8% (n = 36). After 8 years of clinical endothetial cell transplantation, the authors conclude that in vitro endothelialization of ePTFE grafts results in a patency rate of arterial prostheses comparable with that of vein grafts. ASAIO Journal 1997; 43:M515-M521.
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