Meinhart J, Deutsch M, Zilla P
First Department of Surgery, Lainz Hospital, Vienna, Austria.
ASAIO J. 1997 Sep-Oct;43(5):M515-21.
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 endothelial 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.
经过多年的体外研究和非人灵长类动物植入实验后，作者于1989年开始了他们的自体聚四氟乙烯（ePTFE）移植物体外内皮化临床项目。基于一项针对49例患者的初步研究（I期）（1:2随机分组，将33例患者分配到内皮化组，16例分配到对照组）的3年成功结果，作者从1993年6月起为所有没有合适大隐静脉的患者提供体外内皮化移植物（II期）。在移植项目的第二阶段，另外72例患者接受了81个成功内皮化的ePTFE移植物。在I期随机试验中，Kaplan-Meier生存分析显示，内皮化移植物的3年主要通畅率为84.7%，对照移植物为55.4%。5年后，内皮化组为73.8%，对照组为20.8%。在7年随访期结束时，内皮化移植物的主要通畅率仍高达73.8%，而对照移植物的通畅率降至零（对数秩检验；p = 0.001，Wilcoxon检验；p = 0.003）。随后II期内皮化ePTFE移植物的常规临床植入显示，所有股腘动脉重建的3.5年主要通畅率为72.9%。作者对内皮化股腘动脉ePTFE移植物（n = 108）进行的7年总体随访显示通畅率为66.0%。用纤连蛋白预处理（n = 43）时，7年通畅率为72.1%。在膝上组，用纤连蛋白处理的移植物7年通畅率高达75.8%（n = 36）。经过8年的临床内皮细胞移植，作者得出结论，ePTFE移植物的体外内皮化导致动脉假体的通畅率与静脉移植物相当。
