Hastings O M, Jain K M, Hobson R W, Swan K G
Ann Surg. 1978 Dec;188(6):743-7. doi: 10.1097/00000658-197812000-00005.
A prospective, double-blind, randomized study was performed to determine the relative patency rate of polytetrafluoroethylene (PTFE) grafts, Gore-Tex, Impra, and a Surgikos prototype PTFE graft. The 48 grafts (40 x 4 mm) replaced excised segments of femoral arteries in adult mongrel dogs, whose mean weight was 20.6 +/- 0.9 kg; the grafts were removed after 12 weeks. Sterile technique and antibiotic therapy were included in the study. Anticoagulation was not employed. Anastomoses were performed with 6 = 0 polypropylene. Angiographic assessment of each anastomosis was made at surgery and prior to sacrifice. Patency was assessed daily by palpation and Doppler flow signals, as well as angiographically, prior to sacrifice. The overall patency rate was 62.5%. There were no statistically significant differences in patency rates among the three groups (Gore-Tex, 56%; Impra, 75%, Surgikos, 56%). Histologic evaluation revealed incomplete neointima formation and significant pannus formation in all three types of grafts without any significant discernible difference among them. The results suggest that further experimental evaluation of PTFE, as a small vessel substitute, is indicated prior to its use clinically in preference to autogenous vein.
进行了一项前瞻性、双盲、随机研究，以确定聚四氟乙烯（PTFE）移植物、戈尔特斯（Gore-Tex）、英普拉（Impra）和一种外科ikos原型PTFE移植物的相对通畅率。48根移植物（40×4毫米）替换了成年杂种犬股动脉的切除段，这些犬的平均体重为20.6±0.9千克；12周后取出移植物。研究包括无菌技术和抗生素治疗。未采用抗凝治疗。用6-0聚丙烯进行吻合。在手术时和处死前对每个吻合口进行血管造影评估。在处死前，每天通过触诊和多普勒血流信号以及血管造影评估通畅情况。总体通畅率为62.5%。三组（戈尔特斯，56%；英普拉，75%；外科ikos，56%）之间的通畅率没有统计学上的显著差异。组织学评估显示，所有三种类型的移植物中都有不完全的新生内膜形成和明显的血管翳形成，它们之间没有任何明显的可辨别差异。结果表明，在临床上优先使用自体静脉之前，作为小血管替代物的PTFE需要进一步进行实验评估。
