Deutsch M, Meinhart J, Fischlein T, Preiss P, Zilla P
Ludwig Boltzmann Institute for Applied Cardiovasc Biol and Clin Quality Control, City Hospital Vienna Lainz, Austria.
Surgery. 1999 Nov;126(5):847-55.
Clinical in vitro endothelialization was assessed for its ability to improve the long-term patency of prosthetic femoropopliteal bypass grafts.
Between June 1989 and May 1998, 100 patients received 113 in vitro endothelialized expanded polytetrafluoroethylene grafts (ePTFE). Bilateral implantations were performed in 13 patients. In phase 1 of the study, 24 patients received 27 endothelialized grafts and 16 patients received 17 untreated grafts. In phase 2, endothelialization was offered to all patients who did not have a suitable saphenous vein available. Phase 2 began in June 1993 and included 76 patients who received 86 endotheliazed ePTFE grafts. In all, 100 patients had autologous endothelial cells harvested from 4- to 5-cm segments of a subcutaneous vein. In phase 1, the external jugular vein was used. In phase 2, the cephalic vein was used. These cells were grown to first-passage mass cultures and were lined confluently onto 6-mm ePTFE grafts, pre-coated with fibrin glue. Patency assessment for Kaplan-Meier survivorship analysis was determined by using duplex sonography and angiography.
In phase 1, the Kaplan-Meier method revealed a primary 9-year patency rate for 65% for the endothelialized group, versus 16% for the control group (log-rank test, P = .002; Wilcoxon test, P = .003). In phase 2, the 5-year primary patency rate for all in vitro endothelialized infrainguinal reconstructions was 68% (66% for above-the-knee grafts and 76% for below-the-knee grafts).
Nine years of clinical in vitro endothelialization provided strong evidence that autologous endothelial cell lining improves the patency of small-diameter vascular grafts and that a cell culture-dependent procedure can be used in a clinical routine.
评估临床体外内皮化改善人工股腘动脉旁路移植长期通畅性的能力。
1989年6月至1998年5月期间,100例患者接受了113条体外内皮化的膨体聚四氟乙烯移植物(ePTFE)。13例患者进行了双侧植入。在研究的第1阶段,24例患者接受了27条内皮化移植物,16例患者接受了17条未处理的移植物。在第2阶段,向所有没有合适大隐静脉的患者提供内皮化治疗。第2阶段始于1993年6月,包括76例接受86条内皮化ePTFE移植物的患者。总共100例患者从4至5厘米长的皮下静脉段采集了自体内皮细胞。在第1阶段,使用颈外静脉。在第2阶段,使用头静脉。这些细胞生长至第一代大规模培养,并汇合排列在预先涂有纤维蛋白胶的6毫米ePTFE移植物上。通过双功超声和血管造影术确定用于Kaplan-Meier生存分析的通畅性评估。
在第1阶段,Kaplan-Meier方法显示内皮化组9年的初始通畅率为65%,而对照组为16%(对数秩检验,P = 0.002;Wilcoxon检验,P = 0.003)。在第2阶段,所有体外内皮化的腹股沟下重建的5年初始通畅率为68%(膝上移植物为66%,膝下移植物为76%)。
九年的临床体外内皮化提供了有力证据,表明自体内皮细胞内衬可改善小直径血管移植物的通畅性,且一种依赖细胞培养的方法可用于临床常规操作。