Bosiers Marc, Deloose Koen, Verbist Jürgen, Schroë Herman, Lauwers Geert, Lansink Wouter, Peeters Patrick
Department of Vascular Surgery, St. Blasius Hospital, Dendermonde, Belgium.
J Vasc Surg. 2006 Feb;43(2):313-8; discussion 318-9. doi: 10.1016/j.jvs.2005.10.037.
Several prosthetic materials have been used for femoropopliteal bypass grafting in patients with peripheral vascular disease in whom a venous bypass is not possible. Expanded polytetrafluoroethylene (ePTFE) is the most commonly used, but patency results have not always equaled those achieved with vein, especially in below-knee reconstructions. This study assessed the performance of a new heparin-bonded ePTFE vascular graft that was designed to provide resistance to thrombosis and thereby decrease early graft failures and possibly prolong patency.
From June 2002 to June 2003, 86 patients (62 men and 24 women; mean age, 70 years; 99 diseased limbs) were enrolled prospectively in a nonrandomized, multicenter study of the heparin-bonded ePTFE graft. Fifty-five above-knee and 44 below-knee (including 21 femorocrural) procedures were performed. Follow-up evaluations consisted of clinical examinations, ultrasonographic studies, and distal pulse assessments. Patency and limb salvage rates were assessed by using life-table analyses.
All grafts were patent immediately after implantation. There were no graft infections or episodes of prolonged anastomotic bleeding. During the 1-year follow-up, 10 patients died, 15 grafts occluded, and 5 major amputations were performed. The overall primary and secondary 1-year patency rates were 82% and 97%, respectively. The limb salvage rate in patients with critical limb ischemia (n = 41) was 87%. Primary patency rates according to bypass type were 84%, 81%, and 74% for above-knee femoropopliteal, below-knee femoropopliteal, and femorocrural bypasses, respectively; the corresponding secondary patency rates were 96%, 100%, and 100%.
In this study, the heparin-bonded ePTFE graft provided promising early patency and limb salvage results, with no device-related complications, in patients with occlusive vascular disease. Longer-term and randomized studies are warranted to determine whether this graft provides results superior to those achieved with other prostheses, especially in patients at increased risk of early graft failure, such as those undergoing below-knee bypass and those with poor run-off or advanced vascular disease.
对于无法进行静脉搭桥的外周血管疾病患者，已使用多种人工血管材料进行股腘动脉搭桥术。膨化聚四氟乙烯（ePTFE）是最常用的材料，但通畅率结果并不总是等同于静脉搭桥所达到的效果，尤其是在膝下重建手术中。本研究评估了一种新型肝素结合ePTFE血管移植物的性能，该移植物旨在抵抗血栓形成，从而减少早期移植物失败并可能延长通畅时间。
2002年6月至2003年6月，86例患者（62例男性和24例女性；平均年龄70岁；99条患肢）前瞻性纳入一项关于肝素结合ePTFE移植物的非随机、多中心研究。进行了55例膝上和44例膝下（包括21例股胫）手术。随访评估包括临床检查、超声检查和远端脉搏评估。采用寿命表分析评估通畅率和肢体挽救率。
所有移植物植入后即刻通畅。无移植物感染或吻合口长时间出血事件。在1年随访期间，10例患者死亡，15条移植物闭塞，5例进行了大截肢手术。总体1年原发性和继发性通畅率分别为82%和97%。严重肢体缺血患者（n = 41）的肢体挽救率为87%。根据搭桥类型，膝上股腘动脉、膝下股腘动脉和股胫动脉搭桥的原发性通畅率分别为84%、81%和74%；相应的继发性通畅率分别为96%、100%和100%。
在本研究中，肝素结合ePTFE移植物在闭塞性血管疾病患者中提供了有前景的早期通畅率和肢体挽救结果，且无器械相关并发症。需要进行长期和随机研究以确定该移植物是否能提供优于其他假体的结果，尤其是在早期移植物失败风险增加的患者中，如接受膝下搭桥手术的患者以及流出道差或患有晚期血管疾病的患者。
