Björck C G, Bergqvist D, Glimåker H, Hallstensson S, Qvarfordt P, Troëng T
Department of Surgery, County Hospital of Falun, Sweden.
Eur J Surg. 1994 Jan;160(1):9-14; discussion 15-6.
To assess the initial results of insertion of a new woven Dacron graft coated with a polymer for occlusive and aneurysmal aortoiliac disease.
Open study.
Four Swedish vascular surgical units.
28 patients who required aortoiliac or aortofemoral reconstruction between September 1988 and June 1989.
Incidence of, and time to, occlusion; type of intervention; whether the graft needed to be replaced; and mortality.
Two patients died in the postoperative period, and five during follow-up, giving an overall mortality of 25%. None of the tube grafts occluded but 17 of 24 bifurcation grafts did (71%), the median time to occlusion being 126 days (range 10-820). Our results have led to this graft being removed from the market while modifications are made in the process of impregnation of polymer.
Strict protocols for the assessment of new graft materials should be introduced and enforced.
评估一种新型的涂有聚合物的编织涤纶移植物用于闭塞性和动脉瘤性主髂动脉疾病植入的初步结果。
开放性研究。
四个瑞典血管外科单位。
1988年9月至1989年6月期间需要进行主髂动脉或主股动脉重建的28例患者。
闭塞的发生率和时间；干预类型；移植物是否需要更换；以及死亡率。
2例患者术后死亡，5例在随访期间死亡，总死亡率为25%。管状移植物均未闭塞，但24个分叉移植物中有17个发生闭塞（71%），闭塞的中位时间为126天（范围10 - 820天）。我们的结果导致这种移植物已从市场上撤下，同时在聚合物浸渍过程中进行改进。
应引入并执行评估新型移植物材料的严格方案。
