Shah D M, Darling R C, Kreienberg P B, Wirth G, Shah R, Lloyd W E, Chang B B, Paty P S, Leather R P
Vascular Surgery Section, Albany Medical College, NY 12208, USA.
Cardiovasc Surg. 1997 Aug;5(4):414-8. doi: 10.1016/s0967-2109(97)00031-8.
Adaptation of new clinical products should be based upon thorough scientific evaluation of properties and performance in vitro and in vivo. Developmental animal research experimentation is classically carried out by the manufacturer with eventual government approval. However, objective data needs to be recorded during clinical trials including handling characteristics, bleeding, tensile strength, kinking, seamline break, dilatation, anastomotic deterioration, patency, and incorporation. Since April 1991, 1010 stretch polytetrafluoroethylene (PTFE) aortic grafts have been implanted at our institution and data were recorded prospectively. Six hundred and seven were for elective abdominal aortic aneurysms, 46 for symptomatic abdominal aortic aneurysms, 58 for ruptured abdominal aortic aneurysms, 17 for elective thoracoabdominal aneurysms, 3 for ruptured thoracoabdominal aneurysms and the remainder were for various aortoiliac pathology. Average age of the patients was 69 (range: 10-95), 66% were males, 25% were diabetics. Overall operative mortality was 5.8% (2.9% in elective cases and 26.6% in emergent cases). There were 23 occlusions; 21 were revised and 2 were replaced with axillofemoral bypasses. Estimated blood loss was 784 cc in elective cases and 1918 cc in emergent cases. Grafts were followed by duplex ultrasound or CT scan every 3 months during the first year and every 6 months thereafter. There were no graft dilatations or false aneurysms in this series. There was one graft infection and no perigraft seromas or anastomotic deteriorations during this follow up. Follow up was complete in 94% of these patients. In conclusion, stretch PTFE graft has acceptable handling characteristics, no excessive bleeding at the suture line and had no anastomotic or graft dilatation. This graft material was suitable for thoracic, visceral, renal and abdominal aortic reconstructions.
新型临床产品的适配应基于对其体外和体内特性及性能的全面科学评估。研发性动物研究实验通常由制造商开展，并最终获得政府批准。然而，在临床试验期间需要记录客观数据，包括操作特性、出血情况、拉伸强度、扭结、缝线断裂、扩张、吻合口恶化、通畅情况及植入情况。自1991年4月以来，我们机构已植入1010条拉伸聚四氟乙烯（PTFE）主动脉移植物，并对数据进行了前瞻性记录。其中607条用于择期腹主动脉瘤，46条用于有症状的腹主动脉瘤，58条用于破裂性腹主动脉瘤，17条用于择期胸腹主动脉瘤，3条用于破裂性胸腹主动脉瘤，其余用于各种主髂动脉病变。患者的平均年龄为69岁（范围：10 - 95岁），66%为男性，25%为糖尿病患者。总体手术死亡率为5.8%（择期手术为2.9%，急诊手术为26.6%）。发生了23次闭塞；21次进行了修复，2次被腋股旁路移植术替代。择期手术的估计失血量为784毫升，急诊手术为1918毫升。术后第一年每3个月通过双功超声或CT扫描对移植物进行随访，此后每6个月随访一次。该系列中未出现移植物扩张或假性动脉瘤。随访期间有1例移植物感染，未出现移植物周围血清肿或吻合口恶化。94%的患者完成了随访。总之，拉伸PTFE移植物具有可接受的操作特性，缝合处无过多出血，且无吻合口或移植物扩张。这种移植物材料适用于胸、内脏、肾和腹主动脉重建。
