Diethrich Edward B
Medical Director, Arizona Heart Institute and Arizona Heart Hospital, 2632 N. 20th Street, Phoenix, AZ 85006, USA.
Expert Rev Med Devices. 2006 Sep;3(5):557-64. doi: 10.1586/17434440.3.5.557.
Open surgical repair of thoracic aortic lesions carries a significant risk of complications, including death. Minimally invasive approaches, however, may improve outcomes. Clinical trials of the Gore TAG Thoracic Endoprosthesis device indicate that subjects receiving the graft are less likely to experience major adverse events, less intraprocedural blood loss, shorter intensive care unit and hospital stays, and reduced recovery times than surgical patients. The US FDA approved the device in March 2005. Since then, the device has been used widely, although a 0.30% rate of complications related to infolding or partial compression of the device prompted a 'Dear Doctor' letter in January 2006. This article profiles the TAG device and evaluates endografting technology in general.
开胸手术修复胸主动脉病变会带来包括死亡在内的显著并发症风险。然而,微创方法可能会改善治疗效果。Gore TAG胸内植入物装置的临床试验表明,与接受手术的患者相比,接受该移植物的受试者发生重大不良事件的可能性更小,术中失血量更少,重症监护病房和住院时间更短,恢复时间也更短。美国食品药品监督管理局于2005年3月批准了该装置。自那时以来,该装置得到了广泛应用,尽管2006年1月因该装置发生折叠或部分受压相关并发症的发生率为0.30%而发出了一封“致医生信”。本文介绍了TAG装置并总体评估了腔内移植物技术。