Böckler D, Riambau V, Fitridge R, Wolf Y, Hayes P, Silveira P, Numan F
University of Heidelberg, Heidelberg, Germany.
J Cardiovasc Surg (Torino). 2011 Oct;52(5):669-81. Epub 2011 Jul 28.
The Endurant Stent-graft System (Medtronic Vascular, Santa Rosa, CA) is a next-generation device intended to expand the applicability of endovascular aortic repair (EVAR). To date, the Endurant has been evaluated in 9 short- and intermediate-term studies, several in patients presenting with challenging aneurysm anatomies. Consistently, the device in these studies has been shown to be safe and effective, with an excellent rate of deployment success and with very low rates of type I/III endoleaks and reinterventions. Single center experience with Endurant in challenging anatomies with short kinked necks and calcified angulated iliac arteries in patients unfit for open repair and challenging anatomies show promising early results with no difference in mortality, morbidity and reintervention rates, but need cautious application for EVAR outside of the device-specific IFU. The Endurant Stent-graft Natural Selection Global Postmarket Registry (ENGAGE) is a long-term 1266-patient 80-site worldwide prospective postmarket study initiated to augment the knowledge base (poolable and comparable) about EVAR in a real-world population implanted with the Endurant. Technical and clinical data for ENGAGE patients will be reported through the expected completion of 5-year follow-up for all ENGAGE registry patients in 2018. We discuss the evolving challenges for EVAR that the Endurant and other next-generation stent-grafts are designed to address and review outcomes published with the Endurant since the CE marking of the device in July 2008.
Endurant覆膜支架系统（美敦力血管公司，加利福尼亚州圣罗莎）是一款旨在扩大血管内主动脉修复术（EVAR）适用范围的下一代设备。迄今为止，Endurant已在9项短期和中期研究中得到评估，其中几项研究针对具有挑战性动脉瘤解剖结构的患者。在这些研究中，该设备始终被证明是安全有效的，部署成功率极高，I/III型内漏和再次干预率极低。在不适合开放修复的患者中，对于具有短而扭曲的颈部和钙化成角髂动脉等具有挑战性解剖结构的Endurant单中心经验显示出有前景的早期结果，在死亡率、发病率和再次干预率方面没有差异，但在设备特定的使用说明书之外进行EVAR时需要谨慎应用。Endurant覆膜支架自然选择全球上市后注册研究（ENGAGE）是一项针对1266例患者的长期、全球80个地点的前瞻性上市后研究，旨在增加关于植入Endurant的真实世界人群中EVAR的知识库（可汇总和可比）。ENGAGE患者的技术和临床数据将在2018年所有ENGAGE注册患者完成5年随访时报告。我们讨论了Endurant和其他下一代覆膜支架旨在解决的EVAR不断演变的挑战，并回顾了自2008年7月该设备获得CE标志以来与Endurant相关的已发表结果。
