Department of Vascular Surgery, Erasmus Medical Center, H-810, 's-Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.
Eur J Vasc Endovasc Surg. 2011 Oct;42(4):489-97. doi: 10.1016/j.ejvs.2011.06.008. Epub 2011 Jul 7.
The Endurant Stent Graft System (Medtronic Vascular, Santa Rosa, CA) is specifically designed to treat patients with abdominal aortic aneurysm, including those with difficult anatomies. This is the 1-year report of a prospective, non-randomised, open-label trial at 10 European centres.
Between November 2007 and August 2008, 80 patients were enrolled for elective endovascular aneurysm repair (EVAR) with the Endurant; 71 with moderate (≤ 60°) and nine with high (60-75°) infrarenal aortic neck angulation. Safety and stent-graft performance were assessed throughout a 1-year follow-up period.
The device was successfully delivered and deployed in all cases. All-cause mortality was 5% (4/80), with one possibly device-related death. Serious adverse events were comparable between the high and moderate angulation groups. There were no device migrations, stent fractures, aortic ruptures or conversions to open repair. Maximal aneurysm diameter decreased >5 mm in 42.7% of cases. A total of 28 endoleaks were observed (26 type II, two undetermined). Three secondary endovascular procedures were performed for outflow vessel stenosis, graft limb occlusion and iliac extension, resulting in a secondary patency rate of 100%. No re-interventions were required in the high angulation group.
The Endurant Stent Graft was successfully delivered and deployed in all cases and performed safely and effectively in all patients, including those with unfavourable proximal neck anatomy.
Endurant 支架移植物系统（美敦力血管，圣罗莎，加利福尼亚）专门设计用于治疗腹主动脉瘤患者，包括那些具有复杂解剖结构的患者。这是在 10 个欧洲中心进行的一项前瞻性、非随机、开放标签试验的 1 年报告。
2007 年 11 月至 2008 年 8 月，80 例患者因择期血管内腹主动脉瘤修复术（EVAR）接受 Endurant 治疗；71 例中度（≤60°）和 9 例高度（60-75°）肾下主动脉颈角。在 1 年的随访期间，评估了安全性和支架移植物的性能。
所有病例均成功输送和展开了该器械。全因死亡率为 5%（4/80），其中 1 例可能与器械相关。严重不良事件在高角和中角组之间相似。没有器械迁移、支架断裂、主动脉破裂或转为开放修复。42.7%的病例最大动脉瘤直径减少超过 5 毫米。共观察到 28 例内漏（26 型 II 型，2 例未确定）。为流出血管狭窄、移植物支闭塞和髂支延伸进行了 3 次二次血管内手术，导致二次通畅率为 100%。高角组无需再次干预。
Endurant 支架移植物在所有病例中均成功输送和展开，在所有患者中安全有效，包括那些近端颈部解剖结构不佳的患者。
