Department of Vascular Surgery, Isala, Zwolle, the Netherlands -
Department of Thoracic and Vascular Surgery, Linköping University Hospital, Linköping, Sweden.
J Cardiovasc Surg (Torino). 2021 Jun;62(3):242-249. doi: 10.23736/S0021-9509.21.11643-X. Epub 2021 Feb 26.
Endovascular aneurysm repair (EVAR) has become the preferred treatment for infrarenal abdominal aortic aneurysms (AAA) over open surgical repair. The Endurant stent graft is widely used, and large registries report low rates of aneurysm-related mortality and reinterventions at midterm follow-up. Reports of long-term follow-up are limited. The aim of this study is to report our experiences and share our results, reintervention rate and mortality at long-term follow-up after using the Endurant stent graft.
All consecutive patients treated between 2009 and 2013 with the Medtronic Endurant I and II stent graft for an infrarenal AAA in an elective setting were included. Primary outcomes were overall and aneurysm-related survival and reintervention rates.
One hundred sixty-five consecutive patients (median age 74; IQR: 68-79) with an aneurysm diameter of 62 mm (IQR: 58-70) and neck length of 29 mm (IQR: 21-40) were electively treated with the Endurant I or II stent graft. One hundred thirty-four patients (81.2%) were treated inside IFU (instructions for use) and 31 (18.8%) outside IFU. At median follow-up of 76 months (IQR: 50-97), 60 patients (36.4%) were deceased. Kaplan-Meier estimates at 10 years follow-up of overall survival and freedom from aneurysm-related mortality were respectively 48.5% (CI: 43.7-53.3%) and 97.3% (CI: 95.7-98.9%). Freedom from reintervention was 86.0% with an CI: 83.1-88.9% at 5 years follow-up and 75.6% with a CI: 70.2-81.0% at 10 years follow-up. A total of 25 (15.2%) patients had an EVAR-related reintervention; indications were endoleak (EL) type 1A (N.=11), EL type 1B (N.=3), EL type 2 (N.=6), EL type 3 (N.=1) and limb occlusion (N.=4). We found no significant differences in outcome between the inside and outside IFU groups. At 5 years follow-up 92.6% of patients had stable or decreased diameter, and 7.4% had an increased diameter.
This large cohort single-center study demonstrates the effectiveness and safety of the Endurant stent graft system at long-term follow-up with low reintervention rates and aneurysm-related mortality.
血管内动脉瘤修复术（EVAR）已成为治疗肾下型腹主动脉瘤（AAA）的首选方法，优于开放手术修复。Endurant 支架移植物被广泛应用，大型注册研究报告称，在中期随访中，与动脉瘤相关的死亡率和再干预率较低。关于长期随访的报告有限。本研究旨在报告我们的经验并分享我们的结果，即使用 Endurant 支架移植物后的长期随访中再干预率和死亡率。
纳入 2009 年至 2013 年间在我院因择期治疗肾下型 AAA 而使用 Medtronic Endurant I 和 II 支架移植物的连续 165 例患者。主要结局为总生存率、动脉瘤相关生存率和再干预率。
165 例连续患者（中位年龄 74 岁；IQR：68-79），动脉瘤直径为 62mm（IQR：58-70），颈部长度为 29mm（IQR：21-40），择期接受 Endurant I 或 II 支架移植物治疗。134 例（81.2%）患者在 IFU（使用说明书）内接受治疗，31 例（18.8%）患者在 IFU 外接受治疗。在中位随访 76 个月（IQR：50-97）后，有 60 例患者（36.4%）死亡。10 年随访的总体生存率和免于动脉瘤相关死亡率的 Kaplan-Meier 估计值分别为 48.5%（CI：43.7-53.3%）和 97.3%（CI：95.7-98.9%）。5 年随访时无再干预率为 86.0%，CI 为 83.1-88.9%，10 年随访时为 75.6%，CI 为 70.2-81.0%。共有 25 例（15.2%）患者发生与 EVAR 相关的再干预；适应证为 1A 型内漏（EL）（n=11）、1B 型 EL（n=3）、2 型 EL（n=6）、3 型 EL（n=1）和肢体闭塞（n=4）。我们发现 IFU 内组和 IFU 外组之间的结果无显著差异。5 年随访时，92.6%的患者动脉瘤直径稳定或缩小，7.4%的患者动脉瘤直径增大。
本大规模单中心研究表明，Endurant 支架移植物系统在长期随访中具有有效性和安全性，再干预率和与动脉瘤相关的死亡率较低。
