Faure Elsa M, Becquemin Jean-Pierre, Cochennec Frédéric
Department of Vascular Surgery, Henri Mondor Hospital, Créteil, France.
Department of Vascular Surgery, Henri Mondor Hospital, Créteil, France.
J Vasc Surg. 2015 May;61(5):1138-45.e2. doi: 10.1016/j.jvs.2014.11.084. Epub 2015 Feb 2.
Greater flexibility and smaller sizes for introducer sheaths in the newest stent grafts increase the feasibility of endovascular aneurysm repair but raise concerns about long-term limb patency. The aim of the study was to determine the incidence of and predictive factors for limb occlusion after use of the Endurant stent graft (Medtronic Inc, Minneapolis, Minn) for abdominal aortic aneurysm.
The Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) prospectively included 1143 patients treated with bifurcated devices who were observed for up to 2 years. Limb occlusions were evidenced by computed tomography, angiography, or ultrasound. To predict stent graft limb occlusion, a two-step model-building technique was applied. We first identified predictors from a total of 47 covariates obtained at baseline and in the periprocedural period. Subsequently, we reduced the set of potential predictors to key factors that are clinically meaningful. To handle large numbers of covariates, we used the Classification And Regression Tree (CART) method.
Forty-two stent graft limbs occluded in 39 patients (3.4% of the patients). At 2 years, the rate of freedom from stent graft limb occlusion calculated by Kaplan-Meier plot was 97.9% (standard error [SE], 0.33%). Of the 42 occlusions, 13 (31%) were observed within 30 days and 30 (71%) within 6 months. The strongest independent predictors were distal landing zone on the external iliac artery, external iliac artery diameter ≤10 mm, and kinking. High-risk vs low-risk patients were identified according to a decision tree based on the strongest predictors. Freedom from stent graft limb occlusion was 96.1% (SE, 0.64%) in high-risk patients vs 99.6% (SE, 0.19%) in low-risk patients.
After Endurant stent grafting, the incidence of limb occlusion was low. Classifying patients as high risk vs low risk according to the algorithm used in this study may help define specific strategies to prevent limb occlusion and improve the overall results of endovascular aneurysm repair using the latest generation of stent grafts.
最新的支架型人工血管中,导入鞘的柔韧性增强且尺寸减小,这提高了血管内动脉瘤修复的可行性,但也引发了对长期肢体通畅性的担忧。本研究旨在确定使用Endurant支架型人工血管(美敦力公司,明尼阿波利斯,明尼苏达州)治疗腹主动脉瘤后肢体闭塞的发生率及预测因素。
Endurant支架型人工血管自然选择全球上市后注册研究(ENGAGE)前瞻性纳入了1143例接受分叉型器械治疗的患者,对其进行长达2年的观察。肢体闭塞通过计算机断层扫描、血管造影或超声检查得以证实。为预测支架型人工血管肢体闭塞,应用了两步模型构建技术。我们首先从基线期和围手术期获取的总共47个协变量中确定预测因素。随后,我们将潜在预测因素集缩减为具有临床意义的关键因素。为处理大量协变量,我们使用了分类与回归树(CART)方法。
39例患者(占患者总数的3.4%)的42条支架型人工血管肢体发生闭塞。至2年时,通过Kaplan-Meier曲线计算得出的支架型人工血管肢体无闭塞率为97.9%(标准误[SE],0.33%)。在42例闭塞病例中,13例(31%)在30天内被观察到,30例(71%)在6个月内被观察到。最强的独立预测因素为髂外动脉的远端锚定区、髂外动脉直径≤10 mm以及血管扭曲。根据基于最强预测因素的决策树,确定了高风险和低风险患者。高风险患者的支架型人工血管肢体无闭塞率为96.1%(SE,0.64%),而低风险患者为99.6%(SE,0.19%)。
Endurant支架型人工血管植入术后,肢体闭塞的发生率较低。根据本研究中使用的算法将患者分为高风险和低风险,可能有助于确定预防肢体闭塞的具体策略,并改善使用最新一代支架型人工血管进行血管内动脉瘤修复的总体效果。