Mid- and long-term device migration after endovascular abdominal aortic aneurysm repair: A comparison of AneuRx and Zenith endografts
Mid- and long-term device migration after endovascular abdominal aortic aneurysm repair: A comparison of AneuRx and Zenith endografts
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DOI：
10.1016/j.jvs.2005.05.040
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发表时间：
2005-09-01
影响因子：
4.3
通讯作者：
Money, SR
中科院分区：
文献类型：
--
作者：
Tonnessen, BH;Sternbergh, WC;Money, SR
背景无移位是动脉瘤腔内修复术（EVAR）耐久性的关键。本研究评价了两种不同覆膜支架的中长期迁移发生率。1997年9月至2004年6月期间，235例患者计划使用AneuRx（Medtronic/AVE Inc.）或Zenith（Cook）覆膜支架。分析了梭形肾下动脉瘤患者和至少12个月的随访，最终队列为130例患者。在轴向计算机断层扫描（CT）（2.5 - 3 mm切口）上评估移位，作为从最尾端肾动脉到含覆膜支架（AneuRx）的第一个切片或到裸肾上支架（Zenith）顶部的距离。在最尾侧肾动脉处测量主动脉瘤颈直径。初始术后CT扫描为基线。移位通过覆膜支架在两个阈值（5 mm和10 mm）下的尾部移动或伴随相关临床事件的任何移位来定义。寿命表分析表明，AneuRx在1年、2年、3年和4年的无移位率（>= 10 mm或临床事件）分别为96.1%、89.5%、78.0%和72.0%。1、2、3和4年时Zenith无移位率分别为100%、97.6%、97.6%和97.6%（P = 0.01，对数秩检验）。更严格的5 mm移位阈值发现，在4年随访时，67.4%的AneuRx患者和90.1%的Zenith患者无移位。12/14例（85.7%）发生迁移（>= 10 mm或临床事件）的AneuRx患者（12/14）接受了14例相关二次手术（13例血管内手术，1例开放性转换）。发生移位（10 mm）的1例Zenith患者无需辅助治疗。平均随访时间为39.0 ± 2.3个月（AneuRx）和30.8 ± 1.9个月（Zenith，P = .01）。发生和未发生移位的患者在年龄、性别比、动脉瘤直径和瘤颈直径方面没有差异。然而，移位患者的初始瘤颈长度较短（22.1 ± 2.1 mm vs 31.2 ± 1.2 mm，P = 0.02）。一个患者子集（21.6%）经历了显著（定义为：3 mm）最大主动脉瘤颈扩张。在AneuRx患者中，主动脉瘤颈扩张>= 3 mm影响了30.8%的迁移者和13.0%的非迁移者（P = 0.20）。覆膜支架移位是一种时间依赖性现象，受器械选择和主动脉瘤颈长度的影响。绝大多数AneuRx器械移位的患者（85.7%）最终需要治疗。少数患者发生的主动脉瘤颈扩张被认为具有临床意义。仔细监测移位是腹主动脉瘤腔内修复术后长期随访的重要组成部分。
Background. Freedom from migration is key to the durability of endovascular aneurysm repair (EVAR). This study evaluates the mid- and long-term incidence of migration with two different endografts.Methods. Between September 1997 and June 2004,235 patients were scheduled for EVAR with an AneuRx (Medtronic/AVE Inc.) or Zenith (Cook) endograft. Patients with fusiform, infrarenal aneurysms and a minimum 12 months of follow-up were analyzed, for a final cohort of 130 patients. Migration was assessed on axial computed tomography (CT) (2.5 to 3 mm cuts) as the distance from the most caudal renal artery to the first slice containing endograft (AneuRx) or to the top of the bare suprarenal stent (Zenith). Aortic neck diameters were measured at the most caudal renal artery. The initial postoperative CT scan was the baseline. Migration was defined by caudal movement of the endograft at two thresholds, :5 mm and :10 mm, or any migration with a related clinical event.Results. Life-table analysis demonstrated AneuRx freedom from migration (>= 10 mm. or clinical event) was 96.1%, 89.5%, 78.0%, and 72.0% at 1, 2, 3, and 4 years, respectively. Zenith freedom from migration was 100%, 97.6%, 97.6%, and 97.6% at 1, 2, 3, and 4 years, respectively (P = .01, log- rank test). The stricter 5-mm migration threshold found 67.4% of AneuRx and 90.1% of Zenith patients free from migration at 4 years of follow-up. Twelve out of 14 (85.7%) AneuRx patients (12/14) with migration (>= 10 mm or clinical event) underwent 14 related secondary procedures (13 endovascular, 1 open conversion). The single Zenith patient with migration ( :10 mm) has not required adjuvant treatment. Mean follow-up was 39.0 +/- 2.3 months (AneuRx) and 30.8 +/- 1.9 months (Zenith, P = .01). Patients with and without migration did not differ in age, gender ratio, aneurysm diameter, and neck diameter. However, initial neck length was shorter in patients with migration (22.1 +/- 2.1 mm vs 31.2 +/- 1.2 mm, P = .02). A subset of patients (21.6%) experienced significant (defined as :3 mm) maximum aortic neck dilation. Of the AneuRx patients, >= 3 mm aortic neck dilation affected 30.8% of migrators vs 13.0% of nonmigrators (P = .20).Conclusions. Endograft migration is a time-dependent phenomenon affected by both device choice and aortic neck length. A great majority of patients (85.7%) with migration of the AneuRx device ultimately required treatment. A minority of patients experienced aortic neck dilation that could be considered clinically significant. Careful surveillance for migration is an essential component of long-term follow-up after EVAR.