Endovascular repair of abdominal aortic aneurysms: Device-specific outcome
Endovascular repair of abdominal aortic aneurysms: Device-specific outcome
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DOI：
10.1067/mva.2003.170
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发表时间：
2003-05-01
影响因子：
4.3
通讯作者：
Sampran, ESK
中科院分区：
文献类型：
--
作者：
Ouriel, K;Clair, DG;Sampran, ESK
目标.腹主动脉瘤的血管内修复虽然因其微创性而具有优势，但福尔斯达不到传统开放手术修复的长期耐久性。诸如器械移位、内漏导致的持续囊加压和移植物分支血栓形成等问题最终导致二次手术的高发生率和无法防止动脉瘤破裂。虽然以前的研究暗示这些术后事件和特定的设备设计之间的相关性，一个单一的比较分析，相关设备属性与临床outcome.Methods：在2002年结束的6年，703例患者接受了肾下腹主动脉瘤血管内治疗。在此期间，使用了5种器械，即Ancure、AneuRx、Excluder、Talent和Zenith，并对6个器械特定组进行了分析; Zenith组被细分为多中心试验（Zenith-MCT）的一部分和非研究者试验用器械豁免试验（Zenith-SIT）的一部分。结果进行了评估与Kaplan-Meier方法的删失数据，和对数秩检验被用来确定设备groups.Results之间的差异：虽然总生存率下降的Zenith-SIT组（P = 0.046），血管紧张素相关死亡的风险是相似的，在所有组（P = 0.336），平均0.2%或更低，在12个月。在所有患者队列中，24个月时无破裂率为98.7% +/- 0.9%，组间无明显差异（P = 0.533）。二次手术率、转为开放修复率或移位率无统计学显著差异。然而，两组间移植物分支闭塞风险和内漏发生率存在显著差异。Ancure器械最常发生肢体闭塞（12个月时为11% +/- 4.6%，P = 0.009）。任何类型的内漏最常见于Excluder器械（12个月时为64% +/- 11%，P =.003），这一发现与该组II型泄漏频率增加直接相关（12个月时为58% +/- 11%，P =.001）。虽然I型或III型内漏的频率没有差异，但观察到AneuRx器械的微漏风险增加趋势（4.0% +/-1.3%，P = 0.054），观察到Zenith器械的组配式分离更多（3.5% +/-2.3%，P = 0.032）。12个月时的收缩与器械组的内漏频率相关，在两个Zenith组（Zenith-MCT组为54% +/- 7.3%，Zenith-SIT组为56% +/- 7.8%）和Talent组（52% +/- 9.7%）中最常见，在Excluder组中最少（12个月时为15% +/- 7.9%，P
Objectives. Endovascular repair of abdominal aortic aneurysms, while advantageous because of its minimally invasive nature, falls short of achieving the long-term durability of traditional open surgical repair. Problems such as device migration, continued sac pressurization from endoleak, and graft limb thrombosis culminate in a high rate of secondary procedures and failure to protect against aneurysm rupture. While prior studies hint at a correlation between these postprocedural events and specific device design, a single comparative analysis that correlates device attributes with clinical outcome has not been performed.Methods: Over 6 years ending in 2002, 703 patients underwent endovascular treatment of infrarenal abdominal aortic aneurysms. During this time, five devices were used, ie, Ancure, AneuRx, Excluder, Talent, and Zenith, and six device-specific groups were analyzed; the Zenith group was subdivided into those placed as part of the multicenter trial (Zenith-MCT) and those under a sponsor-investigator investigational device exemption trial (Zenith-SIT). Results were assessed with the Kaplan-Meier method for censored data, and the log-rank test was used to ascertain differences between device groups.Results: While overall survival was diminished in the Zenith-SIT group (P =.046), risk for aneurysm-related death was similar in all groups (P =.336), averaging.2% or less at 12 months. Among the total cohort of patients, freedom from rupture was 98.7% +/- 0.9% at 24 months, without demonstrable differences between groups (P =.533). There were no statistically significant differences in rate of secondary procedures, conversion to open repair, or migration. There were, however, significant differences in risk for graft limb occlusion and rate of endoleak between groups. Limb occlusion occurred most often with Ancure devices (11% +/- 4.6% at 12 months, P =.009). Endoleak of any type was most common with Excluder devices (64% +/- 11% at 12 months, P =.003), a finding directly related to increased frequency of type II leaks in that group (58% +/- 11% at 12 months, P =.001). While there were no differences in frequency of type I or type III endoleak, a trend toward increased risk for microleak was observed with AneuRx devices (4.0% +/- 1.3%, P =.054), and more modular separations were observed with Zenith devices (3.5% +/- 2.3%, P =.032). Shrinkage at 12 months correlated with frequency of endoleak in the device groups, and was most common in the two Zenith groups (54% +/- 7.3% in the Zenith-MCT group and 56% +/- 7.8% in the Zenith-SIT group) and the Talent group (52% +/- 9.7%) and was least in the Excluder group (15% +/- 7.9% at 12 months, P