Incidence, Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study
Incidence, Characterization, and Clinical Impact of Device-Related Thrombus Following Left Atrial Appendage Occlusion in the Prospective Global AMPLATZER Amulet Observational Study
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DOI：
10.1016/j.jcin.2019.02.003
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发表时间：
2019-06-10
影响因子：
11.3
通讯作者：
Nielsen-Kudsk, Jens Erik
中科院分区：
文献类型：
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作者：
Aminian, Adel;Schmidt, Boris;Nielsen-Kudsk, Jens Erik
目的：本研究旨在报道AMPLATZER Amulet器械（Abbott, Plymouth, Minnesota）左心耳闭塞（LAAO）后器械相关血栓（DRT）的发生率、特征和临床影响。DRT是LAAO的潜在严重并发症，但在现实世界中，DRT的发生率和临床影响尚未得到很好的表征。方法共纳入1088例患者，进行为期1年的多中心前瞻性研究。所有事件都由一个独立委员会裁决，包括DRT的出席。我们回顾了DRT患者的次优装置植入和DRT形成的特征。采用多重Cox回归来确定DRT形成的预测因子。结果1078例（99%）患者植入器械成功，96.3%的患者完成1年随访。17例患者共发生18例DRT（1.7%/年），在1例患者的初始DRT完全消退后出现了第二例DRT。82%的DRT患者左侧上肺静脉嵴未被Amulet椎间盘覆盖，这表明植入不理想，大多数血栓发生在肺静脉嵴与椎间盘上边缘之间的LAA口的未束状区域。3例（18%）DRT患者发生缺血性卒中，均在DRT诊断后3个月内发生。与非DRT患者相比，DRT患者发生缺血性卒中或短暂性缺血性发作的风险更高（风险比：5.27；95%可信区间：1.58 ~ 17.55;p = 0.007）。较大的LAA孔宽度是DRT形成的预测因子（风险比：1.09；95%置信区间：1.00 ~ 1.19;p = 0.04）。结论使用AMPLATZER护身符装置进行LAAO后，很少观察到DRT。尽管与不进行DRT的患者相比，DRT的存在与缺血性卒中或短暂性缺血性发作的发生率增加有关，但绝大多数DRT患者（82%）没有发生任何缺血性神经事件。(C) 2019年由美国心脏病学会基金会发布。
OBJECTIVES This study sought to report the incidence, characteristics, and clinical impact of device-related thrombus (DRT) following left atrial appendage occlusion (LAAO) with the AMPLATZER Amulet device (Abbott, Plymouth, Minnesota).BACKGROUND DRT is a potential serious complication of LAAO, but the incidence and clinical impact of DRTs in a real-world setting are not well characterized.METHODS A total of 1,088 patients were enrolled in a multicenter prospective study and followed for 1 year. All events were adjudicated by an independent committee, including the presence of DRT. Patients with DRT were reviewed for suboptimal device implantation and characterization of DRT formation. Multiple Cox regression was performed to identify predictors of DRT formation.RESULTS Device implantation was successful in 1,078 (99%) patients, with 1-year follow-up completed in 96.3% of patients. A total of 18 DRTs occurred in 17 patients (1.7%/year), as a second DRT developed following complete resolution of an initial DRT in 1 patient. The left upper pulmonary vein ridge was not covered by the Amulet disc in 82% of DRT patients, indicating suboptimal implantation, with most thrombus developing in the untrabeculated area of the LAA ostium between the pulmonary vein ridge and the upper edge of the disc. Three (18%) DRT patients had an ischemic stroke, all within 3 months of DRT diagnosis. Patients with a DRT were at a greater risk for ischemic stroke or transient ischemic attack compared with non-DRT patients (hazard ratio: 5.27; 95% confidence interval: 1.58 to 17.55; p = 0.007). Larger LAA orifice width was a predictor of DRT formation (hazard ratio: 1.09; 95% confidence interval: 1.00 to 1.19; p = 0.04).CONCLUSIONS Following LAAO with the AMPLATZER Amulet device, DRT was observed infrequently. Although the presence of DRT was associated with an increased rate of ischemic stroke or transient ischemic attack as compared with patients without DRT, the large majority of DRT patients (82%) did not experience any ischemic neurologic events. (C) 2019 by the American College of Cardiology Foundation.