Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium.
Cardioangiologisches Centrum Bethanien, Agaplesion Markus Krankenhaus, Medizinische Klinik 3 - Kardiologie, Frankfurt, Germany.
JACC Cardiovasc Interv. 2019 Jun 10;12(11):1003-1014. doi: 10.1016/j.jcin.2019.02.003. Epub 2019 May 15.
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).
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.
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.
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).
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.
本研究旨在报告使用 AMPLATZER Amulet 装置（雅培，明尼苏达州普利茅斯）进行左心耳封堵（LAAO）后与器械相关血栓（DRT）的发生率、特征和临床影响。
DRT 是 LAAO 的一种潜在严重并发症，但在真实环境中 DRT 的发生率和临床影响尚未得到很好的描述。
共有 1088 名患者参加了一项多中心前瞻性研究，并随访了 1 年。所有事件均由独立委员会裁定，包括 DRT 的存在。对 DRT 患者进行了检查，以评估器械植入情况和 DRT 形成情况。采用多因素 Cox 回归分析确定 DRT 形成的预测因素。
1078 名（99%）患者成功植入了设备，96.3%的患者完成了 1 年的随访。17 名患者（1.7%/年）共发生 18 例 DRT，其中 1 名患者在初始 DRT 完全缓解后再次发生 DRT。82%的 DRT 患者的左上肺静脉嵴未被 Amulet 盘覆盖，提示植入不理想，大多数血栓形成于左上肺静脉嵴与盘上缘之间的 LAA 口无小梁区。3 名（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和短暂性脑缺血发作的风险更高（风险比：5.27；95%置信区间：1.58 至 17.55；p=0.007）。较大的 LAA 口宽度是 DRT 形成的预测因素（风险比：1.09；95%置信区间：1.00 至 1.19；p=0.04）。
使用 AMPLATZER Amulet 装置进行 LAAO 后，DRT 的发生率较低。尽管与无 DRT 患者相比，DRT 患者发生缺血性卒中和短暂性脑缺血发作的发生率较高，但绝大多数 DRT 患者（82%）并未发生任何缺血性神经系统事件。
