Aix-Marseille University, Assistance Publique - Hôpitaux de Marseille (APHM), Department of Cardiology, Nord Hospital, Chemin des Bourrelly, 13915 Marseille, Cedex, France; MARS Cardio, Mediterranean Association for Research and Studies in Cardiology, Nord Hospital, Chemin des Bourrelly, 13915 Marseille, Cedex, France.
Aix-Marseille University, Assistance Publique - Hôpitaux de Marseille (APHM), Department of Cardiology, Nord Hospital, Chemin des Bourrelly, 13915 Marseille, Cedex, France; MARS Cardio, Mediterranean Association for Research and Studies in Cardiology, Nord Hospital, Chemin des Bourrelly, 13915 Marseille, Cedex, France.
Heart Lung Circ. 2019 Nov;28(11):1683-1688. doi: 10.1016/j.hlc.2018.08.022. Epub 2018 Sep 27.
Left atrial appendage occlusion (LAAO) is increasingly used for stroke prevention in patients with atrial fibrillation who are considered unsuitable for a lifelong oral anticoagulant regimen. Recently, a single-centre study reported device-related thrombus formation in 16.7% of patients treated with the second-generation Amulet device (St. Jude Medical, St. Paul, MN, USA), presenting a potential major safety concern. As "real-world" data on device-related thrombus formation following LAAO with the Amulet occluder are scarce, we aimed to evaluate this outcome in a retrospective registry.
Clinical and tranosesophageal echocardiography data after LAAO with the Amulet in consecutive patients from three centres were collated.
Among 38 patients (mean age 75.8 years), mean (standard deviation) CHADS-VASc and HAS-BLED scores were 4.4 (1.2) and 3.4 (0.9), respectively. All patients underwent successful device placement without procedure-related adverse events. The antithrombotic regimen at discharge consisted of dual antiplatelet therapy (DAPT) in 27 patients (71.1%), single antiplatelet therapy in 10 patients (26.3%), and no antithrombotic therapy in one patient (2.6%). Device-related thrombus was observed in one patient (2.6%) despite DAPT regimen. The outcome of this patient was uncomplicated after adjustment of oral anticoagulant therapy. No patients presented with a thromboembolic event following LAAO during a mean (standard deviation) follow-up of 15 (5) months.
In this retrospective study, device-related thrombus formation with the second-generation Amulet device was rare and occurred at a rate similar to that of the previous device. Importantly, no patient experienced a device-related thromboembolic event during follow-up. Larger real-life studies are required to confirm the safety profile of this increasingly used device.
左心耳封堵术（LAAO）越来越多地用于因不适合长期口服抗凝而被认为不适合接受治疗的房颤患者的卒中预防。最近，一项单中心研究报告称，第二代 Amulet 装置（圣犹达医疗公司，明尼苏达州圣保罗市）治疗的患者中有 16.7%发生了与器械相关的血栓形成，这是一个潜在的重大安全隐患。由于关于 Amulet 封堵器 LAAO 后与器械相关的血栓形成的“真实世界”数据很少，我们旨在通过回顾性登记来评估这一结果。
对来自三个中心的连续患者进行 LAAO 后 Amulet 器械的临床和经食管超声心动图数据的收集。
在 38 名患者（平均年龄 75.8 岁）中，平均（标准差）CHADS-VASc 和 HAS-BLED 评分分别为 4.4（1.2）和 3.4（0.9）。所有患者均成功放置器械，无手术相关不良事件。出院时的抗栓方案包括 27 名患者（71.1%）的双联抗血小板治疗（DAPT）、10 名患者（26.3%）的单联抗血小板治疗和 1 名患者（2.6%）的无抗栓治疗。尽管采用了 DAPT 方案，但仍有 1 名患者（2.6%）出现与器械相关的血栓。在平均（标准差）15（5）个月的随访中，该患者在调整口服抗凝治疗后病情无并发症。
在这项回顾性研究中，第二代 Amulet 装置与器械相关的血栓形成发生率较低，与前一代装置相似。重要的是，在随访期间没有患者发生与器械相关的血栓栓塞事件。需要更大规模的真实世界研究来证实这种越来越常用的器械的安全性。
