Saad Mohammed, Risha Osama, Sano Makoto, Fink Thomas, Heeger Christian-Hendrik, Vogler Julia, Sciacca Vanessa, Eitel Charlotte, Stiermaier Thomas, Joost Alexander, Keelani Ahmad, Fuernau Georg, Meyer-Saraei Roza, Kuck Karl-Heinz, Eitel Ingo, Richard Tilz Roland
Medical Clinic III, University Hospital Schleswig-Holstein, Kiel, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.
Int J Cardiol Heart Vasc. 2021 Oct 19;37:100893. doi: 10.1016/j.ijcha.2021.100893. eCollection 2021 Dec.
Data reporting a head-to-head comparison between Amulet and Watchman devices are scarce. The aim of this study was to compare the Watchman™ versus Amulet™ left atrial appendage closure (LAAC) devices in a consecutive, industry-independent registry.
Patients who underwent LAAC using Watchman or Amulet devices from January 2014 to December 2019 at the University Heart Center Lübeck, Lübeck, Germany were included in the present analysis. Primary endpoints included periprocedural complications (in-hospital death, pericardial tamponade, device embolization, stroke, major bleeding and vascular access complications), and complications during long-term follow-up (ischemic stroke, hemorrhagic stroke, thromboembolism, device thrombus, bleeding and death).
After matching the patients for age (±5 years), gender, CHA2DS2Vasc score (±1) and HASBLED score (±1), each of the Watchman and the Amulet groups included 113 patients. Patients in the Amulet group had significantly more periprocedural complications (2.7% vs 10.6%, p = 0.029; respectively) and more major bleeding complications (0% vs 5.3%, p = 0.029; respectively). During long-term follow-up, the rate of events was comparable between the Watchman and Amulet groups (18.3% versus 20.8%, p = 0.729; respectively).
Amulet LAAC device was associated with increased periprocedural complications as compared to Watchman LAAC device. On long-term follow-up, both devices showed comparable efficacy and safety.
关于Amulet和Watchman装置进行直接头对头比较的数据很少。本研究的目的是在一个连续的、独立于行业的注册研究中比较Watchman™与Amulet™左心耳封堵（LAAC）装置。
纳入2014年1月至2019年12月在德国吕贝克大学心脏中心使用Watchman或Amulet装置进行LAAC的患者进行本分析。主要终点包括围手术期并发症（院内死亡、心包填塞、装置栓塞、中风、大出血和血管通路并发症）以及长期随访期间的并发症（缺血性中风、出血性中风、血栓栓塞、装置血栓、出血和死亡）。
在对患者的年龄（±5岁）、性别、CHA2DS2Vasc评分（±1）和HASBLED评分（±1）进行匹配后，Watchman组和Amulet组各有113例患者。Amulet组患者的围手术期并发症明显更多（分别为2.7%对10.6%，p = 0.029），大出血并发症也更多（分别为0%对5.3%，p = 0.029）。在长期随访期间，Watchman组和Amulet组的事件发生率相当（分别为18.3%对20.8%，p = 0.729）。
与Watchman LAAC装置相比，Amulet LAAC装置与围手术期并发症增加相关。在长期随访中，两种装置显示出相当的疗效和安全性。
