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通过皮肤关闭左心室尾的护身符或守望装置:瑞士APERO随机临床试验的主要结果

Roberto Galea ¹, Federico De Marco ², Nicolas Meneveau ³

¹Department of Cardiology (R.G., C.G., L.R., M.V.), Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.
²Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy (F.D.M., F.B.).
³Besancon University Hospital, University of Burgundy Franche-Comté, France (N.M.).
⁴Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Belgium (A.A.).
⁵Department of Cardiology, University Hospital of Rouen, France (F.A.).
⁶Department of Diagnostic, Interventional and Pediatric Radiology (A.T.H.), Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.
⁷Department of Cardiology, Henri-Mondor Hospital, Public Assistance Hospitals of Paris, Créteil, France (E.T.).
⁸Department of Pediatric and Adult Congenital Cardiology, Hôpital Cardiologique du Haut-Lévêque, CHU de Bordeaux, Bordeaux-Pessac, France (X.I.).
⁹Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland (F.B.B., D.H.).
¹⁰Department of Advanced Biomedical Sciences, University Federico II University, Naples, Italy (A.F.).
¹¹Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis; Faculty of Medicine and Life Sciences, Hasselt University, Belgium (P.V.).
¹²Department of Neurology (U.F.),Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.
¹³Department of Neurology, University Hospital Basel, University of Basel, Switzerland (U.F.).
¹⁴Cardiocentro Ticino Institute and Università della Svizzera Italiana (USI), Lugano, Switzerland (G.P., M.V.).

⁰Department of Cardiology (R.G., C.G., L.R., M.V.), Bern University Hospital, Clinical Trials Unit, University of Bern, Bern, Switzerland.

Circulation +

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2021年十一月8日

在PubMed上查看摘要

概括

在SWISS APERO试验中,Amulet和Watchman FLX器件之间没有发现左心房膜通透度的显著差异. 然而,Amulet显示出更低的设备泄漏率,而Watchman则出现更少的程序并发症.

科学领域

心脏病学
干预心脏病学
医疗器械

背景情况

通过皮肤关闭左心房附属体 (LAA) 是心房的关键预防策略.
在LAA通透性和临床结果方面,Amulet设备和较新的Watchman FLX设备之间没有直接比较.

研究的目的

在接受穿皮LAA关闭的患者中,将Amulet设备与Watchman FLX设备进行比较.
评估两种设备之间的残留LAA通透度,程序并发症和临床结果的差异.

主要方法

由研究人员发起的SWISS APERO试验随机分配患者 (1:1) 接受Amulet或Watchman (2. 5或FLX).
主要终点是通过CCTA评估的45天的交叉或残留LAA通透度.
二次终点包括手术并发症,血栓,周周器件泄漏和临床结果.

主要成果

在Amulet和Watchman之间没有观察到主要终点 (交叉或LAA通透性) 的显著差异 (67.6%与70. 0%,P=0. 713).
在45天后,Amulet的器件泄漏率显著降低 (13. 7% 对比 27. 5% ,P=0. 020).
主要因出血而导致的重大手术并发症在Amulet治疗中更为频繁 (9. 0%对2. 7%).

结论

与Watchman相比,Amulet的LAA通透率没有降低.
护身符与较低的器件泄漏率有关,但程序并发症较高.
在45天后,Amulet和Watchman组的临床结果相似.

关键词:

前庭附属体计算机断层扫描血管学