Comparison between Amulet and Watchman left atrial appendage closure devices: A real-world, single center experience.

ACP, Amplatzer Cardiac Plug AF, Atrial fibrillation Amulet Anti-coagulation Atrial fibrillation LAA, Left atrial appendage LAAC, Left atrial appendage closure Left atrial appendage closure MACCE, major adverse cardiac and cerebrovascular events OAC, Oral anticoagulants TEE, transesophageal echocardiography Watchman

Journal

International journal of cardiology. Heart & vasculature
ISSN: 2352-9067
Titre abrégé: Int J Cardiol Heart Vasc
Pays: Ireland
ID NLM: 101649525

Informations de publication

Date de publication:
Dec 2021
Historique:
received: 03 10 2021
accepted: 13 10 2021
entrez: 29 10 2021
pubmed: 30 10 2021
medline: 30 10 2021
Statut: epublish

Résumé

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.

Sections du résumé

BACKGROUND BACKGROUND
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.
METHODS METHODS
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).
RESULTS RESULTS
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).
CONCLUSION CONCLUSIONS
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.

Identifiants

pubmed: 34712772
doi: 10.1016/j.ijcha.2021.100893
pii: S2352-9067(21)00181-0
pmc: PMC8529070
doi:

Types de publication

Journal Article

Langues

eng

Pagination

100893

Informations de copyright

© 2021 The Author(s).

Déclaration de conflit d'intérêts

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: RRT: consultant to Boston Scientific, speaker‘s bureau: Boston Scientific, Abbot Medical. MS: proctor in Boston Scientific for Watchman 2.5 and Watchman FLX. All other authors declare no competing financial and/or non-financial interests in relation to the work described.

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Auteurs

Mohammed Saad (M)

Medical Clinic III, University Hospital Schleswig-Holstein, Kiel, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Osama Risha (O)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Makoto Sano (M)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Thomas Fink (T)

Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.
Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Christian-Hendrik Heeger (CH)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Julia Vogler (J)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Vanessa Sciacca (V)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Charlotte Eitel (C)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Thomas Stiermaier (T)

Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Alexander Joost (A)

Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Ahmad Keelani (A)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Georg Fuernau (G)

Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Roza Meyer-Saraei (R)

Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.
Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Karl-Heinz Kuck (KH)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Ingo Eitel (I)

Medical Clinic II, University Heart Center Lübeck, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Roland Richard Tilz (R)

Medical Clinic II, University Heart Center Lübeck, Division of Electrophysiology, Lübeck, Germany.
German Centre for Cardiovascular Research (DZHK), Partner Site Hamburg/Kiel/Lübeck, Lübeck, Germany.

Classifications MeSH