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Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Acute and long-term outcome of occluder implantation in the LAARGE Registry

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Abstract

Background

Left atrial appendage occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) patients who are not eligible for long-term oral anticoagulation. The present paper describes the acute and 1-year follow-up outcome data of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE).

Methods

LAARGE enrolled 641 patients who were scheduled for LAAO implantation. The data collected included demographics, clinical characteristics, procedure indication, details of implantation, and outcome; patients were followed at 1-year post-implant. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively.

Results

A total of 641 consecutive patients (mean age: 75.9 ± 8.0) were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Patient demographics represent a critically-ill population with a calculated mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively, with bleeding events as the main indication for LAAO implantation (79.4%). One-year all-cause mortality post-procedure was 11.5% with a non-fatal stroke/TIA rate of 1.3% (8 patients) and a rate of major bleeding of 1.6% (10 patients). The anticoagulation regimen after 1 year consisted of oral anticoagulation in 5.5% of patients and an antiplatelet therapy (APT) rate of 84.1% (majority single APT with ASS (74.5%), dual APT in 6.7%).

Conclusions

LAARGE, a prospective multicenter real-world and all-comer registry, is unique in its concept, as it is non-manufacturer sponsored and includes all commercially available devices. LAAO implantation is mainly performed in elderly, critically-ill patients with a history of bleeding. LAARGE demonstrates a favorable outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%) while using a single APT in the vast majority of patients.

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Abbreviations

LAAO:

left atrial appendage occluder

AF :

atrial fibrillation

OAC:

oral anticoagulation

LAARGE :

Left Atrial Appendage Occlusion Registry Germany

CAD :

coronary artery disease

CKD :

chronic kidney disease

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Author information

Author notes

  1. Johannes Brachmann and Thorsten Lewalter contributed equally.

Authors and Affiliations

  1. Department of Cardiology, Klinikum Coburg, Coburg, Germany

    Johannes Brachmann

  2. Department of Cardiology and Intensive Care, Peter Osypka Heart Center Munich, Hospital for Internal Medicine Munich South, Am Isarkanal 36, 81379, Munich, Germany

    Thorsten Lewalter

  3. Department of Cardiology, University Hospital Mannheim, Mannheim, Germany

    Ibrahim Akin

  4. Department of Cardiology, Katharinenhospital Frankfurt, Frankfurt, Germany

    Horst Sievert

  5. Department of Cardiology, Klinkum Bad Segeberg, Bad Segeberg, Germany

    Volker Geist

  6. Department of Cardiology, Klinikum Ludwigshafen, Ludwigshafen, Germany

    Uwe Zeymer

  7. Institut für Herzinfarktforschung, Ludwigshafen, Germany

    Uwe Zeymer, Matthias Hochadel & Jochen Senges

  8. Department of Cardiology, University Hospital Giessen, Giessen, Germany

    Damir Erkapic

  9. Department of Cardiology, Klinikum Neuperlach, Munich, Germany

    Harald Mudra

  10. Department of Cardiology, University Hospital Heidelberg, Heidelberg, Germany

    Sven Pleger

Authors
  1. Johannes Brachmann
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  2. Thorsten Lewalter
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Corresponding author

Correspondence to Thorsten Lewalter.

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Conflict of interest

T.L., J.B., and H.S. have received moderate speaker honoraria from Boston Scientific and Abbott, no conflict of interest for the remaining authors

Ethical approval

The LAARGE registry received ethical approval in April 2014 from the State Chamber of Medicine of Rhineland-Palatinate. All aspects of the registry comply with the principles of Good Clinical Practice (GCP) and the Declaration of Helsinki.

Informed consent

All enrolled patients provided written informed consent to be included in the registry and to participate in the follow-up.

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Brachmann, J., Lewalter, T., Akin, I. et al. Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Acute and long-term outcome of occluder implantation in the LAARGE Registry. J Interv Card Electrophysiol 58, 273–280 (2020). https://doi.org/10.1007/s10840-019-00635-7

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  • DOI: https://doi.org/10.1007/s10840-019-00635-7

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