Is spontaneous echo contrast associated with device-related thrombus or embolic events after left atrial appendage occlusion? - Insights from the multicenter German LAARGE registry

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Abstract

Background

Interventional left atrial appendage occlusion (LAAO) provides an alternative to oral anticoagulation (OAC) for prophylaxis of thromboembolic events (TEs) in nonvalvular atrial fibrillation patients, predominantly in those with high bleeding risk and contraindications for long-term OAC. Although spontaneous echo contrast (SEC) is a well-known risk factor for atrial thrombus formation, little is known about whether this means an increased risk of device-related thrombus (DRT) or TEs following LAAO.

Methods

This substudy of the prospective, multicenter German LAARGE registry assessed two groups according to absence (SEC −) or presence of SEC (SEC +) in preprocedural cardiac imaging. Clinical and echocardiographic parameters were registered up to 1 year after LAAO.

Results

Five hundred eighty-eight patients (SEC − 85.5 vs. SEC + 14.5%) were included. More SEC + patients were implanted for OAC non-compliance (11.8 vs. 4.6%, p = 0.008) and a higher proportion received only antiplatelet therapy without OAC at hospital discharge (96.5 vs. 86.0%, p = 0.007). The SEC + patients had larger LA diameters (50 (47; 54) vs. 47 (43; 51) mm, p < 0.001), wider LAA ostia (21 (19; 23) vs. 20 (17; 22) mm at 45°, p = 0.011), and lower left ventricular ejection fraction (50 (45; 60) vs. 60 (50; 60) %, p < 0.001) on admission. Procedural success was very high in both groups (98.1%, p = 1.00). Periprocedural major adverse cardiac and cerebrovascular events and other major complications were rare in both groups (3.8 vs. 4.7%, p = 0.76). At follow-up, DRT was only detected in the SEC − group (3.8 vs. 0%, p = 1.00). The rates of TEs (SEC − 1.2 vs. SEC + 0%, p = 1.00) after hospital discharge and 1-year mortality (SEC − 12.0 vs. SEC + 11.8%, p = 0.96) were not significantly different between the two groups.

Conclusions

Presence of SEC at baseline was not associated with an increased rate of DRT or TEs at 1-year follow-up after LAAO in LAARGE.

Supplementary Information

The online version contains supplementary material available at 10.1007/s10840-023-01567-z.

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Most cited references 31

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(2020)

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Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial.

David Holmes, Vivek Reddy, Zoltan Turi … (2009)

In patients with non-valvular atrial fibrillation, embolic stroke is thought to be associated with left atrial appendage (LAA) thrombi. We assessed the efficacy and safety of percutaneous closure of the LAA for prevention of stroke compared with warfarin treatment in patients with atrial fibrillation. Adult patients with non-valvular atrial fibrillation were eligible for inclusion in this multicentre, randomised non-inferiority trial if they had at least one of the following: previous stroke or transient ischaemic attack, congestive heart failure, diabetes, hypertension, or were 75 years or older. 707 eligible patients were randomly assigned in a 2:1 ratio by computer-generated randomisation sequence to percutaneous closure of the LAA and subsequent discontinuation of warfarin (intervention; n=463) or to warfarin treatment with a target international normalised ratio between 2.0 and 3.0 (control; n=244). Efficacy was assessed by a primary composite endpoint of stroke, cardiovascular death, and systemic embolism. We selected a one-sided probability criterion of non-inferiority for the intervention of at least 97.5%, by use of a two-fold non-inferiority margin. Serious adverse events that constituted the primary endpoint for safety included major bleeding, pericardial effusion, and device embolisation. Analysis was by intention to treat. This study is registered with Clinicaltrials.gov, number NCT00129545. At 1065 patient-years of follow-up, the primary efficacy event rate was 3.0 per 100 patient-years (95% credible interval [CrI] 1.9-4.5) in the intervention group and 4.9 per 100 patient-years (2.8-7.1) in the control group (rate ratio [RR] 0.62, 95% CrI 0.35-1.25). The probability of non-inferiority of the intervention was more than 99.9%. Primary safety events were more frequent in the intervention group than in the control group (7.4 per 100 patient-years, 95% CrI 5.5-9.7, vs 4.4 per 100 patient-years, 95% CrI 2.5-6.7; RR 1.69, 1.01-3.19). The efficacy of percutaneous closure of the LAA with this device was non-inferior to that of warfarin therapy. Although there was a higher rate of adverse safety events in the intervention group than in the control group, events in the intervention group were mainly a result of periprocedural complications. Closure of the LAA might provide an alternative strategy to chronic warfarin therapy for stroke prophylaxis in patients with non-valvular atrial fibrillation. Atritech.

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Prevention of stroke: a global perspective

Jeyaraj Pandian, Seana Gall, Mahesh P. Kate … (2018)

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Author and article information

Contributors

Christian Fastner:

ORCID: http://orcid.org/0000-0001-9367-4386

christian.fastner@umm.de

Journal

Journal ID (nlm-ta): J Interv Card Electrophysiol

Journal ID (iso-abbrev): J Interv Card Electrophysiol

Title: Journal of Interventional Cardiac Electrophysiology

Publisher: Springer US (New York )

ISSN (Print): 1383-875X

ISSN (Electronic): 1572-8595

Publication date (Electronic): 1 June 2023

Publication date PMC-release: 1 June 2023

Publication date (Print): 2024

Volume: 67

Issue: 1

Pages: 119-128

Affiliations

[1 ]GRID grid.411778.c, ISNI 0000 0001 2162 1728, Department of Cardiology, Angiology, Haemostaseology and Medical Intensive Care, , University Medical Centre Mannheim, Medical Faculty Mannheim, Heidelberg University, European Center for AngioScience (ECAS), and German Center for Cardiovascular Research (DZHK) Partner Site Heidelberg/Mannheim, ; Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany

[2 ]GRID grid.416312.3, Department of Cardiology, , Städtisches Klinikum Lüneburg gGmbH, ; Lüneburg, Germany

[3 ]REGIOMED‐Kliniken, Coburg, Germany and University of Split, School of Medicine, ( https://ror.org/00m31ft63) Split, Croatia

[4 ]Department of Medicine, Cardiology and Intensive Care, Hospital Munich‐Thalkirchen, Munich, Germany

[5 ]CardioVascular Center (CVC) Frankfurt, ( https://ror.org/03e2b2m72) Frankfurt, Germany

[6 ]GRID grid.459415.8, ISNI 0000 0004 0558 5853, Department of Cardiology, , University of Witten/Herdecke, Katholisches Klinikum Essen, ; Essen, Germany

[7 ]Department of Cardiology, Klinikum Ludwigshafen, ( https://ror.org/037wq4b75) Ludwigshafen, Germany

[8 ]Stiftung Institut Für Herzinfarktforschung, ( https://ror.org/0213d4b59) Ludwigshafen, Germany

[9 ]GRID grid.411067.5, ISNI 0000 0000 8584 9230, Department of Cardiology, Rhythmology and Angiology, Diakonie Klinikum Siegen, Siegen, Germany and Department of Cardiology and Angiology, , University Hospital Giessen, ; Giessen, Germany

Author information

Christian Fastner http://orcid.org/0000-0001-9367-4386

Article

Publisher ID: 1567

DOI: 10.1007/s10840-023-01567-z

PMC ID: 10770218

PubMed ID: 37261553

SO-VID: 1c9c05f3-e3ef-4d1d-a2f8-d4cd2bbb0566

License:

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

History

Date received : 28 February 2023

Date accepted : 12 May 2023

Funding

Funded by: Stiftung Institut für Herzinfarktforschung

Funded by: Medizinische Fakultät Mannheim der Universität Heidelberg (8990)

Open Access :

Open Access funding enabled and organized by Projekt DEAL.

Custom metadata

ScienceOpen disciplines: Cardiovascular Medicine

Keywords: atrial fibrillation,thromboembolism,ischemic stroke,bleeding risk,interventional approach,left atrial appendage closure

Data availability:

ScienceOpen disciplines: Cardiovascular Medicine

Keywords: atrial fibrillation, thromboembolism, ischemic stroke, bleeding risk, interventional approach, left atrial appendage closure

Is spontaneous echo contrast associated with device-related thrombus or embolic events after left atrial appendage occlusion? - Insights from the multicenter German LAARGE registry

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Abstract

Background

Methods

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Conclusions

Supplementary Information

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Karger: Cardiovascular System

Most cited references 31

OUP accepted manuscript

Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial.

Prevention of stroke: a global perspective

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