Abstract
Introduction and objectives
Vaccines against SARS-CoV-2 have been a major scientific and medical achievement in the control of the COVID-19 pandemic. However, very infrequent cases of inflammatory heart disease have been described as adverse events, leading to uncertainty in the scientific community and in the general population.
Methods
The Vaccine–Carditis Registry has included all cases of myocarditis and pericarditis diagnosed within 30 days after COVID-19 vaccination since August 1, 2021 in 29 centers throughout the Spanish territory. The definitions of myocarditis (probable or confirmed) and pericarditis followed the consensus of the Centers for Disease Control and the Clinical Practice Guidelines of the European Society of Cardiology. A comprehensive analysis of clinical characteristics and 3-month evolution is presented.
Results
From August 1, 2021, to March 10, 2022, 139 cases of myocarditis or pericarditis were recorded (81.3% male, median age 28 years). Most cases were detected in the 1st week after administration of an mRNA vaccine, the majority after the second dose. The most common presentation was mixed inflammatory disease (myocarditis and pericarditis). 11% had left ventricular systolic dysfunction, 4% had right ventricular systolic dysfunction, and 21% had pericardial effusion. In cardiac magnetic resonance studies, left ventricular inferolateral involvement was the most frequent pattern (58%). More than 90% of cases had a benign clinical course. After a 3-month follow-up, the incidence of adverse events was 12.78% (1.44% mortality).
Conclusions
In our setting, inflammatory heart disease after vaccination against SARS-CoV-2 predominantly affects young men in the 1st week after the second dose of RNA-m vaccine and presents a favorable clinical course in most cases.
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Data availability
Raw data were generated and collected at Arnau de Vilanova Hospital and Institut de Reserca Biomèdica Lleida (IRB-Lleida). Derived data supporting the findings of this study are available from the corresponding author on request.
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Acknowledgements
We would like to thank University Hospital Arnau de Vilanova de Lleida and the Institut de Reserça Biomèdica IRB-Lleida for the institutional and logistic support. Special thanks to Joan Escobar for his indispensable help with the database and to Marta Agustí for her tireless work as nurse research coordinator. Spanish Society of Cardiology for the support provided through the Working Group on Myocarditis and Inflammatory Cardiomyopathy. Spanish Agency of Medicines and Health Products, and especially to Dolores Montero, for her collaboration.
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Pastor Pueyo, P., Gambó Ruberte, E., Gayán Ordás, J. et al. Vaccine–carditis study: Spanish multicenter registry of inflammatory heart disease after COVID-19 vaccination. Clin Res Cardiol 113, 223–234 (2024). https://doi.org/10.1007/s00392-023-02225-0
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DOI: https://doi.org/10.1007/s00392-023-02225-0