Supriya S. Jain, New York Medical College
Steven A. Anderson, Food and Drug Administration
Jeremy M. Steele, Yale School of Medicine
Hunter C. Wilson, Emory University School of Medicine
Juan Carlos Muniz, Nicklaus Children's Hospital
Jonathan H. Soslow, Vanderbilt University Medical Center
Rebecca S. Beroukhim, Boston Children's Hospital
Victoria Maksymiuk, New York Medical College
Xander Jacquemyn, Johns Hopkins University School of Medicine
Olivia H. Frosch, University of Michigan Medical School
Brian Fonseca, The Children's Hospital, Aurora
Ashraf S. Harahsheh, The George Washington University School of Medicine and Health Sciences
Sujatha Buddhe, Seattle Children's Hospital
Ravi C. Ashwath, University of Iowa Stead Family Children’s Hospital
Deepika Thacker, Nemours Children's Health System
Shiraz A. Maskatia, Lucile Packard Children's Hospital Stanford
Nilanjana Misra, Northwell Health System
Jennifer A. Su, Children's Hospital Los Angeles
Saira Siddiqui, Goryeb Children's Hospital
Danish Vaiyani, The Children's Hospital of Philadelphia
Aswathy K. Vaikom-House, The University of Oklahoma
M. Jay Campbell, Duke University School of Medicine
Jared Klein, Joe DiMaggio Children's Hospital
Sihong Huang, Helen DeVos Children's Hospital
Christopher Mathis, Children's Mercy Kansas City
Matthew D. Cornicelli, Children's Memorial Hospital
Madhu Sharma, The Childrens's Hospital at Montefiore
Lakshmi Nagaraju, UC Davis Children's Hospital
Marla Johnston, LSU Health Sciences Center - New OrleansFollow
et al

Document Type

Article

Publication Date

9-6-2024

Publication Title

eClinicalMedicine

Abstract

Background: We aimed to study the clinical characteristics, myocardial injury, and longitudinal outcomes of COVID-19 vaccine-associated myocarditis (C-VAM). Methods: In this longitudinal retrospective observational cohort multicenter study across 38 hospitals in the United States, 333 patients with C-VAM were compared with 100 patients with multisystem inflammatory syndrome in children (MIS-C). We included patients ≤ 30 years of age with a clinical diagnosis of acute myocarditis after COVID-19 vaccination based on clinical presentation, abnormal biomarkers and/or cardiovascular imaging findings. Demographics, past medical history, hospital course, biochemistry results, cardiovascular imaging, and follow-up information from April 2021 to November 2022 were collected. The primary outcome was presence of myocardial injury as evidenced by late gadolinium enhancement (LGE) on cardiac magnetic resonance (CMR) imaging. Findings: Patients with C-VAM were predominantly white (67%) adolescent males (91%, 15.7 ± 2.8 years). Their initial clinical course was more likely to be mild (80% vs. 23%, p < 0.001) and cardiac dysfunction was less common (17% vs. 68%, p < 0.0001), compared to MIS-C. In contrast, LGE on CMR was more prevalent in C-VAM (82% vs. 16%, p < 0.001). The probability of LGE was higher in males (OR 3.28 [95% CI: 0.99, 10.6, p = 0.052]), in older patients ( > 15 years, OR 2.74 [95% CI: 1.28, 5.83, p = 0.009]) and when C-VAM occurred after the first or second dose as compared to the third dose of mRNA vaccine. Mid-term clinical outcomes of C-VAM at a median follow-up of 178 days (IQR 114–285 days) were reassuring. No cardiac deaths or heart transplantations were reported until the time of submission of this report. LGE persisted in 60% of the patients at follow up. Interpretation: Myocardial injury at initial presentation and its persistence at follow up, despite a mild initial course and favorable mid-term clinical outcome, warrants continued clinical surveillance and long-term studies in affected patients with C-VAM. Funding: The U.S. Food and Drug Administration.

PubMed ID

39290640

Volume

76

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