Cardiac manifestations and outcomes of COVID-19 vaccine-associated myocarditis in the young in the USA: longitudinal results from the Myocarditis After COVID Vaccination (MACiV) multicenter study

Supriya S. Jain, Department of Pediatrics, Division of Cardiology, New York Medical College-Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY, USA.
Steven A. Anderson, The U.S. Food and Drug Administration, Silver Spring, MD, USA.
Jeremy M. Steele, Yale University School of Medicine, New Haven, CT, USA.
Hunter C. Wilson, Emory University School of Medicine, Sibley Heart Center, Atlanta, GA, USA.
Juan Carlos Muniz, Nicklaus Children's Hospital, Miami, FL, USA.
Jonathan H. Soslow, Vanderbilt University Medical Center, Nashville, TN, USA.
Rebecca S. Beroukhim, Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.
Victoria Maksymiuk, Department of Pediatrics, Division of Cardiology, New York Medical College-Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY, USA.
Xander Jacquemyn, Department of Pediatrics, Johns Hopkins School of Medicine, Helen B. Taussig Heart Center, Johns Hopkins Hospital, Baltimore, MD, USA.
Olivia H. Frosch, University of Michigan Medical School, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.
Brian Fonseca, Children's Hospital Colorado, Aurora, CO, USA.
Ashraf S. Harahsheh, Children's National Hospital and the George Washington University School of Medicine & Health Sciences, WA, USA.
Sujatha Buddhe, Seattle Children's Hospital, Seattle, WA, USA.
Ravi C. Ashwath, University of Iowa Stead Family Children's Hospital, Iowa City, IA, USA.
Deepika Thacker, Nemours Children's Health/Nemours Cardiac Center, Wilmington, DE, USA.
Shiraz A. Maskatia, Lucile Packard Children's Hospital, Stanford, Palo Alto, CA, USA.
Nilanjana Misra, Cohen Children's Medical Center, Northwell Health, New York, USA.
Jennifer A. Su, Children's Hospital of Los Angeles, Los Angeles, CA, USA.
Saira Siddiqui, Goryeb Children's Hospital, Morristown, NJ, USA.
Danish Vaiyani, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Aswathy K. Vaikom-House, The University of Oklahoma Health Science Oklahoma City, Oklahoma, USA.
M Jay Campbell, Division of Pediatric Cardiology, Department of Pediatrics, Duke University, Durham, NC, USA.
Jared Klein, Joe DiMaggio Children's Hospital, Hollywood, FL, USA.
Sihong Huang, Betz Congenital Health Center, Helen DeVos Children's Hospital, Grand Rapids, MI, USA.
Christopher Mathis, Children's Mercy Kansas City, Kansas City, MO, USA.
Matthew D. Cornicelli, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA.
Madhu Sharma, The Children's Hospital at Montefiore Bronx, New York, USA.
Lakshmi Nagaraju, UC Davis Children's Hospital, Sacramento, CA, USA.
Jocelyn Y. Ang, Riley Hospital for Children, Indianapolis, IN, USA.
Santosh C. Uppu, The University of Texas Health Science Center, Children's Heart Institute, Houston, TX, USA.
Preeti Ramachandran, Kentucky Children's Hospital, University of Kentucky, Lexington, KY, USA.
Jyoti K. Patel, Children's Hospital of Michigan, Detroit, MI, USA.

Document Type

Journal Article

Publication Date

10-1-2024

Journal

EClinicalMedicine

Volume

76

DOI

10.1016/j.eclinm.2024.102809

Keywords

COVID-19 vaccine-associated myocarditis; Cardiac MRI; LGE late gadolinium enhancement; MIS-C multisystem inflammatory syndrome in children; Myocardial injury; Myocarditis

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.

Department

Pediatrics

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