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*, Steven A. Anderson, Jeremy M. Steele, Hunter C. Wilson, Juan Carlos Muniz, Jonathan H. Soslow, Rebecca S. Beroukhim, Victoria Maksymiuk, Xander Jacquemyn, Olivia H. Frosch, Brian Fonseca, Ashraf S. Harahsheh, Sujatha Buddhe, Ravi C. Ashwath, Deepika Thacker, Shiraz A. Maskatia, Nilanjana Misra, Jennifer A. Su, Saira Siddiqui, Danish VaiyaniAswathy K. Vaikom-House, M. Jay Campbell, Jared Klein, Sihong Huang, Christopher Mathis, Matthew D. Cornicelli, Madhu Sharma, Lakshmi Nagaraju, Jocelyn Y. Ang, Santosh C. Uppu, Preeti Ramachandran, Jyoti K. Patel, Frank Han, Jason G. Mandell, Jyothsna Akam-Venkata, Michael P. DiLorenzo, Michael Brumund, Puneet Bhatla, Parham Eshtehardi, Karina Mehta, Katherine Glover, Matthew L. Dove, Khalifah A. Aldawsari, Anupam Kumar, Spencer B. Barfuss, Adam L. Dorfman, Prashant K. Minocha, Alexandra B. Yonts, Jenna Schauer, Andrew L. Cheng, Joshua D. Robinson, Zachary Powell, Shubhika Srivastava, Anjali Chelliah, Yamuna Sanil, Lazaro E. Hernandez, Lasya Gaur, Michael Antonchak, Marla Johnston, Jonathan D. Reich, Narayan Nair, Elizabeth D. Drugge, Lars Grosse-Wortmann

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

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.

Original languageEnglish (US)
Article number102809
JournalEClinicalMedicine
Volume76
DOIs
StatePublished - Oct 2024

Funding

ASH: Site PI for the CAMP study - NHLBI funded, Site PI for MUSIC \u2013 NIH funded, Site PI for PREVAIL, supported by a sub-agreement from the Johns Hopkins University with funds provided by Grant No. R61HD105591 from the Eunice Kennedy Shriver National Institute of Child Health & Human Development and the Office of the Director, National Institute of Health (OD). Scientific advisory board member of OP2 DRUGS (\u201COP2\u201D), states that no work has been done. ABY: Institution received funds for conducting phase 3 clinical trials for Pfizer mRNA COVID-19 vaccine (C4591007 and C4591048). LEH: Patent US11457889B2, issued: Oct 4, 2022, Patent US2023/0016283A1 Published: Jan 19, 2023. JK: $530 Honorarium for speaking at Cleveland Clinic Valve Disease, Structural Interventions, and Diastology/Imaging Summit in 2/2023. FH: Payment for Expert Testimony in pending court case as an expert witness to discuss the risk of C-VAM. DT and SS: Grant or contract from New England Research Institute for participation in Pediatric Heart Network CAMP Study. MJC: Subject matter expert for CDC CISA program, Consulting fees Longerone Inc. This study was funded by the U.S Food and Drug Administration, FDA-75F40122C00148. The U.S. Food and Drug Administration.This study was funded by the U.S. Food and Drug Administration, FDA-75F40122C00148, FDA-21F19004-T0006. For assistance in the study, we thank Erida Castro-Rivas, MS for central study coordination, Joel Johnson, MD for data management, Jay Ayar, DrPH(c) and Peter Ondish, Ph.D. for statistical analysis.

Keywords

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

ASJC Scopus subject areas

  • General Medicine

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