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 Steele, Hunter C. Wilson, Juan Carlos Muniz, Jonathan H. Soslow, Rebecca S. Beroukhim, Victoria Maksymiuk, Xander Jacquemyn, Olivia Frosch, Brian Fonseca, Ashraf S. Harahsheh, Sujatha Buddhe, Ravi Ashwath, Deepika Thacker, Shiraz A. Maskatia, Nilanjana Misra, Jennifer Su, Saira Siddiqui, Danish Vaiyani, Aswathy K Vaikom-House, Michael J. Campbell, Jared Klein, Sihong Huang, Christopher Mathis, Matthew Cornicelli, Madhu Sharma, Lakshmi Nagaraju, Jocelyn Y. Ang, Santosh C. Uppu, Preeti Ramachandran, Jyoti Patel, Frank Han, Jason G. Mandell, Jyothsna Akam‐Venkata, Michael P. DiLorenzo, Michael Brumund, Puneet Bhatla, Parham Eshtehardi, Karina Mehta, Katherine Glover, Matthew Dove, Khalifah A Aldawsari, Anupam Kumar, Spencer 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 Hernandez, Lasya Gaur, Michael Antonchak, Marla Johnston, Jonathan D. Reich, Narayan Nair, Elizabeth Drugge, Lars Grosse‐Wortmann
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.