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Original Investigation
August 26, 2024

Long-Term Prognosis of Patients With Myocarditis Attributed to COVID-19 mRNA Vaccination, SARS-CoV-2 Infection, or Conventional Etiologies

Author Affiliations
  • 1EPI-PHARE Scientific Interest Group in Epidemiology of Health Products from the French National Agency for the Safety of Medicines and Health Products and the French National Health Insurance
  • 2University Paris-Saclay, Faculté de pharmacie, Orsay, France
  • 3Cardiologist, Specialized Medical Group, Strasbourg, France
  • 4Centre Ellipse, Strasbourg, France
  • 5University Paris-Saclay, UVSQ, University Paris-Sud, Inserm, Anti-infective evasion and Pharmacoepidemiology Unit/Team, CESP, Montigny le Bretonneux, France
JAMA. 2024;332(16):1367-1377. doi:10.1001/jama.2024.16380
Key Points

Question  What is the long-term prognosis of myocarditis after COVID-19 mRNA vaccination and do clinical outcomes and medical management differ from myocarditis of other origins?

Finding  In this nationwide cohort study including 4635 patients hospitalized for myocarditis in France during the first 1.5 years after COVID-19 vaccination, the 558 individuals with postvaccine myocarditis had less severe cardiovascular events than those with myocarditis of other origins at 18 months of follow-up. However, affected patients, mainly healthy young men, may require medical management up to several months after hospital discharge.

Meaning  These elements should be taken into account for ongoing and future mRNA vaccine recommendations.

Abstract

Importance  Although patients with myocarditis after COVID-19 mRNA vaccination appear to have a good prognosis near hospital discharge, their longer-term prognosis and management remain unknown.

Objective  To study the cardiovascular complications of post–COVID-19 mRNA vaccination myocarditis and other types of myocarditis during an 18-month follow-up, as well as disease management based on a study of the frequency of medical procedures and drug prescriptions.

Design, Setting, and Participants  In this cohort study based on the French National Health Data System, all individuals aged 12 to 49 years hospitalized for myocarditis in France between December 27, 2020, and June 30, 2022, were identified.

Exposure  Individuals were categorized as having postvaccine myocarditis (within 7 days after COVID-19 mRNA vaccine), post–COVID-19 myocarditis (within 30 days of SARS-CoV-2 infection), or conventional myocarditis.

Main Outcomes and Measures  The occurrence of clinical outcomes (hospital readmission for myopericarditis, other cardiovascular events, all-cause death, and a composite outcome of these events) over the 18 months following hospital admission were analyzed using weighted Cox models to standardize the comparisons with the conventional myocarditis group. Also, medical management after hospital discharge was longitudinally assessed using generalized estimated equation models.

Results  In total, 4635 individuals were hospitalized for myocarditis: 558 with postvaccine myocarditis, 298 with post–COVID-19 myocarditis, and 3779 with conventional myocarditis. Patients with postvaccine myocarditis were younger than those with post–COVID-19 and conventional myocarditis (mean [SD] age of 25.9 [8.6], 31.0 [10.9], and 28.3 [9.4] years, respectively) and were more frequently men (84%, 67%, and 79%). Patients with postvaccine myocarditis had a lower standardized incidence of the composite clinical outcome than those with conventional myocarditis (32/558 vs 497/3779 events; weighted hazard ratio, 0.55 [95% CI, 0.36-0.86]), whereas individuals with post–COVID-19 myocarditis had similar results (36/298 events; weighted hazard ratio, 1.04 [95% CI, 0.70-1.52]). The standardized frequency of medical procedures and drugs prescribed in patients with postvaccine myocarditis or post–COVID-19 myocarditis followed a similar trend in the 18 months following hospital discharge to that of patients with conventional myocarditis.

Conclusions and Relevance  Patients with post–COVID-19 mRNA vaccination myocarditis, contrary to those with post–COVID-19 myocarditis, show a lower frequency of cardiovascular complications than those with conventional myocarditis at 18 months. However, affected patients, mainly healthy young men, may require medical management up to several months after hospital discharge.

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