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  • Outcomes at least 90 days s...
    Kracalik, Ian; Oster, Matthew E; Broder, Karen R; Cortese, Margaret M; Glover, Maleeka; Shields, Karen; Creech, C Buddy; Romanson, Brittney; Novosad, Shannon; Soslow, Jonathan; Walter, Emmanuel B; Marquez, Paige; Dendy, Jeffrey M; Woo, Jared; Valderrama, Amy L; Ramirez-Cardenas, Alejandra; Assefa, Agape; Campbell, M Jay; Su, John R; Magill, Shelley S; Shay, David K; Shimabukuro, Tom T; Basavaraju, Sridhar V

    The lancet child & adolescent health, 11/2022, Letnik: 6, Številka: 11
    Journal Article

    Data on medium-term outcomes in indivduals with myocarditis after mRNA COVID-19 vaccination are scarce. We aimed to assess clinical outcomes and quality of life at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults. In this follow-up surveillance study, we conducted surveys in US individuals aged 12-29 years with myocarditis after mRNA COVID-19 vaccination, for whom a report had been filed to the Vaccine Adverse Event Reporting System between Jan 12 and Nov 5, 2021. A two-component survey was administered, one component to patients (or parents or guardians) and one component to health-care providers, to assess patient outcomes at least 90 days since myocarditis onset. Data collected were recovery status, cardiac testing, and functional status, and EuroQol health-related quality-of-life measures (dichotomised as no problems or any problems), and a weighted quality-of-life measure, ranging from 0 to 1 (full health). The EuroQol results were compared with published results in US populations (aged 18-24 years) from before and early on in the COVID-19 pandemic. Between Aug 24, 2021, and Jan 12, 2022, we collected data for 519 (62%) of 836 eligible patients who were at least 90 days post-myocarditis onset: 126 patients via patient survey only, 162 patients via health-care provider survey only, and 231 patients via both surveys. Median patient age was 17 years (IQR 15-22); 457 (88%) patients were male and 61 (12%) were female. 320 (81%) of 393 patients with a health-care provider assessment were considered recovered from myocarditis by their health-care provider, although at the last health-care provider follow-up, 104 (26%) of 393 patients were prescribed daily medication related to myocarditis. Of 249 individuals who completed the quality-of-life portion of the patient survey, four (2%) reported problems with self-care, 13 (5%) with mobility, 49 (20%) with performing usual activities, 74 (30%) with pain, and 114 (46%) with depression. Mean weighted quality-of-life measure (0·91 SD 0·13) was similar to a pre-pandemic US population value (0·92 0·13) and significantly higher than an early pandemic US population value (0·75 0·28; p<0·0001). Most patients had improvements in cardiac diagnostic marker and testing data at follow-up, including normal or back-to-baseline troponin concentrations (181 91% of 200 patients with available data), echocardiograms (262 94% of 279 patients), electrocardiograms (240 77% of 311 patients), exercise stress testing (94 90% of 104 patients), and ambulatory rhythm monitoring (86 90% of 96 patients). An abnormality was noted among 81 (54%) of 151 patients with follow-up cardiac MRI; however, evidence of myocarditis suggested by the presence of both late gadolinium enhancement and oedema on cardiac MRI was uncommon (20 13% of 151 patients). At follow-up, most patients were cleared for all physical activity (268 68% of 393 patients). After at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination, most individuals in our cohort were considered recovered by health-care providers, and quality of life measures were comparable to those in pre-pandemic and early pandemic populations of a similar age. These findings might not be generalisable given the small sample size and further follow-up is needed for the subset of patients with atypical test results or not considered recovered. US Centers for Disease Control and Prevention.