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.

Autor: Jain SS; Department of Pediatrics, Division of Cardiology, New York Medical College-Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY, USA., Anderson SA; The U.S. Food and Drug Administration, Silver Spring, MD, USA., Steele JM; Yale University School of Medicine, New Haven, CT, USA., Wilson HC; Emory University School of Medicine, Sibley Heart Center, Atlanta, GA, USA., Muniz JC; Nicklaus Children's Hospital, Miami, FL, USA., Soslow JH; Vanderbilt University Medical Center, Nashville, TN, USA., Beroukhim RS; Department of Cardiology, Boston Children's Hospital, Boston, MA, USA., Maksymiuk V; Department of Pediatrics, Division of Cardiology, New York Medical College-Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY, USA., Jacquemyn X; Department of Pediatrics, Johns Hopkins School of Medicine, Helen B. Taussig Heart Center, Johns Hopkins Hospital, Baltimore, MD, USA., Frosch OH; University of Michigan Medical School, C.S. Mott Children's Hospital, Ann Arbor, MI, USA., Fonseca B; Children's Hospital Colorado, Aurora, CO, USA., Harahsheh AS; Children's National Hospital and the George Washington University School of Medicine & Health Sciences, WA, USA., Buddhe S; Seattle Children's Hospital, Seattle, WA, USA., Ashwath RC; University of Iowa Stead Family Children's Hospital, Iowa City, IA, USA., Thacker D; Nemours Children's Health/Nemours Cardiac Center, Wilmington, DE, USA., Maskatia SA; Lucile Packard Children's Hospital, Stanford, Palo Alto, CA, USA., Misra N; Cohen Children's Medical Center, Northwell Health, New York, USA., Su JA; Children's Hospital of Los Angeles, Los Angeles, CA, USA., Siddiqui S; Goryeb Children's Hospital, Morristown, NJ, USA., Vaiyani D; The Children's Hospital of Philadelphia, Philadelphia, PA, USA., Vaikom-House AK; The University of Oklahoma Health Science Oklahoma City, Oklahoma, USA., Campbell MJ; Division of Pediatric Cardiology, Department of Pediatrics, Duke University, Durham, NC, USA., Klein J; Joe DiMaggio Children's Hospital, Hollywood, FL, USA., Huang S; Betz Congenital Health Center, Helen DeVos Children's Hospital, Grand Rapids, MI, USA., Mathis C; Children's Mercy Kansas City, Kansas City, MO, USA., Cornicelli MD; Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA., Sharma M; The Children's Hospital at Montefiore Bronx, New York, USA., Nagaraju L; UC Davis Children's Hospital, Sacramento, CA, USA., Ang JY; Riley Hospital for Children, Indianapolis, IN, USA., Uppu SC; The University of Texas Health Science Center, Children's Heart Institute, Houston, TX, USA., Ramachandran P; Kentucky Children's Hospital, University of Kentucky, Lexington, KY, USA., Patel JK; Children's Hospital of Michigan, Detroit, MI, USA., Han F; University of Illinois College of Medicine, Peoria, IL, USA., Mandell JG; University of Rochester-Golisano Children's Hospital, Rochester, NY, USA., Akam-Venkata J; University of Mississippi Medical Center, Jackson, MS, USA., DiLorenzo MP; Columbia University, New York, NY, USA., Brumund M; Louisiana State University Health Sciences Center, Children's Hospital New Orleans, New Orleans, LA, USA., Bhatla P; NYU Langone Health, Hassenfeld Children's Hospital, New York, NY, USA., Eshtehardi P; Northside Hospital Heart Institute, Atlanta, GA, USA., Mehta K; Division of Cardiology, Department of Pediatrics, Oregon Health and Science University-Doernbecher Children's Hospital, Portland, OR, USA., Glover K; Yale University School of Medicine, New Haven, CT, USA., Dove ML; Emory University School of Medicine, Sibley Heart Center, Atlanta, GA, USA., Aldawsari KA; Nicklaus Children's Hospital, Miami, FL, USA., Kumar A; Vanderbilt University Medical Center, Nashville, TN, USA., Barfuss SB; Department of Cardiology, Boston Children's Hospital, Boston, MA, USA., Dorfman AL; University of Michigan Medical School, C.S. Mott Children's Hospital, Ann Arbor, MI, USA., Minocha PK; Children's Hospital Colorado, Aurora, CO, USA., Yonts AB; Children's National Hospital and the George Washington University School of Medicine & Health Sciences, WA, USA., Schauer J; Seattle Children's Hospital, Seattle, WA, USA., Cheng AL; Children's Hospital of Los Angeles, Los Angeles, CA, USA., Robinson JD; Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, IL, USA., Powell Z; The University of Oklahoma Health Science Oklahoma City, Oklahoma, USA., Srivastava S; Nemours Children's Health/Nemours Cardiac Center, Wilmington, DE, USA., Chelliah A; Goryeb Children's Hospital, Morristown, NJ, USA., Sanil Y; Riley Hospital for Children, Indianapolis, IN, USA., Hernandez LE; Joe DiMaggio Children's Hospital, Hollywood, FL, USA., Gaur L; Department of Pediatrics, Johns Hopkins School of Medicine, Helen B. Taussig Heart Center, Johns Hopkins Hospital, Baltimore, MD, USA., Antonchak M; NYU Langone Health, Hassenfeld Children's Hospital, New York, NY, USA., Johnston M; Louisiana State University Health Sciences Center, Children's Hospital New Orleans, New Orleans, LA, USA., Reich JD; The U.S. Food and Drug Administration, Silver Spring, MD, USA., Nair N; The U.S. Food and Drug Administration, Silver Spring, MD, USA., Drugge ED; Department of Pediatrics, Division of Cardiology, New York Medical College-Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, NY, USA., Grosse-Wortmann L; Division of Cardiology, Department of Pediatrics, Oregon Health and Science University-Doernbecher Children's Hospital, Portland, OR, USA.
Jazyk: angličtina
Zdroj: EClinicalMedicine [EClinicalMedicine] 2024 Sep 06; Vol. 76, pp. 102809. Date of Electronic Publication: 2024 Sep 06 (Print Publication: 2024).
DOI: 10.1016/j.eclinm.2024.102809
Abstrakt: 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.
Competing Interests: SSJ, LGW, SA, JMS, HCW, JCM, JHS, RSB, VM, XJ, OHF, BF, SB, RCA, SAM, NM, JAS, SS, DV, AKVH, MJC, JK, SH, CM, MDC, MS, LN, JYA, SCU, PR, JKP, JGM, JAV, MPD, MB, PB, PE, KM, KG, MLD, KAA, AK, SBB, ALD, PKM, JS, ALC, JDR, ZP, AC, YS, LG, MA, MJ, JDR, NN, EDD report no competing interests. ASH: Site PI for the CAMP study—NHLBI funded, Site PI for MUSIC—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 (“OP2”), 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.
(© 2024 The Author(s).)
Databáze: MEDLINE