Los cardiólogos estamos recibiendo muchas consultas en relación con la posible complicación cardiológica tras recibir las vacunas anti-coronavirus, sobre todo ahora que se ha aprobado la vacunación a jóvenes con menos de 13 años. Hay muchos comentarios al respecto, muchos de ellos poco o nada científicos, que lo único que provocan es confundir y generar ansiedad ante un tema que ya, por sí mismo, nos está complicando mucho nuestro día a día. Voy a intentar resumir brevemente lo que está demostrado científicamente.
Se ha hablado sobre la afectación del miocardio, es decir, del músculo cardiaco tras las diferentes dosis de estas vacunas (sobre todo Pfizer y Moderna), en concreto la presencia de miocarditis (inflamación del miocardio). Los últimos datos publicados en revistas de alto impacto científico dejan bien claro que se trata de una complicación muy poco frecuente, y que las personas que pueden tener esta complicación suelen ser adultos varones menores de 21 años y adolescentes, y la mayoría con un curso clínico leve y resolución rápida de los síntomas.
Se ha comprobado que, en caso de padecer una miocarditis, suele aparecer entre unos días y una semana después de la inyección, con una incidencia que varía de menos de 1 hasta 3 personas por cada 100.000 que recibieron 1 ó 2 vacunas-ARNm (Pfizer o Moderna).
Más del 90% de los casos fueron leves y se resolvieron por sí solos sin un resultado adverso importante. Además, hay que destacar que la miocarditis asociada con la infección por SARS-CoV-2 es más probable que la miocarditis relacionada con la vacuna y suele ser mucho más grave y con peores resultados, de tal modo que el riesgo de miocarditis en la infección por SARS-CoV-2 aumentó 18 veces, es decir, nada comparable con la que se aprecia tras vacunación.
Simone et al. en el estudio publicado en JAMA, examinaron la incidencia y los resultados de la miocarditis aguda después de la vacunación con ARNm de COVID-19 en un gran sistema de salud. Durante los 6 meses de seguimiento, hubo 15 casos de miocarditis entre las 2.392.924 personas (miembros de Kaiser Permanente Southern California) que recibieron al menos 1 dosis de las vacunas Pfizer (2 casos) y Moderna (13 casos), lo que representaba 1 caso por 172.414 individuos completamente vacunados (6.3 casos por millón de personas). Las personas afectadas eran todos hombres menores de 40 años sin antecedentes cardíacos, y fueron dados de alta dentro de una semana de tratamiento conservador.
En otro estudio publicado de la base de datos de Israel, de un total de 2.558.421 personas vacunadas, de las cuales el 94% recibió dos dosis, 54 desarrollaron miocarditis confirmada en los 42 días posteriores a la primera dosis (un 0,002%), con una mediana de edad de 27 años, 94% varones, 41 se consideraron leves y 12 de gravedad intermedia, y uno fue una miocarditis fulminante con shock cardiogénico. La incidencia estimada de miocarditis en los 42 días posteriores a la administración de al menos una dosis de vacuna de ARNm fue de 2,13 por 100.000 personas vacunadas.
En el último trabajo publicado, Truong et al. recogieron datos de 26 centros médicos pediátricos en los Estados Unidos y Canadá; los investigadores analizaron 139 pacientes menores de 21 años con sospecha de miocarditis dentro de 1 mes de haber recibido la vacuna COVID-19, con los siguientes hallazgos:
- Mayoría varones (90,6%), blancos (66,2%) con una mediana de edad de 15,8 años.
- Sucedió en 136 pacientes (97,8%) tras vacuna de ARNm, con 131 (94,2%) post vacuna Pfizer-BioNTech. Se produjeron 128 casos (91,4%) después de la segunda dosis.
- Los síntomas comenzaron tras 2 días de administración de la vacuna (rango de 0 a 22 días).
- Síntomas más habituales: dolor torácico (99,3%), fiebre (30,9%) y falta de aire o disnea (27,3%).
- Los pacientes fueron tratados con antiinflamatorios no esteroideos (81,3%), inmunoglobulina intravenosa (21,6%), glucocorticoides (21,6%), colchicina (7,9%) o ningún tratamiento antiinflamatorio (8,6%).
- Precisaron ingreso en unidad de cuidados intensivos (UCI) 26 pacientes (18,7%); 2 recibieron apoyo inotrópico / vasoactivo; ninguno requirió oxigenación por membrana extracorpórea.
- No hubo ningún fallecimiento.
- Tiempo de hospitalización: 2 días.
- Un total de 111 pacientes tenían troponina I elevada (8,12 ng/ml) y 28 tenían troponina T elevada (0,61 ng/ml).
- El 69,8% presentaron electrocardiogramas (ECG) anormales y/o arritmias (7 con taquicardia ventricular no sostenida).
- 26 pacientes (18,7%) presentaron en ecocardiograma una fracción de eyección del ventrículo izquierdo (FEVI) inferior al 55% en el ecocardiograma, que se recuperó en los 25 que regresaron para seguimiento.
- 75 de 97 pacientes (77,3%) que se sometieron a cardiorresonancia cardiaca (mediana de 5 días desde el inicio de los síntomas) tuvieron hallazgos anormales; 74 (76,3%) tenían realce tardío de gadolinio, 54 (55,7%) tenían edema de miocardio y 49 (50,5%) cumplían los criterios de Lake Louise para miocarditis (presencia de al menos 2 de 3 criterios: edema, hiperemia y necrosis o cicatriz).
¿Cuáles son las conclusiones que debemos obtener de estos hallazgos?
- La incidencia de miocarditis después de la vacunación de ARNm de COVID-19 es muy baja: 0,58 por 100.000, o 1 caso por 172.414 adultos completamente vacunados, o 6 casos por millón.
- Se observa principalmente en varones jóvenes pocos días después de la segunda dosis y la mayoría de los pacientes se recuperan rápidamente.
- No hay punto de comparación con la incidencia de miocarditis relacionada con la vacuna y las tasas de hospitalización por COVID-19.
- El riesgo de miocarditis asociado con las dos vacunas de ARNm es pequeño en comparación con la morbilidad y mortalidad de la infección por COVID-19, en la que hasta el 28% de los pacientes hospitalizados mostraron signos de lesión miocárdica.
- Todos los pacientes con miocarditis respondieron bien al tratamiento y mejoraron rápidamente.
- Los médicos tenemos que estar en alerta ante la aparición de síntomas sugestivos de miocarditis post-vacunación para realizar un diagnóstico y tratamiento rápido.
- Los beneficios de la vacuna COVID-19 superan con creces los riesgos que puedan surgir, incluida la miocarditis.
Así pues, ¿hay que preocuparse? No, hay que ocuparse.
REFERENCIAS
Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting.
- Barda N, Dagan N, Ben-Shlomo Y, et al.
- N Engl J Med 2021; 385:1078-1090. https://www.nejm.org/doi/full/10.1056/nejmoa2110475
Myocarditis after Covid-19 Vaccination in a Large Health Care Organization.
- Witberg G, Barda N, Hoss S, et.
- N Engl J Med 2021; 385:2132-2139. Dec 2, 2021. https://www.nejm.org/doi/full/10.1056/NEJMoa2110737?query=recirc_curatedRelated_article
Acute Myocarditis Following COVID-19 mRNA Vaccination in Adults Aged 18 Years or Older.
- Simone A, Herald J, Chen A, et al.
- JAMA Intern Med.2021;181(12):1668–1670.
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2784800
COVID-19 Messenger RNA Vaccination and Myocarditis—A Rare and Mostly Mild Adverse Effect.
- Guduguntla V, Katz MH.
- JAMA Intern Med.2021;181(12):1560. https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2784801
Myocarditis With COVID-19 mRNA Vaccines.
- Kamat BB, Hotez PJ. https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.056135
Clinically Suspected Myocarditis Temporally Related to COVID-19 Vaccination in Adolescents and Young Adults.
- Truong DT, Dionne A, Muniz JC, et al. https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.121.056583
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