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QJM : Monthly Journal of the... Apr 2023Emerging reports raise concerns on the potential association between the COVID-19 vaccines and cardiac manifestations. We sought to evaluate cardiac complications...
Emerging reports raise concerns on the potential association between the COVID-19 vaccines and cardiac manifestations. We sought to evaluate cardiac complications associated with COVID-19 vaccination in a pooled analysis from our institution's cohort study and systematic review. Consecutive patients admitted to a tertiary hospital in Singapore between 1 January 2021 and 31 March 2021, with the onset of cardiac manifestations within 14 days following COVID-19 vaccination, were studied. Furthermore, a systematic review was performed, with PubMed, Embase, Research Square, MedRxiv and LitCovid databases accessed from inception up to 29 June 2021. Relevant manuscripts reporting individual patient data on cardiac complications following COVID-19 vaccination were included. Thirty patients were included in the study cohort, with 29 diagnosed with acute myocardial infarction (AMI) and 1 with myocarditis. Five patients developed heart failure, two had cardiogenic shock, three intubated, and one had cardiovascular-related mortality. In the systematic review, 16 studies were included with 41 myocarditis and 6 AMI cases. In the pooled analysis of the study cohort and the systematic review, 35 patients had AMI and 42 had myocarditis. Majority were men, and myocarditis patients were younger than AMI patients. Myocarditis patients tended to present 72 h postvaccination, while AMI patients were older and typically presented 24 h postvaccination. Majority with AMI or myocarditis developed symptoms after the first and second vaccination dose, respectively. This pooled analysis of patients presenting with cardiac manifestations following COVID-19 vaccination highlights the differences between myocarditis and AMI presentations in temporal association with the vaccination.
Topics: Male; Humans; Female; Myocarditis; COVID-19 Vaccines; Cohort Studies; COVID-19; Myocardial Infarction; Vaccination
PubMed: 34586408
DOI: 10.1093/qjmed/hcab252 -
Clinical Research in Cardiology :... Oct 2022Coronavirus Disease-2019 (COVID-19) vaccination has been associated with the development of carditis, especially in children and adolescent males. However, the rates of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Coronavirus Disease-2019 (COVID-19) vaccination has been associated with the development of carditis, especially in children and adolescent males. However, the rates of these events in the global setting have not been explored in a systematic manner. The aim of this systematic review and meta-analysis is to investigate the rates of carditis in children and adolescents receiving COVID-19 vaccines.
METHODS
PubMed, Embase and several Latin American databases were searched for studies. The number of events, and where available, at-risk populations were extracted. Rate ratios were calculated and expressed as a rate per million doses received. Subgroup analysis based on the dose administered was performed. Subjects ≤ 19 years old who developed pericarditis or myocarditis following COVID-19 vaccination were included.
RESULTS
A total of 369 entries were retrieved. After screening, 39 articles were included. Our meta-analysis found that 343 patients developed carditis after the administration of 12,602,625 COVID-19 vaccination doses (pooled rate per million: 37.76; 95% confidence interval [CI] 23.57, 59.19). The rate of carditis was higher amongst male patients (pooled rate ratio: 5.04; 95% CI 1.40, 18.19) and after the second vaccination dose (pooled rate ratio: 5.60; 95% CI 1.97, 15.89). In 301 cases of carditis (281 male; mean age: 15.90 (standard deviation [SD] 1.52) years old) reported amongst the case series/reports, 261 patients were reported to have received treatment. 97.34% of the patients presented with chest pain. The common findings include ST elevation and T wave abnormalities on electrocardiography. Oedema and late gadolinium enhancement in the myocardium were frequently observed in cardiac magnetic resonance imaging (CMR). The mean length of hospital stay was 3.91 days (SD 1.75). In 298 out of 299 patients (99.67%) the carditis resolved with or without treatment.
CONCLUSIONS
Carditis is a rare complication after COVID-19 vaccination across the globe, but the vast majority of episodes are self-limiting with rapid resolution of symptoms within days. Central illustration. Balancing the benefits of vaccines on COVID-19-caused carditis and post-vaccination carditis.
Topics: Adolescent; Adult; COVID-19; COVID-19 Vaccines; Child; Contrast Media; Gadolinium; Humans; Infant; Male; Myocarditis; Vaccination; Vaccines; Young Adult
PubMed: 35906423
DOI: 10.1007/s00392-022-02070-7 -
Frontiers in Immunology 2023Immune checkpoint inhibitors (ICIs) therapy can be complicated by their potential cardiovascular toxicities, including myocarditis. Nowadays, no prospective trials have...
BACKGROUND
Immune checkpoint inhibitors (ICIs) therapy can be complicated by their potential cardiovascular toxicities, including myocarditis. Nowadays, no prospective trials have focused on ICI-associated myocarditis optimized management. Available evidence only come from case reports or series. A systematic case reports analysis was conducted to collect and evaluate emerging evidence of ICI-associated myocarditis to provide more information to clinicians.
METHODS
We performed a literature search for eligible case reports or series published between January 2018 and May 2023 using the PubMed database. Then, we extracted interesting information via table form. Finally, this study included 113 publications on 106 patients with ICI-associated myocarditis.
RESULTS
Myocarditis was found to be a highly life-threatening disease, with 53.8% of cases. Over half of cases were life-threatening (G4, 23.6%) or severe (G3, 35.8%) and required glucocorticoids. Higher rates of improvement were associated with the best response to ICI for complete response/partial response (72.7% vs. 53.9%), glucocorticoid administration (30% vs. 22%), and discontinuation of ICI (58.8% vs. 32.1%). Consequently, ICI-associated G3-G4 myocarditis should be treated with a combination of discontinuation of ICIs, high-dose glucocorticoids, other drugs, chemical drugs, plasma exchange, and life support. For moderate G1 or G2 cases, discontinuation of ICIs and regular-dose glucocorticoids should be considered.
CONCLUSION
Once full recovery or improvement was achieved; glucocorticoids can be administered at low doses or stopped. Notably, re-challenge with ICIs appears feasible after resolution or meaningful improvement of myocarditis.
Topics: Humans; Glucocorticoids; Heart; Immune Checkpoint Inhibitors; Myocarditis
PubMed: 37876928
DOI: 10.3389/fimmu.2023.1275254 -
Vaccines Sep 2021To identify the safety, immunogenicity, and protective efficacy of COVID-19 vaccines in children and adolescents. (Review)
Review
AIM
To identify the safety, immunogenicity, and protective efficacy of COVID-19 vaccines in children and adolescents.
METHODS
We conducted a systematic review of published studies and ongoing clinical studies related to the safety, immunogenicity, and efficacy of COVID-19 vaccine in children or adolescents (aged < 18 years). Databases including PubMed, Web of Science, WHO COVID-19 database, and China National Knowledge Infrastructure (CNKI) were searched on 23 July 2021. International Clinical Trials Registry Platform (ICTRP) was also searched to identify ongoing studies.
RESULTS
Eight published studies with a total of 2852 children and adolescents and 28 ongoing clinical studies were included. Of the eight published studies, two were RCTs, two case series, and four case reports. The investigated COVID-19 vaccines had good safety profiles in children and adolescents. Injection site pain, fatigue, headache, and chest pain were the most common adverse events. A limited number of cases of myocarditis and pericarditis were reported. The RCTs showed that the immune response to BNT162b2 in adolescents aged 12-15 years was non-inferior to that in young people aged 16-25 years, while with 3 μg CoronaVac injection the immune response was stronger than with 1.5 μg. The efficacy of BNT162b2 was 100% (95% CI: 75.3 to 100), based on one RCT. Of the 28 ongoing clinical studies, twenty-three were interventional studies. The interventional studies were being conducted in fifteen countries, among them, China (10, 43.5%) and United States(9, 39.1%) had the highest number of ongoing trials. BNT162b2 was the most commonly studied vaccine in the ongoing trials.
CONCLUSION
Two COVID-19 vaccines have potential protective effects in children and adolescents, but awareness is needed to monitor possible adverse effects after injection. Clinical studies of the COVID-19 vaccination in children and adolescents with longer follow-up time, larger sample size, and a greater variety of vaccines are still urgently needed.
PubMed: 34696210
DOI: 10.3390/vaccines9101102 -
Journal of Clinical Medicine Feb 2023Myocarditis, diagnosed by symptoms and troponin elevation, has been well-described with COVID-19 infection, as well as shortly after COVID-19 vaccination. The literature...
BACKGROUND
Myocarditis, diagnosed by symptoms and troponin elevation, has been well-described with COVID-19 infection, as well as shortly after COVID-19 vaccination. The literature has characterized the outcomes of myocarditis following COVID-19 infection and vaccination, but clinicopathologic, hemodynamic, and pathologic features following fulminant myocarditis have not been well-characterized. We aimed to compare clinical and pathological features of fulminant myocarditis requiring hemodynamic support with vasopressors/inotropes and mechanical circulatory support (MCS), in these two conditions.
METHODS
We analyzed the literature on fulminant myocarditis and cardiogenic shock associated with COVID-19 and COVID-19 vaccination and systematically reviewed all cases and case series where individual patient data were presented. We searched PubMed, EMBASE, and Google Scholar for "COVID", "COVID-19", and "coronavirus" in combination with "vaccine", "fulminant myocarditis", "acute heart failure", and "cardiogenic shock". The Student's t-test was used for continuous variables and the χ2 statistic was used for categorical variables. For non-normal data distributions, the Wilcoxon Rank Sum Test was used for statistical comparisons.
RESULTS
We identified 73 cases and 27 cases of fulminant myocarditis associated with COVID-19 infection (COVID-19 FM) and COVID-19 vaccination (COVID-19 vaccine FM), respectively. Fever, shortness of breath, and chest pain were common presentations, but shortness of breath and pulmonary infiltrates were more often present in COVID-19 FM. Tachycardia, hypotension, leukocytosis, and lactic acidosis were seen in both cohorts, but patients with COVID-19 FM were more tachycardic and hypotensive. Histologically, lymphocytic myocarditis dominated both subsets, with some cases of eosinophilic myocarditis in both cohorts. Cellular necrosis was seen in 44.0% and 47.8% of COVID-19 FM and COVID-19 vaccine FM, respectively. Vasopressors and inotropes were used in 69.9% of COVID-19 FM and in 63.0% of the COVID-19 vaccine FM. Cardiac arrest was observed more in COVID-19 FM ( = 0.008). Venoarterial extracorporeal membrane oxygenation (VA-ECMO) support for cardiogenic shock was also used more commonly in the COVID-19 fulminant myocarditis group ( = 0.0293). Reported mortality was similar (27.7%) and 27.8%, respectively) but was likely worse for COVID-19 FM as the outcome was still unknown in 11% of cases.
CONCLUSIONS
In the first series to retrospectively assess fulminant myocarditis associated with COVID-19 infection versus COVID-19 vaccination, we found that both conditions had a similarly high mortality rate, while COVID-19 FM had a more malignant course with more symptoms on presentation, more profound hemodynamic decompensation (higher heart rate, lower blood pressure), more cardiac arrests, and higher temporary MCS requirements including VA-ECMO. In terms of pathology, there was no difference in most biopsies/autopsies that demonstrated lymphocytic infiltrates and some eosinophilic or mixed infiltrates. There was no predominance of young males in COVID-19 vaccine FM cases, with male patients representing only 40.9% of the cohort.
PubMed: 36902636
DOI: 10.3390/jcm12051849 -
BMJ Open Jul 2022To determine whether spontaneous reporting rates of myocarditis and pericarditis differed in immunocompromised patients compared with the whole population overall, and...
OBJECTIVES
To determine whether spontaneous reporting rates of myocarditis and pericarditis differed in immunocompromised patients compared with the whole population overall, and in terms of demographics, vaccine dose and time-to-onset.
DESIGN
Systematic review of spontaneously reported data from the European Union/European Economic Area (EU/EEA), the USA and the UK.
DATA SOURCES
EudraVigilance (EU/EEA), Vaccine Adverse Event Reporting System (VAERS; USA) and the Medicines and Healthcare products Regulatory Agency (UK) spontaneous reporting databases were searched from date of vaccine launch to 1 December 2021.
ELIGIBILITY CRITERIA
Publicly available spontaneous reporting data for 'myocarditis' and 'pericarditis' from EU/EEA and USA following COVID-19 messenger RNA vaccines. Reports with comorbidities or concurrent medication indicative of transplantation, HIV infection or cancer ('immunocompromised' population) were compared with each overall database population.
DATA EXTRACTION AND SYNTHESIS
Two researchers extracted data. Spontaneously reported events of myocarditis and pericarditis were presented for immunocompromised populations for each data source, stratified by age, sex, dose and time-to-onset (where available). Seriousness of each event was determined according to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Guideline E2A definition. Proportional reporting ratio (PRR) was calculated.
RESULTS
There were 178 reports of myocarditis and pericarditis among immunocompromised individuals overall. Seriousness was comparable between the immunocompromised and overall populations in both databases. No trends in age or sex were observed among immunocompromised individuals. Most reports followed a second vaccine dose and occurred within 14 days. The frequency of reporting was similar to the wider population (PRR=1.36 (95% CI=0.89 to 1.82) for VAERS population).
CONCLUSIONS
Myocarditis and pericarditis following COVID-19 vaccination are very rare, and benefits of COVID-19 vaccination continue to outweigh any perceived risks. Reporting rates of myocarditis and pericarditis were similar in immunocompromised individuals, however defining characteristics differed compared with the whole population; therefore, continued monitoring of adverse events following vaccination remains vital to understand differences between population subgroups.
Topics: COVID-19; COVID-19 Vaccines; Humans; Immunocompromised Host; Myocarditis; Pericarditis; Transplant Recipients
PubMed: 35777878
DOI: 10.1136/bmjopen-2021-060425 -
Frontiers in Immunology 2022Immune checkpoint inhibitors (ICIs) in combination withother anti-cancer treatments have been approved for a variety of cancers. While the difference in the incidence of... (Meta-Analysis)
Meta-Analysis
Immune checkpoint inhibitors (ICIs) in combination withother anti-cancer treatments have been approved for a variety of cancers. While the difference in the incidence of cardiovascular adverse events has not been fully investigated. We aimed to assess the the differences in cardiotoxicity among cancer patients receiving different ICI therapies. PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov. websites were searched for all randomized controlled trials (RCTs) of ICI. The primary outcomes were any grade cardiotoxicity and Grade 3-5 cardiotoxicity, the secondary outcomes were any grade myocarditis and Grade 3-5 myocarditis, with sub-analyses based on cancer type and does of ICI. A systematic review and frequency network meta-analysis were then performed for cardiotoxicity events. 91 RCTs (n=52247) involving 12 treatment arms were finally included. We observed that PD-L1 + CTLA-4 had the highest risk among all therapies inducing any grade cardiotoxicity, and the differences were significant except PD-1 + CTLA-4, PD-1 + TTD and PD-L1 + TTD. In addition, CTLA-4 had a higher risk of Grade 3-5 cardiotoxicity than PD-1 and anit-PD-L1. For Grade 1-5 myocarditis and Grade 3-5 myocarditis, no significant difference was found among differences therapies. No differences were observed in subgroup analyses according to does and cancer type. There were differences in the incidence of cardiotoxicity among different ICI therapies. For ICI monotherapy, CTLA-4 may be linked to Grade 3-5 cardiotoxicity than PD-1 or PD-L1. For dual therapy, the cardiotoxicity of dual ICI therapy seems to be higher than that of chemotherapy or targeted therapy.
Topics: B7-H1 Antigen; CTLA-4 Antigen; Cardiotoxicity; Humans; Immune Checkpoint Inhibitors; Myocarditis; Neoplasms; Network Meta-Analysis; Programmed Cell Death 1 Receptor
PubMed: 36189211
DOI: 10.3389/fimmu.2022.1006860 -
Biomolecules Oct 2022Myocarditis and inflammatory dilated cardiomyopathy are cardiac diseases leading to heart failure. Liquid biopsy is a concept of replacing traditional biopsy with... (Review)
Review
Myocarditis and inflammatory dilated cardiomyopathy are cardiac diseases leading to heart failure. Liquid biopsy is a concept of replacing traditional biopsy with specialized blood tests. The study aim was to summarize and assess the usefulness of microRNAs and circulating free DNA as biomarkers of myocardial inflammation. For this systematic review, we searched Scopus, Embase, Web of Science, and PubMed. All studies measuring microRNAs in serum/plasma/cardiac tissue or circulating free DNA during myocarditis and non-ischemic dilated cardiomyopathy in humans in which healthy subjects or another cardiac disease served as a comparator were included. Data were extracted and miRNAs were screened and assessed using a scale created in-house. Then, highly graded miRNAs were assessed for usability as liquid biopsy biomarkers. Of 1185 records identified, 56 were eligible and 187 miRNAs were found. We did not identify any studies measuring circulating free DNA. In total, 24 of the screened miRNAs were included in the final assessment, 3 of which were selected as the best and 3 as potential candidates. We were not able to assess the risk of bias and the final inclusion decision was made by consensus. Serum levels of three miRNAs-miR-Chr8:96, miR-155, and miR-206-are the best candidates for myocardial inflammation liquid biopsy panel. Further studies are necessary to prove their role, specificity, and sensitivity.
Topics: Humans; Cardiomyopathy, Dilated; Myocarditis; MicroRNAs; Cell-Free Nucleic Acids; Biomarkers; Liquid Biopsy; Inflammation
PubMed: 36291684
DOI: 10.3390/biom12101476 -
Frontiers in Cardiovascular Medicine 2020Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated cardiac injury has been postulated secondary to several mechanisms. While tissue diagnosis is...
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-associated cardiac injury has been postulated secondary to several mechanisms. While tissue diagnosis is limited during the acute illness, postmortem studies can help boost our understanding and guide management. To report the cardiac tissue autopsy findings in coronavirus disease 2019 (COVID-19) decedents. Articles published in PubMed and Embase reporting postmortem cardiac pathology of COVID-19 decedents till September 2020. We included adult studies excluding preprints. The Joanna Briggs Institute Critical Appraisal Checklist for Case Reports was used to assess quality. We extracted gross and histology data as well as the incidence of myocarditis, cardiac ischemia, thrombosis, and dilatation. We also looked at the reported cause of death (PROSPERO registration CRD42020190898). Forty-one relevant studies identified including 316 cases. The deceased were mostly male (62%) and elderly (median age, 75; range, 22-97 years). The most common comorbidities were hypertension (48%) and coronary artery disease (33%). Cardiac pathologies contributed to the death of 15 cases. Besides chronic cardiac pathologies, postmortem examination demonstrated cardiac dilatation (20%), acute ischemia (8%), intracardiac thrombi (2.5%), pericardial effusion (2.5%), and myocarditis (1.5%). SARS-CoV-2 was detected within the myocardium of 47% of studied hearts. SARS-CoV-2 can invade the heart, but a minority of cases were found to have myocarditis. Cardiac dilatation, ischemia, mural, and microthrombi were the most frequent findings. The systematic review was limited by the small number of cases and the quality of the studies, and there is a need to standardize the cardiac postmortem protocols.
PubMed: 33585586
DOI: 10.3389/fcvm.2020.626975 -
Drug Design, Development and Therapy 2016The aim of the study was to evaluate the effectiveness, safety, and cost associated with Wenxin keli in the treatment of cardiovascular diseases based on meta-analysis. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The aim of the study was to evaluate the effectiveness, safety, and cost associated with Wenxin keli in the treatment of cardiovascular diseases based on meta-analysis.
METHODS
The terms "Wenxin keli" and "Wenxin" were used as the search terms in the PubMed, ProQuest, Springer, the Cochrane Library, CNKI (China National Knowledge Infrastructure), VIP (Chinese Scientific Journals Database), and Wan fang electronic databases (from January 2000 to October 2015). Relevant print journals and conference papers were also searched. Studies on randomized controlled trials (RCTs) of Wenxin keli used in the treatment of cardiovascular diseases were screened, and its indications were classified. Meta-analysis of these studies was conducted using the RevMan 5.2 software.
RESULTS
A total of 49 RCTs (n=4,610) were included, 29 of which focused on arrhythmia, seven on angina, seven on heart failure, two on viral myocarditis, and four on menopausal syndrome. Analysis of the therapeutic indications of Wenxin keli showed that it was comparatively more curative and effective than other available treatments for cardiovascular diseases.
CONCLUSION
Wenxin keli showed better clinical efficacy in the treatment of arrhythmia, angina, and heart failure; however, more high-quality evidence is needed to support its use in the clinical setting.
Topics: Angina Pectoris; Arrhythmias, Cardiac; Cardiovascular Diseases; Drugs, Chinese Herbal; Female; Heart Failure; Humans; Male; Menopause; Myocarditis; Randomized Controlled Trials as Topic; Virus Diseases
PubMed: 27881911
DOI: 10.2147/DDDT.S112333