Current evidence of COVID-19 vaccination-related cardiovascular events.

Currently, the world is recovering from the shock of the coronavirus disease 2019 (COVID-19) pandemic; however, this situation is still fragile. Health authorities recommend administering COVID-19 vaccines as the safest and most reliable tool for eliminating COVID-19. Subsequent to the extensive administration of the COVID-19 vaccines, a series of cardiovascular adverse effects have been reported. This comprehensive review aimed to provide an update on the etiology, pathophysiology, clinical features, and management of the cardiovascular adverse events associated with COVID-19 vaccines, including myocarditis, pericarditis, thrombosis with thrombocytopenia syndrome, myocardial infarction, cardiac arrhythmias, hypertension, and stress-induced cardiomyopathy. The benefits of COVID-19 vaccination far outweigh the reported adverse events. It would be clinically important to provide diagnostic scoring systems to differentiate COVID-19-related cardiovascular adverse events from other causes and develop therapeutic approaches for their management. Further evaluation of cardiovascular adverse events of the COVID-19 vaccines is crucial for implementing vaccination programs and developing safer and more reliable vaccines.

Cardiovascular Adverse Events Associated with Monoclonal Antibody Products in Patients with COVID-19.

Little is known about cardiovascular safety profiles for monoclonal antibody products that received the FDA Emergency Use Authorization for COVID-19. In this study, data from the FDA Adverse Event Reporting System from the first quarter of 2020 to the second quarter of 2022 were used to investigate cardiovascular safety signals associated with seven monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, sotrovimab, tocilizumab, bebtelovimab, tixagevimab + cilgavimab) in COVID-19 patients. Disproportionality analyses were conducted using reporting odds ratio and information component to identify safety signals. About 10% of adverse events in COVID-19 patients were cardiovascular adverse events. Four monoclonal antibody products (casirivimab + imdevimab, bamlanivimab, bamlanivimab + etesevimab, and bebtelovimab) were associated with higher reporting of hypertension. Tocilizumab was associated with higher reporting of cardiac failure and embolic and thrombotic event. Casirivimab + imdevimab and bamlanivimab were also associated with higher reporting of ischemic heart disease. No cardiovascular safety signals were identified for sotrovimab and tixagevimab + cilgavimab. The results indicate differential cardiovascular safety profiles in monoclonal antibodies. Careful monitoring of cardiovascular events may be considered for certain COVID-19 patients at risk when they are treated with monoclonal antibodies.

Case report: Sudden cardiorespiratory collapse in a healthy male after coronavirus disease 2019 vaccination at a vaccination center.

Since 2020, new vaccines were developed to fight the coronavirus disease 2019 (COVID-19). Vaccination is important in preventing mortality and achieving herd immunity. However, due to vast vaccination, fatal adverse events could be seen. We report a case of a previously healthy, young male who had a cardiopulmonary arrest 2 min after receiving the Oxford- AstraZeneca (ChAdOx1 nCoV-19) COVID-19 vaccination. After targeted temperature management, a coronary angiogram was performed after neurological recovery and showed severe stenosis at the proximal left anterior descending artery. Stenting was done and he was discharge. No similar case of sudden cardiorespiratory collapse immediately after COVID-19 vaccination has been reported. Our patient did not have any effort-related angina or dyspnea on exertion before this event. The sudden cardiorespiratory collapse was probably related to underlying coronary artery disease, complicated with a vasovagal event. We stress the importance of coronary angiography in out of hospital cardiac arrest patients after neurological recovery. In the era of COVID-19 vaccination, even though fatal adverse events following immunization are rare, heightened awareness of severe side effects needing medical attention is very important.

Troponin T in COVID-19 hospitalized patients: Kinetics matter.

BACKGROUND: Coronavirus disease 2019 (COVID-19) emerged as a worldwide health crisis, overwhelming healthcare systems. Elevated cardiac troponin T (cTn T) at admission was associated with increased in-hospital mortality. However, data addressing the role of cTn T in major adverse cardiovascular events (MACE) in COVID-19 are scarce. Therefore, we assessed the role of baseline cTn T and cTn T kinetics for MACE and in-hospital mortality prediction in COVID-19. METHODS: Three hundred and ten patients were included prospectively. One hundred and eight patients were excluded due to incomplete records. Patients were divided into three groups according to cTn T kinetics: ascending, descending, and constant. The cTn T slope was defined as the ratio of the cTn T change over time. The primary and secondary endpoints were MACE and in-hospital mortality. RESULTS: Two hundred and two patients were included in the analysis (mean age 64.4 ± 16.7 years, 119 [58.9%] males). Mean duration of hospitalization was 14.0 ± 12.3 days. Sixty (29.7%) patients had MACE, and 40 (19.8%) patients died. Baseline cTn T predicted both endpoints (p = 0.047, hazard ratio [HR] 1.805, 95% confidence interval [CI] 1.009-3.231; p = 0.009, HR 2.322, 95% CI 1.234-4.369). Increased cTn T slope predicted mortality (p = 0.041, HR 1.006, 95% CI 1.000-1.011). Constant cTn T was associated with lower MACE and mortality (p = 0.000, HR 3.080, 95% CI 1.914-4.954, p = 0.000, HR 2.851, 95% CI 1.828-4.447). CONCLUSIONS: The present study emphasizes the additional role of cTn T testing in COVID-19 patients for risk stratification and improved diagnostic pathway and management.

Cardiovascular Adverse Events Reported from COVID-19 Vaccines: A Study Based on WHO Database.

BACKGROUND: Thirteen COVID-19 vaccines are granted emergency approval. It is crucial to monitor their adverse events post vaccination. The present study focuses on cardiovascular adverse events post-COVID-19 vaccination and aims to determine adverse events with the administered vaccine. METHODOLOGY: The cardiovascular (CVS) adverse events were extracted for three broad headings (SOCs) - cardiac disorders, vascular disorders, and investigations. Descriptive statistics were reported in the form of percentage and frequency, and the disproportionality analysis was conducted. RESULTS: For the cardiovascular system, 4863 adverse events (AEs) were reported from BNT162b2 Pfizer, 1222 AstraZeneca, Moderna, and other COVID-19 vaccines. Common adverse events observed with vaccines under study were tachycardia (16.41%), flushing (12.17%), hypertension (5.82%), hypotension (3.60%) and peripheral coldness (2.41%). Based on disproportionality analysis (IC025 values), acute myocardial infarction, cardiac arrest, and circulatory collapse were linked to the vaccines in the age group >75 years. Hypertension, severe hypertension, supraventricular tachycardia, sinus tachycardia, and palpitations were associated across all age groups and either gender. Amongst the investigations, abnormal ECG findings raised C-reactive protein, elevated D dimer, and troponin were reported in specific age groups or gender or all subjects. CONCLUSION: Although cardiovascular events have been reported with the COVID-19 vaccines, the causality is yet to be established because such CVS AEs are also usually associated with the general public even without intervention. Hence, people should be administered these vaccines, and sustained monitoring of these AEs should be done.

Cardiovascular adverse events associated with hydroxychloroquine and chloroquine: A comprehensive pharmacovigilance analysis of pre-COVID-19 reports.

AIM: There is a clinical need for safety data regarding hydroxychloroquine (HCQ) and chloroquine (CQ) during the coronavirus (COVID-19) pandemic. We analysed real-world data using the U.S. Food and Drug Administration Adverse Events Reporting System (FAERS) database to assess HCQ/CQ-associated cardiovascular adverse events (CVAEs) in pre-COVID-19 reports. METHODS: We conducted disproportionality analysis of HCQ/CQ in the FAERS database (07/2014-9/2019), using reporting odds ratio (ROR) and the lower bound of the information component 95% credibility interval (IC025 ). RESULTS: The full database contained 6 677 225 reports with a mean (±SD) age of 53 (±17) years and 74% females. We identified 4895 reports of HCQ/CQ related adverse events, of which 696 (14.2%) were CVAEs. Compared with the full database, HCQ/CQ use was associated with a higher reporting rate of major CVAEs, including cardiomyopathy (n = 86 [1.8%], ROR = 29.0 [23.3-35.9]), QT prolongation (n = 43 [0.9%], ROR = 4.5 [3.3-6.1]), cardiac arrhythmias (n = 117 [2.4%], ROR = 2.2 [1.8-2.7]) and heart failure (n = 136 [2.8%], ROR = 2.2 [1.9-2.7], all IC025 > 0). No statistically significant differences were observed between sex and age groups. CVAEs were reported more often in patients with systemic lupus erythematosus and Sjogren's syndrome. HCQ/CQ-associated CVAEs demonstrated subsequent hospitalization and mortality rates of 39% and 8%, respectively. Overdose reports demonstrated an increased frequency of QT prolongation and ventricular arrhythmias (35% and 25%, respectively). CONCLUSION: In a real-world setting, HCQ/CQ treatment is associated with higher reporting rates of various CVAEs, particularly cardiomyopathy, QT prolongation, cardiac arrhythmias and heart failure. HCQ/CQ-associated CVAEs result in high rates of severe outcomes and should be carefully considered as an off-label indication, especially for patients with cardiac disorders.

A Pharmacovigilance Study of Hydroxychloroquine Cardiac Safety Profile: Potential Implication in COVID-19 Mitigation.

In light of the favorable outcomes of few small, non-randomized clinical studies, the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to Hydroxychloroquine (HCQ) for hospitalized coronavirus disease 2019 (COVID-19) patients. In fact, subsequent clinical studies with COVID-19 and HCQ have reported limited efficacy and poor clinical benefits. Unfortunately, a robust clinical trial for its effectiveness is not feasible at this emergency. Additionally, HCQ was suspected of causing cardiovascular adverse reactions (CV-AEs), but it has never been directly investigated. The objective of this pharmacovigilance analysis was to determine and characterize HCQ-associated cardiovascular adverse events (CV-AEs). We performed a disproportionality analysis of HCQ-associated CV-AEs using the FDA adverse event reporting system (FAERS) database. The FAERS database, comprising more than 11,901,836 datasets and 10,668,655 patient records with drug-adverse reactions, was analyzed. The disproportionality analysis was used to calculate the reporting odds ratios (ROR) with 95% confidence intervals (CI) to predict HCQ-associated CV-AEs. HCQ was associated with higher reporting of right ventricular hypertrophy (ROR: 6.68; 95% CI: 4.02 to 11.17), left ventricular hypertrophy (ROR: 3.81; 95% CI: 2.57 to 5.66), diastolic dysfunction (ROR: 3.54; 95% CI: 2.19 to 5.71), pericarditis (ROR: 3.09; 95% CI: 2.27 to 4.23), torsades de pointes (TdP) (ROR: 3.05; 95% CI: 2.30 to 4.10), congestive cardiomyopathy (ROR: 2.98; 95% CI: 2.01 to 4.42), ejection fraction decreased (ROR: 2.41; 95% CI: 1.80 to 3.22), right ventricular failure (ROR: 2.40; 95% CI: 1.64 to 3.50), atrioventricular block complete (ROR: 2.30; 95% CI: 1.55 to 3.41) and QT prolongation (ROR: 2.09; 95% CI: 1.74 to 2.52). QT prolongation and TdP are most relevant to the COVID-19 treatment regimen of high doses for a comparatively short period and represent the most common HCQ-associated AEs. The patients receiving HCQ are at higher risk of various cardiac AEs, including QT prolongation and TdP. These findings highlight the urgent need for prospective, randomized, controlled studies to assess the risk/benefit ratio of HCQ in the COVID-19 setting before its widespread adoption as therapy.