Comparative assessment of myocarditis and pericarditis reporting rates related to mRNA COVID-19 vaccines in Europe and the United States.

OBJECTIVES: The novel mRNA vaccines proved to be safe and effective in averting severe COVID-19. Vaccine-related complications recorded by pharmacovigilance systems, such as 'EudraVigilance' in Europe and 'VAERS' in the United States (US), rarely include myocarditis and pericarditis. Given the novelty of the platform and the increasing global-scale vaccine production needs, we assessed their reporting rates comparatively across continents. METHODS: Data of myocarditis and pericarditis cases post COVID-19 vaccination reported from week 52/2020 (December 21 to 27, 2020) to week 40/2021 (October 4 to 10, 2021) were collected for mRNA vaccines from EudraVigilance and VAERS. The corresponding administered vaccine doses were used as denominators to estimate reporting rates for comparison purposes. Cross-tabulation analysis was employed to compare the reporting rates of mRNA vaccines-associated myocarditis and pericarditis between EudraVigilance and VAERS. RESULTS: Low reporting rates of myocarditis (7.64/million vaccine doses) and pericarditis (5.32/million) were found, with higher rates of both disorders in EudraVigilance compared to VAERS; these differences were more pronounced post-mRNA-1273 (5-6-fold, p=0.000 for myocarditis and p<0.001 for pericarditis) than post-BNT162b2 vaccination (1.5-2-fold, p<0.001 for both conditions). Most myocarditis cases occurred in males <30 years. Pericarditis affected predominantly males <40 and both sexes >40 years. The extremely rare fatalities related to myocarditis (0.102/million) or pericarditis (0.017/million) were also higher in EudraVigilance versus VAERS. CONCLUSIONS: Understanding the underlying causes of the observed differences could provide guidance for the enhanced quality of mRNA vaccines that would also foster vaccine acceptance.

Determinants of All-Cause Mortality and Incidence of Cardiovascular Disease (2009 to 2013) in Older Adults: The Ikaria Study of the Blue Zones.

AIM: Ikaria Island (North-East Aegean, Greece) has been recognized as one of the places with the highest life expectancy around the world (the Blues Zones). Risk factors in relation to 4-year all-cause mortality and cardiovascular disease (CVD) incidence in elders were studied. METHODS: From June to October 2009, 330 men and 343 women, aged 65 to 100 years, were enrolled, and in June to July 2013, they were reevaluated. RESULTS: Age-standardized, gender-specific, all-cause mortality rate was 790 deaths per 10 000 inhabitants, and causes of death were CVD (36%), cancer (21%), infection (10%), respiratory disease (2%), and other (31%). Incidence of CVDwas 520 cases per 10 000 men inhabitants and 320 cases per 10 000 women (P = .03). Age, male gender, heart rate, urea levels, left atrial maximum volume, left ventricular hypertrophy, thyroid-stimulating hormone, and moderate to severe depression were positively associated with mortality, whereas left ventricular ejection fraction as well as coffee and tea drinking, fruit intake, and exclusive olive oil use were inversely associated with CVD. CONCLUSION: Heart function markers in addition to antioxidant dietary factors were placed in this puzzle of CVD morbidity.

Assessment of cardiac function with Doppler tissue imaging in asymptomatic HIV-infected patients.

Doppler tissue imaging (DTI) is a useful tool for the detection of subtle systolic function abnormalities related to the longitudinal contraction. We assessed left ventricular (LV) systolic function with DTI in 45 human immunodeficiency virus (HIV)-infected patients without any heart-related symptoms and in 30 healthy control subjects. Although conventional echocardiography showed no differences between groups, DTI revealed lower peak systolic velocities in group A patients when compared with group B ones (Sms: 8.84+/-0.94 cm/s vs. 9.42+/-0.84 cm/s, respectively, P<0.001 and Sml: 9.58+/-1.86 cm/s vs. 10.78+/-2.07 cm/s P=0.003). In group A patients, both peak systolic myocardial velocities at the septal (Sms) and lateral mitral annulus (Sml) correlated with CD4 lymphocyte count (P = 0.034 and 0.009, respectively). We conclude that pulse wave DTI reveals subtle and non-otherwise detectable abnormalities of the longitudinal LV contractile function in asymptomatic patients with positive HIV serology. DTI study should potentially be expanded in the population of HIV-infected patients, aiming at an early identification of LV systolic dysfunction.

Clinical value of B-type natriuretic peptide for the assessment of left ventricular filling pressures in patients with systolic heart failure and inconclusive tissue Doppler indexes.

Invasive hemodynamic monitoring with Swan-Ganz catheterization to guide treatment decisions in heart failure may be hazardous and may lack prognostic value. We assessed the clinical utility of B-type natriuretic peptide (BNP) in estimating left ventricular filling pressures in patients with inconclusive tissue Doppler indexes. In this study, 50 patients with systolic heart failure and an early transmitral velocity to early diastolic mitral annular velocity ratio (E/Ea) between 8 and 15 were studied. Among them, 25 had been admitted for acutely decompensated heart failure (group A) and the remainder were clinically stable outpatients (group B). All patients underwent simultaneous invasive pulmonary capillary wedge pressure (PCWP) determination, BNP measurement, and echocardiography. In group A, BNP correlated with PCWP (r = 0.803, P < 0.001), deceleration time (DT, r = -0.602, p = 0.001), and end-systolic wall stress (SWS, r = 0.565, P = 0.003). In multivariate analysis, BNP was the only parameter independently associated with PCWP (P = 0.023). In group B, no correlation was found between BNP and PCWP or SWS, while DT correlated significantly with both PCWP (r = -0.817, P < 0.001) and BNP (r = -0.8, P < 0.001). We conclude that BNP may be a useful noninvasive tool for the assessment of left ventricular filling pressures in patients with acutely decompensated heart failure and inconclusive tissue Doppler indexes.