Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) by May 31, ...2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance.
We retrospectively reviewed data obtained from December 20, 2020, to May 31, 2021, regarding all cases of myocarditis and categorized the information using the Brighton Collaboration definition. We analyzed the occurrence of myocarditis by computing the risk difference for the comparison of the incidence after the first and second vaccine doses (21 days apart); by calculating the standardized incidence ratio of the observed-to-expected incidence within 21 days after the first dose and 30 days after the second dose, independent of certainty of diagnosis; and by calculating the rate ratio 30 days after the second dose as compared with unvaccinated persons.
Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval CI, 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637.
The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.
Background
Increased weight measured by body mass index is associated with better clinical outcomes in heart failure (HF). The effect of specific components of body mass on outcome is limited. We ...evaluated the impact of fat‐free mass and fat mass on mortality and cardiovascular hospitalization in a large real‐world cohort of patients with chronic HF.
Methods
Body measurements were assessed in patients with chronic HF. Fat‐free mass, fat mass and waist circumference were calculated based on specifically derived formulas.
Results
The cohort included 6328 HF patients. Mean follow‐up was 744 days. Increased body composition indices including body mass index, fat‐free mass index and fat mass index, per cent body fat and waist circumference were associated with better survival. Cox regression analysis after adjustment for other significant parameters demonstrated that these indices were all associated with improved survival. The strongest association was seen with fat‐free mass index with a graded increase in survival; lowest death in the highest quartile compared to reference second quartile (hazard ratio 0.79, 95% confidence interval 0.67‐0.93, P < .01). There was no interaction with sex or HF type. Analysis of the clinical outcome of death and cardiovascular hospitalization demonstrated that a worse prognosis was in the lowest quartile of all the indices. A sensitivity analysis, analysing these indices as continuous parameters using restricted cubic splines, demonstrated a clear continuous association between these indices and increased survival in both sexes.
Conclusions
Body mass including fat‐free mass and fat mass was associated with improved survival in patients with HF.
Background and Aims
Left bundle branch block (LBBB) is common after transcatheter aortic valve replacement (TAVR) and associated with a left or normal QRS axis. We aim to assess the QRS frontal plane ...axis shift changes during LBBB after TAVR and determine if the risk of procedure‐related high degree atrioventricular block (AVB) is affected by QRS axis shift changes.
Methods and Results
In a retrospective single‐center study of 720 consecutive patients who underwent TAVR, 141 (19.6%) with normal baseline QRS duration developed a new LBBB after TAVR and constituted the study group. Most patients (59.6%) were females and the mean age of the cohort was 81.2 ± 6 years.
Results
As compared with the baseline QRS axis before TAVR, the occurrence of LBBB was associated with a leftward QRS axis shift (by 40 ± 28.3°) in 73% of the study patients and a rightward (by 18.6 ± 19.4°) or no change in QRS axis in 25.6% and 1.4% of the study patients, respectively. A left QRS axis (−30°) was observed in 14.9% and 38.3% of the study patients before and after TAVR, respectively. The group of patients exhibiting a rightward or no QRS axis shift had a greater incidence of high degree AVB than the group of patients exhibiting a leftward QRS axis shift (18.4% vs. 6.8%, p = .056).
Conclusion
Although post TAVR‐LBBB is associated with a leftward QRS axis shift in most patients, a non‐negligible proportion of patients (27%) exhibited a rightward or no QRS axis shift. The latter group tend to have a higher risk of developing high degree AVB.
Aims
The European Society of Cardiology Heart Failure Long‐Term Registry (ESC‐HF‐LT‐R) was set up with the aim of describing the clinical epidemiology and the 1‐year outcomes of patients with heart ...failure (HF) with the added intention of comparing differences between participating countries.
Methods and results
The ESC‐HF‐LT‐R is a prospective, observational registry contributed to by 211 cardiology centres in 21 European and/or Mediterranean countries, all being member countries of the ESC. Between May 2011 and April 2013 it collected data on 12 440 patients, 40.5% of them hospitalized with acute HF (AHF) and 59.5% outpatients with chronic HF (CHF). The all‐cause 1‐year mortality rate was 23.6% for AHF and 6.4% for CHF. The combined endpoint of mortality or HF hospitalization within 1 year had a rate of 36% for AHF and 14.5% for CHF. All‐cause mortality rates in the different regions ranged from 21.6% to 36.5% in patients with AHF, and from 6.9% to 15.6% in those with CHF. These differences in mortality between regions are thought reflect differences in the characteristics and/or management of these patients.
Conclusion
The ESC‐HF‐LT‐R shows that 1‐year all‐cause mortality of patients with AHF is still high while the mortality of CHF is lower. This registry provides the opportunity to evaluate the management and outcomes of patients with HF and identify areas for improvement.
Pulmonary hypertension (PH) is a common finding in patients with heart failure (HF) with a subset developing combined post- and pre-capillary PH (CpcPH). There is limited data on the characteristics ...and outcome of patients with CpcPH. We examined the clinical characteristics and echocardiographic properties of subjects with PH and CpcPH and its impact on clinical outcome.
HF patients from a large echocardiography database with comprehensive clinical and outcome data were evaluated for PH severity and outcomes including mortality and cardiovascular hospitalizations. CpcPH was identified by estimating left ventricle mean filling pressures using the mitral E/e' ratio with a calculated transpulmonary gradient >15mmHg.
The study included 2,793 patients with HF. 59% had elevated pulmonary pressures and 20% had CpcPH. Older age, chronic renal failure, severe tricuspid regurgitation, severe mitral regurgitation, higher right atrial pressure, and higher E/e' ratio were all associated with PH. Lower E/e' ratio, severe tricuspid regurgitation, higher peak right ventricular-right atrial gradient, and reduced right ventricular function were all indicative of CpcPH. At a median of 3,225 days follow-up, mortality was significantly higher in patients with PH compared to patients without PH and highest in atients with CpcPH. Cox regression analysis after adjustment for age, sex and other significant clinical variables demonstrated that PH was associated with increased mortality, with CpcPH exhibiting the highest risk (HR 1.53 CI 1.30-1.81, P<0.001). Death and cardiovascular hospitalizations were also significantly increased with PH severity.
PH and CpcPH are highly prevalent in HF and are predictors of a worse prognosis
Abstract Objective We tested whether remote dielectric sensing (ReDS)-directed fluid management reduces readmissions in patients recently hospitalized for heart failure (HF). Background Pulmonary ...congestion is the most common cause of worsening HF leading to hospitalization. Accurate remote monitoring of lung fluid volume may guide optimal treatment and prevent re-hospitalization. ReDS technology is a quantitative non-invasive method for measuring absolute lung fluid volume. Methods Patients hospitalized for acute decompensated HF were enrolled during their index admission and followed at home for 90 days post-discharge. Daily ReDS readings were obtained using a wearable vest, and were used as a guide to optimizing HF therapy, with a goal of maintaining normal lung fluid content. Comparisons of the number of HF hospitalizations during ReDS-guided HF therapy were made, both to the 90 days prior to enrollment and to the 90 days following discontinuation of ReDS monitoring. Results Fifty patients were enrolled, discharged, and followed at home for 76.9 ± 26.2 days. Patients were 73.8 ± 10.3 years old, 40% had LVEF above 40%, and 38% were women. Compared to the pre- and post-ReDS periods, there were 87% and 79% reductions in the rate of HF hospitalizations, respectively, during ReDS-guided HF therapy. The hazard ratio between the ReDS and the pre-ReDS period was 0.07 (95% CI 0.01–0.54 p = 0.01), and between the ReDS and the post-ReDS period was 0.11 (95% CI 0.014–0.88 p = 0.037). Conclusions These findings suggest that ReDS-guided management has the potential to reduce HF readmissions in acute decompensated HF patients recently discharged from the hospital.
Empagliflozin after Acute Myocardial Infarction Butler, Javed; Jones, W Schuyler; Udell, Jacob A ...
The New England journal of medicine,
2024-Apr-25, Volume:
390, Issue:
16
Journal Article
Peer reviewed
Empagliflozin improves cardiovascular outcomes in patients with heart failure, patients with type 2 diabetes who are at high cardiovascular risk, and patients with chronic kidney disease. The safety ...and efficacy of empagliflozin in patients who have had acute myocardial infarction are unknown.
In this event-driven, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, patients who had been hospitalized for acute myocardial infarction and were at risk for heart failure to receive empagliflozin at a dose of 10 mg daily or placebo in addition to standard care within 14 days after admission. The primary end point was a composite of hospitalization for heart failure or death from any cause as assessed in a time-to-first-event analysis.
A total of 3260 patients were assigned to receive empagliflozin and 3262 to receive placebo. During a median follow-up of 17.9 months, a first hospitalization for heart failure or death from any cause occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years (hazard ratio, 0.90; 95% confidence interval CI, 0.76 to 1.06; P = 0.21). With respect to the individual components of the primary end point, a first hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and in 153 patients (4.7%) in the placebo group (hazard ratio, 0.77; 95% CI, 0.60 to 0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (hazard ratio, 0.96; 95% CI, 0.78 to 1.19). Adverse events were consistent with the known safety profile of empagliflozin and were similar in the two trial groups.
Among patients at increased risk for heart failure after acute myocardial infarction, treatment with empagliflozin did not lead to a significantly lower risk of a first hospitalization for heart failure or death from any cause than placebo. (Funded by Boehringer Ingelheim and Eli Lilly; EMPACT-MI ClinicalTrials.gov number, NCT04509674.).
Heart failure is a major public health problem, which is associated with significant mortality, morbidity, and healthcare expenditures. A substantial amount of the morbidity is attributed to volume ...overload, for which loop diuretics are a mandatory treatment. However, the variability in response to diuretics and development of diuretic resistance adversely affect the clinical outcomes. Morevoer, there exists a marked intra- and inter-patient variability in response to diuretics that affects the clinical course and related adverse outcomes. In the present article, we review the mechanisms underlying the development of diuretic resistance. The role of the autonomic nervous system and chronobiology in the pathogenesis of congestive heart failure and response to therapy are also discussed. Establishing a novel model for overcoming diuretic resistance is presented based on a patient-tailored variability and chronotherapy-guided machine learning algorithm that comprises clinical, laboratory, and sensor-derived inputs, including inputs from pulmonary artery measurements. Inter- and intra-patient signatures of variabilities, alterations of biological clock, and autonomic nervous system responses are embedded into the algorithm; thus, it may enable a tailored dose regimen in a continuous manner that accommodates the highly dynamic complex system.
Coronary artery disease (CAD) is the leading cause of mortality worldwide. In chronic and myocardial infarction (MI) states, aberrant levels of circulating microRNAs compromise gene expression and ...pathophysiology. We aimed to compare microRNA expression in chronic-CAD and acute-MI male patients in peripheral blood vasculature versus coronary arteries proximal to a culprit area. Blood from chronic-CAD, acute-MI with/out ST segment elevation (STEMI/NSTEMI, respectively), and control patients lacking previous CAD or having patent coronary arteries was collected during coronary catheterization from peripheral arteries and from proximal culprit coronary arteries aimed for the interventions. Random coronary arterial blood was collected from controls; RNA extraction, miRNA library preparation and Next Generation Sequencing followed. High concentrations of microRNA-483-5p (miR-483-5p) were noted as 'coronary arterial gradient' in culprit acute-MI versus chronic-CAD (
= 0.035) which were similar to controls versus chronic-CAD (
< 0.001). Meanwhile, peripheral miR-483-5p was downregulated in acute-MI and chronic-CAD, compared with controls (1.1 ± 2.2 vs. 2.6 ± 3.3, respectively,
< 0.005). A receiver operating characteristic curve analysis for miR483-5p association with chronic CAD demonstrated an area under the curve of 0.722 (
< 0.001) with 79% sensitivity and 70% specificity. Using in silico gene analysis, we detected miR-483-5p cardiac gene targets, responsible for inflammation (
), oxidative stress (
,
), apoptosis (
), fibrosis (
,
,
), angiogenesis (
,
) and wound healing (
). High miR-483-5p 'coronary arterial gradient' in acute-MI, unnoticed in chronic-CAD, suggests important local mechanisms for miR483-5p in CAD in response to local myocardial ischemia. MiR-483-5p may have an important role as a gene modulator for pathologic and tissue repair states, is a suggestive biomarker, and is a potential therapeutic target for acute and chronic cardiovascular disease.
Atrial fibrillation (AF) is associated with poor prognosis in patients with heart failure (HF). Although platelets play an important role in rendering a prothrombotic state in AF, the exact mechanism ...by which the effect is mediated is still debated. MicroRNAs (miRNAs), which have been shown to be involved in a variety of cardiovascular conditions, are abundant in platelets and in a cell-free form in the circulation. In the present study, we performed a genome-wide screen for miRNA expression in platelets of patients with systolic HF and in controls without cardiac disease, in pursuit of specific miRNAs that are associated with the presence of AF. MiRNA expression was measured in platelets from 50 patients with systolic HF and 50 controls, of which, samples from 41 patients with HF and 35 controls were used in the final analysis because of a quality control process. MiR-150 expression was 3.2-fold lower (p = 0.0003) in platelets of patients with HF with AF relative to those without AF. A similar effect was seen in serum samples from the same patients, in which miR-150 levels were 1.5-fold lower (p = 0.004) in patients with HF with AF. Furthermore, the serum levels of miR-150 were correlated to platelet levels in patients with AF (r = 0.65, p = 0.0087). In conclusion, miR-150 expression levels in platelets of patients with systolic HF with AF are significantly reduced and correlated to the cell-free circulating levels of this miRNA.