Risk of worsening heart failure and all-cause mortality following mRNA COVID-19 vaccination in patients with heart failure: a Danish nationwide real-world safety study

Background: The studies investigating the safety and efficacy of the SARS-COV2 mRNA vaccines only included a limited number of heart failure patients and no separate analyses were performed regarding the safety of the vaccines in this patient population. Purpose: The aims of this study were to investigate the risk of worsening heart failure and all-cause mortality associated with the SARS-COV-2 mRNA vaccines in a nationwide cohort of patients with heart failure. Methods: Using the Danish nationwide registries, two cohorts were constructed;1) all prevalent heart failure patients in 2019 and 2) all prevalent heart failure patients in 2021 who were vaccinated with either of the two mRNA vaccines (BNT162B2 or mRNA-1273). The patients in the two cohorts were matched 1:1 using exact exposure matching on age, sex, and duration of heart failure (intervals). For patients in the 2021 cohort, the index date was defined as the date of the patients' second vaccination. Patients in the 2019 cohort were assigned the index day and month of their 1:1 match in the 2021 cohort, but used the pre-vaccination index year 2019. The primary outcomes were worsening heart failure and all-cause mortality and secondary outcomes were myocarditis and venous thromboembolism. Standardized risks were estimated based on outcome-specific Cox regression analyses, and all models were standardized to age, sex, duration of heart failure, use of SGLT2 inhibitors or Entresto, ischemic heart disease, cancer, diabetes, atrial fibrillation, and admission with heart failure <90 days before index. Results: The total study population comprised 101,786 patients, with 50,893 patients in each cohort. The median age of the study population was 74 (interquartile range (IQR);66,81), and duration of heart failure was 4.1 (IQR: 2.0,6.7) years. The standardized risk of all-cause mortality within 90 days was 2.2% (95% CI: 2.1% to 2.4%) in the 2021 cohort and 2.6% (95% CI: 2.4% to 2.7%) in the 2019 cohort, showing a significantly lower risk difference for all-cause mortality in 2021 versus 2019 (risk difference: −0.3% (95% CI: −0.5% to −0.1%)) Figure 1)). The standardized risk of worsening heart failure within 90 days was 1.1% (95% CI: −1.0% to 1.2%) in the 2021 cohort and 1.1% (95% CI: 1.0% to 1.2%) in the 2019 cohort showing no significant difference in the risk of worsening heart failure between the two cohorts (risk difference: 0% (95% CI: −0.1% to 0.1%)). No significant differences were found for venous thromboembolism or myocarditis. Conclusion: This study showed that the SARS-COV2 mRNA vaccines were not associated with an increased risk of worsening heart failure, venous thromboembolism or myocarditis, but was associated with a decreased risk of all-cause mortality. Our study may suggest that these vaccines are safe in heart failure patients. Funding Acknowledgement: Type of funding sources: Foundation. Main funding source(s): The Danish Heart FoundationLæge Sofus Carl Emil Friis og hustrus legatFigure 1

Return to work after COVID-19 infection - A Danish nationwide registry study.

OBJECTIVES: This study aimed to explore return to work after COVID-19 and how disease severity affects this. STUDY DESIGN: This is a Nationwide Danish registry-based cohort study using a retrospective follow-up design. METHODS: Patients with a first-time positive SARS-CoV-2 polymerase chain reaction test between 1 January 2020 and 30 May 2020, including 18-64 years old, 30-day survivors, and available to the workforce at the time of the first positive test were included. Admission types (i.e. no admission, admission to non-intensive care unit [ICU] department and admission to ICU) and return to work was investigated using Cox regression standardised to the age, sex, comorbidity and education-level distribution of all included subjects with estimates at 3 months from positive test displayed. RESULTS: Among the 7466 patients included in the study, 81.9% (6119/7466) and 98.4% (7344/7466) returned to work within 4 weeks and 6 months, respectively, with 1.5% (109/7466) not returning. Of the patients admitted, 72.1% (627/870) and 92.6% (805/870) returned 1 month and 6 months after admission to the hospital, with 6.6% (58/870) not returning within 6 months. Of patients admitted to the ICU, 36% (9/25) did not return within 6 months. Patients with an admission had a lower chance of return to work 3 months from positive test (relative risk [RR] 0.95, 95% confidence interval [CI] 0.94-0.96), with the lowest chance in patients admitted to an ICU department (RR 0.54, 95% CI 0.35-0.72). Female sex, older age, and comorbidity were associated with a lower chance of returning to work. CONCLUSION: Hospitalised patients with COVID-19 infection have a lower chance of returning to work with potential implications for postinfection follow-up and rehabilitation.

Incidence of acute myocardial infarction-related cardiogenic shock during corona virus disease 19 (COVID-19) pandemic.

AIMS: The hospitalization of patients with MI has decreased during global lockdown due to the COVID-19 pandemic. Whether this decrease is associated with more severe MI, e.g. MI-CS, is unknown. We aimed to examine the association of Corona virus disease (COVID-19) pandemic and incidence of acute myocardial infarction with cardiogenic shock (MI-CS). METHODS: On March 11, 2020, the Danish government announced national lock-down. Using Danish nationwide registries, we identified patients hospitalized with MI-CS. Incidence rates (IR) and incidence rate ratios (IRR) were used to compare MI-CS before and after March 11 in 2015-2019 and in 2020. RESULTS: We identified 11,769 patients with MI of whom 696 (5.9%) had cardiogenic shock in 2015-2019. In 2020, 2132 MI patients were identified of whom 119 had cardiogenic shock (5.6%). The IR per 100,000 person years before March 11 in 2015-2019 was 9.2 (95% CI: 8.3-10.2) and after 8.9 (95% CI: 8.0-9.9). In 2020, the IR was 7.5 (95% CI: 5.8-9.7) before March 11 and 7.7 (95% CI: 6.0-9.9) after. The IRRs comparing the 2020-period with the 2015-2019 period before and after March 11 (lockdown) were 0.81 (95% CI: 0.59-1.12) and 0.87 (95% CI: 0.57-1.32), respectively. The IRR comparing the 2020-period during and before lockdown was 1.02 (95% CI: 0.74-1.41). No difference in 7-day mortality or in-hospital management was observed between study periods. CONCLUSION: We could not identify a significant association of the national lockdown on the incidence of MI-CS, along with similar in-hospital management and mortality in patients with MI-CS.