Transcatheter-based aortic valve replacement vs. isolated surgical aortic valve replacement in 2020.

BACKGROUND: Based on the results of several recent randomized trials, European and American guidelines on valvular heart disease management have substantially expanded the indications for transcatheter aortic valve implantation (TAVI). We present an all-comer data on peri-operative risk profile and in-hospital outcomes from Germany for patients treated by TAVI or isolated surgical aortic valve replacement (iSAVR) in 2020, providing an opportunity to compare study data with data from daily clinical practice. METHODS: Data concerning all isolated aortic valve procedures performed in Germany in 2020 were retrieved from the mandatory nationwide quality control program. Expected mortality was calculated with the annually revised German Aortic valve score (AKL-score) based on the data of either catheter-based (AKL-CATH) or isolated surgical (AKL-CHIR) aortic valve replacement in Germany from the previous year (2019). RESULTS: In 2020 21,903 TAVI procedures (20,810 transvascular (TV; vs. 2019: 22.973; - 9.4%), 1093 transapical (TA; vs. 2019: 1413; - 22.6%)) and 6144 (vs. 2019 7905; - 22.5%) iSAVR were performed in Germany. Patients who received TAVI showed a significantly higher perioperative risk profile than patients undergoing iSAVR based on older age and more severe co-morbidities. While in-hospital mortality after TAVI (2.3%) was numerically lower than in 2019 (2.5%), this difference was not significant (p = 0.11). In-hospital mortality after iSAVR was identical in 2020 and 2019 (2.8%) and thus higher than after TAVI (p = 0.003), resulting in an observed expected mortality ratio of 1.02 after TAVI and 1.05 after iSAVR. After exclusion of the emergency procedures, in-hospital mortality did not differ significantly between the groups (TAVI 2.2% vs. iSAVR 1.9%, p = 0.26). CONCLUSION: Total numbers of both iSAVR and TAVI in Germany were lower in 2020 than in 2019, most likely due to the COVID-19 pandemic. However, the relative number of patients treated by TAVI as compared to iSAVR continues to increase. Despite older age and more severe comorbidities compared to patients undergoing iSAVR the in-hospital mortality after TAVI continued to decrease in 2020 and remains significantly lower than after iSAVR.

Intramyocardial Inflammation after COVID-19 Vaccination: An Endomyocardial Biopsy-Proven Case Series.

Myocarditis in response to COVID-19 vaccination has been reported since early 2021. In particular, young male individuals have been identified to exhibit an increased risk of myocardial inflammation following the administration of mRNA-based vaccines. Even though the first epidemiological analyses and numerous case reports investigated potential relationships, endomyocardial biopsy (EMB)-proven cases are limited. Here, we present a comprehensive histopathological analysis of EMBs from 15 patients with reduced ejection fraction (LVEF = 30 (14-39)%) and the clinical suspicion of myocarditis following vaccination with Comirnaty® (Pfizer-BioNTech) (n = 11), Vaxzevria® (AstraZenica) (n = 2) and Janssen® (Johnson & Johnson) (n = 2). Immunohistochemical EMB analyses reveal myocardial inflammation in 14 of 15 patients, with the histopathological diagnosis of active myocarditis according the Dallas criteria (n = 2), severe giant cell myocarditis (n = 2) and inflammatory cardiomyopathy (n = 10). Importantly, infectious causes have been excluded in all patients. The SARS-CoV-2 spike protein has been detected sparsely on cardiomyocytes of nine patients, and differential analysis of inflammatory markers such as CD4+ and CD8+ T cells suggests that the inflammatory response triggered by the vaccine may be of autoimmunological origin. Although a definitive causal relationship between COVID-19 vaccination and the occurrence of myocardial inflammation cannot be demonstrated in this study, data suggest a temporal connection. The expression of SARS-CoV-2 spike protein within the heart and the dominance of CD4+ lymphocytic infiltrates indicate an autoimmunological response to the vaccination.

Impact of the COVID-19 pandemic on cardiovascular mortality and catherization activity during the lockdown in central Germany: an observational study.

AIMS: During the COVID-19 pandemic, hospital admissions for cardiac care have declined. However, effects on mortality are unclear. Thus, we sought to evaluate the impact of the lockdown period in central Germany on overall and cardiovascular deaths. Simultaneously we looked at catheterization activities in the same region. METHODS AND RESULTS: Data from 22 of 24 public health-authorities in central Germany were aggregated during the pandemic related lockdown period and compared to the same time period in 2019. Information on the total number of deaths and causes of death, including cardiovascular mortality, were collected. Additionally, we compared rates of hospitalization (n = 5178) for chronic coronary syndrome (CCS), acute coronary syndrome (ACS), and out of hospital cardiac arrest (OHCA) in 26 hospitals in this area. Data on 5,984 deaths occurring between March 23, 2020 and April 26, 2020 were evaluated. In comparison to the reference non-pandemic period in 2019 (deaths: n = 5832), there was a non-significant increase in all-cause mortality of 2.6% [incidence rate ratio (IRR) 1.03, 95% confidence interval (CI) 0.99-1.06; p = 0.16]. Cardiovascular and cardiac mortality increased significantly by 7.6% (IRR 1.08, 95%-CI 1.01-1.14; p = 0.02) and by 11.8% (IRR 1.12, 95%-CI 1.05-1.19; p < 0.001), respectively. During the same period, our data revealed a drop in cardiac catherization procedures. CONCLUSION: During the COVID-19-related lockdown a significant increase in cardiovascular mortality was observed in central Germany, whereas catherization activities were reduced. The mechanisms underlying both of these observations should be investigated further in order to better understand the effects of a pandemic-related lockdown and social-distancing restrictions on cardiovascular care and mortality.