The Direct and Indirect Effects of COVID-19 on Acute Coronary Syndromes.

The novel SARS-CoV-2 has directly and indirectly impacted patients with acute coronary syndrome (ACS). The onset of the COVID-19 pandemic correlated with an abrupt decline in hospitalizations with ACS and increased out-of-hospital deaths. Worse outcomes in ACS patients with concomitant COVID-19 have been reported, and acute myocardial injury secondary to SARS-CoV-2 infection is recognized. A rapid adaptation of existing ACS pathways has been required such that overburdened health care systems may manage both a novel contagion and existing illness. As SARS-CoV-2 is now endemic, future research is required to better define the complex interplay of COVID-19 infection and cardiovascular disease.

Design and evaluation of an interactive quality dashboard for national clinical audit data: a realist evaluation

BackgroundNational audits aim to reduce variations in quality by stimulating quality improvement. However, varying provider engagement with audit data means that this is not being realised.AimThe aim of the study was to develop and evaluate a quality dashboard (i.e. QualDash) to support clinical teams’ and managers’ use of national audit data.DesignThe study was a realist evaluation and biography of artefacts study.SettingThe study involved five NHS acute trusts.Methods and resultsIn phase 1, we developed a theory of national audits through interviews. Data use was supported by data access, audit staff skilled to produce data visualisations, data timeliness and quality, and the importance of perceived metrics. Data were mainly used by clinical teams. Organisational-level staff questioned the legitimacy of national audits. In phase 2, QualDash was co-designed and the QualDash theory was developed. QualDash provides interactive customisable visualisations to enable the exploration of relationships between variables. Locating QualDash on site servers gave users control of data upload frequency. In phase 3, we developed an adoption strategy through focus groups. ‘Champions’, awareness-raising through e-bulletins and demonstrations, and quick reference tools were agreed. In phase 4, we tested the QualDash theory using a mixed-methods evaluation. Constraints on use were metric configurations that did not match users’ expectations, affecting champions’ willingness to promote QualDash, and limited computing resources. Easy customisability supported use. The greatest use was where data use was previously constrained. In these contexts, report preparation time was reduced and efforts to improve data quality were supported, although the interrupted time series analysis did not show improved data quality. Twenty-three questionnaires were returned, revealing positive perceptions of ease of use and usefulness. In phase 5, the feasibility of conducting a cluster randomised controlled trial of QualDash was assessed. Interviews were undertaken to understand how QualDash could be revised to support a region-wide Gold Command. Requirements included multiple real-time data sources and functionality to help to identify priorities.ConclusionsAudits seeking to widen engagement may find the following strategies beneficial: involving a range of professional groups in choosing metrics;real-time reporting;presenting ‘headline’ metrics important to organisational-level staff;using routinely collected clinical data to populate data fields;and dashboards that help staff to explore and report audit data. Those designing dashboards may find it beneficial to include the following: ‘at a glance’ visualisation of key metrics;visualisations configured in line with existing visualisations that teams use, with clear labelling;functionality that supports the creation of reports and presentations;the ability to explore relationships between variables and drill down to look at subgroups;and low requirements for computing resources. Organisations introducing a dashboard may find the following strategies beneficial: clinical champion to promote use;testing with real data by audit staff;establishing routines for integrating use into work practices;involving audit staff in adoption activities;and allowing customisation.LimitationsThe COVID-19 pandemic stopped phase 4 data collection, limiting our ability to further test and refine the QualDash theory. Questionnaire results should be treated with caution because of the small, possibly biased, sample. Control sites for the interrupted time series analysis were not possible because of research and development delays. One intervention site did not submit data. Limited uptake meant that assessing the impact on more measures was not appropriate.Future workThe extent to which national audit dashboards are used and the strategies national audits use to encourage uptake, a realist review of the impact of dashboards, and rigorous evaluations of the impact of dashboards and the effectiveness of adoption strategies should be explored.Study registrationThis study is registered as ISRCTN18289782.FundingThis project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research;Vol. 10, No. 12. See the NIHR Journals Library website for further project information.

CODE-EHR best practice framework for the use of structured electronic healthcare records in clinical research.

Big data is central to new developments in global clinical science aiming to improve the lives of patients. Technological advances have led to the routine use of structured electronic healthcare records with the potential to address key gaps in clinical evidence. The covid-19 pandemic has demonstrated the potential of big data and related analytics, but also important pitfalls. Verification, validation, and data privacy, as well as the social mandate to undertake research are key challenges. The European Society of Cardiology and the BigData@Heart consortium have brought together a range of international stakeholders, including patient representatives, clinicians, scientists, regulators, journal editors and industry. We propose the CODE-EHR Minimum Standards Framework as a means to improve the design of studies, enhance transparency and develop a roadmap towards more robust and effective utilisation of healthcare data for research purposes.

CODE-EHR best-practice framework for the use of structured electronic health-care records in clinical research.

Big data is important to new developments in global clinical science that aim to improve the lives of patients. Technological advances have led to the regular use of structured electronic health-care records with the potential to address key deficits in clinical evidence that could improve patient care. The COVID-19 pandemic has shown this potential in big data and related analytics but has also revealed important limitations. Data verification, data validation, data privacy, and a mandate from the public to conduct research are important challenges to effective use of routine health-care data. The European Society of Cardiology and the BigData@Heart consortium have brought together a range of international stakeholders, including representation from patients, clinicians, scientists, regulators, journal editors, and industry members. In this Review, we propose the CODE-EHR minimum standards framework to be used by researchers and clinicians to improve the design of studies and enhance transparency of study methods. The CODE-EHR framework aims to develop robust and effective utilisation of health-care data for research purposes.

The Direct and Indirect Effects of COVID-19 on Acute Coronary Syndromes.

The novel SARS-CoV-2 has directly and indirectly impacted patients with acute coronary syndrome (ACS). The onset of the COVID-19 pandemic correlated with an abrupt decline in hospitalizations with ACS and increased out-of-hospital deaths. Worse outcomes in ACS patients with concomitant COVID-19 have been reported, and acute myocardial injury secondary to SARS-CoV-2 infection is recognized. A rapid adaptation of existing ACS pathways has been required such that overburdened health care systems may manage both a novel contagion and existing illness. As SARS-CoV-2 is now endemic, future research is required to better define the complex interplay of COVID-19 infection and cardiovascular disease.

Aortic stenosis post-COVID-19: a mathematical model on waiting lists and mortality.

OBJECTIVES: To provide estimates for how different treatment pathways for the management of severe aortic stenosis (AS) may affect National Health Service (NHS) England waiting list duration and associated mortality. DESIGN: We constructed a mathematical model of the excess waiting list and found the closed-form analytic solution to that model. From published data, we calculated estimates for how the strategies listed under Interventions may affect the time to clear the backlog of patients waiting for treatment and the associated waiting list mortality. SETTING: The NHS in England. PARTICIPANTS: Estimated patients with AS in England. INTERVENTIONS: (1) Increasing the capacity for the treatment of severe AS, (2) converting proportions of cases from surgery to transcatheter aortic valve implantation and (3) a combination of these two. RESULTS: In a capacitated system, clearing the backlog by returning to pre-COVID-19 capacity is not possible. A conversion rate of 50% would clear the backlog within 666 (533-848) days with 1419 (597-2189) deaths while waiting during this time. A 20% capacity increase would require 535 (434-666) days, with an associated mortality of 1172 (466-1859). A combination of converting 40% cases and increasing capacity by 20% would clear the backlog within a year (343 (281-410) days) with 784 (292-1324) deaths while awaiting treatment. CONCLUSION: A strategy change to the management of severe AS is required to reduce the NHS backlog and waiting list deaths during the post-COVID-19 'recovery' period. However, plausible adaptations will still incur a substantial wait to treatment and many hundreds dying while waiting.

Very early invasive angiography versus standard of care in higher-risk non-ST elevation myocardial infarction: study protocol for the prospective multicentre randomised controlled RAPID N-STEMI trial.

BACKGROUND: There are a paucity of randomised data on the optimal timing of invasive coronary angiography (ICA) in higher-risk patients with non-ST elevation myocardial infarction (N-STEMI). International guideline recommendations for early ICA are primarily based on retrospective subgroup analyses of neutral trials. AIMS: The RAPID N-STEMI trial aims to determine whether very early percutaneous revascularisation improves clinical outcomes as compared with a standard of care strategy in higher-risk N-STEMI patients. METHODS AND ANALYSIS: RAPID N-STEMI is a prospective, multicentre, open-label, randomised-controlled, pragmatic strategy trial. Higher-risk N-STEMI patients, as defined by Global Registry of Acute Coronary Events 2.0 score ≥118, or >90 with at least one additional high-risk feature, were randomised to either: very early ICA±revascularisation or standard of care timing of ICA±revascularisation. The primary outcome is the proportion of participants with at least one of the following events (all-cause mortality, non-fatal myocardial infarction and hospital admission for heart failure) at 12 months. Key secondary outcomes include major bleeding and stroke. A hypothesis generating cardiac magnetic resonance (CMR) substudy will provide mechanistic data on infarct size, myocardial salvage and residual ischaemia post percutaneous coronary intervention. On 7 April 2021, the sponsor discontinued enrolment due to the impact of the COVID-19 pandemic and lower than expected event rates. 425 patients were enrolled, and 61 patients underwent CMR. ETHICS AND DISSEMINATION: The trial has been reviewed and approved by the East of England Cambridge East Research Ethics Committee (18/EE/0222). The study results will be submitted for publication within 6 months of completion. TRIAL REGISTRATION NUMBER: NCT03707314; Pre-results.

The collateral damage of COVID-19 to cardiovascular services: a meta-analysis.

AIMS: The effect of the COVID-19 pandemic on care and outcomes across non-COVID-19 cardiovascular (CV) diseases is unknown. A systematic review and meta-analysis was performed to quantify the effect and investigate for variation by CV disease, geographic region, country income classification and the time course of the pandemic. METHODS AND RESULTS: From January 2019 to December 2021, Medline and Embase databases were searched for observational studies comparing a pandemic and pre-pandemic period with relation to CV disease hospitalisations, diagnostic and interventional procedures, outpatient consultations, and mortality. Observational data were synthesised by incidence rate ratios (IRR) and risk ratios (RR) for binary outcomes and weighted mean differences for continuous outcomes with 95% confidence intervals. The study was registered with PROSPERO (CRD42021265930). A total of 158 studies, covering 49 countries and 6 continents, were used for quantitative synthesis. Most studies (80%) reported information for high-income countries (HICs). Across all CV disease and geographies there were fewer hospitalisations, diagnostic and interventional procedures, and outpatient consultations during the pandemic. By meta-regression, in low-middle income countries (LMICs) compared to HICs the decline in ST-segment elevation myocardial infarction (STEMI) hospitalisations (RR 0.79, 95% confidence interval [CI] 0.66-0.94) and revascularisation (RR 0.73, 95% CI 0.62-0.87) was more severe. In LMICs, but not HICs, in-hospital mortality increased for STEMI (RR 1.22, 95% CI 1.10-1.37) and heart failure (RR 1.08, 95% CI 1.04-1.12). The magnitude of decline in hospitalisations for CV diseases did not differ between the first and second wave. CONCLUSIONS: There was substantial global collateral CV damage during the COVID-19 pandemic with disparity in severity by country income classification.

Excess years of life lost to COVID-19 and other causes of death by sex, neighbourhood deprivation, and region in England and Wales during 2020: A registry-based study.

BACKGROUND: Deaths in the first year of the Coronavirus Disease 2019 (COVID-19) pandemic in England and Wales were unevenly distributed socioeconomically and geographically. However, the full scale of inequalities may have been underestimated to date, as most measures of excess mortality do not adequately account for varying age profiles of deaths between social groups. We measured years of life lost (YLL) attributable to the pandemic, directly or indirectly, comparing mortality across geographic and socioeconomic groups. METHODS AND FINDINGS: We used national mortality registers in England and Wales, from 27 December 2014 until 25 December 2020, covering 3,265,937 deaths. YLLs (main outcome) were calculated using 2019 single year sex-specific life tables for England and Wales. Interrupted time-series analyses, with panel time-series models, were used to estimate expected YLL by sex, geographical region, and deprivation quintile between 7 March 2020 and 25 December 2020 by cause: direct deaths (COVID-19 and other respiratory diseases), cardiovascular disease and diabetes, cancer, and other indirect deaths (all other causes). Excess YLL during the pandemic period were calculated by subtracting observed from expected values. Additional analyses focused on excess deaths for region and deprivation strata, by age-group. Between 7 March 2020 and 25 December 2020, there were an estimated 763,550 (95% CI: 696,826 to 830,273) excess YLL in England and Wales, equivalent to a 15% (95% CI: 14 to 16) increase in YLL compared to the equivalent time period in 2019. There was a strong deprivation gradient in all-cause excess YLL, with rates per 100,000 population ranging from 916 (95% CI: 820 to 1,012) for the least deprived quintile to 1,645 (95% CI: 1,472 to 1,819) for the most deprived. The differences in excess YLL between deprivation quintiles were greatest in younger age groups; for all-cause deaths, a mean of 9.1 years per death (95% CI: 8.2 to 10.0) were lost in the least deprived quintile, compared to 10.8 (95% CI: 10.0 to 11.6) in the most deprived; for COVID-19 and other respiratory deaths, a mean of 8.9 years per death (95% CI: 8.7 to 9.1) were lost in the least deprived quintile, compared to 11.2 (95% CI: 11.0 to 11.5) in the most deprived. For all-cause mortality, estimated deaths in the most deprived compared to the most affluent areas were much higher in younger age groups, but similar for those aged 85 or over. There was marked variability in both all-cause and direct excess YLL by region, with the highest rates in the North West. Limitations include the quasi-experimental nature of the research design and the requirement for accurate and timely recording. CONCLUSIONS: In this study, we observed strong socioeconomic and geographical health inequalities in YLL, during the first calendar year of the COVID-19 pandemic. These were in line with long-standing existing inequalities in England and Wales, with the most deprived areas reporting the largest numbers in potential YLL.

Quality of acute myocardial infarction care in England and Wales during the COVID-19 pandemic: linked nationwide cohort study.

BACKGROUND AND OBJECTIVE: The impact of the COVID-19 pandemic on the quality of care for patients with acute myocardial infarction (AMI) is uncertain. We aimed to compare quality of AMI care in England and Wales during and before the COVID-19 pandemic using the 2020 European Society of Cardiology Association for Acute Cardiovascular Care quality indicators (QIs) for AMI. METHODS: Cohort study of linked data from the AMI and the percutaneous coronary intervention registries in England and Wales between 1 January 2017 and 27 May 2020 (representing 236 743 patients from 186 hospitals). At the patient level, the likelihood of attainment for each QI compared with pre COVID-19 was calculated using logistic regression. The date of the first national lockdown in England and Wales (23 March 2020) was chosen for time series comparisons. RESULTS: There were 10 749 admissions with AMI after 23 March 2020. Compared with before the lockdown, patients admitted with AMI during the first wave had similar age (mean 68.0 vs 69.0 years), with no major differences in baseline characteristics (history of diabetes (25% vs 26%), renal failure (6.4% vs 6.9%), heart failure (5.8% vs 6.4%) and previous myocardial infarction (22.9% vs 23.7%)), and less frequently had high Global Registry of Acute Coronary Events risk scores (43.6% vs 48.6%). There was an improvement in attainment for 10 (62.5%) of the 16 measured QIs including a composite QI (43.8% to 45.2%, OR 1.06, 95% CI 1.02 to 1.10) during, compared with before, the lockdown. CONCLUSION: During the first wave of the COVID-19 pandemic in England and Wales, quality of care for AMI as measured against international standards did not worsen, but improved modestly.

Excess deaths from COVID-19 and other causes by region, neighbourhood deprivation level and place of death during the first 30 weeks of the pandemic in England and Wales: A retrospective registry study.

BACKGROUND: Excess deaths during the COVID-19 pandemic compared with those expected from historical trends have been unequally distributed, both geographically and socioeconomically. Not all excess deaths have been directly related to COVID-19 infection. We investigated geographical and socioeconomic patterns in excess deaths for major groups of underlying causes during the pandemic. METHODS: Weekly mortality data from 27/12/2014 to 2/10/2020 for England and Wales were obtained from the Office of National Statistics. Negative binomial regressions were used to model death counts based on pre-pandemic trends for deaths caused directly by COVID-19 (and other respiratory causes) and those caused indirectly by it (cardiovascular disease or diabetes, cancers, and all other indirect causes) over the first 30 weeks of the pandemic (7/3/2020-2/10/2020). FINDINGS: There were 62,321 (95% CI: 58,849 to 65,793) excess deaths in England and Wales in the first 30 weeks of the pandemic. Of these, 46,221 (95% CI: 45,439 to 47,003) were attributable to respiratory causes, including COVID-19, and 16,100 (95% CI: 13,410 to 18,790) to other causes. Rates of all-cause excess mortality ranged from 78 per 100,000 in the South West of England and in Wales to 130 per 100,000 in the West Midlands; and from 93 per 100,000 in the most affluent fifth of areas to 124 per 100,000 in the most deprived. The most deprived areas had the highest rates of death attributable to COVID-19 and other indirect deaths, but there was no socioeconomic gradient for excess deaths from cardiovascular disease/diabetes and cancer. INTERPRETATION: During the first 30 weeks of the COVID-19 pandemic there was significant geographic and socioeconomic variation in excess deaths for respiratory causes, but not for cardiovascular disease, diabetes and cancer. Pandemic recovery plans, including vaccination programmes, should take account of individual characteristics including health, socioeconomic status and place of residence. FUNDING: None.

Substantial decline in hospital admissions for heart failure accompanied by increased community mortality during COVID-19 pandemic.

AIMS: We hypothesized that a decline in admissions with heart failure during COVID-19 pandemic would lead to a reciprocal rise in mortality for patients with heart failure in the community. METHODS AND RESULTS: We used National Heart Failure Audit data to identify 36 974 adults who had a hospital admission with a primary diagnosis of heart failure between February and May in either 2018, 2019, or 2020. Hospital admissions for heart failure in 2018/19 averaged 160/day but were much lower in 2020, reaching a nadir of 64/day on 27 March 2020 [incidence rate ratio (IRR): 0.40, 95% confidence interval (CI): 0.38-0.42]. The proportion discharged on guideline-recommended pharmacotherapies was similar in 2018/19 compared to the same period in 2020. Between 1 February-2020 and 31 May 2020, there was a 29% decrease in hospital deaths related to heart failure (IRR: 0.71, 95% CI: 0.67-0.75; estimated decline of 448 deaths), a 31% increase in heart failure deaths at home (IRR: 1.31, 95% CI: 1.24-1.39; estimated excess 539), and a 28% increase in heart failure deaths in care homes and hospices (IRR: 1.28, 95% CI: 1.18-1.40; estimated excess 189). All-cause, inpatient death was similar in the COVID-19 and pre-COVID-19 periods [odds ratio (OR): 1.02, 95% CI: 0.94-1.10]. After hospital discharge, 30-day mortality was higher in 2020 compared to 2018/19 (OR: 1.57, 95% CI: 1.38-1.78). CONCLUSION: Compared with the rolling daily average in 2018/19, there was a substantial decline in admissions for heart failure but an increase in deaths from heart failure in the community. Despite similar rates of prescription of guideline-recommended therapy, mortality 30 days from discharge was higher during the COVID-19 pandemic period.

Indirect Impact of the COVID-19 Pandemic on Activity and Outcomes of Transcatheter and Surgical Treatment of Aortic Stenosis in England.

[Figure: see text].

International Prospective Registry of Acute Coronary Syndromes in Patients With COVID-19.

BACKGROUND: Published data suggest worse outcomes in acute coronary syndrome (ACS) patients and concurrent coronavirus disease 2019 (COVID-19) infection. Mechanisms remain unclear. OBJECTIVES: The purpose of this study was to report the demographics, angiographic findings, and in-hospital outcomes of COVID-19 ACS patients and compare these with pre-COVID-19 cohorts. METHODS: From March 1, 2020 to July 31, 2020, data from 55 international centers were entered into a prospective, COVID-ACS Registry. Patients were COVID-19 positive (or had a high index of clinical suspicion) and underwent invasive coronary angiography for suspected ACS. Outcomes were in-hospital major cardiovascular events (all-cause mortality, re-myocardial infarction, heart failure, stroke, unplanned revascularization, or stent thrombosis). Results were compared with national pre-COVID-19 databases (MINAP [Myocardial Ischaemia National Audit Project] 2019 and BCIS [British Cardiovascular Intervention Society] 2018 to 2019). RESULTS: In 144 ST-segment elevation myocardial infarction (STEMI) and 121 non-ST-segment elevation acute coronary syndrome (NSTE-ACS) patients, symptom-to-admission times were significantly prolonged (COVID-STEMI vs. BCIS: median 339.0 min vs. 173.0 min; p < 0.001; COVID NSTE-ACS vs. MINAP: 417.0 min vs. 295.0 min; p = 0.012). Mortality in COVID-ACS patients was significantly higher than BCIS/MINAP control subjects in both subgroups (COVID-STEMI: 22.9% vs. 5.7%; p < 0.001; COVID NSTE-ACS: 6.6% vs. 1.2%; p < 0.001), which remained following multivariate propensity analysis adjusting for comorbidities (STEMI subgroup odds ratio: 3.33 [95% confidence interval: 2.04 to 5.42]). Cardiogenic shock occurred in 20.1% of COVID-STEMI patients versus 8.7% of BCIS patients (p < 0.001). CONCLUSIONS: In this multicenter international registry, COVID-19-positive ACS patients presented later and had increased in-hospital mortality compared with a pre-COVID-19 ACS population. Excessive rates of and mortality from cardiogenic shock were major contributors to the worse outcomes in COVID-19 positive STEMI patients.

Revascularisation strategies in patients with significant left main coronary disease during the COVID-19 pandemic.

BACKGROUND: There are limited data on the impact of the COVID-19 pandemic on left main (LM) coronary revascularisation activity, choice of revascularisation strategy, and post-procedural outcomes. METHODS: All patients with LM disease (≥50% stenosis) undergoing coronary revascularisation in England between January 1, 2017 and August 19, 2020 were included (n = 22,235), stratified by time-period (pre-COVID: 01/01/2017-29/2/2020; COVID: 1/3/2020-19/8/2020) and revascularisation strategy (percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG). Logistic regression models were performed to examine odds ratio (OR) of 1) receipt of CABG (vs. PCI) and 2) in-hospital and 30-day postprocedural mortality, in the COVID-19 period (vs. pre-COVID). RESULTS: There was a decline of 1,354 LM revascularisation procedures between March 1, 2020 and July 31, 2020 compared with previous years' (2017-2019) averages (-48.8%). An increased utilization of PCI over CABG was observed in the COVID period (receipt of CABG vs. PCI: OR 0.46 [0.39, 0.53] compared with 2017), consistent across all age groups. No difference in adjusted in-hospital or 30-day mortality was observed between pre-COVID and COVID periods for both PCI (odds ratio (OR): 0.72 [0.51. 1.02] and 0.83 [0.62, 1.11], respectively) and CABG (OR 0.98 [0.45, 2.14] and 1.51 [0.77, 2.98], respectively) groups. CONCLUSION: LM revascularisation activity has significantly declined during the COVID period, with a shift towards PCI as the preferred strategy. Postprocedural mortality within each revascularisation group was similar in the pre-COVID and COVID periods, reflecting maintenance in quality of outcomes during the pandemic. Future measures are required to safely restore LM revascularisation activity to pre-COVID levels.

Racial differences in management and outcomes of acute myocardial infarction during COVID-19 pandemic.

OBJECTIVE: There are concerns that healthcare and outcomes of black, Asian and minority ethnic (BAME) communities are disproportionately impacted by the COVID-19 pandemic. We investigated admission rates, treatment and mortality of BAME with acute myocardial infarction (AMI) during COVID-19. METHODS: Using multisource national healthcare records, patients hospitalised with AMI in England during 1 February-27 May 2020 were included in the COVID-19 group, whereas patients admitted during the same period in the previous three consecutive years were included in a pre-COVID-19 group. Multilevel hierarchical regression analyses were used to quantify the changes in-hospital and 7-day mortality in BAME compared with whites. RESULTS: Of 73 746 patients, higher proportions of BAME patients (16.7% vs 10.1%) were hospitalised with AMI during the COVID-19 period compared with pre-COVID-19. BAME patients admitted during the COVID-19 period were younger, male and likely to present with ST-elevation acute myocardial infarction. COVID-19 BAME group admitted with non-ST-elevation acute myocardial infarction less frequently received coronary angiography (86.1% vs 90.0%, p<0.001) and had a longer median delay to reperfusion (4.1 hours vs 3.7 hours, p<0.001) compared with whites. BAME had higher in-hospital (OR 1.68, 95% CI 1.27 to 2.28) and 7-day mortality (OR 1.81 95% CI 1.31 to 2.19) during COVID-19 compared with pre-COVID-19 period. CONCLUSION: In this multisource linked cohort study, compared with whites, BAME patients had proportionally higher hospitalisation rates with AMI, less frequently received guidelines indicated care and had higher early mortality during COVID-19 period compared with pre-COVID-19 period. There is a need to develop clinical pathways to achieve equity in the management of these vulnerable populations.

Incidence and mortality due to thromboembolic events during the COVID-19 pandemic: Multi-sourced population-based health records cohort study.

BACKGROUND: Evidence supports an excess of deaths during the COVID-19 pandemic. We report the incidence and mortality of thrombo-embolic events (TE) during the COVID-19 pandemic. METHODS: Multi-sourced nationwide cohort study of adults (age ≥18 years) admitted to hospital with TE and deaths from TE in England (hospital and community) between 1st February 2018 and 31st July 2020. Relative risks, adjusted for age, sex, atrial fibrillation, co-morbidities and time trend comparing before and during the COVID-19 pandemic were estimated using Poisson regression. FINDINGS: Of 272,423 patients admitted with TE to 195 hospitals, 86,577 (31.8%) were admitted after 2nd March 2020 (first COVID-19 death in the UK). The incidence of TE hospitalised increased during the COVID-19 pandemic from 1090 to 1590 per 100,000 (absolute risk change 45.9% [95% CI 45.1-46.6%], adjusted relative risk [ARR] 1.43 [95% CI 1.41-1.44]) driven particularly by pulmonary embolism; 1.49, 95% CI 1.46-1.52. TE were more frequent among those with COVID-19; 1.9% vs. 1.6%, absolute risk change 21.7%, 95% CI 21.0-22.4%, ARR 1.20, 95% CI 1.18-1.22. There was an increase in the overall mortality from TE during the pandemic (617, 6.7% proportional increase compared with the historical baseline), with more TE deaths occurring in the community compared with the historical rate (44% vs. 33%). INTERPRETATION: The COVID-19 pandemic has resulted in an increase in the incidence of hospitalised TE. There were more deaths from TE in the community highlighting a number of mechanisms including the hypercoagulable state associated with COVID-19 infection and potential impact of delays in seeking help. RESEARCH IN CONTEXT: Evidence before this study We searched PubMed on 16 November 2020 for articles that documented the incidence and mortality of thrombo-embolic events (TE) during the COVID-19 pandemic using the search terms "COVID-19" OR "Coronavirus*" OR "2019-nCOV" OR "SARS-CoV" AND ("Thromboembolism" OR "Venous Thromboembolism" OR "thromboembol*") with no language or time restrictions. The majority of data on TE in COVID-19 pertains to hospitalised patients from retrospective cohort studies. One study found that TE in hospitalised patients was associated with an increased mortality rate (adjusted hazard ratio 1.82; 95% CI 1.54-2.15). A systematic review and meta-analysis of 35 studies in 9249 hospitalised patients calculated an overall pooled incidence of TE of 17.8% (95% CI: 9.9-27.4%), rising to 22.9% (95% CI: 14.5-32.4%) in patients admitted to intensive care (ICU). The most contemporary data are from a cohort of 1114 patients (715 outpatient, 399 hospitalised, 170 admitted to ICU). With robust COVID-19-specific therapies and widespread thromboprophylaxis the prevalence of venous TE in ICU patients was reported as 7% (n = 12) when catheter-/device-related events were excluded, and among the outpatients there was no TE reported. No published studies have used nationwide data to investigate TE during the pandemic or the effect of the pandemic on outcomes of patients with TE but without Covid-19. Added value of this study This retrospective multi-sourced nationwide unlinked cohort study compares the overall incidence and mortality of TE prior to and during the COVID-19 pandemic. We found an increased incidence of TE despite only a small proportion having a diagnosis of COVID-19. This may highlight the lack of testing, particularly in the community during the initial phase of the pandemic, and the possibility of other factors contributing to TE risk, such as decreased daily activity mandated by home quarantine and alterations in medication concordance. Mortality from TE was higher in the community during the pandemic and this highlights that adverse societal effects of the pandemic, such as aversion to seeking medical assessment, may precipitate worse outcomes related to TE. Implications of all the available evidence Evidence suggests that COVID-19 produces a hypercoagulable state and thromboprophylaxis is recommended in hospitalised patients to prevent excess mortality from TE. Whether to anticoagulate non-hospitalised ambulatory patients with COVID-19 will be answered by ongoing trials. Clinicians should consider the risks posed by decreased daily activity and fear of medical contact, and provide appropriate advice to patients.

Place and Underlying Cause of Death During the COVID-19 Pandemic: Retrospective Cohort Study of 3.5 Million Deaths in England and Wales, 2014 to 2020.

OBJECTIVE: To describe the place and cause of death during the coronavirus disease 2019 (COVID-19) pandemic to assess its impact on excess mortality. METHODS: This national death registry included all adult (aged ≥18 years) deaths in England and Wales between January 1, 2014, and June 30, 2020. Daily deaths during the COVID-19 pandemic were compared against the expected daily deaths, estimated with use of the Farrington surveillance algorithm for daily historical data between 2014 and 2020 by place and cause of death. RESULTS: Between March 2 and June 30, 2020, there was an excess mortality of 57,860 (a proportional increase of 35%) compared with the expected deaths, of which 50,603 (87%) were COVID-19 related. At home, only 14% (2267) of the 16,190 excess deaths were related to COVID-19, with 5963 deaths due to cancer and 2485 deaths due to cardiac disease, few of which involved COVID-19. In care homes or hospices, 61% (15,623) of the 25,611 excess deaths were related to COVID-19, 5539 of which were due to respiratory disease, and most of these (4315 deaths) involved COVID-19. In the hospital, there were 16,174 fewer deaths than expected that did not involve COVID-19, with 4088 fewer deaths due to cancer and 1398 fewer deaths due to cardiac disease than expected. CONCLUSION: The COVID-19 pandemic has resulted in a large excess of deaths in care homes that were poorly characterized and likely to be the result of undiagnosed COVID-19. There was a smaller but important and ongoing excess in deaths at home, particularly from cancer and cardiac disease, suggesting public avoidance of hospital care for non-COVID-19 conditions.