https://orcid.org/0000-0003-0748-0150
Abstract
The European Unified Registries On Heart Care Evaluation and Randomized Trials (EuroHeart) aims to improve the quality of care and clinical outcomes for patients with cardiovascular disease. The collaboration of acute coronary syndrome/percutaneous coronary intervention (ACS/PCI) registries is operational in seven vanguard European Society of Cardiology member countries.
Adults admitted to hospitals with ST-elevation myocardial infarction (STEMI) and non-ST-elevation myocardial infarction (NSTEMI) are included, and individual patient-level data collected and aligned according to the internationally agreed EuroHeart data standards for ACS/PCI. The registries provide up to 155 variables spanning patient demographics and clinical characteristics, in-hospital care, in-hospital outcomes, and discharge medications. After performing statistical analyses on patient data, participating countries transfer aggregated data to EuroHeart for international reporting. Between 1st January 2022 and 31st December 2022, 40 021 admissions (STEMI 46.7%, NSTEMI 53.3%) were recorded from 192 hospitals in the seven vanguard countries: Estonia, Hungary, Iceland, Portugal, Romania, Singapore, and Sweden. The mean age for the cohort was 67.9 (standard deviation 12.6) years, and it included 12 628 (31.6%) women.
The EuroHeart collaboration of ACS/PCI registries prospectively collects and analyses individual data for ACS and PCI at a national level, after which aggregated results are transferred to the EuroHeart Data Science Centre. The collaboration will expand to other countries and provide continuous insights into the provision of clinical care and outcomes for patients with ACS and undergoing PCI. It will serve as a unique international platform for quality improvement, observational research, and registry-based clinical trials.
Introduction
Ischaemic heart disease is the leading cause of morbidity and mortality among patients with cardiovascular disease (CVD) in Europe, accounting for over 70 million disability-adjusted life years annually.1 Evidence-based therapies, including percutaneous coronary intervention (PCI) and secondary preventive treatment are associated with improved outcomes for patients with acute coronary syndromes (ACS).2–5 However, there is variation in the provision of guideline-indicated care for patients with ACS between and within countries.6–9 Identifying and quantifying this variation in practice helps to guide improvement efforts, but previous work relied on retrospective data collection or lacked standardized definitions of CVD and individual patient-level data.
The European Unified Registries On Heart Care Evaluation and Randomized Trials (EuroHeart) was established by the European Society of Cardiology (ESC) in 2019 to address this unmet need.10 Using internationally endorsed, standardized clinical variables and their definitions, as well as aligned data collection across countries, EuroHeart has established a collaboration of national registries for continuous prospective data collection on patients with ACS or those undergoing PCI.11 These registries will serve as national platforms for quality improvement, and their collaboration will provide a European infrastructure for quality enhancement, observational research, and registry-based clinical trials.
Aim
The EuroHeart ACS/PCI registries collaboration aims to support the improvement of quality of care by establishing a collaboration of national quality registries that prospectively collects structured individual participant data for baseline demographics, clinical characteristics, treatments, hospitalized events, and parameters for calculating the ESC acute myocardial infarction quality indicators.12 The European Unified Registries On Heart Care Evaluation and Randomized Trials will provide a European infrastructure for quality improvement, observational research, and registry-based clinical trials across Europe.
Quality of care interventions
To date, seven countries have submitted data: Estonia, Hungary, Iceland, Portugal, Romania, Singapore, and Sweden. Denmark, Lithuania, Ireland, and Italy plan to submit data in the near future.
Setting
For the calendar year 2022, data were submitted from 192 hospitals across seven countries: Estonia (n = 1), Hungary (n = 80), Iceland (n = 1), Portugal (n = 22), Romania (n = 15), Singapore (n = 1), and Sweden (n = 72), Figure 1.
Geoplot of ACS admissions in EuroHeart countries.
There is variation in the extent of coverage by country because not all countries are able to provide consecutive patient entry nationwide. For example, Estonia submitted data from one of its two major tertiary centres, covering approximately 70% of ACS admissions within the country. Hungary submitted data from 80 of the 90 hospitals that provide care for patients with ACS, covering around 86% of within-country patient admissions. Portugal submitted data from 22 of its 59 hospitals, while Sweden reported 100% within-country patient admissions from hospitals providing ACS care. Iceland submitted data from the one major tertiary cardiac centre. Romania submitted data from 15 of its 21 hospitals included in the emergency PCI network, covering approximately 25% of all ACS admissions, and Singapore provided data from one of its eight public hospitals, accounting for about 20–30% of all ACS admissions.
Population and consent
Participating centres from each country record admissions for eligible patients with a final diagnosis of ST-segment elevation myocardial infarction (STEMI) or non-ST-elevation myocardial infarction (NSTEMI) according to the universal definition of myocardial infarction.13,14 Consent from patients is obtained according to local policies and co dinated by participating countries.
In 2022, data from 40 021 admissions with STEMI (46.7%) and NSTEMI (53.3%) were submitted from the seven vanguard countries. This included patients who received emergency, and not elective, PCI. The mean age for the cohort was 68.9 years (standard deviation 12.6 years), 32% were women, and nearly half (46%) of all participants were current or former smokers. The most common co-morbidity amongst ACS admissions was hypertension (67.9%), followed by a history of diabetes mellitus (28%), previous history of PCI (20.2%), heart failure (10.2%), and moderate to severe chronic kidney disease (7.5%).
Start points
All adult patients admitted to hospital with a myocardial infarction according to the fourth universal definition of myocardial infarction, with or without ST-segment elevation,13,14 are eligible for inclusion. Patients under the age of 18 years are excluded.
Patient identification
Individual patient-level data are stored and handled at the national level in accordance with local, national, and European Union regulations and legislation. Individual participant data are not egressed. With country-level permission, de-identified aggregated results of agreed analyses from participating countries are transferred to the EuroHeart Data Science Group based at the University of Leeds, UK.
Baseline and follow-up data
The underlying premise is that data are collected according to, or post-process aligned with, the EuroHeart internationally endorsed clinical variables with standardized data definitions for ACS/PCI.11 The methods detailing the construction and selection of the variables and their definitions have been published previously.15
Baseline data cover the patient journey from ‘call for help’ to discharge from hospital for patients admitted with ACS. Data include patient characteristics and comorbidities (such as age, sex, smoking status, and past medical history, including hypertension, diabetes, previous myocardial infarction, previous PCI, and coronary artery bypass grafting surgery); admission details (including systolic blood pressure, heart rate, creatinine, Killip class, cardiac arrest, and time from symptom onset to hospital admission); in-hospital care (including provision of primary PCI, thrombolysis, time from initial diagnostic ECG to reperfusion, proportion of eligible patients in whom PCI was provided within 90 min of the initial diagnostic ECG, proportion with a radial artery approach, and median length of stay); clinical outcomes (including compilations such as re-infarction, cardiogenic shock, cardiac arrest, major bleeding, new onset atrial fibrillation or flutter [AF], and in-hospital mortality); and medications at discharge [e.g. angiotensin converting enzymeinhibitors, angiotensin receptor blockers, or angiotensin receptor/neprilysin inhibitor; beta blockers; aspirin, P2Y12 inhibitor (clopidogrel, prasugrel, and ticagrelor), statins, ezetimibe, PCSK9 inhibitors, glucagon-like peptide 1 agonists, and sodium-glucose co-transporter-2 inhibitors].
Clinical care is appraised though benchmarking against the ESC Quality Indicators for ACS and includes: reperfusion time for STEMI patients, time between symptom onset and arterial access in STEMI, angiography timing in NSTEMI patients, radial access for angiography, appropriate investigations for ACS before discharge, and the proportion of patients discharged with appropriate medical care.12
The EuroHeart Data Science Group reviews those variables to be reported from the aggregated data provided by the participating countries annually. This is to ensure they are in line with contemporary guidelines and practice, and so that the planned aggregation of data is pre-specified within a statistical analysis plan, which is also reviewed annually and in consultation with the National Leaders and the EuroHeart Executive Committee.
Data capture and storage
Data are collected prospectively by local clinical staff at each hospital within each country and entered into a national IT platform which might be based on a registry IT platform licensed from EuroHeart. All handling and analyses of individual participant-level data are performed within the respective country and at the national level. For the 2022 cohort, numbers were aggregated by final diagnosis (STEMI/NSTEMI), age category (<50, 50–54, 55–59, 60–64, 65–69, 70–74, 75–79, 80–84, and ≥85 years), and sex (male/female).
Data quality
The transferred aggregated data are reviewed by the EuroHeart data scientists, statisticians, and clinical experts before further analysis. The results of the analysis are then shared with the participating country prior to inclusion in a report (see https://www.escardio.org/Research/euroheart/EuroHeart-News-and-Publications for the latest EuroHeart report). For countries that have implemented the EuroHeart IT platform, data completeness, internal consistency, and validity are monitored through underlying programming that alerts users to implausible entries and missing data.
Endpoints and linkage to other data
The in-hospital endpoints collected are re-infarction, major bleeding, cardiac arrest, cardiogenic shock, and mortality.
European Unified Registries On Heart Care Evaluation and Randomized Trials has designed a bespoke Cardiovascular Outcomes Domain that will define longitudinal clinical events relating to the four EuroHeart cardiovascular data standards domains.11,16–18
Access to data
Individual patient level data in the participating national registries are stored by each participating registry at the national level in accordance with national and international regulations and legislation. Permission for access to the aggregated data resides with the ESC.
Conclusion
The EuroHeart collaboration of ACS/PCI registries prospectively collects data for patients with STEMI and NSTEMI, and for 2022, it covered over 40 000 ACS admissions from seven ESC member countries. The initial results are reported for ACS only, with incomplete coverage of the seven countries. However, there are plans for expansion of EuroHeart registries to additional countries and cardiovascular conditions over time, and this unique international infrastructure will provide novel insights into the quality of care for patients by facilitating quality improvement, observational research, and registry-based clinical trials.
Acknowledgements
Many thanks to the national cardiac societies of Denmark, Estonia, Hungary, Iceland, Italy, Lithuania, Portugal, Republic of Ireland, Romania, Singapore, and Sweden for their support and commitment to EuroHeart. We are grateful to the staff and board of the ESC, and the ESC Working Groups and Associations, including: Association of Cardiovascular Nursing and Allied Professions (ACNAP), Association for Acute CardioVascular Care (ACVC), European Association of Percutaneous Cardiovascular Interventions (EAPCI), EURObservational Research Programme (EORP) committee, ESC Patient forum, Working Group on Thrombosis, and Committee for Young Cardiovascular Professionals. We gratefully acknowledge the work of the project manager (Catherine Reynolds) and data manager (Sam Chappell) of the Data Science Group. Pilot phase (up to June 2022) industry partners: Astra Zeneca AB, Daiichi Sankyo Europe GmbH, Amgen (Europe) GmbH, Novartis Pharma AG, Edwards Lifesciences, Boehringer Ingelheim, Swedish Heart Lung Foundation, Janssen Global Services LLC, Bayer AG, and Medtronic International Trading SARL. Consolidation phase (since October 2022) industry partners: Astra Zeneca AB, Boehringer Ingelheim, Novartis Pharma AG, Roche, Swedish Heart Lung Foundation, and Bayer AG.
Funding
Participating countries fund data entry and local collation. The EuroHeart project is funded through the ESC by external sponsors and foundations (detailed below).
Data availability
The data underlying this article will be shared on reasonable request to the corresponding author.
Conflict of interest: There are no declarations with respect to this manuscript. A.B., D.E., I.J.G., þ.J.H., I.J.I., A.J., P.V., and L.W. have nothing to declare. Outside this work, C.W. reports unpaid roles with EHJ Quality of Care and Clinical Outcomes (Associate Editor) and NICE Indicator Advisory Committee (standing member). G.B. reports institutional research grants from the Swedish Heart Lung Foundation, AstraZeneca, and Pfizer; consulting fees from Bayer; honoraria for lectures from AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Pfizer, and Sanofi. J.A. reports payment for lectures from Boehringer Ingelheim, AstraZeneca, MSD, Bayer, and Novartis; advisory board reimbursements from AstraZeneca and Novartis. J.F. reports consulting fees from Boehringer Ingelheim; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Amgen and Bayer; support for attending meetings and/or travel from Amgen; participation on a Data Safety Monitoring Board or Advisory Board from Boehringer Ingelheim, Merck, Sharp Dohme, and Novartis; leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid from the Steering Committees of VESALIUS-CV, OCEAN(a) Outcomes, VICTORION-2-Prevent, ESSENCE CS9, and LIBREXIA-AF. A.I. reports grants from Novartis, Abbott, and Medtronic; support for attending meetings and/or travel from Abbott and Medtronic; leadership or fiduciary role in other board, society, committee or advocacy group, and paid or unpaid from the Estonian Society of Cardiology; other financial or non-financial interests as a part-time employee of the Estonian Agency of Medicines. Z.J. reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Bayer, Boehringer, Pfizer, Richter Gedeon, Egis, Krka, Berlin-Chemie/Menarini, and Novo Nordisk; support for attending meetings and/or travel from Egis; participation on a data safety monitoring board or advisory board from Novo Nordisk and AstraZeneca; leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid from the European Society of Hypertension, the Hungarian Society of Hypertension, and the Hungarian Society of Cardiology. B.A.P. reports speaker fees from GE Healthcare and Hitachi Aloka Medical; receipt of equipment, materials, drugs, medical writing, gifts, or other services from GE Healthcare and Hitachi Aloka Medical. M.S. reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Edwards, Boston, Daiichi Sankyo, Biotronik, Abbott, and Bayer; support for attending meetings and/or travel from Daiichi Sankyo, Medinfar, and Medtronic. D.V. reports research grants from Boehringer Ingelheim and CeleCor; consulting fees from Boehringer Ingelheim and Bayer. J.Y. reports research grants from Singhealth Cardiovascular ACP; speaker's honorarium from Abbott, Biosensors, Biotronik, Boston Scientific, Edwards, GE healthcare, JJ, Kaneka, Medtronic, and Terumo; patents planned, issued, or pending for Ecg and Pcg Monitoring System for Detection of Heart Anomaly; leadership or fiduciary role in other board, society, committee or advocacy group, and paid or unpaid from the Singapore Cardiac Society; other financial or non-financial interests as an editorial board member for the Journal of Asian Pacific Society of Cardiology (JAPSC); this did not influence peer review. A.P.M. reports fees for participation on a data safety monitoring board or advisory board from Bayer; paid or unpaid leadership or fiduciary role in other board, society, and committee or advocacy group from AstraZeneca, Novartis, and Sanofi. B.C. reports other financial or non-financial interests as the Co-chair of the Executive Committee of EuroHeart (not remunerated). C.P.G reports grants or contracts from the Alan Turing Institute, British Heart Foundation, National Institute for Health Research, Horizon 2020, Abbott Diabetes, Bristol–Myers Squibb, and European Society of Cardiology; consulting fees from AI Nexus, AstraZeneca, Amgen, Bayer, Bristol–Myers Squibb, Boehringer Ingelheim, Cardiomatics, Chiesi, Daiichi Sankyo, GPRI Research B.V., Menarini, Novartis, iRhythm, Organon, and The Phoenix Group; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from AstraZeneca, Boston Scientific, Menarini, Novartis, Raisio Group, Wondr Medical, and Zydus; support for attending meetings and/or travel from AstraZeneca; participation on a data safety monitoring board or advisory board from DANBLOCK trial, TARGET CTCA trial; leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid from EHJ Quality of Care and Clinical Outcomes (Deputy Editor), NICE Indicator Advisory Committee, and ESC Quality Indicator Committee (Chair); stock or stock options from Cardiomatics; receipt of equipment, materials, drugs, medical writing, gifts, or other services from EchoNous.
