EuroHeart: European Unified Registries On Heart Care Evaluation and Randomized Trials

In July 2019, the ESC Board agreed to co-ordinate and sponsor the development of the European Unified Registries On Heart care Evaluation And Randomized Trials (EuroHeart) for supporting assessment and improvement of quality of cardiovascular care in Europe based on continuous recording of individual patient data. EuroHeart will offer a common IT- and dataset infrastructure, which will allow participating countries to undertake continuous quality improvement, with the added value of providing a platform for observational and randomized research and post-marketing surveillance of new devices and pharmacotherapies. The national quality development programme, infrastructure, and the database will belong to each participating country. The EuroHeart will have the potential to stepwise include most ESC countries, which could either adopt the proposed EuroHeart common infrastructure or align already existing systems to the EuroHeart data collection. The EuroHeart project will focus on common disease areas: ACS-PCI, valve disease, heart failure, and atrial fibrillation. Initially, EuroHeart will develop standardized datasets and quality indicators for these diseases and devices. In parallel, the SWEDEHEART IT-platform will be updated to be internationally available and transferable, under a license agreement, to participating countries. During the first 2 years, the EuroHeart system will be implemented and evaluated in 2–4 countries. Following this pilot phase, the EuroHeart project may be rolled out to other countries. EuroHeart will also develop a Data Science Centre coordinating similar statistical analyses from participating countries. When implemented in several ESC member countries, EuroHeart will have the potential to improve the standards of cardiovascular care, monitor the safety of new devices and medications, and provide an important collaborative infrastructure for observational research and within-registry randomized controlled trials. Major advances in cardiovascular medicine have been driven by innovations in basic research in biological and technical sciences. The subsequent testing in prospective randomized controlled trials (RCT) has provided the evidence underpinning the introduction of new, more effective, and safer treatments. In 2009, the ESC launched the EuroObservational Research Programme (EORP) which aimed to promote and monitor the implementation of new treatments as well as the adherence to the ESC Clinical Practice Guidelines. The EORP provides important information on the development of the treatment of cardiovascular disease in Europe but has been criticized concerning data quality, representativeness and coverage regarding common diseases. In 2018, it was agreed that there was a need to further develop ESC-generated observational data and simultaneously expand the scope of the registry programme to also include a quality development programme, long-term monitoring of medical devices and pragmatic RCTs and under instruction of the ESC Board, the principles and pilot phase of European Unified Registries On Heart care Evaluation And Randomized Trials (EuroHeart) project were developed in 2019. This article presents a summary of the EuroHeart programme. For rare cardiovascular diseases, EORP constitutes a unique programme of observational research, providing greater understanding of uncommon cardiac diseases and the effects of associated treatments.1–4 However, when applied to common cardiovascular diseases, EORP has been criticized with regard to the quality, representativeness, and coverage of the data at the hospital, country, and European level, partly because the EORP programme records data from a limited number of selected hospitals over short periods of time in each participating country.5–7 There was also the perception that such data collection would be undertaken for the ESC with limited return to the contributing centres and countries. In contrast, continuous individual patient data collection in a large number of hospitals in each country would provide reliable, representative, and generalizable data, which would help the development and monitoring of quality of care programmes at the hospital level both in each country and across different countries, as well as provide an infrastructure for observational research, long-term safety surveillance, and RCTs. Such opportunities are aligned with the ESC’s mission to reduce the burden of cardiovascular disease and address three out of the four strategic trends identified in the strategic plan for 2016–20, that is, technology revolution; globalization, and geographic reach; and the even more stringent regulatory environment. The advantages of continuous national registries aiming to support continuous quality improvement at the hospital and country level have been demonstrated by the Swedish, and more recently, the UK models. These systems use continuous data collection and provide online reports focusing on the processes of care and outcomes concerning common cardiovascular diseases and interventions.8,9 These registry models have an established track record of substantially improving quality of care, resulting in improved outcomes, which has been documented in numerous publications in high-impact journals.10–15 The ESC, therefore, plans to support a programme for continuous data collection of standardized and/or harmonized variables in common cardiovascular diseases and devices using IT-systems that provide immediate feedback to the users in order to monitor and influence quality of care on a day-by-day basis. Over the last decade, there has been an increase in the development and use of new implantable devices for the treatment of cardiovascular diseases. The level of evidence required to obtain regulatory approval for new devices will increase substantially in the forthcoming years. Furthermore, the new European Regulation on Medical Devices mandates that new devices will require post-marketing surveillance for safety and efficacy. Ideally, this should be conducted independently by an academic body or professional medical association, with comprehensive coverage. We believe that continuous national disease-focused registries, coordinated by the ESC, would significantly contribute to post-marketing surveillance of devices, improving quality, being independent, and with reduced costs.16,17 In recent years, there has been a considerable reduction in the development of new drugs for cardiovascular diseases.18 This is partly due to the perception that the price payers would be willing to pay for agents that are expected to yield a moderate beneficial effect on a large number of eligible patients would not bring sufficient financial gains to industry, given the spiralling costs associated with bringing a new drug to the market. In particular, the current complex regulatory environment has contributed to increasing the cost of RCTs manyfold. The ESC believes that access systems with continuous registration of high quality, harmonized patient data at entry and over time, for different diseases across multiple geographies, will allow for performing more pragmatic randomized trials in the general patient populations while substantially reducing the cost burden, as demonstrated by SWEDEHEART.19–21 The key to success of national continuous quality registries is establishing a network of hospitals and healthcare personnel with a culture focused on continuous learning and quality development. To maintain engagement and enthusiasm, the registries need to provide non-selective, continuous monitoring and on-line feedback of patient characteristics, processes of care, and health outcomes. Another important component is the implementation of a reliable, user-friendly informatics infrastructure to support data entry and immediate online feedback on performance including both system- and custom-designed tabular and graphical comparisons over time, with other similar centres and with guidelines. A third important option is the opportunity to obtain long-term outcomes in all patients by merging the data with public registries on vital status, causes of death, hospital admissions, records from general practice, pharmaceutical prescriptions, and eventually patient-related outcome measurements. A fourth component is the access to an advanced epidemiology and statistical data centre ensuring a scientifically robust assessment of the strength of the associations between treatment strategies and health outcomes. Finally, a fifth important part is dissemination of the results through publication in major cardiovascular journals, followed by their inclusion in national and international guidelines, which might lead to changes in treatments and improved outcomes. To date, the Swedish and UK continuous national cardiovascular registries have: Continuously monitored and supported improvements in the quality of cardiovascular care at individual centres and nationwide.9–12 Conducted novel observational research based on long-term follow-up of outcomes in all patients; e.g., concerning temporal and spatial variation in care and outcomes; associations between exposure (environmental/pharmacotherapies) and cardiovascular outcomes; international comparisons of care; development and validation of prognostic models and indicators of quality; and burden of disease in specific populations.9–15 Shown that implementation of new effective treatments is associated with a reduction in the mortality and morbidity of patients with acute myocardial infarction.10–15 Enabled continuous safety surveillance of PCI and valve devices including comparisons of outcomes of different devices and patients managed with and without devices (Sweden).16,17 Performed registry-based randomized controlled trials (RRCTs) that have changed international treatment guidelines and improved health outcomes and cost-effectiveness of healthcare concerning indications for invasive coronary treatments, types of coronary stents, medical treatments in ACS, and the routine use of oxygen (Sweden).19–21 Briefly, the Swedish national cardiology quality registries have established an infrastructure with continuous and online recording of data and immediate feedback concerning processes of care and outcomes on all patients. The associated IT-platform generates both system- and custom-designed user-friendly tabular and graphic reports on processes and changes of care and outcomes for each user, whenever requested.5,6 The system includes information on all implanted devices in enough detail to fulfil the regulatory requirements. Thereby the system can monitor the technical performance of the implanted devices and provide safety surveillance also concerning health outcomes with different devices.5,6 Finally, the infrastructure also includes an application for prospective RRCT, which can be integrated in different registries and may also be combined with more conventional collection of follow-up data in so-called hybrid trials (combining technologies both from RCT and RRCT).8,9 EuroHeart is a new ESC initiative for supporting continuous quality of care development based on individual patient data. The main aims are to support continuous quality of care improvement and provide an infrastructure for observational and randomized research and safety surveillance of new devices and drugs. EuroHeart will be an ESC coordinated programme, which will support the development of national/local registry programmes using a common dataset and where the national infrastructure and database will belong to the respective participating country (Figure 1). EuroHeart will, as an option, provide an IT- and dataset infrastructure to allow participating countries to undertake continuous quality improvement, with the added value of being able to perform collaborative observational and randomized research and the post-marketing surveillance of new devices and pharmacotherapies. The system will address the common disease areas: ACS-PCI, valve disease, heart failure, and atrial fibrillation and the devices used in these conditions. Illustration of the EUROHEART network based on ESC co-ordinated national quality registers with collaboration standardized datasets, device surveillance, registry-based randomized controlled trial, and with an option to use a common IT-infrastructure and access to the EUROHEART data science centre. Illustration of the EUROHEART network based on ESC co-ordinated national quality registers with collaboration standardized datasets, device surveillance, registry-based randomized controlled trial, and with an option to use a common IT-infrastructure and access to the EUROHEART data science centre. EuroHeart has the potential to include most ESC country members through stepwise implementation. Given a harmonized methodology for the collection of standardized data, EuroHeart will enable the pooling and interrogation of data from participating countries. Moreover, this approach has the potential to improve cost efficiency both at the country level and at the European level. Notably, EuroHeart is completely aligned with the ESC mission to reduce the burden of cardiovascular disease. Acting as the project sponsor, the ESC will create and support the EuroHeart organization, which will work with national cardiac societies and/or other local stakeholders on the development and deployment of an efficient and harmonized infrastructure for running continuous quality registries. Presently around 20 countries have indicated an interest in developing a similar infrastructure and participate in the EuroHeart project. During the first 2 years, the plan is to perform a pilot phase by implementing the international version of the EuroHeart system and IT-platform in 2–4 countries (Figure 2). The selection of the countries will be based on the availability of dedicated national champions working with a network of hospitals willing to join and invest time and efforts in the quality registry programme and with the potential to develop and sustain an administrative and IT-infrastructure primarily based on their own national resources. Participating countries will also need to have a public healthcare system based on personal identifiers with an option to get information on long-term clinical outcomes through linkage of their data with other databases. There will also be a requirement of the pilot countries to have support from the local health authorities and preferably also from the governments. EUROHEART—pilot phase overview. EUROHEART—pilot phase overview. The pilot phase will investigate the possibility of promoting and facilitating the adoption of the continuous national registry model, as developed by SwedeHeart, for data acquisition, quality development, device surveillance, and RRCTs on major cardiovascular disease areas across several of the ESC countries. After this pilot study, the EuroHeart project may be rolled out to other countries. Representatives from the participating and interested countries will be involved from the very beginning in the development of EuroHeart and be members of the different subcommittees. EuroHeart will be organized as an ESC coordinated collaboration between national quality registries of cardiovascular diseases where all members are autonomous parts of the system controlling their own registry infrastructure, their IT-platform, their databases and all national activities (Figure 1). The executive committee coordinating the scheduled activities in the pilot phase is presented in Figure 3. EuroHeart—pilot phase organization. EuroHeart—pilot phase organization. Initiate, support, and co-ordinate the development of national continuous quality registry infrastructures. Provide a common dataset of standardized variables and quality indicators for common cardiovascular diseases for use in the national registries. Provide an optional IT-infrastructure for quality registries [e.g. the QReg5 platform developed and maintained in Uppsala Clinical Research Center (UCR), Sweden] providing tools for local quality development, data management, local statistical analyses, device monitoring, and registry-based clinical trials. Support the development and analyses of common datasets by providing tools for preparing national datasets of predefined variables for use in collaborative analyses. Establish a data science centre (IT system and platform) that will co-ordinate and support the statistical analyses and reporting of results from common datasets based on initiatives from any of the participants in the collaborative group. Establish a support organization that ensures the sustainability of EuroHeart over time. The ESC decision to co-ordinate and sponsor the development of the EuroHeart registry system is a change of paradigm on how to further reduce the burden of cardiovascular disease with large geographic reach in an era of IT-technology revolution but often unsurmountable costs of clinical trials and an increasingly stringent regulatory environment. When implemented in several ESC member countries, EuroHeart will have the potential to continuously improve the standards of cardiovascular care, monitor the safety of new devices and medications, and provide an important collaborative infrastructure for observational research and RCTs. Conflict of interest: none declared. References are available as supplementary material at European Heart Journal online.