SWEDEHEART: Improving the quality of cardiology care in Sweden and beyond!

The team’s dedication to developing and advancing cardiovascular registries has not only improved the quality of care in Sweden but also paved the way for other national and international registries. The evidence generated has helped answer important clinical questions with global impact and their pioneering work on prospective registry-based randomised clinical trials will have a long-lasting legacy. SWEDEHEART – the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies – was launched in December 2009. It was formed following the merger of RIKS-HIA (Register of Information and Knowledge About Swedish Heart Intensive Care Admissions), SCAAR (Swedish Coronary Angiography and Angioplasty Registry), SEPHIA (National Registry of Secondary Prevention) and the Swedish Heart Surgery Registry.¹ Since then, new subregistries have come under the SWEDEHEART umbrella, promoting the quality of care in other areas including SWENTRY (Swedish Transcatheter Cardiac Intervention Registry) and sections for heart failure, atrial fibrillation/coagulation and cardiogenetics.

Here, Lars Wallentin and Stefan James discuss some of SWEDEHEART’s evolution, aims and achievements:

“When we started the acute cardiovascular care quality registry, RIKS-HIA, in 1995, there were only two of us working with basic computers installed in selected units. In the 2000s, when the internet became widely available, a large group of programmers helped to develop national systems that were continuously available. Registries existed for different areas and we merged these into SWEDEHEART to avoid duplication of efforts and provide a more unified approach.

According to Swedish law, every citizen is entitled to the same care. We have a socialised system, with very little private healthcare, which affords the opportunity for a truly national all-encompassing registry. With SWEDEHEART, we observed wide variations in the numbers of procedures and treatments across centres nationally and differences in mortality. SWEDEHEART data are published in an annual report. It had already been noted that differences between centres persisted over the years. However, when the detailed performance measures were made public, there was a rapid improvement and equalisation in standards of care, especially in poorly performing centres. SWEDEHEART is designed to give immediate feedback. For instance, you can monitor the performance of your centre yesterday compared with last month and compared with other centres. This has been key to driving standards higher and improving care equity. Some people think that healthcare is an art. But it isn’t. It is a system and all healthcare personnel need to take responsibility for that system – to monitor performance and improve themselves and others.

Initially there was a lot of resistance to registry data, but thanks to the rigour of SWEDEHEART, real-world evidence has become increasingly accepted. Over time, the data collected have become more and more useful for science. And so it seems, by collaborating to improve the quality of care, exciting scientific observations can also be made, for example, to further our understanding of different diseases, treatments, devices and so on. Publishing in high-impact journals has never been our main aim but it has been an enlightening spin-off.

Interest in quality-of-care improvements has grown, with other countries such as the UK also setting up continuous national cardiovascular registries. Inspired by SWEDEHEART, the European Society of Cardiology launched EuroHeart (European Unified Registries On Heart Care Evaluation and Randomized Trials) in 2019.² Using SWEDEHEART IT infrastructure, EuroHeart is supporting the development of national registry programmes using standardised variables and datasets to enable the pooling and interrogation of data from participating countries across Europe. In a year or two, we hope to have around 20 countries participating and 200,000 patients per year will be monitored, creating a collaboration that promotes equity of care not only between centres but between countries in Europe. We have come a long way in 30 years!”

“Developing the initial registries into complete national registries and then merging them – bringing together patients with coronary artery disease, with and without interventions, surgical cases and those being followed for secondary prevention – were key steps in the evolution of SWEDEHEART. 

SCAAR itself rose to ‘fame’ internationally when we compared outcomes with drug-eluting stents versus bare-metal stents.³⁴ In our first analysis from 2003 to 2004, we were surprised to observe that drug-eluting stents were associated with higher mortality than bare-metal stents.³ We considered the observational methodology and potential confounding biases, but with such a large signal against drug-eluting stents, we discussed our findings with regulators and the manuscript was published in the New England Journal of Medicine. The original randomised trials had been relatively small and with limitations, and our all-comers registry was able to provide a different perspective. Our observations prompted the community to look at different ways to improve drug-eluting stent implantation including polymer type, drug doses, stent length, implantation techniques, antithrombotic therapies and patient selection. We conducted a second analysis from 2003 to 2006 and showed a similar long-term incidence of death with drug-eluting stents and bare-metal stents.⁴ Although the initial analysis was a shock to us all, we believe results from SCAAR helped to improve safety in the long term. And the reliable variables and ability to perform large analyses in a complete population meant an increased respect for registry findings among the medical community. Data from SWEDEHEART have resulted in more than 500 scientific papers published in high-impact journals that have informed and improved clinical care globally.

Not long after, we conducted SWEDEHEART’s first prospective registry-based randomised trial. We introduced a randomisation module into the SCAAR platform and performed the TASTE (the Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia) trial,⁵ the largest randomised trial of a medical device. Advantages of this approach include broad inclusion criteria to ensure wide clinical applicability, a simplified process to facilitate enrolment, a substantial cost reduction and high rates of follow-up. This pragmatic trial was extremely easy to conduct and very important for two reasons. Firstly, for its scientific findings – we found no benefit of thrombus aspiration – and secondly, equally importantly, we showed it is possible to perform trials in a completely different way. Numerous very large registry-based randomised trials have since been conducted within SWEDEHEART that have changed international guidelines. The concept is being introduced into EuroHeart, with the potential to conduct very large, simple trials rapidly across hundreds of thousands of patients in Europe.

References

1. Jernberg T, et al. Heart. 2010;96:1617–1621.
2. Wallentin L, et al. Eur Heart J. 2019;40:2745–2749.
3. Lagerqvist B, et al. N Engl J Med. 2007;356:1009–1019.
4. James SK, et al. N Engl J Med. 2009;360:1933–1945.
5. Fröbert O, et al. Am Heart J. 2010;160:1042–1048.

 

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