Standardised and hierarchically classified heart failure and complementary disease monitoring outcome measures: european Unified Registries for heart Care evaluation and randomised trials (EuroHeart)

Asad Bhatty; Chris Wilkinson; Gorav Batra; Suleman Aktaa; Adam B Smith; Ali Wahab; Sam Chappell; Joakim Alfredsson; David Erlinge; Jorge Ferreira; Ingibjörg J Guðmundsdóttir; Þórdís Jóna Hrafnkelsdóttir; Inga Jóna Ingimarsdóttir; Alar Irs; András Jánosi; Zoltán Járai; Manuel Oliveira-Santos; Bogdan A Popescu; Peter Vasko; Dragos Vinereanu; Jonathan Yap; Raffaele Bugiardini; Edina Cenko; Ramesh Nadarajah; Matthew R Sydes; Stefan James; Aldo P Maggioni; Lars Wallentin; Barbara Casadei; Chris P Gale

doi:10.1093/ehjqcco/qcae086

Standardised and hierarchically classified heart failure and complementary disease monitoring outcome measures: european Unified Registries for heart Care evaluation and randomised trials (EuroHeart)

Eur Heart J Qual Care Clin Outcomes. 2024 Oct 9:qcae086. doi: 10.1093/ehjqcco/qcae086. Online ahead of print.

Authors

Asad Bhatty^{1

2

3}, Chris Wilkinson^{4

5}, Gorav Batra⁶, Suleman Aktaa^{1

3}, Adam B Smith^{1

2}, Ali Wahab^{1

2

3}, Sam Chappell^{1

2}, Joakim Alfredsson⁷, David Erlinge⁸, Jorge Ferreira⁹, Ingibjörg J Guðmundsdóttir^{10

11}, Þórdís Jóna Hrafnkelsdóttir^{10

11}, Inga Jóna Ingimarsdóttir^{10

11}, Alar Irs¹², András Jánosi¹³, Zoltán Járai¹⁴, Manuel Oliveira-Santos¹⁵, Bogdan A Popescu¹⁶, Peter Vasko⁷, Dragos Vinereanu¹⁶, Jonathan Yap¹⁷, Raffaele Bugiardini¹⁸, Edina Cenko¹⁸, Ramesh Nadarajah^{1

2

3}, Matthew R Sydes^{19

20

21}, Stefan James⁶, Aldo P Maggioni¹⁸, Lars Wallentin⁶, Barbara Casadei²², Chris P Gale^{1

2

3}

Affiliations

¹ Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
² Leeds Institute for Data Analytics, University of Leeds, Leeds, UK.
³ Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
⁴ Hull York Medical School, University of York, York, UK.
⁵ Academic Cardiovascular Unit, South Tees NHS Foundation Trust, James Cook University Hospital, Middlesbrough, UK.
⁶ Department of Medical Sciences, Cardiology and Uppsala Clinical Research Centre, Uppsala University, Uppsala, Sweden.
⁷ Linköping University Hospital, Linköping, Sweden.
⁸ Lund University, Sweden.
⁹ Hospital de Santa Cruz, Centro Hospitalar de Lisboa Ocidental, Portugal.
¹⁰ Department of Cardiology, Landspitali University Hospital, Reykjavik, Iceland.
¹¹ Department of Health Sciences, Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
¹² Tartu University Hospital, Estonia.
¹³ György Gottsegen National Cardiovascular Institute, Hungary.
¹⁴ South Buda Center Hospital, Szent Imre Teaching Hospital, Hungary.
¹⁵ Cardiology Department, Unidade Local de Saúde de Coimbra, Portugal.
¹⁶ University of Medicine and Pharmacy Carol Davila, Emergency Institute for Cardiovascular Diseases, Bucharest, Romania.
¹⁷ National Heart Centre Singapore, Singapore.
¹⁸ ANMCO Research Centre, Heart Care Foundation, 50121 Florence, Italy.
¹⁹ MRC Clinical Trials Unit at UCL, University College London, London, UK.
²⁰ BHF Data Science Centre, Health Data Research UK, HDR UK, London, UK.
²¹ Data for R&D Programme, NHS England, London, UK.
²² Division of Cardiovascular Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford.

PMID: 39384575
DOI: 10.1093/ehjqcco/qcae086

Abstract

Aims: The lack of standardised definitions for heart failure outcome measures limits the ability to reliably assess effectiveness of heart failure therapies. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) aimed to produce a catalogue of internationally endorsed data definitions for heart failure outcome measures.

Methods: Following the EuroHeart methods for the development of cardiovascular data standards, a working group was formed of representatives from the European Society of Cardiology Heart Failure Association and other leading heart failure experts. A systematic review of observational and randomised clinical trials identified current outcome measures, which was supplemented by clinical practice guidelines and existing registries for contemporary definitions. A modified Delphi process was employed to gain consensus for variable inclusion and whether collection should be mandatory (Level 1) or optional (Level 2) within EuroHeart. In addition, a set of complementary outcome measures were identified by the Working Group as of scientific and clinical importance for longitudinal monitoring for people with heart failure.

Results: Five Level 1 and two Level 2 outcome measures were selected and defined, alongside five complementary monitoring outcomes for patients with heart failure.

Conclusion: We present a structured, hierarchical catalogue of internationally endorsed heart failure outcome measures. This will facilitate quality improvement, high quality observational research, registry-based trials, and post market surveillance of medical devices.