A structured, tiered catalogue of standards for heart failure outcome measures has been developed through a major international collaboration, harmonising long-standing inconsistencies that have hindered research, quality improvement and regulatory assessment.
Led by the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart), in partnership with the European Society of Cardiology’s Heart Failure Association and 42 specialists from 16 countries, the study aimed to standardise clinical data collection, define the most clinically relevant heart failure outcomes, and establish a robust foundation for future observational studies, registry-based trials and post-marketing device surveillance.
Using robust EuroHeart methodology, a systematic review of literature published between 1 January 2000 and 7 September 2023 identified 4,728 studies, of which 861 met the inclusion criteria.
From 176 heart failure studies, 34 candidate outcome measures were extracted. These measures were supplemented with definitions from existing registries, clinical guidelines and consensus documents. A modified Delphi process was then used to gain consensus on the most important measures.
Standards for heart failure outcomes
Five Level 1 mandatory outcome measures were selected for use across all EuroHeart registries, including left ventricular ejection fraction, all-cause hospitalisation, heart failure hospitalisation, left ventricular assist device implantation and heart transplantation.
Device implantation and resuscitated ventricular tachyarrhythmia were designated Level 2 optional outcomes, reflecting their clinical relevance but variable applicability across centres.
The authors also endorsed five complementary monitoring outcomes to support longitudinal disease monitoring and real-world research, including atrial fibrillation subtype, N-terminal pro-B-type natriuretic peptide levels, estimated glomerular filtration rate, change in left ventricular ejection fraction, and New York Heart Association class.
These measures aligned with, but also extended beyond, previous frameworks, including the Academic Research Consortium definitions. Unlike earlier efforts, the EuroHeart set incorporated hierarchical grading to clarify relative priorities and introduced monitoring variables, including left ventricular ejection fraction recovery and the interplay between atrial fibrillation and heart failure. Both underscore the value of consistent serial measurement and might serve as surrogate markers of disease progression or treatment response, the authors said.
Continuous improvements in care
Although a systematic review informed the outcome definitions, the final selection relied on expert consensus and may therefore reflect selection bias, although the expert working group did represent a broad geographic and professional range. Patient involvement was limited to later review rather than participation in the voting process and the remit did not extend to patient-reported outcome measures, despite the growing recognition of their importance, the authors noted.
It is hoped that the unified outcome definitions will drive continuous improvements in patient care for heart failure. The authors emphasised that adopting these standardised measures would facilitate more consistent benchmarking, support international quality improvement initiatives, and strengthen the external validity of research.
Reference
Bhatty A et al. Standardized 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 Clin Outcomes 2025;11:900–9.