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. 2023 Sep 12;9(6):609-620.
doi: 10.1093/ehjqcco/qcac068.

Data standards for atrial fibrillation/flutter and catheter ablation: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)

Gorav Batra  1 , Suleman Aktaa  2 , A John Camm  3 , Francisco Costa  4 , Luigi Di Biase  5 , David Duncker  6 , Laurent Fauchier  7 , Nikolaos Fragakis  8 , Lars Frost  9 , Ziad Hijazi  1 , Tord Juhlin  10 , José L Merino  11 , Lluis Mont  12 , Jens C Nielsen  13 , Jonas Oldgren  1 , Anna Polewczyk  14 , Tatjana Potpara  15 , Frederic Sacher  16 , Philipp Sommer  17 , Roland Tilz  18 , Aldo P Maggioni  19 , Lars Wallentin  1 , Barbara Casadei  20 , Chris P Gale  2
Affiliations

Data standards for atrial fibrillation/flutter and catheter ablation: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart)

Gorav Batra et al. Eur Heart J Qual Care Clin Outcomes. .

Abstract

Aims: Standardized data definitions are essential for monitoring and assessment of care and outcomes in observational studies and randomized controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart) project of the European Society of Cardiology aimed to develop contemporary data standards for atrial fibrillation/flutter (AF/AFL) and catheter ablation.

Methods and results: We used the EuroHeart methodology for the development of data standards and formed a Working Group comprising 23 experts in AF/AFL and catheter ablation registries, as well as representatives from the European Heart Rhythm Association and EuroHeart. We conducted a systematic literature review of AF/AFL and catheter ablation registries and data standard documents to generate candidate variables. We used a modified Delphi method to reach a consensus on a final variable set. For each variable, the Working Group developed permissible values and definitions, and agreed as to whether the variable was mandatory (Level 1) or additional (Level 2). In total, 70 Level 1 and 92 Level 2 variables were selected and reviewed by a wider Reference Group of 42 experts from 24 countries. The Level 1 variables were implemented into the EuroHeart IT platform as the basis for continuous registration of individual patient data.

Conclusion: By means of a structured process and working with international stakeholders, harmonized data standards for AF/AFL and catheter ablation for AF/AFL were developed. In the context of the EuroHeart project, this will facilitate country-level quality of care improvement, international observational research, registry-based RCTs, and post-marketing surveillance of devices and pharmacotherapies.

Keywords: Atrial fibrillation; Atrial flutter; Catheter ablation; Data standards; Data variables; EuroHeart.

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Conflict of interest statement

G.B. reports, outside the submitted work, institutional research grants from Pfizer, expert committee and consulting fees to his institution from Bayer. Honoraria for lectures and scientific advice from AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Pfizer, and Sanofi.

Figures

Graphical Abstract
Graphical Abstract
EuroHeart 2022 data standards for atrial fibrillation/flutter and catheter ablation
Figure 1
Figure 1
European Unified Registries for Heart Care Evaluation and Randomized Trials data standards and aims of the European Unified Registries for Heart Care Evaluation and Randomized Trials project. EuroHeart, European Unified Registries for Heart Care Evaluation and Randomized Trials
Figure 2
Figure 2
European Unified Registries for Heart Care Evaluation and Randomized Trials IT platform and collection form for atrial fibrillation/flutter and catheter ablation. EuroHeart, European Unified Registries for Heart Care Evaluation and Randomized Trials.
Figure A1
Figure A1
Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow chart for the literature review for the development of the European Unified Registries for Heart Care Evaluation and Randomized Trials atrial fibrillation/flutter and catheter ablation data standards. PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; EuroHeart, European Unified Registries for Heart Care Evaluation and Randomized Trials.
See this image and copyright information in PMC

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