Aktaa, S, Batra, G, James, SK, Blackman, DJ, Ludman, PF, Mamas, MA, Abdel-Wahab, M, Angelini, GD, Czerny, M, Delgado, V, De Luca, G, Eustachio, A, Foldager, D, Hamm, CW, Iung, B, Mangner, N, Mehilli, J, Murphy, GJ, Mylotte, D, Parma, R, Petronio, AS, Popescu, BA, Sondergaard, L, Teles, RC, Sabaté, M, Terkelsen, CJ, Testa, L, Wu, J, Maggioni, AP, Wallentin, L, Casadei, B and Gale, CP (2022) Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart). European Heart Journal - Quality of Care and Clinical Outcomes. ISSN 2058-1742

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Abstract

AIMS: Standardized data definitions are necessary for the quantification of quality of care and patient outcomes in observational studies and randomised controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) project of the European Society of Cardiology (ESC) aims to create pan-European data standards for cardiovascular diseases and interventions, including transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We followed the EuroHeart methodology for cardiovascular data standard development. A Working Group of 29 members representing 12 countries was established and included a patient representative, as well as experts in the management of valvular heart disease from the European Association of Percutaneous Cardiovascular Interventions (EAPCI), the European Association of Cardiovascular Imaging (EACVI) and the Working Group on Cardiovascular Surgery. We conducted a systematic review of the literature and used a modified Delphi method to reach consensus on a final set of variables. For each variable, the Working Group provided a definition, permissible values and categorized the variable as mandatory (Level 1) or additional (Level 2) based on its clinical importance and feasibility. In total, 93 Level 1 and 113 Level 2 variables were selected, with the level 1 variables providing the dataset for registration of patients undergoing TAVI on the EuroHeart IT platform. CONCLUSION: This document provides details of the EuroHeart data standards for TAVI processes of care and in-hospital outcomes. In the context of EuroHeart, this will facilitate quality improvement, observational research, registry-based RCTs and post-marketing surveillance of devices and pharmacotherapies.

Item Type: Article
Additional Information: © The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial License (https://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Medicine and Health Sciences > School of Medicine
Related URLs:
Depositing User: Symplectic
Date Deposited: 22 Nov 2022 14:46
Last Modified: 22 Nov 2022 14:46
URI: https://eprints.keele.ac.uk/id/eprint/11698

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