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. 2023 Aug 7;9(5):529-536.
doi: 10.1093/ehjqcco/qcac063.

Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

Suleman Aktaa  1   2   3 , Gorav Batra  4 , Stefan K James  4 , Daniel J Blackman  1   3 , Peter F Ludman  5 , Mamas A Mamas  6 , Mohamed Abdel-Wahab  7 , Gianni D Angelini  8 , Martin Czerny  9 , Victoria Delgado  10 , Giuseppe De Luca  11 , Eustachio Agricola  12 , Dan Foldager  13 , Christian W Hamm  14   15 , Bernard Iung  16 , Norman Mangner  17 , Julinda Mehilli  18   19   20 , Gavin J Murphy  21 , Darren Mylotte  22 , Radoslaw Parma  23 , Anna Sonia Petronio  24 , Bodgan A Popescu  25 , Lars Sondergaard  26 , Rui C Teles  27 , Manel Sabaté  28 , Christian J Terkelsen  29 , Luca Testa  30 , Jianhua Wu  2   31 , Aldo P Maggioni  32 , Lars Wallentin  4 , Barbara Casadei  33 , Chris P Gale  1   2   3
Affiliations

Data standards for transcatheter aortic valve implantation: the European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

Suleman Aktaa et al. Eur Heart J Qual Care Clin Outcomes. .

Erratum in

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.

One-sentence summary: The EuroHeart data standards for transcatheter aortic valve implantation (TAVI) are a set of internationally agreed data variables and definitions that once implemented will facilitate improvement of quality of care and outcomes for patients receiving TAVI.

Keywords: Aortic valve; Data definitions; Data standards; EuroHeart; Quality of care; Registry; TAVI; Variables.

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Conflict of interest statement

M.A. reports that his hospital receives speaker's honoraria and/or consultancy fees on his behalf from Boston Scientific and Medtronic. E.A. reports, outside the submitted work, institutional research grants from Abbott, institutional research grants from Edwards Lifesciences, honoraria for lectures Abbott, Edwards Lifesciences and Philips. G.B. reports, outside the submitted work, institutional research grants from Pfizer, honoraria for lectures and scientific advice from AstraZeneca, Boehringer Ingelheim, Novo Nordisk, Pfizer and Sanofi, expert committee and consulting fees from Bayer. A.C. reports, outside the submitted work, honoraria and/or lecture fees (AstraZeneca, Bayer, Boehringer Ingelheim, Menarini, Novartis, Nutricia, Servier, Vifor, Abbott, Actimed, Arena, Cardiac Dimensions, Corvia, CVRx, Enopace, ESN Cleer, Faraday, Gore, Impulse Dynamics, Respicardia, Viatris). B.C. is ESC Board Member and Immediate Past President and reports, outside the submitted work, in kind support (Roche Diagnostics and iRhythm) for research projects and lecture fee (Menarini Foundation). V.D. reports, outside the submitted work, speaker fees (Abbott Vascular, Edwards Lifesciences, GE Healthcare, Medtronic, MSD, and Novartis) and consultancy (Edwards Lifesciences, Novo Nordisk). D.M. is a proctor and consultant for Medtronic, Boston Scientific, and Microport. J.M. receives lecture fees (Biotronik; SIS Medical, Bayer Vital GmbH, Daiichi Sankyo Europe GmbH, AstraZeneca, Insitutional grant (Ludwig-Maximilian University Clinic), and Boston Scientific. C.P.G. reports, outside the submitted work, consultancy (AstraZeneca, Bayer, Bristol Myers Squibb, Boehrinher-Ingleheim, Chiesi, Daiichi Sankyo, Menarini, speaker fees (AstraZeneca, Menarin, Raisio Group, Wondr Medical, Zydus), editorship (Deputy Editor: European Heart Journal Quality of Care and Clinical Outcomes, Oxford University Press), grants (British Heart Foundation, National Institute for Health Research, Horizon 2020, Abbott Diabetes, Bristol Myers Squibb), advisory Board (Amgen, Bayer, Bristol Myers Squibb, Boehrinher-Ingleheim, Chiesi, Daiichi Sankyo, Menarini), leadership (NICE Indicator Advisory Committee, Chair ESC Quality Indicator Committee). C.H. sits on the Advisory Board of Medtronic. G.J.M. declares grants from the British Heart Foundation and National Institute for Health Research, and NHSX, and support for academic activities from Terumo. N.M. has received personal fees from B.Braun, Edwards Lifesciences, Medtronic, Biotronik, Novartis, Sanofi Genzyme, AstraZeneca, Pfizer, Bayer, Abbott, Abiomed, and Boston Scientific outside the submitted work. L.S. has received consultant fees and/or institutional research grants from Abbott, Boston Scientific, Medtronic, and SMT. M.S. reports, outside the submitted work, consultant fees from Abbott Vascular and iVascular, stent manufacturer companies. L.T. declares Consulting fees, Honoraria personal and Institutional, advisory board participation from Abbott, Medtronic, Boston Scientific Corporation, Terumo Lifesciences, Meril, Cardionovum, Concept Medical.

Figures

Graphical Abstract
Graphical Abstract
EuroHeart = European Unified Registries for Heart Care Evaluation and Randomised Trials, HRQoL = health-related quality of life, TAVI = transcatheter aortic valve implantation.
Figure 1
Figure 1
Role of EuroHeart registries in monitoring individual patients care. ACS, acute coronary syndrome; AF, atrial fibrillation; HF, heart failure; PCI, percutaneous coronary intervention; TAVI, transcatheter aortic valve implantation.
Figure 2
Figure 2
An illustration of the IT platform. AV, aortic valve; LAD, left anterior descending artery; Lcx, left circumflex artery; LMS, left main stem; RCA, right coronary artery.
See this image and copyright information in PMC

References

    1. Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel Get al. STS-ACC TVT Registry of Transcatheter Aortic Valve Replacement. Ann Thorac Surg. 2021;111:701–722. - PubMed
    1. NATIONAL CARDIAC AUDIT PROGRAMME. ANNUAL REPORT 2021. Available at: https://www.nicor.org.uk/wp-content/uploads/2021/10/NCAP-Aggregate_-Repo.... Accessed 26 April 2022.
    1. Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs Jet al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease: Developed by the Task Force for the management of valvular heart disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2021;43:561–632.
    1. Barbato E, Noc M, Baumbach A, Dudek D, Bunc M, Skalidis Eet al. Mapping interventional cardiology in Europe: the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas Project. Eur Heart J. 2020;41:2579–2588. - PubMed
    1. Bekeredjian R, Szabo G, Balaban Ü, Bleiziffer S, Bauer T, Ensminger Set al. Patients at low surgical risk as defined by the Society of Thoracic Surgeons Score undergoing isolated interventional or surgical aortic valve implantation: in-hospital data and 1-year results from the German Aortic Valve Registry (GARY). Eur Heart J. 2019;40:1323–1330. - PubMed

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