TY - JOUR

T1 - Data standards for transcatheter aortic valve implantation

T2 - The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

AU - Aktaa, Suleman

AU - Batra, Gorav

AU - James, Stefan K.

AU - Blackman, Daniel J.

AU - Ludman, Peter F.

AU - Mamas, Mamas A.

AU - Abdel-Wahab, Mohamed

AU - Angelini, Gianni D.

AU - Czerny, Martin

AU - Delgado, Victoria

AU - De Luca, Giuseppe

AU - Agricola, Eustachio

AU - Foldager, Dan

AU - Hamm, Christian W.

AU - Iung, Bernard

AU - Mangner, Norman

AU - Mehilli, Julinda

AU - Murphy, Gavin J.

AU - Mylotte, Darren

AU - Parma, Radoslaw

AU - Petronio, Anna Sonia

AU - Popescu, Bodgan A.

AU - Sondergaard, Lars

AU - Teles, Rui C.

AU - Sabate, Manel

AU - Terkelsen, Christian J.

AU - Testa, Luca

AU - Wu, Jianhua

AU - Maggioni, Aldo P.

AU - Wallentin, Lars

AU - Casadei, Barbara

AU - Gale, Chris P.

N1 - Publisher Copyright: © 2022 The Author(s). Published by Oxford University Press on behalf of the European Society of Cardiology.

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

KW - Aortic valve

KW - Data definitions

KW - Data standards

KW - EuroHeart

KW - Quality of care

KW - Registry

KW - TAVI

KW - Variables

U2 - 10.1093/ehjqcco/qcac063

DO - 10.1093/ehjqcco/qcac063

M3 - Journal article

C2 - 36195332

AN - SCOPUS:85166734826

VL - 9

SP - 529

EP - 536

JO - European Heart Journal - Quality of Care and Clinical Outcomes

JF - European Heart Journal - Quality of Care and Clinical Outcomes

SN - 2058-5225

IS - 5

ER -