Skip to main content

Research Repository

Advanced Search

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

Aktaa, Suleman; Batra, Gorav; James, Stefan K; Blackman, Daniel J; Ludman, Peter F; Mamas, Mamas; Abdel-Wahab, Mohamed; Angelini, Gianni D; Czerny, Martin; Delgado, Victoria; De Luca, Giuseppe; Agricola, Eustachio; Foldager, Dan; Hamm, Christian W; Iung, Bernard; Mangner, Norman; Mehilli, Julinda; Murphy, Gavin J; Mylotte, Darren; Parma, Radoslaw; Petronio, Anna Sonia; Popescu, Bodgan A; Sondergaard, Lars; Teles, Rui C; Sabaté, Manel; Terkelsen, Christian J; Testa, Luca; Wu, Jianhua; Maggioni, Aldo P; Wallentin, Lars; Casadei, Barbara; Gale, Chris P

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


Authors

Suleman Aktaa

Gorav Batra

Stefan K James

Daniel J Blackman

Peter F Ludman

Mohamed Abdel-Wahab

Gianni D Angelini

Martin Czerny

Victoria Delgado

Giuseppe De Luca

Eustachio Agricola

Dan Foldager

Christian W Hamm

Bernard Iung

Norman Mangner

Julinda Mehilli

Gavin J Murphy

Darren Mylotte

Radoslaw Parma

Anna Sonia Petronio

Bodgan A Popescu

Lars Sondergaard

Rui C Teles

Manel Sabaté

Christian J Terkelsen

Luca Testa

Jianhua Wu

Aldo P Maggioni

Lars Wallentin

Barbara Casadei

Chris P Gale



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.

Journal Article Type Article
Acceptance Date Sep 30, 2022
Online Publication Date Oct 4, 2022
Publication Date Aug 7, 2023
Publicly Available Date May 30, 2023
Journal European Heart Journal - Quality of Care and Clinical Outcomes
Print ISSN 2058-5225
Publisher Oxford University Press
Volume 9
Issue 5
Pages 529-536
DOI https://doi.org/10.1093/ehjqcco/qcac063
Keywords Data standards; Variables; Data definitions; TAVI; Quality of care; Registry; EuroHeart; Aortic valve
Publisher URL https://academic.oup.com/ehjqcco/advance-article/doi/10.1093/ehjqcco/qcac063/6748204

Files




You might also like



Downloadable Citations