Echocardiography Core Laboratory Methodology for TAVR: A Transatlantic Consensus.

Inter-echocardiography core laboratory (ECL) harmonization is pivotal to consider data from different ECLs interchangeable. On the basis of the experience of the first trans-Atlantic harmonization of 2 established ECLs in the field of transcatheter aortic valve replacement (TAVR) trials, this review describes the harmonized ECL methodology in analyzing and adjudicating the post-TAVR echocardiographic endpoints according to Valve Academic Research Consortium 3 definitions. This review presents the feasibility and intra- and inter-ECL reproducibility, explains the root cause of potential important inter-ECL variability, and formulates ECL recommendations for optimal post-TAVR echocardiographic image acquisition. The implementation of inter-ECL harmonization may further define the best practice of ECLs and have logistic and regulatory implications for the realization of future TAVR trials.

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Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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Funding Support and Author Disclosures This study was self-funded by the participating institutions. Dr Ren has received institutional contracts for echocardiography core laboratory analyses with Boston Scientific, Cardiawave, Edwards Lifesciences, and NVT/Biosensors, for which she has received no personal compensation; and has received speaker fees from Abbott. Dr Van Mieghem reports institutional grant support from Abbott, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, PulseCath, Daiichi Sankyo, Teleflex, AstraZeneca and scientific advisory fees from Siemens, Pie Medical, Abbott, Boston Scientific, Medtronic, PulseCath, Daiichi Sankyo, Amgen, Teleflex, Abiomed, JenaValve, Anteris. Dr Spitzer has received institutional contracts for which he has received no direct compensation with Boston Scientific, Cardiawave, Edwards Lifesciences, Medtronic, Shanghai MicroPort Medical, NVT, Pie Medical Imaging, and Siemens Healthcare. Dr Pibarot has received funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Phoenix for echocardiography core laboratory analyses and research studies in the field of transcatheter valve therapies, for which he has received no personal compensation; and has received lecture fees from Edwards Lifesciences and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.