TY - JOUR
T1 - Echocardiography Core Laboratory Methodology for TAVR
T2 - A Transatlantic Consensus
AU - Ren, Claire B.
AU - Tardif, Danielle
AU - Brandenburg, Hans Jelle
AU - Roux, Mathieu
AU - Mrevlje, Blaz
AU - Geleijnse, Marcel L.
AU - Van Mieghem, Nicolas M.
AU - Spitzer, Ernest
AU - Pibarot, Philippe
N1 - Publisher Copyright:
© 2024 American College of Cardiology Foundation
PY - 2024/12
Y1 - 2024/12
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85199202547
U2 - 10.1016/j.jcmg.2024.04.014
DO - 10.1016/j.jcmg.2024.04.014
M3 - Review article
C2 - 38970592
AN - SCOPUS:85199202547
SN - 1936-878X
VL - 17
SP - 1480
EP - 1500
JO - JACC: Cardiovascular Imaging
JF - JACC: Cardiovascular Imaging
IS - 12
ER -