Abstract：
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.
摘要：
超声心动图核心实验室（ECL）协调对于考虑来自不同ECL的可互换数据至关重要。根据经导管主动脉瓣置换术（TAVR）试验领域2个已建立的ECL首次跨大西洋协调的经验，这篇综述描述了根据瓣膜学术研究联盟3定义,在分析和裁定TAVR后超声心动图终点时采用的协调ECL方法.这篇综述介绍了ECL内和ECL间的可行性和可重复性，解释了潜在的重要ECL间变异性的根本原因，并为优化TAVR后超声心动图图像采集制定ECL建议。ECL间协调的实施可能会进一步定义ECL的最佳实践，并对未来TAVR试验的实现具有后勤和监管意义。
