Collaborative study on 4-dimensional echocardiography for the diagnosis of fetal heart defects: the COFEHD study.

Objective. Congenital anomalies are the leading cause of infant mortality in the United States, and congenital heart defects (CHDs) are the most common type of birth defects. Recently, 4-dimensional ultrasonography (4DUS) with spatiotemporal image correlation (STIC) has been introduced for fetal echocardiography. Accumulating evidence indicates that 4DUS with STIC may facilitate the examination of the fetal heart. Our objectives were to determine the accuracy of 4DUS for the diagnosis of CHDs and the agreement among centers. Methods. This study included 7 centers with expertise in 4D fetal echocardiography. Fetuses with and without confirmed heart defects were scanned between 18 and 26 weeks, and their volume data sets were uploaded onto a centralized file transfer protocol server. Intercenter agreement was determined using a kappa statistic for multiple raters. Results. Ninety volume data sets were randomly selected for blinded analysis. Overall, the median (range) sensitivity, specificity, positive and negative predictive values, and false-positive and -negative rates for the identification of fetuses with CHDs were 93% (77%-100%), 96% (84%-100%), 96% (83%-100%), 93% (79%-100%), 4.8% (2.7%-25%), and 6.8% (5%-22%), respectively. The most frequent CHDs were conotruncal anomalies (36%). There was excellent intercenter agreement (kappa = 0.97). Conclusions. (1) Four-dimensional volume data sets can be remotely acquired and accurately interpreted by different centers. (2) Among centers with technical expertise, 4DUS is an accurate and reliable method for fetal echocardiography.