Study on diagnostic performance of fetal intelligent navigation echocardiography for congenital heart defect

Abstract

Objective To explore the sensitivity and specificity of fetal intelligent navigation echocardiography(FINE, 5D Heart) in the prenatal detection of congenital heart defect(CHD), and to compare its diagnostic performance with spatiotemporal image correlation(STIC) loop (STICloop). Methods A total of 250 pregnant women having a singleton pregnancy in the second and third trimesters from April 2018 to May 2019 in Sir Run Run Shaw Hospital, Zhejiang University College of Medicine were enrolled in this prospective study. 2D ultrasound diagnosis has been made before acquiring STIC volume data set. After the appropriateness of each volume data set was preliminarily determined, all identifying informations were concealed and the appropriate volumes were randomly distributed to less experienced sonographer for analysis using 5D Heart software. The sensitivity and specificity, positive and negative likelihood ratios, as well as area under the receiver operating characteristic curve (AUC) of the two methods were determined respectively, and the differences between the two methods were statistically analyzed. Results The diagnostic performance of 5D Heart for the prenatal detection of CHD was: sensitivity of 95.45% (105/110), specificity of 94.29% (132/140), positive likelihood ratio of 16.72, negative likelihood ratio of 0.05, and AUC of 0.95, respectively. Among cases with confirmed CHD, the 5D Heart diagnosis completely matched the final diagnosis in 77.27% (85/110). The diagnostic performance of STICloop for the prenatal detection of CHD was: sensitivity of 90.91% (100/110), specificity of 92.86% (130/140), positive likelihood ratio of 12.73, negative likelihood ratio of 0.10, and AUC of 0.92. The sensitivity and secificity of 5D Heart in diagnosing CHD were both higher than 90%, and it could successfully detect a broad spectrum of severe fetal CHD. Among cases with confirmed CHD, even the STICloop diagnosis completely matched the final diagnosis in 61.81%(68/110), its diagnostic accuracy was relatively lower than 5D Heart (P=0.013). However, there were no statistical differences between the two methods in sensitivity and specificity(all P>0.05). Conclusions The sesitivity and specifity of 5D Heart in diagnosis CHD were both higher than 90%, and it could successfully detect a broad spectrum of severe fetal CHD. STICloop could be used for preliminary screening of CHD, as it has the same high sensitivity and specificity as 5D Heart. Further examination may be recommended when fetal heart abnormalities are suspected. Key words: Echocardiography; Congenital heart defect; Fetal intelligent navigation echocardiography; Spatiotemporal image correlation