Study On Diagnostic Performance Of Fetal Intelligent Navigation Echocardiography(FINE Or 5D Heart)

ObjectiveTo 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 loop(STICloop).MethodA total of 250 pregnant women having a singleton pregnancy in the second and third trimesters 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 information was concealed and the 250 optimal volumes were randomly distributed to less experienced sonographer A for analysis using 5D Heart software.The sensitivity and specificity,positive and negative likelihood ratios,as well as area under the curve(AUC)of two methods were determined respectively.The differences between the two methods were statistically analyzed.ResultThe 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 likelihoodratio of 16.72,negative likelihood ratio of 0.05,and AUC of 0.95.Among cases with confirmed CHD,the 5D Heart diagnosis completely matched the final diagnosis in77.27%(85 of 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.Among cases with confirmed CHD,even the STICloop diagnosis completely matched the final diagnosis in 61.81%(68/110),its diagnostic accuracy is relatively lower than 5D Heart(P=0.013).However,there is no statistical difference between the two methods in sensitivity and specificity(P>0.05).ConclusionThe sensitivity and specificity of 5D Heart in diagnosing CHD were both higher than 90%,and it could successfully detect a broad spectrum of severe fetal CHD.Therefore,it has a high clinical application value.STICloop could be used for preliminary screening of CHD,as it has the same high sensitivity and specificity as 5D Heart,and when fetal cardiac abnormalities suspected,a further examination is recommended for.