| Objective: Using the cardiac auscultation plus POX as the congenital heart disease screening method was suggested by Children’s Hospital of Fudan University and was applied in single-center to obtian the data of neonatal congenital heart disease in this area between 2016-2018.In this study,we aimd to observe the incidence of neonatal congenital heart disease in the local area and to investigate the feasibility and reliability of screening for congenital heart disease using pulse oximetry(POX)combined with cardiac auscultation.The results of such a study can provide clinical evidence for early screening,detection,diagnosis and timely evaluation of congenital heart disease.Methods: 8305 newborns who were born from January 2016 to December 2018 at a local hospital were screened.POX and cardiac auscultation were performed at newborns aged from 24 hours to 72 hours after the birth.Newborns who had positive pulse oximetry or cardiac auscultation findings were subjected to echocardiography.For infants who had nagative screening results,clinical follow-up was done in combination with feedback from parents about cardiac symptoms such as cyanosis,tachypnea,and feeding difficulty.The data of these three tests for separate or combined screening,which contained the sensitivity,specificity,positive / negative predictive value and Yoden index,together with the area under the ROC curve(AUC),were calculated and compared.Results: Among 8305 newborns,6 patients had congenital heart disease comfirmed by echocardiography out of 22(0.26%)positive pulse oximetry cases without positive cardiac auscultation.Among them,3cases were diagnosed with complete transposition of great arteries(CTGA),2with anomalous pulmonary venous return(APVR)and1 with pulmonary atresia(PA),and the diagnosis rate is 27.2% in this POX group.Out of 83(0.99%)cases with positive cardiac auscultation without positive pulse oximetry,47 patients had congenital heart disease.Among them,26 cases were diagnosed with ventricular septal defect(VSD),10 with atrial septal defect(ASD),4with patent ductus arteriosus(PDA),4with pulmonary stenosis(PS)and 3with coarctation of aorta(CA),and the diagnosis rate is 56.6% in this auscultation group.All 8(0.09%)patients who had positive pulse oximetry and positive cardiac auscultationn had congenital heart disease,Among them,3 cases were diagnosed with Tetralogy of Fallot(TOF),1 with ventricular septal defect(VSD),2with patent ductus arteriosus(PDA),1with pulmonary stenosis(PS),and 1with double outlet of right ventricle(DORV),and the diagnosis rate is 100% in this double positive group.An additional 4patients with congenital heart disease were diagnosed later by clinial follow up.Among them,2cases were diagnosed with atrial septal defect(ASD,>5mm)and 2 with patent ductus arteriosus(PDA,which fail to shut down in 3 months).It was found that the sensitivity,specificity,positive predictive value,and negative predictive value of the test for combined screening are 93.85%,99.37%,53.98%,and 99.95%.The study also showed that the Jordan index is 0.93,and the AUC(area under the ROC curve)is 0.966.The sensitivity of the test for combined screening is higher than either test alone(P <0.05),so is the AUC of the test for combined screening(P <0.001).It can be seen that the method of combining POX with cardiac auscultation is simple,non-invasive,low-cost and high accuracy,which meets the requirements of disease screening.The study revealed that 65 children with positive screening and subsequent follow-up were eventually diagnosed as having congenital heart disease by echocardiography.The overall incidence of congenital heart disease is 7.82 per 1000 live birth.Among them,27 cases with ventricular septal defect account for 41.5% of the total,12 cases with atrial septal defect account for 18.4% of the total and 8 cases with patent ductus arteriosus account for 12.3% of the total.All these three types of congenital heart disease mentioned above account for 72.3% of the total congenital heart disease,and ventricular septal defect is the most common one.Conclusions: 1.A combination of pulse oximetry and cardiac auscultationn was used as a screening index for neonatal congenital heart disease in single-center.It was revealed that the sensitivity,Yoden index and AUC of the test for combined screening are higher than either test alone.Combined screening can reduce missed diagnosis and increase the detection rate of children with congenital heart disease.It is a safe,noninvasive,feasible method as a routine screening method which is suggested applying in other areas.2.The incidence of neonatal congenital heart disease in single-center is about 7.82 per 1000 live birth,which is similar to that in other regions.Ventricular septal defect is the most common congenital heart disease,followed by atrial septal defect and patent ductus arteriosus.3.It has been known that the missed diagnosis can not have vanished in any screening test.In this study,the missed diagnosis rate of congenital heart disease screening program is 6.15%,In this case,the power of education should be emphasized to make sure that newborns are to be allowed to accept the congenital heart disease-related examination in time.4.As early diagnosis and early intervention could improve the outcomes of neonates and reduce the burden on families and society,precaution taken by government are necessary. |