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Pulse Oximetry and Auscultation for Congenital Heart Disease Detection

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Pulse Oximetry and Auscultation for Congenital Heart Disease Detection Xiao-jing Hu, PhD,a Xiao-jing Ma, MD, a, b Qu-ming Zhao, MD, a Wei-li Yan, PhD, a, b Xiao-ling Ge, MD, a Bing Jia, MD, a Fang Liu, MD, a PulseLin Wu, MD,a Ming Ye,Oximetry MD, a Xue-cun Liang, MD,a Jing and Zhang, MD, aAuscultation Yan Gao, MD, a Xiao-wen Zhai, MD, a Guo-ying for Huang, MDa, b Congenital Heart Disease Detection OBJECTIVES: abstract Pulse oximetry (POX) has been confirmed as a specific screening modality for critical congenital heart disease (CCHD), with moderate sensitivity. However, POX is not able to detect most serious and critical cardiac lesions (major congenital heart disease [CHD]) without hypoxemia. In this study, we investigated the accuracy and feasibility of the METHODS: addition of cardiac auscultation to POX as a screening method for asymptomatic major CHD. A multicenter prospective observational screening study was conducted at 15 hospitals in Shanghai between July 1, 2012, and December 31, 2014. Newborns with either an abnormal POX or cardiac auscultation were defined as screen positive. All screen- ’ positive newborns underwent further echocardiography. False-negative results were identified by clinical follow-up, parents feedback, and telephone review. We assessed the RESULTS: accuracy of POX plus cardiac auscultation for the detection of major CHD. CHD screening was completed in all 15 hospitals, with a screening rate of 94.0% to 99.8%. In total, 167190 consecutive asymptomatic newborn infants were screened, of – which 203 had major CHD (44 critical and 159 serious). The sensitivity of POX plus cardiac – auscultation was 95.5% (95% confidence interval 84.9% 98.7%) for CCHD and 92.1% (95% confidence interval 87.7% 95.1%) for major CHD. The false-positive rate was 1.2% for CONCLUSIONS: detecting CCHD and 1.1% for detecting major CHD. In our current study, we show that using POX plus cardiac auscultation significantly improved the detection rate of major CHD in the early neonatal stage, with high sensitivity and a reasonable false-positive rate. It provides strong evidence and a reliable method for neonatal CHD screening. WHAT’SW KNO N ON THIS SUBJECT: The accuracy of aChildren’s Hospital of Fudan University, Shanghai, China; and bShanghai Key Laboratory of Birth Defects, pulse oximetry (POX) as a screening tool for critical Shanghai, China congenital heart disease (CHD) has been extensively Dr Huang contributed to the study design and the establishment of the screening system, studied. However, POX detects only lesions with organized and conducted the project, and finalized the manuscript; Dr Hu organized and hypoxemia with moderate sensitivity. Most cases conducted the project, undertook data management and data analysis, and drafted the report; of serious CHD without hypoxemia cannot be Drs Ma, Zhao, and Ge undertook data management and data analysis; Dr Yan contributed to recognized early enough to avoid heart failure or the study design and data analysis; and all authors discussed, critically revised, and approved collapse. the final study protocol, discussed and approved the final strategy for analysis, and discussed, revised, and approved the final manuscript as submitted and agree to be accountable for all WHAT THIS STUDY AddS: Many structural heart aspects of the work. defects present as a cardiac murmur. Using POX in The Shanghai Public Health 3-Year Action Plan, sponsored by the Shanghai Municipal Government, conjunction with cardiac auscultation significantly monitored study progress but had no role in study design, data collection, data interpretation, or improved the detection rate of both critical and writing of the report. The corresponding author had full access to all the data in the study and serious CHD in the early neonatal stage, with high had final responsibility for the decision to submit for publication. sensitivity and reasonable false-positive rate. DOI: https:// doi. org/ 10. 1542/ peds. 2017- 1154 Accepted for publication Jun 30, 2017 To cite: Hu X-j, Ma X-j, Zhao Q-m, et al. Pulse Oximetry and Auscultation for Congenital Heart Disease Detection. Pediatrics. 2017;140(4):e20171154 Downloaded from www.aappublications.org/news by guest on September 26, 2021 PEDIATRICS Volume 140, number 4, October 2017:e20171154 ARTICLE Hu et al https://doi.org/10.1542/peds.2017-1154 October 2017 Pulse Oximetry and Auscultation for Congenital Heart Disease Detection 4 140 Pediatrics 2017 ROUGH GALLEY PROOF FIGURE 1 The delivery number and screening rate in 15 hospitals. Screening rate (%) = screening number ÷ number of deliveries × 100%. Congenital heart diseases (CHDs) with clinical assessment could (hospitals 14 and 15 in Fig 1) in are a leading cause of infant death be successfully implemented in Shanghai. Of the 15 hospitals, 8 were worldwide1 and affect 8 in 1000 common hospital settings with few urban and 7 were suburban; 5 were live births. About 1 to 2 per 1000 barriers, and combining POX with tertiary and 10 were secondary newborn infants have critical CHD clinical assessment resulted in a high9 hospitals. Ten hospitals (67.0%) had (CCHD), which is defined as CHD that detection rate of major and CCHD. echocardiography available on-site, Importantly, in a post hoc analysis, whereas the remaining hospitals causes death or needs intervention ’ in the neonatal period. Neonates we observed that POX combined referred neonates with positive with CCHD2 benefit most from early with cardiac murmur had the same screening results to the Children s detection. Because of this, CCHDs sensitivity as did POX plus clinical Hospital of Fudan University (CHFU) have become the target for screening assessment in the detection of major for a diagnostic echocardiogram schemes in developed countries, CHD (90.0%) and CCHD (93.0%), free of charge. All consecutive and pulse oximetry (POX) has been whereas the false-positiveP rate (FPR) asymptomatic newborn infants were confirmed as an effective– screening was significantly lower (2.4%P vs included (irrespective of gestational modality, with moderate3 7 sensitivity 2.7% for major CHD, < .0001, and age), but newborn infants with and high specificity. However, 2.5% vs 2.9% for CCHD, < .0001), prenatally diagnosed CHD were POX detects only those lesions with suggesting that POX plus cardiac excluded from the analysis of the hypoxia. Most simple but serious auscultation may be a screening current study. cases of CHD, such as severe left strategy for major CHD. With this This study was approved by the heart obstructive lesions and large study, we aimed to investigate ethics committee of CHFU. Oral left-to-right shunt lesions, cannot be the accuracy and feasibility of the ’ informed consent was obtained from recognized early enough by POX to addition of cardiac auscultation the participants parents. avoid heart failure, collapse, or even to POX as a screening method for Procedures irreversible pulmonary8 vascular asymptomatic major CHD, hoping disease at a later stage. Therefore, to provide a more comprehensive all major CHDs (those causing death reference for routine neonatal CHD Screening methodology, POX or requiring intervention during screening policy. measurement criteria, and the infancy, including CCHD and serious METHODS definition of CHD severity were 9 defects) should be regarded as9 main the same as our previous study, targets of neonatal screening. Study Design and Participants but in this study, we only screened asymptomatic neonates, and In 2014, we reported the first screening modalities included large-scale prospective study on A multicenter prospective only POX and cardiac auscultation. neonatal CHD screening in China and observational screening study was Cardiac auscultation was performed – proposed that the benefits of POX conducted at 13 hospitals (hospitals and immediately followed by POX recorded in high-income countries 1 13 in Fig 1) between July 1, measurement by the same clinician. could be translated with success 2012, and December 31, 2014, and A positive screen result was defined to China as well; we also suggested at 2 hospitals between February as presence of any abnormality in the that POX used in conjunction 1, 2013, and December 31, 2014, 2 examinations as presented in Fig 2. Downloaded from www.aappublications.org/news by guest on September 26, 2021 2 HU et al Hu et al https://doi.org/10.1542/peds.2017-1154 October 2017 Pulse Oximetry and Auscultation for Congenital Heart Disease Detection 4 140 Pediatrics 2017 ROUGH GALLEY PROOF compare differences in sensitivity and specificity. A logistic regression model was performed to test the trend of FPRs across 7 time intervals χ during2 which screening occurred. decomposition analysis was further performed to identify the difference of the FPRs between time intervals. RESULTS The Complete Compliance of POX Plus Cardiac Auscultation Screening All 15 hospitals that participated in the study were able to complete routine CHD screening and complete or refer for echocardiography in a timely and effective manner, with a screening rate of 94.0% to 99.8% as shown in Fig 1. There was no significant difference in positive screening – P results between these hospitals (1.1% 1.8%, > .05). Among 172865 consecutive deliveries, 4108 infants with incomplete screening data, 90 infants with major CHD (28 infants with FIGURE 2 CCHD and 62 infants with serious CHD) identified prenatally, and CHD screening protocol. SpO2, pulse oxygen saturation. 1385 symptomatic newborns were transported to the NICU without screening at birth hospitals (92 Neonates who screened positive hospital. In addition, the first infants with major CHD, including for CHD were referred for consecutive 27201 neonates who 34 with CCHD and 58 with serious CHD among them) were excluded echocardiography within 24 hours screened negative were followed of screening. CHFU was responsible up via telephone at 1 year of age, for screening accuracy analysis for the confirmation of a diagnosis which was done to determine if the (Fig 3). In total, 167190 asymptomatic newborns were screened by using by echocardiography for neonates infant had cardiac symptoms or the standard screening protocol.
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