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 Table of Contents  
ORIGINAL ARTICLE
Year : 2019  |  Volume : 8  |  Issue : 1  |  Page : 28-33

Assessing the use of pulse oximetry screening for critical congenital heart disease in asymptomatic term newborns


1 Department of Pediatrics, Hatyai Medical Education Center, Pediatric Cardiology Unit, Hatyai Hospital, Songkhla, Thailand
2 Department of Pediatrics, Hatyai Medical Education Center, Neonatal Intensive Care Unit, Hatyai Hospital, Hatyai, Songkhla, Thailand
3 Division of Physics, School of Science, Walailak University, Nakhon Si Thammarat, Thailand

Date of Web Publication29-Jan-2019

Correspondence Address:
Dr. Suwan Danworapong
Department of Pediatrics, Hatyai Medical Education Center, Pediatric Cardiology Unit, Hatyai Hospital, 182 Rattakarn Road, Songkhla 90110
Thailand
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/jcn.JCN_79_18

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  Abstract 


Background: Even though pulse oximetry screening (POS) is widely used for the early detection of critical congenital heart disease (CCHD) in unrecognized newborns, the missing cases of CCHD are still found in our practice. Aims: To evaluate the accuracy of POS for CCHD in asymptomatic term newborns and to identify the missing cases. Subjects and Methods: This retrospective cohort study was performed in asymptomatic term newborns born from June 2016 to September 2017 at Hatyai Hospital. Central electronic medical records (including POS and echocardiograms) during birth hospitalization and subsequent medical records at 6 months after discharge were reviewed. Statistical Analysis Used: The diagnostic accuracy of POS for CCHD was assessed by using sensitivity and specificity (with 95% confidence interval [CI]). Results: A total of 7137 asymptomatic term newborns were enrolled. POS had a sensitivity of 42.86% (95% CI 9.90–81.59) and a specificity of 99.96% (95% CI 99.88–99.99). Nearly 57.14% (4 out of 7 cases of CCHD) constituted secondary target group. All the late diagnoses (3 cases) were of coarctation of the aorta (COA). The mortality rate of late detected CCHD was 33.3%. Conclusions: POS displayed low detection rate in secondary target group, particularly those with COA. POS decreased late detection of CCHD by 57.1%. The mortality rate of COA was high in late detection. It was found that the appropriate time span for POS follow-up should be up to 4 months.

Keywords: Critical congenital heart disease, newborns, pulse oximetry, screening


How to cite this article:
Danworapong S, Nakwan N, Napapongsuriya C, Choksuchat D, Danworaphong S. Assessing the use of pulse oximetry screening for critical congenital heart disease in asymptomatic term newborns. J Clin Neonatol 2019;8:28-33

How to cite this URL:
Danworapong S, Nakwan N, Napapongsuriya C, Choksuchat D, Danworaphong S. Assessing the use of pulse oximetry screening for critical congenital heart disease in asymptomatic term newborns. J Clin Neonatol [serial online] 2019 [cited 2019 Jul 22];8:28-33. Available from: http://www.jcnonweb.com/text.asp?2019/8/1/28/250985




  Introduction Top


Critical congenital heart disease (CCHD) is one of the major causes of infant mortality. The prevalence is approximately 1–4/1000 live births.[1],[2],[3],[4],[5] CCHD is a group of life-threatening cardiac lesions that require early intervention.[1],[2],[6] Physical examination is insufficient to detect all pathologies during birth hospitalization because of mild hypoxemia, ventricular dysfunction, and patent duct as well as the absence of murmur.[3] Undetected newborns are then discharged home where related symptoms can later be developed. Serious morbidity and mortality normally result from hemodynamic compromise which comes in the form of cardiovascular collapse and end-organ damage. Approximately 20%–30% of CCHD cases are undiagnosed during birth hospitalization.[6],[7],[8] The mortality rate of late detection is twice of those detected early.[7]

Pulse oximetry screening (POS) can help to increase the chance of CCHD detection in the postpartum ward.[9],[10],[11],[12],[13],[14],[15],[16],[17],[18],[19] The United State Secretary of Health and Human Services has added POS to the Recommended Uniform Screening Panel in 2011.[20],[21]

In this work, we aim to navigate the accuracy of POS protocol for early detection of CCHD in asymptomatic term newborns and to identify the missing cases for those having negative POS initially via monitoring health record for 6 months.


  Subjects and Methods Top


Ethics

This study was approved by the Ethical Committee of Hatyai Hospital (HH) in accordance with the Helsinki declaration.

Setting

HH is a regional public hospital in Hatyai district, Songkhla province, located in the south of Thailand. Based on the latest registration record, the population of Hatyai district is 397,397. Because of the universal health coverage scheme of the National Health Security Office, HH has become the referral and cardiac center of the region. Infants with cardiac problems are directly referred to HH for further medical processes. The hospital has a birth delivery rate of around 7000 cases annually.

Study design and subjects

The retrospective consecutive cohort study was performed in all healthy term newborns at the postpartum ward in HH. Central electronic medical records of newborns from June 2016 to September 2017 were used in this study. To account for late detection of CCHD, 6 additional months' follow-up medical information of those discharged home was collected using their later medical history or direct communication.

All asymptomatic newborns with a gestational age of >37 weeks were chosen for this study. Sick newborns before the screening or outborn neonates were excluded.

Medical records including history, physical examination, POS results, and investigations during birth admission and after discharged were reviewed.

POS was performed in all healthy newborns at the postpartum ward whose ages were above 24 h before being discharged home. We used the Novamatrix Oxypleth Pulse Oximeter model 520 A (Soma Technology, Inc., USA, FDA approved, product code: DQA, recall number: Z-1559-2009, event ID: 52041) with reusable neonate soft sensor probes. The probe was initially placed on the right hand and then on either the left or right foot. Oxygen saturation (SpO2) was recorded when the pulse oximetry showed stable waveforms. A negative POS result was registered when SpO2 in the right hand (preductal) or foot (postductal) was >95% with the maximum of 3% difference between preductal and postductal SpO2. It was considered positive if preductal or postductal SpO2 was <90%, or if preductal and postductal SpO2 were between 90% and 94% or if the difference between preductal and postductal SpO2 was more than 3% after three repeated screenings with 1 h apart. Evaluation of life-threatening conditions was carried out by attending pediatricians. An echocardiogram was performed by pediatric cardiologists in all newborns with positive screening result and those showing clinical signs of having CCHD.

Definitions

CCHD is defined as severe congenital heart lesions requiring surgical or catheter intervention in early life.[1],[2],[6] The lesions could be ductal-dependent pulmonary or systemic circulation or nonductal dependent with hypoxemia.[4],[5] The CCHD was diagnosed by using echocardiogram as a gold standard.

Early detection of CCHD is defined as CCHD detected during the birth hospitalization.

Late detection of CCHD is defined as CCHD detected after discharged home from birth hospitalization with negative POS for CCHD.

Statistical analysis

The clinical parameters were analyzed by mean ± standard deviation (SD), median (range: minimum–maximum), interquartile range (IQR 25th–75th percentiles), percentiles, frequency, and percentage as appropriate. Diagnostic accuracy of the cohorts was assessed by using sensitivity, specificity, negative and positive predictive values, false-positive rate, and diagnostic accuracy (with corresponding 95% confidence interval [CI]). The analysis was performed using the SPSS software version 13.0 (SPSS Inc., Chicago, IL, USA). The list-wise method was used for handling the missing data.


  Results Top


We had 9098 live births during the study period. Preterm and sick newborns before the assessment for POS were excluded from the study. Twelve cases of CCHD developed clinical symptoms shortly after birth before the screening as detailed in [Figure 1] and [Table 1]. A total of 265 cases were missing due to the lack of subsequent medical records. The 7137 asymptomatic term newborns were enrolled as the study profile in [Figure 1].
Figure 1: The study profile. ACHD – Acyanotic congenital heart disease; 2° ASD – Secundum atrial septal defect; AVSD – Atrioventricular septal defect; CHD – Congenital heart disease; COA – Coarctation of the aorta; DORV – Double-outlet right ventricle; Dx – Diagnosis; HLHS – Hypoplastic left heart syndrome; PA – Pulmonary atresia; PDA – Patent ductus arteriosus; POS – Pulse oximetry screening; SV – Single ventricle; TAPVR – Total anomalous pulmonary venous return; TGA – Transposition of the great arteries; TTNB – Transient tachypnea of the newborn

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Table 1: Details of newborns with critical congenital heart disease diagnosed before timing for pulse oximetry screening

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The average birthweight and gestational age were 3123 ± 416 g (mean ± SD) and 38.9 ± 1.2 weeks (mean ± SD), respectively. The median screening age was 39.5 h (range 24–192 h, IQR 26–48, 99th percentile = 100). The percentage of screening age of 150 h or more was accounted for 0.08% (6 out of 7137), and 3591 newborns (50.3%) were male.

The incidence of CCHD was 2.1/1000 live births (19 out of 9098) without a prenatal diagnosis [Table 1] and [Table 2]. CCHD was detected early before timing for POS in 63.2% of cases (12 out of 19). Coarctation of the aorta (COA) was found in 5.5/10,000 live births (5 out of 9098).
Table 2: Details of newborns with critical congenital heart disease in pulse oximetry screening study

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Three true positives and three false positives were detected as shown in [Figure 1] and [Table 2]. Four false negatives were diagnosed as COA. One was detected from physical examination before discharged home. Three other cases indicated late diagnosis as detailed in [Table 2].

The accuracy of POS for CCHD is shown in [Table 3]. This screening had a sensitivity of 42.86% (95% CI 9.90–81.59) and a specificity of 99.96% (95% CI 99.88–99.99). The combination of POS and physical examination improved the sensitivity up to 57.14% with a specificity of 99.73%.
Table 3: The accuracy of pulse oximetry screening and physical examination for detecting critical congenital heart disease

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Three cases of CCHD were late detection (3 out of 19, 15.7%). Two of them presented with congestive heart failure at 19 days and 125 days of life. The other one came to the emergency room with cardiac arrest at the age of 40 days [Table 2]. All of them were COA; one was associated with a single ventricle.

The overall mortality rate of CCHD was 36.8% (7 out of 19). The mortality rate of early detection was 37.5% (6 out of 16). Late detection of CCHD had a mortality rate of 33.3% (1 out of 3).


  Discussion Top


The targets of POS are primary and secondary targets of CCHD. The sensitivity of POS for CCHD in primary targets is greater than that in secondary targets. Primary targets usually present early with hypoxemia.[14],[17],[22],[23] The seven primary targets are hypoplastic left heart syndrome, pulmonary atresia, tetralogy of Fallot, dextro-transposition of the great arteries, tricuspid atresia, truncus arteriosus, and total anomalous pulmonary venous return. The five secondary targets of the screening are COA, double-outlet right ventricle, Ebstein anomaly, interrupted aortic arch, and single ventricle.[24]

The sensitivity of POS in our study (42.86%) was lower than that in other studies (65.5%–100%)[4],[11],[25],[26] because of the following reasons: first, 63.2% of cases with CCHD were already detected before the screening and 83.3% of them were primary targets and second, there was a high percentage of cases diagnosed as COA (57.1%) in this screening study. As it is known that secondary targets of screening, especially COA, have a low sensitivity of POS for CCHD (36%–53.3%),[4],[11],[14],[22] we found very high percentage of COA (100%) in late detection, but there were only two cases (12.5%) for early detection. Whereas other studies found COA of 33%–54% in late diagnosis and 17% in early diagnosis.[6],[8] Our incidence of COA (5.5/10,000 live births) was also higher than that from another study (3.7/10,000 live births).[14] Finally, our study had a low number of CCHD (only seven cases) which undermined the power of a study. This was due to too small sample size or short duration of the study.

We found that physical examination had lower sensitivity (28.57%) than POS for CCHD detection. In addition to physical examination, POS helped to decrease late detection of CCHD in four cases (57.1%). It confirms that POS is a useful method for early CCHD detection in daily practice.

A false-positive rate in this study (0.04%) was lower than that given in previous studies[4],[17],[22] because sick newborns from other causes were already excluded before the screening.

The pulse oximeter used in this work detected all primary target group during the birth hospitalization. We, however, still missed secondary target group. COA with small or closed duct may show slight desaturation of postductal SpO2, but it may yield small pulse volume. New-generation pulse oximeter that displays Peripheral Perfusion Index (PPI) may be helpful for the detection of critical left heart obstruction.[27],[28],[29] Previous studies proposed cutoff value of PPI for the detection of left heart obstruction to be below the 5th percentile (PPI <0.7), with an odds ratio of 23.75.[27],[28] PPI may be the additional screening method in our practice to decrease the diagnostic gap for the detection of CCHD, especially left ventricular outflow tract obstruction.[27],[28],[29]

One of our late diagnoses of CCHD was COA diagnosed with a single ventricle, with a preductal SpO2 of 95% and a postductal SpO2 of 95%. Specifications of our pulse oximeter had an accuracy of SpO2± 2% (for SpO2 80%–100%). We proposed to repeat POS if both preductal and postductal SpO2 are 95% in our hospital. This idea requires further study.

For late detection of CCHD, our work was extended for 6 additional months of follow-up for those with negative POS result after discharged home, whereas other studies had offered the follow-up for <6 weeks after discharged home.[12],[18],[22],[25] We found a higher percentage of late diagnosis of CCHD in those with negative POS (15.7%) than another study (4.4%).[9] However, we had the same percentage of late detection of CCHD according to the simulation model given by Ailes et al. (15%).[14] Previous studies reported that late detection cases had a clinical presentation at an age of 3 days–26 days.[9],[10],[29] From our finding, two cases of CCHD were diagnosed at 40 days and 125 days of age. This reflects that perhaps we should carefully evaluate the clinical signs and symptoms of CCHD including POS extended to 2 months or 4 months of age at a well-baby clinic.

The mortality rate of undetected cases in our study (33.3%) was similar to that of other studies (27%).[7],[24] However, we had a higher mortality rate of early diagnosed CCHD at 37.5% as compared to another study (16%).[7] This was because our cases were associated with syndromatic CCHD and more complex and severe CCHD in early detected CCHD. Nevertheless, there was no death in early detected COA. We found one death for late diagnosis of COA.

This study was a retrospective cohort study which had certain limitations in data collection. As a result, possible errors in cardiac examination records and human errors in performing POS may exist. However, the missing data (3.6% [265 of 7402]) yielded insignificant influence on results and conclusion. The proportion of the missing data of <5% is acceptable for data analysis.[30],[31] Another weakness was a low power of the study due to a small sample size and a low number of index cases.


  Conclusions Top


This study had a low sensitivity of POS for CCHD, <50%. POS helps to decrease the diagnostic gap in the primary targets, but this is still questionable for the secondary targets. However, we continue using POS in our practice because of the following findings from our study: first, POS combined with physical examination could decrease the late detection of CCHD by half and second, there was a higher mortality rate of late detection of COA as compared to the early detection of COA. PPI may be the other additional tool for early detection of CCHD, especially in left ventricular outflow tract obstruction.

Our work indicates that the time duration for assessing CCHD should be prolonged to 4 months in order to detect false-negative POS.

Acknowledgments

We would like to give our special thanks to Dr. Wanida Limmun for her assistance in statistical analysis.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Tables

  [Table 1], [Table 2], [Table 3]



 

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