Elsevier

The Lancet

Volume 379, Issue 9835, 30 June–6 July 2012, Pages 2459-2464
The Lancet

Articles
Pulse oximetry screening for critical congenital heart defects in asymptomatic newborn babies: a systematic review and meta-analysis

https://doi.org/10.1016/S0140-6736(12)60107-XGet rights and content

Summary

Background

Screening for critical congenital heart defects in newborn babies can aid in early recognition, with the prospect of improved outcome. We assessed the performance of pulse oximetry as a screening method for the detection of critical congenital heart defects in asymptomatic newborn babies.

Methods

In this systematic review, we searched Medline (1951–2011), Embase (1974–2011), Cochrane Library (2011), and Scisearch (1974–2011) for relevant citations with no language restriction. We selected studies that assessed the accuracy of pulse oximetry for the detection of critical congenital heart defects in asymptomatic newborn babies. Two reviewers selected studies that met the predefined criteria for population, tests, and outcomes. We calculated sensitivity, specificity, and corresponding 95% CIs for individual studies. A hierarchical receiver operating characteristic curve was fitted to generate summary estimates of sensitivity and specificity with a random effects model.

Findings

We screened 552 studies and identified 13 eligible studies with data for 229 421 newborn babies. The overall sensitivity of pulse oximetry for detection of critical congenital heart defects was 76·5% (95% CI 67·7–83·5). The specificity was 99·9% (99·7–99·9), with a false-positive rate of 0·14% (0·06–0·33). The false-positive rate for detection of critical congenital heart defects was particularly low when newborn pulse oximetry was done after 24 h from birth than when it was done before 24 h (0·05% [0·02–0·12] vs 0·50 [0·29–0·86]; p=0·0017).

Interpretation

Pulse oximetry is highly specific for detection of critical congenital heart defects with moderate sensitivity, that meets criteria for universal screening.

Funding

None.

Introduction

Congenital heart defects are a leading cause of infant death, accounting for more deaths than any other type of malformation.1 Up to 40% of all deaths from congenital defects2 and 3–7·5% of infant deaths1 are due to such abnormalities. Surgery greatly improves survival, particularly for infants with potentially life-threatening critical disorders. Most newborn babies with critical congenital heart defects can be diagnosed with echocardiography and, if necessary, stabilised with prostaglandin infusion and treated with surgery or transcatheter intervention.3 If defects are not detected early, there is a risk of circulatory collapse, which can result in shock and acidosis with a substantial adverse effect on prognosis. Poor clinical status at the time of operation increases surgical mortality;4 thus, timely diagnosis improves outcome.5, 6, 7

Screening strategies to detect congenital heart defects include antenatal ultrasound and physical examination of the newborn baby. Both techniques have a fairly low detection rate for isolated defects and many babies are discharged from hospital before diagnosis.8, 9, 10, 11, 12 Pulse oximetry has been developed as a screening method to detect the defects in newborn babies.1 The rationale for use of this method is that most critical congenital heart defects have a degree of hypoxaemia that would not necessarily produce visible cyanosis and therefore might not be clinically detectable. Although health-care systems and governments worldwide are considering pulse oximetry as a screening strategy for newborn babies,13 uncertainty exists about false-positive rates and test accuracy.13 The American Heart Association and the American Academy of Pediatrics have called for analysis of pooled collaborative data before generating recommendations.3 An expert panel in the USA cited emerging evidence to propose a national plan to screen newborn babies with pulse oximtery for early detection of critical congenital heart defects. The recommendation did not provide updated data about the performance of pulse oximetry in this setting.14

Results of individual studies and previous systematic reviews might be imprecise because of low prevalence of congenital heart defects.1, 15 With the addition of more than 100 000 babies in studies published since the last review,16, 17, 18 the accuracy estimates of pulse oximetry should be updated to guide screening policy. We aimed to assess the performance of pulse oximtery as a screening method for the detection of critical congenital heart defects in asymptomatic newborn babies.

Section snippets

Search strategy and selection criteria

This systematic review was undertaken with a prospective protocol using recommended methods.19, 20 We searched Medline (1951–2011), Embase (1974–2011), Cochrane Library (2011), and Scisearch (1974–2011) for relevant citations, and hand searched the reference lists of relevant articles for eligble studies. We examined the reference lists of all known primary and review articles to identify cited articles not captured by the electronic searches. We applied no language restrictions. We considered

Results

Of 552 studies, we identified 13 primary studies that were eligible for inclusion, with data for 229 421 newborn babies (figure 1). The table shows accuracy estimates of the primary studies.16, 17, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 12 cohort16, 17, 24, 25, 26, 28, 29, 30, 31, 32, 33, 34 and one case-control study27 assessed the accuracy of pulse oximetry in the detection of critical congenital heart defects in asymptomatic newborn babies. Nine studies excluded babies who were suspected

Discussion

Our findings show that pulse oximetry is a highly specific test for detection of critical congenital heart defects in asymptomatic newborn babies with low false-positive rates. The false-positive rates were affected by the timing of the test and were significantly lower when the screening was done after 24 h of birth than when it was done before 24 h. This reduction did not compromise test sensitivity; the sensitivity of the test was moderate overall.

In this Article we collated the largest set

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