de-Wahl Granelli A, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganas L, et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: A Swedish prospective screening study in 39 821 newborns. BMJ 2009;338:a3037.
Question
Among newborns, what is the accuracy of pulse oximetry in screening for early detection of life-threatening congenital heart disease?
Design
Prospective screening study.
Setting
All 5 maternity units in West Götaland, Sweden, and the supraregional referral center for neonatal heart surgery.
Participants
A total of 39821 screened babies born between July 2004 and March 2007. Total duct-dependent circulation cohorts: West Götaland n = 60, other regions n = 100.
Intervention
Pulse oximetry before discharge from newborn nurseries in West Götaland.
Outcomes
Sensitivity, specificity, positive and negative predictive values, and likelihood ratio for pulse oximetry screening and for neonatal physical examination alone.
Main Results
In West Götaland, 29 babies in well baby nurseries had duct-dependent circulation undetected before neonatal discharge examination. In 13 cases, pulse oximetry showed oxygen saturation ≤90%, and clinical staff were immediately told of the results. Of the remaining 16 cases, physical examination alone detected 10 (63%). Combining physical examination with pulse oximetry screening had a sensitivity of 82.8% (95% CI 64.2% to 95.2%) and detected 100% of the babies with duct-dependent lung circulation. Five cases were missed (all with aortic arch obstruction). The false-positive rate with pulse oximetry was substantially lower than that with physical examination alone (0.17% vs 1.90%, P < .0001), and 31/69 of the “false-positive” cases with pulse oximetry had other disease. The risk of leaving the hospital with undiagnosed duct-dependent circulation was 28% in other regions versus 8% in West Götaland (P < .0025, relative risk 3.36 [95% CI 1.37 to 8.24]). In the other regions, 44% of babies with transposition of the great arteries left hospital undiagnosed versus 0/18 in West Götaland (P < .0010), and severe acidosis at diagnosis was more common (33% vs 12%, P < .0025, relative risk 2.8 [1.3 to 6.0]). Excluding premature babies and Norwood surgery, babies discharged without diagnosis had higher mortality rates than those diagnosed in the hospital (18% vs 0.9%, P < .0054). No baby died of undiagnosed duct-dependent circulation in West Götaland versus 5 babies from the other regions.
Conclusions
Introducing pulse oximetry screening before discharge improved total detection rate of duct-dependent circulation to 92%. Such screening seems cost neutral in the short term, but the probable prevention of neurologic morbidity and reduced need for preoperative neonatal intensive care suggest that such screening will be cost-effective in the long term.
Commentary
Infants discharged from the birth hospital without identification of their critical congenital heart disease have increased mortality and morbidity rates compared with those who receive a diagnosis; universal neonatal pulse oximetry screening has been introduced as a means to identify a greater proportion of such infants. The authors of this study demonstrated a reduction in the proportion of infants discharged without a diagnosis from 28% (consistent with other data) to 8% with the introduction of screening. Other very large studies have similar results.1 Saturation in a lower limb < 96% obtained from a new-generation motion artefact–resistant oximeter after 20 hours of age, when performed by adequately trained technicians for at least 360 seconds, appears to be a reliable indicator of duct-dependent right-sided heart disease.2 A gradient of more than 3% between the right hand and a foot may be a useful indicator of left-sided disorders.2 The 0.17% false-positive rate reported by de-Wahl Granelli et al seems reasonable if it can be reproduced in routine usage, which will be important to minimize the potential harm of parental stress. Even so, screening for a relatively rare condition will usually result in more false positive than true-positive results, and counselling must take this into account. Screening does not detect all critical congenital heart disease, particularly coarctation of the aorta as these authors again demonstrate, and infants presenting with clinical signs consistent with heart disease must still have consideration of this as a diagnostic possibility, even if previously screened. In 2005, a systematic review labeled pulse oximetry screening “promising”3; these new large studies suggest that the promise is being fulfilled.
References
1. 1Meberg A, Brngmann-Pieper S, Due R, Eskedal L, Fagerli Ir, Farstad T, et al.First day of life pulse oximetry screening to detect congenital heart defects. J Pediatr. 2008;152:761–765. Abstract | Full Text |
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2. 2de Wahl Granelli A, Mellander M, Sunnegardh J, Sandberg K, Ostman-Smith I. Screening for duct-dependant congenital heart disease with pulse oximetry: a critical evaluation of strategies to maximize sensitivity. Acta Paediatr. 2005;94:1590–1596. MEDLINE |
CrossRef
3. 3Knowles R, Griebsch I, Dezateux C, Brown J, Bull C, Wren C. Newborn screening for congenital heart defects: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2005;9:1–152. MEDLINE
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