Congenital Critical Heart Defect Screening in a Health Area of the Community of Valencia (Spain): A Prospective Observational Study

Abstract

Despite the progress in the fetal echocardiographic detection of congenital critical heart defects and neonatal physical examination, a significant number of newborn infants are discharged and readmitted to the hospital in severe condition due to cardiac failure or collapse. The aim of this study was to assess the incidence of undetected critical congenital heart disease (CCHD) by a pulse oximetry-screening program in the maternity wards of hospitals with Perinatal Services in a specific geographic area. This is a prospective observational study performed in in the health area corresponding to the city of Valencia. Eligible infants were consecutively admitted newborn infants in the maternities of the participating hospitals with negative fetal echocardiography after normal physical examination in the delivery room. All patients were screened following a specific pulse oximetry protocol before discharge. A total of 8856 newborn infants were screened. A total of three babies presented with severe congenital cardiac malformation and two babies presented with early onset sepsis. Sensitivity was 100% and specificity was 99.97%, with a positive predictive value of 60% and negative predictive value of 100%. Pulse oximetry screening programs in the early neonatal period constitute a valuable tool to avoid inadvertent hospital discharge of severe cardiac malformations and the subsequent life-threatening complications derived.

Pulse oximetry test for screening congenital heart diseases: a systematic review

“…Subsequently, subgroup analyses were carried out for sensitivity and specificity, according to the time of birth and the first POT measurement between 24 and 48 hours (Figures S1 and S2). In this meta-analysis, 20 studies were included (21)(22)(23)(24)27,28,(31)(32)(33)(35)(36)(37)(38)(40)(41)(42)(44)(45)(46)(47)(48) with a sample of 203,992 participants. An increase in sensitivity to 67% (95% CI: 62% to 72%) and specificity to 97% (95% CI: 97% to 97) was demonstrated.…”

“…A third analysis including studies that were carried out with protocols that contained retests after the first measurement, comprising 13 studies (21,24,27,28,31,32,34,35,37,38,42,44,45) and a sample of 124,469 participants was also developed (Figures S3 and S4). In this analysis, there was a similar increase in sensitivity to 91% (95% CI: 85% to 95%) and specificity to 100% (95% CI: 100% to 100%).…”

Newborn screening: a comprehensive approach to the diagnosis of hereditary and congenital diseases

“…Якщо пульсоксиметрія викликає занепокоєння щодо ВВС, необхідно здійснити діагностичну ехокардіограму. У дослідженнях E. Cubells et al (2018) проведено скринінг у 8856 новонароджених за визначеним протоколом пульсоксиметрії, серед яких у трьох немовлят виявлено КВВС, у двохранній сепсис. Чутливість тесту становила 100%, специфічність -99,97%, з позитивною прогностичною цінністю 60% і негативною прогностичною цінністю 100% [11].…”

“…Отже, у дослідженнях більшості авторів доведено, що поєднання пульсоксиметрії з антенатальною УЗД та клінічним оглядом новонароджених підвищує діагностику ВВС до 92-96%. Пульсоксиметричний скринінг в ранньому неонатальному періоді є цінним інструментом уникнення випадкової виписки новонародженого з лікарні із серйозними серцевими вадами та наступними небезпечними для життя ускладненнями [11]. Водночас пульсоксиметрія призначена для виявлення гіпоксемії, проте не є діагностичною для ВВС; вона визначає категорію дітей для подальшого спостереження та визначення причини гіпоксії.…”

Pulse Oximetry Screening for Critical Congenital Heart Defects: A Life-Saving Test for All Newborn Babies

“…In Europe, significant progress has been made by a multinational group of clinicians working towards a Europe-wide implementation of PO screening [31] and recently publishing a European consensus statement, endorsed by leading figures from European Paediatric and Neonatal Societies [32]. In this special edition, further national recommendations are published from Germany [33] and South and Central America [34], in addition to a local study from Valencia, Spain [35], which was one of the precursors to the recent Spanish recommendation [36]. In the UK, almost half of all maternity units are screening [37] but there is no national recommendation as yet.…”