Role of Pulse Oximetry in Examining Newborns for Congenital Heart Disease: A Scientific Statement from the AHA and AAP

BACKGROUND: The purpose of this statement is to address the state of evidence on the routine use of pulse oximetry in newborns to detect critical congenital heart disease (CCHD). METHODS AND RESULTS: A writing group appointed by the American Heart Association and the American Academy of Pediatrics reviewed the available literature addressing current detection methods for CCHD, burden of missed and/or delayed diagnosis of CCHD, rationale of oximetry screening, and clinical studies of oximetry in otherwise asymptomatic newborns. MEDLINE database searches from 1966 to 2008 were done for English-language papers using the following search terms: congenital heart disease, pulse oximetry, physical examination, murmur, echocardiography, fetal echocardiography, and newborn screening. The reference lists of identified papers were also searched. Published abstracts from major pediatric scientific meetings in 2006 to 2008 were also reviewed. The American Heart Association classification of recommendations and levels of evidence for practice guidelines were used. In an analysis of pooled studies of oximetry assessment performed after 24 hours of life, the estimated sensitivity for detecting CCHD was 69.6%, and the positive predictive value was 47.0%; however, sensitivity varied dramatically among studies from 0% to 100%. False-positive screens that required further evaluation occurred in only 0.035% of infants screened after 24 hours. CONCLUSIONS: Currently, CCHD is not detected in some newborns until after their hospital discharge, which results in significant morbidity and occasional mortality. Furthermore, routine pulse oximetry performed on asymptomatic newborns after 24 hours of life, but before hospital discharge, may detect CCHD. Routine pulse oximetry performed after 24 hours in hospitals that have on-site pediatric cardiovascular services incurs very low cost and risk of harm. Future studies in larger populations and across a broad range of newborn delivery systems are needed to determine whether this practice should become standard of care in the routine assessment of the neonate.

[1]  K. Sandberg,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 , 2009, BMJ : British Medical Journal.

[2]  Kenneth M. Johnson,et al.  Natural Increase: A New Source of Population Growth in Emerging Hispanic Destinations in the United States , 2008 .

[3]  O. J. Johansen,et al.  First day of life pulse oximetry screening to detect congenital heart defects. , 2008, The Journal of pediatrics.

[4]  B. Connolly,et al.  The Reliability of a Single Pulse Oximetry Reading as a Screening Test for Congenital Heart Disease in Otherwise Asymptomatic Newborn Infants , 2008, Pediatric Cardiology.

[5]  R. Chang Abstract 2765: How Many Infants with Critical Congenital Heart Disease Are Missed? , 2007 .

[6]  L. Kruse,et al.  Delayed diagnosis of critical congenital cardiovascular malformations (CCVM) and pulse oximetry screening of newborns , 2007, Acta paediatrica.

[7]  John B Carlin,et al.  Clinical assessment of infant colour at delivery , 2007, Archives of Disease in Childhood Fetal and Neonatal Edition.

[8]  C. Wren,et al.  Twenty-year trends in diagnosis of life-threatening neonatal cardiovascular malformations , 2007, Archives of Disease in Childhood Fetal and Neonatal Edition.

[9]  Rachel L Knowles,et al.  Comparing the clinical and economic effects of clinical examination, pulse oximetry, and echocardiography in newborn screening for congenital heart defects: A probabilistic cost-effectiveness model and value of information analysis , 2007, International Journal of Technology Assessment in Health Care.

[10]  Melonie P. Heron,et al.  Deaths: leading causes for 2003. , 2007, National vital statistics reports : from the Centers for Disease Control and Prevention, National Center for Health Statistics, National Vital Statistics System.

[11]  K. Khan,et al.  Accuracy of pulse oximetry in screening for congenital heart disease in asymptomatic newborns: a systematic review , 2007, Archives of Disease in Childhood - Fetal and Neonatal Edition.

[12]  David V Glidden,et al.  Temporal and Anatomic Risk Profile of Brain Injury With Neonatal Repair of Congenital Heart Defects , 2007, Stroke.

[13]  R. D. Merz,et al.  Use of prenatal diagnostic procedures in pregnancies affected with birth defects, Hawaii, 1986-2002. , 2006, Birth defects research. Part A, Clinical and molecular teratology.

[14]  T. Graham,et al.  Report of the Tennessee Task Force on Screening Newborn Infants for Critical Congenital Heart Disease , 2006, Pediatrics.

[15]  O. Onuzo How effectively can clinical examination pick up congenital heart disease at birth? , 2006, Archives of Disease in Childhood - Fetal and Neonatal Edition.

[16]  L. Valentin,et al.  Routine ultrasound examination at 12 or 18 gestational weeks for prenatal detection of major congenital heart malformations? A randomised controlled trial comprising 36 299 fetuses , 2006, BJOG : an international journal of obstetrics and gynaecology.

[17]  S. Waisbren,et al.  Expanded Newborn Screening for Biochemical Disorders: The Effect of a False-Positive Result , 2006, Pediatrics.

[18]  I. Timor-Tritsch As Technology Evolves, So Should Its Application , 2006, Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine.

[19]  E. Tegnander,et al.  Prenatal detection of heart defects in a non‐selected population of 30 149 fetuses—detection rates and outcome , 2006, Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology.

[20]  R. Arlettaz,et al.  The contribution of pulse oximetry to the early detection of congenital heart disease in newborns , 2006, European Journal of Pediatrics.

[21]  K. Brown,et al.  Delayed diagnosis of congenital heart disease worsens preoperative condition and outcome of surgery in neonates , 2006, Heart.

[22]  P. Isquith,et al.  Relationship of Surgical Approach to Neurodevelopmental Outcomes in Hypoplastic Left Heart Syndrome , 2006, Pediatrics.

[23]  C. Bull,et al.  Newborn screening for congenital heart defects: a systematic review and cost-effectiveness analysis. , 2005, Health technology assessment.

[24]  M. Mellander,et al.  Screening for duct‐dependent congenital heart disease with pulse oximetry: A critical evaluation of strategies to maximize sensitivity , 2005, Acta paediatrica.

[25]  D. Henson,et al.  The effectiveness of the Heidelberg Retina Tomograph and laser diagnostic glaucoma scanning system (GDx) in detecting and monitoring glaucoma. , 2005, Health technology assessment.

[26]  A. Bakr,et al.  Combining Pulse Oximetry and Clinical Examination in Screening for Congenital Heart Disease , 2005, Pediatric Cardiology.

[27]  A. Bakr,et al.  Normal values of pulse oximetry in newborns at high altitude. , 2005, Journal of tropical pediatrics.

[28]  John W. Severinghaus,et al.  Effects of Skin Pigmentation on Pulse Oximeter Accuracy at Low Saturation , 2005, Anesthesiology.

[29]  R. Thiagarajan,et al.  Total anomalous pulmonary venous connection: an analysis of current management strategies in a single institution. , 2005, The Annals of thoracic surgery.

[30]  K. Khan,et al.  Accuracy of fetal echocardiography in the routine detection of congenital heart disease among unselected and low risk populations: a systematic review , 2005, BJOG : an international journal of obstetrics and gynaecology.

[31]  L. B. Dahl,et al.  Major congenital heart disease in Northern Norway: shortcomings of pre‐ and postnatal diagnosis , 2004, Acta obstetricia et gynecologica Scandinavica.

[32]  K. Hartmann,et al.  Racial and Ethnic Disparities in the Use of Pregnancy-Related Health Care Among Medicaid Pregnant Women , 2004, Maternal and Child Health Journal.

[33]  Gabriel J Escobar,et al.  Chorioamnionitis and cerebral palsy in term and near-term infants. , 2003, JAMA.

[34]  Takuo Aoyagi,et al.  Pulse oximetry: its invention, theory, and future , 2003, Journal of Anesthesia.

[35]  R. Stoddard,et al.  Operational Evaluation of Pulse Oximetry in NICU Patients with Arterial Access , 2003, Journal of Perinatology.

[36]  J. Salyer,et al.  Neonatal and pediatric pulse oximetry. , 2003, Respiratory care.

[37]  Charlotte M Druschel,et al.  Effectiveness of pulse oximetry screening for congenital heart disease in asymptomatic newborns. , 2003, Pediatrics.

[38]  J. Huhta,et al.  The use of pulse oximetry to detect congenital heart disease. , 2003, The Journal of pediatrics.

[39]  S. Gidding,et al.  What Pediatric Residents Should Learn (or What Pediatricians Should Know) about Congenital Heart Disease , 2003, Pediatric Cardiology.

[40]  D. Danford Sorting through the haystack--decision analysis and the search for heart disease among children with murmur. , 2002, The Journal of pediatrics.

[41]  Robert A. Zimmerman,et al.  An MRI Study of Neurological Injury Before and After Congenital Heart Surgery , 2002, Circulation.

[42]  S. Berger,et al.  Improved Survival of Patients Undergoing Palliation of Hypoplastic Left Heart Syndrome: Lessons Learned From 115 Consecutive Patients , 2002, Circulation.

[43]  R. Jonas,et al.  Neurodevelopmental Outcome After Congenital Heart Surgery: Results From an Institutional Registry , 2002, Circulation.

[44]  S. Richmond,et al.  Routine pulse oximetry in the asymptomatic newborn , 2002, Archives of disease in childhood. Fetal and neonatal edition.

[45]  B. Byrne,et al.  Oxygen Saturation as a Screening Test for Critical Congenital Heart Disease: A Preliminary Study , 2002, Pediatric Cardiology.

[46]  Catherine Limperopoulos,et al.  Predictors of developmental disabilities after open heart surgery in young children with congenital heart defects. , 2002, The Journal of pediatrics.

[47]  W. Hay,et al.  Reliability of Conventional and New Pulse Oximetry in Neonatal Patients , 2002, Journal of Perinatology.

[48]  S. Nicolson,et al.  Risk factors for mortality after the Norwood procedure. , 2002, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[49]  A. Becker,et al.  Oxygen saturation in healthy newborn infants immediately after birth measured by pulse oximetry , 2002, Archives of Gynecology and Obstetrics.

[50]  B. Rosenblatt,et al.  Functional limitations in young children with congenital heart defects after cardiac surgery. , 2001, Pediatrics.

[51]  Cjb Ward,et al.  Diagnostic accuracy of paediatric echocardiograms interpreted by individuals other than paediatric cardiologists , 2001, Journal of paediatrics and child health.

[52]  M. Turrentine,et al.  Arterial switch operation: factors impacting survival in the current era. , 2001, The Annals of thoracic surgery.

[53]  J E Goin,et al.  Impact of prenatal diagnosis on survival and early neurologic morbidity in neonates with the hypoplastic left heart syndrome. , 2001, Pediatrics.

[54]  J. David Erickson,et al.  Mortality Associated With Congenital Heart Defects in the United States: Trends and Racial Disparities, 1979–1997 , 2001, Circulation.

[55]  N. Silverman,et al.  Improved Surgical Outcome After Fetal Diagnosis of Hypoplastic Left Heart Syndrome , 2001, Circulation.

[56]  J D Erickson,et al.  Racial and temporal variations in the prevalence of heart defects. , 2001, Pediatrics.

[57]  H. C. Nielsen,et al.  Pulse oximetry: What's normal in the newborn nursery? , 2000, Pediatric pulmonology.

[58]  D. Danford Clinical and basic laboratory assessment of children for possible congenital heart disease , 2000, Current opinion in pediatrics.

[59]  L. Allan A practical approach to fetal heart scanning. , 2000, Seminars in perinatology.

[60]  A. Rosano,et al.  Infant mortality and congenital anomalies from 1950 to 1994: an international perspective , 2000, Journal of epidemiology and community health.

[61]  S. Hunter,et al.  Prenatal diagnosis of congenital heart disease in the northern region of England: benefits of a training programme for obstetric ultrasonographers , 2000, Heart.

[62]  K. Gauvreau,et al.  Cognitive development after the Fontan operation. , 2000, Circulation.

[63]  C. Poets,et al.  Oxygen saturation during the first 24 hours of life , 2000, Archives of disease in childhood. Fetal and neonatal edition.

[64]  C. Poets Assessing oxygenation in healthy infants. , 1999, The Journal of pediatrics.

[65]  D. Wypij,et al.  Developmental and neurological status of children at 4 years of age after heart surgery with hypothermic circulatory arrest or low-flow cardiopulmonary bypass. , 1999, Circulation.

[66]  C. Cans,et al.  Efficacy of routine fetal ultrasound screening for congenital heart disease in Isère county, France , 1999, Prenatal diagnosis.

[67]  C. Loffredo,et al.  Failure to diagnose congenital heart disease in infancy , 1999, Pediatrics.

[68]  E. Foster,et al.  Diagnostic accuracy of pediatric echocardiograms performed in adult laboratories. , 1999, The American journal of cardiology.

[69]  J Kachaner,et al.  Detection of transposition of the great arteries in fetuses reduces neonatal morbidity and mortality. , 1999, Circulation.

[70]  J. Wyllie,et al.  Prevalence and clinical significance of cardiac murmurs in neonates , 1999, Archives of disease in childhood. Fetal and neonatal edition.

[71]  J. Brenner,et al.  Neurodevelopmental Outcomes in Children Surviving d‐Transposition of the Great Arteries , 1998, Journal of developmental and behavioral pediatrics : JDBP.

[72]  J. Bofill,et al.  Obstetric sonography. Who to scan, when to scan, and by whom. , 1998, Obstetrics and gynecology clinics of North America.

[73]  W. Williams,et al.  Mortality in potential arterial switch candidates with transposition of the great arteries. , 1998, Journal of the American College of Cardiology.

[74]  N. Talner,et al.  Report of the New England Regional Infant Cardiac Program, by Donald C. Fyler, MD, Pediatrics, 1980;65(suppl):375-461. , 1998, Pediatrics.

[75]  E. Merz,et al.  Prenatal diagnosis of major malformations: quality control of routine ultrasound examinations based on a five‐year study of 20 248 newborn fetuses and infants , 1998, Prenatal diagnosis.

[76]  D. Wypij,et al.  Patterns of Developmental Dysfunction After Surgery During Infancy to Correct Transposition of the Great Arteries , 1997, Journal of developmental and behavioral pediatrics : JDBP.

[77]  S J Barker,et al.  Effects of Motion on the Performance of Pulse Oximeters in Volunteers , 1996, Anesthesiology.

[78]  C. Poets,et al.  Detection of movement artifact in recorded pulse oximeter saturation , 1996, European Journal of Pediatrics.

[79]  W. Gersony,et al.  Early diagnosis of coarctation of the aorta in children: a continuing dilemma. , 1996, Pediatrics.

[80]  C. Poets,et al.  Arterial oxygen saturation in healthy term neonates , 1996, European Journal of Pediatrics.

[81]  Gregory L. Holmes,et al.  Developmental and neurologic status of children after heart surgery with hypothermic circulatory arrest or low-flow cardiopulmonary bypass. , 1995, The New England journal of medicine.

[82]  G. Katzman The newborn's SpO2: a routine vital sign whose time has come? , 1995, Pediatrics.

[83]  E. Morgan Prenatal detection of neuroblastoma--a noninvasive approach. , 1995, Pediatrics.

[84]  E. Hey,et al.  Presentation of obstructive left heart malformations in infancy. , 1994, Archives of disease in childhood. Fetal and neonatal edition.

[85]  T. Nolan,et al.  Impact of cyanotic heart disease on school performance. , 1994, Archives of disease in childhood.

[86]  E. Shaffer,et al.  Arterial oxygenation and pulmonary arterial pressure in healthy neonates and infants at high altitude. , 1993, The Journal of pediatrics.

[87]  J. Walton,et al.  Profile and stability of sensorineural hearing loss in persistent pulmonary hypertension of the newborn. , 1991, Journal of speech and hearing research.

[88]  W B Runciman,et al.  Pulse oximeter probes A comparison between finger, nose, ear and forehead probes under conditions of poor perfusion * , 1991, Anaesthesia.

[89]  O. Pryds,et al.  Vasoparalysis associated with brain damage in asphyxiated term infants. , 1990, The Journal of pediatrics.

[90]  H. Levison,et al.  Transcutaneous monitoring of oxygenation: what is normal? , 1986, The Journal of pediatrics.

[91]  M. Lees Cyanosis of the newborn infant , 1970 .

[92]  J. Clarke,et al.  Medicine , 1907, Bristol medico-chirurgical journal.

[93]  J. Stockman First Day of Life Pulse Oximetry Screening to Detect Congenital Heart Defects , 2010 .

[94]  G. Matherne,et al.  Scientific Statement from the AHA and AAP Role of Pulse Oximetry in Examining Newborns for Congenital Heart Disease: A , 2009 .

[95]  R. Chang,et al.  Screening Newborns for Congenital Heart Disease with Pulse Oximetry: Survey of Pediatric Cardiologists , 2008, Pediatric Cardiology.

[96]  A. Fanaroff Clinical assessment of infant colour at delivery , 2008 .

[97]  C. D. Kurth,et al.  Brain magnetic resonance imaging abnormalities after the Norwood procedure using regional cerebral perfusion. , 2005, The Journal of thoracic and cardiovascular surgery.

[98]  G. Latini,et al.  Indications and limitations for a neonatal pulse oximetry screening of critical congenital heart disease , 2005, Journal of perinatal medicine.

[99]  Craig A Sable,et al.  Impact of telemedicine on the practice of pediatric cardiology in community hospitals. , 2002, Pediatrics.

[100]  B. Clark,et al.  Unexpected death after reconstructive surgery for hypoplastic left heart syndrome. , 2001, The Annals of thoracic surgery.

[101]  C. Samango-Sprouse,et al.  Developmental concerns in children with congenital heart disease. , 1997, Current opinion in cardiology.

[102]  J. Severinghaus,et al.  History and recent developments in pulse oximetry. , 1993, Scandinavian journal of clinical and laboratory investigation. Supplementum.

[103]  W. Hay Physiology of oxygenation and its relation to pulse oximetry in neonates. , 1987, Journal of perinatology : official journal of the California Perinatal Association.

[104]  Report of the New England Regional Infant Cardiac Program. , 1980, Pediatrics.

[105]  M. Lees Cyanosis of the newborn infant. Recognition and clinical evaluation. , 1970, The Journal of pediatrics.