Universal Pulse Oximetry Screening Research Articles

Coarctation of the aorta: Prenatal assessment, postnatal management and neonatal outcomes

Coarctation of the aorta (Coa) is a potentially life threatening diagnosis. It occurs in 0.3 per 1000 live births and accounts for 6-8% of all infants with congenital heart defects. Neonates with severe Coa may be completely asymptomatic at birth, as the ductus arteriosus can provide flow to the lower body. Those who are not diagnosed prenatally may be diagnosed only after constriction of the ductus arteriosus, when they present in cardiogenic shock. This group has a higher risk for mortality and morbidity relative to those diagnosed prenatally. Despite the increasing practice of universal pulse oximetry screening, many cases with significant coarctation of the aorta still go undiagnosed in the newborn period. In this article, we present the pathophysiology, diagnosis, presentation, treatment and outcomes of Coa.

Lessons Learned from Infants with Late Detection of Critical Congenital Heart Disease.

Late detection of critical congenital heart disease (CCHD) is multifactorial and ill defined. We investigated the results of pulse oximetry screening (POS) and points in the care chain that contribute to delayed detection of CCHD. The medical records of 13 infants with delayed detection at a single pediatric cardiac center between 2013 and 2016 were identified and reviewed. Left heart obstructive lesions were the most common diagnosis (n = 8; 62%) and included coarctation of the aorta (n = 6), interrupted aortic arch with ventricular septal defect (n = 1), and critical aortic stenosis (n = 1). Tetralogy of Fallot (TOF) (n = 2), truncus arteriosus (n = 1), pulmonary atresia with ventricular septal defect (n = 1), and total anomalous pulmonary venous drainage (n = 1) made up the remainder of the conditions. Routine prenatal care was reported in most infants (10/13). Infants with late detection had either a true negative POS (10/13 infants) or no POS performed (3/13 infants). At the time of detection, 5/6 (83%) infants with coarctation had normal pulse oximetry values, whereas 6/7 (86%) infants with other CCHD developed abnormal pulse oximetry values. At diagnosis, 11/13 (85%) infants had significant signs or symptoms of clinical deterioration; only 2 infants were completely asymptomatic. Late detection of CCHD is uncommon and multifactorial. Eliminating late detection is dependent upon improving detection on screening obstetrical ultrasounds, enforcement of universal POS, and attention to the neonatal physical exam.

Reflections on Pulse Oximetry Screening for CCHD.

The idea of using pulse oximetry to screen for critical congenital heart disease (CCHD) began >20 years ago.1 The concept, which is simple in principle, took a laborious path from curious possibility to national standard.Much of the delay in implementing this screening process related to anxiety about the impact of false-positive tests and the burden on the health care system. Thankfully, since the broader acceptance of this screening approach, much of the anxiety has been allayed through our increased understanding of the logistics of pulse oximetry screening.In this issue of Pediatrics, Schwartz et al describe their experience at a large community hospital over 8 years.2 It should be noted that this hospital and this clinical team were instrumental in moving the pulse oximetry screening model forward. It is exciting to see this longer-term experience.The results described by Schwartz et al are largely reassuring. The positive predictive value for screening was 39% for CCHD. Over an 8-year period, only 31 out of almost 65 000 newborns failed the pulse oximetry screening. When the concept of universal pulse oximetry screening was first proposed, there were concerns that a high proportion of newborns would require detailed and expensive cardiology screening with echocardiography and, potentially, additional consultation. But, as Schwartz and others have shown, this turns out not to be the case. Most centers have been able to implement the pulse oximetry screening in an efficient manner incorporated into the routine care of newborns. Although there is admittedly substantial amount of work to screen 65 000 newborns only to uncover 12 children with critical congenital heart disease, such early detection can certainly be lifesaving. The yield is higher than many other newborn screens that have been endorsed by national organizations.3At this point, the pulse oximetry screening paradigm has largely been embraced. There had been some hope that, over time, prenatal detection might continue to increase such that the need for pulse oximetry screening would be unnecessary. However, the trends in prenatal diagnosis improvement seem to have plateaued. Therefore, for the foreseeable future, pulse oximetry–based CCHD screening in the newborns will continue to have an important role.Several investigators have shown that pulse oximetry screening for CCHD is cost-effective and lifesaving.4 The work by Schwartz et al has helped catalyze this national effort to advance pulse oximetry screening. This new critical appraisal of their experience over 8 years helps to provide context and further refinement to the pulse oximetry screening model. Their work, and that of others, has suggested refinements to this screening paradigm to minimize work but still achieve a high yield but low false-negative rate.5 Schwartz et al and the other pioneers in this arena deserve to be congratulated. Children with CCHD are alive today and thriving because of pulse oximetry–based screening. We can celebrate a successful paradigm of public health, clinician, and most importantly, patient and family collaboration to reduce unnecessary deaths from missed CCHD.

New born pulse oximetry screening: A global perspective

The possibility of pulse oximetry screening (POS) for congenital heart defects was first described over 20 years ago. Since then, an accumulation of research evidence and clinical practice experience has established POS as an important test to detect critical congenital heart defects (CCHDs). POS meets the criteria for universal screening and professional bodies around the globe have recommended universal POS. Many countries have already adopted POS while several others are working towards its implementation. In low and low-middle-income countries (LLMIC), POS has the additional potential for reducing morbidity and mortality from neonatal sepsis. This review summarises the evidence for POS and looks at current global uptake and different approaches to the implementation of POS.

Pulse Oximetry Screening and Critical Congenital Heart Disease in the State of Oregon.

Late diagnosis of critical congenital heart disease (CCHD) is associated with higher levels of morbidity and mortality in neonates. Nearly all states have passed laws mandating universal pulse oximetry screening (POxS) of newborns to improve early detection rates of CCHD. We performed a retrospective chart review of all transthoracic echocardiograms (TTEs) interpreted by our institution on patients between 0 and 30 days of life in the years 2010 (prior to POxS) and 2015 (after POxS). Between 2010 and 2015, the number of neonatal TTEs interpreted by our institution decreased by 18.2%. In 2015, there were 46 neonates diagnosed with CCHD with a 78% prenatal detection rate. There was only one case of a true-positive POxS. Our study demonstrated that the initiation of POxS coincided with a significant decrease in neonatal TTEs, suggesting universal POxS may impart reassurance to primary providers leading to a decrease in TTE utilization.

Pulse oximetry screening for detection of congenital heart defects at 1646 m in Albuquerque, New Mexico.

To determine the false-positive rate of pulse oximetry screening at moderate altitude, presumed to be elevated compared with sea level values and assess change in false-positive rate with time. We retrospectively analysed 3548 infants in the newborn nursery in Albuquerque, New Mexico, (elevation 5400 ft) from July 2012 to October 2013. Universal pulse oximetry screening guidelines were employed after 24 hours of life but before discharge. Newborn babies between 36 and 36 6/7 weeks of gestation, weighing >2 kg and babies >37 weeks weighing >1.7 kg were included in the study. Log-binomial regression was used to assess change in the probability of false positives over time. Of the 3548 patients analysed, there was one true positive with a posteriorly-malaligned ventricular septal defect and an interrupted aortic arch. Of the 93 false positives, the mean pre- and post-ductal saturations were lower, 92 and 90%, respectively. The false-positive rate before April 2013 was 3.5% and after April 2013, decreased to 1.5%. There was a significant decrease in false-positive rate (p = 0.003, slope coefficient = -0.082, standard error of coefficient = 0.023) with the relative risk of a false positive decreasing at 0.92 (95% CI 0.88-0.97) per month. This is the first study in Albuquerque, New Mexico, reporting a high false-positive rate of 1.5% at moderate altitude at the end of the study in comparison to the false-positive rate of 0.035% at sea level. Implementation of the nationally recommended universal pulse oximetry screening was associated with a high false-positive rate in the initial period, thought to be from the combination of both learning curve and altitude. After the initial decline, it remained steadily elevated above sea level, indicating the dominant effect of moderate altitude.

CCHD Screening Implementation Efforts in Latin American Countries by the Ibero American Society of Neonatology (SIBEN).

Congenital heart disease (CHD) is among the four most common causes of infant mortality in Latin America. Pulse oximetry screening (POS) is useful for early diagnosis and improved outcomes of critical CHD. Here, we describe POS implementation efforts in Latin American countries guided and/or coordinated by the Ibero American Society of Neonatology (SIBEN), as well as the unique challenges that are faced for universal implementation. SIBEN collaborates to improve the neonatal quality of care and outcomes. A few years ago, a Clinical Consensus on POS was finalized. Since then, we have participated in 12 Latin American countries to educate neonatal nurses and neonatologists on POS and to help with its implementation. The findings reveal that despite wide disparities in care that exist between and within countries, and the difficulties and challenges in implementing POS, significant progress has been made. We conclude that universal POS is not easy to implement in Latin America but, when executed, has not only been of significant value for babies with CHD, but also for many with other hypoxemic conditions. The successful and universal implementation of POS in the future is essential for reducing the mortality associated with CHD and other hypoxemic conditions and will ultimately lead to the survival of many more Latin American babies. POS saves newborns’ lives in Latin America.

Detecting Critical Congenital Heart Disease in Nevada.

We reviewed data on patients born with critical congenital heart disease in the state of Nevada and analyzed detection via prenatal diagnosis versus newborn pulse oximetry screening, location of birth, and gestational age at birth. We inquired our databases and electronic health records for all patients with critical congenital heart disease born in Nevada between January 2016 and May 2019. We identified 218 live born patients. Of the 218, average gestational age was 38 weeks (±2.2 weeks). Of the 218, 171 (78%) were prenatally diagnosed, 37 (17%) were diagnosed by immediate postnatal signs and symptoms, 8 (4%) had false-negative pulse oximetry screens that resulted in post-hospital discharge presentations, and 2 (1%) had positive pulse oximetry screens. The eight post-hospital discharge presentations included four in extremis, two with extreme cyanosis, and two dying at home. Of the 171 prenatally diagnosed patients, 157 (92%) were born at the Nevada hospital with the congenital cardiac unit. To the best of our knowledge, our results represent the highest statewide, general population prenatal detection of critical congenital heart disease in the United States. Our high prenatal detection rate led to the majority of patients being born at the Nevada facility with the congenital heart unit, limiting intrastate neonatal transports. On average, patients were born at term. Further, in Nevada, state-mandated, universal pulse oximetry screening resulted in more false-negative results than positive results.

A Reply to Comment on Kluckow M. Barriers to the Implementation of Newborn Pulse Oximetry Screening: A Different Perspective. Int. J. Neonatal Screen. 2018, 4(1), 4.

The commentary provided by Gentles et al. argues for the implementation of a universal pulse oximetry screening program, and I agree that, if it is possible, this is the optimum way to introduce this important health care measure for all of the reasons set out by the authors.[...]

An investigation into the challenges and limitations of implementing universal pulse oximetry screening for critical congenital heart disease in asymptomatic newborns

Neonatal pulse oximetry has been identified as an important screening tool for critical congenital heart disease. This oximetry screening, although mandatory in many developed countries, is not routinely implemented in South African hospitals. The objective of this study was therefore to determine the feasibility of implementing pulse oximetry in a typical level 2 hospital in the province of KwaZulu-Natal. Challenges and limitations experienced in implementing the screening were documented. The study was an observational analytical descriptive study which was conducted in the postnatal ward of Addington Hospital, Durban. Nursing staff were educated regarding the importance of pulse oximetry screening and were subsequently trained to perform the procedure. A total of 2 453 newborns were admitted to the hospital from January to August 2016 with 599 of these being eligible for enrolment in the study. Consent and screening were initially performed by participating nursing staff. During the last 4 months, consent was obtained by a dedicated research assistant. Of the 599 eligible newborns, 22 were excluded resulting in 577 being available for analysis. There were 29 newborns who fulfilled criteria for a second screening, however, in 21 of these newborns, the protocol was not appropriately followed. This study suggests that while routine neonatal saturation monitoring appears to be a simple, cost-effective tool to detect critical congenital heart disease, several barriers to its implementation were detected. The main barriers were inadequate staffing and infrastructure. This, in turn, highlighted the need for appropriate human resource provision and training as well as adequate infrastructure. These may not be easily achievable in a resource constrained environment.

P.4.a.005 - Chronic social defeat stress: impact on sleep in susceptible mice

The possibility of pulse oximetry screening (POS) for congenital heart defects was first described over 20 years ago. Since then, an accumulation of research evidence and clinical practice experience has established POS as an important test to detect critical congenital heart defects (CCHDs). POS meets the criteria for universal screening and professional bodies around the globe have recommended universal POS. Many countries have already adopted POS while several others are working towards its implementation. In low and low-middle-income countries (LLMIC), POS has the additional potential for reducing morbidity and mortality from neonatal sepsis. This review summarises the evidence for POS and looks at current global uptake and different approaches to the implementation of POS.

Universal Pulse Oximetry Screening for Critical Congenital Heart Disease in Asymptomatic Newborns

Submit Manuscript | http://medcraveonline.com screening newborns for CCHDs after the first 24 hours of life [3]. The New Jersey protocol requires both pre-ductal (right hand) and post-ductal (either foot) measured oxygen saturations to be 95% or higher. Any infant who fails the pulse oximetry screen should have a diagnostic echocardiogram. In June 2011, New Jersey passed a law requiring pulse oximetry screening in all licensed birthing facilities. Soon after, the Department of Health developed a screening algorithm that specified pre and post-ductal screening between 24 and 48 hours of life or prior to hospital discharge. In September 2011, Kathleen Sebelius, the US Secretary of Health and Human Services, recommended that all states add pulse oximetry screening for CCHDs to the uniform screening panel for newborns. Subsequently, the American Academy of Pediatrics published a policy statement endorsing the Health and Human Services’ recommendation [4]. The American College of Cardiology Foundation and the American Heart Association recommended that screening should be done no earlier than 24 hours of life and before hospital discharge. Many states are moving toward legislation mandating all birthing centers and hospitals to screen for CCHDs. Today, many hospitals in the US have voluntarily initiated routine pulse oximetry screening for CCHDs in asymptomatic newborns.

Identification of Critical Congenital Heart Disease in Vermont: The Role of Universal Pulse Oximetry Screening in a Rural State.

Pulse oximetry screening (POS) is becoming the standard of care in screening for critical congenital heart disease (CCHD). Our objective was to characterize the historical diagnostic pattern in a rural tertiary care children's hospital and explore how universal POS might affect morbidity, mortality, and care delivery. We identified patients <6 months of age in the Vermont Children's Hospital echocardiogram database with CCHD diagnosed between 2002 and 2011. Charts were reviewed to characterize timing of diagnosis, course, and outcome. The medical examiner was consulted to identify deaths due to undetected CCHD during the study period. Of 60 329 live births, 73 (0.12 %) were diagnosed with CCHD. Of these, 31 (42%) were diagnosed prenatally, 34 (47%) were diagnosed by clinical examination in the nursery, 7 (9.6%) were diagnosed after nursery discharge, and 1 (1.4%) was born at home. The 8 patients not diagnosed by prenatal ultrasound or in the nursery were considered cases of undetected CCHD. Three had normal oxygen saturation (>95%) at diagnosis. Three presented with cardiovascular compromise. None died and all were well at the most recent follow-up. Review of autopsy reports from patients <6 months found no deaths from undetected CCHD during the study period. Over a 10-year period at our institution, universal POS could have identified 5 patients with undetected CCHD, possibly avoiding the need for resuscitation in 3. Examination of local diagnostic data may affect the cost/benefit considerations of universal POS initiatives in a setting of limited healthcare resources.

Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study

Several pioneering studies have provided evidence for the introduction of universal pulse oximetry screening for critical congenital heart disease. However, whether the benefits of screening reported in studies from high-income countries would translate with similar success to low-income countries is unknown. We assessed the feasibility and reliability of pulse oximetry plus clinical assessment for detection of major congenital heart disease, especially critical congenital heart disease, in China. We did a pilot study at three hospitals in Shanghai to assess the accuracy of pulse oximetry plus clinical assessment for detection of congenital heart disease. We made a data collection plan before recruitment. We then undertook a large, prospective, and multicentre screening study in which we screened all consecutive newborn babies (aged 6-72 h) born at 18 hospitals in China between Aug 1, 2011, and Nov 30, 2012. Newborn babies with positive screen results (either an abnormal pulse oximetry or abnormal clinical assessment) were referred for echocardiography within 24 h of screening. We identified false-negative results by clinical follow-up and parents' feedback. We calculated sensitivity, specificity, positive and negative predictive values, and positive and negative likelihood ratios for pulse oximetry alone, and in combination with clinical assessment, for detection of major and critical congenital heart disease. In the pilot study, 6785 consecutive newborn babies were screened; 46 of 49 (94%) cases of asymptomatic major congenital heart disease and eight of eight (100%) cases of asymptomatic critical disease were detected by pulse oximetry and clinical assessment. In the prospective multicentre study, we screened 122,738 consecutive newborn babies (120,707 asymptomatic and 2031 symptomatic), and detected congenital heart disease in 1071 (157 critical and 330 major). In asymptomatic newborn babies, the sensitivity of pulse oximetry plus clinical assessment was 93·2% (95% CI 87·9-96·2) for critical congenital heart disease and 90·2% (86·4-93·0) for major disease. The addition of pulse oximetry to clinical assessment improved sensitivity for detection of critical congenital heart disease from 77·4% (95% CI 70·0-83·4) to 93·2% (87·9-96·2). The false-positive rate for detection of critical disease was 2·7% (3298 of 120,392) for clinical assessment alone and 0·3% (394 of 120,561) for pulse oximetry alone. Pulse oximetry plus clinical assessment is feasible and reliable for the detection of major congenital heart disease in newborn babies in China. This simple and accurate combined method should be used in maternity hospitals to screen for congenital heart disease. Key Clinical Research Project sponsored by Ministry of Health, Shanghai Public Health Three-Year Action Plan sponsored by Shanghai Municipal Government, and National Basic Research Project of China.

Abstract 228: A Cost-effectiveness Analysis Of Universal Pulse Oximetry Screening To Detect Critical Congenital Heart Disease In U.s. Newborns

Background and objective: In 2011, critical congenital heart disease (CCHD) was added to the Recommended Uniform Screening Panel for newborns. Most state legislatures have not yet mandated pulse oximetry screening to detect CCHD, and evidence that the screening is cost-effective might be influential in these decisions. This study aimed to estimate the cost-effectiveness of universal newborn pulse oximetry screening for CCHD in the U.S. from the hospital system perspective. Methods: A model was developed to estimate the direct medical costs and health effects of screening all newborns. The health benefits were the number of timely (prior to birth hospital discharge) detected CCHD and life-years saved with the screening compared to existing practice. The analysis focused on ductal-dependent CCHD lesions amenable to pulse oximetry detection. The time horizon was the neonatal period. Costs were not discounted, though future life-years were discounted at 3%. Model inputs related to the epidemiology of CCHD, treatment outcomes, and efficacy of pulse oximetry screening to detect CCHD were derived from published literature. Results: The cost of screening was an estimated $3.83 per newborn, with an incremental cost of $4,693 per life year gained as a result of the screening. Using current U.S. hospital-based births, it was estimated that 248 more cases of CCHD would be identified at birth hospitals and 110 infant deaths averted annually with universal screening. Conclusion: Pulse oximetry screening is a life-saving program and is cost-effective by usual standards of health economic evaluation. The results of this analysis might contribute to policymakers’ decisions on universal pulse oximetry screening and may inform other stakeholders, including health care systems and payers, about likely budget impacts. Further analyses of CCHD hospitalization and screening costs can improve these model estimates.

The Road to Universal Pulse-Oximetry Screening: Are We There Yet?

Congenital heart disease is the most common birth defect and represents nearly 40% of all deaths caused by congenital anomalies.1 Critical congenital heart disease (CCHD), which encompasses the more severe forms, is present in 2.5 to 3 in 1000 live births.2 In general, prenatal ultrasound or physical examination alone can easily miss newborns with CCHD.3,4 Failure to diagnose CCHD early in life can result in high morbidity and mortality rates, because symptoms frequently present after closing of the pulmonary ductus arteriosus, after nursery discharge. Pulse-oximetry screening is a low-cost, painless, noninvasive test that increases the ability to identify newborns with CCHD before they clinically decompensate.5,–,8 In 2009 the American Heart Association and American Academy of Pediatrics published a scientific statement regarding the role of pulse oximetry in examining newborns for CCHD.9 Despite presenting strong support for this method, they stopped shy of recommending universal screening and called for further studies on implementation. In September 2010, the US Department of Health and Human Services (HHS) Secretary's Advisory Committee on Heritable Disorders in Newborns and Children recommended that CCHD be added to the uniform screening panel. However, … Address correspondence to Sandra Cuzzi, MD, Division of Hospitalist Medicine, Children's National Medical Center, 111 Michigan Ave NW, Washington, DC 20010. E-mail: scuzzi{at}childrensnational.org

Neonatal Screening for Life-threatening Congenital Heart Disease

Obstetric Anesthesia Digest: June 2011 - Volume 31 - Issue 2 - p 82 doi: 10.1097/01.aoa.0000397110.10676.03

Critical heart defects—the diagnostic challenge

Infants with potentially life threatening congenital heart defects (CHDs) are discharged from hospital after birth with the condition unrecognized. Improved prenatal ultrasound imaging and universal pulse oximetry screening of babies in nurseries are strategies that probably most would contribute to avoid such defects to be missed. In general combining first day of life pulse oximetry, clinical examination and echocardiography before discharge in suspect cases is a rational strategy for early postnatal detection of heart defects. Universal echocardiography screening of newborns may be too resource consuming to be cost-effective.