New Jersey was the first state to implement legislatively mandated newborn pulse oximetry screening (POxS) in all licensed birthing facilities to detect critical congenital heart defects (CCHDs). The objective of this report was to evaluate implementation of New Jersey’s statewide POxS mandate.
A 2-pronged approach was used to collect data on infants screened in all New Jersey birthing facilities from August 31, 2011, through May 31, 2012. Aggregate screening results were submitted by each birthing facility. Data on failed screens and clinical characteristics of those newborns were reported to the New Jersey Birth Defects Registry (NJBDR). Three indicators were used to distinguish the added value of mandated POxS from standard clinical care: prenatal congenital heart defect diagnosis, cardiology consultation or echocardiogram indicated or performed before PoxS, or clinical findings at the time of POxS warranting a pulse oximetry measurement.
Of 75 324 live births in licensed New Jersey birthing facilities, 73 320 were eligible for screening, of which 99% were screened. Forty-nine infants with failed POxS were reported to the NJBDR, 30 of whom had diagnostic evaluations solely attributable to the mandated screening. Three of the 30 infants had previously unsuspected CCHDs and 17 had other diagnoses or non-CCHD echocardiogram findings.
In the first 9 months after implementation, New Jersey achieved a high statewide screening rate and established surveillance mechanisms to evaluate the unique contribution of POxS. The screening mandate identified 3 infants with previously unsuspected CCHDs that otherwise might have resulted in significant morbidity and mortality and also identified other significant secondary targets such as sepsis and pneumonia.
We congratulate Grag et al., for the evaluation of the statewide Pulse Oximetry screening (POxS), its implementation, benefits, challenges and areas of further improvement. [1] It is evident that the mandate was implemented successfully in New Jersey because 99.1% of eligible infants were screened during the study period. The screening program successfully identified 3 infant in Well Baby Nursery (WBN) with Critical Congenital Heart Defects (CCHD) that might have been missed. Furthermore New Jersey Department of Health (NJDOH) was able to develop a screening algorithm and surveillance mechanisms. The usefulness of POxS has been extensively studied [2] and it is proven that POxS can identify asymptomatic infants with CCHD at birth as well as other CHD and Non-CHD conditions (e.g. pneumonia and sepsis). According to Grag et al., 97 infants were reported with either a failed POxS, CCHD, or both. Forty eight infants had CCHD but no accompanying POxS results; 49 infants had a positive screen with only 30 infants having diagnostic evaluation attributable to failed POxS. Of those 30, 3 (10%) had true CCHD with the rest having either normal result, other types of CHD or non-CHD medical conditions (e.g. Pneumonia and Sepsis). Based on variation of pre-ductal and post-ductal saturation differences in the 30 infants who had positive screen(and lack of information on POxS from infants with known CCHD) the current practice of pre and post ductal saturation measurements for assessment remains advisable [3]. It would be of interest to the readers if the authors could elaborate on the outcome of 3 infants who received a diagnosis of CCHD as well as their follow up plan and clinical management. Providing such information will help in developing clinical and management decision trees and algorithms after positive screen results. Furthermore this report did not provide information regarding best practices of communicating positive results to the parents; this is important because of the emotional stress that parents who are confronted with the unexpected news of an abnormal result experience. It is important that all birthing facilities have some support system to help parents cope with the result until further clinical evaluations are being performed. This study demonstrates that POxS is cost-effective and feasible with no extra work load to the healthcare providers, a finding consistent with other studies [4]. However the cost of further evaluation including echocardiography and cardiac consultation needs to be considered; in addition, lack of on-site echocardiography in many birthing facilities and the transport of patients to other facilities for work-up of suspected CCHD are factors that may affect cost-effectiveness. We feel additional research is warranted regarding development of standardized protocols and surveillance mechanisms nationwide, as well as to assess the cost-effectiveness of such studies.
References
1. Results From the New Jersey Statewide Critical Congenital Heart Defects Screening Program. Pediatrics, 2013. 132(2): p. X17.
2. Kemper, A.R., et al., Strategies for Implementing Screening for Critical Congenital Heart Disease. Pediatrics, 2011. 128(5): p. e1259- e1267.
3. CARDIOLOGY, S.O., et al., Endorsement of Health and Human Services Recommendation for Pulse Oximetry Screening for Critical Congenital Heart Disease. Pediatrics, 2012. 129(1): p. 190-192.
4. Cost-Effectiveness of Routine Screening for Critical Congenital Heart Disease in US Newborns. Pediatrics, 2013. 132(3): p. X15.
Conflict of Interest:
None declared
I read with interest the report by Garg et al entitled "Results from the New Jersey statewide critical congenital heart defects (CCHD) screening program".(1) However authors missed an important opportunity by not highlighting the following findings in their data:
1. The New Jersey protocol requires both pre and post-ductal saturations to be 95% or higher while the protocol endorsed by AAP and AHA requires only one of these two saturations to be 95% or higher to pass.(2, 3) Six "failed" infants in Garg et al(1) study would have "passed" the screening if the algorithm endorsed by AAP and AHA was used. (2,3) None of these infants had CCHD on further evaluation.
2. Several studies have used only post-ductal saturations to identify infants with CCHD. The addition of pre-ductal screening and requiring providers to look for >3% difference in pre and post-ductal saturations add complexity and cost but is considered necessary to improve chances of identifying infants with coarctation of aorta, a lesion which usually presents after discharge from the hospital and is difficult to diagnose on prenatal ultrasound. However in these infants pre-ductal saturations are higher than the post-ductal saturations because of right to left shunting through the ductus arteriosus. Thus a >3% difference in saturations is likely to be important only if pre-ductal saturations are higher. Three infants in Garg et al (1) study failed screening solely because the difference in pre and post-ductal saturations was >3% while each saturation was 95% or higher. Eight infants failed screening because the difference in pre and post-ductal saturations was >3% and one of the two saturations was <95%. However, the post-ductal saturation was higher and above 95% in each of these 11 infants and none of these infants had CCHD on further evaluation. It is important to note that the only infant with coarctation of aorta in this study had a pre-ductal saturation of 97% and post-ductal saturation of 84%, a finding consistent with this lesion.
3. All three CCHD infants identified by screening in this study had a post-ductal saturation of <95% and the addition of pre-ductal saturation did not improve the sensitivity but significantly increased the false positive rate and reduced the positive predictive value.
One of the barriers to the use of pulse oximetry screening has been the concern about the possibility of high rate of false positives in daily practice and the burden it will place on the family and the healthcare system. The results of this study suggest that AAP and AHA should consider a review of the current algorithm and consider recommending that >3% absolute difference in pre or post-ductal oxygen saturations is unlikely to be helpful if post-ductal saturation is higher than the pre-ductal saturation. Although the New Jersey data also suggests that using only post-ductal saturation for screening may significantly reduce the number of false positives, it may be prudent to continue with the current practice of pre and post-ductal screening till more data is available and adequate cost-benefit analyses are available.
Conflict of Interest:
None declared