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Pulse oximetry screening for critical congenital heart disease (CCHD)

What is critical congenital heart disease (CCHD)?

Congenital heart disease (CHD) is defined as a structural abnormality of the heart that is present at birth, which impacts proper and/or optimal blood flow.

More specifically, critical congenital heart disease (CCHD) is a subset of lesions commonly defined as “any potentially life-threatening, duct-dependent heart lesion from which infants either die or require invasive procedures (surgery or cardiac catheterization) in the first 28 days of life,2” although some publications like the CDC extend the definition to include the first year of life.3 

For more information about CCHD and screening protocol, click here.

 

Pulse oximetry for critical congenital heart disease (CCHD) screening

It has been shown that pulse oximetry can be cost-effective as a noninvasive method for improving early diagnosis rates of CCHD, especially in low-resource areas. 1 10-12

According to a model-based cost effectiveness analysis comparing pulse oximetry screening to no pulse oximetry screening from the Ontario healthcare payer perspective, pulse oximetry screening yielded an incremental cost effectiveness ratio of CAD$1,110.79 per quality-adjusted life months. This was well below the predetermined threshold of CAD$4,166.67. 8†  

According to a prospective analysis of costs and cost effectiveness of pulse oximetry screening on 100,000 newborns in the Dutch perinatal care setting. Pulse oximetry screening yielded an incremental cost-effectiveness ratio of €139,000 per additional newborn with CCHD. There was a willingness to pay threshold placed at €20,000 per gained quality adjusted life year.9‡

Neonates with an abnormal pulse oximetry screening are 5.5 times more likely to have CCHD compared to those with a normal screening.13 Additionally, late diagnosis of CCHD is associated with higher rates of hospital admissions and inpatient costs during the first year of life.18 According to a retrospective assessment of states that mandated universal pulse oximetry, there was a 33% decline in early infant CCHD related events after the mandate began.14

Despite the rise of antenatal detection over the years, there remains great variation in detection rates for this method based on location, technology, skill of technician, and screening protocol.1 4 15 16 Even in settings with high antenatal detection, pulse oximetry screening can be beneficial in identifying previously undiagnosed patients with CCHD.7 12 17 18

False-positive cases of pulse oximetry screening have been noted to require medical intervention for non-CCHD related conditions and may be important secondary targets of pulse oximetry screening, especially in low-resource settings.5 10 11 19

Pulse oximetry screening in the NICU is feasible and can be effective at detecting unrecognized CCHD in neonates.20-22
 

Recommendations for pulse oximetry screening

There are several recommendations for screening practices and protocols for CCHD, with numerous protocols used across studies. The main factors for screening, which are influenced by local needs and limitations, include:

  1. Timing of pulse oximetry: Screening prior to 24 hours of age has been shown to increase false positive rates.6 However, some healthcare systems have high rates of early discharge (prior to 24 hours), necessitating earlier screening.12 23
  2. Probe location§: Probe placement on the right hand (preductal) and either foot (post ductal) allows for screening of lesions where the difference between the readings is greater than expected, indicating ineffective blood flow.24 Use of two probes increases the cost and time of each test, which may be a barrier in some settings.
  3. Blood oxygen saturation: Cut-off values for a positive screen vary across studies and recommendations.23 25-27 Currently, most screening protocols (with slight variations) consider a positive screen as:
    • Blood oxygen saturation less than or equal to 95%, and/or;
    • Difference in pre- and post-ductal measures greater than or equal to 2–3%
    • With 2−3 repeat measures taken 1−2 hours apart

The type of CCHD lesion influences pulse oximetry values and the sensitivity of pulse oximetry, with certain lesions being more detectable than others.18 24 28 29
 

Pulse oximeter selection for CCHD screening

Recommendations for pulse oximetry screening of CCHD advise measurements should be obtained using motion-tolerant sensors that can measure in low-perfusion settings.6 23 25 31 32 No specific pulse oximeter brand is mentioned in official recommendation statements for CCHD screening.

Nellcor™ Bedside Respiratory Patient Monitoring Systems meet all pulse oximeter criteria for CCHD screening outlined by the AAP guidelines (Figure 1) 25 as well as those put forth by the European Consensus Group23 and the Canadian Pediatric Cardiology Association.30

  1. Motion-tolerant technology 
    1. Nellcor™ pulse oximetry demonstrates motion tolerance in a variety of settings 12 33 34
  2. Tested in low-perfusion conditions
    1. Nellcor™ pulse oximetry is appropriate for low perfusion settings, as seen in newborns, with successful use in neonates according to several recent studies34-36
    2. In addition to providing accurate measurements (±2) in the standard range of 70%−100% SpO2, the LoSat capability of Nellcor™ technology allows for accurate measurements (±3) in the lower range of 60%−80%37
  3. FDA 510(k) clearance
    1.  The Nellcor™ pulse oximeter has FDA 510(k) clearance (K123581) as a motion-tolerant pulse oximeter and is also compliant with ISO 80601-2-61:2011
  4. 2% root-mean-square accuracy
    1. Root-mean-square for SpO2 is under the 2% recommended cutoff for CCHD screening, even during motion33

One recent clinical study showed that Nellcor™ pulse oximetry demonstrates faster time to post than Masimo Signal Extraction Technology™* (SET™*). A prospective single site study of 60 newborns delivered via Cesarean-section showed34:

  • Time to stable oximeter signal was 12 seconds faster on average when using Nellcor™ pulse oximetry compared to Masimo Signal Extraction Technology™* (SET™*)
  • A stable oximeter signal was achieved in 100% of patients with Nellcor™ pulse oximetry but only 92% of patients when using Masimo Signal Extraction Technology™* (SET™*).

It is important to note that pulse oximetry accuracy depends on certain human factors, such as probe placement, highlighting the need for complete and regular clinician training.11 39

Adhesive sensors on pulse oximeters may pose a risk for skin trauma, especially to the fragile skin of a newborn.38 The Nellcor™ OxySoft™ sensor’s adhesive helps enable easy removal without the skin stripping that can cause pain and secondary trauma to fragile, delicate or thin skin. Nellcor™ OxySoft™ SpO2 sensor with a new silicone adhesive, lower profile, and flexible circuit — so it: 
-       removes 87% less skin cells from fragile skin40
-       stays in place to keep up with those little wiggles
 

More about CCHD and pulse oximetry screening

To learn more about critical congenital heart disease (CCHD), read more on our blog here or review the findings in full in our whitepaper summarizing the clinical evidence in CCHD.

To learn more about how Nellcor™ pulse oximetry can help in CCHD screening, read more on our website.

Related Content

The Nellcor™ pulse oximetry monitoring system should not be used as the sole basis for diagnosis or therapy and is intended only as an adjunct in patient assessment.

§ Please refer to the operator’s manual for your particular product to identify indications, contraindications, warnings, risks, precautions, and placement instructions for your device.

1. Kumar P. Universal pulse oximetry screening for early detection of critical congenital heart disease. Clinical Medicine Insights: Pediatrics 2016;10:CMPed. S33086.

2. Plana MN, Zamora J, Suresh G, et al. Pulse oximetry screening for critical congenital heart defects. Cochrane Database of systematic reviews 2018(3).

3. CDC. Critical Congenital Heart Defects: National Center on Birth Defects and Developmental Disabilities; 2020 [Available from: https://www.cdc.gov/ncbddd/heartdefects/cchd-facts.html accessed 08-24 2021].

4. Bakker MK, Bergman JE, Krikov S, et al. Prenatal diagnosis and prevalence of critical congenital heart defects: an international retrospective cohort study. BMJ open 2019;9(7):e028139.

5. Bruno CJ, Havranek T. Screening for critical congenital heart disease in newborns. Advances in pediatrics 2015;62(1):211-26.

6. Mahle WT, Martin GR, Beekman RH, et al. Endorsement of Health and Human Services recommendation for pulse oximetry screening for critical congenital heart disease. Pediatrics 2012;129(1):190-92.

7. Bartos M, Lannering K, Mellander M. Pulse oximetry screening and prenatal diagnosis play complementary roles in reducing risks in simple transposition of the great arteries. Acta Paediatrica 2015;104(6):557-65.

8. Mukerji A, Shafey A, Jain A, et al. Pulse oximetry screening for critical congenital heart defects in Ontario, Canada: A cost-effectiveness analysis. Canadian Journal of Public Health 2020;111(5):804-11.

9. Narayen IC, Te Pas AB, Blom NA, et al. Cost-effectiveness analysis of pulse oximetry screening for critical congenital heart defects following homebirth and early discharge. European journal of pediatrics 2019;178(1):97-103.

10. Ewer AK. Evidence for CCHD screening and its practical application using pulse oximetry. Early human development 2014;90:S19-S21.

11. Krishna MR, Kumar RK. Diagnosis and Management of Critical Congenital Heart Diseases in the Newborn. The Indian Journal of Pediatrics 2020;87(5):365-71. doi: 10.1007/s12098-019-03163-4.

12. Narayen IC, Blom NA, van Geloven N, et al. Accuracy of pulse oximetry screening for critical congenital heart defects after home birth and early postnatal discharge. The Journal of pediatrics 2018;197:29-35. e1.

13. Thangaratinam S, Brown K, Zamora J, et al. Pulse oximetry screening for critical congenital heart defects in asymptomatic newborn babies: a systematic review and meta-analysis. The Lancet 2012;379(9835):2459-64.

14. Abouk R, Grosse SD, Ailes EC, et al. Association of US State Implementation of Newborn Screening Policies for Critical Congenital Heart Disease With Early Infant Cardiac Deaths. JAMA 2017;318(21):2111-18. doi: 10.1001/jama.2017.17627.

15. Lytzen R, Vejlstrup N, Bjerre J, et al. Live-born major congenital heart disease in Denmark: incidence, detection rate, and termination of pregnancy rate from 1996 to 2013. JAMA cardiology 2018;3(9):829-37.

16. Hill GD, Block J, Tanem J, et al. Disparities in the prenatal detection of critical congenital heart disease. Prenatal diagnosis 2015;35(9):859-63.

17. Cloete E, Bloomfield FH, Cassells SA, et al. Newborn pulse oximetry screening in the context of a high antenatal detection rate of critical congenital heart disease. Acta Paediatrica 2020;109(1):93-99.

18. Ailes EC, Gilboa SM, Honein MA, et al. Estimated number of infants detected and missed by critical congenital heart defect screening. Pediatrics 2015;135(6):1000-08.

19. Singh A, Rasiah SV, Ewer AK. The impact of routine predischarge pulse oximetry screening in a regional neonatal unit. Archives of Disease in Childhood-Fetal and Neonatal Edition 2014;99(4):F297-F302.

20. Suresh G. Pulse oximetry screening for critical congenital heart disease in neonatal intensive care units. Journal of perinatology 2013;33(8):586-88.

21. Lakshminrusimha S, Sambalingam D, Carrion V. Universal pulse oximetry screen for critical congenital heart disease in the NICU. Journal of perinatology 2014;34(5):343-44.

22. Braun KVN, Grazel R, Koppel R, et al. Evaluation of critical congenital heart defects screening using pulse oximetry in the neonatal intensive care unit. Journal of Perinatology 2017;37(10):1117-23.

23. Manzoni P, Martin GR, Luna MS, et al. Pulse oximetry screening for critical congenital heart defects: a European consensus statement. The Lancet Child & Adolescent Health 2017;1(2):88-90.

24. Mawson IE, Babu PL, Simpson JM, et al. Pulse oximetry findings in newborns with antenatally diagnosed congenital heart disease. European journal of pediatrics 2018;177(5):683-89.

25. Kemper AR, Mahle WT, Martin GR, et al. Strategies for implementing screening for critical congenital heart disease. Pediatrics 2011;128(5):e1259-e67.

26. Ewer AK, Middleton LJ, Furmston AT, et al. Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study. The Lancet 2011;378(9793):785-94.

27. de-Wahl Granelli A, Wennergren M, Sandberg K, 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.

28. Oster ME, Kochilas L. Screening for Critical Congenital Heart Disease. Clinics in perinatology 2016;43(1):73-80.

29. Martin GR, Ewer AK, Gaviglio A, et al. Updated strategies for pulse oximetry screening for critical congenital heart disease. Pediatrics 2020;146(1).

30. Wong KK, Fournier A, Fruitman DS, et al. Canadian Cardiovascular Society/ Canadian Pediatric Cardiology Association position statement on pulse oximetry screening in newborns to enhance detection of critical congenital heart disease. Canadian Journal of Cardiology 2017;33(2):199-208.

31. Ma X, Huang G. Neonatal pulse oximetry screening improves detecting of critical congenital heart disease. Chinese medical journal 2013;126(14):2736-40.

32. de‐Wahl Granelli A, Meberg A, Ojala T, et al. Nordic pulse oximetry screening– implementation status and proposal for uniform guidelines. Acta Paediatrica 2014;103(11):1136-42.

33. Watson JN, Mannheimer PD, Kelly S. Nellcor™ Pulse Oximetry Motion Testing. Medtronic White Paper 2013;13-PM-0205(2).

34. Khoury R, Klinger G, Shir Y, et al. Monitoring oxygen saturation and heart rate during neonatal transition. comparison between two different pulse oximeters and electrocardiography. Journal of Perinatology 2021;41(4):885-90.

35. Havranek T, Shatzkin E, Chuang M, et al. Respiratory outcomes after neonatal prone versus supine positioning following scheduled cesarean delivery: a randomized trial. The Journal of Maternal-Fetal & Neonatal Medicine 2021;34(18):2938-44. doi: 10.1080/14767058.2019.1674805.

36. Addison PS, Mannheimer PD, Ochs JP. Pulse Rate Performance of Two Pulse Oximeters During Challenging Monitoring Conditions. Medtronic White Paper 2018;18-PM-0181–[WF#2678399].

37. SpO2 LoSatAccuracysee PMB05N (MFR): 10096850 -Clinical Report, Abbreviated Sensor Line, Connery (P3.2) in N-600x including validation at 70% -100% and 60%-80% (low sat) saturation range with MaxA,MaxN, MaxFast.

38. Widiati E, Nurhaeni N, Gayatri D. Medical-device related pressure injuries to children in the intensive care unit. Comprehensive child and adolescent nursing 2017;40(sup1):69-77.

39. Reich J, Connolly B, Bradley G, et al. Reliability of a single pulse oximetry reading as a screening test for congenital heart disease in otherwise asymptomatic newborn infants: the importance of human factors. Pediatric cardiology 2008;29(2):371-76.

40. Internal test report CSR 2021 03 12 v.1.0 - CyberDERM S20-12.