Pulse oximetry screening for critical congenital heart defects. Where are we and where next?

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1 Pulse oximetry screening for critical congenital heart defects. Where are we and where next? Dr Andrew Ewer Reader in Neonatal Paediatrics University of Birmingham UK Neonatologist, Birmingham Women s Hospital

2 Critical Congenital Heart Defects (CCHD) HLHS Critical CHD (CCHD) ~ 1-3/ /yr in UK TGA May only be recognised when a baby develops life-threatening collapse.

3 CCHD Sweden babies, 109 babies with CCHD 28 (26%) - discharged without diagnosis (44% of TGA) 5 (4.6%) died 33 (30%) - severe acidosis at presentation Granelli et al. BMJ 2009;338:A3037 USA 490 babies with CCHD admitted to cardiac centre 76 (15%) developed significant collapse 40/76 result of undiagnosed CCHD Schultz et al. Pediatrics 2008;121:751-57

4 Neonatal screening Examination for CHD Up to 50% of babies with CHD may be missed by neonatal exam and up to a third of critical CHD Earlier discharge reduces time-window for signs and symptoms to develop Wren et al. Arch Dis Child FN 1999;80:F49 F53. Granelli et al BMJ 2009;338:A3037 Acharya et al Acta Obstet Gynaecol Scand 204;83:1124-9

5 Antenatal screening Anomaly scan detection rates very variable

6 Proportion of babies requiring intervention for CHD within 1 year of life (major CHD excluding PDA and ASD) who were identified antenatally in UK nicor.org.uk

7 - nicor.org.uk

8 Pulse oximetry screening Rationale Clinically undetectable low oxygen levels (low saturations) present in the majority of critical CHD Pulse oximetry may detect babies with CCHD early, before they collapse

9 Pulse oximetry screening First published studies in early 2000s (post-ductal sats only) Richmond, UK (2002) Koppel, USA (2003)

10 Pulse oximetry screening 8 studies patients Small numbers of patients, low prevalence of CCHD, methodological variations More high quality studies (in larger study populations) needed to precisely define test accuracy

11 Included 2 further studies 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 newborn assessment of the neonate

12 The Lancet, Volume 378, Issue 9793, Pages , 27 August 2011

13 Protocol Screened asymptomatic newborns >34 wks Pulse oximetry testing within 1 st 24 hrs or prior to discharge Pre and post ductal saturations Test +ve - <95% in either or >2% difference

14 Results babies screened 24 cases of CCHD Sensitivity 75% (95% CI 53.29%-90.23%) Specificity 99.16% (95% CI 99.02%-99.28%)

15 Added value When combined with anomaly scan and newborn examination screening 92% of CCHD were detected In a cohort of babies PO could detect an additional 245 cases of CCHD Likely to be higher in areas where the AN detection rates are lower

16 Pulse oximetry studies Granelli Sweden, (BMJ 2009) Riede Germany, (EJP 2010) Ewer UK, (Lancet 2011) Turska Kmieć Poland, (Kardiologia Polska 2012)

17 Detection of significant non-cardiac disease an important additional finding in all studies (30-70% of false positives)

18 2 nd May studies patients (c.f. 8 studies, pts) Overall sensitivity 76.5% (95% CI 67.7% %) Overall specificity 99.9% (99.7% -99.9%) False positive rate 0.14% ( ) (FPR <24 hrs 0.5%. FPR >24 hrs 0.05%) (Did not include Polish study)

19 surely the question now is not should pulse oximetry screening be introduced? but why should such screening not be introduced more widely?

20 Further work Pulse oximetry screening Is acceptable to parents and staff Anxiety not increased in false positives Is cost-effective in an NHS setting

21 Limitations Not a perfect test, but better than existing Will miss approximately 25% of CCHD Commonest defects missed CoA, IAA Ewer 43% (3/7) Turska Kmieć 33% (1/3) Granelli 21% (3/14) Riede 0% (0/2) Not a replacement for existing screening

22

23 PEDIATRICS Volume 128, Number 5, November 2011

24 From pulseoxadvocacy.com

25 Switzerland 85% of newborns screened although no central mandate Abu Dhabi introduced routine screening (2012) Ireland RCPI recommended screening (2012) Sweden 91% of nurseries screening (2013) although no central mandate NSW Australia Statewide policy for screening

26 What s happening in the UK? only 15 of 224 units (7%) were screening (Kang et al Arch Dis Child 2011;96:312) 2012 Survey (Singh and Ewer, Lancet 2013;381:535) All units surveyed 204/204 (100%) responded 36/204 (18%) screening (8 about to start) However 71% of non-screening units are considering introduction

27 Why not screen? Not enough staff Too many false positives Will overload echo service/echo unavailable

28 Early or late screening (<24 or >24hrs) Most babies have normal sats within 2 hr FP lower if PO screening >24 hr 0.05 vs 0.5

29 False positives Swedish study* vs PulseOx FP rate 0.17% vs 0.8% (sens 62% vs 75%) - screened later 38 vs 12 hrs However in Granelli s study 28/57 CCHD presented before screening Collapse in 11/57 (19%) [incl. 5 in hospital] c.f. 1/26 (4%) in PulseOx [0 in hospital] *Granelli et al BMJ 2009;338:A3037

30 False positives Need to consider trade off between false positive rate and timely diagnosis Also Earlier diagnosis of respiratory/infective cases Increasing discharges within 24 hours False positives are babies with low oxygen levels No baby should have unexplained persistent hypoxaemia

31 BWH screening programme Total Livebirths: All babies screened in first 12 hrs (mean age 7 hrs) Test positive pulse oximetry: % of all livebirths Just over one admission a week Congenital heart defects identified: Critical CHD: 7 (+2) Serious CHD: 2 Significant CHD: 3 1 CCHD missed by all screening procedures

32 Other significant diagnosis Congenital pneumonia: 49 Sepsis: 29 PPHN: 11 MAS: 3 TTN requiring oxygen: 37 Congenital Pneumonia- inflam markers ± +ve culture, X-Ray changes, O2 requirement, abs 5 days. Sepsis - inflammatory markers ± culture +ve, abs 5 days MAS h/o meconium, respiratory distress, O2 requirement, X-Ray changes TTN requiring oxygen: Tachypnoea with X- Ray changes of fluid retention, oxygen requirement, no rise in inflam markers or +ve culture Pneumothorax 3

33 Results Transitional circulation/mild TTN: 36 (19%) No collapse in the postnatal wards No term baby ventilated for undiagnosed sepsis Echos performed for test +ve pulse Ox: 54/187 (29%) Abnormal Echos: 22/54 (41%)

34 Murmurs and echocardiography 3 year data from BWH 205 echos for babies with murmur 123 (60%) no significant abnormality 72 (35%) septal defects 2 (1%) CCHD [PulseOx 7/54 (13%) CCHD] Singh A et al. Acta Paed 2012;101:

35 Where next? NIPE considering case for presenting pulse oximetry screening to NSC in 2013 Should BAPM/RCPCH offer an opinion? (as professional bodies in other countries have done)

36 Summary Routine pulse oximetry screening is feasible, cost-effective and acceptable to parents and staff adds value to existing screening procedures is likely to identify cases of CCHD which would otherwise go undetected has the additional advantage of detecting other serious (non-cardiac) illnesses

37 No baby should have unexplained persistent hypoxaemia