19. Why? 1 in 100 newborns have congenital heart defects 25% of all CHD are critical (CCHD) requiring intervention in the first days, weeks of life 50% of deaths from CHD occur in 1 st year and 50% of infantile deaths occur in 1 st month of life

20. Why? Poor Prenatal Diagnosis Fewer than 50% of CCHD are diagnosed prenatally, number drops based on geographic / demographic disparity

21. Why? Congenital Heart Disease is the most prevalent birth defect, responsible for 25% of infantile deaths and 31% of neonatal deaths 2 per 1,000 live births impacted, more than all other metabolic conditions combined

22. Prenatal Diagnosis Case Example: Prenatal Detection of Congenital Heart Disease in Nevada 36% prenatal diagnosis 64% exclusively postnatal diagnosis Conclusion: Standard prenatal ultrasound is failing to show heart disease in most fetuses

33. Pulse Oximetry as a Screening Method Measures the amount of oxygen in the blood Non-invasive and painless Accurate with newer generation oximeters Motion resistant (SET) technology for newborns Fast (<3 min), reliable, inexpensive

34. What is a failed pulse ox screening? One value equal or less than 90% OR three times <95% in both sites OR absolute difference of >3 points

35. Steps for Failed Screens 1. Confirm accuracy of reading 2. If <24h, defer discharge and repeat test at 24h or later; otherwise, follow same algorithm as in older infants 3. Perform additional clinical evaluation to assess for non-cardiac causes 4.Echocardiogram (in-center, transfer, telemedicine)

39. 4 million babies born annually in US to be screened for early diagnosis of CCHD Anticipated potential 10-fold increase in rate of detection Single biggest implementation hurdle: access to point of care confirmatory diagnosis

40. Minnesota Case 106 delivery hospitals 3 heart centers 70,000 annual births 700 diagnosed with CHD 175 diagnosed with CCHD Urban Births: 87 Prenatal diagnosis: 44 Undiagnosed at discharge: 8 Rural/Community births: 88 Prenatal diagnosis: 22 Undiagnosed at discharge: 16

47. False positive rate for POX 0.17% Positive Predictive Value of physical exam 1.35% alone Positive Predictive Value of exam + pulse ox: 20.69% False positives 10 times higher without addition of pulse oximetry Early detection of other non-cardiac diseases is additional advantage

51. Progress 3 states implemented 6 states with passed laws or mandates 12 states with CCHD screening legislation introduced

52. Region 4 720,000 Annual Births Estimated number of babies being screened for CCHD: 168,000 (23%)

59. 110 babies born each day in U.S. with CHD 55 will be undiagnosed at birth 20 may be discharged with a missed congenital heart defect 5 will have critical heart defects requiring immediate intervention

60. 30 – 40% of CCHD cases leaving hospital undiagnosed 20 – 35% of infant deaths from CCHD attributed to delayed or missed diagnosis Mortality of babies who left hospital undiagnosed 4/27 (18%) Mortality of babies when diagnosed prior to discharge from hospital 1/110 (0.9%) (source: Swedish Cohort Population Study www.thelancet.com May 2, 2012)

61. Close the Gap Why screen every baby for heart defects? See the CCHD screening trailer: http://bit.ly/MeaxBy