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Early Impact of State-wide Neonatal Critical Congenital Heart Disease Screening

Review of the effectiveness of a critical congenital heart disease screening program, its impact on mortality, interventions, and outcomes, with comparisons between pre- and post-screening eras.

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Early Impact of State-wide Neonatal Critical Congenital Heart Disease Screening

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  1. Early Impact of a State-wide Neonatal Critical Congenital Heart Disease Screening Program UMMC Population Health Grand Rounds February 6th, 2018 Sarosh P. Batlivala, MD, MSCI

  2. Conflicts of Interest • None

  3. Background • Incidence of congenital heart disease (CHD) is ~9 per 1000 livebirths1,2 • ~1/4 are “critical” (definition varies) • Defects with highest mortality in developed world3,4

  4. Critical Congenital Heart Disease Lesions

  5. Background • Critical CHD can be effectively diagnosed with echo, palliated with PGE, then transported for definitive care • Advances in therapies have improved survival5 • Interventions are emergent • Outcomes suboptimal if delayed6-8

  6. Background • Dr. Robert Gross, Children’s Hospital Boston: First successful surgical PDA ligation (1938) • Open procedure • Now via thoracotomy (VATS)

  7. % Blood Flow LV = 34% of flow RV = 66% of flow

  8. Pressure & Saturation

  9. Pressure & Saturation

  10. CCHD: Presenting Age & Mortality 0 - 28 1305 54 29 - 60 258 36 61 - 180 458 22 181 - 364 230 7 Age on First Year Admission # Mortality (4%) (14%) (5%) (3%)

  11. Dodge-Khatami J, Cardiol young, Mar 2016 Dodge-Khatami A, World J PediatrCongenit Heart Surg, Jun 2015

  12. Background • Recap • CCHD is bad • We can effectively treat if diagnosed early • Treatment outcomes are adversely affected by delayed diagnosis

  13. Background • Pulse oximetry shown to be useful tool for screening9-11 • AAP, ACC, AHA developed collaborative recommendations12 • Regions with screening have12-13: • Earlier detection • Decreased mortality • Lower overall costs • MSDOH mandated screening in 201514

  14. Sanandajifar, JMSMA, Nov 2017

  15. Figure 1: Screening Algorithm for Critical Congenital Heart Disease

  16. MS Newborn Screen Collection

  17. Hypotheses • The screening program was associated with: • 1° • Fewer delayed diagnoses • Lower cardiac mortality rates • 2° • Fewer cardiac interventions • Shorter duration of initial hospitalization • Fewer subsequent hospitalizations • Lower complication rates • Smaller proportion with cardiovascular symptoms at most recent follow-up

  18. Methods • Study Design: Ecologic (population-level) • case-control comparisons for secondary analyses • Retrospective data collection • All infants diagnosed and treated with critical CHD • 2-year “eras”: pre- and post-screen • Pre-screen: 7/1/2013 – 6/30/2015 • Post-screen: 7/1/2015 – 6/30/2017 • UMMC IRB approved (IRB #2017-0252)

  19. Methods: Outcome measures • Delayed diagnosis incidence • sub-categorized • mild (10-27 days) • severe (≥28 days) • Mortality rate • Total number of critical CHD infants per era • Total birth data from MSDOH

  20. Methods: Outcome measures • Initial hospital LOS • ICU and total • Subsequent hospitalizations • Related to cardiovascular issues • ICU and general inpatient • Major cardiovascular-related complications • Ongoing cardiovascular symptoms at most recent follow-up

  21. Methods: Statistical Analyses • Characterized demographics, interventions, and outcomes with relation to the screening implementation • pre- vs. post-screen • Secondary analysis: comparison by timing of the diagnosis • on-time vs. delayed diagnoses • mildly-delayed vs. severely-delayed diagnoses

  22. Methods: Statistical Analyses • Categorical characteristics = chi-square test for differences • Continuous characteristics = nonparametric (Kruskal-Wallis/Mann-Whitney U) t-test • Threshold for significance 0.05

  23. Results • 75, 760 infants born in pre-screen era • 74,154 infants born in post-screen era • Post-screen era: • 66,159 infants screened with 80 screen positive (Figure 2)

  24. Figure 2All Screen Positive Infants (N=80)

  25. Results • 121 infants with CCHD in pre-screen era • Figure 3 • 1.59 cases per 1000 LB • 103 infants with CCHD in post-screen era • Figure 4 • 1.39 cases per 1000 LB • Overall incidence of CCHD not significantly different by era (p 0.33)

  26. Figure 3All Infants with Confirmed Critical CHD in the Pre-screen Era (N=121)

  27. Figure 4All Infants with Confirmed Critical CHD in the Post-screen Era (N=103)

  28. Table 2: Demographics and Cardiac Diagnostics of the Cohort and by Screen Era

  29. Results: Mortality by Era • 32 total deaths • 23 deaths from CCHD in pre-screen era • 0.3 cases per 1000 LB • 9 deaths from CCHD in post-screen era • 0.12 cases per 1000 LB • Mortality rate was significant lower post-screen (p 0.03)

  30. Figure 5: Survival of Infants with Critical CHD by Era

  31. Results: Timeliness of Dx by Era • 31 delayed diagnoses • Pre-screen: 18 delayed CCHD diagnoses • 0.24 cases per 1000 LB • Post-screen: 13 delayed CCHD diagnoses • 0.18 cases per 1000 LB • No significant reduction in delayed diagnoses post-screen (p 0.63)

  32. Figure 6All Infants with Delayed CHD Diagnosis in the Pre-Screen era (N=18)

  33. Figure 7All Infants with Delayed CHD Diagnosis in the Post-Screen Era (N=13)

  34. Results: Timeliness of Dx by Era • 2 diagnoses of moderate CoA • Plausibly could “evade” screening • Post-screen era; severely delayed • Pre-screen: 18 delayed CCHD diagnoses • 0.24 cases per 1000 LB • Post-screen: 11 delayed CCHD diagnoses • 0.15 cases per 1000 LB • Trended slightly toward reduction in delayed diagnoses post-screen (18 vs. 11, p 0.29), especially severely-delayed (10 vs. 4, p 0.09)

  35. Table 3: Cardiac Interventions and Outcomes for the Cohort and by Screen Era

  36. Table 4: Demographics and Cardiac Diagnostics by Time of Diagnosis

  37. Table 5: Cardiac Interventions and Outcomes by Time of Diagnosis

  38. Figure 8: Hazard of Death By Time of Diagnosis

  39. Discussion • Overall goal of screening = timely diagnosis & decrease morbidity/mortality • Critical CHD especially good target • Many lesions not immediately clinically apparent

  40. CHD: Age and Mortality 0 - 28 1305 54 29 - 60 258 36 61 - 180 458 22 181 - 364 230 7 Age on First Year Admission # Mortality (4%) (14%) (5%) (3%)

  41. Discussion: Timeliness & Mortality • Data demonstrated a reduction in mortality but not in delayed diagnoses • Begs the question of causes for reduction in mortality • Overall awareness of critical CHD • Improved outcomes of CHC in general • Misclassification bias (unlikely since we diagnosed and treated)

  42. Discussion: Timeliness & Mortality • Speculation: greater diagnostic/referral vigilance by community • Similar findings suggested in other programs • Little change in mildly delayed diagnoses but near significant decrease among severely delayed diagnoses • Mortality decrease is welcomed, but highlights need for ongoing support and training

  43. Discussion: Interventions • Interventions surrogate for overall complexity • Affected by timely diagnosis, but also native anatomy, co-morbid conditions, etc. • Overall post-screen cohort complexity not less than pre-screen • Median total costs for a congenital catheterization have been reported in the range of $13,068-$51,609 30, 31

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