1. The Impact of Intensive Care Unit Structure on Post-operative Outcomes Following Congenital Heart Surgery: Analysis of a Multi-institutional Database Danielle S. Burstein BS, Shubin Sheng MS, Sean M. O’Brien PhD, Anthony F. Rossi MD, Jeffrey P. Jacobs MD, Paul A. Checchia MD, Gil Wernovsky MD, Karl F. Welke, Eric D. Peterson MD MPH, Jennifer S. Li MD MHS, Marshall L. Jacobs MD, Sara K. Pasquali MD American Heart Association Scientific Sessions, November 15, 2010

2. Disclosures Dr. Pasquali National Heart, Lung, and Blood Institute (1K08HL103631-01), and American Heart Association Mid-Atlantic Affiliate Clinical Research Program Dr. J Jacobs Chair, Society of Thoracic Surgeons Congenital Heart Surgery Database Taskforce Medical advisor and shareholder, CardioAccess Dr. Peterson Principal Investigator, Society of Thoracic Surgeons National Databases Analytic Center at the Duke Clinical Research Institute

3. Background n Recently there has been a shift toward providing care to children undergoing heart surgery in dedicated pediatric cardiac intensive care units (CICU) l 45% of US centers now provide care in a CICU l Used in ranking quality of US programs n The impact of a dedicated CICU on patient outcomes has not been evaluated n Previous adult and pediatric studies suggest that cohorting of patients and specialized care for a variety of conditions may improve outcomes

4. Purpose n To evaluate post-operative outcomes associated with a dedicated CICU vs. other ICU models in a multi-institutional population undergoing congenital heart surgery

5. Methods: Data Source n Data from a survey of ICU care models linked to the STS Congenital Heart Surgery Database n ICU Survey l Administered in 2009 l Data on ICU structure was subsequently reviewed and verified by panel of pediatric cardiologists, intensivists, and heart surgeons n STS Congenital Heart Surgery Database l Largest pediatric heart surgery registry in the world l Contains pre-operative, operative, and outcomes data

6. Methods: Definitions n CICU l Freestanding unit dedicated to the care of pediatric patients with congenital and acquired heart disease n Other ICU l Other ICU care models, including general pediatric ICU, neonatal ICU, and CICU within a general pediatric ICU

7. Methods: Study Population n Centers Included: l Completed ICU survey and submitted data to STS from 2007-2009 l Consistent care model during study period l <15% missing data for key study variables n Patients Included: l 0-18 years l Any surgery classified in the Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery (STS-EACTS) risk stratification system STS-EACTS 1 = lowest mortality risk STS-EACTS 5 = highest mortality risk

8. Methods: Data Collection n Patient Data l Demographics l Non-cardiac/genetic abnormalities l Other pre-op risk factors (as defined in STS Database) n Operative Data l STS-EACTS risk category n Center Data l Annual surgical volume n Post-operative Outcomes l In-hospital mortality l Length of stay l Complications (as defined in STS Database)

9. Analysis n Unadjusted and adjusted analyses to evaluate association of CICU with outcome n Multivariable logistic and linear regression l Utilized the GEE method to account for within- center clustering/correlation l Adjusted for age, weight, any non-cardiac/genetic abnormality or other pre-op risk factor, previous CT surgery, STS-EACTS risk category, and center volume l Analyses performed overall and stratified by STS- EACTS category n P-value <0.05 considered statistically significant

10. Results

11. Study Population 79 STS centers 2007-2009 57 centers completed survey 2 switched care model 8 with missing data 47 centers included Excluded

12. Study Population  The 47 included centers were:  Diverse geographically  28% Southeast  19% Midwest  19% Southwest  15% Northeast  13% Northwest  6% West  Had similar outcomes vs. overall STS Database:  In-hospital mortality: 3.8% vs. 3.9%

13. Study Population

14. Study Population Characteristics OverallCICU Other ICU Age (mo)6.6 (1.1-46.8)6.3 (1.0-44.4)7.3 (1.4-54.0) Male55% 54% Weight (kg)6.5 (3.7-15.1)6.3 (3.6-14.7)6.8 (3.8-16.5) Genetic/Non-CV abn30%29%32% Pre-op risk factor28%26%31% ≥1 prior CT surgery22%23%22% STS-EACTS 1-375%74%78% STS-EACTS 4-525%26%22% Annual volume160 (104-259)209 (147-312)118 (78-178)

15. Study Population Characteristics OverallCICU Other ICU Age (mo)6.6 (1.1-46.8)6.3 (1.0-44.4)7.3 (1.4-54.0) Male55% 54% Weight (kg)6.5 (3.7-15.1)6.3 (3.6-14.7)6.8 (3.8-16.5) Genetic/Non-CV abn30%29%32% Pre-op risk factor28%26%31% ≥1 prior CT surgery22%23%22% STS-EACTS 1-375%74%78% STS-EACTS 4-525%26%22% Annual volume160 (104-259)209 (147-312)118 (78-178)

16. Study Population Characteristics OverallCICU Other ICU Age (mo)6.6 (1.1-46.8)6.3 (1.0-44.4)7.3 (1.4-54.0) Male55% 54% Weight (kg)6.5 (3.7-15.1)6.3 (3.6-14.7)6.8 (3.8-16.5) Genetic/Non-CV abn30%29%32% Pre-op risk factor28%26%31% ≥1 prior CT surgery22%23%22% STS-EACTS 1-375%74%78% STS-EACTS 4-525%26%22% Annual volume160 (104-259)209 (147-312)118 (78-178)

17. Study Population Characteristics OverallCICU Other ICU Age (mo)6.6 (1.1-46.8)6.3 (1.0-44.4)7.3 (1.4-54.0) Male55% 54% Weight (kg)6.5 (3.7-15.1)6.3 (3.6-14.7)6.8 (3.8-16.5) Genetic/Non-CV abn30%29%32% Pre-op risk factor28%26%31% ≥1 prior CT surgery22%23%22% STS-EACTS 1-375%74%78% STS-EACTS 4-525%26%22% Annual volume160 (104-259)209 (147-312)118 (78-178)

18. Unadjusted Outcomes CICU Other ICU p In-hospital Mortality3.6%4.1% 0.04 Length of Stay8.5 (4.0-13.0)8.4 (4.0-13.0)<0.01 Complications21% 0.99

19. Adjusted Outcomes Associated with a CICU OR (95% CI)p-value In-hospital Mortality0.88 (0.65-1.19)0.40 Estimate (95% CI)p-value Length of Stay*0.05 (-0.05-0.14)0.35 OR (95% CI)p-value Complications1.11 (0.74-1.67)0.61 *log days

20. Odds Ratio for In-hospital Mortality: CICU vs. Other ICU Favors CICUFavors Other ICU OR 0.47 (0.25-0.86)

21. STS-EACTS 3 n Most common operations: l Complete AV canal repair (37%) l Arterial switch operation (23%) Mortality CICUOther ICU p-value CAVC1.2%3.4% 0.05 ASO0.3%5.6% <0.0001

22. Estimate for Length of Stay: CICU vs. Other ICU Favors CICUFavors Other ICU

23. Odds Ratio for Complications: CICU vs. Other ICU Favors CICUFavors Other ICU

24. Limitations n Observational design, patient and center confounders n Generalizability n Analysis limited to in-hospital outcomes n Only ICU structure was analyzed

25. Conclusions n In this large multi-institutional study, we were not able to detect a difference in post-operative outcomes associated with a dedicated CICU in the overall cohort undergoing congenital heart surgery n There may be a survival benefit for certain subgroups n Further investigation focusing not only on ICU structure but differences in personnel and care processes may elucidate other factors which may impact outcome in this population