The Impact of Intensive Care Unit Structure on Post-operative Outcomes Following Congenital Heart...

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Structure on Post-operative Structure on Post-operative Outcomes Outcomes Following Congenital Heart Surgery: Following Congenital Heart Surgery: Analysis of a Multi-institutional Analysis of a Multi-institutional Database 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

Transcript of The Impact of Intensive Care Unit Structure on Post-operative Outcomes Following Congenital Heart...

The Impact of Intensive Care Unit Structure The Impact of Intensive Care Unit Structure on Post-operative Outcomes on Post-operative Outcomes

Following Congenital Heart Surgery: Following Congenital Heart Surgery: Analysis of a Multi-institutional DatabaseAnalysis 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

DisclosuresDisclosures

Dr. PasqualiNational Heart, Lung, and Blood Institute (1K08HL103631-01), and American Heart Association Mid-Atlantic Affiliate Clinical Research Program

Dr. J JacobsChair, Society of Thoracic Surgeons Congenital Heart Surgery Database Taskforce Medical advisor and shareholder, CardioAccess

Dr. PetersonPrincipal Investigator, Society of Thoracic Surgeons National Databases Analytic Center at the Duke Clinical Research Institute

BackgroundBackground

Recently there has been a shift toward providing care Recently there has been a shift toward providing care to children undergoing heart surgery in dedicated to children undergoing heart surgery in dedicated pediatric cardiac intensive care units (CICU)pediatric cardiac intensive care units (CICU) 45% of US centers now provide care in a CICU45% of US centers now provide care in a CICU Used in ranking quality of US programsUsed in ranking quality of US programs

The impact of a dedicated CICU on patient outcomes The impact of a dedicated CICU on patient outcomes has not been evaluatedhas not been evaluated

Previous adult and pediatric studies suggest that Previous adult and pediatric studies suggest that cohorting of patients and specialized care for a variety cohorting of patients and specialized care for a variety of conditions may improve outcomes of conditions may improve outcomes

PurposePurpose

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

Methods: Data SourceMethods: Data Source

Data from a survey of ICU care models linked to the Data from a survey of ICU care models linked to the STS Congenital Heart Surgery DatabaseSTS Congenital Heart Surgery Database

ICU SurveyICU Survey Administered in 2009Administered in 2009 Data on ICU structure was subsequently reviewed Data on ICU structure was subsequently reviewed

and verified by panel of pediatric cardiologists, and verified by panel of pediatric cardiologists, intensivists, and heart surgeonsintensivists, and heart surgeons

STS Congenital Heart Surgery DatabaseSTS Congenital Heart Surgery Database Largest pediatric heart surgery registry in the worldLargest pediatric heart surgery registry in the world Contains pre-operative, operative, and outcomes Contains pre-operative, operative, and outcomes

datadata

Methods: DefinitionsMethods: Definitions

CICUCICU Freestanding unit dedicated to the care of Freestanding unit dedicated to the care of

pediatric patients with congenital and acquired pediatric patients with congenital and acquired heart diseaseheart disease

Other ICUOther ICU Other ICU care models, including general Other ICU care models, including general

pediatric ICU, neonatal ICU, and CICU within a pediatric ICU, neonatal ICU, and CICU within a general pediatric ICUgeneral pediatric ICU

Methods: Study PopulationMethods: Study Population

Centers Included:Centers Included: Completed ICU survey Completed ICU survey andand submitted data to STS submitted data to STS

from 2007-2009from 2007-2009 Consistent care model during study periodConsistent care model during study period <15% missing data for key study variables<15% missing data for key study variables

Patients Included:Patients Included: 0-18 years0-18 years Any surgery classified in the Any surgery classified in the Society of Thoracic Society of Thoracic

Surgeons-European Association for Cardiothoracic Surgeons-European Association for Cardiothoracic Surgery (STS-EACTS) risk stratification systemSurgery (STS-EACTS) risk stratification system

STS-EACTS 1 = lowest mortality riskSTS-EACTS 1 = lowest mortality riskSTS-EACTS 5 = highest mortality risk STS-EACTS 5 = highest mortality risk

Methods: Data CollectionMethods: Data Collection Patient DataPatient Data

DemographicsDemographics Non-cardiac/genetic abnormalitiesNon-cardiac/genetic abnormalities Other pre-op risk factors (as defined in STS Database)Other pre-op risk factors (as defined in STS Database)

Operative DataOperative Data STS-EACTS risk categorySTS-EACTS risk category

Center DataCenter Data Annual surgical volumeAnnual surgical volume

Post-operative Outcomes Post-operative Outcomes In-hospital mortalityIn-hospital mortality Length of stayLength of stay Complications (as defined in STS Database)Complications (as defined in STS Database)

AnalysisAnalysis Unadjusted and adjusted analyses to evaluate Unadjusted and adjusted analyses to evaluate

association of CICU with outcomeassociation of CICU with outcome

Multivariable logistic and linear regressionMultivariable logistic and linear regression Utilized the GEE method to account for within-Utilized the GEE method to account for within-

center clustering/correlation center clustering/correlation Adjusted for age, weight, any non-cardiac/genetic Adjusted for age, weight, any non-cardiac/genetic

abnormality or other pre-op risk factor, previous CT abnormality or other pre-op risk factor, previous CT surgery, STS-EACTS risk category, and center surgery, STS-EACTS risk category, and center volumevolume

Analyses performed overall and stratified by STS-Analyses performed overall and stratified by STS-EACTS category EACTS category

P-value <0.05 considered statistically significantP-value <0.05 considered statistically significant

ResultsResults

Study PopulationStudy Population

Excluded

Study PopulationStudy Population

The 47 included centers were:The 47 included centers were:

Diverse geographically Diverse geographically 28% Southeast28% Southeast 19% Midwest19% Midwest 19% Southwest19% Southwest 15% Northeast15% Northeast 13% Northwest13% Northwest 6% West 6% West

Had similar outcomes vs. overall STS Database: Had similar outcomes vs. overall STS Database: In-hospital mortality: In-hospital mortality: 3.8% vs. 3.9%3.8% vs. 3.9%

Study PopulationStudy Population

Study Population CharacteristicsStudy Population Characteristics

OverallOverall CICUCICU Other ICUOther ICU

Age (mo) 6.6 (1.1-46.8) 6.3 (1.0-44.4) 7.3 (1.4-54.0)

Male 55% 55% 54%

Weight (kg) 6.5 (3.7-15.1) 6.3 (3.6-14.7) 6.8 (3.8-16.5)

Genetic/Non-CV abn 30% 29% 32%

Pre-op risk factor 28% 26% 31%

≥1 prior CT surgery 22% 23% 22%

STS-EACTS 1-3 75% 74% 78%

STS-EACTS 4-5 25% 26% 22%

Annual volume 160 (104-259) 209 (147-312) 118 (78-178)

Study Population CharacteristicsStudy Population Characteristics

OverallOverall CICUCICU Other ICUOther ICU

Age (mo) 6.6 (1.1-46.8) 6.3 (1.0-44.4) 7.3 (1.4-54.0)

Male 55% 55% 54%

Weight (kg) 6.5 (3.7-15.1) 6.3 (3.6-14.7) 6.8 (3.8-16.5)

Genetic/Non-CV abn 30% 29% 32%

Pre-op risk factor 28% 26% 31%

≥1 prior CT surgery 22% 23% 22%

STS-EACTS 1-3 75% 74% 78%

STS-EACTS 4-5 25% 26% 22%

Annual volume 160 (104-259) 209 (147-312) 118 (78-178)

Study Population CharacteristicsStudy Population Characteristics

OverallOverall CICUCICU Other ICUOther ICU

Age (mo) 6.6 (1.1-46.8) 6.3 (1.0-44.4) 7.3 (1.4-54.0)

Male 55% 55% 54%

Weight (kg) 6.5 (3.7-15.1) 6.3 (3.6-14.7) 6.8 (3.8-16.5)

Genetic/Non-CV abn 30% 29% 32%

Pre-op risk factor 28% 26% 31%

≥1 prior CT surgery 22% 23% 22%

STS-EACTS 1-3 75% 74% 78%

STS-EACTS 4-5 25% 26% 22%

Annual volume 160 (104-259) 209 (147-312) 118 (78-178)

Study Population CharacteristicsStudy Population Characteristics

OverallOverall CICUCICU Other ICUOther ICU

Age (mo) 6.6 (1.1-46.8) 6.3 (1.0-44.4) 7.3 (1.4-54.0)

Male 55% 55% 54%

Weight (kg) 6.5 (3.7-15.1) 6.3 (3.6-14.7) 6.8 (3.8-16.5)

Genetic/Non-CV abn 30% 29% 32%

Pre-op risk factor 28% 26% 31%

≥1 prior CT surgery 22% 23% 22%

STS-EACTS 1-3 75% 74% 78%

STS-EACTS 4-5 25% 26% 22%

Annual volume 160 (104-259) 209 (147-312) 118 (78-178)

Unadjusted OutcomesUnadjusted Outcomes

CICUCICU Other ICUOther ICU pp

In-hospital Mortality 3.6% 4.1% 0.04

Length of Stay 8.5 (4.0-13.0) 8.4 (4.0-13.0) <0.01

Complications 21% 21% 0.99

Adjusted Outcomes Associated with a CICUAdjusted Outcomes Associated with a CICU

OR (95% CI) p-value

In-hospital Mortality 0.88 (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

Complications 1.11 (0.74-1.67) 0.61

*log days

Odds Ratio for In-hospital Mortality: CICU vs. Other ICUOdds Ratio for In-hospital Mortality: CICU vs. Other ICU

Favors CICU Favors Other ICU

OR 0.47 (0.25-0.86)

STS-EACTS 3STS-EACTS 3

Most common operations:Most common operations: Complete AV canal repair (37%)Complete AV canal repair (37%) Arterial switch operation (23%)Arterial switch operation (23%)

Mortality Mortality CICUCICU Other ICUOther ICU p-value p-value

CAVCCAVC 1.2%1.2% 3.4%3.4% 0.05 0.05

ASOASO 0.3%0.3% 5.6%5.6% <0.0001 <0.0001

Estimate for Length of Stay: CICU vs. Other ICUEstimate for Length of Stay: CICU vs. Other ICU

Favors CICU Favors Other ICU

Odds Ratio for Complications: CICU vs. Other ICUOdds Ratio for Complications: CICU vs. Other ICU

Favors CICU Favors Other ICU

LimitationsLimitations

Observational design, patient and center confoundersObservational design, patient and center confounders

GeneralizabilityGeneralizability

Analysis limited to in-hospital outcomesAnalysis limited to in-hospital outcomes

Only ICU structure was analyzedOnly ICU structure was analyzed

ConclusionsConclusions

In this large multi-institutional study, we were not able In this large multi-institutional study, we were not able to detect a difference in post-operative outcomes to detect a difference in post-operative outcomes associated with a dedicated CICU in the overall associated with a dedicated CICU in the overall cohort undergoing congenital heart surgery cohort undergoing congenital heart surgery

There may be a survival benefit for certain subgroupsThere may be a survival benefit for certain subgroups

Further investigation focusing not only on ICU Further investigation focusing not only on ICU structure but differences in personnel and care structure but differences in personnel and care processes may elucidate other factors which may processes may elucidate other factors which may impact outcome in this populationimpact outcome in this population