Modeling Major Adverse Outcomes of Pediatric and Adult Patients with Congenital Heart Disease Undergoing Cardiac Catheterization: Observations from the NCDR IMPACT Registry
Background—Risk-standardization for adverse events following congenital cardiac catheterization is needed to equitably compare patient outcomes among different hospitals as a foundation for quality improvement. The goal of this project was to develop a risk-standardization methodology to adjust for patient characteristics when comparing major adverse outcomes in the NCDR® IMPACTTM (Improving Pediatric and Adult Congenital Treatment) Registry.
Methods—39,725 consecutive patients within IMPACT undergoing cardiac catheterization between January 2011 and March 2014 were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empiric data and expert opinion, as were markers of hemodynamic vulnerability. A multivariable hierarchical logistic regression model to identify patient and procedural characteristics predictive of a major adverse event (MAE) or death following cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%.
Results—The rate of MAE or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and six independent indicators of hemodynamic vulnerability were identified. The final risk adjustment model included procedure-type risk category, number of hemodynamic vulnerability indicators, renal insufficiency, single-ventricle physiology, and coagulation disorder. The model had good discrimination with a C-statistic of 0.76 and 0.75 in the derivation and validation cohorts, respectively. Model calibration in the validation cohort was excellent with a slope of 0.97 (standard error [SE] 0.04; p-value [for difference from 1]= 0.53) and an intercept of 0.007 (SE 0.12; p-value [for difference from 0]= 0.95).
Conclusions—The creation of a validated risk-standardization model for adverse outcomes following congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement.
- Received February 9, 2017.
- Revision received July 6, 2017.
- Accepted August 19, 2017.