Background: Risk standardization for adverse events after 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’s (National Cardiovascular Data Registry) IMPACT Registry (Improving Pediatric and Adult Congenital Treatment).

Methods: Between January 2011 and March 2014, 39 725 consecutive patients within IMPACT undergoing cardiac catheterization were identified. Given the heterogeneity of interventional procedures for congenital heart disease, new procedure-type risk categories were derived with empirical 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 or death after cardiac catheterization was derived in 70% of the cohort and validated in the remaining 30%.

Results: The rate of major adverse event or death was 7.1% and 7.2% in the derivation and validation cohorts, respectively. Six procedure-type risk categories and 6 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, 0.04; P value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; P value [for difference from 0] =0.95).

Conclusions: The creation of a validated risk-standardization model for adverse outcomes after congenital cardiac catheterization can support reporting of risk-adjusted outcomes in the IMPACT Registry as a foundation for quality improvement.

中文翻译：

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小儿和成年先天性心脏病患者行心脏导管插入术的主要不良后果建模

背景：先天性心脏导管插入术后不良事件的风险标准化是必要的，以公平地比较不同医院之间的患者结果，以作为改善质量的基础。该项目的目的是开发一种风险标准化方法，以在比较NCDR（国家心血管数据注册中心）IMPACT注册中心（改善儿科和成人先天性治疗）的主要不良结局时调整患者特征。

方法：确定2011年1月至2014年3月间IMPACT内39 725例接受心脏导管插入术的患者。鉴于先天性心脏病干预程序的异质性，根据经验数据和专家意见得出了新的程序类型风险类别，以及血流动力学脆弱性的标志。该人群中有70％的人采用了多变量分层Logistic回归模型来识别可预测主要不良事件或心脏导管插入后死亡的患者和程序特征，其余30％的人对此进行了验证。

结果：在派生和验证队列中，主要不良事件或死亡的发生率分别为7.1％和7.2％。确定了六个程序类型的风险类别和六个独立的血液动力学脆弱性指标。最终的风险调整模型包括程序类型的风险类别，血液动力学脆弱性指标的数量，肾功能不全，单心室生理和凝血功能障碍。该模型具有良好的辨别力，在派生和验证队列中的C统计量分别为0.76和0.75。验证队列中的模型校准非常好，斜率为0.97（标准误差，0.04；P值[与1的差] = 0.53），截距为0.007（标准误差，0.12；P 值[与0的差] = 0.95）。

结论：为先天性心脏导管插入术后不良后果建立经过验证的风险标准化模型，可以支持IMPACT注册中心报告风险调整后的结果，以此作为改善质量的基础。