Jayaram Natalie, Spertus John A, Kennedy Kevin F, Vincent Robert, Martin Gerard R, Curtis Jeptha P, Nykanen David, Moore Phillip M, Bergersen Lisa
Children's Mercy Hospitals and Clinics, Kansas City, MO (N.J.)
Saint Luke's Mid America Heart Institute, Kansas City, MO (J.A.S., K.F.K.).
Circulation. 2017 Nov 21;136(21):2009-2019. doi: 10.1161/CIRCULATIONAHA.117.027714. Epub 2017 Sep 7.
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).
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%.
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; value [for difference from 1] =0.53) and an intercept of 0.007 (standard error, 0.12; value [for difference from 0] =0.95).
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.
先天性心脏导管插入术后不良事件的风险标准化对于公平比较不同医院的患者结局至关重要，这是质量改进的基础。本项目的目标是开发一种风险标准化方法，以便在比较国家心血管数据注册中心（NCDR）的先天性心脏病介入治疗注册项目（Improving Pediatric and Adult Congenital Treatment，简称IMPACT Registry）中的主要不良结局时，对患者特征进行调整。
在2011年1月至2014年3月期间，在IMPACT Registry中连续纳入39725例接受心脏导管插入术的患者。鉴于先天性心脏病介入手术的异质性，利用经验数据和专家意见得出了新的手术类型风险类别以及血流动力学脆弱性指标。在70%的队列中建立了一个多变量分层逻辑回归模型，以识别心脏导管插入术后主要不良事件或死亡的患者和手术特征，并在其余30%的队列中进行验证。
在推导队列和验证队列中，主要不良事件或死亡的发生率分别为7.1%和7.2%。确定了6种手术类型风险类别和6个血流动力学脆弱性独立指标。最终的风险调整模型包括手术类型风险类别、血流动力学脆弱性指标数量、肾功能不全、单心室生理状态和凝血障碍。该模型具有良好的区分度，在推导队列和验证队列中的C统计量分别为0.76和0.75。验证队列中的模型校准效果极佳，斜率为0.97（标准误为0.04；与1的差值的P值 = 0.53），截距为0.007（标准误为0.12；与0的差值的P值 = 0.95）。
为先天性心脏导管插入术后不良结局建立一个经过验证的风险标准化模型，可以支持在IMPACT Registry中报告风险调整后的结局，作为质量改进的基础。
