Department of Cardiology, Boston Children's Hospital, MA (B.P.Q., L.C.G., S.G.K., K.G., M.J.Y., L.B.).
Division of Cardio-Thoracic Sciences, Sindh Institute of Urology and Transplantation, Pakistan (B.H.).
Circ Cardiovasc Interv. 2024 Mar;17(3):e012834. doi: 10.1161/CIRCINTERVENTIONS.123.012834. Epub 2024 Jan 23.
Current metrics used to adjust for case mix complexity in congenital cardiac catheterization are becoming outdated due to the introduction of novel procedures, innovative technologies, and expanding patient subgroups. This study aims to develop a risk adjustment methodology introducing a novel, clinically meaningful adverse event outcome and incorporating a modern understanding of risk.
Data from diagnostic only and interventional cases with defined case types were collected for patients ≤18 years of age and ≥2.5 kg at all Congenital Cardiac Catheterization Project on Outcomes participating centers. The derivation data set consisted of cases performed from 2014 to 2017, and the validation data set consisted of cases performed from 2019 to 2020. Severity level 3 adverse events were stratified into 3 tiers by clinical impact (3a/b/c); the study outcome was clinically meaningful adverse events, severity level ≥3b (3bc/4/5).
The derivation data set contained 15 224 cases, and the validation data set included 9462 cases. Clinically meaningful adverse event rates were 4.5% and 4.2% in the derivation and validation cohorts, respectively. The final risk adjustment model included age <30 days, Procedural Risk in Congenital Cardiac Catheterization risk category, and hemodynamic vulnerability score (C statistic, 0.70; Hosmer-Lemeshow value, 0.83; Brier score, 0.042).
CHARM II (Congenital Heart Disease Adjustment for Risk Method II) risk adjustment methodology allows for equitable comparison of clinically meaningful adverse events among institutions and operators with varying patient populations and case mix complexity performing pediatric cardiac catheterization.
由于新型手术、创新技术和不断扩大的患者亚群的出现，当前用于调整先天性心脏导管插入术病例组合复杂性的指标已经过时。本研究旨在开发一种风险调整方法，引入一种新的、具有临床意义的不良事件结果，并结合对风险的现代理解。
从所有参与先天性心脏导管插入术结果项目的中心收集年龄≤18 岁且体重≥2.5kg 的仅诊断和介入病例的数据，并定义病例类型。推导数据集由 2014 年至 2017 年期间进行的病例组成，验证数据集由 2019 年至 2020 年期间进行的病例组成。根据临床影响（3a/b/c）将 3 级不良事件分为 3 个等级；研究结果为具有临床意义的不良事件，严重程度≥3b（3bc/4/5）。
推导数据集包含 15224 例，验证数据集包含 9462 例。推导队列和验证队列中具有临床意义的不良事件发生率分别为 4.5%和 4.2%。最终的风险调整模型包括<30 天的年龄、先天性心脏导管插入术风险类别中的手术风险和血液动力学脆弱性评分（C 统计量为 0.70；Hosmer-Lemeshow 值为 0.83；Brier 评分为 0.042）。
CHARM II（先天性心脏病风险调整方法 II）风险调整方法允许在具有不同患者人群和病例组合复杂性的机构和操作人员之间公平比较具有临床意义的不良事件。
