Catheterization for Congenital Heart Disease Adjustment for Risk Method II.

Area of Science:

• Cardiology
• Medical Informatics
• Pediatric Health

Background:

• Current risk adjustment metrics for congenital cardiac catheterization are outdated.
• Novel procedures, technologies, and patient subgroups necessitate updated methodologies.
• Existing metrics do not adequately capture case mix complexity.

Purpose of the Study:

• To develop a novel risk adjustment methodology for congenital cardiac catheterization.
• To introduce a clinically meaningful adverse event outcome.
• To incorporate a modern understanding of patient risk.

Main Methods:

• Data collected from diagnostic and interventional congenital cardiac catheterization cases (patients ≤18 years, ≥2.5 kg).
• Derivation cohort (2014-2017) and validation cohort (2019-2020) used.
• Clinically meaningful adverse events defined as severity level ≥3b; stratified into tiers (3a/b/c).

Main Results:

• Derivation (15,224 cases) and validation (9462 cases) cohorts analyzed.
• Clinically meaningful adverse event rates were 4.5% (derivation) and 4.2% (validation).
• Final model included age <30 days, Procedural Risk in Congenital Cardiac Catheterization category, and hemodynamic vulnerability score (C-statistic 0.70).

Conclusions:

• CHARM II (Congenital Heart Disease Adjustment for Risk Method II) is a new risk adjustment methodology.
• CHARM II enables equitable comparison of clinically meaningful adverse events.
• The methodology addresses varying patient populations and case mix complexity in pediatric cardiac catheterization.