Key result
AI-ECG biomarker identifies ventricular remodeling and cuts CMR use ~13% in repaired TOF.
Why the study?
Periodic CMR is recommended to identify adverse ventricular remodeling in repaired TOF, but access to CMR is uneven and compliance is poor.
Does a 12-lead ECG artificial intelligence biomarker accurately identify CMR-quantified adverse biventricular remodeling in patients with repaired tetralogy of Fallot?
Cohort (n=1,690)
Yes
Does a 12-lead ECG artificial intelligence biomarker accurately identify CMR-quantified adverse biventricular remodeling in patients with repaired tetralogy of Fallot?
Effect estimate: AUROC 0.85 (95% CI 0.83-0.87)
An AI-ECG biomarker can effectively screen for adverse ventricular remodeling in repaired tetralogy of Fallot, potentially reducing unnecessary cardiac MRIs by 13%, though site-specific calibration may be required.
May not yet change CMR screening in repaired TOF; hypothesis-generating for AI-ECG triage.
Background Periodic cardiac MRI (CMR) is recommended to identify adverse ventricular remodeling in repaired tetralogy of Fallot (TOF), but access to CMR is uneven and compliance is poor. We developed a 12-lead electrocardiogram (ECG) artificial intelligence (AI) biomarker to identify CMR-quantified adverse biventricular remodeling in repaired TOF. Methods Six (1 train/5 external test) North American retrospective cohorts with paired ECG and CMR were included. Main outcome was composite of ≥2 TOF-specific CMR abnormalities: RV end-diastolic volume>160 mL/m2, RV end-systolic volume>80 mL/m2, RVEF <47%, LVEF <55%. Model discrimination, calibration, and net benefit as a screening test to rule out ventricular remodeling were assessed. Results 908 patients(2,552 ECGs) were included in training, and 782 patients(1,795 ECGs) in external validation (outcome prevalence 57%). AUROC was 0.85(95% CI 0.83-0.87) and average precision 0.88. At a screening risk-threshold of 0.25 there was 92% sensitivity, 41% specificity, 87% negative predictive value, and 55% positive predictive value for ventricular remodeling, which yielded a 13% net reduction in CMR use on net benefit analysis. There was no difference by sex or race/ethnicity, but there were differences by age and site, with 2 of 5 sites with lower AUROC than the others, and 3 of 5 sites met criteria for miscalibration which improved after center-specific calibration. Conclusions An AI-ECG biomarker in repaired TOF effectively identifies ventricular remodeling to inform timing of advanced imaging. Extensive external validation revealed variation in discrimination and calibration that are important considerations for clinical implementation and regulatory approval pathways of AI-ECG in congenital heart disease.
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Duong et al. (2026) conducted a cohort in Repaired tetralogy of Fallot (n=1,690). 12-lead ECG artificial intelligence biomarker was evaluated on Composite of ≥2 TOF-specific CMR abnormalities: RV end-diastolic volume>160 mL/m2, RV end-systolic volume>80 mL/m2, RVEF <47%, LVEF <55% (AUROC 0.85, 95% CI 0.83-0.87). A 12-lead ECG artificial intelligence biomarker identified adverse biventricular remodeling in repaired tetralogy of Fallot with an AUROC of 0.85 (95% CI 0.83-0.87).
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