Patients with repaired tetralogy of Fallot often develop chronic pulmonary regurgitation leading to progressive right ventricular dilation, arrhythmic risk, and exercise intolerance. Deciding when to proceed with pulmonary valve replacement is pivotal yet challenging, typically relying on serial imaging, electrical markers, and clinical course. An emerging alternative leverages artificial intelligence applied to routine electrocardiograms to infer structural and functional changes relevant to intervention timing.
Building on advances in AI-ECG for ventricular function and valvular disease, a new approach explores whether AI derived from standard 12-lead signals can flag individuals nearing a clinically meaningful threshold for pulmonary valve replacement. The concept, described in a recent report accessible on PubMed, raises the prospect of scalable, low-friction surveillance that could complement imaging workflows, triage referrals, and prioritize resources. What follows considers clinical context, method rationale, potential impact, and guardrails for implementation.
In this article
Among forms of Congenital Heart Disease, Tetralogy of Fallot stands out for its long-term right ventricular burden after repair. Chronic pulmonary regurgitation and residual outflow tract obstruction can drive progressive Right Ventricular Remodeling, arrhythmia vulnerability, and functional decline. Timely Pulmonary Valve Replacement aims to reverse volume overload before irreversible fibrosis, but premature surgery can expose patients to prosthetic degeneration and reintervention. Clinicians therefore navigate a narrow window, synthesizing imaging, electrocardiographic, and clinical signals to choose the right moment. The proposition that an AI-enabled Electrocardiogram could assist in this decision is compelling because it leverages a ubiquitous, low-cost test that already reflects global ventricular mechanics.
Surveillance after repair typically centers on symptoms, exercise performance, and quantitative imaging to track right ventricular size and function. Cardiac Magnetic Resonance is often favored for volumetric assessment and fibrosis characterization, complemented by echocardiography for valve hemodynamics and anatomy. Electrical markers such as prolonged QRS Duration can indicate conduction delay and correlate with ventricular enlargement. Risk models integrate these domains, but concordance is imperfect, and thresholds can be debated across institutions. Repeat testing every 6 to 24 months is common, balancing clinical stability with the need to detect adverse remodeling before it becomes less reversible.
While comprehensive, imaging-centric pathways are resource intensive and can be logistically difficult for geographically dispersed patients transitioning from pediatric to adult care. Variability in scanner protocols, vendor differences, and inter-reader reproducibility can complicate longitudinal comparisons. Radiation exposure from CT is a consideration in certain scenarios, and sedation may be needed in younger or anxious individuals undergoing long examinations. Even when imaging quality is high, structural indices alone may lag behind early myocardial dysfunction or diffuse fibrosis, potentially narrowing the intervention window. These constraints highlight why accessible, high-frequency signals such as the ECG are attractive as adjunctive monitors.
Electrocardiographic features encode conduction, depolarization, and repolarization patterns shaped by chamber size, scar location, and loading conditions. In the repaired outflow tract, patch geometry and operative scars produce conduction heterogeneity evident as right bundle branch block variants and repolarization shifts. Temporal elongation of QRS complexes and axis changes can loosely mirror right ventricular enlargement or dyssynchrony. Subtle morphology patterns, however, are too complex to quantify manually and vary across leads and body habitus. Data-driven methods can therefore extract latent representations from the 12-lead waveform that capture microstructural changes more sensitively than conventional intervals or amplitudes.
Applying Artificial Intelligence to the ECG expands its utility from screening toward individualized Risk Stratification. In other cardiovascular settings, deep learning has inferred left ventricular ejection fraction, valvular disease, incident atrial fibrillation, and age or sex solely from ECG waveforms. The same logic extends to repaired tetralogy of Fallot, where the electrical footprint of right ventricular volume load and scarring may be detectable before overt clinical changes. A model tuned to recognize patterns associated with cross-sectional or longitudinal markers of decompensation could offer a simple probability score indicating proximity to intervention thresholds. Such a score is not a replacement for imaging but a triage tool to prioritize follow-up and inform shared decisions.
Conceptually, supervised learning pairs raw ECG traces with labels representing outcomes or proxy targets relevant to timing of intervention. Targets might include categories reflecting volumetric ranges, diastolic dysfunction, exercise-limiting physiology, or ultimately, clinician-adjudicated decision to proceed with surgery. Convolutional architectures are often used to capture local waveform features, while recurrent or transformer components can model temporal dependencies across the cardiac cycle. Regularization and calibration steps maintain probabilistic interpretability. Beyond performance metrics, interpretability approaches such as saliency mapping can suggest whether the model leverages clinically plausible segments, for instance terminal QRS or ST-T segments implicated in right ventricular strain.
A new report available on PubMed examines an AI-enabled ECG tool designed to guide pulmonary valve replacement timing in repaired tetralogy of Fallot. The approach focuses on whether a probability derived from a single or serial ECGs can help identify patients approaching a clinically meaningful intervention window. Findings suggest the AI-ECG can complement cardiac imaging by highlighting evolving electrical signatures correlated with adverse remodeling. The authors emphasize clinical utility as an adjunct rather than a replacement, envisioning integration into routine visits where actionable alerts prompt expedited imaging or multidisciplinary review. This framing aligns with real-world needs for scalable surveillance during long-term follow-up.
For clinical adoption, discrimination, calibration, and clinical usefulness all matter. Area under the receiver operating characteristic curve quantifies ranking ability, but well-calibrated probabilities facilitate thresholds aligned with local practice. Decision-curve analysis can demonstrate whether using the model confers net benefit across risk thresholds where clinicians would act. Prospective validation with pre-specified endpoints, blinded adjudication, and protocolized imaging is crucial, particularly to assess lead time gained relative to standard care. Drift monitoring and periodic recalibration address changes in ECG hardware, patient demographics, and surgical techniques over time.
Embedding an AI-ECG tool in longitudinal care requires thoughtful workflow design. In outpatient adult congenital clinics, an ECG-derived score could be auto-calculated at check-in and displayed in the electronic record alongside prior imaging results. Traffic-light visualization with clear thresholds and explanatory text can ease interpretation for trainees and allied professionals. Alerts should favor nudges over alarms, for example recommending earlier imaging rather than dictating surgery. Integration with registries could support learning health systems, where model outputs and outcomes feed back to improve performance while generating real-world evidence.
Realizing the promise of AI-ECG for intervention timing in repaired tetralogy of Fallot requires technical rigor and clinical humility. Training data diversity across ages, body sizes, surgical eras, and device vendors helps ensure generalizability. Human factors testing can uncover misinterpretation risks and inform user interface refinements that prevent overreliance on a single number. Governance should delineate responsibilities, performance monitoring, and escalation pathways when outputs conflict with clinical judgment. As with any predictive tool, transparent communication with patients about what the score represents, its limits, and how it will be used is essential to maintain trust.
An advantage of the ECG is its near-universal availability, making AI-ECG a candidate for equity-enhancing surveillance. For patients facing travel barriers to advanced imaging, a reliable ECG screen could lower delays in detecting adverse remodeling. Health systems may benefit if targeted imaging reduces unnecessary repetition without sacrificing safety. Economic analyses should consider costs associated with false positives, downstream testing, and potential earlier surgeries balanced against avoided late complications. Pragmatic deployment strategies might start with high-volume centers, followed by shared models or federated approaches in regional networks.
Interpretability is not merely a research nicety but a clinical safety feature. Saliency maps or lead-wise contribution displays can help clinicians confirm that the model attends to plausible features rather than artifacts. Nevertheless, interpretability tools can be misleading if not validated, and they do not replace rigorous performance and bias auditing. Safety frameworks should log model inputs, outputs, and clinician actions to enable post hoc review when outcomes diverge from expectations. Clear documentation of contraindications, such as paced rhythms or severe bundle branch blocks that may invalidate outputs, can support safer use.
From a regulatory standpoint, software as a medical device intended to inform intervention timing will require quality management, cybersecurity controls, and post-market surveillance. Version control, dataset lineage, and change management processes are central to maintaining clinical confidence. For models that continuously learn, guardrails must define when retraining is allowed and how performance is verified prior to redeployment. Alignment with institutional policies on clinical decision support and documentation standards helps ensure outputs are appropriately recorded and auditable within the patient record. Collaboration between clinicians, data scientists, and compliance teams is critical for sustained quality.
Next steps include prospective, multicenter cohorts with standardized acquisition protocols and predefined clinical outcomes. Endpoints could include adjudicated decisions to proceed with surgery, changes in volumetric indices, and patient-reported outcomes. Substudies might test serial ECG-based trajectories to detect acceleration in risk, rather than relying on a single snapshot. Importantly, external validation in different health systems and geographies can stress-test transportability. Opportunities also exist to fuse ECG-derived embeddings with imaging, biomarkers, and exercise metrics to create multimodal scores that preserve simplicity at the point of care.
Ethical development demands robust privacy protections, minimal data use, and explicit consent processes aligned with institutional review standards. Patient advisory panels can offer insights on acceptable risk thresholds, notification preferences, and how to frame AI-derived probabilities during shared decision-making. Transparency about uncertainties and the intent to augment, not replace, clinician expertise can mitigate concerns about automation. Equity audits should probe performance across sex, race, and socioeconomic strata to ensure that AI-ECG narrows rather than widens disparities. Open scientific reporting, including negative results and failure modes, accelerates collective learning.
Bridging technical outputs to clinical actions is the last mile problem for many AI tools. Calibrated risk categories linked to protocolized next steps can translate a probability into a care pathway. For example, a moderate-risk band might trigger expedited imaging within a few months, whereas a high-risk band prompts multidisciplinary case review. Local customization is necessary to reflect imaging access, surgical scheduling constraints, and patient preferences. By positioning AI-ECG squarely as Decision Support, teams can integrate it alongside other signals without ceding clinical judgment.
In synthesis, AI-enabled ECG guidance for pulmonary valve replacement timing in repaired tetralogy of Fallot is a promising adjunct to imaging-based workflows. It offers a scalable path to more frequent, low-burden assessments that could surface early deterioration and prioritize advanced testing. Yet, robust prospective validation, careful calibration, and explicit safety guardrails are prerequisites for responsible adoption. Multicenter collaboration, transparent reporting, and iterative refinement will determine whether this approach improves outcomes while preserving equity and trust. If those conditions are met, AI-ECG could become a practical, high-value tool in lifelong congenital heart care.
LSF-9859571458 | October 2025
How to cite this article
Team E. Ai-enabled ecg to guide pulmonary valve replacement timing. The Life Science Feed. Published November 6, 2025. Updated November 6, 2025. Accessed December 6, 2025. .
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References
- Artificial intelligence-enabled electrocardiogram guidance for pulmonary valve replacement timing in repaired tetralogy of Fallot. https://pubmed.ncbi.nlm.nih.gov/40886753/.
