What question did this study set out to answer?

Evaluate the intra- and inter-reader reproducibility and clinical utility of a semi-automated ECG tool using the triplicate concatenation method in cardio-oncology patients.

December 19, 2025SHILAP Revista de lepidopterologíaOpen Access

Validation of a novel semi-automated ECG quantification tool, applied to a cardio-oncology

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Why the study?

Manual ECG methods to detect cardiotoxicity are time-consuming and limited by inter-reader variability, highlighting the need for precise, reproducible, and rapid semi-automated digital tools in clinical practice.

Does the triplicate concatenation method using semi-automated ECG software provide reproducible ECG measurements in cardio-oncology patients?

Key Points

Evaluate the intra- and inter-reader reproducibility and clinical utility of a semi-automated ECG tool using the triplicate concatenation method in cardio-oncology patients.
Analyzed 420 ECGs from 31 patients (21 receiving ribociclib and 10 with severe immune checkpoint inhibitor-induced myocarditis) independently evaluated by two readers.
Assessed reader variability using Bland-Altman analyses and intraclass correlation coefficients (ICC).
Modeled time-dependent changes in heart rate, PR interval, Fridericia-corrected QTc, QRS duration, and Sokolow-Lyon voltage via linear mixed-effects models.
Achieved high intra- and inter-reader reproducibility across all parameters, with an ICC > 0.98 (including Sokolow-Lyon voltage) and standard deviations < 4 ms for time-derived metrics.
In ribociclib-treated patients, QTc significantly peaked at day 14 (16 ± 1 ms increase vs. baseline, p < 0.001) before decreasing by day 28 (-6 ± 1 ms, p < 0.001).
In ICI-myocarditis patients, QRS duration increased at day 5 and normalized by day 28, while Sokolow-Lyon voltage peaked under immunosuppression at day 28 (458 ± 49 µV, p < 0.001) and remained stable.

Structured PICO

Does the triplicate concatenation method using semi-automated ECG software provide reproducible ECG measurements in cardio-oncology patients?

Population

31 patients (21 breast cancer patients receiving ribociclib and 10 patients admitted with severe immune checkpoint inhibitors (ICI)-myocarditis) contributing 420 ECGs

Intervention

Triplicate concatenation method (TCM) using a semi-automated ECG software (CalECG-4.2, AMPS®)

Outcome

Intra- and inter-reader variabilities of ECG parameters (HR, PR, QTc, QRS duration and Sokolow-Lyon voltage)surrogate

The triplicate concatenation method using CalECG-4.2 software provides highly reproducible semi-automated ECG measurements, offering a reliable tool for monitoring drug-induced cardiotoxicity.

Implication

May support reliable ECG monitoring in cardio-oncology; leaves open prospective outcome validation.

Abstract

BACKGROUND: Electrocardiogram (ECG) analysis is crucial to detect cardiotoxicity. Manual methods are time-consuming and limited by inter-reader variability, highlighting the need for precise, reproducible and rapid semi-automated digital tools in clinical practice. OBJECTIVE: This study evaluates the triplicate concatenation method (TCM) using a semi-automated ECG software (CalECG-4.2, AMPS®) by assessing intra- and inter-reader variabilities in two distinct cardio-oncology populations: breast cancer patients receiving ribociclib (a QT-prolonging drug) and patients admitted with severe immune checkpoint inhibitors (ICI)-myocarditis, a condition marked by QRS alterations. METHODS: A total of 420 ECG from 31 patients (21 ribociclib, and 10 ICI-myocarditis) were independently analyzed by two readers. Variability was assessed using Bland-Altman analyses and intraclass correlation coefficients (ICC). Linear mixed-effects modelling quantified time-dependent changes in heart rate (HR), PR, QTc (Fridericia's HR correction), QRS duration and voltage (Sokolow-Lyon) accounting for inter-reader variability. RESULTS: Intra and inter-reader reproducibility was excellent (ICC > 0.98, including Sokolow-Lyon voltage; standard-deviation < 4 ms across all time-derived parameters). In ribociclib-treated patients (cycles of 21/28 days on drug), QTc peaked at day 14 (16 ± 1 ms, p < 0.001) before decreasing by day 28 (-6 ± 1 ms, p < 0.001) compared to baseline. In ICI-myocarditis, QRS duration increased at day 5 before returning to baseline starting day 28, while Sokolow-Lyon voltages increased progressively on immunosuppressive treatments, peaking at day 28 (458 ± 49 µV, p < 0.001) and remaining constant afterwards for the next month. CONCLUSION: TCM with CalECG-4.2 ensures a high reproducibility while monitoring key parameters like QTc duration and Sokolow-Lyon voltage, making it a reliable and time-saving alternative for the ECG surveillance of drug toxicities in cardio-oncology.