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Background <p>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.</p> Objective <p>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.</p> Methods <p>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.</p> Results <p>Intra and inter-reader reproducibility was excellent (ICC &gt; 0.98, including Sokolow-Lyon voltage; standard-deviation &lt; 4&#xa0;ms across all time-derived parameters). In ribociclib-treated patients (cycles of 21/28&#xa0;days on drug), QTc peaked at day 14 (16 ± 1&#xa0;ms, <i>p</i> &lt; 0.001) before decreasing by day 28 (-6 ± 1&#xa0;ms, <i>p</i> &lt; 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&#xa0;µV, <i>p</i> &lt; 0.001) and remaining constant afterwards for the next month.</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月19日

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  • Samuel D. Cohen,
  • Maxime Robert-Halabi,
  • Adrien Procureur,
  • Mathieu Jamelot,
  • Martino Vaglio,
  • Fabio Badilini,
  • Edi Prifti,
  • Joe-Elie Salem

摘要

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.