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. 2009 Jan;14 Suppl 1(Suppl 1):S22-9.
doi: 10.1111/j.1542-474X.2008.00260.x.

Automatic extraction of ECG strips from continuous 12-lead holter recordings for QT analysis at prescheduled versus optimized time points

Fabio Badilini  1 , Martino Vaglio, Nenad Sarapa
Affiliations

Automatic extraction of ECG strips from continuous 12-lead holter recordings for QT analysis at prescheduled versus optimized time points

Fabio Badilini et al. Ann Noninvasive Electrocardiol. 2009 Jan.

Abstract

Background: Continuous 12-lead ECG monitoring (Holter) in early-phase pharmaceutical studies is today widely used as an ideal platform to extract discrete ECGs for analysis. The extraction process is typically performed manually by trained readers using commercial Holter processing systems.

Methods: Antares, a novel method for automatic 12-lead extraction from continuous Holter recordings applying minimal noise criteria and heart-rate stability conditions is presented. A set of 12-lead Holter recordings from healthy subjects administered with sotalol is used to compare ECG extractions at fixed time points with ECG extractions generated by Antares optimizing noise and heart rate inside 5 minute windows centered around each expected time point of interest.

Results: Global, low- and high-frequency noise content of extracted ECGs was significantly reduced via optimized approach by Antares. Heart rate was also slightly reduced (from 69 +/- 13 to 64 +/- 13 bpm, P < 0.05). Similarly, the corrected QT interval from optimized extractions was significantly reduced (QTcB from 414 +/- 32 to 402 +/- 30 ms, P < 0.05). Using only baseline data, and after adjusting for intersubject variability, the standard deviation (SD) of QT intervals was highly reduced with optimized extraction (SD of QTcF from 11 +/- 8 to 7 +/- 2 ms, P < 0.05).

Conclusions: Extraction of discrete 12-lead ECG strips from continuous Holter generates less noisy and more stable ECGs leading to more robust QTc data, thereby potentially facilitating the assessment of ECG effects on clinical trials.

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Figures

Figure 1
Figure 1
Schematic description of Antares.
Figure 2
Figure 2
Trend display of RRs and RRo intervals within the optimum window from a representative example (see text for more description of RRs and RRo intervals).
Figure 3
Figure 3
Histograms of global (all frequencies) noise from the 821 ECGs using the fixed time point method (left panel) and using Antares (right panel). The distribution of global noise is overly shifted to the right‐hand side after optimized extraction by Antares.
Figure 4
Figure 4
Example of ECG extraction using a fixed time point (upper plot) and using Antares (bottom plot) in a representative example with presence of noise. Only limb leads are displayed.
Figure 5
Figure 5
Example of ECGs extraction using a fixed time point (left‐hand side) and using Antares (right‐hand side) in a representative example with the presence of heart‐rate fluctuations. The superimposed (butterfly) display of the median beats is also displayed and the QT/RR parameters computed by CalECG are shown.
Figure 6
Figure 6
Scatterplots of global (all frequencies) noise versus heart rate, using the fixed time point method (left panel) and using Antares optimized extractions (right panel). The heart dependency of noise is reduced after optimized extraction by Antares.
See this image and copyright information in PMC

References

    1. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) . E14 Guidance on Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythic Potential for Non‐antiarrythmic Drugs. Available at: http://www.fda.gov/cder/guidance/6922fnl.pdf, 2005.
    1. Sarapa N. Digital 12‐lead Holter in the assessment of drug effects on cardiac repolarization. J Electrocardiol 2006;38:293. - PubMed
    1. Badilini F, Maison‐Blanche P, Childers R, et al QT interval analysis on ambulatory recordings: A selective beat averaging approach. Med Bio EngComp 1999;37:71–79. - PubMed
    1. Extramiana F, Maison‐Blanche P, Haggui A, et al Control of rapid heart rate changes for electrocardiographic analysis: Implications for thorough QT studies. Clin Cardiol 2006;29:534–539. - PMC - PubMed
    1. Badilini F. The ISHNE Holter sandard output file format. Ann Noninvasive Electrocardiol 1998;3:263–266.

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