Automatic Extraction of ECG Strips from Continuous 12‐lead Holter Recordings for QT Analysis at Prescheduled versus Optimized Time Points

Abstract

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. 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. 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). 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.