Background: Automated external defibrillators (AEDs) perform rhythm analysis in order to facilitate defibrillation. The effectiveness of AEDs is dependent on the accuracy of their rhythm classification, which includes differentiation of shockable rhythms from non-shockable rhythms Independent (i.e. non-industry) evaluation of the performance of AEDs against real-world ECG could lead to improvements in their performance. Objective: To evaluate the sensitivity and specificity characteristics of commercial AEDs with respect to quantitative properties of the ECG waveform in several rhythm presentations using real world ECG data. Methods: We conducted a prospective simulation study evaluating three commercially available AEDs from Defibtech, Phillips, and Zoll on the determination of ECG rhythm shockability. Performance was evaluated for 181 human ECG recordings (101 ventricular fibrillation-VF, 55 PEA, and 25 asystole) ranging widely in signal characteristics, obtained from the Pittsburgh site of the Resuscitation Outcomes Consortium. We used a commercially available digital-to-analog converter (National Instruments USB-6001) to inject the recordings into each AED through a direct lead-wire interface, recording shock advisement decisions in a best-out-of-three approach for each device/rhythm pairing. We calculated the sensitivity and specificity for discriminating VF and non-VF rhythms for each device and overall. VF signal characteristics were calculated, including peak frequency, median amplitude, and peak amplitude, and the VF quantitative waveform measures AMSA and median slope. Results: The 101 VF trials featured signals with mean peak frequency 10.02 Hz(IQR 4.80 Hz), mean AMSA 9.13(IQR 7.29), mean median slope 6.72 (IQR 3.66). The sensitivities were: Defibtech 99.0%; Philips 97.0%; Zoll 98.0%. The specificities were: Defibtech 98.7%; Philips 96.2%; Zoll 97.4%. Defibtech recorded 5 discordant advisements and Philips and Zoll recorded eight each. The overall sensitivity was 98.0%, and the specificity 97.4%. Conclusion: Evaluated against a wide variety of real-world signal presentations, commercial AEDs demonstrated a high degree of sensitivity and specificity for shockable ECG rhythms.
Read full abstract