Prospective blinded Evaluation of the smartphone-based AliveCor Kardia ECG monitor for Atrial Fibrillation detection: The PEAK-AF study.

Introduction: The AliveCor Kardia ECG monitor (ACK) offers a smartphone-based one-lead ECG recording for the detection of atrial fibrillation. We compared ACK lead I recordings with the 12-lead ECG and introduce a novel parasternal lead (NPL).
Methods: Consecutive cardiac inpatients were recruited. In all patients a 12-lead ECG, ACK lead I and NPL were obtained. Two experienced electrophysiologists were blinded and separately evaluated all ECG. We calculated sensitivity, specificity, and predictive values of the ACK ECG compared to the 12-lead ECG.
Results: 296 ECG from 99 patients (38 female, age 64 ± 15 years, BMI 27.8 ± 5.1 kg/m ² ) were analyzed. 20% of ACK lead I recordings contained a critical amount of artifact. The electrophysiologists' interpretation of the ACK recordings yielded a sensitivity of 100% and specificity of 94% for atrial fibrillation or flutter in lead I (κ = 0.90) and a sensitivity of 96% and specificity of 97% in the NPL (κ = 0.92). The ACK diagnostic algorithm displayed a significantly lower sensitivity (55-70%), specificity (60-69%), and accuracy (κ = 0.4-0.53) but a high negative predictive value (100%). Patients with atrial flutter (n = 5) and with ventricular stimulation (n = 12) had a high likelihood of being misclassified by the algorithm.
Conclusion: The AliveCor Kardia ECG monitor allows a highly accurate detection of atrial fibrillation by an interpreting electrophysiologist both in the standard lead I and a novel parasternal lead. The diagnostic algorithm offered by the system may be useful in screening recordings for further review. Diagnostic challenges present in atrial flutter and ventricular pacemaker stimulation.
Competing Interests: Decleration of Competing Interest None.
(Copyright © 2019 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)