Wegner FK et al.: Prospective blinded Evaluation of the smartphone-based AliveCor Kardia ECG monitor for Atrial Fibrillation detection: The PEAK-AF study. Eur J Intern Med 73 (2020):72-75
DOI: 10.1016/j.ejim.2019.11.018
Elektrophysiologen der Uni Münster analysierten 296 EKG von 99 Patienten (38 weiblich, Alter 64 ± 15 Jahre) mit dem AliveCor Kardiamobile. 20 % der klassischen „Ableitung-I-EKG“ (mit den Fingern der re. und li. Hand) zeigten ein kritisches Maß an Artefakten. Die EKG-Interpretation durch Elektrophysiologen ergab eine Sensitivität von 100 % und eine Spezifität von 94 % für Vorhofflimmern oder -flattern in Ableitung I (κ = 0.90) und eine Sensitivität von 96 % und Spezifität von 97 % in der links-parasternalen NPL-Ableitung (κ = 0.92). Der Befundungs-Algorithmus des Gerätes ergab eine signifikant geringere Sensitivität (55-70%), Spezifität (60-69%) und Genauigkeit (κ = 0.4-0.53), aber einen hohen negativen prädiktiven Wert von 100 %. Patienten mit Vorhofflattern (n = 5) und mit ventrikulärer Stimulation (n = 12) wurden vom Algorithmus häufig falsch klassifiziert.
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/m2) 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.