Accuracy of a smartwatch based single-lead electrocardiogram device in detection of atrial fibrillation

Abstract

ObjectiveThe AliveCor KardiaBand (KB) is an Food and Drug Administration-approved smartwatch-based cardiac rhythm monitor that records a lead-Intelligent ECG (iECG). Despite the appeal of wearable integrated ECG devices, there is a paucity of data evaluating their accuracy in diagnosing atrial fibrillation (AF). We evaluated whether a smartwatch-based device for AF detection is an accurate tool for diagnosing AF when compared with 12-lead ECG.MethodsA prospective, multi-centre, validation study was conducted in an inpatient hospital setting. The KB paired with a smartwatch, generated an automated diagnosis of AF or sinus rhythm (SR). This was compared with a 12-lead ECG performed immediately after iECG tracing. Where an unclassified or no-analysis tracing was generated, repeat iECG was performed.Results439 ECGs (iECGs (n=239) and 12-lead ECG (n=200)) were recorded in 200 patients (AF: n=38; SR: n=162) from three tertiary centres. Sensitivity and specificity using KB was 94.4% and 81.9% respectively, with a positive predictive value of 54.8% and negative predictive value of 98.4%. Agreement between 12-lead ECG and KB diagnosis was moderate when unclassified tracings were included (κ=0.60, 95% CI 0.47 to 0.72). Combining the automated device diagnosis with blinded electrophysiologists (EP) interpretation of unclassified tracings improved overall agreement (EP1: κ=0.76, 95% CI 0.65 to 0.87; EP2: κ=0.74, 95% CI 0.63 to 0.86).ConclusionThe KB demonstrated moderate diagnostic accuracy when compared with a 12-lead ECG. Combining the automated device diagnosis with EP interpretation of unclassified tracings yielded improved accuracy. However, even with future improvements in automated algorithms, physician involvement will likely remain an essential component when exploring the utility of these devices for arrhythmia screening.Clinical trial registrationURL: https://www.anzctr.org.au/ Unique identifier: ACTRN12616001374459.

Wearables in der Schlaganfallmedizin

“…In einer prospektiven multizentrischen Studie an 200 Patienten (38 mit Vorhofflimmern,162 mit Sinusrhythmus) konnte mit dem KB im Vergleich zu einem 12-Kanal-EKG eine Sensitivität von 94,4 % und eine Spezifität von 81,9 % erreicht werden [35]. Allerdings waren 19,5 % der Aufzeichnungen entweder nicht als Sinusrhythmus oder Vorhofflimmern interpretiert worden (12,5 %) bzw.…”

“…Allerdings waren 19,5 % der Aufzeichnungen entweder nicht als Sinusrhythmus oder Vorhofflimmern interpretiert worden (12,5 %) bzw. waren durch Artefakte nicht analysierbar [35].…”

“…Aufgrund der hohen Zahl von nicht interpretierbaren oder nicht analysierbaren Aufzeichnungen von 19,5-33,7 % sollte das KB deshalb in jedem Fall mit einer visuellen Auswertung durch einen Elektrophysiologen kombiniert werden [34,35].…”

Diagnosing atrial fibrillation by mobile technology: physician decision or device provision?

“…A relevant question is whether or not automated diagnoses provided by a mobile device are an adequate substitution for healthcare provider interpretation. The investigators of this study evaluated whether a smartwatch-based device for AF detection with an automatic interpretation is an accurate tool for diagnosing AF when compared with a physician-interpreted, standard 12-lead ECG 5. The authors studied hospital inpatients using AliveCor’s KardiaBand.…”

Heartbeat: smartwatch devices for detection of atrial fibrillation

“…Smartwatch-based devices for monitoring heart rate and rhythm are increasingly popular with patients but many physicians are concerned about accuracy for detection of atrial fibrillation (AF). In a prospective multi-centre study, Rajakariar and colleagues1 compared automated smartwatch diagnosis of AF plus recording of a lead-intelligent ECG (iECG) with a conventional 12-lead ECG recorded immediately after the iECG in 200 hospitalised patients. Overall, accuracy of the smartwatch-based iECG was high at 84% with a negative predictive value 98% but positive predictive value was only 55%, indicating that physician involvement is essential when the smartwatch-based device suggests AF might be present (table 1).…”