Abstract Background Photoplethysmography (PPG) based consumer accessible devices with algorithms for irregular rhythm detection are gaining popularity as an opportunistic screening tool for atrial arrhythmias, and are FDA cleared for use in patients without a history of atrial fibrillation (AF). However, these devices are increasingly used for the management of AF, a purpose for which some algorithms are not intended. Purpose To compare the performance of the Apple Watch Irregular Rhythm Notification (IRN) with an implantable cardiac monitor (ICM) for the detection of atrial fibrillation (AF) in patients with known AF from the DEFINE AFib study. Methods Patients with known AF, a LINQ or LINQ II ICM, and an Apple Watch with PPG-based IRN activated were included in the analysis. ICM detected AF episodes served as the standard to which Apple Watch IRNs were compared. All AF episodes detected by the ICM device were manually adjudicated by two trained, independent reviewers with a third independent reviewer in situations of disagreement. Only AF episodes ≥60 minutes during a 75-minute window in which the Apple Watch was monitoring were included in accordance with the known Apple Watch algorithm detection parameters. To eliminate oversampling of ICM detected episodes compared to Apple Watch IRNs, 1,000 simulations of one randomly selected episode per subject was done to avoid single-subject bias. Results In total, 97 subjects were analyzed of which 42 had an AF episode ≥60 minutes. Applying the 75-minute window of Apple Watch monitoring to episodes ≥60 minutes, 20 subjects had qualifying, adjudicated ICM detected AF. These 20 subjects accounted for 481 qualifying AF episodes. Of the ICM detected episodes, 191 (40%) occurred while an Apple Watch was not being worn. In total, 11/20 (55%) subjects had an IRN generated by the Apple Watch. Adjudication of the ICM episodes resulted in 290 true positive AF episodes ≥60 minutes during a 75-minute window while the watch was actively monitoring, with 74 (26%) of those episodes triggering an IRN resulting in a per episode sensitivity of 24 ± 7% and PPV of 91 ± 4% (Figure 1A). The efficacy of Apple Watch to detect AF episodes of differing lengths was assessed for episodes between 1-6 hours, 6-12 hours, 12-24 hours, and > 24 hours with sensitivities of 19 ± 19%, 38 ± 8%, 32 ± 10%, and 31 ± 8%, respectively (Figure 1B). The Apple Watch generated an annualized false positive rate of 2.25 IRNs for every patient year of monitoring. At the subject level, Apple Watch had a sensitivity of 48%, specificity of 100%, PPV of 100%, and NPV of 71% (Figure 1A). Conclusions In patients with a history of AF, the Apple Watch IRN was most sensitive at the individual subject level while watch performance was lower by episode. The current IRN algorithm favors longer episode durations. The limited sensitivity, dependence on user wear-time, and reliance on long-durations of AF limit the use of Apple Watch for AF management.
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