Key result
In cryptogenic stroke and TIA patients, the use of a smartwatch for PPG-based mHealth resulted in significantly more clinically useful 12-hour monitoring periods compared to a smartphone (91.4% vs 84.8%).
Why the study?
The study aimed to explore the opportunities and hurdles of using insertable cardiac monitors and photoplethysmography-based mobile health via smartphone or smartwatch to detect AF in cryptogenic stroke and TIA patients.
Does PPG-based mHealth using a smartphone or smartwatch detect atrial fibrillation as effectively as insertable cardiac monitors in cryptogenic stroke or TIA patients?
RCT (n=39)
Double-blind (for mHealth results)
1:1
No
Does PPG-based mHealth using a smartphone or smartwatch detect atrial fibrillation as effectively as insertable cardiac monitors in cryptogenic stroke or TIA patients?
Absolute Event Rate: 91.4% vs 84.8%
p-value: p=<0.001
PPG-based mHealth shows potential for detecting atrial fibrillation in cryptogenic stroke patients, but both mHealth and state-of-the-art ICMs yield false positives requiring physician adjudication, and mHealth compliance decreases over time.
Aim This paper presents the preliminary results from the ongoing REMOTE trial. It aims to explore the opportunities and hurdles of using insertable cardiac monitors (ICMs) and photoplethysmography-based mobile health (PPG-based mHealth) using a smartphone or smartwatch to detect atrial fibrillation (AF) in cryptogenic stroke and transient ischemic attack (TIA) patients. Methods and Results Cryptogenic stroke or TIA patients ( n = 39) received an ICM to search for AF and were asked to use a blinded PPG-based mHealth application for 6 months simultaneously. They were randomized to smartphone or smartwatch monitoring. In total, 68,748 1-min recordings were performed using PPG-based mHealth. The number of mHealth recordings decreased significantly over time in both smartphone and smartwatch groups ( p < 0.001 and p = 0.002, respectively). Insufficient signal quality was more frequently observed in smartwatch (43.3%) compared to smartphone recordings (17.8%, p < 0.001). However, when looking at the labeling of the mHealth recordings on a patient level, there was no significant difference in signal quality between both groups. Moreover, the use of a smartwatch resulted in significantly more 12-h periods (91.4%) that were clinically useful compared to smartphone users (84.8%) as they had at least one recording of sufficient signal quality. Simultaneously, continuous data was collected from the ICMs, resulting in approximately 6,660,000 min of data (i.e., almost a 100-fold increase compared to mHealth). The ICM algorithm detected AF and other cardiac arrhythmias in 10 and 19 patients, respectively. However, these were only confirmed after adjudication by the remote monitoring team in 1 (10%) and 5 (26.3%) patients, respectively. The confirmed AF was also detected by PPG-based mHealth. Conclusion Based on the preliminary observations, our paper illustrates the potential as well as the limitations of PPG-based mHealth and ICMs to detect AF in cryptogenic stroke and TIA patients in four elements: (i) mHealth was able to detect AF in a patient in which AF was confirmed on the ICM; (ii) Even state-of-the-art ICMs yielded many false-positive AF registrations; (iii) Both mHealth and ICM still require physician revision; and (iv) Blinding of the mHealth results impairs compliance and motivation.
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Wouters et al. (2022) conducted an RCT in Cryptogenic stroke or TIA (n=39). PPG-based mHealth using a smartwatch vs. PPG-based mHealth using a smartphone was evaluated on Clinically useful 12-hour periods (at least one recording of sufficient signal quality) (p=<0.001). In cryptogenic stroke and TIA patients, the use of a smartwatch for PPG-based mHealth resulted in significantly more clinically useful 12-hour monitoring periods compared to a smartphone (91.4% vs 84.8%).
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