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Effect of Wearable ECG Monitoring Patch on Detecting AF
Study Questions:
What is the effect of a self-applied wearable electrocardiogram (ECG) patch in detecting atrial fibrillation (AF) and the clinical consequences associated with such a detection strategy?
Methods:
The mSToPS (mHealth Screening to Prevent Strokes) investigators conducted a direct-to-participant randomized clinical trial and prospective matched observational cohort study among members of a large national health plan. Recruitment began November 17, 2015, and was completed on October 4, 2016, and 1-year claims-based follow-up concluded in January 2018. For the clinical trial, 2,659 individuals were randomized to active home-based monitoring to start immediately or delayed by 4 months. For the observational study, two deidentified age-, sex- and CHA2DS2-VASc–matched controls were selected for each actively monitored individual. The actively monitored cohort wore a self-applied continuous ECG monitoring patch at home during routine activities for up to 4 weeks, initiated either immediately after enrolling (n = 1,364) or delayed for 4 months after enrollment (n = 1,291). The primary endpoint was the incidence of a new diagnosis of AF at 4 months among those randomized to immediate monitoring versus delayed monitoring. A secondary endpoint was new AF diagnosis at 1 year in the combined actively monitored groups versus matched observational controls. Other outcomes included new prescriptions for anticoagulants and health care utilization (outpatient cardiology visits, primary care visits, or AF-related emergency department visits and hospitalizations) at 1 year.
Results:
The randomized groups included 2,659 participants (mean [SD] age, 72.4 [7.3] years; 38.6% women), of whom 1,738 (65.4%) completed active monitoring. The observational study comprised 5,214 (mean [SD] age, 73.7 [7.0] years; 40.5% women; median CHA2DS2-VASc score, 3.0), including 1,738 actively monitored individuals from the randomized trial and 3,476 matched controls. In the randomized study, new AF was identified by 4 months in 3.9% (53/1366) of the immediate group versus 0.9% (12/1293) in the delayed group (absolute difference, 3.0%; 95% confidence interval [CI], 1.8%-4.1%). At 1 year, AF was newly diagnosed in 109 monitored (6.7 per 100 person-years) and 81 unmonitored (2.6 per 100 person-years; difference, 4.1; 95% CI, 3.9-4.2) individuals. Active monitoring was associated with increased initiation of anticoagulants (5.7 vs. 3.7 per 100 person-years; difference, 2.0; 95% CI, 1.9-2.2), outpatient cardiology visits (33.5 vs. 26.0 per 100 person-years; difference, 7.5; 95% CI, 7.2-7.9), and primary care visits (83.5 vs. 82.6 per 100 person-years; difference, 0.9; 95% CI, 0.4-1.5). There was no difference in AF-related emergency department visits and hospitalizations (1.3 vs. 1.4 per 100 person-years; difference, 0.1; 95% CI, −0.1 to 0).
Conclusions:
The authors concluded that among individuals at high risk for AF, immediate monitoring with a home-based wearable ECG sensor patch, compared with delayed monitoring, resulted in a higher rate of AF diagnosis after 4 months.
Perspective:
This study reports that among individuals at high risk for AF, immediate monitoring with a home-based wearable ECG sensor patch, compared with delayed monitoring, resulted in a higher rate of AF diagnosis after 4 months. Furthermore, monitored individuals, compared with nonmonitored controls, had higher rates of AF diagnosis, greater initiation of anticoagulants, but also increased health care resource utilization at 1 year. Prospective data are needed to assess clinical implications of AF diagnosis using this strategy and the risks and benefits for the initiation of anticoagulants. Pending demonstration of improvements in hard endpoints such as lowering stroke risks with acceptable bleeding rates, cautious use of this wearable technology is warranted. Clinicians should discuss pros and cons of the strategy with the patient and potentially target those at highest risk for undiagnosed AF.
Keywords: Anticoagulants, Arrhythmias, Cardiac, Atrial Fibrillation, Electrocardiography, Emergency Service, Hospital, Monitoring, Ambulatory, Primary Health Care, Primary Prevention, Risk Assessment, Stroke, Telemedicine, Vascular Diseases
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