Steinhubl SR, et al. - This analysis focused on the impact of a self-applied wearable electrocardiogram (ECG) patch in identifying atrial fibrillation (AF) and the clinical consequences related to such a detection method. Data reported that, vs delayed monitoring, immediate monitoring with a home-based wearable ECG sensor patch resulted in a higher rate of AF diagnosis after 4 months in patients at high risk for AF. Monitored individuals displayed higher rates of AF diagnosis, greater initiation of anticoagulants, and increased healthcare resource utilization at 1-year vs nonmonitored controls.

Methods

• Among members of a large national health plan, a direct-to-participant randomized clinical trial and prospective matched observational cohort study were conducted.
• Enlistment ran from November 17, 2015-October 4, 2016, and 1-year claims-based follow-up concluded in January 2018.
• Two thousand, six hundred fifty-nine people were randomly allocated to active home-based monitoring to begin immediately or delayed by 4 months for the clinical trial.
• Two deidentified age-, sex- and CHA₂DS₂-VASc–matched controls were chosen for each actively monitored individual for the observational study.
• The actively monitored cohort wore a self-applied continuous ECG monitoring patch at home during routine activities for up to 4 weeks, started either immediately after enrolling (n=1,364) or delayed for 4 months after enlistment (n=1,291).
• The primary end point was the occurrence of a new diagnosis of AF at 4 months among those randomized to immediate monitoring vs delayed monitoring.
• New AF diagnosis at 1 year in the combined actively monitored groups vs matched observational controls was a secondary end point.
• 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 were other included outcomes.

Results

• The randomized groups involved 2,659 members (mean [SD] age, 72.4 [7.3] years; 38.6% women), of whom 1,738 (65.4%) completed active monitoring.
• The observational study contained 5,214 (mean [SD] age, 73.7 [7.0] years; 40.5% women; median CHA₂DS₂-VASc score, 3.0), involving 1,738 actively monitored people from the randomized trial and 3,476 matched controls.
• New AF was identified by 4 months in 3.9% (53/1366) of the immediate group vs 0.9% (12/1293) in the delayed group (absolute difference, 3.0% [95% CI, 1.8%-4.1%]) in the randomized study.
• It was observed that 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 at 1 year.
• It was noted that active monitoring was correlated 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]).
• No difference was found 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]).