At-home monitoring with wearable ECG patch associated with higher rate of new afib diagnosis
As part of the industry-supported mHealth Screening to Prevent Strokes (mSToPS) trial, researchers randomized members of a large national health plan who had an increased likelihood of undiagnosed atrial fibrillation to immediately start active home-based monitoring or delay monitoring by four months.
In patients at high risk for atrial fibrillation, immediate versus delayed monitoring with a wearable electrocardiogram (ECG) sensor patch was associated with a higher rate of atrial fibrillation diagnosis at four months, a recent industry-supported study found.
As part of the mHealth Screening to Prevent Strokes (mSToPS) trial, researchers randomized members of a large national health plan who had an increased likelihood of undiagnosed atrial fibrillation to immediately start active home-based monitoring (n=1,364) or delay monitoring by four months (n=1,291). Participants in the active group wore a self-applied continuous ECG monitoring patch at home during routine activities for up to four weeks. Researchers also conducted a prospective matched observational cohort study of 5,214 participants (mean age, 73.7 years; 40.5% women) by matching each individual who completed active monitoring (n=1,738 [65.4%]) with two controls by age, sex, and CHA2DS2-VASc score.
The primary endpoint was a new diagnosis of atrial fibrillation at four months in the immediate monitoring group versus the delayed monitoring group. A secondary endpoint was new atrial fibrillation diagnosis at one year in the combined actively monitored groups versus matched observational controls. Other outcomes included new prescriptions for anticoagulants and health care utilization at one year. Results of the study, which was supported in part by a research grant from Janssen Pharmaceuticals to the Scripps Translational Science Institute, were published online on July 10 by JAMA.
At four months, new atrial fibrillation was identified in 53 (3.9%) participants in the active monitoring group, compared to 12 (0.9%) participants in the delayed monitoring group (absolute difference, 3.0%; 95% CI, 1.8% to 4.1%). At one year, atrial fibrillation was diagnosed in 109 monitored individuals (6.7 per 100 person-years) and in 81 unmonitored individuals (2.6 per 100 person-years), a difference of 4.1 per 100 person-years (95% CI, 3.9 to 4.2).
Active monitoring compared to delayed monitoring was associated with increased initiation of anticoagulants (5.7 vs. 3.7 per 100 person-years; difference, 2.0 [95% CI, 1.9 to 2.2]), more outpatient cardiology visits (33.5 vs. 26.0 per 100 person-years; difference, 7.5 [95% CI, 7.2 to 7.9]), and more primary care visits (83.5 vs. 82.6 per 100 person-years; difference, 0.9 [95% CI, 0.4 to 1.5]). There was no significant difference between groups in atrial fibrillation-related ED visits and hospitalizations.
The study authors noted limitations, such as how fewer than 3% of eligible individuals successfully enrolled and the fact that about one-third of participants never wore a patch. Furthermore, the study's randomized design was limited by four months of follow-up, and the matched observational cohort study “provides less definitive conclusions than would have come from a randomized clinical trial,” an accompanying editorial noted.
“Despite these limitations, mSToPS represents a brave new world for clinical research: an innovative, highly commendable, contemporary pragmatic health care [information technology] study that tested an important question and yielded significant clinical findings,” the editorialists wrote.
Experts shared their thoughts on the future of wearable devices at Internal Medicine Meeting 2018 in New Orleans. Read ACP Internist's coverage, which appeared in the July/August 2018 issue.