A take-home wearable ECG could be key in detecting undiagnosed atrial fibrillation, according to a new study published in JAMA this morning. Researchers from The Scripps Research Institute used the iRhythm Zio patch, an ECG screening wearable, to monitor patients with a risk for the condition.
Researchers discovered that patients who immediately began monitoring were significantly more likely to receive an atrial fibrillation diagnosis than those whose monitoring was delayed by four months. In addition, after one year, those who received the monitoring at any point more frequently received an atrial fibrillation diagnosis than those in a matched control group who received the standard of care.
“Our study shows an almost threefold improvement in the rate of diagnosis of a-fib in those actively monitored compared to usual care,” Dr. Steven Steinhubl, director of digital medicine at Scripps Translational Science Institute and an associate professor at The Scripps Research Institute, said in a statement. “Timely diagnosis of a-fib more effectively can enable the initiation of effective therapies and help reduce strokes and death.”
Atrial fibrillation can lead to health risks such as stroke and other health complications, and impacts 37 percent of people over the age of 55.
The study included a randomized group of 2,659 participants, of which 1,738 completed a period of active monitoring with the iRhythm Zio, which is a water-resistant ECG monitoring skin adhesive patch that last for up to two weeks.
Participants in the intervention arm were then were split into two groups. One group got the patch immediately at the beginning of the study and the other group, called the delayed group, received their patches four months later. Researchers then compared the diagnosis rates of the two groups at the four-month point, and after one year when both groups had received monitoring.
In a secondary observational analysis, these patient groups were matched 1:2 with a control cohort, bringing the total sample to 5,214 patients. The observational cohort came from patients meeting similar eligibility criteria whose data were culled from claims data. Diagnosis rates of the participants who wore the patch monitors were compared to those of the observational control group, who received normal standard of care including doctors visits, at one year.
All study participants were members of Aetna Medicare, which, along with Janssen Pharmaceuticals, worked with Scripps to conduct the study. Patients included in the study had to be at an increased risk of atrial fibrillation and were over 75 years old, or a man over 55 or woman over 65 with a comorbidity that increased the risk.
Among those selected to receive the monitors, 3.9 percent of the immediate monitoring group was diagnosed with atrial fibrillation at four months, compared to .9 percent of the delayed monitoring group. In the secondary observational analysis, atrial fibrillation was diagnosed in 6.7 percent of participants monitored by the patch, as opposed to a 2.6 percent diagnosis rate observed among a patient-matched control group receiving the standard of care.
“Among individuals at high risk for [atrial fibrillation], immediate monitoring with a home-based wearable ECG sensor patch, compared with delayed monitoring, resulted in a higher rate of [atrial fibrillation] diagnosis after four months,” the authors of the study wrote. “Monitored individuals, compared with non-monitored controls, had higher rates of [atrial fibrillation] diagnosis, greater initiation of anticoagulants, but also increased health care resource utilization at one year.”
Researchers noted that participants taking off their patches and changing insurers were limiting factors in the study. But researchers said patches could be the way of the future.
“For clinical research to change practice it needs to be more participant focused and reflect the real world of those participants, by taking advantage of digital tools and infrastructure that is possible as never before,” Dr. Eric Topol, STSI’s founder and director and TSRI professor, said in a statement.