Wearable Patch ECG detects three times more AF cases than routine care : mSToPS trial

In order to find efficient methods for screening populations for undiagnosed atrial fibrillation (AF) to reduce its associated mortality, morbidity, and costs digital technologies, including wearable sensors, had been introduced.The mHealth Screening To Prevent Strokes (mSToPS) trial is a home-based clinical research study that uses wearable sensor technology to identify people with asymptomatic Atrial Fibrillation (AFib)which was developed by iRhythm Technologies and launched by researchers at the Scripps Translational Science Institute (STSI). It was a wireless electrocardiogram (ECG) patch which was an effective, and economical screening method for Monitoring asymptomatic elderly people.In a new study presented by Steven R. Steinhubl, MD, on Saturday, March 10 at ACC.18 in Orlando, FL it has been found that monitoring asymptomatic elderly people with the wireless electrocardiogram (ECG) patch was associated with a nearly threefold increase in atrial fibrillation diagnoses.It has also facilitated greater initiation of guideline-recommended therapies at 1 year compared with routine care.

In the study a total of 1,732 Aetna members were enrolled directly through a web-based platform to undergo active monitoring at home with an iRhythm Zio patch, which continuously records an ECG. The participants were instructed to apply the patch and wear it for an average of 12 days Each case was paired with two age-, sex-, and CHA₂DS₂-VASc-matched controls (n=3,646). Data on AFib treatment, physician and emergency department (ED) visits, and blood clot and stroke events were collected.

The incidence of AFib at one year – the primary endpoint – was 6.3 percent of monitored patients and 2.3 percent of controls. Active monitoring led to a significantly higher rate of initiating anticoagulant therapy (5.4 vs. 3.4 percent in controls), as well as small but significant increase in antiarrhythmic therapy (0.8 vs. 0.3 percent) and pacemaker or implantable cardioverter-defibrillator placement (0.7 vs. 0 percent).

No difference in the stroke rate between the two groups was observed at the time of the analysis (1.9 vs. 2.1 percent). The monitored patients compared with controls had significantly more primary care visits (78.7 vs. 75 percent) and cardiology outpatient visits (31.6 vs. 23.6 percent), but there was no difference in ED visits or hospitalizations. Study participants will be followed for an additional two years.

The researchers concluded that remote AFib monitoring is a feasible, scalable and clinically valuable way to screen for AFib in an at-risk nationwide population. "The quality of data collected through the patch is as good as what we see clinically," Steinhubl said. "What was fascinating is that for the people with AFib, the burden of AFib was quite low—approximately 1 percent of the time on average."

"Further follow-up through 3 years is planned to better understand the clinical impact of ECG monitoring," study author Steven Steinhubl, MD, director of digital mHealth at the Scripps Translational Science Institute, La Jolla, California, said here at the American College of Cardiology (ACC) 2018 Annual Scientific Session.

He noted that the mHealth Screening to Prevent Strokes (mSTOPS) is a pragmatic trial that also provides insights into how today's digital environment can be used to transform clinical trials. Only 1.7% of eligible patients are enrolled in clinical trials, yet 88% of US adults use the internet and 77% own a smartphone.

The finding of trialthat suggests the prevalence of undiagnosed AFib is likely higher than clinicians might suspect, since it can be easy to miss, which could have important implications for how we should ideally screen for the condition.Although Monitoring with the self-applied Wearable Patch ECG Detects More AF than routine care but it was associated with greater use of healthcare resources and no differences in clinical outcomes at 1 year.