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Trial Shows Patch Feasible for Heart Rhythm Detection

Zio patch

Zio patch (iRhythm Technologies Inc.)

12 March 2018. Results from a clinical trial show a wearable patch, applied and used by older adults in their homes, detects more heart rhythm problems than waiting to see a doctor, the usual way these problems are detected. Findings from the study were presented on 10 March at the annual scientific meeting of American College of Cardiology, in Orlando, Florida.

The study led by cardiologist Steven Steinhubl of Scripps Translational Science Institute in La Jolla, California and who presented the results, is testing the ability of sensors in a wearable patch used at home can detect arrhythmia, or irregular heart beat as well as electrocardiograms, or EKGs, taken at a doctor’s office. Arrhythmia is defined as any change from the normal sequence of electrical impulses regulating heart beats. Heart rhythm disorders prevent the heart from pumping adequate supplies of blood throughout the body, and can lead to blood clots, strokes, or damage to other organs.

The clinical trial recruited participants from the customers of Aetna health insurance, one of the sponsors of the study along with Scripps Research Institute and Janssen Pharmaceuticals, a division of Johnson & Johnson. Candidates for the trial, age 55 and over, were first screened with a online system and data from insurance claims to find people with a moderate risk but no prior history of irregular heart beat. From this screening, 1,732 individuals were asked to wear a small patch device cleared by FDA called Zio, made by iRhythm Technologies Inc. in San Francisco.

The Zio device is worn on the chest over the heart and contains sensors to measure heart rhythms for up to 14 days, then is mailed it back to the doctor. People wearing the Zio can also record any suspected heart-related symptoms they encounter with a mobile app, online form, or paper logbook. In the clinical trial, participants were provided instructions for positioning and wearing the Zio, then asked to wear it during the first and last 2 weeks of a 4 month period.

Participants wearing the Zio patch were matched to 3,646 individuals of comparable age, sex, and risk of stroke-related heart rhythm problems using a standard screening scale. After 4 months, individuals without the patch were given a Zio to wear during the first and last 2 weeks of another 4 month period, using the same processes as the first group.

The study team looked primarily for reports of atrial fibrillation, a common form of irregular heart beat over the 4 month test periods. But the researchers also followed up after 12 months, looking for any incidence of atrial fibrillation during that time, as well as stroke. The study team is recording as well overall health care usage and costs of participants, who will be monitored for another 2 years.

The results show after 12 months more participants wearing the Zio, 6 percent, were found with atrial fibrillation than 2 percent of the comparison group receiving the usual care. More participants wearing the Zio also started therapy with anticoagulation drugs and other treatments for irregular heartbeat. No difference was found, however, in the incidence of stroke, about 2 percent in each group.

Somewhat more Zio wearers made visits ot their primary care doctors (79%) than the comparison group (75%), and the Zio group also made more outpatient cardiologist visits (32%) than the usual care participants (24%), but there were no differences between the groups in emergency room visits or hospitalizations.

“The quality of data collected through the patch,” notes Steinhubl in an American College of Cardiology statement, “is as good as what we see clinically.” The researchers conclude remote atrial fibrillation monitoring is feasible for patients and manageable by clinicians.

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Disclosure: The author owns shares in Johnson & Johnson.

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