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Trial Shows Smartphone App Finds More Heart Disease

Kardia device

Kardia device (AliveCor Inc.)

30 August 2017. Results from a clinical trial show an electrocardiogram app on a smartphone detects more cases of irregular heart beats than routine office visits. A team from Swansea University in Wales, U.K. reported the findings in the 28 August issue of the journal Circulation, as well as at yesterday’s sessions of the European Society of Cardiology meeting in Barcelona.

The Swansea team led by cardiology professor Julian Halcox tested a mobile app system for detecting atrial fibrillation, or AFib, a common problem affecting some 33.5 million people worldwide in 2010, including at least 2.7 million people in the U.S., according to CDC. AFib is an irregular heartbeat that can lead to stroke or heart failure, where heart muscle contractions in the upper chambers beat irregularly instead of in a regular rhythm.  Those irregular rhythms can cause blood to pool and lead to blood clots, including clots that move to the brain and cause a stroke. Some 15 to 20 percent of stroke victims have this kind of irregular heartbeat, and left untreated, people with AFib are 4 to 5 times more likely to suffer a stroke.

In many people, AFib does not cause recognizable symptoms, which makes the disorder difficult to diagnose. AliveCor Inc., in Mountain View, California, developed a small monitor that attaches to Apple or Android phones to measure electrical impulses traveling through the heart as it beats. This information is usually collected in an electrocardiogram, a non-invasive test given at a doctor’s office with electrodes attached attached to the patient’s body.

The AliveCor device, called Kardia Mobile, captures the same information with two fingers of each hand placed on pads in a small panel attached to a smartphone for 30 seconds. The phone displays and analyzes the readings with a built-in algorithm for signs of irregular heart beats and sends the results to a physician. A premium service from AliveCor provides unlimited storage of data and summary reports to a patient’s doctor. Both FDA and the European Commission approved the Kardia for home heart monitoring.

The clinical trial enrolled some 1,000 individuals age 65 and older without atrial fibrillation, but considered at higher risk of stroke due to conditions such as high blood pressure, arterial disease, or diabetes. Participants were randomly assigned to use the Kardia device for reporting heart rhythm measurements every 2 weeks for 12 months, or receive routine care from their primary care physicians. The study team looked primarily for the number of new AFib cases detected during the 12-month period, but also evaluated participants’ experience with the Kardia device and checked for any adverse events. In addition, the researchers calculated an economic estimate of remote monitoring for AFib.

The results show more participants using the Kardia Mobile device detected atrial fibrillation than in the comparison group receiving routine care. Among the Kardia users, 19 new AFib cases were found in the 12 month test period, compared to 5 cases in the comparison group. All new AFib cases were confirmed by cardiologists and began treatment with anticoagulants. During the test period, the number of adverse events, such as strokes, among participants, was about the same in the Kardia user and routine care groups.

Participants using the Kardia device on the whole reported their results regularly and appear satisfied with the system. Some 80 percent of Kardia users checked in at least once a week during nearly all weeks of the trial and twice a week in three-quarters of the 52 weeks. The age of participants did not seem to affect compliance, with individuals in all age categories, between 65 and more than 80 years old reporting at about the same rate. As a group, the Kardia users found the system easy to use, did not restrict them from other activities, nor did the device cause anxiety.

The researchers also consider the financial cost reasonable for diagnosing new AFib cases with the system. Adding in costs of equipment, training, and professional evaluation and follow-up after detecting AFib, the team calculated each new case detected by the system to cost £8,255 or $US 10,780. The authors note the estimate is preliminary, but in line with other calculations and lower than some economic models.

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