The Kardia device allows users to get an electrocardiogram reading on their phone. (Courtesy of AliveCor)

The Kardia device allows users to get an electrocardiogram reading on their phone. (Courtesy of AliveCor)

Patients using a smartphone device to monitor their heart rhythm were almost four times more likely to detect an irregularity than those receiving routine medical care, a new study shows.

However, some say the roughly $10,000 cost of each detection is too pricey, especially considering the increased detection didn’t cause a significant drop in the number of patients having strokes — a common complication of an irregular heartbeat known as atrial fibrillation, or AFib.

AFib is implicated in up to a third of all stroke cases. It affects about 33.5 million people worldwide and strokes caused by the condition result in greater disability than those caused by blood vessel disease.

The authors of the study note that the research wasn’t designed to provide definitive answers about whether the device could reduce the risk of strokes. They said their results support further research into whether using the device is a clinically useful and cost-effective way to prevent strokes in people with AFib.

In the U.K. study, presented Tuesday in Barcelona at the European Society of Cardiology Congress and published in Circulation, 1,001 older patients with high blood pressure, diabetes or other risk factors for stroke were divided into two groups and followed for a year. Half measured their heart rhythm using the Kardia monitor attached to a Wi-Fi enabled iPod. The monitor, manufactured by Mountain View, Calif.-based AliveCor, is an electrocardiogram machine that’s smaller than a deck of cards and measures heart rhythm through a person’s fingertips. The iPod downloaded the results and sent them to medical professionals for review. The other half received routine medical care.

Nineteen of the patients using the monitor were diagnosed with AFib compared to five in the group receiving routine care. The majority of patients who used the device were satisfied with it, noting it didn’t restrict their activities or cause anxiety.

ECG reading from Kardia device

(Courtesy of AliveCor)

While the device itself is relatively inexpensive, the 19 diagnoses cost $10,780 each, including the cost of the device, the iPod and expert review of the results. The study authors said the screening is likely to be cost-effective when compared to not screening but that the results didn’t include the expense of treating patients with AFib. The report said it was unlikely that the increased cost of treatment would be substantial enough to negate the benefit of monitoring.

Neither the lead author of the study, Julian Halcox, M.D., chairman of the cardiology department of Swansea University in Wales, nor his university colleagues involved in the research could be reached for comment.

William Lewis, M.D., chief of cardiology at MetroHealth Medical Center’s Heart & Vascular Center and a professor of cardiology at Case Western Reserve University in Cleveland, said that the cost of diagnosis was high, especially considering there were relatively few strokes. The research showed six people in the group using the device suffered a stroke compared with 10 in the routine care group.

Overall, more than half of the $204,830 spent on the intervention was for professionals to read and interpret the results. Lewis said some of his AFib patients use the Kardia device and he doesn’t charge to look at the results from their tests.

“If doctors are willing to look at the results for free, we are looking at a much less expensive program,” said Lewis, who was not involved in the new study. But he adds that the device is easy to use and doesn’t require a medical professional to look at the results.

AliveCor chief executive officer Vic Gundotra declined to release sales information on the product that retails for $99 in the United States. The purchase price includes a lifetime of free, unlimited readings, although for an extra $10 a month, patients receive extra services such as having monthly reports sent to their doctors.

The Food and Drug Administration-approved device isn’t covered by insurance. Gundotra said the company is working toward having insurers pay at least part of the device’s cost.

“We get emails all the time about how the device is saving lives,” said Gundotra, although there still isn’t scientific data to back up the claim. England’s National Health Service said last June that it would begin covering the device, but the process hasn’t begun yet.

“We think that model will be replicated,” Gundotra said. “Payers will connect the dots. If we can catch [atrial fibrillation], the savings to the health care system are massive.”