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Heartbeat-tracking patch from iRhythm may spot signs of stroke risk: study

A wearable patch could detect silent heart abnormalities before they trigger strokes and other events, its maker iRhythm Technologies Inc. said — and health insurers are taking notice.

In a study presented at the American College of Cardiology meeting, the San Francisco-based digital health company worked with medical insurer Aetna Inc. and a unit of U.S. healthcare giant Johnson & Johnson to study the small patch's ability to detect irregular heart rates that can lead to stroke.

Within four months of self-applying the patch, called Zio, 5.1% of monitored Aetna members were diagnosed with atrial fibrillation, or AF, an irregular heartbeat that often shows no noticeable symptoms, making it difficult to detect.

At the one-year mark, 6.3% of those wearing Zio were diagnosed with AF, compared to 2.3% of AF-diagnosed people in the routine care group. In addition, 4% of patients wearing the patch were diagnosed with other heart conditions.

Those diagnoses led to treatment changes for these patients, including the use of blood thinners, pacemakers and other medicines, iRhythm said.

"It's a whole new class for how to do novel research," Judy Lenane, iRhythm's executive vice president and chief clinical officer, said in an interview.

One new approach was enrollment: Aetna, not iRhythm, recruited the participants from among more than 360,000 of its members who could be considered high risk, eventually signing up more than 5,000 volunteers. Those assigned to the Zio group applied the patch themselves, wearing it up to 14 days as real-time data went to iRhythm's servers.

The rise of digital health

With these results in hand, iRhythm is positioning Zio and its analytic power as pharmaceutical companies' and health plans' latest ally in a treatment landscape that increasingly relies on biometric data.

There have been 571 registered digital health studies in the U.S. over the last decade, ramping up from a handful in 2007 to nearly 140 in 2017, according to a recent report by market intelligence firm IQVIA Holdings Inc. While this number includes consumer-focused health apps and fitness trackers, clinical biometric studies have become a part of both healthcare companies' and payers' strategies, particularly as they look to make more efficient research and development decisions.

"We know that there is definitely an interest in what really is the more precise data about patients," Lenane said. "For device manufacturers and pharmaceutical companies, [it's] 'how can we get to that precision?'"

Digital health studies can also be far less expensive than typical mid- and late-stage drug and device trials, which require large patient pools, often cumbersome enrollment and logistical issues such as proximity to a participating hospital, all of which can rack up an average $20 million cost, according to IQVIA.

Meanwhile, for iRhythm, 14 days of continuous heartbeat monitoring amounts to 1.5 to 2 billion heartbeats' worth of data per patient, said Derrick Sung, iRhythm's executive vice president of strategy and corporate development.

The company has developed an artificial intelligence-based algorithm to compute those vast amounts of data, which will be handy for the next milestone, a three-year assessment of Zio's AF monitoring.

"Once this data rolls out, we envision it will be able to start the discussion amongst the clinical community and other health plans," he said.

Calculating stroke cost

"At the highest level, the question we're asking is: by actively monitoring these patients, can we ultimately reduce the long-term, downstream risk of stroke and any sort of cerebral vascular, or cardiovascular, event?" Sung said.

If so, the lower medical burden could be significant. Between 2.7 million and 6.1 million people in the U.S. have AF, according to figures from the U.S. Centers for Disease Control and Prevention. While a number of factors can lead to the roughly 795,000 strokes that occur a year in the country, AF increases risk by four or five times, the agency said.

Ultimately, it estimates that between healthcare costs, medicines and missed work, strokes cost the country an estimated $34 billion a year. Medicare, the U.S. health insurance program for the elderly and disabled, estimated average costs for an acute ischemic stroke to range from $11,898 to $20,270, depending on severity and length of hospital stay, according to its final rule on fiscal 2018 reimbursement rates.

The Zio patch is already on the market to check for a range of irregular heart conditions. It has a U.S. list price of $995 and is covered by most major insurers, according to the company.

Zio retails for £800 in the U.K., according to the country's cost analysis body the National Institute for Health and Care Excellence, which assessed its effectiveness last year. Two of three physicians in the analysis said it would be unlikely to generate cost savings for the U.K. national health system because of its significant cost for each patient.

IRhythm is looking to pin down more of the associated cost burden in undiagnosed AF through an ongoing study with health provider Kaiser Permanente Inc., which is already using Zio as a diagnostic tool and partnered on a 2016 analysis of heart risks using Zio data. Kaiser's investment arm, Kaiser Permanente Ventures, owns a minority stake in iRhythm.

By combining iRhythm's data and analytics with payers' information, "we're seeing this difference in care through better data analytics, and really being able to look at what that pattern of care is over time," Lenane said. She added that they hope to publish the results soon.

IRhythm is a top pick in the small-cap medical technology field for Canaccord Genuity healthcare analyst Jason Mills.

"We think Zio use as a screening tool for asymptomatic AF could generate a lot of attention from insurers (and investors alike)," he wrote in a Mar. 13 note, rating the stock as a "buy."