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September 13, 2018

The new Apple Watch is FDA-approved to conduct EKGs. Is this the 'best day' in cardiology's history—or the 'worst?'

Daily Briefing

    Apple on Wednesday revealed the Apple Watch Series 4 will feature an FDA-approved electrocardiogram (EKG) to monitor heart rhythms, drawing mixed reactions from providers—who said the device could help detect serious medical conditions but could also increase the risk of false positives and over-diagnosis.

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    How Apple's new watch can track users' heart health

    The new heart monitoring application will be the first-ever over-the-counter EKG, Apple's COO Jeff Williams said.

    A typical EKG is conducted in a doctor's office or hospital and requires attaching electrodes to a patient's chest. But Apple's new EKG app requires only a simple press—and 30-second hold—of a button on the watch, after which it informs a user if their heart rhythm is normal or if they are experiencing atrial fibrillation. The data, which Apple said are encrypted, are then stored in the iPhone's Health app, where users can access it and create PDFs to share with their physicians.

    Atrial fibrillation is a heart condition that can increase the risk of stroke. It's estimated to affect about 2.7 million Americans and 34 million people around the globe, the Wall Street Journal reports

    FDA in a statement cautioned that the device is approved only for those who are at least 22 years old and have not been diagnosed with atrial fibrillation. The agency also cautioned that the device is approved only to detect irregular heart rhythms and is not guaranteed to sense every instance an individual's heartbeats are off.

    The latest Apple Watch also will be able to detect if a user falls and send them an alert with the option to place an emergency call. The watch will initiate the call automatically if the user is unresponsive for 60 seconds.

    Potential for good, but some concerns

    Some experts are excited about the potential of the new Apple Watch. Patricia Nguyen, assistant professor of medicine in the cardiovascular division at Stanford University, said the Series 4 "can be game-changing for heart health if it is accurate," but she stressed that accuracy is key "in all types of patients when they are sitting, moving, and exercising."

    Gregory Marcus, a cardiologist at UCSF Health, said people experiencing atrial fibrillation "can be asymptomatic" and often go undiagnosed. He said it's very important to conduct an EKG while patients are experiencing irregular heart rhythms. "This is a very handy way to allow that to happen," Marcus said.

    Ivor Benjamin, president of the American Heart Association, said the ability to capture real-time data on a person's heart "is changing the way we practice medicine."

    However, some experts are concerned that the new watch could lead to false positives. Eric Topol, a cardiologist and director of the Scripps Translational Science Institute, said the app could detect low-risk cases of Afib that don't necessarily require treatment, which could lead to unnecessary prescriptions for blood thinners. Similarly, Marcus said it's important for the app to continue to be tested. "[I]n my mind, the next appropriate step is to rigorously study this and not to feel like this is the stopping point," he said.

    Angela Radcliffe, general manager of clinical trial solutions at PulsePoint, expressed concern about the privacy of the ECG app. "Health care consumer data might be the next part of the gig economy," she said.

    Ethan Weiss, a cardiologist and metabolism scientist at UC San Francisco, in a tweet said he expects there will be "a massive increase in inbound flow from [his] patients as well as probably trips to the office and [ED] visits," as a result of the Series 4's app. "I can't figure out whether today is the best day in the history of [c]ardiology or the worst," he added (Arndt, Modern Healthcare, 9/12; Kim Cohen, Becker's Hospital Review, 9/12; Loftus/Mickle, Wall Street Journal, 9/13; Sheridan, STAT News, 9/12; Baker, "Vitals," Axios, 9/13; Farr, CNBC, 9/12).

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