The Apple ECG, which is still being testing, involves smartwatch users squeezing the frame of the device with the opposite hand, allowing Apple Watch to pass an imperceptible current across the chest to assess heart rhythm, according to Bloomberg, which cited “people familiar with the plan.”
Last month the FDA cleared AliveCor’s KardiaBand ECG device for the Apple Watch, designed to monitor for early signs of atrial fibrillation. First introduced in March 2016, KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch, Mountain View, Calif.-based AliveCor said at the time. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.
Apple may still decide not to include the technology in future products, according to the news site’s sources, who asked not to be identified talking about private plans; Apple spokeswoman Amy Bessette declined to comment.
Over- and mis-diagnosis a concern
Physicians expressed concern that smartwatch ECG technology, potentially useful as a long-term monitoring tool in already-diagnosed patients, could lead to over- and mis-diagnosis.
“The key is the rhythm alert which triggers the user to grab an ECG. It is interesting and I could see it used as a long-term monitor in lieu of, say, an implantable loop recorder. There is space for this. If the technology works, it could be great,” Dr. Ethan Weiss of the University of California-San Francisco told CardioBrief. “But in people with cryptogenic stroke or post-[transient ischemic attack] or even [at] very high risk (say mitral stenosis or extremely high CHA2DS2-VASc scores), this could be a very useful tool. Of course, I expect it will be used by many people in whom there is no indication, and that will lead to a lot of cardiologists trying to sort through a LOT of data they don’t understand.”
“Measuring things is not therapy,” added Mayo Clinic’s Dr. Michael Joyner. “So in terms of patient care applications, if this is not linked to a coherent way to deal with and act on the data, then any assumptions about better outcomes are premature. The well-done [randomized controlled trials] on things like [congestive heart failure] and home monitoring have not been especially impressive.
“It is easy to envision a cascade of over-diagnosis stemming from more monitoring,” Joyner told the website. “The evidence that wearables consistently motivate positive and durable behavior change over time is pretty thin. … Better technology per se is not going to solve complex systems and behavioral challenges.”