Welcome to Point-Counterpoint – the BLOG Edition!
In this series — as in the series by the same name in the journal — authors stake out positions on current issues, highlighting the pros and cons. In this Point-Counterpoint, we discuss the new Apple Watch’s electrocardiogram (ECG) technology, launched with the Apple Watch Series 4. The addition of electrodes on the back of the new watch enables ECG readings with an ECG application (app). The FDA-cleared [PDF] app claims to be able to detect atrial fibrillation — a supraventricular arrhythmia that adversely affects cardiac function of 2.7 million Americans (although those with diagnosed atrial fibrillation are specifically warned against using the app).
Could this device be the next big thing in healthcare?
Point by Red Miguel
Early Detection, Early Treatment
The ECG function on the new Apple Watch could increase earlier diagnosis of atrial fibrillation. This is important because atrial fibrillation is a progressive condition, so earlier intervention could mean improved health outcomes for patients.
The burden attributable to atrial fibrillation is not just from the primary disease, but also from the increased risk it poses for other diseases, such as stroke, congestive heart failure, and sudden cardiac death. The Framingham Study, for example, revealed that atrial fibrillation is associated with a 4-to-5-fold increase in risk for ischemic stroke.
These risks can be prevented with early intervention. According to one meta-analysis, patients with atrial fibrillation given warfarin and anti-platelet agents had a reduced risk of stroke by 64% and 22% respectively. This only is possible if a patient’s atrial fibrillation is diagnosed early enough to receive the treatment.
Unfortunately, a recent study estimated that, in one year, nearly 700,000 cases of atrial fibrillation in the US were undiagnosed. In the same study, half of the undiagnosed cases had moderate-to-high risk of stroke. The Apple Watch’s ECG could therefore advantageous to the community not just because of its impact on atrial fibrillation, but also because it holds promise in lowering the risk for other diseases as well.
Adherence and Ease
Hardly anyone still uses a pocket watch – it’s easier and less intrusive to have a device on your wrist; yet many of us now carry something a lot larger in our pocket: a smartphone. In one 2016 study, participants were requested to provide data on 11 health indicators via four devices and a diet app. Aside from revealing that step counts increased among health participants, the study found that participants experienced “device fatigue” for all devices except for the Fitbit, which patients wore on their wrist.
To add to the ease and ergonomics, the Apple Watch, like other smart watches, is not just a time-telling device – it provides users with immediate, yet discreet, information and connectivity. A smart watch allows the ECG app to continuously monitor users without the difficulties associated with other mobile medical devices. Though the ECG app has not yet been completely rolled out, the current health functions of smart watches have already led to a few success stories. Because of the heart rate monitor function, one person was diagnosed with chronic kidney disease, a person with an erupted ulcer was notified to seek medical attention before it was too late, and another person discovered that he had three blocked coronary arteries despite feeling well. How many lives could be saved because of the new ECG function?
Evolution, not Revolution
Some fear the ECG app on the new Apple Watch because of the de novo classification granted by the FDA. However, the Apple app is not the first wrist-worn technology to detect atrial fibrillation. Late last year, the FDA cleared AliveCor’s Kardiaband as the first medical device for the Apple Watch with the ability to detect atrial fibrillation. This May, the Journal of the American College of Cardiology published the results of a study that found Kardiaband to have 93% sensitivity, 84% specificity, and a K coefficient of 0.77 in detecting atrial fibrillation, compared to a standard ECG. Moreover, artificial intelligence in an Apple Watch-based app called Cardiogram detected atrial fibrillation with 98% sensitivity and 90% specificity. Other studies have showed that Cardiogram, with only the heart rate and step function as its inputs, is capable of detecting hypertension and sleep apnea. The new Apple Watch could prove to be as accurate, if not more accurate, than the current technology.
Counterpoint by Alexa Ortiz
Misdiagnosis
As recent articles in Wired, the Wall Street Journal, and the New York Times point out, the Apple Watch ECG may help people identify health concerns more quickly, but it could also trigger false alarms due to inaccurate readings. The watch’s ability to detect atrial fibrillation may identify users with low-risk atrial fibrillation, resulting in unnecessary prescriptions for blood thinners — which carry their own health risks of increased bleeding. Right now, it isn’t clear if the benefits of detecting and treating asymptomatic cases of atrial fibrillation outweigh the risks.
Increased Anxiety
Your heart is a critical organ, and getting a constant flow of information about your heart rhythm and potential irregularities could be unnerving. Unnecessarily monitoring and sending Apple Watch users warnings about arrhythmias they don’t actually have could result in a significant amount of anxiety. Users won’t know if there’s actually a serious cardiac event happening or if the Apple Watch is just misinterpreting information.
Healthcare Provider Burden
How much health data on one person do we really need? Yes, information is power, but too much information could work against us. With the Apple Watch Series 4, users can store their ECG readings from the app in a PDF file that can then be shared with their physician. These additional readings could be an excessive burden on healthcare providers. Healthcare providers are already crunched for time–the last thing they need is healthy patients bringing in reams of data to analyze. More people with ECGs could result in providers spending precious and limited clinic time re-testing and reassuring people.
Liability
Yes, the FDA’s letter to Apple stressed that “the ECG app is intended for over-the-counter (OTC) use” and that “it’s not intended to replace traditional methods of diagnosis or treatment”; however, the device still poses a liability risk both for users and their medical providers. An article from CNBC poses an interesting question: “What will be the next step for a user who gets an abnormal result, but doesn’t have a doctor nearby? And will Apple be responsible for these users?”
For providers, how much trust should they place in the new Apple Watch’s data? If they ignore the data, they might be disregarding a critical piece of information. Where do we draw the line for providers on using their patient’s self-collected data?
Is the Apple Watch ECG the next big thing in healthcare?
Please feel free to share your take in the comments section below. We look forward to hearing from you!
Red Thaddeus Miguel
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Alexa Ortiz