We live in an era of accelerated change with constant innovation in healthcare technology, including medical devices and applications. Recently, Apple released it’s highly anticipated next-generation smartwatch — the Apple Watch Series 4.
One of the Apple Watch Series 4’s headline feature is the ability to provide a single lead electrocardiogram (ECG) rhythm strip with an algorithm for detecting heart rate as well as whether the rate is too fast, too slow, regular or irregular. The user, when symptom free, can enable notifications from the heart rate app and receive alerts for slow heart rates, fast heart rates or irregular rhythms. In addition, a user can activate the ECG monitor when experiencing symptoms of rapid or skipped heart beats.
The Center for Disease Control estimates 2 to 6 million people in the USA have atrial fibrillation: about 2% of people under age 65 and 9% of people over age 65 have Afib. Approximately 800,000 strokes occur in the USA each year but not all strokes are due to Afib. Having high blood pressure increases stroke risk 2 times and having atrial fibrillation increases stroke risk 5 times. Since hypertension is more prevalent, more strokes are due to hypertension.
How It Works
After a “successful reading” by the ECG app, the watch will provide one of the following results: Sinus rhythm, atrial fibrillation, low heart rate, high heart rate or inconclusive. Apple’s website takes care to mention the app cannot detect other forms of arrhythmia, a heart attack, blood clots, stroke, high blood pressure or heart failure.
Apple notes that the notifications are not for people who have been diagnosed with atrial fibrillation and is not intended for use by people under 22 years of age. The ECG app is currently available in the United States, Puerto Rico, the U.S. Virgin Islands and Guam.
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The Apple Watch also includes fall detection and Emergency SOS capabilities for the user as well as a Health app to monitor and support Activity, Nutrition, Mindfulness and Sleep and Medical ID for listing medications, allergies, other health records and emergency contacts. In addition, Apple ResearchKit and CareKit provide a foundation for new features in the future.
The Apple Watch ECG monitor is FDA “cleared” not FDA approved. This is a new FDA program designed to fast track to approval. It also means that there is not yet any scientific evidence that the Apple Watch provides a statistically significant clinical benefit i.e. use of the Apple Watch ECG monitor may not decrease complications or death rate when compared to conventional medical management.
However, a high-quality single lead ECG with fall detection with better algorithms provides an opportunity to detect more than atrial fibrillation including more serious rhythms such as heart block and ventricular tachycardia. Furthermore, although Apple indicates the app is not for people already diagnosed with atrial fibrillation, it may benefit afib patients by documenting frequency and duration of afib episodes and correlation with symptoms and facilitate medication adjustments by their physicians or direction to other therapies such as ablation.
Apple Watch users need a resource to send their ECGs when they have symptoms and/or the watch sends an alert. Someone will have to be continuously on call 24/7/365 to receive the ECG, confirm the reading and provide care as needed. During the day this service may be provided by physicians’ offices or large healthcare networks and at night the surveillance may be provided by companies that already monitor pacemakers, defibrillators and rhythm detection devices. There will be a cost and a liability incurred for this service.
In addition, if the app is 95% accurate, with millions of People wearing the Apple Watch, there will be many false positive ECG alarms that will affect the healthcare system i.e. MD offices, ERs and monitoring companies. This must be balanced against the benefit of early detection of atrial fibrillation which may not result in symptoms until a stroke occurs.
- Apple Watch Series 4’s takes an ECG measurement of your heart’s electrical pulses to gauge your heart health and give a baseline for your overall wellness
- Apple indicates the app is not for people already diagnosed with atrial fibrillation and is not intended for use by people under 22 years of age
- The Apple Watch ECG monitor is FDA “cleared” not FDA approved
- Use of the Apple Watch ECG monitor may not decrease complications or death rate when compared to conventional medical management
- Apple Watch users will need a resource to send their ECGs
- There will be many false positive ECG alarms that will affect the healthcare system
- The key benefit of the ECG app is early detection of atrial fibrillation
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