Apple on Thursday announced what it says is the first direct-to-consumer product that enables users to take an electrocardiogram from their smartwatch to identify atrial fibrillation.
Available immediately as part of a free update to watchOS 5.1.2, the ECG app on Apple Watch Series 4 and the irregular heart rhythm notification feature analyzes pulse rate data for signs of AFib.
“New electrodes built into the back crystal and Digital Crown on Apple Watch Series 4 work together with the ECG app to enable customers to take an ECG similar to a single-lead reading,” according to the announcement. “After 30 seconds, the heart rhythm is classified as either AFib, sinus rhythm or inconclusive. All recordings, their associated classifications and any noted symptoms are stored securely in the Health app on iPhone. Users can share a PDF of the results with physicians.”
“The role that technology plays in allowing patients to capture meaningful data about what’s happening with their heart, right when it’s happening, like the functionality of an on-demand ECG, could be significant in new clinical care models and shared decision making between people and their healthcare providers,” says Nancy Brown, CEO of the American Heart Association.
In September, the Food and Drug Administration approved the ECG app, which leverages sensor data from the Apple Watch to identify irregular heart rhythms suggestive of AFib and to notify the user.
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According to the vendor, a study found the ECG app on Apple Watch demonstrated 98.3 percent sensitivity in classifying AFib and 99.6 percent specificity in classifying sinus rhythm in classifiable recordings.
In addition, the irregular rhythm notification feature was recently studied with more than 400,000 participants in what the company contends was the largest AFib screening study ever conducted.
“A subset of the data from the Apple Heart Study was submitted to the FDA to support clearance of the irregular rhythm notification feature,” states the tech giant. “In that sub-study, of the participants that received an irregular rhythm notification on their Apple Watch while simultaneously wearing an ECG patch, 80 percent showed AFib on the ECG patch and 98 percent showed AFib or other clinically relevant arrhythmias.”
The irregular rhythm notification feature on Apple Watch “occasionally” checks heart rhythms in the background and sends a notification if an irregular heart rhythm appears to be AFib. However, Apple does not recommend that users take ECG readings multiple times in a row or when not feeling symptoms, adding that the feature is intended to be used when experiencing symptoms such as a rapid or skipped heartbeat.
“We are confident in the ability of these features to help users have more informed conversations with their physicians,” says Sumbul Desai, MD, vice president of health at Apple. “With the ECG app and irregular rhythm notification feature, customers can now better understand aspects of their heart health in a more meaningful way.”
C. Michael Valentine, MD, president of the American College of Cardiology, says that while “the idea that wearables can be used by both …read more
Source:: Daily times