ECG app and irregular heart rhythm notification on Apple Watch coming to Saudi Arabia

Mon, 2020-05-18 23:05

An ECG Apple Watch app is to be released in Saudi Arabia in the
next software update with iOS 13.5 and watchOS 6.2.5, the company
announced on Monday.

The feature marks the first direct-to-consumer product
thatenables customers to take an electrocardiogram right from
their wrist, capturing heart rhythm in a moment when they
experience symptoms like a rapid or skipped heart beat and helping
to provide critical data to physicians. 

The irregular rhythm notification feature on Apple Watch Series
1 or later will also occasionally check heart rhythms in the
background and send a notification if an irregular heart rhythm
that appears to be atrial fibrillation (AFib) is identified. The
ECG app and the irregular rhythm notification feature have received
approval as Class IIa medical devices by the Saudi Food and Drug
Authority, through the Medical Device Marketing
Authorization (MDMA) process.

The ECG app and irregular heart rhythm notification feature will
help users identify signs of AFib, the most common form of
irregular rhythm. When left untreated, AFib is one of the leading
conditions that can result in stroke, the second most common cause
of death around the world.

“Apple Watch has helped so many people around the world and we
are humbled that it has become such an important part of our
customers’ lives,†said Jeff Williams, Apple’s chief
operating officer. “With the release of these heart features,
Apple Watch takes the next step in empowering people with more
information about their health.â€

“We are confident in the ability of these features to help
users have more informed conversations with their physicians,â€
said Sumbul Desai, MD, Apple’s vice president of Health. “With
the ECG app and irregular rhythm notification feature, customers
will be able to better understand aspects of their heart health in
a more meaningful way.â€


New electrodes built into the back crystal and Digital Crown on
Apple Watch Series 4 and later work together with the ECG app to
enable customers to take an ECG similar to a single-lead reading.
To take an ECG recording at any time or following an irregular
rhythm notification, users launch the new ECG app on Apple Watch
Series 4 and later and hold their finger on the Digital Crown. As
the user touches the Digital Crown, the circuit is completed and
electrical signals across their heart are measured. After 30
seconds, the heart rhythm is classified as either AFib, sinus
rhythm, low or high heart rate 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.

Irregular Rhythm Notification

Using the optical heart sensor in Apple Watch Series 1 or later,
the irregular rhythm notification feature will occasionally check
the user’s heart rhythm in the background for signs of an
irregular heart rhythm that appears to be AFib and alerts the user
with a notification if an irregular rhythm is detected on five
rhythm checks over a minimum of 65 minutes.

The ECG app’s ability to accurately classify an ECG recording
into AFib and sinus rhythm was validated in a clinical trial of
around 600 participants. Rhythm classification from a gold standard
12-lead ECG by a cardiologist was compared to the rhythm
classification of a simultaneously collected ECG from the ECG
app. The 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 the study, 87.8 percent of recordings could be classified by the
ECG app.

The irregular rhythm notification feature was studied in the
Apple Heart Study. With over 400,000 participants, the Apple Heart
Study was the largest screening study on atrial fibrillation ever
conducted, also making it one of the largest cardiovascular trials
to date. A subset of the data from the Apple Heart Study was used
to support approval of the irregular rhythm notification feature in
the Kingdom of Saudi Arabia.  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.

To enable these new heart features, customers will be taken
through an onscreen setup that includes details about who can use
these features, what the features can and cannot do, what results
users may get, how to interpret those results, and clear
instructions for what to do if users are feeling symptoms that
require immediate medical attention.


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Source: FS – All – Interesting – News
ECG app and irregular heart rhythm notification on Apple
Watch coming to Saudi Arabia