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Apple Watch ECG now available in Australia

The Apple Watch ECG and its Atrial Fibrillation rhythm identification algorithm has now been approved for use in Australia as a Class II Medical Device

apple watch ecg - australia

The ‘ECG’ (electrocardiogram) App on the Apple Watch is now available in Australia after the app and its Atrial Fibrillation notification feature were both successfully approved to be included in the TherapeuGc Goods Association (TGA) as Class IIa medical devices.

It has been three years since Apple first introduced ECG heart monitoring features on the Apple Watch in 2018, however, it hasn’t yet been available in Australia without approval, which was finally granted earlier this year in March.

What is an ECG?

Typically, in a medical specialist or hospital setting, an ECG is a painless, non-invasive way to measure the electrical signals of a person’s heart by using a set of adhesive electrodes attached to the skin. The skin electrodes detect and chart the electrical activity that flows through the heart with each heartbeat, as a series of ‘waves’ that is then either printed or stored digitally. A cardiologist will review the ECG waveforms, assessing their shape, rhythm and rate. This would then be used in diagnosis of a range of cardiac conditions, including Atrial Fibrillation (AFib), the most common form of irregular heart rhythm disorders.

Now, with the launch of this new wearable technology, electrodes within the Apple Watch Series 4, 5, and 6 can enable wearers to take an ECG themselves – directly from their wrist, via their watch, and view their results in real-time.

Consumers are now empowered to capture their own heart rhythm during their symptoms and through the day, and can now share this critical information about their health with their doctors.

Dr John Hayes, from the Atrial Fibrillation Institute and QCG commented, “Wearable technology is revolutionising the management of cardiac arrhythmias. 
“There are many different types of abnormal heart rhythms, all with different mechanisms, risks and treatment options. While a simple heart rate monitor does not help to differentiate many of these abnormal heart rhythms, the Apple Watch ECG is a game-changer. 
“By recording an ECG rhythm strip with your Apple Watch ECG and sharing this with your Cardiologists or Cardiac Electrophysiologists, they can make better informed recommendations for you, as an individual.”
dr john hayes

How Does the Apple Watch ECG Work?

The sensor technology relies on electrodes that are built into the back crystal and a button on the side of the Apple watch, working together with the ECG app to take a single-lead ECG reading.

To activate a recording, watch wearers simply launch the ECG app on their watch, and hold their finger on the side button. This creates a circuit for the electrical signals from which the algorithm can determine the ECG. The app then classifies the ECG into sinus rhythm (normal rhythm), low or high heart rate, signs of atrial fibrillation. It also notifies if the reading is inconclusive or a poor recording. The wearer can also add a note of any symptoms at the time.

All recordings, their classifications, and any noted symptoms are stored in the Health app on the user’s iPhone. Users can then export and share a PDF of the results with their doctor.

In Apple’s official press release from May this year, Sumbul Desai, MD, Apple’s Vice President of Health said, “We are confident in the ability of these features to help users have more informed conversations with their physicians.”

“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.”

Detecting Irregular Heart Rhythms

The ‘irregular rhythm notification’ feature on the app is also able to help users be alerted to signs of Atrial Fibrillation, which when left undiagnosed or untreated, can lead to an increased risk of stroke.

The irregular rhythm notification feature was studied in the ‘Apple Heart Study,’ which, with over 400,000 participants, was the largest screening study on atrial fibrillation ever conducted, and also according to Apple, one of the largest cardiovascular studies to date.

A notification is sent to the user if the watch detects an irregular heart rhythm that has signs Atrial Fibrillation, and the recorded data can be used to help diagnose the condition. As up to 30% of people with AFib have no symptoms, this early warning system has the potential to support early diagnosis, and through access to treatments, better health outcomes for patients.

As always, any insights from this technology should be discussed with your doctor who can provide additional information and context based on the individual. Apple makes it very clear that the ECG app cannot detect a heart attack, cannot detect blood clots or a stroke, and cannot detect other heart-related conditions such as high blood pressure, congestive heart failure, high cholesterol, or other forms of arrhythmia.

How Reliable is the Information from the Watch for People with Atrial Fibrillation?

The ‘gold standard’ for measuring heart rhythm is a 12-lead ECG, which is the usual ECG you have in your doctor’s clinic or in hospital. After the 12-lead ECG is performed, the tracing and measurements are reviewed by a doctor – interpreting the results from both the recordings and from additional information about the patient.

The Apple Watch ECG is a single lead ECG, which has been approved as a medical-grade device, but it is not the same as a full medical grade 12-lead ECG.

The wording on the TGA filing explicitly states: “The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation with a qualified health professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment.”

Some concerns with the Apple Watch in the context of monitoring for Atrial Fibrillation, are that the capability for detecting AFib is reduced at heart rates above 120bpm – which can be common in episodes of AFib. There are also examples of both false positive readings, and false negatives. The Apple watch also does not take a constant reading of your ECG the whole time you are wearing it. It will take a reading approximately every two hours, depending on your activity levels. If the watch detects an abnormal rhythm in five out of six consecutive readings, then you’ll receive an abnormal rhythm notification.

Is There Anyone Who Shouldn't Use the Apple Watch?

Using the Apple watch is a personal choice. For some people, having a wearable ECG monitor can provide comfort and reassurance. For some others it can cause them to become more aware of their heart rhythm, and increase their anxiety about Atrial Fibrillation. As anxiety or stress can be a factor in some people’s episodes, then a wearable monitor that adds to your worry may not be ideal.

I Have an Implanted Pacemaker or Defibrillator – Is it Safe to Use the Apple Watch?

The Apple Watch is considered to be safe for people who have an implanted pacemaker or defibrillator. The device senses its ECG at the wrist, using detailed algorithms to determine the ECG – it does not directly produce any electrical current at the heart.

If you want to measure your ECG using an Apple Watch for your own information while you have an implanted pacemaker or defibrillator, then that is fine. However, your doctor and medical team will not need the additional information from the watch, as these implanted devices already sense and record a constant ECG that your doctor can access.

Other ECG Monitoring Devices are Coming.

The Apple watch is one of an increasing number of wearable devices on the market with ECG technology available in their latest updates.

At the time of publishing, the only other currently TGA-approved ECG device in Australia is the AliveCor Kardia Mobile ECG, which is another excellent option for people to monitor their AF – it is a handheld device, rather than a wearable.

There are also a large number of other health monitoring devices that are available in, or coming to, the Australian market. So far, these consumer-grade ECG monitors may not have the same medical-grade quality if they are not approved by the TGA. According to TechRadar, the Samsung Galaxy Watch 3, Samsung Galaxy Watch Active 2 and the Fitbit Sense are also fitted with an ECG sensor, but none of them have been given TGA approval for use in Australia…yet.