Technology overview

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of health care professionals to check the regulatory status of any intended use of the technology in other indications and settings.

About the technology

CE marking

The AliveCor Heart Monitor and AliveECG app (application) were CE‑marked to AliveCor as a Class IIa medical device in January 2015.

Description

The AliveCor Heart Monitor provides a portable electrocardiogram (ECG) recorder. The monitor works with a compatible mobile device (such as a smartphone or tablet) running the AliveECG app, which can be used to analyse the ECG recording and send it to a healthcare professional for interpretation. The healthcare professional accesses this information through the Provider Dashboard software.

The AliveCor Heart Monitor is a pocket‑sized rectangular device containing 2 electrodes. It is either attached directly via an adhesive attachment plate to a mobile device, or must be within 30 cm of the mobile device during operation. The AliveCor Heart Monitor can be removed from the plate when not in use, with the plate remaining attached to the mobile device.

The mobile device must be a standard internet‑enabled mobile phone or tablet, onto which the AliveECG app must be downloaded. The AliveCor Heart Monitor and AliveECG app are compatible with devices running Apple or Android operating systems (a full list is available on the manufacturer's website). The manufacturer states they are planning to expand to other operating systems, including Windows.

To record an ECG, the user places 2 or more fingers from the left hand onto 1 of the AliveCor Heart Monitor electrodes and 2 or more fingers from the right hand onto the other electrode. The user keeps contact with the electrodes for at least 30 seconds to ensure that a complete reading is taken, while keeping their arms still because arm movement may interfere with the ECG reading. The manufacturer recommends that the recordings are taken daily, or whenever AF symptoms are experienced. A user may also be given specific advice by their physician on how often to use the device.

After the AliveCor Heart Monitor has taken a reading, it is sent wirelessly by a patented high frequency sound transmission to the mobile device, where it can be viewed using the AliveECG app. The app stores and analyses data from the AliveCor Heart Monitor. It displays the ECG trace, which includes a measure of heart rate, and the in‑built software notifies the patient if their reading is normal or if AF has been detected due to an irregularity in the reading. Patient information, such as name and NHS number, can also be added to the recording. If or when the device has a suitable Wi‑Fi or mobile connection, the recording will automatically synchronise with the secure encrypted AliveCor cloud server. The user can also send the recording directly to a relevant healthcare professional, such as a GP, to be read using the Provider Dashboard, which is a web‑based application run from any standard PC. To access all AliveCor services, the healthcare professional and their patient must each have an AliveCor account. The healthcare professional can then email their patient to link their accounts through the secure Provider Dashboard. The AliveECG app can also be used to email the recording, or create a PDF version that can be printed.

The AliveCor Heart Monitor is not recommended for use in children, or in adults with cardiac pacemakers or other implanted electronic devices.

Setting and intended user

The AliveCor Heart Monitor and AliveECG app is intended for use by adults at risk of AF, to detect abnormal heart rhythms. It is particularly suitable for people with suspected paroxysmal AF, which can go undetected using standard 12‑lead ECG recording due to the intermittent nature of the arrhythmia. Because the AliveCor Heart Monitor is portable, readings can be taken at any time of the day while the user goes about their normal activities. This increases the probability of an arrhythmic episode being detected and recorded. As a portable device, it can be used in any setting but is particularly designed for home use by people.

The manufacturer states that ECG recordings should be reviewed by a physician. Therefore the AliveECG app should not be used by patients to diagnose AF.

The AliveCor Heart Monitor can also be used to evaluate heart rate and rhythm in people with congestive heart failure; however, this is beyond the scope of this briefing.

Current NHS options

The NICE guideline on atrial fibrillation recommends that people with suspected AF have manual pulse palpation to detect any irregular pulse.

AF is commonly suspected in people with any of the following symptoms:

  • breathlessness or dyspnoea

  • palpitations

  • syncope or dizziness

  • chest discomfort

  • stroke or transient ischaemic attack.

The NICE guideline recommends that when an irregular pulse is detected, an ECG should be done regardless of whether the patient has symptoms. Arrhythmias may be missed by conventional 12‑lead ECG in people with paroxysmal AF because of the occasional nature of the arrhythmic episodes.

The NICE guideline on atrial fibrillation defines 2 categories of portable recorders. An ambulatory ECG monitor is a device that can continuously record cardiac electrical activity. This category includes both Holter‑monitors and implanted recorders. An event ECG recorder is a device that records particular events, either automatically by a software programme, or manually by the user. People with suspected paroxysmal AF should use a 24‑hour ambulatory ECG monitor, if symptomatic episodes are less than 24 hours apart. For those with episodes more than 24 hours apart, an event ECG recorder should be used.

Screening for AF in asymptomatic people who are at risk, and aged 65 years or over, is not recommended by the National Screening Committee (NSC 2014), nor is it listed as a recommendation in the NICE guideline.

An irregular pulse may be identified using the WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension, a device recommended by NICE for use in primary care.

NICE is aware of the following CE‑marked devices that appear to fulfil a similar function to the AliveCor Heart Monitor and AliveECG app:

  • Dicare m1CC colour portable ECG recorder (Dimetek)

  • MD100A ECG reader (Choice Medical)

  • MD100E ECG reader (Choice Medical)

  • HCG‑801 ECG reader (Omron).

Costs and use of the technology

The AliveCor system consists of an AliveCor Heart Monitor and the AliveECG app. The AliveCor Heart Monitor costs £62.49, excluding VAT, for a single unit. For orders of 50 units or more, the price reduces to £50 each, excluding VAT. The AliveECG app is available as a free download from the Apple App Store or from Google Play, and the web‑based Provider Dashboard is free to use. There will also be a small cost to the NHS for a healthcare professional's time to review an ECG reading generated by the AliveCor system.

To use the AliveCor Heart Monitor, users must have a compatible mobile device. AliveCor does not provide internet‑enabled mobile phones or tablets for use with the AliveCor system.

People can be trained to use the AliveCor system during a brief appointment with a suitably trained professional, often a healthcare assistant. Instructions for use are also contained in the user manual.

Maintenance consists of cleaning the AliveCor Heart Monitor with an alcohol‑based sanitiser before each use. When the monitor is no longer needed by a person, it can be used by someone else. The manufacturer states that the monitor has no expected lifespan. The 3 volt battery in the monitor should be replaced when needed, generally every 6 to 12 months.

The NICE support for commissioning for transient loss of consciousness estimated the cost of a standard 12‑lead ECG, in which a practice nurse applies the test and a GP reviews the results, to be £36.33 with the cost of an ambulatory ECG as £170 (NICE 2014).

Likely place in therapy

The AliveCor Heart Monitor enables portable event‑monitoring of the electrical activity of the heart and could therefore be used by people during normal activities, while under the care of a primary or secondary healthcare professional, as an alternative to existing portable ECG devices.

Specialist commentator comments

Two commentators stated that the AliveCor Heart Monitor is a useful screening tool for the detection of symptomatic AF. Both highlighted the practicality and ease of use of the device. One of these specialists also remarked that it may be used to detect both paroxysmal and persistent AF in people who are asymptomatic, and advocated the use of the AliveCor Heart Monitor in people with intermittent palpitations to determine the cause of their symptoms. The underlying cause of these symptoms may not always be AF, and a correct diagnosis is important for making treatment decisions. One specialist commentator noted that the available evidence suggested that the AliveCor system is both practical and cost effective, and given the importance of early AF detection in preventing strokes, the system could contribute to improved stroke prevention in the NHS.

One specialist commentator noted that using the AliveCor Heart Monitor is unlikely to cause an increase in, but may decrease, the number of ECGs that need to be interpreted by physicians following manual pulse palpitation. Similarly, a second commentator thought that the AliveCor Heart Monitor would not increase the number of ECGs for interpretation, because it would simply replace other monitoring devices, particularly 7‑day ambulatory ECGs. This commentator believed that use of the AliveCor Heart Monitor needed similar amounts of healthcare assistant time as ambulatory ECGs. However, it may increase overall productivity because of a greater probability of arrhythmias being detected.

One commentator stated that it is unlikely that the NHS would provide a mobile device for use with the AliveCor Heart Monitor. This expert also reflected that paroxysmal AF may occur only once or twice a year and so a loaned AliveCor Heart Monitor could be offered to targeted groups of people. A second expert noted that in their experience most people provide their own mobile device to use with the AliveCor Heart Monitor, but it may be possible for the NHS to provide mobile devices, with a strict returns policy. However, they also stated that organising this would have its challenges and may be impractical.

Equality considerations

NICE is committed to promoting equality and eliminating unlawful discrimination. In producing guidance, NICE aims to comply fully with all legal obligations to:

  • promote race and disability equality and equality of opportunity between men and women

  • eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

The level of manual dexterity needed to record an ECG on the AliveCor Heart Monitor may exclude some people with disabilities from using the device. The AliveCor Heart Monitor is not intended for use in children. Some people at higher risk of AF may not be familiar with how to use a compatible mobile phone or tablet; in particular, adoption may be low amongst older people, reflecting the lower rates of mobile device usage in this group. The prevalence of AF increases in older age and is greater in men. However, the risk of death from AF is slightly higher in women. Disability, age and sex are protected characteristics under the Equality Act (2010).

Patient and carer perspective

A spokesperson acting on behalf of both the Arrhythmia Alliance and the Atrial Fibrillation Association, 2 separate charities with an interest in the detection of AF, gave the following patient perspectives:

  • The patient groups have distributed 1500 AliveCor Heart Monitors to people of all ages, all of whom have provided positive feedback. The feedback included incidents when the AliveCor system had helped to capture an episode of AF, leading to a diagnosis; and an instance when the user's symptoms had been confirmed as anxiety rather than AF.

  • One person out of the 1500 returned their AliveCor Heart Monitor because they felt they were checking their heart rate too often and worrying about the results.

  • The spokesperson commented on the suitability of the AliveCor system for older people. They noted that many older people are regular users of mobile technology and, contrary to some expectations; older people have given positive feedback about using the AliveCor system.

  • The patient groups have also used the AliveCor system in a public engagement campaign, taking it into schools, shopping centres, GP surgeries and pharmacies. At one event, of 480 people monitored using the AliveCor, 26% of recordings showed a previously undetected arrhythmia and 5% were advised to see their doctor urgently.

  • They reported that the benefit of the AliveCor system is that it is relatively inexpensive and can be used anywhere, at any time. The ECG recording can be saved, emailed or printed to show to the user's doctor. The recordings can also be annotated to record information, such as symptoms, medication, and activity immediately before recording, giving a clear history for the doctor to review.

The spokesperson concluded that the AliveCor Monitor was easy for people of all ages to use, and felt that it could save money for the NHS when compared with the cost of ECG recordings made in NHS clinics. They believed that the AliveCor system would help to capture episodes of AF outside of the clinic, enabling earlier diagnosis that could reduce the number of AF‑associated strokes.