AliveCor – PMS Instruments

KardiaMobile 6L NICE Draft Guidance

Last month NICE published first draft guidance from its Early Value Assessment pilot project recommending smartphone-linked ECG devices.

NICE has identified there is an unmet clinical need for a more easily accessible and available ways to measure heart rhythm disturbance such as QT interval in the psychiatric service setting.

Before beginning treatment and at regular intervals during their treatment patients taking antipsychotic medicines may need to be tested for heart problems. Issues such as rhythm disturbance can influence the medicines prescribed to them, the dosing and whether they should stop taking them.

Currently a 12 lead ECG is used to measure QT intervals which psychiatric patients can find distressing as they need to remove clothing and have gel filled electrodes attached to their chests.

The KardiaMobile 6L ECG is a small portable device which can be used in any setting, including home visits and only requires the patient to rest their thumbs or finger on the top of the device and the bottom onto the skin of their left leg. This may be less distressing for the patient.

The KardiaMobile 6L data is recorded electronically and can be sent to any smart phone or tablet.

The economic case for the AliveCor Kardia Mobile ECG

The AliveCor Kardia Mobile ECG has swiftly become one of our more popular products. If you’ve not yet heard of it, the Kardia Mobile ECG is an incredibly handy and portable ECG monitor that is held in the patient’s hand. The only thing it needs is a smart phone with the Kardia app installed.

Using a single channel ECG monitor with automatic ECG evaluation, it can detect possible Atrial Fibrillation (AF). The smartphone application shows a real-time visualisation of the ECG recording, as well as historical data for comparisons.

The device has been popular for the home market, for those needing to track either their own or a relative’s health. However, there’s a serious economic case for the Kardia Mobile ECG to become a standard for surgeries. If surgeries have access to the mobile ECG, to be able to supply to patients, a lot of time can be saved.

Let’s first look at the current representative pathway for patients presenting with palpitations according to a case study from NHS Coastal West Sussex.

Patient present with palpitations > Sees GP > GP refers > Hospital receives letter > Consultant receives letter > Outpatients > 24hr ECG > Negative Test > Has 7-day ECG > Outpatients and decision > Has 7-day ECG > Outpatient and decision > Consider Implantable Loop Recorder (ILR) > Put on waiting list > Lost to system > Sees GP > GP writes letter > Hospital receives letter.

That’s quite a list, 18 steps in all. Goodness knows the time, resource and cost this entire process could be to the system.

Here’s a potential pathway with the Kardia:

Patient presents with palpitations > Sees GP > GP supplies Kardia Mobile ECG > Symptomatic trace > Sees GP > Advice and management.

Already, you can see where the Kardia Mobile ECG being part of your surgery’s strategy could save valuable time and money. The aforementioned case study does give some idea for the potential savings to be made.

The previously quoted pathway is costed up at £1305, nearly £6000 if the ILR (implantable loop recorder) is included. Whilst all of these steps and the costs suggested might not always be the case, it shows that it could be an expensive process. Taking into consideration that an estimated 2,000,000 people in the UK have Atrial Fibrillation, we simply must find a more sensible solution, the AliveCor Kardia Mobile ECG.

The same pathway, with the inclusion of the Kardia Mobile ECG being supplied comes in at just £172.50. That’s an incredible saving.

Across the country, that’s a potential saving of £2,265,000,000 (without ILR, £11,377,000,000 with ILR in every case) which is a staggering figure. This is no longer about whether surgeries should be supplying the Kardia Mobile ECG, it’s a case of when they start.

That time is now.

European Society of Cardiology. Diagnosis and timeley detection of AF.

I have recently been re-reading the 2016 European Society of Cardiology (ESC) Guidelines for the management of atrial fibrillation (European Heart Journal (2016) 37, 2893–2962 doi:10.1093/eurheartj/ehw210.

Of particular interest was the section on “Diagnosis and timely detection of atrial fibrillation” especially in the light of the popularity of the low cost clinically validated Kardia Mobile ECG from AliveCor.

In their latest review, when putting forward proposals to enhance current guidelines the ESC specify 4 different recommendation classes. A Class I recommendation is defined as

“Evidence and/or general agreement that a given treatment or procedure is beneficial, useful, effective”.

Within the section for screening for atrial fibrillation they have issued a class I recommendation that

“Opportunistic screening for AF is recommended by pulse taking or ECG rhythm strip in patients >65 years of age”

Clearly that is advice worth taking but in a busy GP Practice, where appointment time is limited to 10 or 15 minutes and resources under pressure, is it always practical to carry out a 12 lead ECG to get a rhythm strip?

Fortunately technology has the answer and there is the Kardia Mobile ECG App for that!

For under £99 the Kardia Mobile and App produces a 30 second rhythm strip that has the same diagnostic accuracy as a 12 lead single channel ECG Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, et al. Int J Cardiol. 2013;165(1):193-4.

It is therefore ideal for use in Primary Care to implement the recommendations of the ESC. The ESC go on to say

“There is good evidence that prolonged ECG monitoring enhances the detection of undiagnosed AF, e.g. monitoring for 72 h after a stroke…and daily short-term ECG recordings increase AF detection in populations over 75 years of age”

Again the Kardia Mobile is ideally suited for regular home monitoring, for instance once in the morning and once in the afternoon.

As it records a 30 second rhythm strip in real time, it is ideal for capturing paroxysmal AF for later analysis by a GP or Cardiologist.

It can be used to replace manual pulse checks providing qualitative ECG evidence in 30 seconds.

There is also an association with high blood pressure and AF. The Kardia Mobile ECG can help here as well.

To save time during a consultation, as well as to opportunistically screen for AF, why not use a Kardia Mobile before taking a blood pressure reading?

In the UK NICE have provided guidance on this with NICE Guideline CG127 Hypertension in adults: diagnosis and management on whether to use an automatic or manual blood pressure device.

Clause 1.1.2 states

“Because automated devices may not measure blood pressure accurately if there is pulse irregularity (for example, due to atrial fibrillation), palpate the radial or brachial pulse before measuring blood pressure. If pulse irregularity is present, measure blood pressure manually using direct auscultation over the brachial artery.”

Using a clinically validated Kardia Mobile by AliveCor before taking a blood pressure reading can save time as well as ensuring the most appropriate (automatic or manual) BP device is used. For up to date independent reviews on the Kardia Mobile ECG or to purchase visit our website.

Kardia Mobile ECG. What’s in a name?

The AliveCor Mobile ECG is now Kardia Mobile by AliveCor and the AliveECG app is now the Kardia App.

Why change the name? Kardia is more than just a new brand. Users of Kardia and Kardia Mobile will benefit from new features including:

Support for voice memos to provide subjective context to EKG recordings

Integration with Apple’s Health app and Google Fit to fuel more robust, personal heart health reports in addition to EKG recordings
An optional subscription service (Kardia Premium) to provide personalized reports and a detailed ECG recording history via the Journal
All users will have access to a free Kardia Premium trial through September 30, 2016.In addition to these new features, the new Kardia Band for Apple Watch, will enable you to record your ECG and capture a voice memo discreetly from your wrist. Kardia Band is pending 510K clearance and CE mark, and will be available for purchase later in the year.

Kardia by AliveCor lets you take a proactive role in your heart’s health by giving you the ability to record medical-grade EKGs anytime, anywhere, easily. In just 30 seconds, Kardia shows you whether your heart rhythm is normal or if atrial fibrillation (a leading cause of stroke) is detected in your EKG. Kardia delivers accurate results, and makes it easy to share EKG data with your doctor for analysis and diagnosis. Works with Apple iOS and most Android smartphones and tablets. Requires download of the free Kardia app, available on the App Store and Google Play.

The Kardia by AliveCor can be purchased by visiting www.pmsinstruments.co.uk

AliveCor ECG APP Update

The latest version of the AliveCor AliveECG app now comes with two new FDA-cleared and CE-marked automated detectors. The latest version of the mobile app instantly detects when an ECG is either Normal or unreadable. The Normal Detector provides added peace of mind allowing patients to go about their regular daily activities knowing that no abnormalities were detected in their ECG.

The Interference Detector goes a step beyond the existing enhanced filter to make sure the ECG is readable and physicians receive only the highest quality recordings.

Now whenever an ECG is taken with the AliveCor Heart Monitor, the AliveECG app will tell users if atrial fibrillation (AF), a leading cause of stroke is present, if the ECG is normal or if there is too much interference and another ECG should be taken. These features allow for the delivery of more efficient clinical decision-making and follow-up, as Doctors are able to focus on reviewing the ECGs that are most important.

At The Heart Of Healthcare Technology

P.M.S (Instruments) Ltd will now be distributing the AliveCor® Heart Monitor, a single-channel ECG (electrocardiogram) recorder. The AliveCor Heart Monitor provides people with suspected or diagnosed heart conditions, and those at risk of heart conditions, the ability to track their heart health anytime, anywhere, at an affordable cost.

As we celebrate our 40th anniversary in business we are well placed to say that truly unique medical products come along infrequently. The AliveCor® ECG heart monitor is a game changer that looks set to change the way ECG is recorded and the whole management and diagnosis of Atrial Fibrillation.

It is one of a growing number of products that are using the power of smart phones and tablets and turning them into “medical devices”. The AliveCor® and associated App is a fully CE certified and approved validated medical device which looks set to be a true game changer when it comes to medical products.

Using the AliveECG app from iTunes or Google Play with automatic AF detection, patients and physicians can manage existing conditions with intelligent, personalized features. Tracking of medications, lifestyle choices and ongoing symptoms allows patients to have a better understanding of their health status. Advanced search features and enhanced graphical trends provide a more comprehensive and reliable view of a patient’s overall health.

The AliveCor Heart Monitor, when used with the AliveECG app, becomes an, easy-to-use, cost effective medical device that records high resolution, accurate ECGs and heart rate anywhere, and at any time. A user simply attaches the monitor to their mobile device, downloads the AliveECG app, and records an ECG by resting the monitor on the fingers for 30 seconds.

Users will immediately see their ECG recording on the device screen. ECGs are then stored in the app and on secure, encrypted servers located in the EU. ECGs can also be printed or e-mailed directly from a mobile device.

Medical professionals can also utilize the free web-based Patient Management Provider dashboard provided by AliveCor that allows them to choose to receive and review ECG recordings from their patients once given viewing permission.

Once connected, the patient’s future recordings automatically start showing up. This is a great way of monitoring a patient’s condition remotely from pre-diagnosis to long-term care.

Clinical studies have demonstrated the AliveCor Heart Monitor’s accuracy to be comparable to readings from Lead 1 of a standard ECG machines, but at a fraction of the cost.

The AliveCor system is a cost effective atrial fibrillation screening device and heart monitor which can be used by U.K. and Ireland medical professionals, patients and health conscious individuals, to record, display, store, and transfer single-channel electrocardiogram (ECG) rhythms.