Tag: smartphone ecg

KardiaMobile 6L NICE Draft Guidance

Last month NICE published first draft guidance from its Early Value Assessment pilot project recommending smartphone-linked ECG devices.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

New AliveCor KardiaMobile 6L And The Diagnostic Power Of Six Leads

The ECG has come a long way since Nobel prize winning Willem Einthoven invented the first practical electrocardiogram (ECG or EKG) in 1895. The 3 lead string galvanometer also known as the Einthoven galvanometer he introduced in 1901 was 7 metres long, required 5 operators and weighed over 270 kiliograms!

Although the original “Einthoven triangle” configuration which refers to the imaginary inverted equilateral triangle centered on the chest and the points being the standard leads on the arms and leg was chosen largely for convenience it is still in use today.

I wonder what Einthoven would make of the new AliveCor KardiaMobile 6L PMS Instruments have launched today?

Things have definitely come on in the 159 years since he was born.

The new AliveCor KardiaMobile 6L records a six lead 30 second clinically validated ECG using a smartphone or tablet and App.

At 9cm long and weighing 24 g the KardiaMobile 6L has two electrodes on the top and one on the bottom.

The two electrodes on the top are for your fingers, and the one on the bottom to contact the skin of your left leg.

To record a 6 lead ECG hold the KardiaMobile 6L in your hands, placing your fingers on the front electrodes then touch the third electrode to the skin of your left knee or ankle. It’s that easy.

Why six leads?

The 2 fingers and left leg configuration allow the KardiaMobile 6L to record Lead I, II, II, aVL, aVR, and aVF ECG leads which are known as the frontal plane leads recording vertical and lateral electrical forces. By looking at the axis through the heart each of the individual 6 leads records the ECG from a slightly different perspective giving 6 times more information than the original KardiaMobile 1 Lead.

That’s 6 more times data for the KardiaMobile App and for your Doctor to analyse and providing more visibility into certain arrhythmias that are leading indicators of cardiovascular disease

For example with the 6 leads of ECG data the KardiaMobile 6L records it could be possible to identify if there is any deviation of axis out of the normal range in the frontal plane and if P waves are present.

With the launch of the KardiaMobile 6L six really is better than one!

Could AliveCor SmartRhythm Monitoring Revolutionise AF Detection?

The latest App version 5.0.2 from AliveCor introduces a new premium feature “SmartRhythm” monitoring.

What is SmartRhythm monitoring?

SmartRhythm monitoring from AliveCor is a system that takes heart rate and activity data gathered from an Apple Watch, and evaluates it using a deep neural network to predict heart rate patterns. If  heart rate differs from the neural network prediction, SmartRhythm will notify you to record an ECG either on your phone with Kardia Mobile or for convenience and if you have one with the KardiaBand.

Taking frequent ECGs can help you better manage your heart health, and capturing an ECG specifically during times when heart rate does not match activity levels may be useful.

SmartRhythm monitoring uses the Apple Watch Photoplethysmogram (PPG) sensor to evaluate heart rate approximately every 5 seconds. Your heart rate itself depends on many factors such as activity, stress, time of day and more. So at times your heart rate pattern should be high (during exercise), sometimes, it should be low (at rest) and sometimes it may signify a heart problem.

Patented AliveCor SmartRhythm monitoring technology uses an autoregressive, deep neural network that can learn the normal relationship between heart rate and activity, and notify you when it sees an unexpected pattern. It notifies you when the actual data from the Apple Watch doesn’t match what the SmartRhythm model expects to see.

Receiving a SmartRhythm notification does not necessarily mean that something is wrong. There are many perfectly normal situations that can cause a SmartRhythm notification, including exercise the Apple Watch can’t detect, stress or anxiety, consumption of caffeine or alcohol, and even motion artifact from wearing the watch band too loosely.

Conversely, not getting a SmartRhythm notification does not necessarily mean that everything is normal, since the Apple Watch sensor is only measuring your heart rate and does not capture the full complexity of your heart. SmartRhythm monitoring should be used as an additional means to capture frequent ECGs.

Does SmartRhythm monitoring affect Apple Watch battery life?

Yes. SmartRhythm causes a higher battery usage and you will need to charge your Apple Watch more frequently. This is because SmartRhythm requires the Apple Watch to be in Workout mode as it is evaluating heart rate data continually which increases battery usage.

AliveCor internal testing has shown that with a series 2 or newer watch you can expect around 16 hours of battery life. It can still be worn over night just top up the charge for an hour or so.

The first generation Apple Watch is not supported because it has a smaller battery and will only last 5 hours.

What’s Next?

Kardia for Apple Watch is just the first step in bridging the gap between consumer wearable devices and the science of clinically validated ECG healthcare devices.

The availability of a wearable, mobile ECG device like the Kardia has the potential to dramatically improve early detection of arrhythmias. Many arrhythmias start as occasional, intermittent problems that usually don’t show up in a doctor’s office and are notoriously difficult to diagnose.

AliveCor products including the Kardia Mobile and Kardia Band are available directly from UK Distributor PMS Instruments.

AliveCor®, KardiaBand™ and SmartRhythm™ are trademarks of AliveCor, Inc. Apple Watch® is a trademark of Apple Inc.

Published Clinical Research Demonstrates The Effectiveness Of Key Products

At PMS Instruments we are always looking to share published clinical research that demonstrates the effectiveness of key products we distribute.

At the European Society of Cardiology Congress in Barcelona recently there were a number of clinical studies, papers, posters and presentations focusing on the Kardia Mobile ECG and its effectiveness in AFib detection.

This is important as the research helps validate the accuracy of AliveCors medical grade algorithm giving users’ confidence in Kardia Mobile ECG technology and potentially saving lives.

In one recent Study Professor Julian Halcox of Swansea University Hospital in Wales presented The REHEARSE-AF Study with simultaneous publication in Circulation and the The Journal of the American Heart Association. This randomized study provided AliveCor Kardia units to 500 patients, who used them to record two ECGs per week for a year and compared the results to 500 patients who received conventional care from their General Practitioner. At the end of the year, the Kardia group had a 4-fold increase in AFib diagnosis compared to the control group, thereby enabling the initiation of potentially life-saving anticoagulant therapy.

A Cleveland clinic study showed Kardia Mobile AFib detection accuracy similar to that of Doctors. Dr Khaldoun Tarakji from the Cleveland Clinic presented the iREAD Study which evaluated the accuracy of the AliveCor automatic AFib algorithm versus expert cardiology over-read of both the Kardia recordings and 12-lead ECGs. Dr Tarakji found that in 52 patients the Kardia algorithm had a 96.6% sensitivity and a 94% specificity compared to a cardiology over-read of the simultaneous 12-lead ECGs for the diagnosis of AFib. Additionally, over 93% of the patients found the Kardia to be easy to use and that it “lessened AFib-diagnosis anxiety.”

Another Study found that the Kardia Mobile was able to detect more patients with AFib that were previously undiagnosed. Dr Bryan Yan of The Chinese University of Hong Kong presented research of over 12,000 patients aged 65 and older. He found that for each 30-second ECG recorded using the Kardia Mobile, his team were able to identify more patients with previously undiagnosed AFib. This demonstrates the empirical value of convenient, inexpensive self-screening using the Kardia Mobile ECG.

Finally at the ECS Dr Ngai Yin Chan of Princess Margaret Hospital in Hong Kong presented the AFinder Study which used community volunteers to perform opportunistic screening for AFib using AliveCor’ s Kardia Mobile in over 10,000 Hong Kong citizens age 50 and older. 244 participants were found to have AFib, with 74 of those previously undiagnosed. This study verifies that by using Kardia Mobile senior citizens who were not medical professionals could perform medical screening of their peers with successful identification of a serious medical condition.

These are examples of just some of the many published research articles from around the world which demonstrate that if the AliveCor Kardia Mobile ECG is trusted by Clinicians you can trust it to!

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.

 

 

 

 

AliveCor Kardia ECG Technology. Bringing Wearable Medtech and innovation to the NHS.

It’s not hard to get excited about the difference that innovations like the AliveCor Kardia mobile and Kardia Band ECG Watch could make to the NHS and its patients.

Both devices bring low cost wearable medtech to the NHS and capture medical grade ECG recordings using algorithms to monitor and manage heart arrhythmias. They can automatically detect atrial fibrillation (AF) which if undiagnosed can lead to strokes.

In the UK strokes kill 100,000 a year. Each one is estimated to cost the NHS between £9,500 and £14,000.

The financial impact of Atrial Fibrillation (AF), the most common type of arrhythmia, becomes more apparent when considering the cost to the UK economy as a whole which has been estimated to be £2.4 million.

That’s apart from the human impact strokes have on patients quality of life and their carers. Early detection then is crucial.

So how does the NHS currently identify these at risk patients?

As a busy GP at the moment when patients visit you, depending on their age and medical profile they may receive a simple manual pulse check. If you have time you count their pulse over 60 seconds. If you don’t you count to 30 and multiple the figure by 2!

The problem with a manual pulse check is that it remains a ‘one off’ check. An assessment of an irregular heart rhythm with this method is a snap shot in time and in part relies on chance to identify at risk patients, especially those with asymptomatic paroxysmal atrial fibrillation.

Depending on the result you may or may not then refer to secondary care for a 24 hour or 7 day Holter ECG to confirm the findings. The CCG will remind you there is a cost for this oh and probably a waiting list!

The existing pathway takes the time and resources of both you, your patients and the NHS.

What can AliveCor technology and innovation do to help?

The AliveCor Kardia Mobile and Kardia Band ECG devices offers huge benefits in early diagnosis of AF as they allow simple validated, quantitative and qualitative assessment of a patient’s ECG and heart health using a smart phone App.

 

With AliveCor ECG technology patients can record a 30 second medical grade ECG unobtrusively at any time helping reduce appointment times and detect AF.

At a time when Primary Care resources are under real pressure it means less time and money is wasted on nurse appointments, resources and follow ups for the NHS and patients.

It also means the anxiety some patients feel about their condition can be removed and they can take a proactive role in their heart health.

The wider adoption of AliveCor technology by the NHS and Primary Care will be a big step forward. It’s one to watch for sure.

The AliveCor Kardia Mobile costs £94.99 and the Kardia Band for the Apple Watch costs £226. Buy both from our web site.

 

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.