NICE One! KardiaMobile Recommended For AF Detection.

The National Institute for Health and Care Excellence (NICE) have recently published a Medical Technology Guidance report (MTG) 64 featuring the AliveCor KardiaMobile. KardiaMobile is now the first and only NICE recommended personal ECG device for detecting atrial fibrillation in an ambulatory setting.

KardiaMobile is now NICE accredited.

KardiaMobile is recommended for detecting atrial fibrillation (AF) for people with suspected paroxysmal AF, who present with symptoms such as palpitations and are referred for ambulatory electrocardiogram (ECG) monitoring by a clinician.

Why did NICE make this recommendation?

Detecting atrial fibrillation in people with suspected paroxysmal AF usually involves wearing a continuous ECG Holter monitor. KardiaMobile is a portable wireless ECG recorder that can help detect AF.

The NICE committee consisting of a panel of experts looked at published clinical evidence that shows significantly more people had AF detected using the KardiaMobile single-lead device compared with a Holter monitor.

The clinical experts agreed that monitoring with KardiaMobile could increase infrequent AF event detection because it could record an AF event whenever symptoms are presented. 

Cost modelling shows that KardiaMobile is cost saving compared with a Holter monitor by an average of £13.22 per patient over 2 years in people presenting with symptoms such as palpitations. 

This positive recommendation acknowledges AliveCor’s digital innovative technology and empowers patients and doctors to remotely monitor their heart rhythm.

KardiaMobile can support an earlier diagnosis of AF in an ambulatory setting and this recommendation highlights AliveCor’s commitment to the NHS Long Term Plan to reduce the incidence of cardiovascular disease in the UK.

KardiaMobile is the world’s most clinically-validated personal ECG. Unlike traditional ECGs, KardiaMobile provides a compact, patchless and wireless solution that can be used at any time and anywhere.

The user starts a 30-second ECG recording on their smartphone via the Kardia app – by placing two fingers from each hand on each of the two top electrodes – enabling the patient to remotely capture a medical-grade recording of their heart activity. KardiaMobile provides instant detection of AF, bradycardia and tachycardia, which are leading indicators of cardiovascular disease.

KardiaMobile can also detect normal heart rhythm, offering users peace of mind.

This guidance replaces NICE’s earlier medtech innovation briefing on KardiaMobile for the ambulatory detection of atrial fibrillation (MIB232) published in October 2020.

The twenty year wait has been worth it!

The new A&D Medical TM-2440 and TM-2441 Ambulatory Blood Pressure Monitors are now available to pre-order from lead distributor PMS Instruments. They replace the old TM-2430 which PMS originally introduced in 1998.

Engineered in Japan, they are the 4th generation of A&D ABPM monitor PMS Instruments have launched in the UK and easily the most advanced to date. Both new models have a number of new innovative premium features.

With the launch of 2 new ABPM monitors at once the twenty year wait has been worth it!

The A&D TM-2440 Classic abpm comes as standard with fast measurement time, silent operation and with a world first in an A&D ABPM, IHB (Irregular Heart Beat) analysis technology.

This ground breaking technology pioneered by A&D in 2001 is now used worldwide assisting in the opportunistic detection of arrhythmias – which include AFib (or Atrial Fibrillation). It features Oscillometric waveform measurement analysis and with the new analysis software you can check the waveform record for each measurement.

The TM-2441 Premium ABPM with it’s all in one design concept offers the clinician and patient complete flexibility, providing Ambulatory (ABPM), Home (HBPM), Office (OBP), Automatic Night Blood Pressure (ANBP), and Automatic Self Blood Pressure (ASBP) measurement/monitoring in one device.

In addition to the Irregular Heart Beat analysis technology, it records environmental factors including Activity using a built in Accelerometer, Temperature and Air Pressure. The new TM-2441 provides additional more insightful view of the patient beyond just blood pressure recording and heart rate information – helping build a better picture for clinical decision making.

Both models for the first time are available with 4 different cuff sizes small, adult, large adult and extra-large adult with sizes fitting an arm circumference from 15-22cm right up to 36-50cm.

The new AND Analysis software allows PDF reports to be exported to popular clinical management systems like EMIS and SystmOne and is compatible with the old TM-2430.

The TM-2440/TM-2441 feature both USB and Bluetooth communication, use just 2 AA batteries and at just 120g, the TM-2440 is one of the smallest, lightest ABPM monitors on the market.

To discuss competitive upgrades or arrange a demonstration or trial call us today.

Latest AliveCor Kardia Mobile ECG Clinical Paper

Use of the Kardia Mobile may permit patients with palpitations to be evaluated in primary care.

The Kardia Mobile from AliveCor provides convenient patient driven electrocardiogram (ECG) recording over extended periods. That’s one of the key findings from a recently published clinical paper in the UK at Hammersmith Hospital.

The widespread uptake of smartphones makes the Kardia Mobile an appealing method for investigating intermittent palpitations in the absence of syncope.

In the researcher’s experience, the vast majority of patients were able to use the device at the time of symptoms, and a symptom-rhythm correlation was possible for all patients who submitted recordings.

In the cohort of patients with intermittent palpitations, use of the Kardia Mobile enabled the correlation of symptoms with heart rhythm in the bulk (76%) of individuals. This compares favourably to the reported diagnostic yield of 24-hour Holter recordings.

They demonstrated the utility of the Kardia Mobile in the diagnosis of intermittent palpitations in a low-risk population. Based on their findings they propose that many patients presenting with intermittent palpitations could be investigated in primary care as a first line investigation of palpitations.

The minority of patients diagnosed with an arrhythmia can then be triaged appropriately allowing cardiologists to target patients who need their expertise.

The Kardia Mobile is cost effective and helps reduce delays in the diagnosis of arrhythmia or gives reassurance where heart rhythm is normal and will improve the patient experience.

The paper Diagnostic utility of real-time smartphone ECG in the initial investigation of palpitations can be viewed here 10.5837/bjc.2018.006

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.

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.

 

 

 

 

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.