Kardia Mobile – 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KardiaMobile 6L NICE Draft Guidance

Last month NICE published first draft guidance from its Early Value Assessment pilot project recommending smartphone-linked ECG devices.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

Kardia Mobile ECG App now detects Bradycardia and Tachycardia

The latest update of the AliveCor Kardia mobile ECG app for Apple iOs and Android devices now includes 2 new FDA-cleared, medical-grade ECG detectors, Bradycardia and Tachycardia.

This brings the total to 4 clinically relevant detectors including automatic instant analysis for Bradycardia, Tachycardia, Atrial Fibrillation, and Normal ECGs.

What is Bradycardia?

Kardia Instant Analysis Bradycardia indicates that atrial fibrillation is not detected in the ECG, and the heart rate is less than 50-beats per minute, which is slower than normal for most people. The normal range for heart rate depends on your age and physical condition. A heart rate of less than 50-beats per-minute can be normal for healthy adults, athletes and during sleep.

What is Tachycardia?

Kardia Instant Analysis Tachycardia indicates that atrial fibrillation is not detected in the ECG, and the heart rate is faster than 100 beats per minute. This can be normal with stress or physical activity. The normal range for heart rate depends on your age and physical condition. The most common form of tachycardia is sinus tachycardia, which is a normal increase in heart rate.

While Bradycardia (heart rate less than 50 beats per minute) and Tachycardia (heart rate higher than 100 beats per minute) are often nonthreatening, these arrhythmia’s can be indicative of heart disease or other health conditions, such as thyroid disease.

A slow or fast heart rate may be asymptomatic, or cause symptoms such as dizziness or shortness of breath. Kardia Mobile users will now be able to detect these arrhythmias and use the insight to inform conversations with their doctor.

Beyond the patient-doctor relationship, Kardia Mobile also provides peace of mind by diminishing the number of unclassified readings that users may receive.

The latest Basic version of the App now also allows multiple ECG’s to be stored on the mobile device.

Improving the AF clinical pathway with the Kardia Mobile

Clinical Background

1.4 million people in the UK have atrial fibrillation; that’s 2.4% of the population. It’s known that in the 45 – 65 age group over 80% of people will suffer from the condition.

Public Health England (PHE) believes almost half a million people with AF remain undiagnosed. AF is known to be a direct cause of a third of all strokes and consequently 2,000 premature deaths per year. Early diagnosis could help avoid this.

AF and AF-related illness costs the National Health Service over £2.2 billion annually – a cost that is expected to rise as the incidence of AF increases due to the ageing population.

Current Clinical Pathway

The current clinical pathway varies according to each GP surgery and CCG but generally it can be a lengthy and costly process to achieve a definitive diagnosis.

The process typically begins with a manual pulse check and then auscultation, a 5 or 12 lead ECG in the surgery is followed by a 24 hour ECG tape or seven day Holter recording which then has to be analysed. With a positive (or indecisive) test, the patient is then referred to a cardiologist. If a diagnosis of AF is confirmed, the patient is then referred back to the GP for anticoagulant therapy.

PHE estimates that 2,000,000 people in the UK have Atrial Fibrillation and that the cost per patient using the current pathway is £1,305 without interventional procedures. This includes three GP visits, 12 lead ECG and Holter recordings, and outpatient costs.

The cost reduction achieved by using Kardia Mobile is significant. Assuming the patient requires two GP visits and a Kardia Mobile is provided for each patient, the cost is £189 rising to £352 if a patient is also sent for a 12 lead ECG. The minimum saving is therefore in the region of £950 per patient.

The cost to the NHS of screening the population with the current pathway is prohibitive. Kardia Mobile makes it possible.

Cost £ Of Current Pathway

First GP visit (incl. ECG test)	£81
Outpatients	£230
24 hr ECG	£163
7 day Holter test	£163
Outpatients and decision	£230
Implantable loop recorder (ILP)	£4021-£4556
Second GP visit	£45
Total	£1305 with ILR £5861

Cost £ When Using Kardia Mobile

First GP visit (incl. ECG test)	£81
GP Supplies Kardia Mobile	£99
Second GP visit	£81
Total	£189

Therefore using the AliveCor Kardia Mobile is a faster, simpler and more effective pathway.

Added Benefits. Early diagnosis of AF in 30 seconds

In surgery, the GP or the nurse can use the Kardia Mobile for a quick check when a patient presents with palpitations, fast heart rate or irregular rhythm.

The presence of AF can be immediately identified. Due to its simplicity, speed of use and low cost, Kardia Mobile can routinely be used to screen patients for AF and become part of the protocol for health checks in key age groups.

It can also be used to screen newly registered patients, in the well woman/well man NHS health checks and to form part of the routine in flu clinics.

As AF may be transient in nature, a test in the GP’s surgery may still not reveal the presence of the condition. A doctor can then issue a Kardia device to the patient for home use to make a recording when he or she experiences symptoms.

Kardia Mobile will also provide a simple ECG rhythm strip recording with heart rate when used during home visits.

The Cost/Benefit Analysis Of Using The Kardia Includes

Reduction in the number of ECG tests, 24 hour tapes and 7 day Holter recordings.
Reduction in the number of GP appointments and outpatient appointments.
Savings to the NHS through early diagnosis of AF and prevention of stroke.

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.

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!

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