KardiaMobile NICE MIB232

This guidance has been updated and replaced by NICE medical technologies guidance 64 published 6th January 2022.

The AliveCor KardiaMobile ECG PMS Instruments distribute has just been recognised by the National Institute for Health and Care Excellence (NICE) for the fast and precise ambulatory detection of atrial fibrillation.

The recently published NICE Medtech Innovation Briefing (NICE MIB232) demonstrates how AliveCor’s technology can support patients and health care professionals, and highlights alignment to the NHS long term plan.

Highlights from the NICE MIB232 report conclude:

  • The published evidence from 11 studies, across 1,218 adult patients, demonstrates that KardiaMobile can detect more cardiac arrhythmias, but can do so faster than standard care.
  • The brief showcases KardiaMobile’s diagnostic accuracy for detection of cardiac arrhythmias with sensitivity ranging between 77.0% and 96.6% and specificity ranging between 76.0% and 99.1%.
  • KardiaMobile is suitable for patients to use with suspected paroxysmal AF, which might not be detected using a standard 12-lead ECG if the person is not in arrhythmia at the time of recording.
  • The convenience of an at-home medical-grade ECG that can be taken at any time of the day increases the diagnostic yield of an arrhythmic episode being detected and recorded.

It was also noted that patients preferred not having electrodes connected to the skin or travel to and from the surgery or hospital especially during the Covid 19 Pandemic.

All six experts involved with the studies described the technology as innovative. With one stating that it had already changed clinical pathways for those with suspected arrhythmia, one that it had potential to change standard of care, and another suggested it could be used in settings, outside of healthcare.

All of the experts thought that this technology had the potential to change standard care in some way (earlier diagnosis, quicker intervention, fewer hospital visits and referrals, fewer strokes) improving both patient outcomes and patient satisfaction.

At a cost of only £82.50 + VAT and ease of use compared to the cost of an ECG event recorder the KardiaMobile ECG could be a cost effective way of diagnosing AF earlier in suspected patients and improving patient outcomes.

FDA Guidance Allows Use of KardiaMobile 6L to Measure QTc in COVID-19 Patients

The KardiaMobile 6L – the world’s only six-lead personal ECG – is now cleared for use in the measurement of a patient’s QTc and detection of potentially dangerous QT prolongation.

A prolonged QTc can lead to a potentially fatal side effect, called drug-induced sudden cardiac death (DI-SCD) linked with the use of several medicines now being used in the treatment of COVID-19.

The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system. Abnormal prolongation of the QTc can stem from congenital long QT syndrome, many disease states, electrolyte abnormalities, and over 100 FDA-approved medications that have the potential for unwanted QT prolongation.

Patients with a prolonged QTc are at greater risk of their hearts going into a potentially dangerous arrhythmia called Torsades de Pointes which can lead to sudden cardiac arrest and even worse, sudden cardia death.

With the global pandemic of COVID-19, several drugs being used off-label to treat COVID-19 which have the potential for unwanted QT prolongation and worse, DI-SCD.

With the KardiaMobile 6L a patient’s QTc can be obtained without exposing clinical staff to affected patients which helps to conserve personal protection equipment (PPE) and thereby expand the capacity of strained medical resources.

Healthcare professionals can now use KardiaMobile 6L to collect a six-lead ECG (Lead I, II, III, aVR, aVL, aV), and then use manual tools to calculate QT duration allowing them to make assessments with respect to patient medication.

Lead I I-ECGs could detect AF more accurately than a manual pulse check

A new study which looks at Lead-I ECG for detecting atrial fibrillation in patients with an irregular pulse using single time point testing has been published in Health Technology Assessment Volume: 24, Issue: 3 January 2020 https://doi.org/10.3310/hta24030

This study aimed to assess whether or not the use of lead-I ECGs in GP surgeries could benefit patients and offer good value for money to the NHS.

The objective was to assess the diagnostic test accuracy, clinical impact and cost-effectiveness of using single time point lead-I ECG devices for the detection of AF in people presenting to primary care with relevant signs or symptoms, and who have an irregular pulse compared with using manual pulse palpation (MPP) followed by a 12-lead ECG in primary or secondary care.

The study found that if GPs were to routinely use lead-I ECG devices, including the AliveCor KardiaMobile, people with suspected AF could receive treatment while waiting for the AF diagnosis to be confirmed by a 12-lead ECG.

The study found that using a manual pulse check followed by a lead-I ECG offers better value for money when compared with a manual pulse check followed by a 12-lead ECG. This is mostly because patients with AF can begin treatment earlier when a GP has access to a lead-I ECG device.

The report also stated that the AliveCor KardiaMobile lead –I ECG is the most cost-effective option in a full incremental analysis.

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.

Kardia Mobile Recommended In UK Accident & Emegency Departments

The latest clinical validation study on the AliveCor Kardia Mobile ECG has just been published in The Lancet. The study was funded by research awards from Chest, Heart and Stroke Scotland (CHSS) and the British Heart Foundation (BHF).

Whilst previous clinical studies have concentrated on the AliveCor’s use to detect Atrial Fibrillation (AFib) in Community Pharmacy and Primary Care settings this latest multi-centre trial looked at patients presenting to Accident and Emergency Departments with palpitations and pre-syncope but with no obvious cause at their initial consultation. 

The multi-centre, randomised controlled trial included 243 patients recruited over an 18 month period from 10 prestigious centres across the UK including Hospitals in Edinburgh, Reading, London, Exeter, Plymouth, Chesterfield, Leicester and Nottingham.

What was the problem the researchers identified?

It is estimated that Palpitations and pre-syncope are together responsible for 300,000 annual Accident and Emergency Department attendances in the United Kingdom (UK) alone. However diagnosis of the underlying rhythm is difficult as many patients are fully recovered by the time they attend Hospital and their ECG is normal.

What was the outcome?

Use of the AliveCor Kardia Mobile ECG smartphone-based event recorder in Accident and Emergency units was five times more effective at detecting heart rhythm problems than standard tests and should be used in all Accident and Emergency units, researchers say.

Use of the Kardia Mobile ECG also increased the number of patients diagnosed with cardiac arrhythmia.

The Study participation survey and questionnaire demonstrated the Kardia Mobile was well received and liked by patients with the majority agreeing or strongly agreeing the Kardia Mobile was easy to use.

The £99 Kardia Mobile ECG recorder also cut the cost of diagnosis by more than £900 per patient and cut the time taken to diagnose by more than three weeks.

A copy of the paper can be accessed using the following link

M.J. Reed, N.R. Grubb, C.C. Lang, et al., Multi-centre Randomised Controlled Trial of a Smartphone-based Event Recorder Alongside Standard Car…, , https://doi.org/10.1016/j.eclinm.2019.02.005

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.

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!

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.

 

 

 

 

Quality, customer service Feefo Gold Trusted Award

I am pleased to announce that PMS Instruments have won a Feefo Gold Service award, an independent seal of excellence that recognises businesses for delivering exceptional experiences, rated by real customers.

Created by Feefo, Trusted Service is awarded to businesses that use Feefo to collect genuine ratings and reviews. A badge of honour, this accreditation remains unique as all the awards are based purely on the interactions with verified customers. This feedback has been collated by the Feefo review platform, with the accolades being awarded based upon performance.

PMS Instruments have met the criteria of achieving a Feefo service rating of between 4.5 and 5.0 between January 1st 2016 and December 31st 2016.

It’s a real honour to receive this award from Feefo. To be recognised for delivering exceptional experiences to our customers is a great achievement. We’ve been working hard to ensure our customers receive the best service possible, and being able to listen, understand and respond to their needs has enabled us to improve our offering in 2016. We have been working closely with all our customers to build trust and transparency online, and ultimately helping shoppers buy with confidence and make better decisions.

Feefo ensures that all feedback is authentic, by matching it to a legitimate transaction which combats the rising issue of fake reviews.

Our stand out product is the AliveCor Kardia mobile ECG with a rating of 4.7 out of 5 over the last year.

We’re looking forward to another successful year ahead. You can look at our latest reviews here.

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.

 

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.

Why You Should Use ECG Event Recorders in Primary Care.

The updated NICE clinical guideline CG180 (2014) was published in June 2014. It gives guidance on the management of atrial fibrillation and recommends an ECG should be performed on all patients where atrial fibrillation is suspected where an irregular pulse has been detected, whether symptomatic or not.

It recommends using ambulatory ECG recording in patients with suspected paroxysmal AF as follows:

  • A 24-hour Holter ECG monitor should be used in those with suspected asymptomatic episodes or symptomatic episodes less than 24 hours apart.
  • An event recorder ECG should be used in those with symptomatic episodes more than 24 hours apart.

The National Service Framework for Coronary Heart Disease chapter on cardiac arrhythmias lists three quality requirements relating to patient support, diagnosis and treatment and sudden cardiac death.

So why aren’t more GPs using Event Recorders in Primary Care?

There are two main types of ECG recorders worn by patients in an ambulatory setting away from the

Surgery. They are Holter ECG recorders like the Meditech CardioMera or Event Capture ECG recorders like the Meditech CardioBlue and DCBiomed InstantCheck.

They are generally used to investigate suspected symptoms of arrhythmia including palpitations, light-headedness or syncope (partial or complete loss of consciousness), which have not been detected during a shorter 12 lead, surgery based ECG.

Holter or event recorder

Continuous full disclosure Holter ECG monitors were first used in the 1970s and typically operate for 24-48 hours recording every single heartbeat during this period.

This can mean that upwards of 100,000 beats are recorded over a 24 hour period. They are especially useful if the wearer does not feel or is not aware of the ECG abnormality, and are typically more expensive than event recorders.

In most cases data is now stored digitally either on internal flash memory or on removable SD data cards.

Data is uploaded to a computer where software automatically analyses the recording classifying it by beat type, identifying and labelling specific arrhythmias and in some cases, providing a textual summary for the clinician.

Reports should be customisable and have the ability to be attached to the patient’s clinical notes electronically.

Most Holter analysis software can run on a desktop PC and a separate dedicated PC is not required. This makes the analysis of the recording much quicker.

Event ECG recorders are different and are designed for patients who experience symptoms very infrequently and require monitoring over several days or even weeks.

This type of recorder is usually patient activated by pushing a button, but some can be programmed to record automatically at pre-set intervals or will trigger automatically at the onset of certain arrhythmias.

Some event recorders record post event data only. Others operate in a ‘loop’ memory mode so the device records 30 seconds of pre event and 30 seconds post event data. This is useful should the patient lose consciousness and allows the clinician to view the ECG immediately leading up to the event.

Traditionally, post event recorders would have had an external lead with electrodes fitted to the patient’s chest or be held against the chest to record. Recent advances in technology have seen the development of new recorders, which have built in finger or wrist watch type electrodes, which permit long term monitoring without the discomfort or irritation of a patient lead.