Category: Kardia Mobile 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KardiaMobile 6L NICE Draft Guidance

Last month NICE published first draft guidance from its Early Value Assessment pilot project recommending smartphone-linked ECG devices.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

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This guidance has been updated and replaced by NICE medical technologies guidance 64 published 6th January 2022.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

Cardiovascular disease a national call to action

The fight begins against the nation’s biggest killer. Prevention is better than cure.

That’s the message from the latest guidance jointly released today by Public Health England and NHS England.

They have agreed ambitions and a goal over a 10 year period to improve the detection and treatment of (A) atrial fibrillation, (B) high blood pressure and (C) high cholesterol the A-B-C of major causes of cardiovascular disease (CVD) in England.

It is estimated CVD costs the wider economy £15.8 billion per year and causes 1 in 4 deaths.

It’s well known that many people are living with undiagnosed CVD or if diagnosed it is badly managed. These conditions often carry no symptoms meaning millions of people are unaware they are at risk and in need of treatment. It is believed that over 5 million are currently living with undiagnosed high blood pressure in England alone.

Today CVD causes 1 in 4 deaths in England or 1 every 4 minutes. In 2016 heart disease was the leading cause of death for men and the second biggest for women after dementia.

The NHS long term plan (NHSLTP) has the ambition to prevent 150,000 cases of Strokes, heart attacks and dementia over the next 10 years.

The old adage prevention is better than cure is the mantra and Health Secretary Matt Hancock is on record as saying

“Prevention is at the heart of our vision for improving the health of the nation, empowering people to stay healthy, not just treating them when they’re ill. Millions of people are needlessly at risk of heart attacks or strokes when it could be prevented. So I want to help more people take the time out to protect their future health and get checked.”

These are the ambitions for Atrial Fibrillation (AFib) and Blood Pressure.

Atrial Fibrillation

  • 85% of the expected number of people with AF are detected by 2029
  • 90% of people with AF who are known to be at high risk of stroke to be adequately anti-coagulated by 2029.

Blood Pressure

  • 80% of the expected number of people with high BP are diagnosed by 2029
  • 80% of the total number of people diagnosed with high BP are treated to target as per NICE guidelines by 2029

How do we achieve these objectives when Primary Care is already overstretched?

By using the NHS Health Check to support early diagnosis and management can encourage people to make healthy life style choices such as eating well, reducing alcohol and taking more exercise is one approach.

New technology and new approaches can also help.

I’ve written previously on this Blog about opportunistic screening in different settings including community settings. Pharmacists for instance are already using new technologies and products like the AliveCor Kardia Mobile ECG and A&D UA-767 S blood pressure monitor with AFib + technology to actively and opportunistically identify at risk patients.

Already used extensively throughout the NHS the Kardia Mobile ECG monitor is clinically validated and automatically detects AFib in 30 seconds. Its quick uses a smartphone App and costs under £99.

Published today the CVD goals and ambitions Public Health England and NHS England hope to achieve by 2029 should be welcomed. If made a reality, the prospects of millions of at risk people will be transformed for the good.

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

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.