Tag: Alivecor ECG

At The Heart Of Healthcare Technology For 48 Years!

As we celebrate our 48th year in business I’ve recently taken a nostalgic look back over the various innovative products PMS have introduced to the UK healthcare market since 1975.

Some of them really were ahead of their time and have led to the development of subsequent products still in use today. Here I take a look back at a few of the more notable ones.

1994 – A&D Medical TM-2421 24 Hour Blood Pressure Monitoring System

The UK’s first dual method, Korotkoff Sound/Oscillometric 24 hour BP monitor, it proved to be very popular from 1994 to 2007 when it was replaced by the improved A&D TM-2430 24 Hour BP monitor.

1995 – E – Z Therm The 3 Second Thermometer

This was one of the UK’s first Tympanic thermometers. It was very popular and sold in large numbers. The fast measurement time meant it was popular for use in children and as a replacement for Mercury thermometers.

1997- A&D Medical UA 767 Digital Blood Pressure Monitor

The classic low cost and easy to use three in one digital BP monitor that gave systolic, diastolic and heart rate simultaneously on a large LCD display. Clinically validated it was popular with GPs and Hospitals as well as being used for clinical research. The latest generation is the A&D Medical UA-767 + AFib still one of our most popular digital BP monitors used extensively by the NHS.

2003 – Meditech Merlin ECG watch

Ahead of its time and before Smartwatches were available the Merlin watch was a low-cost ECG event recorder designed to capture transient arrhythmias. It was easy to wear and activate and could store up to 15 minutes of ECG recordings. PMS sold the watch until 2013 when it was discontinued by Meditech. It led to the development of the Meditech CardiUP3! Holter ECG. The latest AliveCor KardiaMobile 1L and 6L are great examples of how mobile ECG technology has moved on.

2009 – Tidi Disposable Cuff Barriers

Originally introduced by PMS as a cost-effective alternative to expensive single use blood pressure cuffs and as a hygienic solution to using fabric cuffs. They are still by the NHS today and were especially popular during the COVID-19 pandemic.

Introducing these products helped establish the PMS Instruments ethos of being At The Heart Of Healthcare Technology and to the development our innovative product range which still includes 24 hour blood pressure monitors, waiting room and digital blood pressure monitors, and mobile, resting and Holter ECG monitors.

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.

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.

KardiaMobile 6L-Different but the same

Since we launched the KardiaMobile 6L last week we’ve seen phenomenal interest in the new product which has the potential to be a real game changer in the diagnosis of Atrial Fibrillation as well as potentially other arrhythmias.

It’s important to point out that both products use the same clinically proven AI technology but the KardiaMobile provides 6 times more of it!

For instance both versions of the KardiaMobile will display and record a Premature Ventricular Contraction (PVCs) but now with KardiaMobile 6L Cardiologists can identify where they originate from in the heart.

As well as recording 30 seconds of 6 Lead ECG (Lead I, Lead II, Lead III, aVR, aVL and aVF) ECG in real time it can also be set to record Lead 1 only so it offers the best of both worlds! You can buy yours from our Web site

KardiaMobile 6L KardiaMobile
CE Marked and FDA cleared 6 lead
personal ECG 		CE Marked and FDA cleared 1 lead personal ECG
Detects Atrial Fibrillation, Bradycardia, Tachycardia, and Normal Sinus Rhythm Detects Atrial Fibrillation, Bradycardia, Tachycardia, Normal Sinus Rhythm
Increased ability to identify cardiac arrhythmias such as atrial flutter, heart block and PVCs Clinically proven AI- technology
Clinically proven AI-technology Most widely-used 1-lead personal ECG in the world
Select single or 6-lead ECG, depending on patients’ unique remote monitoring needs  
£149 + VAT £99 + VAT

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

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

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

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

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

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

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

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

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

Why six leads?

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

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

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

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

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.

 

 

 

 

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.