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

PMS Instruments Awarded Feefo Gold Trusted Service Award 2018

I am pleased to report that PMS Instruments has again been awarded the Feefo Gold Service award, an independent seal of excellence that recognises businesses for delivering exceptional experiences, as rated by real customers.

Created by Feefo, Trusted Service is awarded only to those businesses that use Feefo to collect genuine ratings and reviews. Those that meet the high standard, based on the number of reviews they have collected, and their average rating, are awarded. A badge of honour, this accreditation remains unique, as it is based purely on the interactions with verified customers.

As all reviews are verified as genuine, the accreditation is a true reflection of a business’ commitment to outstanding service.

PMS Instruments met the criteria of collecting at least 50 reviews between January 1st 2017 and December 31st 2017, with a Feefo service rating of between 4.5 and 5.0.

I am proud of the team at PMS and 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. We’re looking forward to another successful year ahead.

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!

Hokanson Cuff Changes Are Ahead.

Hokanson whose range of vascular instruments, cuffs and accessories are distributed in the UK and Ireland by PMS Instruments recently announced some changes to their cuffs. All cuffs manufactured after 31st August 2017 will now be supplied with male bayonet connectors.

Hokanson vascular cuffs have been the standard in vascular laboratories and clinics throughout the world for over 40 years and as they have been using “leur” type connectors for many years why the change now?

As ever the idea is to make medical devices safer and in the case of “small bore connectors” which includes blood pressure and vascular cuffs minimize medical device tubing misconnections.

Small-bore connectors are parts used to connect medical devices such as tubing, syringes, IV lines and other accessories that deliver fluids and gases for patient care. Although thankfully rare, tubes using standard luer connectors but with different functions have in the past been mismatched and connected incorrectly.

In the USA the FDA provide several examples of this happening on their website including the case of a blood pressure cuff which was accidentally connected to an IV catheter.

The FDA, and the International Organization for Standardization (ISO), decided to take action and IEC 80369-5:2016 was published in March 2016 to provide specifications for the small-bore connectors used with blood pressure cuffs. Hokanson have standardised on a male bayonet connector.

The following cuffs will be affected.

Hokanson UDC/UPC cuffs, the DP and SC cuffs that currently come with a Luer connector will be changed to a bayonet connector. This includes the SC10, SC12, TMC7 and SC5.

Hokanson cuffs with D rapid version hoses (SC12D, SC12LD, etc.) will remain unchanged. CC thigh cuffs will come with the bayonet connectors, and that connector can be cut off for use with an E20 rapid cuff inflator Y-connector (as with the Luer).

We will be providing Permanent Conversion Kits as well as Adaptor Kits to ensure compatibility and allow you to use legacy leur connector cuffs. Conversion kits are for permanent conversion of cuffs already being used that will change them to the new standard bayonet connector. Adapter kits are for customers who want to use both Luer and bayonet connectors, until all cuffs in use have bayonet connectors.

There is no requirement requiring customers to remove or stop using products currently in use from the market.

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.

The missing 5.5 million with undiagnosed high BP.

A new resource – Blood Pressure – How Can We Do Better? – has just been launched and can be accessed at the British Heart Foundation website.

It has been developed by stakeholders including GPs, nurses and pharmacists working with organizations including NHS England, Public Health England, the British Heart Foundation, the Stroke Association and the Royal College of General Practitioners.

It is well known that high blood pressure affects one in four adults in England and is one of the leading causes of premature death in England. At least half of all heart attacks and strokes are associated with high blood pressure.

Treatment thankfully is very effective – for every 10mmHg reduction in blood pressure, the risk of a life changing heart attack or stroke is reduced by 20%.

What’s the challenge?

Finding undiagnosed hypertensives, around 25000 in the average CCG or 5.5 million in England, unaware of their increased risk and not receiving treatment is the challenge. It’s also worth remembering that of those diagnosed with high BP, one in three, are not treated to target.

GP Practices and Clinical Commissioning Groups (CCGS) need to do things differently to improve detection and increase opportunistic screening.

What practical steps should GP Practices take?

Think BP! Whether in routine consultations, or in nurse led clinics, like COPD, asthma and diabetes. Encourage opportunistic screening and ensure identification of poor BP control is the responsibility of all clinicians.

Think BP! In accordance with NICE CG127 guideline on Hypertension always offer ambulatory 24 hour blood pressure monitoring or when appropriate home blood pressure monitoring to confirm a diagnosis of high BP. Ensure BP equipment is serviced and calibrated regularly by reputable third parties with experience of the devices you use.

Think BP! Use clinically validated waiting room self-test BP monitors like the A&D Medical TM-2657P to make it easier to collect BP data, save appointment time and empower patients to actively use this equipment.

Think BP! Advise patients of the option to buy clinically validated low cost blood pressure monitors like the UA-767S from established suppliers so they can monitor their blood pressure at home.

There is also a role for Clinical Commissioning Groups (CCGs) who need to do things differently to improve detection, support GP Practices and increase opportunistic screening.

They can use the BHF website to see how many people in their CCG have undiagnosed high blood pressure.

How do we diagnose more patients with high blood pressure?

Time pressured consultations and other clinical priorities are a factor and simply mean in many instances there isn’t enough time to record a blood pressure. The answer is the wider adoption of technology like the A&D Medical TM-2657P waiting room BP monitor and doing things differently.

How does it work?

Patient self-measurement of blood pressure using A&D waiting room blood pressure monitors have been used in the UK since PMS Instruments introduced them in 2002. They are an established part of many GP Practices hypertension diagnosis and management pathways. Put simply the patient records their blood pressure which is printed on a paper slip. This is then shown to the clinician during the consultation. The readings can be input to the patient’s clinical record.

What does the future for detection and management of high BP hold?

With no extra capacity at present the situation won’t be improved by GP’s working harder. It may be improved by doing things differently, changing the system and the wider adoption of new technology. If you are a GP Practice, CCG or GP Federation and want to find out more about the latest BP measuring technology contact me.

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

The right monitor for the job?

All blood pressure monitors are really all the same aren’t they? Which is the most accurate? I’m confused as all BP monitors seem to be the same. What about reliability and durability?

These are some of the questions our sales team are frequently asked and it’s true many digital blood pressure monitors offer similar features and claim to offer similar “clinically validated accuracy”.

But what about durability and reliability?

Continue reading “The right monitor for the job?”

Waiting Room Blood Pressure Monitors Rebooted

The TM-2657P is the latest waiting room blood pressure monitor from A&D Medical. It builds on the speed, reliability and accuracy of the previous TM-2655P, which it replaces, but now features a new ergonomic, modern, compact design.

The new integrated arm rest helps ensure the patient’s arm is comfortable and in the correct position during a measurement. A new antibacterial arm cuff cover is also now fitted as standard with the TM-2657P.

Designed and engineered in Japan, the new TM-2657P has a faster printout speed and offers added optional connectivity features including Bluetooth.

The “Torque Controlled Belt drive Method” (TCBM) cuff mechanism in the TM-2657P provides sophisticated automatic cuff size adjustment, ensuring the arm is positioned correctly for accurate high speed measurement, first time, every time.

With a centrally located simple one button operation, it can be used on children (13 years or above) and adults with either the left or right arm.

After the reading, the results are output to the inbuilt thermal printer with the date, time systolic, diastolic and pulse rate clearly displayed. New printing options also permit the inclusion of a barcode or QR code on the print out.

The printout will also display (if present) an irregular heartbeat symbol. An irregular heartbeat is defined as a heartbeat that varies by 25% from the average of all heartbeats during the blood pressure measurement.

Like the previous model, the TM-2657P looks set to be popular with GP Practices looking for a clinically validated, easy to use professional waiting room blood pressure monitor.

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.

Measurements Made Easy

The demise of the mercury sphygmomanometer in clinical practice has been discussed and debated for over 10 years.

Until recently they could still be sold for professional use in the healthcare sector. However, since 10 April 2014 and the implementation of EU Commission regulation no 847/2012 the sale of mercury-containing sphygmomanometers to the healthcare sector, is now prohibited.

The exception is where new sphygmomanometers will be used in ongoing epidemiological studies or as reference standards in clinical validation studies of mercury-free sphygmomanometers.

Despite this and as recently as December 2013, the MHRA were still recommending that calibrated, non-mercury devices, which are not automatic, should be made available in all clinical areas.

They should be used to check automatic device results and should also be used in clinical conditions where automatic monitors may be inappropriate e.g. arrhythmia, pre-eclampsia or specific vascular disease.

This presents the Practice Manager and Clinician with a potential dilemma. How do they comply with the MHRA guidelines?

Fortunately for Clinicians with the right training and skillset, there are a number of manual devices available which include shock resistant aneroid sphygmomanometers (ERKA Switch) and manual electronic devices like the A&D Medical UM-101A which have the same look and feel as Mercury.

Assuming Clinicians are comfortable using the Auscultation (manual) technique of recording blood pressure with a stethoscope, then a new generation of hybrid devices like the  Omron HBP-1300 are now also available.

These new devices are designed specifically with the professional user in mind. During an automatic measurement if the Irregular Pulse Wave symbol feature is indicated, the user can switch to manual mode and use a stethoscope to verify a reading is accurate without having to change device or cuff.

This is in line with MHRA recommendations.

Conclusion

Mercury sphygmomanometers have not been banned but new ones cannot now be purchased for general clinical use. That doesn’t mean the end of manual readings which in certain clinical situations may be required.

Suitable alternative clinically validated mercury free sphygmomanometers are available, so clinicians do still have a choice.

New hybrid automatic and manual blood pressure monitors specifically designed for the professional market are now available. They offer the advantage of a clinically validated automatic measurement or back up of a manual measurement where circumstances dictate.

Ambulatory blood pressure monitors. Are you getting good value?

The cost of ABPM monitors has fallen considerably in recent years but purchasers should check that there are no hidden extras and that the supplier is able to offer free technical support, installation training and advice to nurses who generally fit the monitor.

As some manufacturers offer expensive additional warranties or support contracts the true “whole life” running costs including maintenance should be factored in to the purchasing decision.

All modern 24-hour monitors like the Meditech ABPM-04, Meditech ABPM-05 and TM-2430 now use PC-based software and in most instances it is possible to attach the patient’s report to popular clinical management systems, such as EMIS and SystmOne.

Again it is worth checking that this is included and that there are no expensive annual licence fees or dongles required, as well as checking that multiple copies can be installed without additional cost.

An ABPM report should include, as a minimum, daytime and night-time averages, a list of BP data and trend graph on one or 2 sheets of A4 paper.

Normal mean levels for ABPM in adults are slightly lower than surgery readings at 135/85 for daytime average and 120/70 when asleep.

The results can usually be interpreted by suitably qualified clinicians. The latest version of CardioVisions that works with the Meditech ABPM-04 and Meditech ABPM-05 provides additional automatic analysis to the NICE 2011 guidelines and this can save time and ensure consistent reporting.

Ideally, the monitor should be able to use rechargeable batteries to minimise costs. A wide range of cuff sizes should be available but the adult and large adult will probably be used the most popular. Cuff barriers like those from TIDI can help keep cuffs hygienic and prevent soiling.

Most but not all companies will offer additional training if required.

As with any piece of medical equipment used in patient diagnosis, routine calibration and servicing is important. This should only be undertaken by authorised service technicians that have access to original manufacturer parts and test equipment.

With any ABPM this should be available in the UK from the supplier to avoid unnecessary downtime.

As with all things it’s unwise to pay too much but sometimes risky to pay too little.