New Application For Hokanson Rapid Cuff Inflator

PMS Instruments have been the UK Distributor for Hokanson vascular products for over 20 years. During this time their products have been used in leading edge clinical research in the UK by Universities, Hospital and Pharmaceutical companies.

When we first started selling their products the majority of our sales were for applications that used Strain Gauge Plethysmography using Mercury (now Indium Gallium) strain gauges for arterial inflow studies. This concept was invented by Hokanson, is unique and has become well accepted as an industry standard technique.

Two Hokanson products the E20 rapid cuff inflator and AG101 air source were originally used as part of the setup for Strain Gauge Plethysmography. They have now become popular in their own right in the areas of Clinical Pharmacology, Sports Medicine and Sports and Exercise Physiology.

The combination of the Hokanson E20 rapid cuff inflator and AG101 air source can help improve duplex scanning for Venous Reflux and Venous Insufficiency tests.

Rather than manually inflating cuffs which is time consuming and can be uncomfortable for the operator the Hokanson E20 has several advantages:

  • It eliminates squatting to squeeze the patient’s leg.
  • It compresses all of the soft tissue
  • It holds pressure for precisely the correct amount of time
  • It rapidly releases the pressure while the leg is duplex scanned for venous reflux
  • There is no need for a second person to do the compression

The E20 inflates any cuff in 0.3 sec, holds the pressure indefinitely or for whatever time your protocol needs and then instantaneously deflates the cuff. It works every time no matter the size of the cuff or limb. Simply dial in the pressure needed and push the button for inflation and then push the button to deflate. An optional foot switch and cycle timer is also available.

The combination of the Hokanson E20 rapid cuff inflator and AG101 air source and ease of use mean that brachial artery endothelial function can be measured using the flow-mediated dilation (FMD) technique. The technique still requires skill but is much more reliable and reproducible solution for instant cuff inflation/deflation.

For more information on FMD and Hokanson this recent clinical paper is a good reference

Do acute effects of exercise on vascular function predict adaptation to training? Dawson, E.A., Cable, N.T., Green, D.J. et al. Eur J Appl Physiol (2018) 118: 523. https://doi.org/10.1007/s00421-017-3724-8

In this study the arm was extended and positioned at an angle of ~ 80° from the torso. A forearm cuff was rapidly inflated and deflated using the Hokanson E20 to provide a stimulus to forearm ischemia.

After 20 years it’s great to see Hokanson equipment still being used for new clinical and research applications in the UK.

What’s the future for manual blood pressure measurement devices?

Since 10 April 2014 and the implementation of EU Commission regulation no 847/2012 the sale of new Mercury sphygmomanometers to the healthcare sector has been banned.

The alternative? Electronic manual sphygmomanometers like the A&D UM-102A mimic the Mercury sphygmomanometer but have none of the inherent disadvantages. These devices blend the best of modern, reliable vertical LCD technology, with the traditional advantage and reassurance of a manual measurement whilst listening to Korotkoff sounds with a stethoscope.

Unlike Mercury sphygmomanometers, devices like the A&D UM-102A sphygmomanometer don’t require routine cleaning or maintenance and can be used at any angle with a wide range of cuffs sizes and on patients with arrhythmias.

There is no oxidisation of the LCD which could alter the dynamic response and readings can be read to a single digit mm/Hg. Most importantly, if a product like the A&D UM-102A gets dropped you won’t end up with a contaminated treatment room and an expensive and time consuming mercury spill to clean up!

Alternative clinically validated Mercury free sphygmomanometers are available, so clinicians do still have a choice as to whether they use a manual method to record blood pressure with a stethoscope or an automatic device.

Manual devices, like the A&D UM-102A, are more tactile to use and can provide the clinician with additional useful information, like regularity or strength of pulse, provided they are used correctly and users have proper training.

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.

Meditech CardiUP!3 24 Hour Holter ECG introduced

January 2018 sees the official UK launch of the new Meditech CardiUP!3 Holter ECG.

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.

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

Is there still a need for Holter ECG recorders?

NICE clinical guideline Clinical guideline CG180  on Atrial Fibrillation management recommends the use of a 24‑hour ambulatory ECG monitor in patients with suspected asymptomatic episodes or symptomatic episodes less than 24 hours apart  or with suspected paroxysmal atrial fibrillation undetected by standard ECG recording.

What’s different with the CardiUP!3 Holter?

The latest generation CardiUp!3 from Meditech has a large internal memory which means it can record continuous digital full disclosure ECG from 24 hours or for up to 7 days using just 1 AA battery!

The large LCD screen displays real-time ECG which lets you verify ECG quality, ensuring accurate hook up in real time. Connection is by a new standard mini USB connection.

The CardiUP!3 has a manual programming option which means it can be programmed without connection to a PC. This can be useful if a PC is not available or a treatment room is occupied.

The Meditech CardioVisions analysis software supplied with the CardiUP!3 provides automatic beat-by-beat ECG, ST, PQ, QT and HRV analysis and includes pacemaker beat detection. The QRS detection algorithm of the software is 99.9% accurate according to the IEC 60601-2-47 International Standard and AHA and MIT databases and gives rapid automatic ECG annotation and analysis in minutes.

Running costs are minimised thanks to the latest low power electronic design techniques. The CardiUp!3 Holter uses just 1 AA Alkaline or rechargeable battery.

To find out more or to arrange a demonstration just call us on 01628 773233.

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.

 

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.

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.