KardiaMobile 6L NICE Draft Guidance

Last month NICE published first draft guidance from its Early Value Assessment pilot project recommending smartphone-linked ECG devices.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This guidance has been updated and replaced by NICE medical technologies guidance 64 published 6th January 2022.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.

Is 24 Hour ABPM Still An Indispensable Tool In The Management Of Hypertension?

Ambulatory Blood Pressure Measurement (ABPM) has been used increasingly in clinical practice over the last 30 years. With the rise and adoption of low cost home blood pressure monitoring is it still an indispensable tool in the management of hypertensives in General Practice?

I first asked this question in an article I wrote for Practice Management magazine in 2010. I concluded that it was but in the intervening years is this still the case?

In the light of clinical developments and the publication of guidelines like NICE Guideline CG127 on Hypertension in 2011 and latest update in November 2016 is it still relevant?

Some background

In recognition of the importance of ABPM, the British Hypertension Society (now the British and Irish Hypertension Society), the European Society of Hypertension and NICE CG127 have all published guidelines for the use and interpretation of ABPM in clinical practice.

Traditionally, hypertensive patients had been assessed using clinic based blood pressure readings by a Nurse or Doctor. This changed in 2011 and recognition was formally given to the importance of using 24 hour ABPM monitoring.

The old “snapshot” approach to blood pressure measurement could give inconsistencies and over-estimate a patient’s blood pressure by anything up to 30mmHg.

The so called White Coat Hypertension, leading to elevated blood pressure is well documented and can lead to unnecessary prescription of hypertensive medicines. This has a profound clinical and financial relevance to Primary Care and can lead to inappropriate diagnosis and treatment. Ambulatory Blood Pressure Monitors provide much more consistent readings over a 24-hour period and give multiple measurements throughout the day and night.

CardioVisions NICE Software keeps it simple.

Modern ABPM software can produce a plethora of statistics and data which even for experienced clinicians can be overwhelming.

As a response to this and in view of the 2011 NICE guidelines we introduced our CardioVisions NICE software. This provided a meaningful textual analysis ensuring clinicians got reporting continuity to a recognised clinical standard as well as importantly saving Doctor and Nurse time. It’s compatible with the Meditech ABPMs and a typical report may read something like this.

“The ABPM was worn by the patient for 24 hours. During this period the average daytime blood pressure was 169/118 and the pulse rate was 88 beats per minute. According to NICE guidelines the patient exhibits stage 2 hypertension. The examination was divided into day 06:00-22:00, night 22:00-06:00. 64 successful readings were taken during the daytime period and the NICE key quality requirement for 14 has been met. During the daytime there were 64 readings (100.0%) above the NICE guideline figure of 135/85. The highest reading was 202/134 recorded at 9:15 22/05/1997. During the night time period 24 successful readings were taken and the average blood pressure was 135/87.”

The detailed stats, graphs and readings are still there for those that want them but the textual analysis summary can be copied and pasted into the patient notes and also attached to popular clinical management systems like EMIS Web and SystmOne. There is no annual licence fee and multiple copies can be installed.

What about home blood pressure monitoring?

The cost of clinically validated home blood pressure monitors has fallen since 2010 and a number of GP Practices have been loaning monitors like the UA-767S-W to patients. Home monitoring is great for the small number of patients that find ambulatory blood pressure monitoring inconvenient or difficult tolerate but it’s not ideal for everyone and can be difficult to manage in practice.

For home blood pressure monitoring NICE recommend patients should measure their blood pressure twice a day, ideally once in the morning and once in the evening, while sitting down. Each time they do this, they should take two readings, 1 minute apart. They should continue to measure their blood pressure twice daily for at least 4 days and ideally for 7 days. Some patients may find this onerous and patient compliance can vary. A 24 hour monitor is only worn for 24 hours!

All the measurements taken after the first day are used to work out average day time blood pressure but again this can be time consuming and may be subject to error.

Whilst home blood pressure monitoring gives multiple readings, it relies on proper patient technique, patient training and compliance for up to seven days to give meaningful results.

As a complementary technique to 24 hour ABPM it can be useful to monitor patients with long term chronic conditions such as diabetes and coronary heart disease.

On the flip side the detail, automatic analysis and reporting, 24 hour ABPM provides with very little user or patient input just isn’t available with home blood pressure monitoring.

Night time readings cannot be recorded and for many 24 hour ABPM remains the “Gold Standard”.

So why doesn’t everyone use 24 hour ABPM?

For some the initial cost is off putting but the cost of 24 hour ABPM monitors has fallen since 2010.

The latest 24 hour BP monitors like the Meditech ABPM-04 and ABPM-05 are reliable with low running costs, long warranties and a low overall cost of ownership.

PMS Instruments now offer a flexible rental ABPM service which means cost can be spread over several months and for a low monthly fee service and calibration is covered.

“Is 24 Hour ABPM Still An Indispensable Tool In Management Of Hypertension?” my answer would still be yes.

To arrange a free trial of one of our latest ABPM monitors and find out for yourself please contact us on 01628 773233.

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.

24/7 ABPM Guidelines Revisited

NICE clinical guideline 127 states that ABPM monitoring is the most accurate method for confirming a diagnosis of hypertension, and its use should reduce unnecessary treatment in people who do not have true hypertension. Originally published in 2013 it was updated in September 2015.

In a recent review with our technical support team I asked them what were the practical questions they were most frequently asked about the guideline and ABPM in general.

I thought I would share the results on our Blog as they may be of interest to other ABPM customers. In no particular order this is what they told me.

Continue reading “24/7 ABPM Guidelines Revisited”