Tag: Meditech ABPM-05

New NICE Hypertension Guideline NG136

NICE have today published their Hypertension in Adults guidance NG136 which replaces CG127.

This provides updated guidance on the diagnosis of hypertension and measuring blood pressure. Although there are some changes since 2011, the recommendation that ABPM should be used as a preferred method of diagnosis still stands. 

“Based on the evidence in the previous guideline and the committee’s experience and knowledge, it was agreed that ABPM remains the gold standard for the accurate measurement of blood pressure in primary care. ABPM has therefore been retained as the preferred method for the diagnosis of hypertension.” NG136 recommendations 1.2.1 to 1.2.5 &1.2.8

Although this recommendation was made in 2011 there is still a large variation in practice. NICE have suggested that new resources and training are needed. NG136 recommendations 1.2.1 to 1.2.5 &1.2.8

Meditech’s CardioVisions may be a solution to the training aspect. CardioVisions software works with both Meditech’s ABPM-04 and ABPM-05. Supplied by PMS Instruments it supports Windows 7, 8 &10 and is very easy to use. With colour coded trend graphs, flexible programming and data retrieval. Patient’s results are automatically classified from normal to stage 2 Hypertension.   

NICE NG136 also suggests that the initial cost of using ABPM’s is outweighed by the long term benefits of accurate diagnosis and subsequent treatment. NG136 recommendations 1.2.1 to1.2.5 &1.2.8

A new guide line is the recommendation of the use of ABPM for a patient with a clinic blood pressure reading of 140/90 to180/120 to confirm hypertension.

“If clinic blood pressure is between 140/90 mmHg and 180/120 mmHg, offer ambulatory blood pressure monitoring (ABPM) to confirm the diagnosis of hypertension”. NG136 1.2.3

In addition there is a recommendation for the use of ABPM for patients with white-coat effect Hypertension

“Consider ABPM or HBPM, in addition to clinic blood pressure measurements, for people with hypertension identified as having a white-coat effect or masked hypertension (in which clinic and non-clinic blood pressure results are conflicting).” NG136 1.4.18

Meditech are on the list of validated blood pressure monitoring devices provided on the British and Irish Hypertension Society’s website.

Why Buy A Clinically Validated Blood Pressure Monitor?

The sales team at PMS often get asked the same questions from customers wanting to purchase a blood pressure monitor. Questions like which one would you recommend and which is the best one we sell will depend on the features a user is looking for and their budget.

One question we are always happy to answer is “What does clinical validation mean?”

Many customers are familiar with the CE mark on consumer electrical items.

Medical devices like blood pressure monitors must also have a CE mark by law. The CE mark means that, provided you use it correctly, the device will work properly and is safe but doesn’t mean it will necessarily give accurate readings or that it is clinically validated.

Whether you are going to record your blood pressure at home or in a clinical setting surely accuracy is the whole point of buying a monitor in the first place!

When a manufacturer like Meditech or A&D Medical state their product is “clinically validated” it means an independent validation of the device has been performed by a professional group

The most common validation protocols are the British and Irish Hypertension Society (BIHS), formerly British Hypertension Society, the European Society of Hypertension International Protocol (ESH-IP), and the Association for the Advancement of Medical Instrumentation (AAMI).

While each of the protocols may have many similarities, there are some differences in their testing requirements. In many cases, however, a product that passes one protocol may also satisfy the criteria of other protocols as well. Recently, the AAMI, ESH, and ISO experts agreed to develop a single universally acceptable standard (AAMI/ESH/ISO), which will replace all previous protocols.

Often, the clinical validation report is published in a peer-reviewed journal like Blood Pressure Monitoring.  Publication in a peer-reviewed journal is essential because of the rigorous review processes a clinical validation must go through to make sure there are no protocol violations and the chosen validation protocol has been adhered to.

The time and conditions demanded by the various protocols are extremely difficult to fulfil as a large number of subjects have to be recruited, a wide range of blood pressures are required and it can be difficult to recruit skilled staff . They can also be expensive.

There is a great overview of the detailed process involved from the Working Group on Blood Pressure Monitoring of the European Society of Hypertension here.

For these reasons not every blood pressure manufacturer will conduct a clinical validation.

PMS Instruments only distribute blood pressure monitors from manufacturers that do. Clinical validation provides so much more than a CE mark!

Whether you are a healthcare professional, or someone looking to keep a check on their blood pressure at home a clinically validated blood pressure monitor from Meditech or A&D Medical gives you the confidence to know you’re using a reliable, accurate device to make a clinical decision.

A&D Medical clinical validation studies

Validation of the A&D UM-211 device for office blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010
Fania, Claudio; Albertini, Federica; Palatini, Paolo
Blood Pressure Monitoring, October 2017,22(5):302-305

Validation of the A&D UM-201 device for office blood pressure measurement according to the European Society of Hypertension International Protocol Revision 2010
Fania, Claudio; Albertini, Federica; Palatini, Paolo
Blood Pressure Monitoring, August 2017,22(4):234-237

Validation of the fully automated A&D TM-2656 blood pressure monitor according to the British Hypertension Society Protocol (equivalent to TM-2657P)
Zeng, Wei-Fang; Liu, Ming; Kang, Yuan-Yuan; Li, Yan; Wang, Ji-Guang
Blood Pressure Monitoring, August 2013,18(4):223-226

Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010
Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo
Blood Pressure Monitoring, June 2015,20(3):164-167

Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010
Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo
Blood Pressure Monitoring, February 2014,19(1):50-53

Validation of the A&D UA-1020 upper-arm blood pressure monitor with six different-shaped or different-sized cuffs according to the British Hypertension Society protocol
Zeng, Wei-Fang; Kang, Yuan-Yuan; Liu, Ming; Li, Yan; Wang, Ji-Guang
Blood Pressure Monitoring, October 2013,18(5):272-277

Validation of the A&D UA-1020 upper-arm blood pressure monitor for home blood pressure monitoring according to the British Hypertension Society Protocol
Zeng, Wei-Fang; Kang, Yuan-Yuan; Liu, Ming; Li, Yan; Wang, Ji-Guang
Blood Pressure Monitoring, June 2013,18(3):177-181

Validation of A&D UA-778 blood pressure monitor in children
Narogan, Marina V.; Narogan, Marina I.; Syutkina, Elena V.
Blood Pressure Monitoring, October 2009,14(5):228-231

Validation of A&D UA-85X device for blood pressure measurement
Bonso, Elisa; Ragazzo, Fabio; Palatini, Paolo
Blood Pressure Monitoring, December 2008,13(6):339-341

Validation of A&D TM-2430 upper-arm blood pressure monitor for ambulatory blood pressure monitoring in children and adolescents, according to the British Hypertension Society protocol
Yip, Gabriel Wai-Kwok; So, Hung-Kwan; Li, Albert Martin; Tomlinson, Brian; Wong, Sik-Nin; Sung, Rita Yn-Tz
Blood Pressure Monitoring, April 2012,17(2):76-79

Validation of the A&D UM-101 professional hybrid device for office blood pressure measurement according to the International Protocol
Stergiou, George S.; Giovas, Periklis P.; Gkinos, Charilaos P.; Tzamouranis, Dimitris G.
Blood Pressure Monitoring, February 2008,13(1):37-42

Meditech clinical studies

Reproducibility of 24-h ambulatory blood pressure and measures of autonomic function
Morrin, Niamh M.; Stone, Mark R.; Henderson, Keiran J.
Blood Pressure Monitoring, June 2017,22(3):169-172
Brief Report

Obstructive sleep apnea increases systolic and diastolic blood pressure variability in hypertensive patients
Shi, Jing; Piao, Jingyan; Liu, Bin; Pan, Yujiao; Gong, Yongtai; Deng, Xianzhu; Sun, Weiyan; Lu, Shuang; Li, Yue
Blood Pressure Monitoring, August 2017,22(4):208-212
Clinical Methods and Pathophysiology

The influence of physical training status on postexercise hypotension in patients with hypertension: a cross-sectional study
Imazu, Alexandre A.; Goessler, Karla F.; Casonatto, Juliano; Polito, Marcos D.
Blood Pressure Monitoring, August 2017,22(4):196-201
Clinical Methods and Pathophysiology

Clinical practice of ambulatory versus home blood pressure monitoring in hypertensive patients
Paolasso, Jorge A.; Crespo, Florencia; Arias, Viviana; Moreyra, Eduardo A.; Volmaro, Ariel; Orías, Marcelo; Moreyra, Eduardo Jr
Blood Pressure Monitoring, December 2015,20(6):303-309
Clinical Methods and Pathophysiology

The association of night-time systolic blood pressure with ultrasound markers of subclinical cardiac and vascular disease
O’Flynn, Anne Marie; Ho, Emily; Dolan, Eamon; Curtin, Ronan J.; Kearney, Patricia M.
Blood Pressure Monitoring, February 2017,22(1):18-26
Clinical Methods and Pathophysiology

Myocardial ischemia during everyday life in patients with arterial hypertension: prevalence, risk factors, triggering mechanism and circadian variability
Uen, Sakir; Un, Ismail; Fimmers, Rolf; Vetter, Hans; Mengden, Thomas
Blood Pressure Monitoring, August 2006,11(4):173-182

Development of normative ambulatory blood pressure data in children: Marianne Soergel and the Arbeitsgruppe Pädiatrische Hypertonie
Blood Pressure Monitoring, June-August 1999,4(3):121-126

Making ambulatory blood pressure monitoring accessible in pharmacies
James, Kirstyn; Dolan, Eamon; O’Brien, Eoin
Blood Pressure Monitoring, June 2014,19(3):134-139

Simultaneous recording of blood pressure and ST-segment with combined, triggered ambulatory 24-h devices
Uen, Sakir; Vetter, Hans; Mengden, Thomas
Blood Pressure Monitoring, February 2003,8(1):41-44

Silent myocardial ischaemia in treated hypertensives with and without left ventricular hypertrophy
Stojanovic, Milos M.; O’Brien, Eoin; Lyons, Simon; Stanton, Alice V.
Blood Pressure Monitoring, February 2003,8(1):45-51

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.

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”

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.

PMS algorithm for blood pressure measurement

The CG127 2011 NICE Hypertension guidelines includes generic guidance on the measurement of blood pressure, including the key recommendation that 24 hour ambulatory blood pressure measurement be used before anti-hypertensive treatment is initiated. However out of the entire 317 page document, there is only one 6 page section on measuring blood pressure.

This section focuses on the different ways and methods of measuring blood pressure and the different types of devices available. The question is could the selection of the latest devices       streamline the blood pressure measurement process and save time, as well as clinical resources?

Is there a case for developing a suggested PMS algorithm for blood pressure measurement and what form should this take?

Step One Use a Waiting Room BP Monitor

Monitors like the TM-2655P waiting room monitor for patient self-measurement have been available for some time. They are convenient, easy to use and cost effective. They can be effective opportunistic screening devices and may identify patients with undiagnosed Hypertension.

Many also provide additional clinical information such as whether an Irregular Heartbeat is present. Many GP practices utilize them as part of a drop in service as they allow patients to monitor their own BP without making an appointment. This frees up clinicians for other duties. As with any BP monitor, it is important to check the monitor is listed on the BHS web site (www.bhsoc.org). Monitors that measure from the upper arm are recommended.

Step 2 Confirmation with a manual measurement

If it is felt that a reading from a waiting room blood pressure monitor needs clarification, an additional measurement should be taken. The BHS provide “best practice” guidance on the correct way to record blood pressure using an automatic or manual device. Most clinicians will rely on a clinically validated automatic monitor.

Most of these low cost devices like the UA-1010 feature an irregular heartbeat indicator and some have a “Tricheck” feature, which will automatically repeat a measurement three times, in accordance with BHS recommendations.

For patients identified with an irregular heartbeat, non-Mercury manual devices like the UM-101 are available.

Step 3 Use ABPM – The Gold Standard

The cost of ambulatory blood pressure monitors has fallen considerably over the last few years.  Like spirometers and ECG machines, the latest models such as the Meditech ABPM-05 feature software that provides automatic analysis of the results for consistent, time saving reporting to NICE Guidelines.