Improving the AF clinical pathway with the Kardia Mobile

Clinical Background

1.4 million people in the UK have atrial fibrillation; that’s 2.4% of the population. It’s known that in the 45 – 65 age group over 80% of people will suffer from the condition.

Public Health England (PHE) believes almost half a million people with AF remain undiagnosed. AF is known to be a direct cause of a third of all strokes and consequently 2,000 premature deaths per year. Early diagnosis could help avoid this.

AF and AF-related illness costs the National Health Service over £2.2 billion annually – a cost that is expected to rise as the incidence of AF increases due to the ageing population.

Current Clinical Pathway

The current clinical pathway varies according to each GP surgery and CCG but generally it can be a lengthy and costly process to achieve a definitive diagnosis.

The process typically begins with a manual pulse check and then auscultation, a 5 or 12 lead ECG in the surgery is followed by a 24 hour ECG tape or seven day Holter recording which then has to be analysed. With a positive (or indecisive) test, the patient is then referred to a cardiologist. If a diagnosis of AF is confirmed, the patient is then referred back to the GP for anticoagulant therapy.

PHE estimates that 2,000,000 people in the UK have Atrial Fibrillation and that the cost per patient using the current pathway is £1,305 without interventional procedures. This includes three GP visits, 12 lead ECG and Holter recordings, and outpatient costs.

The cost reduction achieved by using Kardia Mobile is significant. Assuming the patient requires two GP visits and a Kardia Mobile is provided for each patient, the cost is £189 rising to £352 if a patient is also sent for a 12 lead ECG. The minimum saving is therefore in the region of £950 per patient.

The cost to the NHS of screening the population with the current pathway is prohibitive. Kardia Mobile makes it possible.

Cost £ Of Current Pathway

First GP visit (incl. ECG test) £81
Outpatients £230
24 hr ECG £163
7 day Holter test £163
Outpatients and decision £230
Implantable loop recorder (ILP) £4021-£4556
Second GP visit £45
Total £1305 with ILR £5861

Cost £ When Using Kardia Mobile

First GP visit (incl. ECG test) £81
GP Supplies Kardia Mobile £99
Second GP visit £81
Total £189

Therefore using the AliveCor Kardia Mobile is a faster, simpler and more effective pathway.

Added Benefits. Early diagnosis of AF in 30 seconds

 In surgery, the GP or the nurse can use the Kardia Mobile for a quick check when a patient presents with palpitations, fast heart rate or irregular rhythm.

The presence of AF can be immediately identified. Due to its simplicity, speed of use and low cost, Kardia Mobile can routinely be used to screen patients for AF and become part of the protocol for health checks in key age groups.

It can also be used to screen newly registered patients, in the well woman/well man NHS health checks and to form part of the routine in flu clinics.

As AF may be transient in nature, a test in the GP’s surgery may still not reveal the presence of the condition. A doctor can then issue a Kardia device to the patient for home use to make a recording when he or she experiences symptoms.

Kardia Mobile will also provide a simple ECG rhythm strip recording with heart rate when used during home visits.

The Cost/Benefit Analysis Of Using The Kardia Includes

  •  Reduction in the number of ECG tests, 24 hour tapes and 7 day Holter recordings.
  • Reduction in the number of GP appointments and outpatient appointments.
  • Savings to the NHS through early diagnosis of AF and prevention of stroke.

Why Is There A Need For The Systoe Toe Pressure Measurement System?

Clinical situation

Peripheral arterial disease (PAD) is when the arteries, in this case, to the legs, become fully or partially blocked. This blockage most commonly occurs due to atherosclerotic (cholesterol) plaques.

Arterial blood brings oxygen and nutrients to the muscles of the legs, and when blocked may result in pain in the legs, also called intermittent claudication. Intermittent claudication is typically described as pain in the patient’s calf after walking a distance that goes away when the patient rests.

In advanced peripheral arterial disease, the patient may have pain in the legs at rest, and may develop leg ulcers and gangrene.

When a patient is first seen and suspected of having PAD, the underlying diagnosis is usually not difficult if a proper history and physical examination is performed.

For this purpose the Ankle brachial index (ankle systolic pressure/brachial systolic pressure) is usually measured.


Why is there a need for the Systoe?

Limitations of Ankle Brachial Index (ABI)

In the case of diabetic patients, old patients and renal failure patients, medial calcification (deposit of calcium on the middle part of the artery wall) of the tibial/peroneal arteries may prevent the measurement of the ABI pressure.

ABI measurement is impossible in

  • 15 %  of diabetic patients at the time of the diagnosis.
  • 20 % of the diabetic patient present a PAD
  • 30 % after 15 years

Weitz et al. Circulation. 1996; 94: 3026-3049

As the toe arteries are affected by medial calcification later than the leg arteries, the toe systolic pressure can be measured to circumvent the problem of medial calcification of the tibial/peroneal arteries. Toe pressures are a clinical indicator. For clinical purposes a normal Toe brachial Index (TBI = toe systolic pressure/brachial systolic pressure) is considered to be higher than 0.7

For any value less than that, the patient will be found to have some occlusive disease proximal to the recording site.

A major advantage of TBI is its use following the progress of disease and after any form of intervention.

The Atys SysToe can also be used in the following circumstances

  • Triage patients before referral to vascular specialist
  • Opportunistic Screening and follow up after intervention
  • Wound and Ulcer healing

The Atys SysToe is a fully automatic clinically validated device that gives consistent readings which are not operator dependent. Using the SysToe clinicians can quickly determine whether a patient does or doesn’t have PAD without necessarily referring to a specialist Ultrasound Dept saving time and money

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

The twenty year wait has been worth it!

The new A&D Medical TM-2440 and TM-2441 Ambulatory Blood Pressure Monitors are now available to pre-order from lead distributor PMS Instruments. They replace the old TM-2430 which PMS originally introduced in 1998.

Engineered in Japan, they are the 4th generation of A&D ABPM monitor PMS Instruments have launched in the UK and easily the most advanced to date. Both new models have a number of new innovative premium features.

With the launch of 2 new ABPM monitors at once the twenty year wait has been worth it!

The A&D TM-2440 Classic abpm comes as standard with fast measurement time, silent operation and with a world first in an A&D ABPM, IHB (Irregular Heart Beat) analysis technology.

This ground breaking technology pioneered by A&D in 2001 is now used worldwide assisting in the opportunistic detection of arrhythmias – which include AFib (or Atrial Fibrillation). It features Oscillometric waveform measurement analysis and with the new analysis software you can check the waveform record for each measurement.

The TM-2441 Premium ABPM with it’s all in one design concept offers the clinician and patient complete flexibility, providing Ambulatory (ABPM), Home (HBPM), Office (OBP), Automatic Night Blood Pressure (ANBP), and Automatic Self Blood Pressure (ASBP) measurement/monitoring in one device.

In addition to the Irregular Heart Beat analysis technology, it records environmental factors including Activity using a built in Accelerometer, Temperature and Air Pressure. The new TM-2441 provides additional more insightful view of the patient beyond just blood pressure recording and heart rate information – helping build a better picture for clinical decision making.

Both models for the first time are available with 4 different cuff sizes small, adult, large adult and extra-large adult with sizes fitting an arm circumference from 15-22cm right up to 36-50cm.

The new AND Analysis software allows PDF reports to be exported to popular clinical management systems like EMIS and SystmOne and is compatible with the old TM-2430.

The TM-2440/TM-2441 feature both USB and Bluetooth communication, use just 2 AA batteries and at just 120g, the TM-2440 is one of the smallest, lightest ABPM monitors on the market.

To discuss competitive upgrades or arrange a demonstration or trial call us today.

CardXplore your mini cardiology lab

The Meditech CardXplore is a combined 24hr ABPM and Holter ECG recorder.

It is a multifunctional device and can be used just as an ABPM, an ECG Holter monitor or ABPM and ECG combined. It features automatic beat by beat analysis and automatic report generation. CardXplore provides an analysis of the relationship between hypertension and cardiovascular disease.

As hypertension is the most common risk factor for cardiovascular diseases, it is important to assess blood pressure and ECG data at the same time. CardXplore combines 24-hour blood pressure monitoring with Holter ECG recording and actigraphy.

Hokanson Rapid Inflation System

Unfortunately Hokanson recently chose not to renew the CE mark and end distribution of Class I electronic instruments to the European Market. The list of instruments that are no longer available for sale to the EU are:

  • AG101 Air Source
  • AI6 Arterial Inflow System
  • EC6 Strain Gauge & Photo Plethysmograph
  • E20 Rapid Cuff Inflator
  • MD6RP Photo Plethysmograph
  • MD6VR Chart Recorder

Regrettably due to this action we are no longer able to sell the above products in the UK although service and support remains available for the expected lifetime of each product. Replacement parts such as transducers, hoses and batteries will also remain available. Vascular cuffs and aneroid sphygmomanometers are still available for purchase and distribution for UK customers so orders for those products will be processed as usual.

Ideal Professional BP Package

Up until now many Hospitals and GP Practices have purchased low cost digital blood pressure monitors designed originally for home or retail use. As good as some of these monitors are they are not necessarily designed for repeated use on a daily basis or designed to stand up to the rigours of Hospital or Primary Care use.

Monitors in these environments can be subjected to drops and knocks associated with a busy ward or unit.

Expensive vital signs type monitors are available but with extra features not necessarily needed by all.

The A&D Medical UM-201 aims to sit somewhere between these two camps and is aimed at the clinician looking for simple one button operation, accurate readings, cost effectiveness whilst anticipating heavy daily use. It concentrates on features customers actually want, like a large LCD display, long cuff tube, fast measurement times and simple one button operation.

The durable and chemical resistant body and cuffs are easy to clean and disinfect with common antiseptic agents and the low whole life running costs make this suitable for the Hospital environment. The UM-201 features A&D’s latest Electronic Constant Exhaust Valve (ECEV) for enhanced measurement accuracy as well as Irregular Heartbeat Detection (IHB) technology.

We recently introduced a UM-201 Pro package which includes a small (16-24 cm), adult (22-32cm) and large (31-45cm) cuffs as well as a mains adaptor. At £99 it is proving a popular package and for most the complete professional blood pressure solution.

 

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.