Title

Home A

Presented By:

Edward Gammans

Value of WatchBP

Microlife

 World’s Largest Manufacturer of Non Contact Thermometers

(Brands include J & J and Calpol)

 World’s 2 nd Largest Manufacturer of Blood Pressure Monitors

 Presence in over 180 Countries World Wide

 WatchBP Range 2 Years ahead of the competition

© 2011All Rights Reserved. No copy and distribution without permission

*Approximate Figures

Value of WatchBP

Validations

 Safe Study / Trial

(Compared Pulse – ECG in Primary Care) *

GP’s Results were Sensitivity 80% - Specificity 92%

PN’s Results were Sensitivity 77% - Specificity 85%

Overall Results were Sensitivity 78% - Specificity 88%

 Wiesel

(New York - ISH)

**

Results were Sensitivity 97% - Specificity 89%

Stergiou

(Athens - ESH)

***

Results were Sensitivity 100% - Specificity 89%

Overall Results were Sensitivity 97-100% - Specificity 89%

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(Wiesel, 2004)

(Stergiou, 2009)

(Wiesel, 2009)

(Marazzi, 2011)

Results clinical studies

Patients

450

72

405

503

Readings used

1

2

1

2

3

1

3

3

Readings needed for diagnosis

1

2

1

1

2

1

3

3

Sensitivity

(95% CI)

1

1

Specificity

(95% CI)

0.84

0.92

0.93 (0.74–0.99) 0.89 (0.76–0.96)

1 (0.84-1.00) 0.76 (0.60–0.87)

1.00 (0.84–1.00) 0.89 (0.75–0.96)

0.95 (0.93-0.98)

0.97 (0.91-0.99)

0.92

0.86 (0.84-0.89)

0.89 (0.85-0.92)

0.97

Device compared with 12-lead ECG performed and read by a consultant

Results pulse palpation

AF+100 AF- 89

Hobbs et al. Health Technology Assessment 2005; Vol. 9: No. 40

Example WatchBP vs. Pulse palpation

• GP population 10M of ≥ 55y, AF prevalence of 4.4%

ECG

AF+ AFpp

(87,81%) AF+

AF-

382.800

57.200

1.816.400

7.743.600

WatchBP

(100, 89%)

With WatchBP:

AF+

AF-

AF+

440.000

0

AF-

1.051.600

8.508.400

57,200 AF patients more diagnosed

764,800 patients less false positives

Pulse palpation

Liable to observer bias

• Dependent of GP’s/nurses who know the guidelines

• Dependent of GP’s/nurses who adhere to the guidelines

Home vs. GP’s practice

Home screening

A Patient with AF has 35% chance of getting stroke (4% per year)

Visit to the GP

Time (yrs)

Task Force for the Management of Atrial Fibrillation of the European

Society of Cardiology (ESC). Europace 2010;12:1360-1420.

One Measurement = No Measurement

Untreated (540)

Systolic

175

170

165

160

140

0

• 5 mmHg

• 7 mmHg

1 2

Meting

3

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Value of WatchBP

Pathway

 GP Surgery:

Normal Blood pressure check

If Afib Symbol appears – 3/3 Will confirm AF

Any uncertainty then the patient should be sent home with a device to perform a 7 day diagnostic programme.

 Home:

This is also advised if the patient complains of symptoms that are undiagnosed - chest pains, dizziness, falling over and when asymptomatic paroxysmal AF is expected.

This would result in approx 28 readings – the equivalent of 28 visits to the clinician

NB: If the patient is feeling unwell at a specific time during the day they can also perform a one of measurement on casual mode.

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Value of WatchBP

Nice Guidelines

(New Guidelines to be published in Sept 2011)

 BHS are represented at both the ESH and the ISH

 NICE makes recommendations to the NHS on blood pressure monitoring Via the BHS:

 WatchBP Home is the only device with the new Guidelines built in “Patented” is the only device that has been proved that it can detect AF and has been Validated

“Patented”

Is one of only device validated for use in End Stage Renal Disease (ERD) pregnancy – preeclampsia

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Value of WatchBP

Benefit of WatchBP Home A

NICE:

Medical technology guidance: WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension.

Issue date: January 2013 – Hypertension Revised Sept 2013 http://guidance.nice.org.uk/MT/InDevelopment http://guidance.nice.org.uk/MT/145

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1 Recommendations

1.1 The case for adopting WatchBP Home A in the NHS, for opportunistically detecting asymptomatic atrial fibrillation during the measurement of blood pressure by primary care professionals, is supported by the evidence.

The available evidence suggests that the device reliably detects atrial fibrillation and may increase the rate of detection when used in primary care. This would allow prophylactic treatment to be given to reduce the incidence of atrial fibrillation-related stroke.

WatchBP Home A should be considered for use in people with suspected hypertension and those being screened or monitored for hypertension, in primary care.

1.2 People suspected of having atrial fibrillation after use of WatchBP

Home A should have an electrocardiogram (ECG) in line with NICE clinical guideline 36, Atrial fibrillation.

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1 Recommendations

1.3 Use of WatchBP Home A in primary care is associated with estimated overall cost savings per person measured, ranging from

£2.98 for those aged between 65 and 74 years to £4.26 for those aged 75 years and over.

There is uncertainty about the costs and benefits for people younger than 65, however it is plausible that using the device in this group will benefit patients and the healthcare system.

As well as cost savings Fatal Strokes that could be prevented per

100,000 screened could be as many as 182, in age groups 65 years

& 75 years were 53 –117 (average 85) and Non Fatal Strokes prevented per 100,000 screened in age groups 65 years & 75 were 28

– 65 (average 47).

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Results from primary care practice

In order to obtain more evidence with regard to the clinical evidence of the WatchBP device with Afib detection a clinical study has been performed on behalf of NICE.

In the Hull area (UK) 80 devices were distributed among 15 GP practices. After 6 months 288.000 (of which 54.000 (19%) with the

WatchBP Home) GP patients were screened for AF. This led to 160 newly identified Afib patients of whom 71 patients (44%) were detected with the WatchBP Home. This means that 44% of all newly detected Afib patients were found by only 19% of all GP’s

Results from clinical practice showed that GP’s who used WatchBP detected over 3 times as many patients with Afib as GP’s who used the conventional method

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200

150

100

50

0

400

350

300

250

Extrapolating these figures to routine clinical practice showed that

373 patients with Afib would be detected if all GP’s in the Hull area would have used WatchBP for routine clinical blood pressure measurement. This amount is significantly (3.4 times) more than when all GP’s would only rely on wrist palpation as this would result in 109 newly detected patients with AF. From this example from real clinical practice it was shown that using the WatchBP home would lead to an increase in Afib detection by 240%.

1/2 year screening in GP practice

274

WatchBP home A Pulse Palpation

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Value of WatchBP

WatchBP Home A

 Download Software.

Free Software is available on our web-site which is continually up-dated .

www.watchbp.co.uk

Support

Software

Home WatchBP Home Analyzer

© 2011All Rights Reserved. No copy and distribution without permission

Patient information Leaflets

Endorsed by all the major UK Charities

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Device RRP

Mains

Adaptor Single Measurement

3 Consecutive

Measurements

BHS / NHS

Embedded

Guidelines AF Detection PC Link & Free software

Home A £90 £20

Home £70 £20

Home S £60 £20

Yes

Yes

Yes

Yes

No

Yes

Yes

Yes

No

Yes

No

Yes

Yes

Yes

No

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Value of WatchBP

References:

*Jonathan Mant, David A Fitzmaurice, F D Richard Hobbs,

Sue Jowett, Ellen T Murray, Roger Holder, Michael Davies and Gregory Y H Lip

** Joseph Wiesel, Lorenzo Fitzig, Yehuda Herschman and

Frank C. Messineo

*** GS Stergiou, N Karpettas, A Protogerou, EG Nasothimiou and M Kyriakidis Hypertension Center, Third University

Department of Medicine, Sotiria Hospital, Athens, Greece

© 2011All Rights Reserved. No copy and distribution without permission

Value of WatchBP

I thank you for your time

Edward Gammans

© 2011All Rights Reserved. No copy and distribution without permission