Venice brochure 4013

GOOD NEWS FOR YOUR HEART

Microlife AFIB technology

Atrial Fibrillation An innovative technology for the early detection of Atrial Fibrillation

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Table of Contents What is Atrial Fibrillation? ..................................................................................................1 The importance of Atrial Fibrillation screening for STROKE prevention............................1 AFIB Patented Technology for the early detection of Atrial Fibrillation............................1 What are benefits of AFIB screening? ...............................................................................2 Collaborations & endorsement ............................................................................................3 Evidence-based and clinically-validated AFIB detection technology.........................5 Experience from Practice.......................................................................................................8

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MICROLIFE AFIB TECHNOLOGYTHE NEW TECHNOLOGY FOR

What is Atrial Fibrillation?

AFIB Patented Technology for the early detection of Atrial Fibrillation

Atrial fibrillation (AFIB) is the most common cardiac arrhythmia. It affects over one percent of the general population and is related 15 to 20% of all strokes. AFIB-related strokes are more severe than those not related to AFIB; associated with an increased likelihood of permanent disability and greater short-and long-term mortality. Costs of AF-related strokes could be at least â‚Ź10 billion in Europe and $5 billion in the US each year causing a major burden to healthcare.

The importance of Atrial Fibrillation (AFIB) screening for STROKE prevention

New technology patented by Microlife allows simultaneous blood pressure measurement and AFIB screening. The AFIB technology entails an algorithm that calculates the irregularity index (standard deviation divided by mean) based on interval times between heartbeats. If the irregularity index exceeds a defined threshold value, AFIB is likely present and an AFIB icon is displayed on the device5. The AFIB technology is very accurate as is demonstrated in several clinical studies3. Microlife AFIB technology detects AFIB with a high sensitivity (97-100%) and specificity (89%), as compared with ECG, and therefore can be used as a reliable screening test for early diagnosis.

Atrial fibrillation (AFIB) is the number one cause of stroke1. The risk of stroke in people affected with AFIB is three to five times higher than that of a healthy population1. AFIB is often asymptomatic, and around 30% of AFIB patients are diagnosed incidentally when hospitalized for other reasons2, including stroke3. Evidence is accumulating for more effective primary and secondary prevention strategies and better recognition of people at highest risk4. Screening and early detection of AFIB enables initiation of an appropriate treatment to reduce thromboembolic risk, reducing the risk of cardiovascular disease and stroke, along with associated complications5. Early detection of AFIB can reduce the number one cause of strokes by 68%.

1

Number of Patients

Age (Years)

Hypertensive Patient

Diabetic Patient

Cardiac patient

Sensitivity (%)

(%)

Stergiou6

72

49-92

63%

15%

40%

100

89

Wiesel7

405

34-98

52%

15%

44%

97

89

ATRIAL FIBRILLATION SCREENING

GOOD NEWS FOR YOUR HEART What are benefits of AFIB screening?

1. Early detection of AFIB to prevent Stroke AFIB itself is not life threatening. If left untreated, however, the side effects of AFIB can be life threatening, leading to stroke. Microlife AFIB technology helps to deliver an innovative and effective stroke prevention program by detecting atrial fibrillation at an early stage.

2. Cost-saving and economic benefit for health care systems According to findings of the NICE committee, based on economical analysis of available evidence, use of WatchBP Home A in primary care is associated with estimated overall cost savings8. NICE estimates it could save the NHS £26 million a year in the UK for direct health care14.

Age

Cost savings per patient screened Strokes (fatal) saved per 100.000 screened

65-74

75+

£2.98 ($4.77)

£4.26 ($6,82)

53 (28)

117(65)

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MICROLIFE AFIB TECHNOLOGYTHE NEW TECHNOLOGY FOR

Collaborations & endorsement

United Kingdom Microlife WatchBP Home A received NICE guidance8 Since January 2013 the WatchBP Home A Blood Pressure Monitor is recommended by the National Institute for Health and Care Excellence (NICE).

NICE supports the use of the device in the NHS for “opportunistically detecting asymptomatic AFIB during the measurement of blood pressure by primary care professionals”.

The available evidence suggests that the WatchBP Home A reliably detects AFIB and may increase AFIB detection when used in primary care. NICE recommend WatchBP Home A should be considered for use in people with suspected hypertension and those being screened or monitored for hypertension, in primary care. People suspected of having AFIB after use of WatchBP Home A should have an ECG to confirm the diagnosis.

Results from primary care practice “Using the WatchBP Home A device has enabled one Clinical Commissioning Group (CCG) to identify 72 new patients with AFIB. Another CCG reported that in the first three months, 50 new AFIB cases were identified”

Publicity

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ATRIAL FIBRILLATION SCREENING

GOOD NEWS FOR YOUR HEART

Italy Guidelines of the Società Italiana di Medicina Generale (SIMG) recommend using AFIB for both clinical and home blood pressure measurement13

(P11~P14)

CONCLUSION “ Due to increasing use of automated blood pressure monitors in clinical practice doctors rarely verify the presence of cardiac arrhythmias by mean of pulse palpation or auscultation. For this reason it is considered of vital importance to use an automated blood pressure monitor with a validated algorithm that can detect the presence of atrial fibrillation.”

“ The increasingly widespread of home blood pressure monitors for self-measurement should induce similar consideration in particular, for those patients at increased risk of having AFIB. Patients who have a device with implemented AFIB detector should be well-instructed what to do in case an AFIB signal appears.”

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MICROLIFE AFIB TECHNOLOGY

THE NEW TECHNOLOGY

Evidence-based and clinically-validated AFIB detection technology Microlife automated blood pressure monitor with implemented AFIB detection system has been validated for its high sensitivity and specificity, and has proven to be a useful tool for early diagnosis of AFIB.

What is the best way to screen for atrial fibrillation in primary care?

A comparison of the accuracy of 3 methods: nurse pulse palpation, a hand-held ECG, and a modified BP monitor 9 A randomized clinical trial The Oxford university compared the feasibility and operating characteristics of the Microlife WatchBP Home A monitor and hand-held single-lead ECG systems with pulse palpation to detect AFIB. Results showed that the WatchBP Home A is most suitable for AFIB screening in primary care.

CONCLUSION “The modified BP flash indicator also has high specificity, leading to a follow on 12 lead ECG rate of around 10%, which is feasible in routine care. It outperforms pulse palpation and can be incorporated into routine blood pressure monitoring, either by the patient or the clinic.� 9

Screening for Asymptomatic Atrial Fibrillation While Monitoring the Blood Pressure at Home: Trial of Regular versus Irregular Pulse for Prevention of Stroke 10

CONCLUSION "Home screening for asymptomatic AF while taking BP measurements can be performed accurately. This can be used to detect new AF, allowing treatment with anticoagulation to reduce the future risk for stroke" 10

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AL FIBRILLATION SCREENING

GOOD NEWS FOR YOUR HEART

Accuracy of oscillometric blood pressure monitors for the detection of atrial fibrillation: a systematic review 11

CONCLUSION "Direct comparison against a 12-lead ECG showed that the highest sensitivity, 97% (95% CI: 94–100%), for detecting AF was obtained when three readings were assessed with two or three AF-positive readings. The highest specificity (97%) was obtained when performing three measurements, of which all three must be AF positive. The modified BP monitor (Microlife Corporation, Taipei, Taiwan) has high potential in improving AF screening" 11

Diagnostic accuracy of a home blood pressure on it or to detect atrial fibrillation 6

CONCLUSION "These data suggest that an electronic device for self-home BP monitoring, which implements an algorithm for AF diagnosis has an excellent diagnostic accuracy and might, therefore, be used as a reliable screening test for the early diagnosis" 6

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MICROLIFE AFIB TECHNOLOGY

THE NEW TECHNOLOGY

Detection of Atrial Fibrillation Using a Modified Microlife Blood Pressure Monitor 7

CONCLUSION "This device is able to detect AF with high sensitivity and specificity. Use of this device by patients who monitor their blood pressure at home may help detect asymptomatic AF and allow for treatment prior to the development of a stroke" 7

Switching from traditional to automatic sphygmomanometer increases opportunistic detection of atrial fibrillation in hypertensive patients 12

CONCLUSION “our data show that switching from the traditional device to an automatic device with algorithm for irregular heart beat detection increases the identification rate of previously unknown AF in hypertensive population� 12

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AL FIBRILLATION SCREENING

GOOD NEWS FOR YOUR HEART Experience from Practice The Microlife automated blood pressure monitor with implemented AFIB detection system has been validated for its high sensitivity and specificity, and proven a useful tool for early diagnosis of AFIB.

Implementation of the WatchBP Home A device in the North Hull area (UK)

Introduction: Results On the first 6 months of implementation of the WatchBP Home A device: 1. AFIB prevalence had increased from 1.17% to 1.22%.

2. The prevalence of newly identified AF had doubled (from 0.4% to 0.8%) as compared to previous 6 months within the GP's practices that used the WatchBP Home A. For More information, please access the link below: http://www.nice.org.uk/usingguidance/sharedlearningimplementingniceguidance/examplesofimplementation/eximpresults.jsp?o=620

Erewash Clinical Commissioning Group, Derbyshire

Introduction: The AFIB Detection Program was launched at the Quest event on 13th June. This presented the case for the AFIB Detection Program, launched the program and trained the practice staff on use of the new BP machines.

Results • Modeling of the impact of the AFIB Detection Program to date, 8 strokes will have been prevented of which 2 or 3 would have been fatal.

• The saving in avoiding a stroke is £18,000 in NHS costs. A reduction of 8 strokes per annum in Erewash would save £144,000. The scheme will result in cost savings to the NHS and social care in both the short and long-term.

For More information, please access the link below: http://www.atrialfibrillation.org.uk/files/file/Clinicians%20Area/130408-sh-2-Erewash%20case%20study.pdf

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References 1. Camm, A. J., et. al., Guidelines for the management of atrial fibrillation: The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). European Heart Journal. 2010. 31 (19): 2369-2429.

2. Price Waterhouse Coopers, The Economic Costs of Atrial Fibrillation in Australia. 2010.

3. Dewar RI, Lip GY, Guidelines Development Group for the NICE clinical guideline for the management of atrial fibrillation. Identification, diagnosis and assessment of atrial fibrillation. Heart 2007; 93:25–8.

4. National Institute for Health and Clinical Excellence (NICE), NICE Clinical Guideline 68: Stroke. 2008.

5. NHS Technology Adoption Centre, Microlife Home A Adoption Pack. 2013.

6. Stergiou, G.S., et. al., Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation. J Hum Hypertens. 2009. 23: 654-8.

7. Wiesel, J., et. al., Detection of atrial fibrillation using a modified microlife blood pressure monitor. Am J Hypertens. 2009. 22: 848-52.

8. National Institute for Health and Clinical Excellence (NICE), NICE medical technology guidance 13: WatchBP Home A for opportunistically detecting atrial fibrillation during diagnosis and monitoring of hypertension. 2013. www.nice.org.uk/MTG13 9. Kearley, K., et. al., What is the best way to screen for atrial fibrillation in primary care? A comparison of the accuracy of 3 methods: nurse pulse palpation, a hand-held ECG and a modified BP monitor.

10. Wiesel J. et. al., Screening for asymptomatic atrial fibrillation while monitoring the blood pressure at home: trial of regular versus irregular pulse for prevention of stroke (TRIPPS 2.0). Am J Cardiol 2013; 111: 1598-601 11. Verberk WJ, de Leeuw PW. Accuracy of oscillometric blood pressure monitors for the detection of atrial fibrillation: a systematic review. Expert Rev Med Devices. 2012; 9(6): 635-40 12. Giuliano E., et al., Switching from traditional to automatic sphygmomanometer increases opportunistic detection of atrial fibrillation in hypertensive patients, British Journal of Medical Practitioners, June 2013, Volume 6, Number 2.

13. Fibrillazione Atriale in Medicina Generale, Guidelines of the SocietĂ Italiana di Medicina Generale (SIMG), 2013.

14. http://www.telegraph.co.uk/health/healthnews/9803348/Pulse-monitor-will-pick-up-thousands-of-stroke-risk-patients.html

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Europe / Middle-East / Africa Microlife AG Espenstrasse 139 9443 Widnau, Switzerland Tel: + 41 71 727 7000 Fax: + 41 71 727 7011 watchbp@microlife.ch www.watchbp.com www.watchbp.nl WatchBP Microlife solutions B.V. Mercator I Toernooiveld 220 6525 EC Nijmegen The Netherlands watchbp@microlife.ch www.watchbp.nl

Microlife Health Management Ltd. St John's Innovation Centre Cowley Road Cambridge CB4 0WS United Kingdom Tel: + 44 (0) 1223 422 444 Fax: + 44 (0) 1223 420 844 info@watchbp.co.uk service@watchbp.co.uk www.watchbp.co.uk United States Microlife Medical Home Solutions, Inc. 2801 Youngfield St., Suite 241 Golden, CO 80401, USA Tel: + 1 303 274 2277 Fax: + 1 303 274 2244 www.mimhs.com www.watchbp.com

More information about Microlife AFIB ?

Latin America / Canada Microlife USA Inc., 1617 Gulf to Bay Blvd, 2nd Floor Clearwater, FL 33755, USA Tel. +1-727-4425353 Fax. +1-727-4425331 msa@microlifeusa.com www.watchbp.com Asia Microlife Corporation 9F, 431, RuiGang Road, NeiHu Taipei, 114, Taiwan, R.O.C. Tel: + 886 2 8797 1288 Fax: + 886 2 8797 1283 watchbp@microlife.com.tw www.watchbp.com

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