More than 30,000 strokes can be preventedand over € 500 million in healthcare costs can besaved within the European Union.

STROKEPrevention

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Microlife Afib technologyAn innovative technology for the earlydetection of Atrial Fibrillation

Microlife Afib technology

What is Atrial Fibrillation (Afib)?Atrial fibrillation (Afib) is the most common cardiac arrhythmia. Itaffects over one percent of the general population and is related to20 % of all strokes. Afib-related strokes are more severe than thosenot related to Afib; associated with an increased likelihood of per-manent disability and greater short-and long-term mortality. Costs ofAfib-related strokes could be at least € 10 billion in Europe and$ 5 billion in the US each year causing a major burden to healthcare.

New technology patented by Microlife allows simultaneous bloodpressure measurement and Afib screening. The Afib technology isvery accurate as is demonstrated in several clinical studies (see tablebelow). Microlife Afib technology detects Afib with a high sensitivity(97 - 100 %) and specificity (89 %), as compared with ECG, andtherefore can be used as a reliable screening test for early diagnosis.

The importance of Afib screeningfor STROKE preventionAfib is the number one cause of stroke 1, it is often asymptomatic,and around 30 % of Afib patients are diagnosed incidentally whenhospitalized for other reasons 2, including stroke 3.Screening and early detection of Afib followed by appropriate treat-ment can reduce the chance of stroke by 68 %.

Afib Patented Technology for theearly detection of Atrial Fibrillation

Guidelines recommended

Nice guidelines for “Diagnosis and assessment of hypertension” recommend usingMicrolife Home Afib technology for routine blood pressure measurement in primary care!Based on clinical evidence and economic analysis the NICE committee concluded that using theMicrolife Afib technology in general primary care may lead to an estimated:

Prevention of 2,000 strokes per year (81 per 100,000 patients screened aged 65 - 75years and 182 per 100,000 patients aged 75 years and older).Healthcare cost savings of € 31 million a year.

United Kingdom:Microlife Afib technology received NICE guidance 7,8

Patients (n) Setting Age (y) Afibn (%)

Non-Afibarrhythmia

n (%)

Sensitivity(%)

Specificity(%)

Wiesel 2004 2 450 Hospital 69 53 (12) (±25) 100 92

Stergiou 2009 3 72 Hospital 71 27 (37) 23 (31) 100 89

Wiesel 2009 4 405 Hospital 73 93 (23) 64 (14) 97 89

Oxford trial 2013 5 893 Primary carepractice

80 100 (11) n.s. 94 90

Tripps study 2013 6 139 Home 67 14 (10) n.s. 99* 93*

All studies were compared against 12-lead ECG unless otherwise indicated; Afib indicates atrial fibrillation; n.s., not specified; *, compared against electrocardiographic event monitor

Microlife Afib technology

Publicity

Italy: Guidelines of the Società Italiana di Medicina Generale (SIMG) recommend using Afib for both clinical and home

Due to the increased use of automated blood pressure monitors in clinical practice doctors rarely verify the presence of cardiac arrhythmias bymean of pulse palpation or auscultation. For this reason the Italian primary care guidelines recommend using an automated blood pressuremonitor with a validated algorithm that can detect the presence of atrial fibrillation. Thus far the Afib detector of Microlife blood pressuremonitors is the only arrhythmia detector that demonstrated its accuracy in multiple clinical studies.

Evidence based and clinically validated Afib detectiontechnology

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 Microlife BP monitor 5

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 monitorK Kearley 1, MP Selwood 1, A Van den Bruel 1 R Hobbs 1, D Mant1 D Fitzmaurice 2 C Heneghan 1

Department of Primary Health care Sciences University of Oxford 1

Department of Primary Care Clinical Sciences, University of Birmingham 2

The ProblemAtrial fibrillation (AF) is a risk factor for stroke, appropriate anticoagulation reduces its incidence by 64%1. 4-8% of all strokes occur in previously undiagnosed AF,creating an opportunity to prevent stroke by enhanced identification of AF 2

AimsTo compare the feasibility and operating characteristics of two new technologies:the modified blood pressure monitor with flashing AF indicator and hand-heldsingle-lead ECG systems, compared with pulse palpation to detect AF .

DiscussionInterim results suggest all four methods have high sensitivity fordetecting AF in an elderly primary care population thus are usefulfor ruling out AF.

The modified BP flash indicator also has high specificity, leading to afollow-on 12-lead ECG rate of around 10%, which is feasible inroutine care. It outperforms pulse palpation and can beincorporated into routine blood pressure monitoring, either by thepatient or at the clinic.

The specificity of both single-lead ECGs was variable and highlydependant on which cardiologist was interpreting the trace. In anundifferentiated GP population it is likely that expertise in ECGanalysis would be lower, so reducing specificity even more.

Next stepsThe next step would be an impact analysis, to evaluate whetherscreening for atrial fibrillation improves patient outcome s and atwhat cost.

The technologies

Method1000 participants aged over 75 years were recruited from primary care . For allparticipants, a registered nurse recorded :

1) pulse rhythm2) whether the modified blood pressure monitor's AF indicator flashed3) two single-lead ECGs4) a 12-lead ECG (the reference standard).

Nine nurses in five practices contributed to the data collection. The single-leadECG systems were interpreted by two cardiologists who responded yes/no/dk inresponse to whether the ECG showed AF. Inconclusive responses were countedas positive . The test operating characteristics for each index test was calculatedusing standard 2x2 tables. The 12-lead ECGs were analysed by two cardiologists,with a third resolving any discrepancies.

Results (interim)Participants

Diagnostic accuracy of index tests for detection of AF

N Sensitivity Specificity(%) (%)

Falsepositiverate (%)

Inconclusiveresult

BP monitorAF indicator flash

893 94 90 10 0

OMRONSingle lead ECG

893 91-97 76-97 3-24 0-5

MERLINSingle lead ECG

878 85-97 76-96 4-24 0-33

NURSEpulse palpation *

268* 100 77 23 9

268

NURSEpulse palpation**

86-2578

87-97 70-81 19-30 n/a

*from 4 studies in primary care 3,4,5,6

Total number of patients 893 (recruitment rolling)Age (mean) 79.6 years (CI 79.4-79.9)Gender (%) 456 (51) femaleDiagnosis of AF in medical summary (%) 100 (11)

References1.Hart et al .Meta-analysis::antithrombotic therapy to prevent stroke in patients who havenonvalvular AF. Ann Intern Med. 2007 146:857-67.2Lin et al. Newly diagnosed AF and acute stroke. The Framingham Study. Stroke .19953Morgan et al. Randomised trial of 2 approaches to screening for AF. Br J Gen Pract.20024.Sudlow et al .Identification of AF in general practice. BMJ 1998. 317-275.Somerville et al. AF, a comparison of methods in

Gen Practice. Br J Gen

Pract .20006.Hobbs et al The SAFE Study. Health Tech Assess. 2005.1-74

OMRON hand heldsingle lead ECGrecorder

Merlin Wristwatch single leadECG recorder

Modified bloodpressure monitorwith AF flashindicator

*Nurses blind for 268/873 patients

School for Primary Care Research

A randomized clinical trialThe university of Oxford in the UK, known as one ofthe best medical universities in the world, has per-formed a randomized clinical trial among 1,000 GPpatients to reveal the best method for Afib screeningin primary care. This study showed that using theMicrolife WatchBP Home A is the best method andis recommended for Afib screening in primary carepractice and for patients at home. Microlife now offerthe same level of technology in the A6PC homeproduct.

Screening for Asymptomatic Atrial Fibrillation While Monitoring the Blood Pressure at Home:Trial of Regular versus Irregular Pulse for Prevention of Stroke 6

A study performed among 139 patients suspected of having paroxysmal (intermittent) Afib. The patients were using the Microlife blood pressuremonitor with Afib detector A6PC on a daily basis for a period of 30 days. The device demonstrated a sensitivity of 99 % and a specificity of 93 %as compared to the event loop recorder and thus is a useful tool for detecting new Afib.

blood pressure measurement 9

Microlife Afib technology

A systematic review of all clinical evidence to the Microlife Afib detector showed that the highest sensitivity value (97 %) is obtained whenthree sequential blood pressure measurements were performed with two or three Afib positive readings. The highest specificity value (97 %) isobtained when with three sequential measurements, of which all three must be Afib positive. For this reason the Microlife blood pressure moni-tors with Afib detector automatically measure three times.

Three automated sequential measurements (MAM) for the best results 10

Experience from Practice

Results from clinical practiceArea Patients

(n)Setting Duration Outcome

Hull, UK 11 n.s. Primary carepractice

6 months • Afib prevalence increased by 0.8 % in Microlife practices and 0.4 %in non-Microlife practices.

• Microlife practices covered 19 % of the screened population butgenerated 44 % (n=71) of new Afib cases.

Erewash, UK12 6,556 Flu clinics

Primary carepractices

7 months • 116 patients Afib patients identified• Afib patients diagnosed increased by 7.7 % across GP practices• 8 strokes prevented (2 or 3 fatal)• Estimated cost savings € 172,000

Bologna, Italy 13 12,294 Primary carepractices

4 months • Afib prevalence within practices increased from 0.37 % to 0.63 % ascompared to previous 4 months

References1. Nichols M, T.N., et al., European Cardiovascular Disease Statistics 2012. European Heart Network, Brussels, European Society of Cardiology, Sophia

Antipolis, 2012.2. Wiesel, J., et al., The use of a modified sphygmomanometer to detect atrial fibrillation in outpatients. Pacing Clin Electrophysiol, 2004. 27: p. 639-43.3. Stergiou, G.S., et al., Diagnostic accuracy of a home blood pressure monitor to detect atrial fibrillation. J Hum Hypertens, 2009. 23: p. 654-8.4. Wiesel, J., et al., Detection of atrial fibrillation using a modified microlife blood pressure monitor. Am J Hypertens, 2009. 22: p. 848-52.5. 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 Submitted, 2013.6. 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, 2013.7. NICE, WatchBP Home A for opportunistically detection atrial fibrillation during diagnosis and monitoring of hypertension.

http://guidance.nice.org.uk/MTG13, 20138. NICE, Diagnosis and assessment of hypertension. http://pathways.nice.org.uk/pathways/hypertension, 20139. Fibrillazione Atriale in Medicina Generale, Guidelines of the Società Italiana di Medicina Generale (SIMG), 2013.10. Verberk, W.J., et al., Accuracy of oscillometric blood pressure monitors for the detection of atrial fibrillation: a systematic review. Expert Rev Med Devices,

2012. 9: p. 635-40.11. Hull PCT. http://www.nice.org.uk/usingguidance/sharedlearningimplementingniceguidance/examplesofimplementation/eximpresults.jsp?o=620, 201212. EREWASH case study: an example from primary care practice.

http://www.atrialfibrillation.org.uk/files/file/Clinicians%20Area/130408-sh-2-Erewash%20case%20study.pdf, 201313. Ermini, G., et al., Switching from traditional to automatic sphygmomanometer increase opportunistic detection of atrial fibrillation in hypertensive patients.

BJMP, 2013. 6: p. a6161.

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