Remote Monitoring From Home - Zensor

remoteMonitoringTopImage.pngEarly detection of cardiac arrhythmia can save people’s lives. Zensor enables the accurate detection and capture of five common arrhythmias. When applied to a patient’s torso, the small, discreet, wearable solution provides recording of 3-lead ECG, respiration and motion, and with intelligent real-time analysis, involving proprietary algorithms, it can identify crucial indicators for life-threatening conditions such as stroke.

As our aging populations continue to grow, so too does the incidence and burden of chronic disease. Our healthcare systems are faced with the difficult challenge of continuing to provide the first class care we expect, in spite of reduced resources and evolving patient needs. 117 million people in the USA alone suffer from at least one chronic disease.1 In addition, every year, 15 million people worldwide suffer a stroke, with nearly 6.7 million dying and 5 million left with permanent disability.2 Accordingly, stroke is the second leading cause of global mortality2 and the leading cause of adult disability2 The EU currently spends €38 billion annually on treating stroke.3In the US the cost is estimated at $65.5 billion.4 This includes direct, indirect and informal care costs.

After hypertension, the second biggest risk factor for ischaemic strokes, is a common heart arrhythmia known as Atrial Fibrillation (AF). Epidemiological studies estimate a prevalence of AF in 0.5% of the global population, representing 33.5 million people worldwide5 In the developed world this prevalence increases to 2%6

Diagnosing AF before the first complications occur is a recognized priority for the prevention of strokes.7 Recent data collected in patients with implanted devices,8 and by Holter electrocardiograms (ECGs) in epidemiological studies,9 reinforce the assumption that even short episodes of ‘silent’ AF convey an increased risk for stroke. The European Society of Cardiology recommend that, in patients aged 65 years or over, opportunistic screening for AF should be considered for the early detection of AF.7

However, detection is not always straightforward. Between 25-62% of patients experience paroxysmal AF.10 In these cases, the AF can come and go infrequently and sporadically. In addition, up to 90% of these paroxysmal AF patients are also asymptomatic.11 Existing technology such as Holter ECG with their limited windows of monitoring (24-72 hours) and patient activated Event monitors, which require the patient to be aware of symptoms to trigger a recording, will often miss these paroxysmal AF events. This can be a particular difficulty in determining if AF is the root cause in cryptogenic stroke patients.

The Zensor system offers a unique and reliable solution for the detection and reporting of incidents of AF. Features and benefits of the system include:

  • Ten day full ECG disclosure AND event monitoring, provides the functionality of two traditional monitoring systems into a single unit
  • Additional vital signs monitoring of respiration and motion give context to data collection, leading to a more informed diagnosis
  • Real time data analysis, using proprietary algorithms, provides auto-detection of arrhythmia events
  • Wireless transmission of detected arrhythmias and rate limit breaches providing near real-time reporting irrespective of patient location
  • The small, easy to apply, body-worn device provides a discreet and comfortable to wear solution

The Zensor solution has CE approval, FDA and FCC clearance and has been involved in a number of clinical studies, focussed mainly on screening for Atrial Fibrillation and investigations into clinical service pathway improvements for the diagnosis of patients with palpitations. More information on these studies can be found here:

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1 www.cdc.gov/chronicdisease/overview

www.who.int/mediacentre/factsheets/fs310/en/

3  www.heartrhythmalliance.org/files/files/aa/for-clinicians/141127-FINAL-Interactive_Route_Map_for_Change.pdf

4 Di Carlo A, Human and Economic burden of Stroke; Age and Ageing, Volume 38, Issue 1, P4-5

5 Chugh SS et al; Worldwide epidemiology of atrial fibrillation: A global burden of disease 2010 study. Circulation 2013, Volume 134, Issue 21

6 Zoni-Berisso M , Epidemiology of atrial fibrillation: European perspective. Clin Epidemiol 2014, 6:213-220

Camm et al; 2012 focused update of the ESC Guidelines for the management of atrial fibrillation; Eur.Heart Journal 2012 33, 2719–2747

8 Healey JS et al; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med 2012;366:120–129.

9 Binici Z et al; Excessive supraventricular ectopic activity and increased risk of atrial fibrillation and stroke. Circulation 2010;121:1904–1911.

10 www.qjmed.oxfordjournals.org/content/94/12/665

11 www.medpagetoday.com/resource-center/atrial-fibrillation/Paroxysmal-Atrial-Fibrillation-Diagnosis-Progression-Stroke-Risk/a/32419