*Please note that CardioCare Afib is now known as Afib Flow.*
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This is part one of a two-part series on the role of remote patient monitoring in the post-stroke pathway.

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Every year, millions of people around the world suffer a stroke, a medical condition caused by either a blocked (ischaemic) or burst (haemorrhagic) blood vessel in the brain. As the second leading cause of death globally, accounting for over 6 million fatalities, and a primary cause of disability, stroke’s societal impact cannot be overstated. The last two decades have witnessed a 50% increase in stroke incidence, with one in four people now at risk of experiencing a stroke during their lifetime. Over 12 million people in Europe alone are grappling with the aftermath of a stroke. This escalating situation, fuelled by an aging population, unhealthy lifestyles, and the proliferation of risk factors like high blood pressure and elevated cholesterol levels, demands urgent, innovative strategies for prevention and post-stroke treatment.

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Following a stroke, identifying the cause is critical to prevent a secondary (recurrent) stroke. Yet, in 30%-40% of cases the cause isn’t readily identifiable, leading to what is known as a cryptogenic stroke. Despite advancements in diagnostic tools and treatment options, approximately 25% of stroke survivors will experience a secondary stroke, with the risk already being significant in the weeks immediately following the primary event. For cryptogenic stroke patients, extensive research underscores the critical role of heart monitoring for cardiac risk factors as an early step in their post-stroke care path. Atrial Fibrillation or Atrial Flutter (AF), for instance, plays a significant role in stroke risk. People with AF face a stroke risk that is five to seven times higher than those without this condition (1). Effective treatments are available; for example, oral anticoagulants (NOACs) for AF patients have shown to reduce the chance of a stroke. Therefore, rapidly identifying these previously unknown risk factors, like AF, is vital to avert secondary events and give stroke survivors a fighting chance at rehabilitation and reintegration.

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In this article, we explore the current post-cryptogenic stroke care landscape, highlighting opportunities for improvement through (the adoption of) remote patient monitoring solutions. With these new tools, we hope to enhance post-stroke care by empowering healthcare professionals and hospitals, alleviating their pain points, and facilitating timely and accurate patient care. These improvements will not only enhance the patient experience, they will improve patient outcomes. In the second part of this series, we will discuss how Byteflies developed Afib Flow to turn this vision into a reality.

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The state of care for cryptogenic stroke patients

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The general diagnostic (Dx) steps to rule out AF for a cryptogenic stroke patient are as follows, although differences exist from provider to provider.

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1. 12-lead ECG in hospital: A short cardiac monitoring done with multiple wires and electrodes on the chest that can detect frequent or continuous heart irregularities. If negative then,

2. 1–7 days in-hospital and/or mobile Holter monitor: Monitoring with multiple wires and a bulky wearable device worn on the body. If negative then,

3. Implantable Loop Recorder (ILR) insertion and/or event monitoring for multiple months up to years: A ILR is a small device implanted under the skin of the chest that can continuously monitor the heart for several years.

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The current system of stroke care is fraught with several notable shortcomings. Notably the limited availability of stroke monitoring devices can lead to a daunting wait time of 4–8 weeks for patients (see note 1 below). This delay is particularly concerning, as the first few weeks post-stroke pose a significant risk of a secondary event (2), leaving patients in an unnecessarily anxious state during this critical time. The current Holter technology only compounds the problem. Despite recording continuous heart monitoring, clinicians can only analyze data after the monitoring period is done and the Holter has been returned, further prolonging the time required for diagnosis and initiation of treatment.

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Patient adherence with Holter monitors at home also remains a concern, given their bulky and wired design, lack of user-friendliness, and general discomfort. Furthermore, the decision to implant an implantable loop recorder (ILR) is based on Holter data. As a result, the delay in Holter analysis cascades into additional delays in ILR decision for critical patients. Despite the medical value of ILRs, they require patients to cope with an inserted device for up to several years, and hospitals must commit resources to monitoring and follow-up during this period.

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Here, an alternative approach presents itself: If cardiac risk factors were not identified during the short Holter monitoring, and before resorting to inserting an ILR, patients could benefit from a more intensive follow up for a period of a few weeks (1–4) using a wearable, continuous cardiac monitoring system. These systems can solve the issues of Holter monitoring described above — from patient comfort and adherence, wait times and delays in diagnosis and treatment. This period of monitoring can also be enough to detect risk factors, potentially eliminating the need for longer ILR monitoring. This would lessen the likelihood of unnecessary invasive procedures and alleviate costs for healthcare institutions.

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Unfortunately, the available technology for multi-day to multi-week ambulatory monitoring has been lacking, leaving a treatment gap. Nevertheless, a new generation of long-term cardiac monitoring tools is poised to address this deficiency.

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The case for longer-term wearable cardiac monitoring

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An alternative to traditional, cumbersome, multi-lead wired Holter monitors can be comfortable cardiac “patches”.

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These innovative solutions offer extended monitoring durations, ranging from hours or days to multiple weeks or even months. By enabling patients to be comfortably monitored for longer periods, these tools unlock a wealth of valuable data for comprehensive analysis and timely intervention. An abundance of clinical trials, medical studies and international cardiology guidelines support the use of long-term cardiac monitoring for cryptogenic stroke patients. Although an in-depth exploration of the medical literature is beyond the scope of this article, it is worth highlighting key takeaways from the analysis of studies and treatment guidelines published by the leading US and European medical associations (3,4,5):

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• Long-term ECG monitoring is recommended in cases of cryptogenic stroke or transient ischemic attack (TIA).
• The main cardiac rhythm risk factors, atrial fibrillation and atrial flutter (collectively “AF”), can be reliably detected in a post-acute stroke or clinical TIA population with a variety of ECG-based monitoring devices. This proves especially true when compared to very brief monitoring periods of less than three days.
• Typically, a proper monitoring strategy will lead to a 3–7 fold increase in the detection of AF.
• Preliminary evidence indicates that the increased rate of AF detection can lead to improved outcomes (less secondary stroke and improved quality of life), although more studies are needed to confirm this.
• It is recommended to initiate ECG monitoring as soon as possible and maintain it for as long as feasible, as this approach proves both clinically prudent and cost-effective.
• Novel tools and technologies, including implants and wearables, present additional diagnostic opportunities for the screening and detection of AF in patients at risk.
• Advancements in digital ECG analysis techniques, such as machine learning and artificial intelligence, alongside emerging wearable and injectable technologies, hold great promise in personalizing therapy for AF.

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At Byteflies, we firmly believe that transforming healthcare means saving lives. To us, this boils down to using our technology to empower healthcare professionals to provide comprehensive care for patients, both in and out of the hospital. Every solution we build (Our “What”) is fueled by a purpose (our “Why”). In this context, our ‘Why’ stems from a passionate commitment to elevate the quality of care for patients. Additionally, we aim to address the unique challenges faced by healthcare professionals, based on the many insightful conversations we have had with them over time.

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Long-term continuous cardiac monitoring is undeniably advantageous for the treatment of stroke patients; however, hospitals encounter several significant challenges while implementing this practice. Financial constraints emerge as a key obstacle as hospitals operate under strict budgetary limits for medical devices. Procuring numerous monitoring devices not only presents a cost issue, but also results in wasteful allocation of resources when these devices remain idle on shelves, awaiting utilization. Alternatively, a sudden increase in demand results in acute device shortages. Additionally, conventional devices such as Holters come with costly licenses and software that cannot be easily updated, further adding a layer of complexity. To further compound the problem, hospitals must allocate resources to the regular maintenance of these devices.

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To address these pressing issues, our comprehensive analysis laid the groundwork for the development of Afib Flow. Aligning with established clinical practice guidelines and drawing upon a vast body of data from clinical studies, our mission with Afib Flowis crystal clear: we aim to enhance stroke care standards by improving the detection of cardiac rhythm factors associated with the risk of stroke and clinical TIA through a patient-centric and versatile cardiac monitoring service. By offering improved access to crucial diagnostic information, we anticipate immediate and measurable benefits, including a reduced likelihood of severe complications such as secondary ischemic stroke or related events. Ultimately, this leads to an enhanced quality of life for patients and societal benefits in the form of reduced costs associated with managing these severe complications. Moreover, by pioneering a novel service-based approach, we enable hospitals to manage their budgets more effectively, providing flexibility in adapting to patient volumes and immediate needs.

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In the subsequent installment of this series, we will delve into the intricacies of the Afib Flow solution, unveiling the numerous technological and service innovations we have meticulously developed. Meanwhile, we invite you to explore our website and discover Cardiology Flows, along with the wide range of services we offer.

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Note 1: Holter wait times based on conversations with Belgian cardiologists and neurologists.

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The information contained in this article represents the views and opinions of the writer(s) and does not necessarily represent the views or opinions of other parties referenced or mentioned therein.

The article is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare professional with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you read in this article.

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