ONGOING CLINICAL TRIALS
Evaluating the potential of watchful waiting via remote, real-time monitoring
Objective: To evaluate the effectiveness of a watchful-waiting approach and to prove it is at least as, if not more, beneficial than routine care pathways consisting of either early or delayed cardioversion.
Project outline: At present, the standard approach to treating acute episodes of atrial fibrillation involves so-called acute or delayed cardioversion. However, this multi-centre randomised controlled clinical trial initiated by Maastricht University Medical Center evaluates the potential benefits of a “watchful-waiting” approach where rate control medication is administered with a view to alleviating symptoms. As part of the trial, FibriCheck’s innovative and fully scalable telemonitoring infrastructure is used to guide rate control in real time and without the need for additional hardware. After discharge from the emergency department, all patients continue using the FibriCheck application for four weeks to monitor for recurrences and to guide ongoing rate control therapy.
Conclusion: The fact that FibriCheck’s remote monitoring platform is both scalable and fully compatible with a wide range of consumer devices means that there is real potential for a watchful-waiting approach. As well as enabling physicians to adapt therapies in accordance with regular and real-time data, such an approach could radically transform routine care and improve outcomes for atrial fibrillation outpatients. Once finalised, the results of this study will provide a more accurate impression of these potential benefits. The study is expected to be completed around June 2025. Stay tuned for more details as they become available.
REAL WORLD EVIDENCE: INTEGRATIONS
Bringing the benefits of mHealth to a whole new group of users
Methods: To capitalise on the increasing popularity of wearables in order to offer an even broader user base an easy and convenient way to measure heart rates and rhythms via smartwatch.
Project outline: Amidst the growing uptake of digital and mobile health solutions and against the backdrop of significant growth in consumer wearables, such as smartwatches, FibriCheck collaborated with Samsung to develop a smartwatch app that was not only fully compatible with the new Samsung Galaxy Watch3 and Galaxy Watch Active2 but even transformed them into fully certified and approved medical devices. FibriCheck was selected by Samsung on the strength of its regulatory portfolio, having obtained approval in the US, Australia and Europe. As a result of the agreement, potentially millions of Samsung users now have access to FibriCheck’s solution via the convenience of a consumer wearable device.
Conclusion: Even within just one month of being made available, several thousand users took advantage of an introductory offer to download the FibriCheck smartwatch app to detect potential heart rhythm disorders simply while wearing their Samsung Galaxy Watch3 or Galaxy Watch Active2. As well as add value for users, this integration is yet another demonstration of how FibriCheck can help manufacturers compete in the fight for consumers by offering new and innovative total solutions. FibriCheck’s software is unique in that it analyses the raw signals generated by the PPG sensor built into almost every smartwatch and consumer wearable. As such, FibriCheck can be easily integrated within a whole range of devices and across all platforms. Coupled with the platform’s international reach, proven ease of use, robust compliance and regulatory approvals FibriCheck was a clear choice to extend the functionality of the Samsung Galaxy Watch3. Moreover, the added convenience for users to instantaneously measure their heart rate and rhythm via their watch, brings mHealth to an even broader audience and allows an even larger user base to take advantage of FibriCheck’s life-saving technology.
Partnering with the popular wellness tracker provider to drive positive health outcomes
Methods: To bring the proven benefits of FibriCheck’s remote heart monitoring solution to Fitbit smartwatch users in Belgium, the Netherlands, Ireland, UK, France, Germany, Italy and Spain.
Project outline: FibriCheck’s device-agnostic solution allowed it to be easily integrated into Fitbit’s extensive range of consumer wearables. By leveraging the built-in photoplethysmography (PPG) sensors, available in virtually all devices, FibriCheck developed a fully compliant and fully compatible app that runs on Fitbit OS. Enhancing their value proposition for prospective buyers boosting functionality for existing users.
Conclusion: FibriCheck’s partnership with Fitbit aligns with the company’s vision to help transform the lives of millions of consumers around the world. It does so by offering wearable users a low-threshold way of measuring and detecting irregular heart rhythms that frequently go unnoticed until it’s too late. Users can view the results of their measurements in real time and gain a better understanding of their own heart health, either directly on their smartwatch or via their smartphone. Most importantly, those results can be instantly and automatically shared with the user’s doctor via FibriCheck’s robust cloud infrastructure. Helping to inform diagnosis and potentially life-saving intervention. As such, the FibriCheck app for Fitbit brings the power of FibriCheck’s medically-certified, regulatory-approved and clinically-tested solution to potentially millions of consumers’ worldwide. Since its launch in September 2019, over half a million heart rhythm measurements have been made using Fitbit devices, realising the benefits of mhealth innovation to a whole new cross-section of the public and improving the health outcomes for thousands of users.
REAL WORLD EVIDENCE: CASE FINDING & POPULATION HEALTH
Comprehensive media campaign demonstrates the potential of at-home diagnosis
Objective: To investigate the feasibility of population based approach to detection of atrial fibrillation via a comprehensive media campaign. Assessing the potential impacts to clinical care.
Project outline: In what is probably the clearest demonstration to date of FibriCheck’s scalability potential, the solution was put to the test as part of a comprehensive country-wide detection and awareness raising campaign in Belgium. The call for participants for this nationwide study was published both online and in print, with collaboration support from several major news outlets. In addition to supporting the recruitment of over 62,000 study participants, the campaign successfully increased public awareness about atrial fibrillation, reaching over 2 million people in total.
Conclusion: 62,821 people activated and downloaded the FibriCheck app via QR codes published in various newspapers and online media. Over 98% of participants completed the 8-day programme, taking 60-second measurements with their smartphone 1-2 times per day and additionally when experiencing symptoms. The resulting PPG data (over 588,000 measurements in all) was first analysed by the FibriCheck app and then validated by skilled medical technicians to assess the accuracy of the algorithm’s findings under the supervision of cardiologists. The result? 791 (1.3%) cases of possible atrial fibrillation were detected, illustrating the significant impact large scale detection programmes can have on population health outcomes improvement. While, the diagnostic yield for AF increased from 0.5% with one measurement to 1.8% after 8 days, this was untargeted, opportunistic case finding. When applied in a targeted approach to high-risk cohorts, these results would be even higher, owing to the gains associated with prolonged and on-demand measuring potential. Which is especially crucial in the early stages of AF, when episodes are largely intermittent and difficult to capture during routine appointments. In addition to proving a tripling in detection rate by monitoring over the course of a week, compared to a single spot-check, 65% of participants reported benefit in the referral of irregular results to their physician. Most importantly, this project confirmed the feasibility and potential cost-effectiveness of supervised digital screening at scale. Further demonstrating that the yield of new AF cases did not increase excess burden on the healthcare system.
Empowering people to take control of their health via population health screening in Luxembourg
Objective: To boost the efficacy of traditional, industry-sponsored awareness campaigns via innovative technology that empowers Luxembourg residents to play an active role in their own diagnosis.
Project outline: As part of Heart Health Month, FibriCheck partnered with the Luxembourg Ministry of Health, Cardiology Society, Patient Association and the Pfizer-BMS Alliance to co-develop a nationwide detection programme to raise awareness and improve atrial fibrillation detection rates in the general population. As the digital enabler of the campaign via on and offline media, the FibriCheck app played an integral role in engaging both healthcare professionals and the general public. . The two-pronged approach to the campaign consisted of an awareness phase focusing on heart health, lifestyle and prevention and a screening phase in which the public could use FibriCheck for free for 7 days.
Conclusion: There are at least two shortcomings of traditional, industry-sponsored health awareness campaigns. Firstly, they lack a concrete mechanism to prompt people to take action and seek medical advice. Secondly, they lack meaningful and actionable data that can be used to facilitate treatment and evaluate the performance and impact of the campaign itself. As a crucial component in this nationwide disease awareness campaign, FibriCheck proved its scalability and agility in solving both these issues. On the one hand, it empowers people to play an active role in their own diagnosis with a strong focus on prevention, thus giving them tangible incentives to seek further medical help. On the other, it generates extremely valuable data and insights that can streamline the process of care while yielding clear KPIs and response rates. As of the time of writing, an estimated 12,000 people in Luxembourg suffer from atrial fibrillation; a figure which is expected to double by 2050. By offering large cross-sections of the population a certified, hardware-free diagnostic solution to detect arrhythmias such as atrial fibrillation, FibriCheck demonstrates the transformative power of digital health in improving patient outcomes and potentially saving lives.
Awareness raising and public screening during Heart Rhythm Week
Objective: To boost public awareness of heart arrhythmias together with the Belgian Heart Rhythm Association (BeHRA), by targeting 10,000 high-risk patients to remotely self-screen during Heart Rhythm Week.
Project outline: As part of Heart Rhythm Week (7 to 13 June 2021), BeHRA launched a nationwide screening campaign until October 2021. The campaign invites people from across the country to complete an online risk assessment survey to identify and enable those with a heightened CHA2DS2-VASc score to receive a free, 7-day FibriCheck prescription to self test at home. The results of this targeted screening programme will help grow the repository of evidence around digital screening for public health promotion.
Conclusion: As public screening campaigns are typically untargeted, this project highlights the ease, impact and efficiency that come with pairing digital health tech with online engagement initiatives. This campaign illustrates the scale and impact of FibriCheck collaborations with medical societies and trade associations. This public health partnership is but one example, demonstrating FibriCheck’s credibility amongst the clinical community, in raising detection rates for potentially life-threatening heart rhythm disorders and, by extension, improving patient outcomes and quality of life. The precise magnitude of that impact in this specific project is yet to be determined, pending the completion of the screening programme. Stay tuned for the final results, which will be published here in due course.
REAL WORLD EVIDENCE: HOSPITALS, PHARMACISTS
Improving access for high-risk patients in parallel with vaccination programme
Introduction: COVID-19 restrictions posed a challenge for general practitioners (GPs) to maintain the standard of care for at-risk patients. By replacing in-centre checks with FibriCheck, Wanstead and Woodford Primary Care Network (PCN) had a powerful at-home tool to improve AF detection rates and patient outcomes, safely and efficiently.
Objective: To safeguard continuity of care during the pandemic via remote monitoring. Achieving performance targets, AF detection metrics and better patient outcomes through primary care vaccination initiatives.
Project outline: With many patients hesitant or simply unable to attend clinic appointments due to the pandemic, Wanstead and Woodford PCN were searching for a way to reduce stroke risk and address their AF detection targets, without increasing the burden on acute care services. The solution came in the form of FibriCheck’s remote monitoring platform. The project was rolled out as part of the PCN’s Flu and COVID-19 vaccination programme, ensuring virtual access to care for at-risk patients and improving efficiency for healthcare professionals (HCPs).
Conclusion: The project is a strong demonstration of just how effective and efficient remote AF detection can be with FibriCheck. The remote monitoring programme achieved a 100% approval rating from both patients and practitioners. All participating HCPs indicated that they would recommend the platform to their colleagues. All practices within the network also agreed that the solution was beneficial and even enhanced their ability to carry out AF detection. The pathway not only simplifies detection and monitoring of at-risk patients, it also facilitates the next steps in treatment and care. Fibricheck enabled HCPs to easily rule out innocent presentations and prioritise those that required further investigation. This significantly reduced the number of referrals for 24h Holter monitors. Most significant, however, were the high adoption and approval ratings amongst patients. 97% of patients found the installation and use of the FibriCheck app easy. By combining the roll-out of the project with the network’s vaccination efforts, HCPs were also able to reach more patients safely and efficiently.
Enabling pharmacists to lead AF awareness and detection efforts in the community
Introduction: In meeting people where they are, pharmacists are uniquely placed to deliver effective place based care owing to their positioning within community settings. Their regular engagement with high-risk individuals with long term conditions affords an effective mechanism to raise awareness about the risks of cardiac arrhythmias. This collaboration pilot with the Belgian association of community pharmacists (Royal Association of Limburg Pharmacists – KLAV) demonstrated the enormous value pharmacy networks can bring to communities by increasing detection rates, especially for those who have asymptomatic atrial fibrillation.
Objective: To investigate the potential future spread of pharmacist-delivered atrial fibrillation education and remote screening within community pharmacies via awareness raising. In partnership with KLAV, FibriCheck and member pharmacists aim to increase detection rates.
Project outline: As a first point of contact for many patients, pharmacist networks have enormous outreach potential. This project was designed to qualify and quantify the potential for increasing timely detection of cardiac arrhythmias. Participating pharmacists invited customers to use the FibriCheck app over a 7-day period. They were advised to perform measurements twice daily and whenever they experienced symptoms such as palpitations, chest pain, dizziness, etc. The consolidated end-reports were forwarded by e-mail to the user along with the advice to consult a general practitioner in cases where atrial fibrillation was detected.
Conclusion: FibriCheck remote monitoring was met with positive reception, both by pharmacists and their customers. A small region was selected to pilot the approach, from which 110 people participated. A total of 19 (17.3%) cases of possible arrhythmias were detected. 13.6% were non-atrial fibrillation (AF) arrhythmias and 3.6% were identified as possible AF. All possible AF cases were advised to consult a doctor, which resulted in further investigation, timely treatment and in the case of 1 patient, surgical intervention to prevent future strokes. The insights generated by this project clearly illustrate the important role pharmacists can play in ensuring timely detection of AF and broader condition awareness in a community setting.
Demonstrating the power of digital transformation in healthcare
Objective: To ensure continuity of care for patients during the COVID-19 pandemic through TeleCheck-AF: a remote monitoring teleconsultation approach powered by FibriCheck, in collaboration with clinics across Europe.
Project outline: The pandemic has placed tremendous pressure on healthcare professionals to provide care safely and efficiently. Moreover, restrictions on face-to-face consultations and reallocation of resources in many hospitals made it extremely difficult for many patients with pre-existing conditions to access timely care. The Europe-wide TeleCheck-AF project was subsequently developed by FibriCheck in close collaboration with clinician-scientist Dr. Dominik Linz MD and Biosense Webster in order to provide an efficient, effective and scalable pathway approach that could be easily adopted and replicated in multiple clinics. Providing a safe and convenient solution for patients, and an efficient source of reliable real-time data for physician decision making.
Conclusion: Implemented in over 40 clinics across Europe and reaching a total of 3,253 heart patients, TeleCheck-AF is a powerful demonstration of digital transformation in delivering high quality patient care while reducing the burden on healthcare systems. Especially in cardiology practices with cancelled or delayed care pathways, TeleCheck-AF proved the efficacy of FibriCheck in supporting ongoing treatment via remote monitoring. Participating centres and their patients were highly satisfied with the at-home offering and data capability, powered and backed by FibriCheck’s compliant cloud infrastructure. Moreover, given that more than half of the AF episodes detected by the FibriCheck app were asymptomatic, the project also clearly demonstrates the added value of the solution in general diagnostic pathways, post the pandemic and beyond. The majority of participating centres predict that mHealth approaches such as TeleCheck-AF will continue to be used for the follow-up and management of patients, e.g. post AF ablation. Overall, the efficacy, efficiency, scalability and reliability of the TeleCheck-AF approach makes it an effective alternative and/or supplement to traditional face-to-face consultations, as reflected by the changes many European centres have made to their current standard of practice guidelines.
Pilot project to explore future models of primary care
Objective: To increase detection rates of atrial fibrillation (AF) in primary care while generating new insights and health economic data to support the case for change in partnership with Daiichi-Sankyo.
Project outline: The NHS’s ‘Long Term Plan’ encompasses multiple digitisation projects. These projects are aimed at harnessing the power of digital solutions such as FibriCheck to increase both the effectiveness and cost-efficiency of care. In this context, FibriCheck’s solution for at-home detection and monitoring of heart rhythm disorders such as atrial fibrillation is well aligned with the NHS’s future vision. This pilot project involving 5 UK primary care networks (PCNs) is the first step towards national roll-out of a completely digital pathway. As a joint working project with pharmaceutical company, Daiichi-Sankyo and several other technology partners, this pathway project aims to bolster the growing repository of evidence around the effectiveness and efficiency of remote care delivery and its impact on patient outcomes, detection rates, time to diagnosis and overall efficiency and cost effectiveness to standard clinical care.
Conclusion: There are currently no remote end-to-end AF detection or diagnosis pathways embedded in the NHS. This pilot project is a landmark initiative and a crucial first step in a partnership aimed at boosting the detection and diagnosis of atrial fibrillation, while giving at-risk patients improved access to the right treatments at the appropriate time. All without increasing the burden on the healthcare system. While the pilot project is still ongoing, early reactions from stakeholders to the FibriCheck solution, interface and accompanying support material have been extremely positive. More detailed findings will be published here in due course, as the final submissions to NHS England and NICE are prepared.