NICE recommends the first smartphone ECG to detect atrial fibrillation in the event of suspected paroxysmal atrial fibrillation as part of outpatient monitoring

12.01.2022

MOUNTAIN VIEW, Calif., May 23 / PRNewswire / – * AliveCor’s KardiaMobile® is the only personal electrocardiogram (EKG) recommended by the National Institute for Health and Care Excellence (NICE) for use in the NHS1

* [1] NICE 1’s positive recommendation provides patients and doctors across England and Wales with access to a medical-grade EKG to aid in home monitoring of paroxysmal atrial fibrillation (AF) without the need for multiple hospital visits

* Atrial fibrillation, a type of irregular heartbeat and one of the most common causes of stroke, affects approximately 1.3 million people in the UK2, almost half of whom go undiagnosed3

* Paroxysmal atrial fibrillation is when the symptoms of atrial fibrillation, such as B. palpitations, occur intermittently and resolve on their own within seven days of their occurrence

1. https://www.nice.org.uk/guidance/mtg64

AliveCor, the world’s leading provider of FDA-cleared EKG technology, announced today that the National Institute for Health and Care Excellence (NICE) has issued Medical Technologies Guidance (MTG) including KardiaMobile as an option for atrial fibrillation detection It is recommended to people with suspected paroxysmal atrial fibrillation who have symptoms such as palpitations and who are referred by a doctor for ambulatory EKG monitoring. KardiaMobile is the first personal EKG recommended by NICE for use in the National Health Service (NHS) in England and Wales. KardiaMobile is prescribed by a healthcare professional when the symptoms of an arrhythmia (irregular heartbeat) are more than 24 hours apart. The instructions for use state that all interpretations of EKG recordings will be reviewed by a healthcare professional and used to aid clinical decision-making

Atrial fibrillation, the most common type of arrhythmia2, is a leading cause of atrial fibrillation-related stroke.4 Nearly half of the 1.3 million people in the UK who live with atrial fibrillation are undiagnosed2,3, which puts them at particular risk, the life changing and the often suffer the devastating effects of this severe form of stroke.5 Stroke detection and prevention is central to the NHS long-term plan6 to save thousands of lives and reduce the tremendous cost of the disease – about £ 3 billion a year in direct terms Cost to the NHS and an additional £ 4 billion to the UK economy from lost productivity, disability and care. 7

“AF diagnosis rates in the UK were already too low before the pandemic. Given the difficulty of accessing personal care and the longer waiting times, there is concern that diagnosis rates have continued to drop and put thousands of people at risk of life-threatening cardiovascular complications such as: Atrial fibrillation-related stroke, “said Professor Matt Reed, RCEM Professor, Advisor, and NRS Fellow in Emergency Medicine at NHS Lothian.” Given the congestion on the NHS, it is encouraging that NICE is realizing the value of working smarter Today’s recommendation from KardiaMobile – a clinically validated digital tool that enables people to monitor their heart rate at home so they don’t have to go to the hospital – is a huge step forward for us cardiac care. ”

“A lot of people have a variety of symptoms, but they don’t know that it could be a heart rhythm disorder like atrial fibrillation. Failure to seek medical attention puts them at a much higher risk of having an atrial stroke. KardiaMobile can monitor a person’s heart rhythm at all times, whether or not the person is showing signs or symptoms of atrial fibrillation. Ultimately, this means atrial fibrillation can be detected more quickly, resulting in faster diagnosis and thus more lives protected from atrial fibrillation-related stroke and the aftereffects of atrial fibrillation, “said Trudie Lobban MBE, Founder and Trustee of the Arrhythmia Alliance & AF Association .

KardiaMobile is the world’s most clinically validated personal EKG. In contrast to conventional EKGs, KardiaMobile offers a compact, patchless and wireless solution that can be used anytime and anywhere. The user starts a 30-second EKG recording on his smartphone via the Kardia app by placing two fingers on each hand on the two upper electrodes. In this way, the patient can remotely create a medically high-quality recording of his or her heart activity. KardiaMobile enables instant detection of atrial fibrillation, bradycardia and tachycardia, which are leading indicators of cardiovascular disease. KardiaMobile can also detect a normal heart rhythm, providing the user with peace of mind.

Commenting on the announcement, Priya Abani, CEO of AliveCor, “AliveCor is proud to offer the only NICE recommended personal EKG to support remote care of patients who are away from their cardiologist. Today’s recommendation not only underscores KardiaMobile’s clinical superiority over current standards of care, but also its position as a more cost-effective solution, which justifies its value as a clinical tool to aid in the rapid diagnosis of atrial fibrillation. ”

NICE’s recommendation of KardiaMobile as a clinical and cost-effective medical technology is supported by evidence from 27 different studies1, including five randomized controlled trials.8,9,10,11,12 The data presented to NICE shows that KardiaMobile is five times more effective at detecting cardiac arrhythmias than standard tests alone9, and that with better usability.9,13

NICE’s MTG evaluates new, innovative medical devices and diagnostics. It evaluates medical technologies that enable treatment, give patients more independence, and detect or monitor diseases.

The NICE MTG recommendation can be viewed here: https://www.nice.org.uk/guidance/mtg64

Information on AliveCor

AliveCor, Inc. is transforming cardiac care with deep learning. The FDA cleared KardiaMobile device is the most clinically validated personal EKG solution in the world. KardiaMobile 6L enables immediate detection of atrial fibrillation, bradycardia, tachycardia, sinus rhythm with supraventricular ectopia, sinus rhythm with premature ventricular contractions, sinus rhythm with wide QRS, and normal sinus rhythm in an EKG. Kardia is the first AI-powered platform to support patients and doctors in the early detection of atrial fibrillation, the most common arrhythmia associated with a greatly increased risk of stroke. AliveCor’s enterprise platform enables third-party vendors to manage their patients ‘and customers’ heart conditions using state-of-the-art tools that enable easy front-end and back-end integration of AliveCor technologies. AliveCor protects its customers with strict data security and compliance practices and achieves HIPAA compliance and SOC2 type 1 and type 2 certifications. AliveCor is a privately held company headquartered in Mountain View, California. “Consumer” or “Personal” ECGs are ECG machines that are available for direct sale to consumers. For more information, please visit alivecor.com.

references

[1] NICE Medical Technologies Guidance. KardiaMobile for detecting atrial fibrillation (MTG64). Available at: https://www.nice.org.uk/guidance/mtg64. Last accessed January 2022.

[2] British Heart Foundation. Managing atrial fibrillation in primary care. Available at: https: //www.bhf.org.uk/for-professionals/healthcare-p … ovation-in-care / managing-atrial-fibrillation-in-primary-care. Last accessed January 2022

[3] Heart Rhythm Alliance. Heart Rhythm Week. Available at: https://www.heartrhythmalliance.org/afa/uk/heart-rhythm-week. Last accessed January 2022.

[4] Heart Rhythm Alliance. AF-related stroke? AF-related stroke. Available at: https://www.heartrhythmalliance.org/afa/uk/af-related-stroke. Last accessed January 2022.

[5] Heart Rhythm Alliance. Atrial Fibrillation Management. Available at: https://www.heartrhythmalliance.org/files/files/Atrial Fibrillation Management_2010 Full Report.pdf. Last accessed January 2022.

[6] NHS. Long term plan. Available at: https://www.longtermplan.nhs.uk/areas-of-work/stroke. Last accessed January 2022.

[7] NHS England. Press release: NHS stroke action will save hundreds of lives. Available at: https: //www.england.nhs.uk/2019/05/nhs-stroke-action-will … ds-of-lives /. Last accessed January 2022.

[8] Goldenthal IL, Sciacca RR, Riga T, et al. Recurrent atrial
fibrillation/flutter detection after ablation or cardioversion using
the AliveCor KardiaMobile device: iHEART results. J Cardiovasc
Electrophysiol. 2019. 30(11):2220-2228.

[9] Reed MJ, Grubb NR, Lang CC et al. Multi-centre Randomised
Controlled Trial of a Smartphone-based Event Recorder Alongside
Standard Care Versus Standard Care for Patients Presenting to the
Emergency Department with Palpitations and Pre-syncope: The IPED
(Investigation of Palpitations in the ED) study. EClinicalMedicine.
2019. 19(1):711.

[10] Koh KT, Law WC, Zaw WM et al. Smartphone electrocardiogram for
detecting atrial fibrillation after a cerebral ischaemic event: a
multicentre randomized controlled trial. Europace. 2021.
18;23(7):1016-1023.

[11] Caceres B, Hickey K, Bakken S, et al. Mobile Electrocardiogram
Monitoring and Health-Related Quality of Life in Patients With Atrial
Fibrillation. J Cardiovasc Nurs. 2020. 35(4):327-336.

[12] Guhl, E, Althouse A, Pusateri A, et al. The Atrial Fibrillation
Health Literacy Information Technology Trial: Pilot Trial of a Mobile
Health App for Atrial Fibrillation. JMIR Cardio. 2020. 4(1):17162.

[13] Narasimha N, Hanna N, Beck H et al. Validation of a
smartphone-based event recorder for arrhythmia detection. Pacing Clin
Electrophysiol. 2018. 41(5):487-494.

Photo – https://mma.prnewswire.com/media/1721631/AliveCor_KardiaM…

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