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

Mountain View, Kalifornien (ots/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
– NICE’s positive recommendation (https://www.nice.org.uk/guidance/mtg64 )1 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 around 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

AliveCor (https://www.alivecor.co.uk/), 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 ), which recommends KardiaMobile (https://store.alivecor.co.uk/products/kardiamobile) as an option for detecting atrial fibrillation in people suspected of having paroxysmal atrial fibrillation who are showing symptoms such as palpitations and can be consulted by a doctor outpatient 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. With difficulties in accessing personal care and longer waiting times, there is concern that diagnosis rates have continued to fall 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. “With the NHS congested, it is encouraging that NICE has recognized the value of using intelligent technology to assist physicians. Today’s recommendation from KardiaMobile – a clinically validated digital tool that enables people to monitor their heart rhythm at home so that they don’t have to go to the hospital – is a big step forward in cardiac care. “

“A lot of people have a variety of symptoms but don’t know that it could be a heart rhythm disorder like atrial fibrillation. If they don’t seek medical help, they’re at a much higher risk of having an atrial stroke. KardiaMobile can control the heart rhythm A person can be monitored at all times, whether or not the person is showing signs or symptoms of atrial fibrillation, which ultimately means atrial fibrillation can be detected more quickly, resulting in faster diagnosis and more life from atrial fibrillation-related stroke and its aftermath 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, said: “AliveCor is proud to offer the only NICE recommended personal EKG to assist in the remote care of patients who are away from their cardiologist. Today’s recommendation does not underscore only the clinical superiority of KardiaMobile 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 (https://www.alivecor.com/security) and achieves HIPAA compliance and SOC2 certifications Type 1 and Type 2. AliveCor is a private company with headquarters 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-professionals/innovation-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 (https://www.heartrhythmalliance.org/files/files/Atrial%20Fibrillation%20Management_2010%20Full%20Report.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-save-hundreds-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_KardiaMobile.jpg

Press contact:

Ruder Finn,
Frankie Dundon,
+44 (0) 73122 74086,
[email protected]; AliveCor,
Hans Jaeger,
[email protected]

Original content by: AliveCor, transmitted by news aktuell
Original message: https://www.presseportal.de/pm/161008/5119321

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