- Sweden's Dental and Pharmaceutical Benefits Agency, TLV evaluated the combination of the KardiaMobile® and KardiaPro personal electrocardiogram (ECG) and software compared to the current standard of care, Holter ECG
- The health economic assessment found a higher degree of atrial fibrillation (AF) detection and resource-saving with KardiaMobile compared to Holter ECG 24 hours1
- KardiaMobile and KardiaPro, provide at home monitoring of AF without the requirements for multiple hospital appointments
- AF, a type of irregular heart rhythm and leading cause of stroke, affects about three percent of Sweden's population over the age of 202 and ten percent over the age of 803
Mountain View, CA /PRNewswire/ - AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology, today announced that Sweden's Dental and Pharmaceutical Benefits Agency, TLV, has indicated KardiaMobile and KardiaPro can provide greater benefit at a lower cost than Holter ECG in the detection of atrial fibrillation (AF). The TLV's health economic evaluation will be part of the decision basis for the MTP Council's forthcoming national recommendation for the use and procurement of KardiaMobile and KardiaPro in Swedish clinical practice.
The TLV evaluated KardiaMobile and KardiaPro as a combined solution. The personal ECG and software were recommended for the home monitoring of patients who have undergone some form of surgery, such as ablation – a procedure to treat AF – as well as patients who are on frequency-regulating drug treatment for the condition.1 For diagnosis, KardiaMobile can be used for patients who seek primary care support with AF-related symptoms, and for whom no AF diagnosis can be made at the first primary care visit.1 KardiaMobile is a medical device that is intended to be used to periodically record, store, and transmit single-channel ECGs. KardiaMobile is used together with the KardiaApp application for patients and the KardiaPro software for healthcare professionals.1
KardiaMobile and KardiaPro were compared to the 'usually used' Holter ECG. The TLV concluded that a higher degree of AF detection and resource-saving was achieved with KardiaMobile compared to Holter ECG over a period of 24 hours, which is interpreted by specialists in specialised care when used for 30 days. The scenario analysis in the health economic evaluation concluded that the use of KardiaMobile and KardiaPro can provide greater benefit at a lower cost. Even if no stroke is avoided, using KardiaMobile saves costs compared to Holter ECG 24-hours.1
AF is the most common arrhythmia in adults. About three percent of Sweden's population over the age of 202 and ten percent over the age of 803 are estimated to have AF. It is a leading cause of stroke4, a condition that can have a devastating impact on patients and their families if left untreated. Stroke is estimated to cost €1.2 billion (approximately 13 billion SEK) in Sweden.5 Early diagnosis of AF is essential to help prevent AF-related stroke and the consequences of suffering with AF.
Commenting on the announcement, Hans Jaeger, Business Director DACH & Nordics, AliveCor said, "Following TLV's assessment, AliveCor is proud to be able to offer a cost-effective, medical-grade personal ECG, to support remote cardiac care services for patients not in front of their cardiologist. TLV's recommendation highlights the clinical benefit and cost effectiveness of KardiaMobile and KardiaPro, demonstrating its suitability as a clinical tool for Sweden's need to support rapid diagnosis of AF."
KardiaMobile is the world's most clinically-validated personal ECG. Unlike traditional ECGs, KardiaMobile provides a compact, patchless and wireless solution that can be used at any time and anywhere. The user starts a 30-second ECG recording on their smartphone via the Kardia app - by placing two fingers from each hand on each of the two top electrodes - enabling the patient to remotely capture a medical-grade recording of their heart activity. KardiaMobile provides instant detection of AF, bradycardia, tachycardia and sinus rhythms, which are leading indicators of cardiovascular disease. KardiaMobile can also detect normal heart rhythm, offering users peace of mind. KardiaPro is a web-based portal that presents medical-grade patient data from KardiaMobile and the Kardia app. KardiaPro is used by providers to support clinical decision making. Actionable data is organized and triaged based on customised practice parameters for efficiency.
AliveCor recently announced that KardiaMobile received a positive recommendation from the National Institute for Health and Care Excellence (NICE), making it the first personal ECG to be used within the National Health Service (NHS) in England and Wales. The recommendation from TLV and NICE are the first two health agency recommendations of KardiaMobile outside of the US.
The Dental and Pharmaceutical Benefits Agency, TLV, is a Swedish central government agency whose remit is to determine whether a pharmaceutical product, medical device or dental care procedure shall be subsidised by the state. The Swedish Medical Technologies Product (MTP) Council initiates which medical technology products TLV has to evaluate. The MTP Council then makes a recommendation to the regions based on the TLV's health economic assessment.
The TLV recommendation can be found here: https://www.tlv.se/in-english/medical-devices/health-economic-evaluations/completed-health-economic-evaluations%E2%80%8B/arkiv/2022-02-07-health-economic-evaluation-of-kardiamobile-in-atrial-fibrillation.html
AliveCor, Inc. is transforming cardiological care using deep learning. The FDA-cleared KardiaMobile device is the most clinically-validated personal ECG solution in the world. KardiaMobile 6L provides instant detection of Atrial Fibrillation, Bradycardia, Tachycardia, Sinus Rhythm with Supraventricular Ectopy, Sinus Rhythm with Premature Ventricular Contractions, Sinus Rhythm with Wide QRS and Normal Sinus Rhythm in an ECG. Kardia is the first AI-enabled platform to aid patients and clinicians in the detection of atrial fibrillation, the most common arrhythmia and one associated with a highly-elevated risk of stroke. AliveCor's enterprise platform allows third party providers to manage their patients' and customers' heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies. AliveCor protects its customers with stringent data security and compliance practices, achieving HIPAA compliance and SOC2 Type 1 and Type 2 attestations. AliveCor is a privately-held company headquartered in Mountain View, Calif. "Consumer" or "Personal" ECGs are ECG devices available for direct sale to consumers. For more information, visit alivecor.com.
1 TLV, Health economic evaluation of KardiaMobile in atrial fibrillation. Available at: https://www.tlv.se/in-english/medical-devices/health-economic-evaluations/completed-health-economic-evaluations%E2%80%8B/arkiv/2022-02-07-health-economic-evaluation-of-kardiamobile-in-atrial-fibrillation.html. Last accessed February 2022
2 National Board of Health and Welfare, Screening for atrial fibrillation in order to prevent stroke-Recommendation and assessment data. Available at: https://www.socialstyrelsen.se/sok/?q=screening+f%C3%B6rmaksflimmer. Last accessed February 2022.
3 The Swedish Board for Medical and Social Evaluation (SBU), "Atrial fibrillation Prevalence and risk of stroke" 2013. Available: https://www.sbu.se/sv/publikationer/SBU-utvarderar/formaksflimmer---forekomst-och-risk-for-stroke/. Last accessed February 2022.
4 Heart Rhythm Alliance. AF-related stroke? AF-related stroke. Available at: https://www.heartrhythmalliance.org/afa/uk/af-related-stroke. Last accessed February 2022.
5 Ghatnekar O. The burden of stroke in Sweden:Studies on cost and quality of life based on Riks-Stoke, the Swedish stroke register. Umeå, Department of Public Health and Clinical Medicine. Available at: http://www.diva-portal.org/smash/get/diva2:652080/FULLTEXT02. Last accessed February 2022