AliveCor's KardiaMobile® 6L Becomes First Personal ECG Device Recommended for Use in Psychiatric Services in England and Wales

• KardiaMobile® 6L is the first smartphone-based personal electrocardiogram (ECG) to be conditionally recommended by the National Institute for Health and Care Excellence (NICE) as part of its Early Value Assessment (EVA) pilot project.¹
• KardiaMobile 6L has been recommended for use in psychiatric services as an option to measure cardiac QT interval for adults having or about to have antipsychotic medication, subject to the generation of additional evidence.¹
• People taking antipsychotic medication are at increased risk of severe cardiac events ¹ and their life expectancy is significantly lower than the general population.²
• There is an unmet need for more accessible and available measurements for detecting cardiac abnormalities in psychiatric services.¹

MOUNTAIN VIEW, Calif., Sept. 26, 2023 /PRNewswire/ -- AliveCor, the world's leading innovator in personal electrocardiogram (ECG) technology, today announced the publication of the Early Value Assessment (EVA) by the National Institute for Health and Care Excellence (NICE) which conditionally recommends the use of KardiaMobile 6L in psychiatric services as an option to measure cardiac QT interval for adults having, or about to have, antipsychotic medication.¹

There is an unmet clinical need for a more easily accessible and available measurement for detecting cardiac abnormalities in NHS psychiatric services, as antipsychotic medication can prolong the QT interval* and lead to severe cardiac events.¹ Detecting cardiac abnormalities in people taking antipsychotic medication – such as prolonged QT interval – can inform choice of therapy, dosing and whether to stop therapy, and potentially avoid severe cardiac events, which are contributing to the significantly lower life expectancy of these patients, as compared to the general population. ^{1, 2} KardiaMobile 6L is a portable ECG recording device that provides instant detection of cardiac abnormalities and can be used to measure heart changes including cardiac QT interval.¹

"Timely ECG monitoring of patients who are on antipsychotic medication can save lives. Having access to KardiaMobile 6L will mean potentially vulnerable patients can now be seen in the comfort of their homes, reducing their stress whilst ensuring that this essential monitoring is completed anywhere, at any time. It's encouraging that NICE has recognised the need for early access to this important technology," said Dr Mani Krishnan, Consultant Psychiatrist and Specialty Clinical Director, Tees, Esk and Wear Valleys NHS Foundation Trust.

KardiaMobile 6L has been recommended as part of NICE's EVA pilot project, created to drive earlier access to promising healthcare innovations for use within the National Health Service in England and Wales. The first and only NICE recommended smartphone-based ECG device, KardiaMobile 6L can be used by healthcare professionals in both a hospital setting and as part of routine home visits.¹ This may reduce stress and anxiety amongst psychiatric patients as the test can be completed in familiar surroundings.¹ Portable ECG testing also eliminates the need for travel and the requirement for conductive gel and undressing, which can cause reluctance and distress for patients.¹ KardiaMobile 6L has the potential to ensure timely ECG testing is available which could help adults having antipsychotic medication get faster access to safe and effective antipsychotic treatment.¹

"We are delighted that KardiaMobile 6L has been recognised by NICE and reviewed by the Early Value Assessment pilot project. This decision is testament to the clinical importance of detecting and monitoring heart disturbances both in clinic and at home, something especially important in psychiatric services," said Sean Warren, Business Director UK&I, AliveCor. "We have a wealth of clinical data on the use of KardiaMobile 6L in cardiology, with NICE's EVA recommendation we will now support the collection of real-world evidence as to its effectiveness in psychiatric services. We applaud NICE and the physicians that have worked on this project for their forward-thinking approach to the use of novel health tech within the NHS, as we know it is patients that will be the ultimate beneficiaries."

NICE's decision was based on a systematic review of eight studies that evaluated the technical performance of KardiaMobile 6L compared with a 12-lead device.¹ Conditional to NICE's positive recommendation is that further evidence on the use of this innovative technology in psychiatric services must be generated to inform a further full technology reassessment.¹

*A prolonged QT interval indicates an abnormality detected on an ECG.³ This abnormality reflects a disturbance in the conduction of electricity in the lower chamber (ventricles) of the heart.³ Multiple factors can trigger prolonged QT interval including high doses of medications such as antihistamines, decongestants, diuretics, antibiotics, and antidepressants.³

Notes to editor

NICE's EVA recommendation for KardiaMobile 6L's use in psychiatric services¹

KardiaMobile 6L can be used in psychiatric services as an option to measure cardiac QT interval for adults having or about to have antipsychotic medication while more evidence is generated only if:

• A repeat QT interval measurement using a 12-lead electrocardiogram (ECG) device is offered to:
  • Women with a corrected QT interval (QTc) longer than 470 milliseconds
  • Men, trans people having hormone treatment, and intersex people who have QTc longer than 440 milliseconds
  • People who have a follow-up ECG with more than a 50 millisecond increase in QTc
  • For trans people not having hormone treatment, use the QTc threshold for their sex registered at birth
• Training for healthcare professionals on recording an ECG, and measuring and interpreting QT interval is provided
• People are offered information about why this testing is done and why testing may be repeated using a 12-lead device after it has been measured using KardiaMobile 6L

Additional evidence required by NICE on KardiaMobile 6L in the use of psychiatric services¹

NICE has requested that additional evidence is generated on:

• The accuracy of KardiaMobile 6L to measure QT interval in adults having or about to have antipsychotic medications
• How the test result affects clinical decision making
• How long the testing takes, who interprets the results and how often the test is repeated using a 12-lead device
• Patient preferences
• How long it takes before antipsychotic medication is started
• How many adults who need an ECG to measure QT interval have one
• How common prolonged QT is in adults having antipsychotic medication

About AliveCor

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 efficient 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 ISO 27001 Certification, SOC 2 Type 2 Certification and HIPAA compliance attestation. 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.

For further information please contact:

Ruder Finn
Annabelle Redfern
T: +44 (0) 79509 17945
annabelle.redfern@ruderfinn.co.uk 

AliveCor
For media enquiries:
Chris Shelford
chris.shelford@alivecor.com 

For business enquiries:
Sean Warren
sean.warren@alivecor.com

References

¹   NICE. Health Technology Evaluation: KardiaMobile 6L for measuring cardiac QT interval in adults having antipsychotic medication (HTE10). 2023. Available at: https://www.nice.org.uk/guidance/hte10. Last accessed: September 2023.

² NICE. Diagnostics Assessment Programme: KardiaMobile 6L for measuring QT interval in people having antipsychotic medication. Final scope. 2022. Available at: https://www.nice.org.uk/guidance/gid-hte10026/documents/final-scope. Last accessed: September 2023.

³ NHS Long QT Syndrome. 2017. Available at: https://www.nhs.uk/conditions/long-qt-syndrome. Last accessed: September 2023.