NICE Conditionally Recommends AliveCor’s KardiaMobile for Measuring Cardiac QT Intervals in Adults Taking Antipsychotic Medication

AliveCor’s KardiaMobile® 6L has achieved a significant milestone as it becomes the first smartphone-based personal electrocardiogram (ECG) device to receive conditional recommendation from the National Institute for Health and Care Excellence (NICE) in England and Wales. The recommendation is part of NICE’s Early Value Assessment (EVA) pilot project, and it positions KardiaMobile 6L as a valuable tool in psychiatric services for measuring the cardiac QT interval in adults either currently on or about to start antipsychotic medication, subject to the generation of additional evidence.
The recommendation was made as part of the NICE Early Value Assessment pilot project aims to introduce innovation, including digital products, medical devices, and diagnostics, to healthcare professionals to address unmet national needs. The current method for measuring the QT interval involves using a 12-lead ECG device, which requires partial undressing and the use of conductive gel on the skin for electrode contact. This process can cause discomfort and reluctance in patients. The recommendation is to offer KardiaMobile 6L as an option in psychiatric services for measuring heart rhythm disturbances, like the QT interval, in individuals taking or about to take antipsychotic medication. This recommendation is made while additional real-world evidence is gathered to better understand the effectiveness of KardiaMobile 6L in psychiatric settings.
Antipsychotic medications can prolong the QT interval and pose an increased risk of severe cardiac events, which have been linked to lower life expectancy in patients. The recommendation addresses an unmet need for accessible and readily available measurements for detecting cardiac abnormalities in psychiatric services.
KardiaMobile 6L is a portable ECG recording device that offers instant detection of cardiac abnormalities, including measuring the cardiac QT interval. Its use in psychiatric services can enable timely ECG monitoring of patients, potentially saving lives. Moreover, KardiaMobile 6L’s ability to be used in familiar settings reduces stress and anxiety among psychiatric patients, as it eliminates the need for travel and the use of conductive gel.
NICE’s recommendation is based on a systematic review of studies comparing KardiaMobile 6L’s technical performance to a 12-lead device. While the conditional recommendation is a significant step, further evidence is required to inform a full technology reassessment.
Dr. Mani Krishnan, Consultant Psychiatrist and Specialty Clinical Director at Tees, Esk and Wear Valleys NHS Foundation Trust, praised the decision, emphasizing the importance of timely ECG monitoring for patients on antipsychotic medication.
KardiaMobile 6L’s recognition by NICE highlights its role in improving cardiac care in psychiatric services and its potential to save lives by enabling early detection and monitoring of heart disturbances.
KardiaMobile is a smart device that can record a medical-grade electrocardiogram (EKG) using your smartphone. EKGs measure your heart’s electrical activity and are typically performed in hospitals to identify irregular heart rate or rhythm, potentially signaling heart conditions like atrial fibrillation (AFib). KardiaMobile records a single-lead EKG, offering valuable heart health information for you and your healthcare provider. It can detect conditions like AFib, Bradycardia, and Tachycardia, with additional determinations accessible through a KardiaCare membership. The device costs between $79 and $149 and for $10 a month or $99 a year patients can receive regular reviews of their heart data by a cardiologist.
NICE has also recommended KardiaMobile as an option for detecting atrial fibrillation (AF) in individuals suspected to have paroxysmal AF and experiencing symptoms like palpitations. These individuals are usually referred for ambulatory electrocardiogram (ECG) monitoring by a clinician. The recommendation is based on clinical evidence demonstrating that KardiaMobile, a portable ECG recorder, is more effective in detecting AF compared to traditional Holter monitors. In this indication, NICE also performed cost monitoring that indicated that KardiaMobile was cost-effective, resulting in average savings of £13.22 per patient over two years for individuals with symptoms like palpitations. These savings are attributed to reduced diagnostic costs, including the cost of the device itself.