In the new draft guidance, NICE has recommended KardiaMobile 6L, a smartphone ECG device for people taking antipsychotic medication.
People taking antipsychotic medication often require regular testing for heart problems before starting treatment and then again at regular intervals during their treatment. It is important to detect heart problems such as rhythm disturbances as this can inform medications, dosage, whether to stop them and potentially avoid severe cardiac events. However, there are minimal options for patients to easily measure heart rhythm disturbance outside clinical settings, which is where a portable smartphone ECG device comes into play.
NICE identified this unmet need and has reviewed the KardiaMobile 6L, a smartphone ECG device in draft guidance which could revolutionise how patients track their heart rate.
What is KardiaMobile 6L?
KardiaMobile 6L is a portable smartphone ECG device offering a less intrusive method of measuring heart changes due to medication for psychiatric disorders. It has two electrodes on the top that are touched to the fingers and one on the bottom to make contact with the left leg.
The smartphone ECG device records ECG, in any psychiatric setting, including during a home visit by a community health professional, which may reduce the stress and anxiety of people attending an outpatient appointment. The data is recorded and transmitted wirelessly to a mobile device.
Current practices measure QT intervals using a 12-lead ECG device. However, due to the design, the person needs to partially undress and use conductive gel on the skin to create contact with electrodes. This can cause reluctance and distress, whereas the smartphone ECG device requires minimal implementation.
NICE recommends the smartphone ECG device
In the draft guidance, NICE recommend that KardiaMobile 6L be offered as an option in psychiatric services to measure heart rhythm disturbances in people taking antipsychotic medication whilst further real-world evidence is collected. This is required to test how well the smartphone ECG device performs in measuring QT intervals in the psychiatric service setting.
The KardiaMobile 6L is part of the NICE Early Value Assessment pilot project, which was designed to drive innovation for health and care professionals by actively drawing in digital products, medical devices, and diagnostics that address national unmet needs.
This process will encourage quicker assessments of early value to identify the latest technologies that can be used in the NHS. This means that healthcare professionals can take advantage of medical technologies quicker whilst further data is collected on the cost and effectiveness.
Once real-world data is collected, the appraisal will return to the independent NICE committee for it to undergo a full assessment.