NICE has today (Friday 12 August 2022) issued draft guidance recommending the KardiaMobile 6L for measuring the cardiac QT interval in people taking antipsychotic medication.
People taking antipsychotic drugs may need tests for heart problems before starting treatment and at regular intervals during their treatment. Detecting heart problems such as arrhythmias can inform the choice of drugs, their dosage, whether to stop them, and potentially the avoidance of serious cardiac events.
NICE has identified that there is an unmet clinical need for a more accessible and readily available way of measuring heart rhythm disturbance such as the QT interval in the psychiatric service setting.
The KardiaMobile 6L is a portable ECG recording device that is a less invasive way to measure heart changes that may influence the choice of medication taken for psychiatric disorders. There are two electrodes at the top that are touched with the fingers, and one at the bottom to contact the skin of the left foot.
The ECG can be recorded using the KardiaMobile 6L, in any psychiatric setting, including during a home visit by a community health professional, which can reduce the stress and anxiety of people attending outpatient appointments. Data is recorded and transmitted wirelessly to a mobile device such as a smartphone or tablet.
Current practice to measure the QT interval is to use a 12-lead ECG device. This requires the person to partially undress and use conductive gel on the skin to make contact with the electrodes. This can cause reluctance and anxiety.
The recommendation is that the use of the KardiaMobile 6L should be offered as an option in psychiatric services to measure heart rhythm disturbances, such as a QT interval, in people taking or about to take antipsychotic medication, while further real-world evidence is generated. . This is to address the uncertainty about how well the use of the KardiaMobile 6L works for measuring the QT interval in the psychiatric service setting.
The NICE Early Value Assessment pilot project is designed to drive innovation in the hands of health and care professionals by actively using digital products, medical devices and diagnostics that address unmet national needs.
It will provide faster early value assessments to identify the most promising technologies that can be used in the NHS. This means that clinicians and patients can benefit from medical technologies while further data is collected to inform a full NICE assessment of the device’s cost and clinical effectiveness.
Once the real-world evidence is established, the assessment will be returned to the independent NICE committee for full assessment.
A consultation has started on the recommendations contained in the early value guidance consultation document evaluating the KardiaMobile 6L for measuring the cardiac QT interval in people taking antipsychotic medication. Comments must be submitted by Thursday 25 August 2022 via nice.org.uk.
