KardiaMobile 6L for measuring QT interval in people having antipsychotic medication to inform early value assessment: a systematic review.

Background

The indication for this assessment is the use of the KardiaMobile six-lead electrocardiogram device for the assessment of QT interval-based cardiac risk in service users prior to the initiation of, or for the monitoring of, antipsychotic medications, which are associated with an established risk of QT interval prolongation.

Objectives

To provide an early value assessment of whether KardiaMobile six-lead has the potential to provide an effective and safe alternative to 12-lead electrocardiogram for initial assessment and monitoring of QT interval-based cardiac risk in people taking antipsychotic medications.

Review methods

Twenty-seven databases were searched to April/May 2022. Review methods followed published guidelines. Where appropriate, study quality was assessed using appropriate risk of bias tools. Results were summarised by research question; accuracy/technical performance; clinical effects (on cardiac and psychiatric outcomes); service user acceptability/satisfaction; costs of KardiaMobile six-lead.

Results

We did not identify any studies which provided information about the diagnostic accuracy of KardiaMobile six-lead, for the detection of corrected QT-interval prolongation, in any population. All studies which reported information about agreement between QT interval measurements (corrected and/or uncorrected) with KardiaMobile six-lead versus 12-lead electrocardiogram were conducted in non-psychiatric populations, used cardiologists and/or multiple readers to interpret electrocardiograms. Where reported or calculable, the mean difference in corrected QT interval between devices (12-lead electrocardiogram vs. KardiaMobile six-lead) was generally small (≤ 10 ms) and corrected QT interval measured using KardiaMobile six-lead was consistently lower than that measured using 12-lead electrocardiogram. All information about the use of KardiaMobile six-lead, in the context of QT interval-based cardiac risk assessment for service users who require antipsychotic medication, was taken from retrospective surveys of staff and service users who had chosen to use KardiaMobile six-lead during pilots, described in two unpublished project reports. It is important to note that both these project reports relate to pilot studies which were not intended to be used in wider evaluations of KardiaMobile six-lead for use in the NHS. Both reports included survey results which indicated that the use of KardiaMobile six-lead may be associated with reductions in the time taken to complete an electrocardiogram and costs, relative to 12-lead electrocardiogram, and that KardiaMobile six-lead was preferred over 12-lead electrocardiogram by almost all responding staff and service users.

Limitations

There was a lack of published evidence about the efficacy of KardiaMobile six-lead for initial assessment and monitoring of QT interval-based cardiac risk in people taking antipsychotic medications.

Conclusions

There is insufficient evidence to support a full diagnostic assessment evaluating the clinical and cost effectiveness of KardiaMobile six-lead, in the context of QT interval-based cardiac risk assessment for service users who require antipsychotic medication. The evidence to inform the aims of this early value assessment (i.e. to assess whether the device has the potential to be clinically effective and cost-effective) was also limited. This report includes a comprehensive list of research recommendations, both to reduce the uncertainty around this early value assessment and to provide the additional data needed to inform a full diagnostic assessment, including cost-effectiveness modelling.

Study registration

This study is registered as PROSPERO CRD42022336695.

Funding

This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR135520) and is published in full in

Some medicines used for people with certain mental health problems can increase the risk of developing serious heart conditions. Although these heart conditions are rare, it is generally recommended that people have an electrocardiogram examination before starting to take these medicines. People who need to continue these medications over a period of time may need additional electrocardiograms every so often, to check for any heart problems that have developed recently. KardiaMobile six-lead (or 6-lead) is a portable electrocardiogram that may offer a less intrusive way to take electrocardiogram measurements. This is because less undressing is needed as the electrodes are only applied to fingers of the left and right hand and the left ankle or knee and the cold gel is not needed. Testing using the KardiaMobile six-lead device can be carried out at the patient’s home. These features might mean that the KardiaMobile six-lead device could be more acceptable than the 12-lead electrocardiogram to some patients. This assessment considered whether the KardiaMobile six-lead device has the potential to provide an effective and safe alternative to 12-lead electrocardiogram for initial assessment and monitoring of the risk of heart problems in people taking antipsychotic medications. Based on the available evidence, it remains unclear whether KardiaMobile six-lead has adequately demonstrated sufficient evidence of potential advantage(s) over current practice to justify further research to inform assessment of its clinical effectiveness and cost effectiveness. Our report provides detailed recommendations about the research needed, to provide further information about potential benefits so that a decision can be made about whether it should be used in the NHS in England, after further research has been completed.