KardiaMobile® for detecting atrial fibrillation
Scottish Health Technologies Group (SHTG)
SHTG Recommendations for NHSScotland
Single-lead KardiaMobile® is recommended as an option for detecting atrial fibrillation (AF) for people with suspected paroxysmal AF, who present with symptoms such as palpitations and are referred for ambulatory electrocardiogram (ECG) monitoring by a clinician.
The Scottish Health Technology Group (SHTG) recommendation is based on guidance produced by the National Institute for Health and Care Excellence (NICE) in 2022.1
NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice.
How the Council reached the recommendation
When formulating their recommendations, the Council took into account the NICE guidance and the evidence review underpinning it, and the views of the Scottish topic experts.
- The Council noted that the 6-lead KardiaMobile® device (KardiaMobile-6L®) has extra functionality compared with the single-lead device. For example, the single-lead KardiaMobile® device sends the ECG recording wirelessly to a smartphone using high frequency sound waves, whereas the six-lead device uses Bluetooth which may be less influenced by background noise. The Council agreed that because the clinical and cost effectiveness evidence in the NICE guidance was only on the single-lead device, that the recommendation for NHSScotland should be limited to the single-lead device.
- The Council accepted that most people find KardiaMobile® easy to use, and that the technology has the potential to improve access to care particularly for people in remote and rural areas. Consideration needs to be given to ensure equity of access across all populations. For example, where necessary, access to a smart device should be provided alongside KardiaMobile® to ensure otherwise eligible people are not excluded.
- The Council felt that further consideration needs to be given to the impact of KardiaMobile® on the workload of healthcare professionals using the device. Devices like KardiaMobile® have the potential to reduce overall hospital appointments. KardiaMobile® traces may be quicker to analyse than the extensive data produced from some other ambulatory ECG monitors, yet provision of KardiaMobile® may make workloads less predictable compared to other types of monitors, and there may be training requirements for some professional groups (for example, staff in primary care).
- There is no definitive guidance in the UK on whether a diagnosis of AF should rely on a standard 12-lead ECG recording. The Council noted guidelines from the European Society of Cardiology, which state that a single-lead ECG tracing of ≥30 seconds or 12-lead ECG showing AF analysed by a physician with expertise in ECG rhythm interpretation is necessary to establish a definitive diagnosis of AF.
Date of publication: 27 July 2022