Summary

Summary

The AliveCor Heart Monitor and AliveECG app are, respectively, a pocket‑sized ECG recorder and a mobile device application for analysis and communication of the results. Two fingers from each hand are placed on the AliveCor Heart Monitor to record an ECG, which is transmitted wirelessly to the AliveECG app. The aim of the device is to identify paroxysmal atrial fibrillation (AF). Two clinical studies reported that the AliveCor Heart Monitor and the AliveECG app have sensitivity above 85% and specificity above 90% in identifying AF. An AliveCor Heart Monitor unit costs £62.49, excluding VAT; the AliveECG app is free of charge. An Australian study found that opportunistic, community‑based screening for undiagnosed AF, using the AliveCor Heart Monitor and the AliveECG app, was cost effective.

The AliveCor Heart Monitor was rebranded as Kardia Mobile in October 2016. AliveCor Heart Monitor and Kardia Mobile are functionally identical.

Product summary and likely place in therapy

  • The AliveCor Heart Monitor is a pocket‑sized electrocardiogram (ECG) recorder that is used with a mobile device app (application).

  • It detects paroxysmal atrial fibrillation and can be used by people with intermittent palpitations to help determine the cause of their symptoms.

  • The system would be used in any setting in place of existing portable ECG recorders. It is particularly designed to be used by people during their normal activities.

Effectiveness and safety

  • Two studies reported sensitivity higher than 85% and specificity higher than 90% for the AliveCor Heart Monitor and the AliveECG app, in detecting atrial fibrillation.

  • Two further studies of a clinician's ability to interpret AliveCor Heart Monitor readings reported sensitivity and specificity rates higher than 90%.

  • A user preference survey reported that most users preferred the AliveCor Heart Monitor to traditional transtelephonic monitors.

Technical and patient factors

  • The monitor contains 2 electrodes. It can be connected to the back of a smartphone or tablet using an adhesive attachment plate or used within range of a mobile device, to allow it to communicate wirelessly (using proprietary high frequency sound transmission) with the AliveECG app. The user places 2 fingers from each hand on the monitor for 30 seconds to take an ECG recording.

  • The AliveECG app analyses the ECG and alerts the user if AF is detected. The data held in the app is synchronised to the company's encrypted server and can be accessed by a healthcare professional using either a web‑based application or an emailed report.

  • The AliveECG app is available for Apple and Android operating systems.

  • Minimal training is needed to enable people to make ECG readings at any time.

Cost and resource use

  • An AliveCor Heart Monitor unit costs £62.49, excluding VAT. The AliveECG app and the Provider Dashboard are free of charge.

  • A health economic evaluation of community‑based screening in Australia reported that the AliveCor system was cost effective in detecting AF and preventing stroke, with an ICER of £2799 when compared with standard diagnostic assessment for AF, which included consultation with a GP and a specialist, and a 12‑lead ECG.