KardiaMobile NICE MIB232

This guidance has been updated and replaced by NICE medical technologies guidance 64 published 6th January 2022.

The AliveCor KardiaMobile ECG PMS Instruments distribute has just been recognised by the National Institute for Health and Care Excellence (NICE) for the fast and precise ambulatory detection of atrial fibrillation.

The recently published NICE Medtech Innovation Briefing (NICE MIB232) demonstrates how AliveCor’s technology can support patients and health care professionals, and highlights alignment to the NHS long term plan.

Highlights from the NICE MIB232 report conclude:

  • The published evidence from 11 studies, across 1,218 adult patients, demonstrates that KardiaMobile can detect more cardiac arrhythmias, but can do so faster than standard care.
  • The brief showcases KardiaMobile’s diagnostic accuracy for detection of cardiac arrhythmias with sensitivity ranging between 77.0% and 96.6% and specificity ranging between 76.0% and 99.1%.
  • KardiaMobile is suitable for patients to use with suspected paroxysmal AF, which might not be detected using a standard 12-lead ECG if the person is not in arrhythmia at the time of recording.
  • The convenience of an at-home medical-grade ECG that can be taken at any time of the day increases the diagnostic yield of an arrhythmic episode being detected and recorded.

It was also noted that patients preferred not having electrodes connected to the skin or travel to and from the surgery or hospital especially during the Covid 19 Pandemic.

All six experts involved with the studies described the technology as innovative. With one stating that it had already changed clinical pathways for those with suspected arrhythmia, one that it had potential to change standard of care, and another suggested it could be used in settings, outside of healthcare.

All of the experts thought that this technology had the potential to change standard care in some way (earlier diagnosis, quicker intervention, fewer hospital visits and referrals, fewer strokes) improving both patient outcomes and patient satisfaction.

At a cost of only £82.50 + VAT and ease of use compared to the cost of an ECG event recorder the KardiaMobile ECG could be a cost effective way of diagnosing AF earlier in suspected patients and improving patient outcomes.