Tag: KardiaMobile

NICE One! KardiaMobile Recommended For AF Detection.

The National Institute for Health and Care Excellence (NICE) have recently published a Medical Technology Guidance report (MTG) 64 featuring the AliveCor KardiaMobile. KardiaMobile is now the first and only NICE recommended personal ECG device for detecting atrial fibrillation in an ambulatory setting.

KardiaMobile is now NICE accredited.

KardiaMobile is recommended 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.

Why did NICE make this recommendation?

Detecting atrial fibrillation in people with suspected paroxysmal AF usually involves wearing a continuous ECG Holter monitor. KardiaMobile is a portable wireless ECG recorder that can help detect AF.

The NICE committee consisting of a panel of experts looked at published clinical evidence that shows significantly more people had AF detected using the KardiaMobile single-lead device compared with a Holter monitor.

The clinical experts agreed that monitoring with KardiaMobile could increase infrequent AF event detection because it could record an AF event whenever symptoms are presented. 

Cost modelling shows that KardiaMobile is cost saving compared with a Holter monitor by an average of £13.22 per patient over 2 years in people presenting with symptoms such as palpitations. 

This positive recommendation acknowledges AliveCor’s digital innovative technology and empowers patients and doctors to remotely monitor their heart rhythm.

KardiaMobile can support an earlier diagnosis of AF in an ambulatory setting and this recommendation highlights AliveCor’s commitment to the NHS Long Term Plan to reduce the incidence of cardiovascular disease in the UK.

KardiaMobile is the world’s most clinically-validated personal ECG. Unlike traditional ECGs, KardiaMobile provides a compact, patchless and wireless solution that can be used at any time and anywhere.

The user starts a 30-second ECG recording on their smartphone via the Kardia app – by placing two fingers from each hand on each of the two top electrodes – enabling the patient to remotely capture a medical-grade recording of their heart activity. KardiaMobile provides instant detection of AF, bradycardia and tachycardia, which are leading indicators of cardiovascular disease.

KardiaMobile can also detect normal heart rhythm, offering users peace of mind.

This guidance replaces NICE’s earlier medtech innovation briefing on KardiaMobile for the ambulatory detection of atrial fibrillation (MIB232) published in October 2020.

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.

Lead I I-ECGs could detect AF more accurately than a manual pulse check

A new study which looks at Lead-I ECG for detecting atrial fibrillation in patients with an irregular pulse using single time point testing has been published in Health Technology Assessment Volume: 24, Issue: 3 January 2020 https://doi.org/10.3310/hta24030

This study aimed to assess whether or not the use of lead-I ECGs in GP surgeries could benefit patients and offer good value for money to the NHS.

The objective was to assess the diagnostic test accuracy, clinical impact and cost-effectiveness of using single time point lead-I ECG devices for the detection of AF in people presenting to primary care with relevant signs or symptoms, and who have an irregular pulse compared with using manual pulse palpation (MPP) followed by a 12-lead ECG in primary or secondary care.

The study found that if GPs were to routinely use lead-I ECG devices, including the AliveCor KardiaMobile, people with suspected AF could receive treatment while waiting for the AF diagnosis to be confirmed by a 12-lead ECG.

The study found that using a manual pulse check followed by a lead-I ECG offers better value for money when compared with a manual pulse check followed by a 12-lead ECG. This is mostly because patients with AF can begin treatment earlier when a GP has access to a lead-I ECG device.

The report also stated that the AliveCor KardiaMobile lead –I ECG is the most cost-effective option in a full incremental analysis.