NICE wants more data before recommending heart arrhythmias device

NICE has published new guidance stating the Zio XT “patient friendly” monitor for detecting abnormal heart rhythms is recommended only if NHS organisations collect further evidence of its benefits.

Patients will have access to the technology for three years while more data is collected to address “evidence gaps” about its benefits. 

After this time, NICE (the National Institute for Health and Care Excellence) will review the technology and make a final recommendation on its routine use in the NHS.

Worn constantly

The device is worn constantly for up to 14 days and can be fitted by a patient at home, and worn under clothes.

More than 1.2 million people in the UK are diagnosed with atrial fibrillation (AF), one of the most common cardiac arrhythmias. A further 500,000 people are believed to be living with undiagnosed AF. 

The Zio XT service could – if commissioned by the NHS – be used by more than 150,000 people.

AI algorithm

The technology comprises a waterproof biosensor patch and a report with a summary of data analysed using an artificial intelligence (AI) led algorithm. 

The biosensor patch is a small, lightweight, easy to wear electrocardiogram (ECG), that records and measures the heart’s electrical activity. 

The quantity of analysable data is larger than with the 24-hour Holter monitor which is current NHS standard practice. This means Zio XT is more likely to pick up arrhythmia. 

After use the patient removes the patch and sends it via Freepost for analysis.

Once the ECG recordings are analysed a report is sent to the NHS clinician for final analysis and interpretation.

Contact-free process

The process can be contact-free, which has proved useful during the COVID-19 pandemic. Patients have a telephone/video consultation before the biosensor is sent out to them.

Currently 12 hospital trusts across England are evaluating the Zio XT service, which costs £265 per patient.

Meindert Boysen, Deputy Chief Executive and Director of the Centre for Health Technology Evaluation at NICE, said: “This easy to use and innovative technology can aid the detection of cardiac arrhythmias with continuous monitoring for up to 14 days while allowing the patient to get on with their everyday life.

“The evidence shows that Zio XT increases how many people are diagnosed with cardiac arrhythmias. The diagnostic accuracy of the artificial intelligence-led algorithm looked to perform well in recognising arrhythmias.

“While we are pleased to recommend the use of Zio XT service, our committee has requested that further data must be collected to allow us to fully understand its impact on NHS resources and the long-term consequences of its use.”

Earlier this year Zio XT’s developer, iRhythm technologies, were winners of the Artificial Intelligence in Health and Care Award run by the Accelerated Access Collaborative with NHSX and NIHR (the National Institute for Health Research).

NHS AI Lab

Indra Joshi, director of AI at NHSX, said: “We will be testing ZIO XT and a number of other cutting edge technologies through our AI Lab in NHS services up and down the country to see how they could safely help patients and save resources.

“If the tests work well, it could generate the evidence for wider adoption across the NHS of an important potential heart disease detection tool.”

Zio XT is likely to be cost saving or similar in cost as using 24-hour Holter monitoring. This system involves a portable heart recording device fitted by a technician in a healthcare setting, who places electrodes on the patient’s chest to record their heartbeat for up to seven days.