NICE has today published medical technology guidance which recommends the Zio XT service for detecting abnormal heart rhythms, only if NHS organisations collect further evidence of its benefits.
Patients will have access to this promising new technology for three years while more data is collected to address evidence gaps about its benefit. After this time, NICE’s committee will review the technology with the new evidence and make a final recommendation on whether to recommend Zio XT for routine use on the NHS.
More than 1.2 million people in the UK are diagnosed with having atrial fibrillation (AF), one of the most common cardiac arrhythmias, an abnormality of the heart's rhythm. Another 500,000 people are believed to be living with undiagnosed AF. Zio XT service could – if commissioned by the NHS – be used by more than 150,000 people.
The Zio XT service comprises a waterproof biosensor patch and a report with a summary of data that has been 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. It is worn constantly for up to 14 days and can be fitted by a patient at home, discreetly underneath their clothes.
As the patch can be worn for up to two weeks, the amount of analysable data is larger than the 24-hour Holter monitor which is current NHS standard practice and therefore Zio XT is more likely to pick up arrhythmia. After use the patient removes the patch and sends it via freepost for analysis.
The ECG recordings are analysed using an artificial intelligence developed algorithm, overseen by the company’s cardiographic technicians. A full report is then supplied to the NHS clinician for final analysis and interpretation.
The process can be contact free, especially useful during the COVID-19 pandemic, allowing the patient to first have a telephone/video consultation before the Zio XT biosensor is dispatched direct to their home.
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 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.
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 – 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.