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NICE recommends Zio XT system to detect cardiac arrhythmias but say more research is needed

The National Institute for Health and Care Excellence (NICE) now recommends, in a new medical technology guidance, the use of the Zio XT system (iRhythm) to detect cardiac arrhythmias in people who would benefit from ambulatory electrocardiogram (ECG) monitoring for longer than 24 hours. However, according to NICE, the recommendation is with the caveat that further data for the system “must be collected”.

Under the new guidance, people at risk of cardiac arrhythmias will have access to the new service for three years while more data are collected to address evidence gaps about its benefit. A press release reports that, 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 in the NHS.

According to the press release, 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 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 arrhythmias. After use, the patient removes the patch and sends it via freepost for analysis. The ECG recordings are then analysed using an AI-developed algorithm, overseen by the company’s cardiographic technicians. A full report is then supplied to the NHS clinician for final analysis and interpretation.

Currently 12 hospital trusts across England are evaluating the Zio XT service, which costs £265 per patient. The press release notes that the Zio XT process can be contact free, which it says is “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”.

Meindert Boysen, deputy chief executive and director of the Centre for Health Technology Evaluation at NICE, comments: “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 AI led algorithm looked to perform well in recognising arrhythmias.” Additionally, Zio XT is likely to be cost saving or similar in cost as using 24-hour Holter.

Commenting on the news, Justin Hall, GM and VP EMEA at iRhythm says: “We are delighted that Zio has received such positive guidance from NICE in this first-of-its-kind evaluation, especially at such a critical time. Throughout the COVID-19 pandemic we have seen a number of cardiac patients avoiding hospitals and suffering in silence, even when experiencing serious conditions such as strokes. This has led to a backlog of patients requiring care, putting additional pressure on medical staff and services.”

Via its Patient Resources pages, Arrhythmia Alliance offers free of charge the “Which ECG is right for you” booklet. This booklet helps people understand the reasons why an ECG might be needed and provides an overview of the different types of ECG that are available.

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