Written evidence submitted by iRhythm Technologies
- Organisation name: iRhythm Technologies
- Your role in lead organisation: UK Product Marketing Manager
- iRhythm Technologies is a digital healthcare company redefining the way cardiac arrhythmias are clinically diagnosed. We combine wearable biosensor devices worn for up to 14 days and cloud-based analytics with powerful proprietary algorithms that distil data from millions of heartbeats into clinically actionable information. As an organisation, we believe improvements in arrhythmia detection and characterisation have the potential to change clinical management of patients.
- We created Zio XT, a unique service to enable clinicians to diagnose arrhythmias more quickly and efficiently than traditional technologies, reducing the need for multiple indeterminate tests and enabling sufficient medical intervention to reduce the likelihood of more serious events, such as strokes.
- Wearing Zio for 14 days is preferred than wearing a Holter for 24hrs , as it is easily fitted and almost unnoticeable to wear – ensuring they can continue with their daily activities as normal, including sleeping, showering, and exercising. Our own data has also indicated that 98% of patients comply with the prescribed wear time with Zio XT.
- The device is worn by patients for up to 14 days and is analysed by an AI algorithm alongside a a team of certified cardiac technicians. The longer wear time is beneficial in comparison to a traditional 24-hour Holter monitor because Zio detects 57% more arrhythmia events. If these same patients wore a Holter for 24-48 hours it is likely that their arrhythmia would have been missed, leading to unnecessary repeat testing, more time taken out of clinicians’ days and most importantly, patients potentially being misdiagnosed.
- In September 2020, iRhythm was named a winner of NHS England’s Artificial Intelligence (AI) in Health and Care Award, in partnership with the Accelerated Access Collaborate (AAC), NHSX (now merged with NHS Digital) and the National Institute for Health Research (NIHR). The aim of the Award was to benefit patients by combining AI with NHS expertise to improve health and care outcomes.
- The funding gained from the Award was used to evaluate Zio XT at 8 selected NHS sites across England, including Barts Hospital, Liverpool Heart and Chest Hospital and East Kent Hospitals University NHS Foundation Trust.
- The reason we are responding to the Department for Health and Social Care’s (DHSC) Call for Evidence is because we acknowledge and understand first-hand the severity of patient waiting lists and the NHS backlog, particularly in the aftermath of the Covid-19 pandemic. Waiting lists are a particular concern for cardiology, as conditions such as Atrial Fibrillation causes 20% of all strokes, which kills thousands of people each year and costs the NHS billions. The longer a person continues to be untreated for AF, the more likely a stroke is to occur. Speed is of the essence when dealing with cardiovascular conditions – still the leading cause of death in the UK – so it is vital to make provisions to ensure that waiting list times are reduced as much as possible.
- As an organisation that has worked extensively with NHS trusts in England, we feel we are appropriately placed to comment on the role of DHSC and NHS England in providing positive patient outcomes.
- iRhythm Technologies would like to see the design and implementation of national recovery plans from the Covid-19 pandemic centre around the positive impact that digital innovators within the health sphere can – and continue to – have on facilitating better patient outcomes and supporting more productive clinician workflows.
- As the blurb of this Call for Evidence draws attention to the use of independent sector providers (such as iRhythm Technologies), we feel it is important for DHSC and NHS England officials to commit to working extensively with charities, social enterprises, private and public limited companies, all of whom have detailed understandings of their specific health areas.
About cardiology in healthcare
- According to the British Heart Foundation, there are approximately 7.6 million people in the UK living with a heart or circulatory disease: 4 million men and 3.6 million women. This significant figure is due to a variety of reasons, including increased sedentary lifestyles, poor diets, and a rise in tobacco use.
- Atrial fibrillation (AF) is a heart condition that often causes irregular heart rates. It is the most commonly sustained cardiac arrhythmia, and NICE has estimated that its overall population prevalence in England is 2.5%. Having AF makes you five times more likely to have a stroke, affecting around 100,000 people a year and causing approximately 38,000 deaths. NHS statistics also estimate that strokes cost the health service around £3 billion every year, in addition to a further £4 billion in lost productivity, disability and informal care.
- Data provided by all NHS trusts across England has found that, as of September 2022, 338,232 people were waiting for key cardiology appointments that could provide them with the diagnosis and support needed to continue living healthy lives. This is an increase of 1.08% from the previous month, as well as a 51.23% increase since January 2020, which equates to 114,579 more people waiting for a cardiology appointment. This is likely to continue to grow even further and put additional strains on an already overwhelmed health service unless effective interventions are put in place.
Design of national recovery plans
- iRhythm Technologies welcomed the elective recovery plan to tackle the backlog. The plan was developed by the NHS together with Royal Colleges, patient groups and health charities. We felt the plan was inclusive of addressing the key challenges in capacity and giving patients more freedom over their own care.
- iRhythm Technologies especially welcomed the emphasis on building on from the positive lessons we learnt from the pandemic, by further including digital tools and data to drive delivery of services to manage waiting lists. The TechForce19 Challenge awarded up to £25,000 to innovations that offered a digital way to support people who needed to stay at home during the pandemic. Innovations awarded the money were then rapidly implemented nationally to support the Government’s efforts during the pandemic.
- The example of Techforce19 could have been taken even further if private providers were brought in on the design-stage of the plans. iRhythm Technologies’ Zio XT has been proven to increase arrythmia detection 3x compared to traditional Holter monitors. This is because of the quality and quantity of data collected from the device, analysed using AI algorithms, and over seen by cardiac technicians providing data-driven accuracy, fast.
- If this approach, that many private providers and digital healthcare companies value, was taken into account at the design stage of the elective recovery plans, we believe we would have seen a bigger role for technology and data not only in prioritising the take-up of time saving technologies and devices, but as an overarching theme in the efforts to reduce patient backlogs.
- The limited engagement with the private health sector also meant a lack of incentives provided in the plans to innovate technology specifically aimed at reducing the backlog. Other sectors have already initiated similar efforts to accelerate connecting technology to the broader ecosystem. For example, in the insurance sector, The Lloyd’s Lab was created by Lloyd’s of London as a tactic to reinforce its long-term sustainability. In short, the Lloyd’s market outlines the current barriers and challenges to growth and innovation, then the Lab seeks to find innovative businesses and individuals globally who have the technological solutions to solve these challenges. Its cohort-based system has been hugely successful in the insurance market, and it is a system that could be effectively replicated in the NHS, where a dedicated team seeks to find the most innovative businesses globally and connects them to health leaders and key sites to implement these solutions at speed.
- The plan for tackling the backlog of elective care revolved around maximising NHS capacity. The plan was to support systems to deliver around 30 per cent more elective activity than before the pandemic by 2024-25. The plan was backed by a £700 million scheme to speed up the recovery of elective services, by giving this money to 180 NHS trusts, split between 870 different schemes such as operating theatres and mobile diagnostic centres. Whilst it was right to invest this money on facilities, the lack of plan to overcome chronic workforce shortages is clear.
- The design of a workforce plan has been seen as a priority by patient and health groups. Whilst the plan to tackle backlogs recognised that delivering elective recovery will require more staff and more opportunities for existing staff, it should also recognise the possibilities for maximising staff’s time. iRhythm values and recognises the need for this, which is why we have designed our service to help reduce outpatient follow-ups and thus save clinicians’ time.
- There was scope to include a workforce plan within the backlog recovery plans and it was disappointing that this was not done. Thus, the whole health system could benefit from a separate workforce plan that not only addresses the shortage, but could implement innovation and technology that saves time, creates staff and system efficiencies, releasing resource and improving capacity.
Progress made in recovering services
- Digital healthcare companies have played a key role in supporting NHS waiting lists, and cardiology is no different. As part of iRhythm’s funding from the NHS’ AI in Health and Care Award, reducing patient backlogs has been a key achievement of the process, highlighting the importance of engagement with private industry players to support the NHS’ biggest challenges.
- It is therefore vital that DHSC and NHS officials fully understand the key role that digital innovators have already played in the NHS framework. These positive case studies in hospitals as part of the AI Awards highlight the potentially huge improvements that can be implemented at speed across the NHS nationwide if technologies such as Zio XT were adopted. After all, waiting times have increased significantly within cardiology, so it is important for the NHS and DHSC to look at innovative ways to reduce this – especially as heart and circulatory diseases cause a quarter of all deaths in the UK.
- The Government and the NHS must encourage more people to visit their GP, as there is a very real risk of undiagnosed conditions rising across various health conditions, leading to costly and deadly conditions such as strokes.
- The current process for long-term funding within the NHS framework is long and uncertain, particularly as the current adoption pathways – whilst welcomed and undoubtedly useful – do not provide a guarantee of funding, which can cause issues if Trust/ICS budgets cannot accommodate an in-year increase in costs, even if it leads to savings over three years.
- The NHS has shown that it is willing to find solutions to these challenges, and it is a welcomed step that the NHS believes healthtech can play a vital role in this – shown by the introduction of the MedTech Funding Mandate.
- It is also worth noting that AF prevalence rates across the UK have not been updated since 2020. This means that there is not a clear national estimate of how many people across the country are currently living with the condition, as of 2022. It is vital to have this information, as it would help to inform both the NHS and the DHSC whether the growing rate of diagnosis is consistent. The lack of current data could suggest that a significant number of people living with the condition are not being diagnosed – which is certainly likely given that the Covid-19 pandemic led to people avoiding seeing their GP and going to hospitals - putting them at significant risk of future medical episodes such as strokes.
Implementation of recovery plans (including the use of independent sector providers)
- The recovery plans have a focus on improving patient outcomes and their experience of NHS services. To do this, Sir David Sloman, Chief Operating Officer of NHS England, and Sir James Mackey, National Director of Elective Recovery, outlined the following ways as priority areas.
- Making progressive improvements on long waits, with a goal to eliminate waits of over one year by March 2025 and waits of over two years by July 2025.
- Reduce diagnostic waiting times, with the aim of least 95% of patients receiving tests within 6 weeks by March 2025.
- Deliver the cancer faster diagnosis and return the 62-day backlog to pre-pandemic levels by March 2023.
- Working with patient groups and stakeholders to better monitor and improve both waiting times and patients’ experience of waiting for first outpatient appointments over the next three years.
- The implementation of the delivery plans for tackling the backlog of elective care has been taken forward rapidly. This has required significant investment in capacity as well as skills whilst balancing the problems of the workforce shortage.
- The recovery plans have also seen the opening of more surgical hubs across England, that focus on high-volume routine surgery. These hubs have created extra capacity for the routine surgeries. In August, Secretary of State Steve Barclay announced 50 new hubs providing at least 100 operating theatres and 1,000 beds. Given the focus of these hubs on high-volume low complexity surgeries, they have less of an effect on cardiology waiting times.
- Community diagnostics centres were introduced in 2021 as part of the efforts to clear backlogs. There were 40 centres, backed by £2.3 billion of funding. In April 2022, 73 centres were operational, providing an additional 30,000 tests a week.
- One goal of the elective recovery plan was also to “ensure that innovations put in place by local areas can be expanded”. Though hard to measure, no estimates have been made on the progress of this. For example, iRhythm’s Zio patch has helped clinicians in Liverpool reduce the need for patient appointments which helped tackle waiting lists, resulting in a reduced wait time at the Trust from eight weeks at its highest, to just a few days. Devices and technologies that have proven outcomes like Zio could be more readily implemented nationally to reduce patient backlogs.
- Delays discharging into the community/social care continue to apply additional pressure on bed capacity in hospitals, with only 45% of patients discharged when they were ready a month earlier, and an average of 13,388 beds a day in August were taken up by patients who no longer need to be there.
- The problem of late discharge was the focus of the previous administration’s plan for patients. The £500 million funding was supposed to be targeted at freeing more beds in helping to clear the NHS backlog. With iRhythm’s technology, instead of spending 24-48 hours in hospital taking up a bed and being connected to a traditional Holter, which can often happen with patients required to wear a Holter, the patient can go home and wear a device through which they can be monitored remotely. Innovations like the Zio XT patch are readily available to ease the burden on hospitals, and iRhythm would welcome an opportunity to highlight further how innovations such as these can be implemented at scale and at speed across the NHS in England.
 Barrett et al., Comparison of 24-hour Holter Monitoring with 14-day Novel Adhesive Patch
Electrocardiographic Monitoring. American Journal of Medicine, 2014.
 Data on file. iRhythm Technologies, 2019.
 Barrett et al., Comparison of 24-hour Holter Monitoring with 14-day Novel Adhesive Patch Electrocardiographic Monitoring. American Journal of Medicine, 2014.
 British Heart Foundation, Facts and figures, 2022.
 NICE, Atrial fibrillation: How common is it? 2022.
 Stroke Association, Atrial fibrillation, 2022.
 NICE, Stroke and TIA: What is the prevalence of stroke and TIA in the UK? 2022.
 NHS, NHS Stroke action will save hundreds of lives, 2019.
 NHS Trusts in England, Waiting list tracker, 2022.
 NHS Trusts in England, Waiting list tracker, 2022.
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 Public Health England, Research and analysis: Atrial fibrillation prevalence estimates for local populations, 2020.
 Liverpool Echo, ‘AI device cuts waiting times for heart patients to 'matter of days'’, 2022.