3 Committee discussion

The medical technologies advisory committee considered evidence on digital technologies to support cardiac rehabilitation from several sources. This included evidence submitted by the companies, a review of clinical and cost evidence by the external assessment group (EAG), and responses from stakeholders. Full details are available in the project documents for this guidance.

The condition

3.1

Cardiovascular disease (CVD), also known as heart and circulatory disease, is a long-term condition that affects the heart and blood vessels supplying the organs in the body. The term CVD includes but is not limited to:

  • Coronary heart disease: This includes conditions that cause narrowing or complete blockage of the blood vessels supplying the heart. This results in increased pressure on the heart and can lead to acute coronary syndrome and heart failure.

  • Acute coronary syndromes: These are medical emergencies that include myocardial infarction (heart attack) and unstable angina (unexpected, severe chest pain).

  • Heart failure: This is when there is a structural or functional abnormality of the heart in which the heart cannot pump blood efficiently.

  • Valvular heart disease: This includes conditions in which one or more of the valves in the heart does not function properly.

  • Congenital heart disease: This is a group of conditions present at birth that affect the structure of the heart and the normal way the heart works.

  • Peripheral arterial disease: This is a condition that results from a build-up of fatty deposits in the walls of the arteries, which restricts blood supply to the muscles in the leg.

    CVD risk is higher in older people, in people living in more deprived areas and in certain ethnic groups. The incidence of CVD is increasing in younger people.

Current practice

Conventional cardiac rehabilitation

3.2

Cardiac rehabilitation is an established option for secondary prevention of CVD. A meta-analysis comparing cardiac rehabilitation programmes with at least 6 months of follow-up data compared with no exercise reported a statistically significant risk reduction in cardiovascular mortality and hospitalisations (Dibben et al. 2023). Conventional cardiac rehabilitation may consist of face-to-face sessions, or a hybrid programme of in-person group-based and home-based programmes (including paper manuals, live online classes, home visits or telehealth).

Core components of cardiac rehabilitation

Regional variation

3.4

Not all people with CVD are currently offered cardiac rehabilitation, and the provision of rehabilitation services varies by region (see NHS England's commissioning standards for cardiovascular rehabilitation). It is beyond the remit of this evaluation to determine whether cardiac rehabilitation should be offered to a wider population than in current practice. But the committee noted that offering additional modes of delivery for cardiac rehabilitation could reduce regional variation.

Unmet need

3.5

Cardiac rehabilitation in England, Northern Ireland and Wales is prioritised for people with acute coronary syndromes, coronary revascularisation and heart failure, in line with NHS England's commissioning standards for cardiovascular rehabilitation. In England in 2023, only 41% of people with acute coronary syndrome and 13% of people with heart failure who were eligible participated in cardiac rehabilitation programmes (National Audit of Cardiac Rehabilitation, 2024 [PDF only]). Stakeholders stated that a lack of access to cardiac rehabilitation services for people with heart failure. Digital technologies have the potential to improve access, uptake and adherence to cardiac rehabilitation programmes. This could reduce unplanned hospital admissions and acute events resulting from the condition progressing. Improved access could also reduce health inequalities by making cardiac rehabilitation accessible to people who would otherwise be unable to do in-person programmes.

Patient considerations

Features, personalisation and accessibility

3.6

The patient experts explained that cardiovascular conditions are lifelong conditions which affect all aspects of their life. They said that all the core components of cardiac rehabilitation are important (see section 3.3), not just exercise. They also said that digital tools should not exclude the human and social aspects of cardiac rehabilitation. One patient expert stated that having access to peer support is valuable to reduce feelings of isolation. They emphasised the importance of personalisation to ensure that digitally supported programmes meet the needs of the person with CVD. One patient expert suggested that digital platforms could be made more engaging by gamification. The committee agreed that the features, potential for personalisation and accessibility of a digital platform were important considerations when choosing a suitable programme.

Meeting the needs of different patient groups

3.7

The patient experts highlighted that current cardiac rehabilitation is typically focused on older people with prioritised conditions such as myocardial infarction. This does not meet the needs of all people with CVD, especially people who are younger, or who were previously fit and exercising frequently. There is limited evidence on the views of people with CVD who think that the current offer of conventional cardiac rehabilitation does not work for them. The patient experts suggested that offering digital options could help avoid feelings of alienation and exclusion, which reduce uptake and completion in these groups. To better understand when different modes might be suitable, the committee concluded that further research was needed on:

  • patient experiences of the current offer of cardiac rehabilitation

  • reasons for declining offers of cardiac rehabilitation.

    Stakeholders commented that the Pumping Marvellous Cardiac Rehab Platform was the only option available for cardiac rehabilitation for people with heart failure in some areas of the country where the service is not commissioned in the NHS.

Clinical effectiveness

Evidence base

3.8

The EAG prioritised 15 clinical-effectiveness studies for this evaluation, of which 5 were randomised controlled trials (RCTs). Eligible evidence was available for 8 of the 13 technologies:

  • 3 studies on Activate Your Heart (2 RCTs)

  • 1 study on Datos Health

  • 2 studies on D REACH‑HF

  • 1 study on Digital Heart Manual

  • 1 study on Gro Health HeartBuddy

  • 2 studies on KiActiv (1 RCT)

  • 2 studies on myHeart (1 RCT)

  • 3 studies on R Plus Health (1 RCT).

    For the other 5 technologies, no relevant evidence on clinical effectiveness was available.

Generalisability of study populations

3.9

The committee thought that the study populations were generally representative of the populations that access cardiac rehabilitation in the NHS. The studies included various populations, including people with stable angina, myocardial infarction, heart failure, coronary artery disease and revascularisation, as well as broad CVD populations. The populations typically included older adults (mean or median ages between 50 and 66 years) with a high proportion of White men. People who were less comfortable or skilled in using digital technology or had reduced access to the internet or smart devices, were commonly excluded across studies. In some studies, people with high depression or anxiety scores, or cognitive impairment, were also excluded. The EAG did not identify any other evidence addressing the scoped subgroups to determine whether the interventions had different effects in groups already underserved such as women, younger people and ethnic minority groups. So, further research is needed that includes underserved populations, and that analyses outcomes by subgroup.

Generalisability of non-UK evidence

3.10

The committee concluded that evidence from outside the UK was unlikely to be generalisable to clinical practice in the NHS. Studies providing evidence for Datos Health took place in Israel, and those for R Plus Health were in the US and China. The EAG noted that both population and healthcare system can affect generalisability. It stated that the population and healthcare systems in Israel and China were quite different to that in the UK. It also noted that the study done in the US was likely to have a more similar population, but the healthcare setting was very different. A clinical expert noted that the design of cardiac rehabilitation programmes is also very different between countries. They also noted that outcomes collected in these studies, such as peak oxygen uptake (VO2 peak), were not typically collected in NHS practice. The committee concluded that technologies should be designed to support cardiac rehabilitation programmes similar to those currently used in the NHS. It also concluded that evidence based in the UK is important to show the feasibility and effectiveness of digital platforms in the NHS.

Generalisability of evidence for paper manuals

3.11

The Digital Heart Manual and D REACH‑HF are digital formats of the paper manuals used to support home-based cardiac rehabilitation. The EAG did not think the evidence for paper manuals was relevant for this assessment. This was because it had received clinical advice that paper manuals and digital versions do not perform the same role in cardiac rehabilitation. The committee agreed that evidence for a paper manual is not necessarily generalisable to a digital tool because the change in format may affect how people use it. The company representatives mentioned that the content and healthcare professional facilitation for the Digital Heart Manual were identical between the paper and digital versions. But it added that D REACH‑HF includes remote monitoring of the user's progress tracker by the facilitating (supporting) healthcare professional.

Home-based cardiac rehabilitation is recommended as an option in NICE's guideline on acute coronary syndromes and NICE's guideline on chronic heart failure in adults, which would typically involve using a paper manual. The clinical experts stated that the risk that the digital versions would result in significantly worse outcomes than the paper manuals was low, but that this was uncertain. The committee concluded that further data would be needed to determine any difference in effectiveness between the paper formats and digital versions of the Digital Heart Manual and D REACH‑HF. Representatives for the Pumping Marvellous Cardiac Rehab Platform stated that it is based on evidence-based cardiac rehabilitation programmes used in the NHS. The committee noted that there was no direct evidence for the clinical effectiveness of the Pumping Marvellous Cardiac Rehab Platform. But, based on clinical advice and comments from stakeholders, it judged that the clinical risk to people with heart failure and financial risk to the NHS associated with using this technology compared to the cardiac rehabilitation programmes it is based on was low. So, these technologies could still be used while the evidence is generated.

Uptake, adherence and completion

3.12

Many studies reported uptake, adherence and completion of digital cardiac rehabilitation programmes, but the definitions of the outcomes varied. Uptake ranged from 7.51% to 100%, and completion ranged from 82.0% to 92.4% across the studies. There was limited data comparing uptake and completion between digital and conventional programmes. Because of the lack of subgroup analysis, there was no evidence that digital tools would increase uptake in underserved populations. But 1 study on Activate Your Heart reported that 54% of users would not have attended conventional outpatient cardiac rehabilitation. Users generally reported positive usability experiences across the studies, but the scales used were not validated. A prepublication study submitted reported that 6% of people with heart failure registered for the Pumping Marvellous Cardiac Rehab Platform had previously taken part in cardiac rehabilitation. The committee noted that most people in this study had not been referred by heart failure or cardiac rehabilitation teams. The clinical and patient experts stated that it was likely that digital technologies would increase uptake in certain groups who cannot or do not want to access in-person cardiac rehabilitation. This could include people with full-time work or caring commitments, younger people or people who think that the in-person offering is not suited to their needs (see section 3.6 and section 3.9). The committee concluded that further evidence is needed on uptake, adherence and completion in subgroups that are likely to benefit from using digital technologies.

Clinical outcomes

3.13

The committee noted that the evidence supporting the clinical benefit of digital cardiac rehabilitation was limited, but the available evidence suggested that the digital technologies could improve clinical outcomes. Definitions of clinical outcomes varied across the studies. Overall, the limited evidence available showed improvements in exercise capacity, cardiovascular risk profile and health-related quality of life for people using digital technologies. The maximum length of follow up in the included studies was 6 months. So, the effectiveness of the digital tools beyond 6 months is uncertain. The committee noted that long-term data was needed to evaluate the true effectiveness of these technologies. It also highlighted the importance of consistency in the outcome measures in future research and evidence generation.

Adverse events

3.14

The available evidence did not provide substantial information on adverse events or hospitalisation because of adverse events. The patient experts highlighted that it is important that tools are suited for the condition of the person having cardiac rehabilitation because inappropriate exercises could lead to adverse effects. The committee noted that some digital platforms are publicly accessible without referral by a healthcare professional. The clinical experts stated that a full clinical assessment would be needed before using any digital technology, to make sure the technology was suitable. The committee concluded that people should only be given access to digital platforms after an initial assessment, and that more evidence is needed on the rate and type of adverse events.

Cost effectiveness

Economic model

Model structure
3.15

The EAG developed an early economic model that estimated the cost effectiveness of digitally supported cardiac rehabilitation compared with conventional cardiac rehabilitation. It consisted of a short-term decision tree and a long-term state transition model with a 10‑year time horizon. For technologies for which information on uptake, completion and risk of secondary cardiovascular events was not available, these inputs were assumed to be the same as for conventional cardiac rehabilitation. The EAG did not include any subgroup analyses in the economic model because there was not enough evidence to inform inputs. The committee concluded that the model structure was appropriate but that the inputs were highly uncertain.

Base-case results
3.16

In the base case, all the technologies were cost saving compared with conventional cardiac rehabilitation. There were very small increases in quality-adjusted life years produced for technologies for which there was applicable evidence of clinical benefit. These results were driven by a decrease in costs associated with delivering cardiac rehabilitation sessions between the initial and final in-person assessment.

Modelling of decision question
3.17

The NICE scope defined the intervention as the choice between conventional and digital cardiac rehabilitation, compared with conventional cardiac rehabilitation alone. There was no evidence evaluating digital technologies alongside conventional cardiac rehabilitation. So, the EAG's model directly compared digital cardiac rehabilitation with conventional cardiac rehabilitation. In a scenario in which the choice of modes was compared with the offer of conventional cardiac rehabilitation only, the EAG noted that the total costs and utilities for the choice arm would be a weighted average of both options depending on uptake rates for each mode. This would be cost effective using the EAG's assumptions.

Assumption of clinical equivalence
3.18

The limited evidence on the impact of digital technologies on secondary cardiovascular events showed that they had similar treatment effects to conventional cardiac rehabilitation. So, clinical equivalence was assumed for most technologies in the base case. Only 2 technologies (R Plus Health and Gro Health Heart Buddy) had evidence of impact on cardiovascular risk that could be used in the model. The EAG tested the assumption of equivalence of digital cardiac rehabilitation and conventional cardiac rehabilitation in a scenario analysis. This showed that digital cardiac rehabilitation remained cost effective as long as the 10‑year risk of secondary cardiovascular events was no more than 0.1% to 0.3% higher than with conventional cardiac rehabilitation. The committee accepted that the assumption was plausible but uncertain. It noted that the model did not provide information on how effective digital cardiac rehabilitation would have to be to be cost effective compared with no cardiac rehabilitation for the people who would not otherwise have conventional cardiac rehabilitation. But it agreed that digital cardiac rehabilitation was likely better than no cardiac rehabilitation. The existing evidence base also supported significant clinical benefit with cardiac rehabilitation compared with no cardiac rehabilitation (see section 3.2).

Cost of conventional cardiac rehabilitation

3.19

The committee recalled that cost effectiveness was driven by the cost differences resulting from the reduced number of face-to-face appointments (see section 3.15). For the base case, the cost for each cardiac rehabilitation session was based on NHS reference costs. This resulted in a total cost of £862.17 for 8 sessions including consultant-led initial and final assessments. The model was sensitive to the cost of an in-person session, which was explored in the sensitivity analyses using alternative cost inputs. When lower costs for cardiac rehabilitation sessions were used, digital tools were dominated by (that is, were more expensive and less effective than) conventional cardiac rehabilitation.

The clinical experts questioned the use of consultant-led reference costs for the initial and final assessments. They stated that these appointments are usually held by a cardiac rehabilitation nurse or physiotherapist. They also stated that it is unlikely that a consultant would lead this task, and that multiple allied healthcare professionals may be involved. The EAG suggested that the cost of a consultant-led session presented in their report could be seen as representing the time of 1 or more cardiac rehabilitation specialists. The EAG also noted that this cost was applied for both digital and conventional cardiac rehabilitation arms, so had little impact on the results. The cost difference between arms was largely because of the avoidance of 6 non-consultant-led sessions when using the digital technologies. The committee concluded that further data is needed to determine the true cost of conventional cardiac rehabilitation.

Suitability of technologies for evidence generation

3.20

The committee recalled that the available clinical evidence suggested that digital technologies for supporting cardiac rehabilitation may be clinically effective (see section 3.8). But it also recalled that it was uncertain whether digital and conventional cardiac rehabilitation could be considered equivalent (see section 3.18). It noted that there was limited evidence on the impact on overall uptake of cardiac rehabilitation of offering digital tools. But it thought it was likely that introducing them would increase uptake. The committee concluded that offering digital technologies was likely to improve health by providing an option for people who currently have nothing at all. But it said that there needs to be an initial assessment to determine suitability of the technology for the person.

There is limited UK evidence on some digital technologies to support cardiac rehabilitation. The committee noted that the health systems and structure of cardiac rehabilitation programmes in China, Israel and the US are not comparable to those in the UK (see section 3.10). So, UK evidence is needed before Datos Health and R Plus Health can be widely used. It recalled that the Digital Heart Manual and D REACH‑HF did not have clinical evidence, but that there was a substantial evidence base for the predecessor paper manuals. The committee concluded that it is unlikely that the change in format would add much clinical risk, especially for people who would otherwise not do cardiac rehabilitation (see section 3.11). So, it concluded that these technologies can be used while more evidence is generated on the impact of changing the mode of delivery.

The committee recalled that there was no direct evidence of the clinical effectiveness of the Pumping Marvellous Cardiac Rehab Platform. The committee heard that it was designed using evidence-based cardiac rehabilitation programmes used in the NHS for people with heart failure (see section 3.11). It also noted that the Pumping Marvellous platform has no licence fee. Based on clinical advice and comments from stakeholders, it concluded that the clinical risk for people with heart failure and financial risk to the NHS resulting from offering the option of using the platform was low. This was particularly so, considering the already low uptake of conventional cardiac rehabilitation by people with heart failure (see section 3.5). The committee considered that it would be beneficial to include the platform in the evidence generation because it was likely to be used widely because of the low cost. Beat Better, Luscii vitals and Get Ready had no relevant clinical evidence, so the committee concluded that they should be used in research only.

Equality considerations

Age and sex

3.21

The committee noted that younger people with CVD may prefer digital tools because they allow more independence while still providing support from healthcare professionals. They stated that people with work or caring commitments are less likely to do in-person cardiac rehabilitation (see section 3.12) and noted that most unpaid carers are women. So, introducing digital tools could reduce inequalities in uptake of and adherence to cardiac rehabilitation by age and sex.

Groups that may find digital tools challenging to use

3.22

The committee recognised that using digital tools may be challenging for some people such as:

  • older people

  • people with dexterity issues

  • people who do not have regular access to smart devices or the internet

  • people who do not have English as a first language

  • people experiencing homelessness or living in houses in multiple occupation or in residential care.

    Additional support and resources may be needed for these groups. The clinical experts also noted that some of these groups are already less likely to do cardiac rehabilitation, so introducing digital tools could widen existing equality gaps. The EAG's economic model assumed that a tablet computer and monthly internet access would be provided to reduce the risk of digital exclusion. The committee also recalled that the evidence base was limited and that there was no analysis on subgroups (see section 3.9). The committee concluded that more data is needed on the usability and acceptability of digital tools in different groups.

    The committee recalled that many studies excluded people with high depression or anxiety scores, or cognitive impairment (see section 3.9). The clinical experts stated that these people would need further clinical support outside of the cardiac rehabilitation programme, and that this should be recognised at the initial assessment. The committee concluded that further research is needed on uptake and effectiveness in these subgroups. But it added that the suitability of the technology should be considered in the initial assessment.

Ethnic, religious and cultural background

3.23

The clinical experts noted that people's ethnic, religious or cultural background may affect how cardiac rehabilitation should be delivered. For example, dietary advice may need to be tailored to the cultural background of the person with CVD. The committee stated that healthcare professionals should discuss the language and cultural content of digital technologies as part of the initial assessment.

Evidence gap review

3.24

The EAG identified the following evidence gaps relating to the population, intervention and comparator, outcomes, and costs and resource use.

Population

3.25

The clinical experts highlighted that the study populations did not entirely represent the cardiac rehabilitation population. The studies generally excluded people less comfortable and skilled in using digital technologies, with limited access to the internet or smart devices or with significant comorbidities. These are factors that may affect people who currently benefit less from cardiac rehabilitation. These people could be disadvantaged by using digital technologies. The committee agreed that further research is needed on the benefits and risks of using digital cardiac rehabilitation in populations commonly excluded from cardiac rehabilitation.

Intervention and comparator

3.26

There was no eligible evidence for some of the technologies. Evidence comparing the digital technologies with the scoped comparator of conventional cardiac rehabilitation was limited. The committee agreed that further research is needed on the offer of both digital and conventional cardiac rehabilitation compared with conventional cardiac rehabilitation alone. There is also a need for research on any differences in effectiveness between the paper and digital formats.

Outcomes

3.27

The reported outcomes varied across the studies. Length of follow up was relatively short, with no studies having follow up of longer than 6 months. There was no evidence for outcomes in the subgroups defined in the scope, especially for uptake and completion of the programmes. No evidence on adverse events was reported. The committee noted that long-term data is needed to evaluate the true effectiveness of these technologies. Also, more research is needed to determine whether digital technologies improve uptake and completion of cardiac rehabilitation programmes in certain subgroups (see section 3.9). More research is also needed on adverse events.

Costs and resource use

3.28

The cost of conventional cardiac rehabilitation was a key area of uncertainty, which had a substantial effect on the model results. So, more evidence is needed on the cost of delivering conventional cardiac rehabilitation.