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KardiaMobile for detecting atrial fibrillation

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4 Committee discussion

Clinical-effectiveness overview

KardiaMobile single-lead device is associated with improved detection of atrial fibrillation

4.1 The committee noted considerable evidence from 6 comparative studies, including 3 RCTs, showed improved atrial fibrillation (AF) detection using the single-lead KardiaMobile. The clinical experts agreed that monitoring with KardiaMobile could increase AF detection because it could record an AF event whenever symptoms are presented. The committee agreed that there is a strong case for patient benefit.

KardiaMobile single-lead device is an option for detecting AF but there is no evidence on the 6-lead device

4.2 The committee noted that all the evidence on the clinical effectiveness of KardiaMobile was on the single-lead device. It was advised that the single-lead device is commonly used in clinical practice to detect AF, and the use of the 6-lead device is limited in the NHS. The clinical experts agreed that the 6-lead device had no additional benefit for detecting AF but it could be helpful to detect other arrhythmia. The committee concluded there was no additional benefit from using the 6-lead device compared with the single lead KardiaMobile for AF detection.

KardiaMobile is an easy-to-use technology and its accessibility means it is well suited for ambulatory monitoring

4.3 Evidence from published studies and patient experts shows the KardiaMobile device is easier to use compared with other electrocardiogram (ECG) monitors such as the Holter monitor. People who had experience of using KardiaMobile found the device to be accessible at symptom onset and allowed improved access to care when needed. The experts noted that age is not a barrier preventing people from using KardiaMobile. It has been well accepted across people in different age groups if they have a compatible mobile device. The committee concluded that KardiaMobile is a convenient device that people can use at home to monitor their heart rhythms.

Evidence supports the use of KardiaMobile for improved detection of atrial fibrillation and atrial fibrillation recurrence, especially in people with palpitations and who need to monitor AF recurrence

4.4 The clinical evidence supported the use of KardiaMobile in 6 broad populations groups (see section 3.1). The EAC advised the evidence base was strongest in people with undiagnosed palpitations and people with a history of AF who need to monitor their AF recurrence. The experts noted that, in clinical practice, KardiaMobile has been most commonly used in these 2 groups. The committee concluded that the population groups in the evidence base reflected use of the KardiaMobile device in a wide range of relevant clinical contexts but it considered the most persuasive clinical cases were people with undiagnosed palpitations and people with a history of AF who need to monitor their AF recurrence.

Additional information about the long-term clinical consequences of using KardiaMobile would be valuable

4.5 The clinical experts advised that AF is a chronic condition. After AF is diagnosed, people are likely to be on medications such as anticoagulation or anti-arrhythmia to reduce the risk of stroke and control symptoms for a long time. The experts noted that KardiaMobile could improve medication management; for instance, some medications can only be used when normal heart rhythm is restored. However, no direct evidence was available on the clinical benefits of KardiaMobile after diagnosis of AF; for example the association between the early AF detection and reduction in longer-term outcomes such as stroke events. The committee understood the limitations of the evidence base and concluded that more research on the long-term clinical outcomes of using KardiaMobile would be valuable.

NHS considerations overview

Patient selection will improve the care pathway and should be guided by clinical judgement

4.6 Patient selection is important and should be guided by clinical judgement. The clinical experts emphasised that devices need to be offered to people on an individual basis guided by clinical assessment of individual circumstances. Key factors to consider include: risk of developing AF, age, comorbidities, and the availability of primary and secondary care resources to interpret ECG traces. Furthermore, other factors such as the compatibility of mobile devices and patient preference also need to be considered. They noted that widespread use of KardiaMobile in the NHS without careful patient selection may place extra demand on local services. The committee concluded that healthcare professionals should assess individuals and indications when considering whether to prescribe KardiaMobile.

KardiaMobile is not intended to be used for diagnosing AF and its outputs should be reviewed by a healthcare professional

4.7 The committee noted that one of KardiaMobile's advantages over some other technologies is that it is a portable device that provides real-time ECG traces and heart rhythm classification. Despite this, the external assessment centre (EAC) confirmed that clinical interpretation of all recorded ECGs is needed, in line with the device instructions for use, to limit the effect of false negative and false positive results. The clinical experts added that expertise in interpreting ECG traces is essential to ensure the accuracy of AF diagnosis. Also, the experts added that a considerable proportion of unreadable and unclassified ECG recordings would be interpretable by experienced healthcare professionals to inform clinical decision making. The committee concluded that ECG data generated by KardiaMobile should be reviewed by an experienced healthcare professional before a diagnosis is made.

Training is important to minimise unreadable ECG recordings when using KardiaMobile

4.8 The clinical experts highlighted the issue of unreadable ECG traces. They explained that the way people used the device is likely to affect the quality of ECG recordings. In clinical practice, healthcare professionals often provide support for people to set up the device, allowing them to also advise on effective use. There are also self-help videos that explain how to use the device. The clinical experts noted that a lack of experience using the device may lead to unreadable ECG recordings. The committee concluded that training is important to make sure people use the device correctly and minimise possible interference while taking the recording.

Cost-modelling overview

The company's cost model estimated KardiaMobile to be cost saving compared with other ECG monitors but could not be validated by the EAC

4.9 The committee noted that the results from the company's cost model showed that KardiaMobile is cost saving compared with Holter monitor and the Zio patch over a 5-year time horizon. The committee noted however, that the EAC could not validate the company's model and did not replicate it because the EAC considered that the model structure, underlying assumptions, and parameters did not reflect the care pathway. The committee concluded that the cost savings presented in the company model are uncertain.

The EAC's cost calculator does not fully capture the cost impact of KardiaMobile

4.10 The committee noted that the EAC presented a cost calculator to further explore the cost consequences of using KardiaMobile to detect AF, based on the 6 published comparative clinical studies. The cost calculator results suggested that KardiaMobile could be cost saving in some scenarios over a 1-year time horizon. The potential savings were driven by the increased rate of detection of AF with KardiaMobile, leading to a reduction in the number of strokes. The EAC acknowledged the limitations of its cost calculator approach including a small selection of studies, comparators being restricted by the selected studies and without considering the effect of novel oral anticoagulants on stroke risk. The committee concluded that in the absence of a robust cost model the cost impact of using KardiaMobile is uncertain and it was therefore not possible to recommend for routine adoption in the NHS.

Further research

Further evidence on the cost impact of KardiaMobile for atrial fibrillation detection compared with standard care is needed

4.11 The single-lead KardiaMobile shows promise for improving atrial fibrillation detection, but further research is needed to evaluate the cost impact compared with standard care in the NHS. The committee agreed that further economic evidence based on robust modelling would help to better understand the cost impact of KardiaMobile for detecting atrial fibrillation and atrial fibrillation recurrence. This should include an economic model based on the evidence base where KardiaMobile shows greatest promise, including people presenting with palpitations and people who need to monitor AF recurrence.