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Health economic evaluation of Coala Heart Monitor Pro in atrial fibrillation

TLV has performed a health economic evaluation of the medical device Coala Heart Monitor Pro on request of the Swedish regions. Coala Heart Monitor is a medical device for self-recording of ECG that is used by patients together with the Coala App. With the help of the Coala Care Portal, healthcare professionals can access patients' registered ECGs including associated data.

On the request of the regions' Medical Technology Council, the MTP Council, TLV has carried out a health economic evaluation of Coala Heart Monitor Pro. TLV's health economic evaluation will be part of the decision basis for the MTP Council's forthcoming national recommendation for the use and procurement of Coala Heart Monitor Pro in clinical praxis.

Atrial fibrillation is the most common arrhythmia in adults. About three percent of Sweden's population over the age of 20 and ten percent over the age of 80 are estimated to have atrial fibrillation. Atrial fibrillation carries an increased risk of blood clots, which can cause ischemic stroke (cerebral infarction caused by decreased blood flow). Therefore, it is important to diagnose atrial fibrillation early and, if necessary, treat with, for example, oral anticoagulants to reduce the risk of stroke. Atrial fibrillation diagnosis is made by electrocardiogram (ECG). A 12-lead ECG is routinely used to diagnose atrial fibrillation during a health care visit. If necessary, the examination can additionally be performed with ECG equipment that measures continuously over a longer period, for example Holter ECG.

Coala Heart Monitor Pro consists of three parts, the handheld ECG device Coala Heart Monitor, Coala App, and the software Coala Care Portal. Coala Heart Monitor is a medical device used by patients with the Coala App to record, view and transmit dual-channel ECGs and heart sounds. With the help of the Coala Care Portal, healthcare professionals can reach patients' ECGs including associated data.

According to TLV's clinical experts, hand-held ECG devices can be used to diagnose atrial fibrillation. However, they provide more limited information than conventional ECG measurements. TLV therefore estimates that hand-held ECG devices will mainly be used for the investigation of suspected atrial fibrillation.

The patient population that TLV has considered as relevant based on the MTP Council's request regarding diagnosis are patients who seek primary care with some form of symptoms that may be related to atrial fibrillation, and for whom no atrial fibrillation diagnosis can be made at the first primary care visit.

The scientific support for the product is based on a small ongoing study and a conference poster. TLV concludes that the ongoing study is relevant, but that the use of the preliminary results entails a very high degree of uncertainty regarding the effect size, as important information is missing, and the study is relatively small.

The uncertainty in the health economic result is considered to be high to very high, which has a certain effect on the result of the analysis. However, these uncertainties have been managed through scenario analyzes and sensitivity analyzes and are not considered to be so large that they affect the conclusion about the product's cost-effectiveness.

The analysis shows that the use of Coala Heart Monitor Pro in comparison with the Holter ECG 24-hours leads to a gain of between 0 and 0.0024 quality-adjusted life years (QALY) and a cost saving of between approximately 606 to 929 Swedish krona. The scenario analyzes in TLV's health economic assessment thus indicate that the use of Coala Heart Monitor Pro can provide greater benefit than the comparator, at a lower cost.

Publicerad 07 februari 2022

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