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Health economic evaluation of Zenicor-EKG in atrial fibrillation

TLV has performed a health economic evaluation of the medical device Zenicor-EKG on request of the Swedish regions. The intended use of Zenicor-EKG is self-registration of ECG and transmission of the registrations via mobile network to the healthcare provider. With the help of Zenicor-EKG Backend-system, 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 Zenicor-EKG. 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 Zenicor-EKG 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.

The Zenicor-EKG consists of two parts, the Zenicor-EKG-2 handheld ECG device, and the Zenicor-EKG Backend-system. Zenicor-EKG-2 is a medical device that is intended to be used for regular, periodic self-recording of ECG. The measurements can be transmitted via mobile network to the care provider. With the help of the Zenicor-EKG Backend-system, healthcare professionals can access patients' registered ECGs including associated data.

According to TLV's clinical experts, hand-held ECG devices can be used to diagnose atrial fibrillation. However, they provide limited information compared to 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 are patients who seek primary care and who have some form of symptom that may be related to atrial fibrillation, as well as for whom no atrial fibrillation diagnosis can be made at the first primary care visit.

The clinical results of the company's studies are likely to reflect the benefit for patients seeking care with some form of symptom that may be related to atrial fibrillation. This applies when using the Zenicor-EKG in direct comparison with the 24-hour Holter ECG. However, the main study is relatively small and performed at only a single center which introduces uncertainty about the size of the effect measure.

The uncertainty in the health economic result is judged to be moderate, which has some effect on the result of the analysis. However, these uncertainties have been addressed through sensitivity analyzes and are not so large that they affect the conclusion about the product's cost-effectiveness.

The analysis shows that the use of Zenicor-EKG in comparison with Holter ECG 24-hours leads to a gain of 0.0037 quality-adjusted life years (QALY) on average with a cost saving of 384 Swedish krona. The basic scenario in TLV's health economic assessment thus indicates that the use of Zenicor-EKG provides greater benefit than the comparator, at a lower cost.

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7 February 2022
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