We are excited to see Everion being used in a rapidly increasing number of clinical studies and RWE type of applications.
Atrial fibrillation (AFib) affects an estimated 1% of the population and is the leading cause of stroke. However, due to its irregular occurrence current diagnosis methods like ECG often miss those episodes. In some cases even the monitoring with a Holter ECG system fails to detect episodes of AFib, leading to an increased risk for the development of consecutive stroke. In addition, existing continuous monitoring techniques for detection of AFib are often expensive and cumbersome to use.
But what if the monitoring window could be substantially prolonged without compromising user comfort and thus leading to high compliance of wearing a measurement device? The Everion could be the answer to this with its motion tolerant high data accuracy, particularly around Heartrate and Inter-Beat-Interval measurements combined with the proven long term usability and remarkably high user adoption rate.
A growing number of studies indicate that detection of Afib could be possible by PPG based wearable systems. In a study published last week in JAMA Cardiology by Geoffrey H. Tison et al and under the lead of Gregory M. Marcus researchers at UCSF found that such a PPG based sensor, combined with an algorithm designed to detect AFib, performed well among sedentary patients undergoing a medical procedure and with a reduced accuracy under ambulatory conditions. This indicates the potential to passively detect AFib using a mobile application and ML.
In an accompanying editorial, Stanford University cardiology researcher Mintu P. Turakhia, M.D. hence indicated "the need for the right balance between high diagnostic accuracy and convenience, ubiquitousness, and continuous monitoring still to be found”. Numerous researchers and institutions like Stanford Medicine Dean Lloyd Minor, M.D. have expressed high hopes in such studies and for such technology to contribute towards a more decentralised healthcare. However, further investigation and refinement is needed to achieve the required specificity and sensitivity.
Therefore, we are very excited to see a German University Hospital is starting to collect continuous data with the Everion and gold standard Holter ECG monitoring to detect episodes of AFib. In the 1st step of the study, 50 patients with either sinus rhythm or high risk of AFib episodes are wearing both devices for later analysis. The 2nd step will focus on validation.
This is an open-label, two step, single-arm trial in 100 patients with high risk for Afib to asses the ability of Everion to detect episodes of AFib in comparison to gold standard of ECG Holter monitoring (positive-control) in an outpatient setting.