- AliveCor has presented clinical data suggesting its KardiaBand wearable electrocardiogram (ECG) is about as good at detecting atrial fibrillation as implantable loop recorders (ILRs).
- The study compared AliveCor’s sub-$200 Apple Watch add-on to ILRs that can cost 100 times as much across 31,000 hours of patient data.
- KardiaBand detected 74 of 76 atrial fibrillation episodes that lasted at least one hour, leading AliveCor to predict future versions of the technology will play a big role in patient monitoring.
AliveCor has had an eventful 12 months. This time last year, FDA greenlit AliveCor’s KardiaBand for use in the capture of ECGs, making it the first Apple Watch medical device accessory with regulatory clearance. AliveCor’s reign was short, though. In September, Apple received FDA clearance for its own Apple Watch electrocardiogram app, eliminating a key reason to buy KardiaBand.
Apple's clearance has pressured AliveCor to differentiate its technology. AliveCor was already looking into novel applications of KardiaBand and supporting software, but the new competitive landscape has dialed up the importance of these efforts.
AliveCor presented data from its latest set of studies at the American Heart Association Scientific Sessions over the weekend. The presentations included data from the aforementioned study into atrial fibrillation, which saw researchers at Northwestern Medicine gather 31,000 hours of data on patients with ILR devices and a history of sudden recurrences of the cardiovascular condition.
The previously-implanted ILR devices detected 76 atrial fibrillation events that lasted one hour or more over the course of the study. AliveCor’s KardiaBand detected 74 of these events, resulting in a sensitivity of 97.4%. The correlation between the duration of the cardiovascular episodes detected by ILR and KardiaBand was 0.997.
Given atrial fibrillation can go undetected and cause stroke, the availability of a cheaper, less invasive way of monitoring for the condition could prove attractive to healthcare systems. The researchers see the study as an encouraging sign that wearables can provide such monitoring.
"Our study is a proof-of-concept that you can use a wearable device to not only show whether or not you have atrial fibrillation, but how much atrial fibrillation you are having," senior author Rod Passman said in a statement.
The method for detecting atrial fibrillation is still experimental and pending FDA review. It remains to be seen how accurate a wearable test will need to be gain acceptance. The two cases KardiaBand missed in the study could be significant for the individuals involved, and a 97.4% specificity rate could result in many missed atrial fibrillation events when scaled across the real-world population.
AliveCor also used the AHA event to present data on studies that assessed the use of KardiaMobile, a smartphone app and accompanying ECG device, in the screening of patients with palpitations and in other contexts.