Cleveland Clinic Study Affirms Accurate Detection of Atrial Fibrillation by KardiaBand for Apple Watch
ORLANDO, Fla., March 12, 2018 /PRNewswire/ -- AliveCor, the leader in FDA-cleared personal electrocardiogram (ECG) technology, today announced findings from two new studies that further support the use of its portable ECG devices to provide groundbreaking health monitoring capabilities.
A new Cleveland Clinic study -- which marks the first time Apple Watch's role in health care has been studied in a peer-reviewed manuscript -- affirms KardiaBand's ability to accurately detect atrial fibrillation (AFib), a leading cause of stroke. The Cleveland Clinic study, which has been accepted for publication in the Journal of the American College of Cardiology, set out to determine whether the KardiaBand for Apple Watch could differentiate between AFib and normal heart rhythm. Researchers found that KardiaBand successfully detected Atrial Fibrillation and normal sinus rhythm with an accuracy level comparable to physicians interpreting the same ECGs. In the study, the Kardia algorithm correctly interpreted AFib versus normal sinus rhythm with 93 percent sensitivity and 84 percent specificity. With physician review of KardiaBand recordings, sensitivity increased to 99%. KardiaBand, introduced in November, is the first and only FDA-cleared medical device accessory for Apple Watch.
Additional new research, presented today, reveals that, when paired with new artificial intelligence technology, AliveCor's ECG device is able to perform non-invasive detection of high potassium levels in blood, a condition known as hyperkalemia. The study used over 2 million ECGs linked with 4 million serum potassium values collected between 1994 to 2017, as well as prospective data from an AliveCor smartphone ECG device, to develop an AI algorithm to detect hyperkalemia. The sensitivity for hyperkalemia detection ranged between 90 to 94 percent.
Hyperkalemia is commonly associated with congestive heart failure, chronic kidney disease, diabetes, and with the medications used to treat these conditions. The condition, associated with significant mortality and arrhythmic risk, is often missed because it is frequently asymptomatic, making detection of hyperkalemia challenging. Until now, the only means of testing for hyperkalemia was through a blood test.
This capability, which over time may be commercialized through AliveCor's KardiaBand for Apple Watch, could help to save more lives as AliveCor changes the way patients monitor their own health.
Both studies were presented at the American College of Cardiology's 67th Annual Scientific Session.
"As our team continues to push the bounds on innovation in digital health, we are on a path to changing the way AFib and hyperkalemia can be detected, and to defining the ways in which products like Apple Watch can play a role in the future of health care," said Vic Gundotra, CEO, AliveCor.
In February 2018, AliveCor was recognized for transforming digital health and named the No.1 artificial intelligence company in Fast Company's Top 50 Most Innovative Companies. It also ranked 20th overall in an evaluation of thousands of companies worldwide.