AliveCor , the leader in artificial intelligence and FDA-cleared personal electrocardiogram (ECG) technology, today announced new medical research suggesting the use of AliveCor's AI technology as a potential alternative to surgically implanted heart monitors.
In a study presented at the American Heart Association Scientific Sessions, researchers from Northwestern Medicine demonstrated that the performance of AliveCor's KardiaBand with an experimental version of SmartRhythm artificial intelligence (AI) in detecting atrial fibrillation (AFib) compares favorably to an implantable loop recorder (ILR), the current industry standard.
Traditionally, ILRs have been viewed as the industry gold standard, allowing for long-term surveillance of AFib. ILRs, however, are invasive as they require surgery; expensive, as they can cost over $20,000 to be implanted and monitored; and opaque, as they provide no real-time feedback to the patient. In contrast, KardiaBand allows patients to record and see a lead I ECG from the wrist, with instant analysis for AFib. With the SmartRhythm AI, which continuously evaluates the smartwatch-provided heart rate and activity level, users are prompted to record an ECG when discordance between the two is detected.
Investigators sought to determine whether KardiaBand with an experimental version of SmartRhythm could accurately detect episodes of AFib compared to an ILR. The study announced today found that KardiaBand ECG prompted by the experimental SmartRhythm detected 74 of 76 episodes of AFib of at least 1 hour in duration, with a sensitivity of 97.4%. The correlation for AF episode duration between KardiaBand and ILR was high, at 0.997. The investigators concluded that KardiaBand with the experimental SmartRhythm holds promise as an inexpensive and non-invasive approach to long term AFib surveillance and management. The studied method used to detect AFib is investigational and pending FDA review.
“As atrial fibrillation is increasingly recognized as a major cause of stroke, an inexpensive and accurate wearable device will be an important tool for detecting and managing heart arrhythmias in millions of individuals who either already have the disease or are at risk of developing atrial fibrillation,” said senior author Rod S. Passman, MD, MSCE. “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. We are excited for the impact that wearable technologies will have on the future of care.”
“The introduction of KardiaBand represents a huge shift in the way heart health can be monitored,” said Vic Gundotra, CEO, AliveCor. “This new research validates KardiaBand performance with our experimental AI algorithms against legacy solutions and gives patients an inexpensive and immensely more comfortable way to allow long term heart monitoring. With cost-savings in the tens of thousands of dollars, we're confident that future versions will have the ability to lead the next generation of monitoring technology.”
Northwestern began this study in May of 2017. In this cohort, over 31,000 hours of the experimental SmartRhythm and ILR rhythm monitoring were collected over a four-month period and were analyzed to determine comparative efficacy. Patients with a previously implanted ILR device and a history of paroxysmal AF were eligible for enrollment.
AliveCor also announced the results of two additional studies at the conference. In the first, researchers from the University of Arizona gave 50 urgent care patients with palpitations a KardiaMobile to use for 1 month, alongside a 1-day Holter monitor. KardiaMobile, AliveCor's FDA-cleared mobile ECG device, was found to be diagnostically superior to or concordant with Holter monitoring in 82 percent of patients. Researchers concluded that KardiaMobile is a cost-effective device that can be used to screen urgent care patients experiencing palpitations to determine whether further cardiac investigation is required. The study is ongoing.
In the second, researchers from the University of Buffalo screened 211 high-risk nursing home residents (mean age 88 years; 83% female) for AFib using KardiaMobile on 4 different occasions, and found that 15 (7.1%) had a diagnostic tracing of AFib. 14 of the 15 residents had AFib on the first recording. Intermittent ECG screening with KardiaMobile resulted a higher diagnostic yield than observed in past AFib screening studies.
AFib is the most common heart arrhythmia, and is widely recognized as a leading cause of stroke. The condition affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it. While millions of people around the world are unknowingly living with AFib, two out of three strokes are preventable when AFib is detected and treated appropriately.
About AliveCor
AliveCor, Inc. is pioneering the creation of FDA-cleared machine learning techniques to enable proactive heart care and is recognized around the world for transforming cardiac care. The FDA-cleared KardiaMobile is the most clinically validated mobile ECG solution on the market. It is recommended by leading cardiologists and used by people worldwide for accurate ECG recordings. KardiaMobile and KardiaBand, when paired with the Kardia app, provide instant analysis for detecting atrial fibrillation (AFib) and normal sinus rhythm in an ECG. Kardia is the first A.I. enabled platform to help clinicians manage patients for the early detection of atrial fibrillation, the most common cardiac arrhythmia and one that leads to a five times greater risk of stroke. KardiaBand is the first FDA-cleared medical device accessory for Apple Watch. AliveCor was named the No.1 artificial intelligence company on Fast Company’s Top 50 Most Innovative Companies , in addition to ranking 20th overall in an evaluation of thousands of companies worldwide. AliveCor owns pending patent applications and issued patents covering ideas presented in this press release including issued U.S. Patent Numbers 9,839,363; 9,572,499; 9,986,925; 9,833,158; 9,351,654; 9,220,430; and 9,579,062. AliveCor is a privately-held company headquartered in Mountain View, Calif. For more information, visit alivecor.com .