AliveCor, the company that develops mobile electrocardiogram (ECG) technology, was all proud to announce new medical research suggesting the use of AliveCor’s AI technology as a potential alternative to surgically implanted heart monitors.
The study, prepared by researchers from Northwestern Medicine and presented at the American Heart Association Scientific Sessions, demonstrated that the performance of AliveCor’s KardiaBand with an experimental version of SmartRhythm AI in detecting atrial fibrillation (AFib) compares favorably to an implantable loop recorder (ILR), the current industry standard.
This is significant considering that 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 wanted to determine whether KardiaBand with an experimental version of SmartRhythm could accurately detect episodes of AFib compared to an ILR. And they have 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 percent! 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,” senior author Rod S. Passman, MD, MSCE said in a statement. “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.”
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.
“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,” added Vic Gundotra, CEO of AliveCor. “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.”
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 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. Fourteen 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.