MOUNTAIN VIEW, Calif., Nov. 12, 2018 /PRNewswire/ -- AliveCor, the leader in FDA-cleared personal electrocardiogram (ECG) technology, has announced that a research version of its mobile technology can identify ST-elevation myocardial infarction (STEMI), the most severe form of heart attack. The findings of the ST LEUIS International Multicenter Study, to be announced at the 2018 American Heart Association's Scientific Sessions in Chicago, determined that AliveCor's smartphone technology can identify the condition with good correlation and high sensitivity compared to a standard 12-lead ECG.
The new research indicates that lives could be saved by allowing 12-lead equivalent ECGs to be taken in situations where traditional ECG technology may not be immediately available.
"Rapid diagnosis of STEMI is key to survival for these heart attack victims," said principal investigator Joseph B. Muhlestein MD, a cardiovascular researcher at the Intermountain Medical Center Heart Institute in Salt Lake City. "It's vital to immediately identify the type of episode a person is having so they can be properly expedited through the emergency room process. Today, the lack of accessibility to a traditional 12-lead ECG is often a barrier."
Unfortunately, many people who experience STEMI do not seek immediate medical care due to unfamiliarity or unawareness of symptoms, and of those who do seek care, only 27 percent transported by first responders receive an ECG before arriving at the hospital. Thus, most deaths caused by STEMI occur within two hours of onset.
"The ability for our technology to accurately identify the most serious type of heart attack has the potential to save thousands of lives worldwide," said Vic Gundotra, CEO, AliveCor. "In countries where standard ECG technology isn't available, or in residential environments where people are uncertain if they should call 911 -- a faster, more accessible solution than today's standard is now possible."
In September, AliveCor announced its work on Project Triangle, a six-lead smartphone ECG for consumers which is likely to come to market in the coming year. These innovations are continuing to propel the company forward as it leads the industry into the future of heart health.
Methodology & Results
Consenting subjects presenting with chest pain or STEMI protocol activation had simultaneous recordings performed with a standard 12-lead ECG and the AliveCor smartphone '12-lead equivalent' ECG derived from a research version of a KardiaMobile device equipped with 2 ECG wires. Matched smartphone and standard ECGs were evaluated separately, both quantitatively and qualitatively, by a panel of blinded, experienced readers, and were classified as STEMI or left bundle branch block (LBBB), non-STEMI, or not interpretable. Interpretable ECG pairs also were subjectively graded as showing good, fair, or poor correlation.
A total of 204 subjects (age = 60 years, males = 57%, STEMI activation = 45%) were enrolled from 5 international sites. For all interpretable smartphone ECGs (n=190), versus standard ECGs, the sensitivity, specificity, positive, and negative predictive value for STEMI/LBBB were 0.89, 0.84, 0.70 and 0.95, respectively. Qualitative, interpretable paired ECG evaluations showed 166 (87.4%), 23 (12.0%), and 1 (0.5%) pairs with good, fair and poor correlation, respectively.
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 (AF) 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.