|[November 07, 2012]
Study Points to Mobile Device as Breakthrough for Community Screening and Stroke Prevention
SAN FRANCISCO --(Business Wire)--
The results of a recent study presented yesterday at the American Heart
Association Scientific Sessions 2012 conference in Los Angeles showed
that a high-quality single-lead ECG can be quickly and easily recorded
using an iPhone (News - Alert)® with the AliveCor™ medical device
and application to diagnose atrial fibrillation (AF). The study
concluded that the mobile device could be an innovative approach to
community screening to prevent stroke.
The study, "Validation of an iPhone ECG Application Suitable for
Community Screening for Silent Atrial Fibrillation: A Novel Way to
Prevent Stroke," was presented by Dr. Jerrett Lau, from Sydney,
Australia. The principal investigator was Dr. Ben Freedman, MBBS, PhD,
FACC, Cardiologist, Department of Cardiology, Concord Hospital and
Professor of Cardiology at the University of Sydney, Sydney, Australia.
The researchers tested a novel iPhone application suitable for community
use (AliveCor Heart Monitor), which records and sends a high-quality
single-lead ECG to a server for automated analysis and subsequent
interpretation by a physician to diagnose atrial fibrillation (AF). The
study included 109 patients (70 sinus rhythm and 39 AF) who had
single-lead ECGs recorded with the AliveCor Heart Monitor before a
12-lead ECG had been performed, in order to develop the optimized
algorithm. The AF diagnosis was then validated in another 204 patients
The study results indicate that a high-quality single-lead ECG can be
rapidly and simply recorded using an iPhone with the AliveCor
application and Heart Monitor device to accurately diagnosis AF. The
results presented during the session were statistically significant with
accuracy rates of 94% and 95% for the two cardiologists interpreting the
raw trace, and 97% for the automated algorithm, which was optimized to
enhance sensitivity (sensitivity 98%, specificity 97%).
AF is the most common sustained arrhythmia and carries a five-fold
increased risk of stroke. It is common in the elderly; previously
unrecognized AF is estimated to occur in 1-2% of those over 65. A
significant proportion of ischemic strokes are due to previously
unrecognized AF, which is largely asymptomatic, and may therefore
require community screening to detect the arrhythmia.
Until now, community ECG screening has not been considered to be a
feasible approach for AF detection.
Dr. Freedman concluded of the AliveCor Heart Monitor, "At last, we have
an effective and simple way to do community ECG screening for unknown
atrial fibrillation, with the real potential to reduce the stroke
Authors of the study include Jerrett Lau, Nicole Lowres, Lis
Neubeck, David B. Brieger, Raymond W. Sy, Concord Hospital and
University of Sydney, Sydney, Australia; Connor Galloway, David E.
Albert, AliveCor, Oklahoma City, OK; Ben Freedman, Concord Hospital and
University of Sydney, Sydney, Australia.
The AliveCor Heart Monitor, awaiting FDA 510(k) clearance, is a
clinical-quality, low-cost mobile ECG heart monitor compatible with the
iPhone 4 and 4S that enables patients to monitor their heart health
anywhere, at any time, and provides physicians with an additional heart
health assessment tool. The device and corresponding app allow for
wireless recordings of rhythm strips of any duration, which are stored
on the iPhone and securely in the cloud for later analysis, sharing and
printing through AliveCor's secure website. The ECG data is sent
wirelessly to the iPhone from the Heart Monitor via AliveCor's
low-power, proprietary communication protocol (akin to Bluetooth, Wi-Fi
or near field), and requires no pairing between the iPhone and the Heart
AliveCor, a privately held company based in San Francisco, CA (News - Alert), is
currently developing medical ECG heart monitoring devices and
corresponding applications for mobile platforms. AliveCor aims to
provide medical professionals, patients, and consumers worldwide with
mobile-powered devices, data, and analysis to identify, prevent, and
manage life-altering diseases from anywhere in the world.
The company was founded by Dr. David Albert and Australian co-founders
Bruce Satchwell and Kim Barnett, who began working on the heart
monitoring device in 2005, and is led by Judy Wade, President and CEO.
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