Heart and Stroke Foundation and CardioComm Solutions Release First HeartCheck™ ECG Screening Results for Atrial Fibrillation Detection in Stroke Prevention Program

CardioComm Solutions, Inc., a global medical provider of electrocardiogram (ECG) acquisition and management software solutions, announced the positive results on the diagnostic accuracy of an arrhythmia screening project with the Heart and Stroke Foundation of Canada and St. Michael's Hospital (Toronto), using the HeartCheck™ ECG Monitor, and the Company's SMART Monitoring solution. The results were reviewed by academics from Sunnybrook Hospital, the Center for Innovation in Complex Care and St. Michael's Hospital, all University of Toronto teaching hospitals, as well as from the Canadian Heart Research Centre, Toronto. A comparison of 1,400 ECG readings by C4 ECG technologists (C4T) versus full disclosure C4 physician (C4P) over-reads was completed to determine arrhythmia burden and classification as well as accuracy of C4T readings compared with that of a C4P electrophysiology specialist. Thirty-second, Lead I ECG rhythm strips were acquired from disposable electrodes placed on the wrists of participants and attached to the HeartCheck™ ECG monitor through an accompanying lead set. Use of wrists-based electrodes removed the need for privacy screens associated with Lead II chest placements and avoided the need for sanitization of devices required if passed among participants for hand-held ECG acquisition, thereby increasing the speed of screening. ECG acquisition quality was confirmed through visual inspection of the real-time display on the HeartCheck™ ECG Monitor. ECG findings were classified as: normal sinus rhythm (NSR), bradycardia (HR150bpm), bundle branch block, atrioventricular (AV) block, premature ventricular beat (PVB) or atrial fibrillation (AF). Participants were encouraged to see their family physician if they had any questions, believed they have or do experience symptoms and if the ECG screening suspected the presence of an arrhythmia. Two hundred and twenty seven (227) adult subjects (70.5% female, age 66.5 ± 11.2 years) were screened. Average heart rate was 72.9 ± 10.8bpm with NSR in 71% of participants. Correlation between C4T and C4P was a kappa of 0.96 (1.0 is a 100% correlation). Arrhythmias were confirmed by C4T in 47 (20.7%) and by C4P in 46 (20.3%) of subject (kappa 0.99). Notable C4P detected arrhythmias were: AF 2.2%, PVB 4.4%, premature atrial contraction 2.2%, sinus tachycardia 1.8%, sinus bradycardia 4.8%, supraventricular rhythm 1.3% and wide QRS 4.8%. "Finding an AF prevalence of 2.2% in people unaware they have an arrhythmia like AF is novel and highlights that relatively little data of this nature is available likely due to the previous non-existence of simplified ECG acquisition and interpretation solutions," said Dr. David Newman, electrophysiologist and member of the Company's Board of Directors. "Risk of stroke from AF is over 25%, and in this higher risk age group we would have expected to see more individuals with an awareness of their underlying disease status. Given this was one random 30-second ECG acquisition, the potential benefit for such screening efforts as performed by the Heart and Stroke has been demonstrated and calls for larger screening undertakings of this kind," stated Dr. Anatoly Langer, Chairman of the Board for CardioComm Solutions. "The project results demonstrated the HeartCheck™ ECG Monitor provides an easy and efficient arrhythmia screening tool with little noise. The capacity to upload collected ECG recordings to a central ECG analysis center enables appropriate technologist-based ECG review and triaging with near diagnostic equivalence to a physician interpretation and, in concert with our recent North American 2012 award as an enabling company for cardiac arrhythmia monitoring technologies, this academic validation of our ECG reading competencies bodes as we prepare for the receipt of HeartCheck™ PEN ECG reading requests and expansion of our C4 medical call center client base," said Etienne Grima, CEO of CardioComm Solutions. "The clinical relevance of random, single assessment population arrhythmia screening was demonstrated by a 20% prevalence rate and more notably a 2.2% AF prevalence in an unsolicited and undiagnosed population. The population demographics indicated that participants were representative of an atrisk population based on age," concluded Dr. Chi-Ming Chow, staff cardiologist at St Michael's Hospital and Vice President of the Heart and Stroke Foundation's Chinese Canadian Council. About CardioComm Solutions CardioComm Solutions' patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms (ECGs) for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. The Company has earned the ISO 13485 certification, is HPB approved, HIPAA compliant, and has received FDA market clearance for its software devices. CardioComm Solutions is headquartered in Toronto, Ontario, Canada, with offices in Victoria, British Columbia, Canada.