TEWKSBURY, Mass.--(BUSINESS WIRE)--Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that results of the PREVENT-SCD trial, published in the journal Clinical Research in Cardiology, reinforce the value of the Microvolt T-Wave Alternans™ (MTWA) test in identifying patients at risk of Sudden Cardiac Death (SCD). Preliminary results of the study were originally presented at the American Heart Association Scientific Sessions in 2009.
PREVENT-SCD (PRospective EValuation of VENtricular Tachyarrhythmic Events and Sudden Cardiac Death in Patients with Left Ventricular Dysfunction), a prospective multi-center study of patients with cardiomyopathy and ejection fraction of 40 percent or lower, enrolled a total of 453 patients from 38 institutions in Japan. Two hundred eighty (280) patients underwent non-invasive MTWA testing using the analytic spectral method and were followed for an average of three years.
At a median follow-up time of 36 months, patients with an abnormal MTWA test were 4.4 times more likely to experience a life-threatening arrhythmia or SCD than those with a normal test and were almost eight times more likely to die of cardiac causes. The negative predictive value was 100 percent at one year, 98.6 percent at two years, and 97.0 percent at three years, indicating that patients with a normal or negative MTWA test are at low risk for experiencing sudden death. In the sub-group of patients with non-ischemic cardiomyopathy, the negative predictive value was 100 percent out to three years.
“The event-free rate for severe ventricular tachyarrhythmias in TWA-negative patients was excellent,” said Dr. Satoshi Shizuta, Kyoto University Hospital, Kyoto, Japan, lead author of the study. In PREVENT-SCD, 29 percent of patients eligible for the test had a negative MTWA result. He also noted that these patients are at very low risk for SCD in the next three years.
“The PREVENT-SCD trial confirms the predictive value of MTWA in patients with left ventricular dysfunction,” said Ali Haghighi-Mood, President and Chief Executive Officer of Cambridge Heart. “These powerful results illustrate MTWA’s utility in assessing the risk of SCD in a real-world population of cardiomyopathy patients, whether their disease is ischemic or non-ischemic in origin.”
The PREVENT-SCD manuscript can be found on the publisher’s website at: http://www.springerlink.com/content/r243743418357826/
About Cambridge Heart, Inc.
Cambridge Heart develops and commercializes non-invasive diagnostic tests for cardiac disease, with a focus on identifying those at risk for sudden cardiac arrest (SCA). The Company’s products incorporate proprietary Microvolt T-Wave Alternans measurement technologies, including the patented Analytic Spectral Method® and ultrasensitive disposable electrode sensors. The Company’s MTWA test, originally based on research conducted at the Massachusetts Institute of Technology, is reimbursed by Medicare under its National Coverage Policy.
Cambridge Heart, founded in 1990, is based in Tewksbury, MA. It is traded on the Over-The-Counter Bulletin Board (OTCBB) under the symbol CAMH.OB.
http://www.cambridgeheart.com.
Statements contained in this press release that are not purely historical are forward-looking statements. In some cases, we use words such as “believes”, “expects”, “anticipates”, “plans”, “estimates”, “could”, and similar expressions that convey uncertainty of future events or outcomes to identify these forward-looking statements. These forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties. Forward-looking statements include statements about the Company’s plans with respect to future clinical trials and regulatory approvals pertaining to the Company’s MTWA test. Actual results may differ materially from those indicated by these forward-looking statements. Factors that may cause or contribute to such differences include failure to obtain funding necessary to fund operations and to develop or enhance our technology, adverse results in future clinical studies of our technology, material deviations from our current operating plan, lower than expected sales by Cardiac Science of its Q-Stress System, failure to obtain or maintain adequate levels of government and third-party reimbursement for use of our MTWA test, customer delays in making final buying decisions, decreased demand for our products, failure to obtain or maintain patent protection for our technology and other factors identified in our most recent Annual Report on Form 10-K under “Risk Factors”, which is on file with the SEC and available at www.EDGAR.com. In addition, any forward-looking statements represent our estimates only as of today and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so except as may be legally necessary, even if our estimates should change.