New Study Published in Heart Rhythm Journal Shows Patients with Positive Test Result Are Nearly Nine Times More Likely To Experience Sudden Cardiac Arrest
TEWKSBURY, Mass.--(BUSINESS WIRE)-- Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that a new study published on-line in the Heart Rhythm Journal confirms the value of Microvolt T-Wave Alternans™ (MTWA) testing for identifying patients at risk of sudden cardiac arrest (SCA). The pooled analysis of 2,883 patients shows that MTWA is a statistically significant predictor of SCA in patients whose heart muscle is damaged (ejection fraction less than or equal to 35%), as well as in patients with more preserved cardiac function (ejection fraction > 35%).
Overall, patients with a positive MTWA result were, on an annual basis, nearly nine times more likely to experience sudden cardiac arrest than patients with a negative test. A negative MTWA test result identified a population of patients at very low risk of SCA during the following 24 months, regardless of ejection fraction (EF) (annual event rate 0.9% in patients with EF ≤ 35% and 0.3% with EF > 35%).
“In this pooled analysis of patients without implantable cardioverter defibrillators, MTWA is a powerful predictor of SCA in patients with a broad range of ejection fractions. A negative MTWA test result identifies a cohort of patients with very low risk of sudden death, and a positive MTWA test identifies a patient group at high risk,” stated Dr. Antonis Armoundas, senior author of the study. “These findings may have important implications for refining primary prevention ICD treatment algorithms.”
“This analysis of almost 3,000 patients is an important contribution to the literature on MTWA,” noted Ali Haghighi-Mood, CEO of Cambridge Heart. “The results confirm the test’s predictive value and support the clinical utility of MTWA in a broad spectrum of cardiac patients who are considered to be at risk for sudden cardiac arrest.”
SCA is the leading cause of mortality in the U.S. accounting for an estimated 300,000 deaths each year - more than lung cancer, breast cancer and HIV/AIDS combined. Out-of-hospital survival is less than 8%, making prediction and prevention critically important. Microvolt T-Wave Alternans is a marker of SCA risk which is measured during a non-invasive treadmill test.
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.
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. Actual results may differ materially from those indicated by these forward-looking statements. Factors that may cause or contribute to such differences include adverse results in future clinical studies of 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.
At Cambridge Heart:
Vincenzo LiCausi, 978-654-7600 x 6645
Chief Financial Officer
Edna Kaplan, 781-639-1910
Allen & Caron
Matt H. Clawson, 949-474-4300
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