Healthcare Industry News: Microvolt T-Wave Alternans
News Release - May 8, 2006
Largest US Study Confirms Predictive Ability of Microvolt T-Wave Alternans
768 patient study concludes MTWA is strong and independent predictor of mortalityBEDFORD, Mass.--(HSMN NewsFeed)--May 8, 2006--Cambridge Heart, Inc. (OTCBB-CAMH) today announced the publication in the current issue of JACC - The Journal of the American College of Cardiology, of a new clinical study titled, "Prognostic Utility of Microvolt T-Wave Alternans in Risk Stratification of Patients with Ischemic Cardiomyopathy."
The study enrolled 768 consecutive patients with ischemic cardiomyopathy and an ejection fraction less than or equal to 35%. The patients were enrolled from four outpatient clinics under the coordination of the Ohio Heart and Vascular Center and the Lindner Clinical Trials Center, Cincinnati, Ohio. Dr. Theodore Chow from the Lindner Center was the Principal Investigator of the study.
All of the patients evaluated had no history of ventricular arrhythmia and would now meet the recent SCD-HeFT criteria for ICD eligibility. While the enrollment took place prior to the expansion of ICD eligibility, the authors studied MTWA to discern if MTWA was an independent predictor of mortality, and could therefore identify which of the individuals would be at the highest risk of death and most likely to benefit from ICD therapy.
After a mean follow-up period of 18 months, the MTWA non-negative or abnormal group of patients was associated with a significantly higher risk for all cause and arrhythmic mortality with hazard ratios of 2.51 and 2.93 respectively. Event free survival for MTWA negative patients was significantly higher than for MTWA non-negative patients with p=0.0002. In the group of patients that were not treated with implantable defibrillator therapy the arrhythmic death rate for MTWA negative patients was approximately 2% per year while the MTWA non negative patients death rate was more than 3 times higher.
In their discussion the authors comment, "The ability to more selectively target devices (ICDs) in high risk individuals using a screening test such as MTWA might lead to more complete treatment of those who are most likely to benefit."
Speaking for Cambridge Heart, David Chazanovitz, President and CEO said, "Dr. Chow's work with MTWA is bridging the gap between academic study and the practical application of the technology to private practice. The paper continues to add to the body of peer reviewed literature supporting the diagnostic power of MTWA. This study confirms our belief that MTWA testing adds significant value to the clinical judgment of physicians when considering which patients are most likely to benefit from ICD therapy. As an electrophysiologist in private practice, Dr. Chow is pioneering the use of our technology by demonstrating for his implanting peers how MTWA can help deliver the most appropriate patient care."
The study can be found at:
http://content.onlinejacc.org/cgi/content/full/47/9/1820
About Cambridge Heart
Cambridge Heart is engaged in the research, development and commercialization of products for the non-invasive diagnosis of cardiac disease. Using innovative technologies, the Company is addressing such key problems in cardiac diagnosis as the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary technology, Microvolt T-Wave Alternans, and are the only diagnostic tools cleared by the U.S. Food and Drug Administration to non-invasively measure microvolt levels of T-wave alternans. The Company, founded in 1990, is based in Bedford, Massachusetts and is traded on the OTCBB under the symbol CAMH. Cambridge Heart can be found on the World Wide Web at www.cambridgeheart.com
About the Cambridge Heart Microvolt T-Wave Alternans Test
The Cambridge Heart Microvolt T-Wave Alternans Test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. These tiny heartbeat variations - measured at one millionth of a volt - are detected in any clinical setting where titration of the heart rate is possible. The preparation for the test consists of placing proprietary sensors on a patient's chest. Extensive clinical research has shown that patients with symptoms of, or who are at risk of, life threatening arrhythmias that test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events including sudden death, while those who test negative are at minimal risk.
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Source: Cambridge Heart
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