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NIH Sponsored Study in JACC Extends Predictive Ability of Microvolt T-Wave Alternans

Posted on: Thursday, 15 December 2005, 09:00 CST

Cambridge Heart, Inc. (OTCBB-CAMH) today announced the publication of an NIH sponsored study in the online version of JACC - The Journal of the American College of Cardiology. The study, receiving expedited review, is titled, "Microvolt T-Wave Alternans and the Risk of Death or Sustained Ventricular Arrhythmias in Patients with Left Ventricular Dysfunction."

Conducted in 11 clinical centers, the study enrolled 549 patients with left ventricular dysfunction as measured by an ejection fraction (measure of the heart's pumping efficiency) less than or equal to 40%. All patients exhibited symptoms of clinical heart failure but importantly had no history of sustained ventricular arrhythmias. The population studied is similar to the individuals studied in the well publicized Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) published in the January 2005 issue of The New England Journal of Medicine. This publication expands on the initial findings of the authors, published in Circulation in September 2004, on a subset of this population which met the well documented MADIT II criteria.

In this study population Microvolt T-Wave Alternans (MTWA) was shown to be highly effective at separating individuals at very low risk of death or ventricular arrhythmia from those at high risk. Utilization of MTWA as a risk stratifier can thus make possible the potential for more appropriate use of implantable cardioverter defibrillators (ICDs).

Based on a two year actuarial rate for both sudden death and ventricular arrhythmias, an individual testing MTWA abnormal was 6.5 times more likely to have an event than a patient testing MTWA normal / negative. Most significantly, MTWA was the most effective risk stratifier and an independent predictor of events regardless of ejection fraction and 6 other confounding variables including two additional measures of heart failure severity.

The Principal Investigator, Dr. Daniel Bloomfield, Adjunct Associate Professor of Medicine, Columbia University College of Physicians and Surgeons, commenting on the results of the study said, "This study demonstrates that a MTWA test, which can be easily performed in the doctor's office, clearly separates a large group of patients who are unlikely to benefit from implantation of an ICD from those who may benefit from the device."

David A. Chazanovitz, President and CEO of Cambridge Heart, Inc. commented, "We appreciate the hard work from this outstanding group of clinical investigators. The results strongly confirm our belief that the use of MTWA can add a significant element of efficiency in the utilization of life saving ICDs. The use of MTWA in this patient population can assist physicians and their patients in making the best possible decisions for appropriate care."

The study can be found at: http:// content.onlinejacc.org/cgi/content/abstract/j.jacc.2005.11.026v1 (Due to the length of this URL, it may be necessary to copy and paste it into your Internet browser's URL address field. You may also need to remove an extra space in the URL if one exists.)

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: Business Wire

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