Microvolt T-Wave Alternans Identifies Patients with Dilated Cardiomyopathy at Risk for Sudden Cardiac Death; Study Demonstrates Value in Difficult-to-Predict Population.

Business Editors and Health/Medical Writers

BEDFORD, Mass.--(BW HealthWire)--Nov. 15, 2001

Cambridge Heart, Inc. (NASDAQ:CAMH) announced that at yesterday's final session of the 2001 Scientific Sessions of the American Heart Association in Anaheim, a study was presented demonstrating that Microvolt T-Wave Alternans Testing identifies patients with Non-Ischemic Dilated Cardiomyopathy (DCM) that are at risk for sudden cardiac death. Patients with DCM suffer from a condition unrelated to coronary artery disease where the heart becomes enlarged, weak and does not pump efficiently. It is a common cause of heart failure, and patients with DCM are at increased risk of sudden cardiac death.

It has been difficult to identify which patients with DCM are at greatest risk, because the standard invasive electrophysiology test used for this purpose is not an accurate predictor in these patients. Thus physicians can not be sure which DCM patients require specific treatment to prevent sudden cardiac death.

According to the study, presented by Dr. Thomas Klingenheben of JW Goethe University Hospital in Frankfurt, Germany, patients who tested positive for Microvolt T-Wave Alternans had a 30% probability of having an event within 18 months. Patients who tested negative were four times less likely to have an event. DCM, which often affects people in their forties and fifties, has been considered a disease with a severe prognosis often leading to either sudden cardiac death, or death from congestive heart failure. DCM has a mortality rate of 25% to 50% in the first two years after diagnosis, and approximately half of these deaths are sudden. According to this study of 133 patients followed for an average of 12 months, Microvolt T-Wave Alternans was the only non-invasive test to demonstrate statistical significance in predicting events in this patient population.

"We are especially pleased to see such encouraging results presented on this difficult-to-detect and consequently difficult to treat population," said David Chazanovitz, Cambridge Heart President and Chief Executive Officer. "Electrophysiologist and general cardiologist will both welcome this tool to help them determine which DCM patients are at highest risk of sudden death."

Mr. Chazanovitz also stated, "There are excellent prophylactic treatment modalities available, namely ICDs, but physicians still must identify the appropriate patients for implantation. Microvolt T-Wave Alternans continues to demonstrate its usefulness in helping physicians to risk stratify their patients."

Cambridge Heart's Microvolt T-Wave Alternans test is the only non-invasive test to receive clearance by the Food and Drug Administration to identify patients at risk of life threatening arrhythmias and subsequent sudden cardiac death.

About the Cambridge Heart Alternans Test 

The Cambridge Heart 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 during a typical treadmill or bicycle exercise stress test by proprietary sensors placed on a patient's chest. Extensive clinical research has shown that patients with symptoms of or at risk of life threatening arrhythmias who test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events including sudden death.

About Cambridge Heart

Cambridge Heart is engaged in the research, development and commercialization of products for the noninvasive 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 early detection of coronary artery disease and the prompt and accurate diagnosis of heart attack. The Company, started in 1992, is based in Bedford, Mass., and is traded on the NASDAQ/NMS under the symbol CAMH.

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