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Studies Further Confirm Cambridge Heart's T-wave Alternans Test as Effective Predictor of the Cause of Sudden Cardiac Arrest.


BEDFORD, Mass.--(BW HealthWire)--May 12, 1999--

Data To Be Presented at the North American Society of

Pacing and Electrophysiology Conference This Week

Cambridge Heart, Inc. (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
:CAMH CAMH Centre for Addiction and Mental Health
CAMH Contemporary Arts Museum Houston (Houston, TX)
CAMH Comprehensive Accreditation Manual for Hospitals
) today announced that data from several studies further validate T-wave alternans testing as a powerful diagnostic tool for patients at risk of sudden cardiac arrest (SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. ). The studies will be presented at the North American Society of Pacing and Electrophysiology (NASPE NASPE National Association for Sport and Physical Education
NASPE North American Society of Pacing and Electrophysiology
NASPE National Association of State Personnel Executives
) Conference this week in Toronto. Collectively, these studies identify additional patient populations for which the Alternans Test is a valuable diagnostic tool, as well as showing its superiority to Signal Averaged Electrocardiography signal averaged electrocardiography Cardiology A technique that amplifies late potentials–high-frequency, low-amplitude signals at the end of the QRS complex, attributed to fragmented and delayed conduction through the borders of a myocardial scar  (SAECG SAECG Signal-Averaged Electrocardiogram ). The Cambridge Heart Alternans Test was cleared by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 on April 13, 1999; it is the only non-invasive test to be cleared to identify patients at risk of the heart rhythm disorders which cause sudden cardiac arrest.

One study shows that the Alternans Test can predict the heart arrhythmias that cause sudden cardiac arrest in patients with non-ischemic dilated cardiomyopathy (DCM). Other than ejection fraction, a measure of overall cardiac functioning, no other test, including invasive electrophysiology (EP) testing, has been demonstrated to be effective in predicting SCA in these patients. Another study shows early promising results in a rare congenital disease, arrhythmogenic right ventricular cardiomyopathy Cardiomyopathy Definition

Cardiomyopathy is a chronic disease of the heart muscle (myocardium), in which the muscle is abnormally enlarged, thickened, and/or stiffened.
. Finally, data from another study indicate that T-wave alternans is a better predictor of a positive EP test and cardiac events than SAECG.

"These research findings further confirm that the Alternans Test is a valuable cardiac diagnostic tool," said Jeffrey M. Arnold, chairman, president and chief executive officer of Cambridge Heart. "Data from these studies and others indicate that T-wave alternans is a powerful predictor of deadly arrhythmias, seemingly independent of the underlying heart disease."

The studies being presented at the NASPE conference include:

--Exercise Induced Microvolt microvolt

one-millionth (10-6) of a volt; abbreviated µV.
 Level T-wave Alternans Identifies Patients with Non-Ischemic Dilated Cardiomyopathy at High Risk of Ventricular Tachyarrhythmic Events

Thomas Klingenheben, M.D., studied 56 patients with non-ischemic dilated cardiomyopathy (DCM). Other tests have not been able to predict risk of ventricular tachyarrhythmic events (VTE) satisfactorily. He concludes that the T-wave Alternans Test appears to identify DCM patients at high risk of VTE.

--T-wave Alternans Predicts Arrhythmia Vulnerability in Patients with Ischemic Cardiomyopathy

Karen MacMurdy, M.D., evaluated 87 patients with ischemic heart disease Ischemic heart disease
Insufficient blood supply to the heart muscle (myocardium).

Mentioned in: Myocarditis

ischemic heart disease 
 who had low ejection fraction (which indicates poor cardiac function) and were referred for EP testing. Data show that T-wave alternans testing is an accurate predictor of risk of SCA in patients with ischemic heart disease and poor cardiac function. One implication of this study is that T-wave alternans testing can help identify patients who need implantable cardioverter defibrillators (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device.

ICD
abbr.
) with more specificity than ejection fraction alone.

--Microvolt T-wave Alternans in Patients with Arrhythmogenic Right Ventricular Cardiomyopathy and Dilated Cardiomyopathy

Yee Guan Yap, MRCP MRCP Member of Royal College of Physicians.

MRCP
abbr.
Member of the Royal College of Physicians
, performed T-wave alternans testing on 48 patients with DCM and 13 patients with a rare congenital disease called ARVC ARVC National Association of RV Parks & Campgrounds
ARVC Arrhythmogenic Right Ventricular Cardiomyopathy
. The study found that patients with DCM or ARVC have higher rates of positive T-wave alternans results. The implication is that a positive T-wave alternans result may help cardiologists to identify patients with undiagnosed DCM or ARVC; and possibly those who are positive are at elevated risk of SCA.

--A Comparison of T-wave Alternans and Signal Averaged Electrocardiography in Predicting Outcome of Electrophysiology Testing

Daniel Bloomfield, M.D., examined the results from 103 patients who had T-wave Alternans, SAECG and EP tests. He found that T-wave alternans is a non-invasive predictor of a positive EP test, which in turn is a predictor of SCA. Further, a positive T-wave alternans result predicts a positive EP test better than SAECG.

About Sudden Cardiac Arrest and the Alternans Test

SCA is caused by ventricular arrhythmia, an abnormality in the beating pattern of the heart resulting in alterations in the rate and frequency of the electrical impulses in the ventricles Ventricles
The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues.
. SCA claims approximately 300,000 lives a year in the United States.

The Alternans Test works like a "super stress test" and measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. T-wave alternans is not visible on electrocardiograms used in conjunction with ordinary exercise stress tests. These tiny heartbeat variations--measured at one millionth of a volt--are detected during a typical treadmill or bicycle exercise stress test by specially designed, high-resolution electrodes placed on a patient's chest.

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 early detection of coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue.  and the prompt and accurate diagnosis of heart attack. The Company's first product, the Alternans Test, was cleared by the FDA on April 13, 1999, as the first non-invasive test cleared to identify patients at risk of arrhythmia, the cause of sudden cardiac arrest. The Company, started in 1992, is based in Bedford, Mass., and is traded on the NASDAQ/NMS under the symbol CAMH.

Statements made in this press release that are not historical facts include forward-looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include uncertainties associated with regulatory approval processes and other factors that are included in Cambridge Heart's Annual Report on Form 10-K for the year ending December 31, 1998.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:May 12, 1999
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