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New Research Shows T-Wave Alternans Identifies Non-Ischemic Dilated Cardiomyopathy Patients With Life Threatening Arrhythmias.

BEDFORD, Mass.--(BW HealthWire)--Aug. 23, 1999--

Cambridge Heart Alternans Test Seen as Useful Diagnostic Tool

Cambridge Heart, Inc. (NASDAQ:CAMH) today announced that a study published in the August Journal of the American College of Cardiology (34(2); 374-380, 1999) found that the presence of microvolt T-wave alternans (TWA), an alternating pattern in the heartbeat, was correlated with that of ventricular tachyarrhythmia (VT) in patients with non-ischemic dilated cardiomyopathy (DCM). The Cambridge Heart Alternans Test is the only non-diagnostic test available that measures T-wave alternans during routine exercise, pacing, or pharmacologic stress. VT, a rapid heart beating in the ventricles, can give rise to a life-threatening situation called ventricular fibrillation where the lower chambers quiver and the heart cannot pump blood. Patients with DCM suffer from a condition unrelated to coronary artery disease where the heart becomes enlarged, weak and does not pump properly.

"These study findings are especially significant because invasive electrophysiology study, the current gold standard in arrhythmia diagnosis, is not considered useful in diagnosing patients with non-ischemic DCM," said Jeffrey M. Arnold, Cambridge Heart Chairman, President, and Chief Executive Officer. "Cambridge Heart's Alternans Test gives physicians a non-invasive tool to help diagnose this difficult-to-detect population in time to offer therapeutic alternatives, such as drug therapy or cardioverter/defibrillator implantation."

Cambridge Heart's 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.

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, T-wave alternans testing was the only non-invasive test to reliably predict VT in this patient population. Other tests, including invasive electrophysiology study and non-invasive (1-8) signal-averaged ECG, QT dispersion, standard exercise testing, heart rate variability, and echocardiography were not useful in identifying DCM patients with life threatening arrhythmias.

The study, titled "Determinant of Microvolt-Level T-Wave Alternans in Patients With Dilated Cardiomyopathy," by Adachi et al, included 58 consecutive patients with DCM. All patients underwent a complete non-invasive and invasive evaluation, including T-wave alternans testing. The sensitivity, specificity, and predictive accuracy of T-wave alternans for VT were 88%, 72%, and 77%, respectively.

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. 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. 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.

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.

(1) Fei L, Goldman JH, Prasad K, et al. QT dispersion and RR variations on 12-lead ECGs in patients with congestive heart failure secondary to idiopathic dilated cardiomyopathy. Eur Heart J 1996;17:258-63.

(2) Hofmann T, Meinertz T, Kasper W, et al. Mode of death in idiopathic dilated cardiomyopathy: a multivariate analysis of prognostic determinants. Am J Cardiol 1988;116:1455-63,

(3) Larsen L, Markham J, Haffajee CI. Sudden death in idiopathic dilated cardiomyopathy. PACE Pacing Clin Electrophysiol 1993;16:1051-9.

(4) Berger RD, Kasper EK, Baughman KL, et al. Beat-to-beat QT interval variability: novel evidence for repolarization lability in ischemic and nonischemic dilated cardiomyopathy. Circulation 1997;96:1557-65.

(5) Grimm W, Hoffmann J, Knop U, et al. Value of time- and frequency-domain analysis of signal-averaged electrocardiography for arrhythmia risk prediction in idiopathic dilated cardiomyopathy. PACE Pacing Clin Electrophysiol 1996;19:1923-7.

(6) Grimm W, Steder U, Menz V, et al. QT dispersion and arrhythmic events in idiopathic dilated cardiomyopathy. Am J Cardiol 1996;78:458-61.

(7) Silverman ME, Pressel MD, Brackett JC, et al. Prognostic value of the signal-averaged electrocardiogram and a prolonged QRS in ischemic and nonischemic cardiomyopathy. Am J Cardiol 1995;75:460-4.

(8) Keeling PJ, Kulakowski P, Yi G, et al. Usefulness of signal-averaged electrocardiogram in idiopathic dilated cardiomyopathy for identifying patients with ventricular arrhythmias. Am J Cardiol 1993;72:78-84.
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Date:Aug 23, 1999
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