Studies Confirm T-wave Alternans Test as Predictor of Sudden Cardiac Arrest May 12, 1999 - Cambridge Heart Inc, today announced that several studies prove that T-wave alternans testing is a very good tool for diagnosing patients at risk of sudden cardiac arrest (SCA). These studies identify patient groups for which the Alternans Test is good. The Alternans Test was cleared by the FDA on April 13, 1999. It is the only NON-INVASIVE test approved to identify patients at risk of heart rhythm problems that may cause sudden cardiac arrest. One study shows that the Alternans Test can predict arrhythmias that cause sudden cardiac arrest in patients with non-ischemic dilated cardiomyopathy (DCM). No other test has proved effective in predicting sudden cardiac death in these patients. Another study shows promising results in a rare congenital disease called arrhythmogenic right ventricular cardiomyopathy. A third study shows that the new test is a better predictor of a positive EPS and of cardiac events than signal-averaged ECG. These tests are described at the end of this article. 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 changes in the rate and frequency of electrical impulses in the ventricles. SCA kills about 300,000 people a year in the USA. The Alternans Test works like a "super stress test." It measures extremely subtle beat-to-beat changes in a person's heartbeat called T-wave alternans. T-wave alternans is not visible on the electrocardiograms used with ordinary exercise stress tests. These tiny heartbeat changes are detected during a treadmill or bicycle stress test by specially designed, high-resolution electrodes on a patient's chest. Cambridge Heart Inc is based in Bedford, Mass. The studies presented at the Electrophysiology conference include: 1) Exercise Induced Microvolt Level T-wave Alternans Identifies Patients with Non-Ischemic Dilated Cardiomyopathy at High Risk of Ventricular Tachyarrhythmic Events, by Thomas Klingenheben, MD. It studied 56 patients with non-ischemic DCM. Other tests have not been able to predict the risk of ventricular arrhythmic events very well. This concludes that the T-wave Alternans Test seems to identify DCM patients at high risk of VTE. 2) T-wave Alternans Predicts Arrhythmia Vulnerability in Patients with Ischemic Cardiomyopathy, by Karen MacMurdy, MD. The researchers studied 87 patients with ischemic heart disease who had low EF and were referred for EP testing. Data show that T-wave alternans testing is an accurate predictor of risk of Sudden Cardiac Arrest in patients with ischemic heart disease and poor heart function. One implication of this study is that T-wave alternans testing may help identify patients who need an ICD. 3) Microvolt T-wave Alternans in Patients with Arrhythmogenic Right Ventricular Cardiomyopathy and Dilated Cardiomyopathy, by Yee Guan Yap, MRCP. The researchers did T-wave alternans testing on 48 patients with DCM and 13 patients with a rare congenital disease called ARVC. 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 identify patients with undiagnosed DCM or ARVC. 4) A Comparison of T-wave Alternans and Signal Averaged Electrocardiography in Predicting Outcome of Electrophysiology Testing, by Daniel Bloomfield, MD. The researchers examined results from 103 patients who had T-wave Alternans, ECG and EP tests. They found that T-wave alternans is a non-invasive predictor of a positive EP test, which in turn is a predictor of Sudden Cardiac Arrest. Further, a positive T-wave alternans result predicts a positive EP test better than signal-averaged ECG.