Results of the PREVENT - SCD Trial Published in Clinical Research in Cardiology
TEWKSBURY, Mass.-- Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that results of the PREVENT-SCD trial, published in the journal Clinical Research in Cardiology, reinforce the value of the Microvolt T-Wave AlternansTM (MTWA) test in identifying patients at risk of Sudden Cardiac Death (SCD). Preliminary results of the study were originally presented at the American Heart Association Scientific Sessions in 2009.
PREVENT-SCD (PRospective EValuation of VENtricular Tachyarrhythmic Events and Sudden Cardiac Death in Patients with Left Ventricular Dysfunction), a prospective multi-center study of patients with cardiomyopathy and ejection fraction of 40 percent or lower, enrolled a total of 453 patients from 38 institutions in Japan. Two hundred eighty (280) patients underwent non-invasive MTWA testing using the analytic spectral method and were followed for an average of three years. At a median follow-up time of 36 months, patients with an abnormal MTWA test were 4.4 times more likely to experience a life-threatening arrhythmia or SCD than those with a normal test and were almost eight times more likely to die of cardiac causes. The negative predictive value was 100 percent at one year, 98.6 percent at two years, and 97.0 percent at three years, indicating that patients with a normal or negative MTWA test are at low risk for experiencing sudden death. In the sub-group of patients with non-ischemic cardiomyopathy, the negative predictive value was 100 percent out to three years.
"The event-free rate for severe ventricular tachyarrhythmias in TWA-negative patients was excellent," said Dr. Satoshi Shizuta, Kyoto University Hospital, Kyoto, Japan, lead author of the study. In PREVENT-SCD, 29 percent of patients eligible for the test had a negative MTWA result. He also noted that these patients are at very low risk for SCD in the next three years.
"The PREVENT-SCD trial confirms the predictive value of MTWA in patients with left ventricular dysfunction," said Ali Haghighi-Mood, President and Chief Executive Officer of Cambridge Heart. "These powerful results illustrate MTWA's utility in assessing the risk of SCD in a real-world population of cardiomyopathy patients, whether their disease is ischemic or non-ischemic in origin."
The PREVENT-SCD manuscript can be found on the publisher's website at:http://www.springerlink.com/content/r243743418357826/.