Cambridge Heart, a developer of non-invasive diagnostic tests for cardiac disease, announced that results of the PREVENT-SCD trial reinforce the value of the Microvolt T-Wave Alternans (MTWA) test in identifying patients at risk of sudden cardiac death. These results were published in the journal Clinical Research in Cardiology.
PREVENT-SCD (Prospective evaluation of ventricular tachyarrhythmic events and sudden cardiac death in patients with left ventricular dysfunction), a prospective multicentre study of patients with cardiomyopathy and ejection fraction of 40% or lower, enrolled a total of 453 patients from 38 institutions in Japan. Two hundred and eighty 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 sudden cardiac death than those with a normal test and were almost eight times more likely to die of cardiac causes. The negative predictive value was 100% at one year, 98.6% at two years, and 97.0% 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-ischaemic cardiomyopathy, the negative predictive value was 100% out to three years.
“The event-free rate for severe ventricular tachyarrhythmias in TWA-negative patients was excellent,” said Satoshi Shizuta, Kyoto University Hospital, Kyoto, Japan, lead author of the study. In PREVENT-SCD, 29% of patients eligible for the test had a negative MTWA result. He also noted that these patients are at very low risk for sudden cardiac death 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 CEO of Cambridge Heart. “These powerful results illustrate MTWA’s utility in assessing the risk of sudden cardiac death in a real-world population of cardiomyopathy patients, whether their disease is ischaemic or non-ischaemic in origin.”