Cambridge Heart, Inc. (OTCBB: CAMH), a developer of non-invasive diagnostic tests for cardiac disease, today announced that results of a prospective, 155-patient trial reinforce the value of the Microvolt T-Wave AlternansTM (MTWA) test as a predictor of life-threatening heart rhythms and Sudden Cardiac Death (SCD). The results were published this week in the journal Kardiologia Polska.
Researchers from the Medical University of Silesia in Zabrze, Poland studied 155 patients who received an implantable cardioverter defibrillator (ICD) for secondary prevention of SCD. Patients underwent MTWA testing using Cambridge Heart's analytic spectral method prior to implantation and were followed for major arrhythmic cardiac events (MACE) including SCD or intractable life-threatening arrhythmias requiring ablation or heart transplant.
At a median follow-up time of 22 months, patients with an abnormal MTWA test were 11 times more likely to experience a major arrhythmic cardiac event than patients with a normal MTWA result. The negative predictive value was 98.6 percent, indicating that patients with a normal or negative MTWA test are at very low risk of experiencing life-threatening arrhythmias.
"The most important finding of our study was that abnormal MTWA was demonstrated to be a strong, independent risk factor for MACE following ICD implantation," said Dr. Beata Sredniawa, lead author of the study. "These results suggest that standardized MTWA evaluation can be useful for risk stratification in clinical practice."
"This exciting new published data is an important addition to an already extensive body of literature supporting the clinical role of MTWA in managing patients at risk of sudden cardiac arrest," said Ali Haghighi-Mood, President and Chief Executive Officer of Cambridge Heart. "These results are significant in that they confirm the prognostic value of MTWA in predicting arrhythmic events that are truly life-threatening."