Cambridge Heart, developer of non-invasive diagnostic tests for cardiac disease, today announced that the results of a 155-patient trial test of the Microvolt T-Wave Alternans™ (MTWA) confirm the technology as a valuable predictor of life-threatening heart rhythms and Sudden Cardiac Death (SDC).
MTWA measures the risk of sudden cardiac arrest (SCA), which is determined during a non-invasive treadmill test using Cambridge Heart’s proprietary technologies. The company notes that MTWA test is the only one of its kind that is reimbursed by Medicare under a National Coverage Policy.
The study involved 155 patients who first underwent MTWA testing using Cambridge Heart’s analytic spectral method. Patients then received an implantable cardioverter defibrillator (ICD) as a secondary prevention of SCD, 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, the study demonstrated that 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 results show that the negative predictive value of 98.6 percent indicates 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,” Dr. Beata Sredniawa, lead author of the study, stated in the press release. “These results suggest that standardized MTWA evaluation can be useful for risk stratification in clinical practice.”
Additionally, the results were published this week in the journal Kardiologia Polska.
“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 CEO 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.”
For more information, visit www.campbridgeheart.com
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