Cambridge Heart Inc., maker of a previously covered HearTwave® II Microvolt T-Wave Alternans System, is reporting that the results of a large trial have shown that the company’s noninvasive testing system is as good at predicting sudden cardiac death as the invasive electrophysiology (EP) testing, a catheterization procedure. Primary investigators who presented the research were Otto Costantini, M.D. and David S. Rosenbaum, M.D. from Case Western Reserve University in Cleveland.
From yesterday’s company press release:
New clinical trial results from the Alternans Before Cardioverter Defibrillator (ABCD) trial were presented today at the American Heart Association’s 2006 Scientific Sessions conference in Chicago…
This first-of-its-kind study investigated the use of MTWA, in which electrocardiogram sensors are placed on the chest, to eliminate or reduce the need for more costly and complicated invasive tests, where catheter electrodes are placed into the patient’s heart and electrical impulses are delivered to deliberately induce an abnormal heart rhythm.
It is anticipated this new tool will be used by referring physicians to better identify which patients have life-threatening arrhythmias and need therapy provided by implantable cardioverter defibrillators (ICDs). Current estimates show that only one in eight patients who needs such a device actually gets one implanted. SCD from ventricular arrhythmias accounts for nearly 50 percent of all cardiovascular deaths worldwide and, although treatable with an ICD, it’s difficult to predict which patients are most at risk…
“The positive and negative predictive values of a MTWA-directed strategy and that of an EP test alone were essentially identical,” said Costantini. “This is most important, as the clinically relevant question today is not who should receive an ICD, but who is unlikely to benefit from ICD therapy. The use of a non-invasive approach to help us answer this question represents a significant step forward.”
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