MADIT II Type Patients Successfully Risk Stratified By MTWA; Microvolt T-Wave Alternans Negative Patients are at Extremely Low Risk Of Sudden Cardiac Death

New clinical data demonstrate that MTWA can risk stratify MADIT II type patients to determine which ones will benefit from ICD therapy

BEDFORD, Mass., Jun 24, 2002 (BW HealthWire) -- Cambridge Heart, Inc. (NASDAQ:CAMH) today announced clinical results presented at the Cardiostim meeting in Nice, France that demonstrate that Microvolt T-Wave Alternans (MTWA) testing can play a critical role in risk stratifying MADIT II type patients. Dr. Stephan Hohnloser, Director of Electrophysiology at J.W. Goethe University, Frankfurt, Germany presented compelling clinical data demonstrating that MADIT II type patients who tested negative for MTWA are at very low risk of dying suddenly from a cardiac event.

The MADIT II trial demonstrated that patients with prior myocardial infarction and left ventricular ejection fraction of 0.30 or less have a mortality benefit from prophylactic placement of an implantable cardioverter defibrillator (ICD). Dr. Hohnloser presented data on 120 MADIT II type patients drawn from two previously published prospective clinical trials involving 957 patients. The primary endpoint of the analysis was sudden cardiac death and resuscitated cardiac arrest. The secondary endpoint also included sustained ventricular tachycardia. Twenty-eight percent of the patients tested MTWA negative, 59% tested positive, and 13% had an indeterminate result. Kaplan Meier analysis at 24 months of follow-up for the primary endpoint revealed an event rate of zero for patients who tested MTWA negative and an event rate of 16.4% for the remaining patients. Similar analysis for the secondary endpoint revealed an event rate of 6% for patients who tested MTWA negative and an event rate of 33% for the remaining patients.

MTWA testing successfully identified a subgroup of MADIT II type patients who are at low risk of dying suddenly and therefore should not require ICD therapy. Conversely, MADIT II type patients who do not test MTWA negative would be expected to have a greater mortality benefit from ICD therapy than that reported in the original MADIT II study.

"It is not unanticipated that these results show that MTWA testing is a valuable tool to help further risk stratify this important patient group. We expect that these data will be welcome news to both physicians and payers who are looking for a tool to help determine which of their MADIT II type patients will most benefit from ICD therapy " said David Chazanovitz, Cambridge Heart President and CEO. "Physicians may use MTWA testing for risk stratification in order to save MADIT II type patients who test MTWA negative from unnecessary morbidity, psychological trauma and cost of an ICD. At the same time, physicians will have a compelling reason to refer for ICD therapy those MADIT II type patients who test MTWA positive."