Largest Prospective Study of Microvolt T-Wave Alternans in Patients with Non-ischemic Cardiomyopathy Confirms the Predictive Value of MTWA.
BEDFORD, Mass. -- Cambridge Heart, Inc. (OTCBB-CAMH) announced today the presentation of a multi-center, prospective study during the Late-Breaking Clinical Trials session of the American College of Cardiology Scientific meeting in New Orleans assessing the utility of Microvolt T-Wave Alternans[TM] (MTWA), using the CH2000 or HearTwave system, in predicting risk of sudden death among patients with non-ischemic cardiomyopathy.
The ALPHA study (Prognostic Value of T-Wave ALternans in Patients with Heart FAilure Due to Nonischemic Cardiomyopathy) enrolled 446 consecutive patients with NYHA Class II or III non-ischemic cardiomyopathy and left ventricular ejection fraction (LVEF) less than or equal to 40%. On the primary endpoint (cardiac death and life-threatening arrhythmias) an abnormal MTWA test had a Hazard Ratio of 4.01 (p=0.002), or four times the risk than a normal MTWA test. The 12-month negative predictive value of the test was reported to be 98.7%, indicating that patients with a negative test result are at very low risk of sudden cardiac death. For patients with LVEF less than 35%, the Hazard Ratio and negative predictive value were 4.28 (p=0.004) and 99%, respectively.
Dr. Gaetano M. De Ferrari, Head of the Intensive Care Unit in the department of cardiology at San Matteo Hospital in Pavia, Italy and a member of the ALPHA Steering Committee, presented the results during the Sunday morning session. Dr. De Ferrari commented, "Presently, all NYHA Class II and III heart failure patients with a left ventricular ejection fraction less than or equal to 35% are considered candidates for an ICD. The ALPHA study strongly suggests that one third of these patients will have a normal MTWA test result and are less likely to benefit from the ICD. Knowing this, we are better able to treat the two thirds of patients who truly need a device."
"This is another significant study as it confirms the prognostic value of MTWA in the non-ischemic cardiomyopathy population, a group in which risk stratification has traditionally been challenging," said Dr. Ali Haghighi-Mood, CTO and COO of Cambridge Heart, Inc. "This well-designed study underscores the value of risk stratification in this segment of the primary prevention population."
About Cambridge Heart
Cambridge Heart (www.cambridgeheart.com) is engaged in the development and commercialization of products for the non-invasive diagnosis of cardiac disease, particularly the identification of those at risk of sudden cardiac arrest. The Company's products incorporate its proprietary Microvolt T-Wave Alternans measurement technologies, coupled with its patented Spectral Analytic Method and ultra-sensitive disposable electrodes. Only Spectral Analytic Method MTWA tests are reimbursed by Medicare under its National Coverage Policy that covers patients with a wide variety of cardiac symptoms. Other major insurers in the USA also have coverage policies for the test. The T-Wave Alternans test is included in the Guideline for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death jointly developed by the American College of Cardiology (ACC), The American Heart Association (AHA) and the European Society of Cardiology (ESC). The Company, founded in 1990, is based in Bedford, Massachusetts and is traded on the OTCBB under the symbol CAMH.
About the Cambridge Heart Microvolt T-Wave Alternans Test
The Cambridge Heart Microvolt T-Wave Alternans Test measures extremely subtle beat-to-beat fluctuations in a person's heartbeat called T-wave alternans. These tiny heartbeat variations - measured at one millionth of a volt - are detected in any clinical setting where titration of the heart rate is possible. The preparation for the test consists of placing proprietary sensors on a patient's chest. Extensive clinical research has shown those patients with symptoms of, or who are at risk of, life threatening arrhythmias that test positive for T-wave alternans are at significant risk for subsequent sudden cardiac events including sudden death, while those who test negative are at minimal risk.
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|Article Type:||Clinical report|
|Date:||Mar 26, 2007|
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