1000 Patient Study Supports Microvolt TWA as a Risk
Stratifier for this Large Low-Risk Population. Finds 17% Could Possibly Benefit From
Therapy Such as Defibrillator ImplantationBEDFORD, Mass.--(BUSINESS WIRE)--Dec. 4,
2006--Cambridge Heart, Inc. (OTCBB-CAMH) announced today the publication of a study in the
Journal of the American College of Cardiology assessing the utility of Microvolt T-Wave
Alternans(TM) (MTWA) in predicting risk of sudden death among patients who have previously
suffered a heart attack (Acute Myocardial Infarction; MI) yet have preserved cardiac
function. This group of patients is outside of the MADIT II and SCDHeFT populations as the
study included only patients with a left ventricular ejection fraction (LVEF) greater than
or equal to 0.40, while the two aforementioned studies involved LVEF (less than or equal
to) 0.30 and LVEF (less than or equal to) 0.35 patients respectively. The results indicate
that the MTWA test, using the Cambridge Heart patented Spectral Analytic Method during low
heart rate exercise, identifies those patients who are at elevated risk for sudden cardiac
death and therefore may benefit from implantation of a defibrillator.
The US post-MI population consists of approximately 7,200,000 people. 565,000 new MI
patients join this group annually and 225,000 die each year from another MI. Patients with
an LVEF greater than or equal to 0.40 represent a very large fraction of the post-MI
population. The existence of an easy, low cost test that can be performed in a doctor's
office and determines which patients may benefit from defibrillator therapy represents a
significant step forward in patient management. The publication reports that 74% of the
patients studied had a negative MTWA test as might be expected in this population of
post-MI patients who are at overall lower risk due to their preserved ejection fraction.
Nine percent of the patients were indeterminate with some patient condition interfering
with the measurement. However 17% of these patients were positive and therefore likely to
benefit from therapy such as an implantable defibrillator.
"Recent studies have shown that an "abnormal" MTWA test (i.e. both
positive and indeterminate results) is a useful marker for the identification of high-risk
patients, and a negative or normal MTWA test is a marker of low risk. These studies
assessed the value of MTWA in post-MI patients with a reduced LVEF" said Takanori
Ikeda, MD, PhD, FACC, Professor of Medicine at Kyorin University and the study's principal
investigator. "In the present study, we assessed its value in patients with preserved
cardiac function (i.e., a low-risk population). Interestingly, an indeterminate test
result was not associated with arrhythmic events and "a positive MTWA test"
alone had a significant association. We think that a positive MTWA test could be a strong
risk stratifier for sudden cardiac death in the setting of acute MI and LVEF greater than
or equal 0.40. At present, EP testing has been proposed to be a tool in identifying
patients who would benefit from implantation of an ICD. However, EP testing is invasive,
done in a hospital setting, and expensive. So, we would like to recommend noninvasive MTWA
to detect high-risk patients, particularly in patients with preserved cardiac
function."
The study was a large collaborative cohort study enrolling 1,041 post-MI patients at
eight medical centers in Japan. All patients had an LVEF greater than or equal 0.40 and
the average LVEF was 0.55. Microvolt TWA testing was performed 48 to 66 days after acute
MI, and 10 other risk variables were also evaluated.
The JACC article stated that "The end points were prospectively defined as sudden
cardiac death or life-threatening arrhythmic events. During a follow-up of 32 +/- 14
months, 38 patients (3.7%) died of nonarrhythmic causes and were not considered for
analysis. Of the 1,003 evaluable patients, 18 (1.8%) reached an end point. Microvolt TWA
was positive in 169 patients (17%), negative in 747 (74%), and indeterminate in 87 (9%). A
positive microvolt TWA test, nonsustained ventricular tachycardia, and ventricular late
potentials were predictors of events, and percutaneous coronary intervention decreased the
risk rate. On multivariate analysis, a positive microvolt TWA test was the most
significant predictor, with a hazard ratio of 19.7 (p (less than) 0.0001). This marker had
the highest sensitivity and negative predictive value for events."
"This is a significant study for Spectral Analytic Microvolt T-Wave Alternans(TM)
as it points to the value of MTWA as a sudden cardiac death risk stratifier across the
full spectrum of patients who have had an MI" said Jeffrey Langan, President and CEO
of Cambridge Heart, Inc. "Our customer base routinely uses MTWA to determine if
borderline and questionable patients with an LVEF (less than or equal to) 0.35 should
receive an ICD or not. They also use it to demonstrate to those patients who are resistant
to receiving an ICD that they do or do not need one. Now, as many of them have already
begun to find out, it is useful in those patients with an LVEF greater than or equal 0 .40
in determining what therapeutic actions to take."
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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"anticipates", "plans", "estimates", "could" and
similar expressions that convey uncertainty of future events or outcomes to identify these
forward-looking statements. Actual results may differ materially from those indicated by
these forward-looking statements. Factors that may cause or contribute to such differences
include customer delays in making final buying decisions, decreased demand for our
products, failure to obtain funding necessary to develop or enhance our technology,
adverse results in future clinical studies of our technology, failure to obtain or
maintain patent protection for our technology, failure to obtain or maintain adequate
levels of third-party reimbursement for use of our products and other factors identified
in our most recent Annual Report on Form 10-K under "Factors Which May Affect Future
Results", which is on file with the SEC. In addition, any forward-looking statements
represent our estimates only as of today and should not be relied upon as representing our
estimates as of any subsequent date. While we may elect to update forward-looking
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even if our estimates change.
CONTACT: Cambridge Heart, Inc.
Roderick de Greef,
Chief Financial Officer
(781) 271-1200 x231
roderickd@cambridgeheart.com
or
Consulting Office
for Strategic Growth
Stanley Wunderlich
(800) 625-2236
info@csfg1.com
SOURCE: Cambridge Heart