What
is Microvolt T-Wave Alternans (MTWA)?
Microvolt T-Wave Alternans is a beat-to-beat fluctuation in
the amplitude of the T-wave at a microvolt level. When detected
this indicates the presence of a type of cellular metabolic
activity that frequently leads to tachyarrhythmias. Microvolt
T-Wave Alternans testing was cleared by the FDA for its ability
to predict ventricular tachyarrhythmias and sudden cardiac death.
What is the MTWA test?
The Microvolt T-Wave Alternans test is a risk stratification
tool to help you determine your patient's risk of Sudden Cardiac
Death. It is non-invasive, easy to perform diagnostic test
clinically proven to identify patients at risk of Sudden Cardiac
Death. The proprietary Analytic Spectral Method algorithm
measures alternans to as small as a millionth of a volt and
processes the data to determine each patient's risk profile.
. Multiple prospective clinical trials demonstrate that a
majority of patients from broad groups of at risk populations
who test MTWA negative will likely live event-free for 12
to 24 months after their initial test.
Why should I risk stratify my patients?
The CMS decision that now makes over 1,000,000 patients eligible
for ICD therapy is one very good reason to risk stratify.
Current studies1,2 demonstrate that most patients
who receive ICD therapy will not derive any benefit from their
implant. With the proven negative predictive value of the
MTWA testing, you have a tool that helps determine which patients
have the lowest risk of Sudden Cardiac Death and are not likely
to benefit from ICD therapy.
What does the clinical
validation say about the reliability of MTWA testing?
There is a compelling body of evidence that Microvolt T-Wave
Alternans provides accurate negative prediction of VT and
sudden cardiac death. Studies also show that the positive
predictive value of MTWA testing is at least equivalent to
that of an EP study. For a summary of the key clinical results,
click
here.
Which patients should be MTWA tested?
Any patient eligible for ICD implant in primary or secondary
prevention of Sudden Cardiac Death.
Is the test reimbursed?
The procedure is reimbursed by Medicare and by some private
insurers. For specific information about reimbursement in
your area, click here.
How do we measure Microvolt T-Wave Alternans?
Our technology measures Microvolt T-Wave Alternans non-invasively
during routine exercise, pharmacological, or pacing using
proprietary algorithms and signal processing techniques. The
MTWA testing system includes a computer with proprietary software
that can be configured for both hospital and office settings.
What role does MTWA testing play in
MADIT II and SCD-Heft patients?
In both MADIT II and SCD-Heft patient groups are now eligible
for ICD therapy as a primary prevention treatment and are
ideal candidates to be risk stratified by MTWA testing prior
to referral to electrophysiologist. Patients in these groups
who have a normal MTWA test are not likely to experience a
sudden cardiac event for 1-2 years and therefore not likely
to benefit from ICD therapy.
What equipment do I need to perform
a Microvolt T-Wave Alternans Test?
You need a product that measures T-wave alternans using the
Analytic Spectral Method. The systems available from Cambridge
Heart include CH2000 and
the HearTwave®
II System.
How is the test performed?
Preparation for a Microvolt T-Wave Alternans test is the same
as it is for an exercise stress test.
Fourteen Sensors - 7 Micro-V
Alternans sensors and 7 standard electrodes are placed
in the Frank-lead
configuration. These electrodes are connected to the digital
ECG amplifier that leads back to the Microvolt T-Wave Alternans
enabled system.
At the beginning of the test, the patient is directed to
begin walking on a treadmill to raise the heart rate. The
exercise portion of the test will be approximately 8-10 minutes.
Information will be collected for the Microvolt T-Wave Alternans
Test while at rest, during exercise and at rest again.
How long does an average test take?
Including electrode prep, an average test takes less than
30 minutes.
How do I see the test results?
An automatic report is printed after the data have been processed
by the MTWA proprietary algorithm. The report includes an
interpretation of your patient's results which is classified
as negative, positive, or indeterminate.
What do I do if my patient tests MTWA
negative/normal?
Studies demonstrate that in patients who have a normal MTWA
test the risk of sudden cardiac death is very low. In fact,
the negative predictive value of MTWA testing has been shown
to be 98% accurate for follow-up periods of 12 -24 months
in various clinical studies. Negative patients should be retested
every 12 months as cardiac function can change over time.
What do I do with patients who test
positive?
Patients who test MTWA positive are at higher risk for Sudden
Cardiac Death than those testing negative and should be referred
to an electrophysiologist for further evaluation.
What do I do with patients who are indeterminate?
Patients who have an indeterminate test result should be retested
immediately. Studies indicate that over 50% of patients who
initially test as indeterminate, become determinate if retested
during the same session. If the indeterminacy is to due to
an inability to achieve heart rate or dense ectopy, the patient
should be considered at risk for SCD and referred on to an
electrophysiologist.
References
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