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Department of Health and Human Services

Topic Suggestion Description

View Topic Suggestion Disposition (PDF) 53 kB

Date submitted: August 04, 2011

Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
In order to prevent the 350,000 annual sudden cardiac deaths a year in the USA and the 21% of unnecessary implanted defibrillator patients why is Cambridge Hearts Microvolt T-Wave Alternans Test a guideline and provided more ?
Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)
If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:
The Microvolt T-Wave Alternans Test vs standards stress test and nuclear test.
Cambridge Hearts diagnostic products incorporate proprietary technology for the measurement of Microvolt T-Wave Alternans™ (MTWA). Microvolt
T-Wave Alternans is an extremely subtle beat-to-beat fluctuation in the T-wave segment of a patient's heartbeat. The use of our products and technology in the performance of a Microvolt T-Wave Alternans Test can detect these tiny heartbeat variations, measured down to one millionth of a volt vs standard stress or nuclear test.
What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)
Applies to everyone. By everyone I mean there are 350,000 annual Sudden Cardiac Deaths across numerous demographics.
Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
The test applies to all however certainly a higher percentage of certain people apply. For example fire workers, obese, diabetic, elderly, athletes just to name a few.
Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
Preventing the 350,000 annual deaths to to sudden cardiac death. With boomers this number will exponentially increase very soon.
Describe any health-related risks, side effects, or harms that you are concerned about.
The Cambridge test is proven to be non-invasive, low cost and very convenient taking about 5 minutes. The Cambridge test uses no nuclear as well. NO SIDE Effects from the Cambridge Test.

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?
Which priority area(s) and population(s) does this topic apply to? (check all that apply)
EHC Priority Conditions (updated in 2008)
  • Cardiovascular disease, including stroke and hypertension
  • Diabetes mellitus
  • Obesity
  • Pulmonary disease/asthma
  • Substance abuse
AHRQ Priority Populations
Federal Health Care Program
  • Medicaid
  • Medicare
  • Other


Describe why this topic is important.
350,000 annual deaths a year from sudden cardiac death and soon will be growing with boomer population.
What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)
A wide range of published clinical data has shown that patients with symptoms of or at risk of life threatening arrhythmias who have a normal
or negative MTWA test are at minimal risk for a sudden cardiac event while those who have an abnormal or positive test are at increased risk
for subsequent sudden cardiac events including sudden death. We believe that this data demonstrates that our Microvolt T-Wave Alternans technology is the only non-invasive test comparable or superior to the
invasive "gold standard" electrophysiology study in the prediction of sudden death.
Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)
If yes, please explain:
About 10 international studies conclude this test is necessary none have not. Roughly 80% of insurers cover the test including Center for Medicaid Services however the test is not being provided out in the industry.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?
Describe the timeframe in which an answer to your question is needed.
Every two minutes someone dies from Sudden Cardiac Death it is up to you.
Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Nominator Information

Other Information About You: (optional)
Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)
  • Other
Are you making a suggestion as an individual or on behalf of an organization?
Please tell us how you heard about the Effective Health Care Program
A commercial while watching a Purdue basketball game last winter. I submitted the question to AHRQ which seemed to be a great fit and ended up hear over time.