New Japanese MTWA trial results offer SCA prevention hope
November 19, 2009
This week at the annual Scientific Sessions of the American Heart Association (AHA) , the renowned Framingham Heart Study released the alarming findings that one in eight males and one in 24 females in the US who reach the age of 40 are likely to die of sudden cardiac arrest (SCA).
According to the AHA, 12 M Americans are at risk of SCA–and every year, some 350 thousand US individuals die of SCA, making SCA one of this nation’s leading killers.
But—there is hope. Also at the AHA, a Japanese research team released clinical trial results reaffirming that a non-invasive treadmill test developed by Cambridge Heart, Inc., of Tewksbury MA, can effectively predict the risk of sudden cardiac arrest for many cardiac patients—and can quite accurately which patients are NOT at risk. (Disclosure; I’m paid to help Cambridge Heart with media relations).
The test, called MTWA (Microvolt T-wave Alternans) measures a tiny heartbeat irregularity believed to cause SCA. Administered on a treadmill like a stress test, the MTWA test helps doctors assess whether riskier, more costly invasive testing is needed. While studies show that MTWA is often as accurate as invasive testing in predicting SCA, invasive (and potentially risky) electrophysiology tests are still generally used to determine whether cardiac defribrillators—which shock stopped hearts back into action- should be implanted.
The newly reported study, which enrolled 458 patients in 38 medical centers in Japan, was called “ PREVENT-SCD” (PRospective EValuation of VENtricular Tachyarrhythmic Events and Sudden Cardiac Death in Patients with Left Ventricular Dysfunction It included patients with cardiomyopathy and ejection fraction of 40% or lower. In the study, 280 patients underwent non-invasive MTWA testing using the analytic spectral method and were followed for up to three years.
At a median follow-up time of 36 months, patients with an abnormal MTWA test were 4.4 times more likely to experience a life-threatening arrhythmia or SCD than those with a normal test, the researchers found. The 3-year negative predictive value was reported to be 97.0%, indicating that patients with a normal or negative MTWA test are at low risk for experiencing sudden death.
According to lead author Satoshi Shizuta, MD, of Kyoto University Hospital, Kyoto, Japan, “MTWA has a very high negative predictive value for lethal arrhythmias in this population He noted that these patients are at very low risk for SCD in the next three years.
According to Dr. Ali Haghighi-Mood, President and Chief Executive Officer of Cambridge Heart, “The PREVENT-SCD trial further confirms the results of several previously published studies of MTWA in patients with left ventricular dysfunction…The value of MTWA as an accurate predictor of sudden cardiac arrest in this population has become very well established.”
The Japanese trial was not funded by Cambridge Heart, nor was Cambridge Heart aware of the results before they were announced at AHA.
However, the Japanese announcement follows close on the heels of a joint announcement last week by Cambridge Heart and Cardiac Science, a Washington State stress test manufacturer, that the two companies will collaborate on developing a “super stress test” that will include an MTWA testing component.
More information about the Japanese trial is available on Cambridge Heart’s Web site at <http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.cambridgeheart.com%2Fcontent%2FShared%2FFAQ.shtml&esheet=6103292&lan=en_US&anchor=MTWA&index=1&md5=a98add7e8a88beb9b2b0e62edffa32f7> ) . The Web site (www.cambridgeheart.com) also offers information about SCA, other studies of MTWA, and the MTWA test itself. The test is reimbursable by Medicare and many private insurers.
—Anita M. Harris
HarrisComBlog is a publication of the Harris Communications Group of Cambridge MA. We also publish the New Cambridge Observer.
Scientia Advisors of Cambridge, MA, and Palo Alto, CA, has found that while HIT’s share of the $1 trillion healthcare products market by will grow by 25% through 2013, some segments will do better than others as a result of government incentives and regulations and a changing healthcare marketplace, worldwide.
Based on an industry review released today, Scientia, which is my client, says that in order to remain competitive, companies must factor in government incentives, new clinical decision-making and electronic health record requirements, as well as emerging competitors and markets in Asia and elsewhere in the developing world.
“Historically, therapeutics and medical devices have captured more than 90 per cent of worldwide healthcare product sales,” said Harry Glorikian, Scientia Advisors’ managing partner.
“But with declining marginal benefits from new interventional products and greater emphasis on appropriate use of existing interventions, we project accelerating HIT-related sales.” By 2013, indications are that HIT sales will grow from four per cent of the worldwide health care products market to five per cent—representing a 25% increase in HIT’s market share.
The review assessed HIT’s likely impact on “front” and “back office systems,” clinical testing, diagnostics , and pharmacies; how government mandates in North American, Germany, Norway, the UK, China and Australia will affect worldwide HIT opportunity– including a 25% CAGR in China; how the US stimulus bill will impact electronic health records, clinical decision support systems and the adoption of HIT by hospitals of various sizes; and the consequences of CDSS for healthcare market participants.
The review, funded by Scientia itself, was based on extensive primary and secondary research and proprietary analytic methods. It’s available for download from Scientia’s Web site at www.scientiaadv.com.
HarrisComBlog is a publication of the Harris Communications Group of Cambridge, MA. We also publish New Cambridge Observer.
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Despite Recession, Cosmeceutical Market Grows at Rapid Clip
November 6, 2009
In bad economic times, cosmetics ordinarily do fine–because, experts say, women are likely to buy small things, like lipstick, instead of big ticket items–to make themselves feel happier. So I was interested to read in today’s Wall Street Journal that Loreal is planning to offer lower priced items–following a 7 per cent decline in profits, this year.
But there is a bright spot. My client, Scientia Advisors, released a study this week showing that the global market for cosmeceuticals (cosmetics offering health benefits) is growing nearly twice as fast as the overall cosmetics and toiletries market.
Scientia found that in order to sustain such rapid growth, manufacturers and brand owners must fill a relentless demand for new ingredient concepts in a context of changing government regulations, market dynamics and cultural trends.
Cosmeceuticals are personal care products that go beyond cosmetics by providing an added health benefit –such as UV skin protection, wrinkle or acne reduction, or hair or skin moisturizing—but do not claim a therapeutic effect. Cosmeceuticals are also known as biofunctional materials, dermaceuticals, functional cosmetics, performance cosmetics, active cosmetics, and dermocosmetics.
For more info you can download the study from Scientia’s Web site at www.scientiaadv.com.
–Anita Harris
HarrisComBlog is a publication of the Harris Communications Group of Cambridge, MA. We also publish the New Cambridge Observer.
