Boca Raton firm addressing the Russert reality
August 8th, 2008
By John Johnston
Managing Editor
Yet another Boca Raton firm is on the brink of making history – developing a product that will have universal application in the rapid and accurate diagnosis of potential and actual heart problems.
Carl Friedrich Gauss referred to mathematics as "the Queen of the Sciences.” A century later Albert Einstein said, "as far as the laws of mathematics refer to reality, they are not certain; and as far as they are certain, they do not refer to reality.”
What’s quite real, however, is that young soldiers die on the battlefield because a rapid enough analysis of who should be treated first (triage) is not available to mobile army surgical hospital (MASH) personnel.
What’s also very real is that there are approximately 400 000 deaths annually in the US from Sudden Cardiac Death (SCD) syndrome – something the family of NBC News star Tim Russert knows all too well.
In the next several years – and using mathematics -- Boca Raton based Vicor Technologies, Inc. wants to do something about both the battlefield and SCD dilemmas.
Risk Stratification
Actually, Vicor Chief Medical Officer Dr. Daniel Weiss told the Boca Raton News that what Vicor has developed is something it calls a “PD2i Risk Stratification Algorithm,” a patented, proprietary algorithm that is the platform for its products.
An algorithm is a mathematical tool generally defined as “a step-by-step problem-solving procedure, especially an established, recursive computational procedure for solving a problem in a finite number of steps.”
Sci-Tech Encyclopedia further refines the definition of an algorithm as follows:
“A well-defined procedure to solve a problem. The study of algorithms is a fundamental area of computer science. In writing a computer program to solve a problem, a programmer expresses in a computer language an algorithm that solves the problem, thereby turning the algorithm into a computer program.”
Stratification is in turn defined as “a layered configuration” – and thus medical risk stratification is a layering of the medical necessities against what the body is actually doing -- providing both the battlefield physician and the in-office cardiologist an invaluable tool.
Einstein might indeed have something to say about all this, but in any case, Vicor’s Dr. Weiss says that his firm has two separate studies underway. Both use Vicor’s risk stratification algorithm to, in the first case, analyze the likelihood of a person suffering an SCD; and in the second case, uses a variation of that same algorithm on the battlefield, deploying it in Iraq to more intelligently determine which injured solider should receive treatment first.
Dr. Weiss explained that, and using a non-invasive, hand-held, low-cost, user-friendly, PC Windows-based diagnostic tool, the algorithm analyzes data from patients who are at high risk of sudden cardiac death -- or those who need treatment on a battlefield to determine who should be treated first.
In sum, Dr. Weiss explains that in both cases the tool examines and analyses “how the brain instructs the heart on what to do.”
Such an examination takes about 15 minutes for the SCD susceptible person – someone with a weak heart -- and one to two minutes on the battlefield, Weiss said.
SCD Different
SCD is in fact the leading cause of death in the US said Dr. Weiss – but contrary to common perception, SCD is not the same as a heart attack – the much-storied “myocardial infarction.”
A heart attack is considered a cardiac "plumbing" problem wherein part of the heart muscle's blood supply is interrupted, resulting in the heart failing. Typically a heart attack is not immediately fatal in and of itself, Dr Weiss said.
An SCD on the other hand is the result of a fatal arrhythmic event, commonly known as a heart palpitation. Dr. Weiss said these events are now believed to result from a breakdown of the normal neurological communication between the heart and the brain. Swift, unexpected, and often occurring in individuals without any prior heart problem symptoms, SCD generally results in death within six minutes in the absence of appropriate medical attention.
Even with prompt emergency medical attention, only five percent of SCD victims survive; Tim Russert was among the 95 percent who don’t.
“Overimplanting”
At present, the treatment of choice for SCD prevention is an implantable cardioverter defibrillator (ICD).
Trouble is, Dr. Weiss says, and without reliable information about those who are most likely to suffer an SCD in the next 12 months, the medical community is “overimplanting” ICD units.
According to current statistics, Dr. Weiss said approximately 12 million US cardiac patients meet the criteria for being at an elevated risk of SCD and, as a result, are able to receive an ICD. Recent studies, however, reveal that 76 percent of ICDs implanted never fire, suggesting a lack of true need in those patients and resulting in unnecessary ICD implantations with all of the associated health risks and costs – about $75,000 per person.
Conversely, and perhaps more importantly Dr. Weiss continues, “Only 20-30 percent of those who do have an episode of SCD would have met the current criteria for preventive ICD implantation, leaving the remaining 70-80 percent unprotected.”
According to Robert Califf, a Duke University cardiologist speaking at a conference of the American College of Cardiology back in April, (as reported in The Wall Street Journal (Heart Device's Sales Slow as Wider Use is Sought - 4/1/08)), "'None of the tests [to separate patients who would benefit from ICDs from those who don't] are any good.' Dr. Califf described the current diagnostic situation as 'chaos.'"
Dr. Weiss said that’s where Vicor’s risk stratification tools come in – and the US Army agrees, signing a contract with Vicor in January to do actual battlefield studies using Vicor’s risk stratification algorithm.
Vicor has completed two studies (one human, one animal) and is in the process of completing two more, said Dr. Weiss.
The results of these studies, thus far, have been “very positive” -- and the U.S. Army is eager to put the tool to use, given pressure from a Congressional mandate to reduce battlefield fatalities, he said.
Additionally, Vicor is involved in a comprehensive trial being conducted by the Harvard Clinical Research Institute. That trial involves 700-900 patients in 30 sites, and should be completed by early in 2010, said Dr. Weiss, adding that the army studies should be completed in 2009.
“It’s all in the algorithm,” he said.
Editor’s Note: At press time, The Boca Raton News learned that David Fater, CEO of Vicor Technologies, Inc. will present the firm’s proprietary technology at the Smart Monitoring 2008 Forum Sunday in St. Petersburg Beach.
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