New Test, VENDYS(R), Helps Detect Silent Heart Disease

Main Category: Heart Disease
Also Included In: Cardiovascular / Cardiology;  Medical Devices / Diagnostics
Article Date: 10 Nov 2008 - 2:00 PST

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Results from the latest clinical study evaluating the predictive value of VENDYS®, the new FDA-approved cardiovascular test, will be presented to cardiovascular opinion leaders and luminaries during the 2008 annual conference of the American Heart Association in New Orleans. The study shows that a simple, inexpensive test that measures temperature changes at the fingertips can help detect hidden coronary artery disease.

"We now have hundreds of patients studied at our center with VENDYS, and the results have consistently shown strong correlation between low fingertip temperature rebound and high burden of coronary plaques. The lower the temperature rebound, the more plaque buildup and blockage," said Dr. Mathew Budoff, Associate Professor of Medicine and Director of Cardiac CT Laboratory at Harbor UCLA. "This is truly amazing! VENDYS is the only non-invasive, non-imaging, office-based test that I am aware of with such a high predictive value for detection of high risk coronary patients. We are seeing similar results in CT angiography, as well as nuclear, studies."

Researchers hope that VENDYS, by measuring a dynamic marker of vascular disease, can fill the gap in existing cardiovascular risk assessment and complement traditional risk factor measurements as well as advanced, structural imaging tests, such as CAT scan and MRI.

"I acknowledge that it doesn't seem logical that measuring the temperature of your finger can predict your likelihood of having a heart attack," said Dr. Craig Hartley, a Professor of Cardiovascular Sciences at Baylor College of Medicine. "Many of us were skeptical too, but the physiology for evaluating vascular reactivity is well established, and the preliminary data clearly show the potential of the method."

Researchers at Harbor UCLA Medical Center examined patients with the VENDYS® test before they underwent coronary CT angiography and a thallium nuclear scan. The study showed that those with coronary blockage and abnormal scan results often had low fingertip temperature reactivity. Dr. Budoff and colleagues also studied apparently healthy individuals with a family history of heart disease or with other cardiovascular risk factors. They discovered that the lower the fingertip thermal reactivity, the higher the chance of having a coronary blockage or calcium score >100 -both of which would place these individuals at a high risk of a future heart attack.

"We came up with this simple idea at the Texas Heart Institute while working on vulnerable plaque detection," said Dr. Morteza Naghavi, inventor of the VENDYS® technology. "Despite exciting developments in intracoronary plaque characterization, it became obvious to me that we needed a non-invasive and inexpensive way to screen and monitor at risk patients, simply because you can't cath asymptomatic people, nor can you put stable patients into CT or MRI machine every 3 months to evaluate their progress." He added, "Frankly, at the time, I didn't expect it to be so surprising in terms of its predictive value compared to risk factors. But now, looking at the data, it makes sense, because it does not measure an individual risk factor, like cholesterol; instead, it reflects vascular function which is affected by numerous risk and protective factors, much like blood pressure. Furthermore, unlike coronary calcium or carotid IMT, it is a dynamic marker and changes quickly with the progression and regression of the disease."

Every year, over 1.4 million heart attacks occur in the United States and many more worldwide. About half of these heart attacks happen in healthy-looking individuals who had no previous symptoms of heart disease. Had these individuals been tested by existing, cardiovascular risk factor-based screening tests on the day before their heart attack, the majority (over 70%) of them would not have been classified as high risk. This clearly illustrates the shortcomings of the status quo (Problem 1). The other half of heart attacks happens in patients with known heart disease, who were believed to be on adequate treatments. This illustrates the inadequacy of existing methods of monitoring patients' response to treatments (Problem 2).

Current methods for screening and early detection of CVD include blood tests for measurement of traditional risk factors (such as high cholesterol) or advanced, non-invasive imaging techniques such as CAT scan and MRI. While traditional risk factors are good for long-term prediction of future CVD, they do not assess the state of an individual's vascular health. Moreover, advanced imaging modalities are costly (e.g., MRI) or pose hazardous radiation (e.g., CT scan); therefore, they cannot be used frequently (weekly or monthly).

"I am amazed by the predictive power that VENDYS has shown in these studies," said Dr. Harvey Hecht, Chairman of Endothelix Scientific Advisory Board and Director of Cardiovascular Computed Tomography at Lenox Hill Heart and Vascular Institute. "In terms of sensitivity and specificity for the detection of high risk patients, its area under the ROC curve is well above all traditional risk factors put together. If these findings are corroborated by others, it will be the first non-imaging test that has exhibited a predictive value close to that of imaging tests, which obviously are far more expensive and less suitable for mass screening. I am so impressed that I have personally incorporated VENDYS into my office practice, and I believe it can improve risk assessment in patients with low to intermediate Framingham risk."

About Endothelix

Endothelix is based in Houston, Texas. The company is positioned as the first to incorporate non-invasive, non-imaging vascular and neurovascular function monitoring technologies into the existing risk factor based assessment of cardiovascular risk. Endothelix aims to help physicians address the two major problems that exist in cardiovascular care today, namely 1) inaccurate individualized assessment of cardiovascular risk and 2) inadequate monitoring of vascular response to treatments.

Endothelix