New Indicator for Early-Stage Heart Disease

Originally Published MDDI September 2004

R&D DIGEST

Erik Swain

By measuring for atherosclerosis, a new device could enable early identification of people at risk for heart disease or stroke.

The noninvasive test device, which looks like a blood-pressure cuff, allows doctors to gauge artery stiffness by measuring blood volume in the leg. Early detection could lead to earlier treatment to reduce the likelihood of further cardiovascular disease. Detecting heart disease risk factors is crucial because 50% of men and 64% of women who die suddenly of coronary heart disease have had no previous discernible symptoms.

David M. Herrington, MD, a cardiologist at Wake Forest University Baptist Medical Center (Winston-Salem, NC), found that the test results for 267 patients were “strongly predictive of the extent of aortic atherosclerosis.” He published his findings in an on-line edition of Circulation, a journal of the American Heart Association. 

Previous ways to measure artery stiffness have not been as accurate, Herrington said. “A lot of indirect measures, such as taking pulse pressure, have been used,” he said. “But it's difficult to tease out the differences between pulse pressure and blood pressure. And previous direct measures have not really been able to demonstrate that there was a benefit above and beyond other cardiovascular risk factors.” 

The difference with this device, he said, is that “an internal calibration is employed with each measurement, and that helps ensure it's properly calibrated for each patient it's used on. And we are able to measure pulse volume through a range of cuff pressures, so we can find the one that is equal to diastolic pressure. This allows us to take blood pressure out of the equation and evaluate the mechanoelastic parameters of the vessel walls independently.” 

Another benefit, he said, is that “it is a user-friendly, automated procedure. You put the cuff on your leg, push a button, and it carries out the procedures required to measure properly. There are lots of quality control responses built into the software and hardware to help ensure the result is an informative one.”

The good news, he said, is that the manufacturing issues have all been worked out. The bad news, he said, is that the company that developed the device, Vasocor Inc., has gone bankrupt, and the owner of its assets, Credit Suisse First Boston (CSFB), is looking for a buyer, so commercialization can't take place until that happens. 

CSFB partially funded Herrington's study, which it sees as a key step in finding a buyer for the technology, said Greg Grimaldi, a CSFB vice president. “This is the study that we hoped would validate the value of the product,” he said. “Before [the study], there was nothing to show that this was any better than other alternatives. It is a crucial component that we feel makes it a salable asset.” CSFB is open to selling Vasocor's assets piece by piece or as a whole, he said.

Herrington's study also included patients at the Atlanta Veterans Administration Medical Center, Columbia University Medical Center, and Jackson Memorial Hospital at the University of Miami Medical Center.

Copyright ©2004 Medical Device & Diagnostic Industry