Non-Invasive Medical Devices for Measuring Arterial Elasticity for Cardiovascular Disease
DESCRIPTION
An example of a non-invasive medical device that measures arterial elasticity is the CVProfilor™DO-2020 CardioVascular Profiling System. These devices can provide an indication of arterial compliance (elasticity indices for both large and small arteries), which can be used to determine if patients have potential underlying vascular disease. The medical devices also measure systolic, diastolic, and mean arterial pressures, and pulse rate, and calculate body surface area, body mass index, and pulse pressure.
These devices obtain upper-arm blood pressure values and waveform data by non-invasive methods, via the use of an oscillometric blood pressure module and via the application of specially designed equipment.
The acquisition of calibrated radial artery blood pressure waveform data involve, the coordinated use of a blood pressure cuff placed on the left upper-arm and a piezoelectric-based, direct contact, acoustical transducer placed over the right radial artery adjacent to the styloid process of the radius (by the wrist). The cuff systolic and diastolic pressures are utilized to calibrate the radial artery waveform data into units of pressure based on the median high and low value contained in a 30-second collection of blood pressure waveform data.
An embedded computer performs a pulse contour analysis of the calibrated, digitized blood pressure waveform data, and generates a report. The clinical data collected and analyzed are accurate and repeatable, and can be used in determining hemodynamic parameters relating to the structure, function and changes of a patient's cardiovascular system.
The report summarizes the pulse contour analysis performed on a 30-second collection of the radial artery blood pressure waveforms. The results are based on the use of an electrical analog model which represents the vasculature as consisting of a capacitative compliance element (Large Artery Elasticity Index), an oscillatory or reflective compliance element (Small Artery Elasticity Index), an inductance and a resistance, during the diastolic decay portion of the cardiac cycle.
POLICY
Non-invasive medical devices for measuring arterial elasticity for cardiovascular disease are considered investigational.
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ADDITIONAL INFORMATION
Blood pressure is the most frequently measured property of peripheral vasculature. However, compliance reflecting the change in vascular dimensions relative to the pulse pressure may be a more subtle index of vascular dysfunction associated with aging and diseases such as hypertension, diabetes mellitus, coronary heart disease or congestive heart failure. The development of computerized pulse waveform analysis (CAPWA) has simplified the acquisition and analysis of data, and has made these measurements accessible in an outpatient setting.
Previous studies indicate that patients with documented vascular disease or with a history of vascular events tend to have less compliant arteries than individuals who do not have documented vascular disease. Individuals with a history of vascular events also tend to have less compliant arteries than control subjects. In addition, multiple risk factors for the future development of vascular disease may also be associated with a less compliant arterial circulation. Therefore, a reduced arterial compliance may provide an index of early arterial damage that could predispose patients to the development of major vascular disease.
No controlled studies were found in the published literature that validate the application of non-invasive medical devices for the measuring of arterial elasticity for cardiovascular disease or that provide comparisons to other noninvasive techniques. No evidence was found to show that evaluation of the status of the arterial elasticity is predictive and, thus, that type of evaluation cannot be used to alter the treatment of individuals.
SOURCES
Dolan, E., Thijs, L., Li, Y., Atkins, N., McCormack, P., McClory, S., et al. (2006). Ambulatory arterial stiffness index as a predictor of cardiovascular mortality in the Dublin outcome study. Hypertension, 47 (3), 365-370. (Level 2 Evidence - Independent study)
Huck, C., Bronas, U., Williamson, E., Draheim, C., Duprez, D., & Dengel, D. (2007). Noninvasive measurements of arterial stiffness: repeatability and interrelationships with endothelial function and arterial morphology measures. Vascular Health risk Management, 3 (3), 343-349. (Level 4 Evidence - Industry supported)
Schiallaci, G., Parati, G., Pirro, M., Pucci, G., Mannarino, M., Sperandini, L., et al. (2007). Ambulatory stiffness index is not a specific marker of reduced arterial compliance. Hypertension, 49 (5), 986-991. (Level 3 Evidence - Independent study)
U. S. Food and Drug Administration. (2000, November). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K001948. Retrieved June 15, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf/K001948.pdf.
U. S. Food and Drug Administration. (2007, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K070795. Retrieved June 15, 2010 from http://www.accessdata.fda.gov/cdrh_docs/pdf7/K070795.pdf.
ORIGINAL EFFECTIVE DATE: 5/12/2007
MOST RECENT REVIEW DATE: 9/9/2010
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