A non-invasive fingertip test can identify coronary disease at its earliest stages and may provide an easy to use tool for daily clinical practice, according to a recent study published in the Journal of the American College of Cardiology.
The Endo-PAT 2000, a novel and proprietary system for assessing vascular endothelial dysfunction, an early indicator of atherosclerosis, was developed by Itamar Medical of Caesarea, Israel. Distributed in the United States by Cholestech Corporation, it is the only system to have received clearance from the Food & Drug Administration for use as an aid in the detection of coronary artery endothelial dysfunction. Cholestech, a leader in point of care testing, expects to launch the Endo-PAT 2000 for broad clinical use in 2005.
In the paper titled "Noninvasive Identification of Patients With Early Coronary Atherosclerosis by Assessment of Digital Reactive Hyperemia," researchers from Mayo Clinic in Rochester, Minn., investigated the value of the Endo-PAT to assess the relationship between dysfunction in the heart region and dysfunction in extremities. Through invasive testing in the catheterization lab of the 94 patients participating, coronary endothelial dysfunction was found in 55 patients. By comparing these results against the Endo-PAT, the researchers found a threshold value for the fingertip test that would have identified the majority of the patients with early heart disease.
According to Amir Lerman, M.D., F.A.C.C., a cardiologist from Mayo Clinic, "This test is a noninvasive and easy-to-perform technique to assess peripheral endothelial function that has the potential to become a valuable tool for cardiovascular risk stratification in daily clinical practice.
"All of the currently available tests for the assessment of endothelial function are more or less invasive or operator-dependent, which precludes their use as a screening tool in clinical practice. In contrast, the Endo-PAT is noninvasive, easy to perform and operator independent. We found a strong correlation, and that the fingertip test was very sensitive in identifying patients with early heart disease," Dr. Lerman added.
The Endo-Pat 2000 System consists of three components. Peripheral Arterial Tonometry (PAT) signals are obtained using two disposable probes placed on fingers of the individual being tested. A portable unit connects to and operates the probes, and signal analysis and the endothelial dysfunction report are generated via a laptop computer. Endothelial dysfunction assessments can be completed in a 20-minute office visit. FDA clearance was obtained by demonstrating equivalence of the Endo-Pat 2000 System with an invasive procedure that assessed endothelial dysfunction in coronary arteries. The clinical research was conducted at the Mayo Clinic.
"We are pleased that the study findings validate the role of the Endo-PAT 2000 system as a test to identify individuals at risk prior to an invasive procedure such as angiogram, or potentially to find patients who need more aggressive treatment to slow or stop the progression of cardiovascular disease," said Warren E. Pinckert II, president and CEO of Cholestech. "The fact that this non-invasive test can be completed in a short office visit is a tremendous addition to our portfolio of office-based tools that enable physicians to assess and monitor heart disease and diabetes quickly and accurately."
The Endo-Pat 2000 is under continuing clinical investigation at major medical centers such as Mayo Clinic, Harvard and Yale. In addition, pharmaceutical companies developing new agents to treat endothelial dysfunction are now including it in trials, and it was recently incorporated into the Framingham Heart Study.