Atlanta, GA. January 19, 2010 – Testing a patient's cardiac respiratory stress response (RSR) can quickly and accurately detect the presence of significant coronary artery disease (S-CAD), according to new research published in the current issue of Cardiovascular Revascularization Medicine. The results found patients with S-CAD had a significantly lower RSR compared to patients without (6.7% vs. 17.4%, respectively) suggesting RSR is a strong indicator for the disease.
To determine cardiac respiratory stress response (RSR), Washington Hospital Center researchers used a new innovative respiratory stress test. The test uses a Pulse Oximeter (PPG) to measure blood flow in the finger in response to paced breathing over a 90 second time period. The PPG data are immediately captured and analyzed using a proprietary algorithm that determines the RSR. All findings were confirmed using Quantitative Coronary Angiography (QCA). In comparison to QCA, the test results were highly accurate, with a sensitivity and specificity of 86% and 81%, respectively. No adverse events were reported.
"It is always challenging to detect significant coronary artery disease in patients at the physician's office and often required a physical stress test, including nuclear imaging and often cardiac catheterization" said lead investigator Ron Waksman, MD, Associate Director, Division of Cardiology, Washington Hospital Center and professor of medicine (cardiology) at Georgetown University in Washington DC. "The RSR test is simple and fast to perform in a doctor's office without the need for significant expense and hardship to the patient, and the results of the study support its accuracy to detect significant coronary artery disease. We believe it could be a useful diagnostic option."
The test is not yet cleared for use in the US. The safety and efficacy of the test compared to stress electrocardiography in detecting S-CAD is currently the subject of the pivotal 1,000-patient SCORE (Spirocor Coronary Outcome by Respiratory stress Examination) study. Dr. Waksman is a co-primary investigator of the study, which is being conducted in over 25 cardiology clinics across the US.
Study Methodology and Findings
In this prospective observational cohort study, the RSR test was performed on 153 consecutive patients referred for coronary angiography with symptoms or signs suggestive of CAD. The RSR tests were conducted in a holding area of the catheterization laboratory by a single examiner blinded to the patient's clinical data. Coronary angiography was performed on all subjects and analyzed by one cardiologist blinded to the subject's clinical data and RSR using a validated QCA algorithm. In accordance with American Heart Association guidelines, S-CAD was defined as at least a 70% narrowing of at least 1 epicardial artery or at least a 50% narrowing of the left main coronary artery.
A valid RSR was obtained in 150 patients (98%). Thirty-six patients (24%) were found to have S-CAD, 31 had single-vessel disease, and 5 had multi-vessel disease. The mean age of patients was 58.7, and the majority were male (67%). The clinical characteristics of the 150 analyzed patients were similar except for a higher rate of statin and antiplatelet therapy in patients with S-CAD. The mean RSR was significantly reduced in patients with S-CAD, regardless of age, gender, the existence of risk factors, and medical treatment.
Using a receiver operating characteristic curve analysis, the results suggest that an RSR of < 10.2% is a non-invasive indicator of S-CAD, with a sensitivity and specificity of 86% and 81%, respectively; positive and negative predictive values of 59% and 95%, respectively; and positive and negative likelihood ratios of 4.46 and 0.17, respectively.
Additional multicenter, community-based studies under varying clinical settings and patient populations are warranted to rigorously assess the value of this test for the detection of S-CAD.
About the RSR Test
The proprietary respiratory stress test system developed by SPIROCOR features a non-invasive PPG finger probe connected to a computer with analyzing software residing on a central server, accessed via the internet. The patient performs a controlled breathing exercise which consists of inhaling and exhaling seven times. The PPG signal is automatically captured and the data transmitted for analysis. The RSR report is then automatically generated and made available on a password secured website for the cardiologist to review and make a decision regarding the next diagnostic and therapeutic step.
About Coronary Artery Disease (CAD)
Coronary artery disease is caused by a reduction of blood flow to the heart due to a narrowing or blockage of the coronary arteries. According to the American Heart Association, more than 13 million Americans suffer from CAD. It is the leading cause of death in the US and costs the economy more than $142 billion annually. Cardiac stress tests are the most common non-invasive testing methods used to evaluate patients with suspected CAD, with approximately 20 million stress tests performed annually in the US alone. Unfortunately, these tests are often expensive, time consuming and can involve exposure to ionizing radiation. As a result, they are not always available.
About SPIROCOR
SPIROCOR has advanced significant coronary artery disease (S-CAD) diagnosis by developing an office based, effective, low-cost, low-risk, non-invasive, functional diagnostic test assessing cardiovascular respiratory response. The web based platform, via its secure electronic access, enables cardiologists throughout the world to evaluate and fast track the diagnosis and treatment of S-CAD.
The SPIROCOR system provides significant leverage through global scalability of operation and control of intellectual property with data being utilized to create new analyses and subgroup optimizations supporting expanded diagnostic and monitoring applications. SPIROCOR's headquarters, manufacturing and R&D facilities are located in Israel. For more information, please visit www.SPIROCOR.com.
Journal
Cardiovascular Revascularization Medicine