Author + information
- Joseph Thomas1,
- Jason Cole2,
- Jeffrey Chambers3,
- Sabahat Bokhari4,
- Demetris Yannopoulos5,
- Morton Kern6 and
- Robert Wilson7
- 1Harbor UCLA Medical Center, Torrance, California, United States
- 2Cardiology Associates, Mobile, Alabama, United States
- 3Metropolitan Cardiology Consultants, Minneapolis, Minnesota, United States
- 4Columbia University, New York, New York, United States
- 5University of Minnesota, Minneapolis, Minnesota, United States
- 6University of California, Irvine, Long Beach, California, United States
- 7Interventional Cardiologist, Osseo, Minnesota, United States
Noninvasive detection of turbulent coronary flow may enable diagnosis of significant coronary artery disease (CAD) using novel sensor and analytic technology.
Patients with chest pain and CAD risk factors undergoing nuclear stress tests were studied with the CADence (AUM Cardiovascular Inc., Northfield MN) acoustic detection (AD) system. AD analysis was blinded to clinical, core lab-adjudicated angiographic, and nuclear data. The non-inferiority primary endpoint was diagnostic accuracy of AD as compared to an objective performance criteria (OPC) for nuclear SPECT.
1014 subjects without prior coronary revascularization or Q-wave myocardial infarction were enrolled at 24 clinical sites. The mean age was 59±10 years with diabetes, hypertension, dyslipidemia, and smoking present in 25%, 71%, 71%, and 16% of subjects, respectively. Primary analysis was performed on subjects with complete angiographic and AD data (per protocol population, n = 763) including 111 subjects (15%) with severe CAD based on CCTA or invasive angiography (Figure). AD demonstrated a 78% sensitivity (p = 0.012 for non-inferiority versus OPC) and 91% negative predictive value for significant CAD. Specificity was only 35% in the studied population.
The acoustic signals associated with non-laminar coronary artery flow can be detected using noninvasive sensor, noise filtering and analytic technology. The detection of the physiologic occurrence of coronary turbulence appears to be a highly sensitive diagnostic approach for evaluating CAD in low- to intermediate-risk patients with chest pain.
IMAGING: FFR and Physiologic Lesion Assessment