The detection of coronary artery microbruits, subaudible bruits too faint to be heard through standard auscultation, may provide an alternative means to diagnose coronary artery disease (CAD). The aim of this study was to test the accuracy of a novel digital electronic stethoscope, the Cardiac Sonospectrographic Analyzer (CSA; SonoMedica model 3.0, SonoMedica, Inc., Vienna, Virginia, United States Food and Drug Administration 510[k] cleared) to diagnose CAD compared to gold-standard diagnosis using cardiac computed tomographic (CT) angiography. In this blinded, single-site study, adults previously referred for CT imaging were selected. Patients underwent CT and CSA evaluations. CSA exams entailed recording heart sounds at 9 positions on the chest for 40 seconds at each position. An algorithm then processed these data to generate a microbruit score. The CT scans were read blinded to patients' microbruit scores. Sensitivity and specificity of the CSA in detecting CAD compared to CT imaging were estimated using standard receiver-operating characteristic curves calculated from logistic regression models. A total of 161 patients, aged 57 ± 13 years (range 22 to 85), 53% with hypertension and 40% with obesity (body mass index ≥30 kg/m(2)), completed the protocol and had evaluable CT and CSA examinations. The overall sensitivity of the CSA to identify >50% stenosis in any major epicardial coronary artery as determined by CT imaging was 89.5% (p <0.0001). Gender-specific models based on smaller sample sizes had slightly poorer results and lower specificity among men with heavy chest hair. In conclusion, the CSA showed high sensitivity and specificity for the detection of significant early CAD in an outpatient setting and represents a new noninvasive device for detecting abnormal coronary blood flow as occurs in CAD.
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