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Signal Acquisition, Score Interpretation, and Economics of a Non-Invasive Point-of-Care Test for Coronary Artery Disease
Published on: August 9, 2024
Diagnostic performance of an acoustic-based system for coronary artery disease risk stratification
Simon Winther1, Louise Nissen2, Samuel Emil Schmidt3
1Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.
Insights
A new acoustic device for detecting coronary artery disease (CAD) shows promise. With a 96% negative predictive value, it could help rule out the need for further invasive testing in many patients.
Area of Science:
- Cardiology
- Biomedical Engineering
- Diagnostic Technology
Background:
- Diagnosing coronary artery disease (CAD) is resource-intensive.
- Acoustic analysis of heart sounds offers a potential non-invasive diagnostic approach.
- Obstructive CAD can cause intracoronary turbulence detectable via heart sounds.
Purpose of the Study:
- To evaluate the diagnostic accuracy of a novel portable acoustic device for CAD detection.
- To assess the utility of an acoustic CAD-score algorithm in identifying hemodynamically significant CAD.
Main Methods:
- 1675 patients with low-to-intermediate CAD likelihood underwent acoustic analysis.
- Patients were referred for CT angiography, with invasive angiography and FFR for suspected obstructions.
- An initial acoustic CAD-score was evaluated, followed by an updated algorithm incorporating clinical risk factors.
Main Results:
- Hemodynamically significant CAD was found in 10% of patients (n=145).
- The updated acoustic CAD-score achieved 81% sensitivity and 53% specificity for diagnosing significant CAD.
- A negative predictive value of 96% was observed for the acoustic rule-out system.
Conclusions:
- Sound-based CAD detection provides superior risk stratification compared to clinical scores.
- The acoustic device demonstrates potential as a supplementary tool for clinical assessment.
- A high negative predictive value suggests its utility in guiding decisions on further diagnostic investigations.
Objective:
Diagnosing coronary artery disease (CAD) continues to require substantial healthcare resources. Acoustic analysis of transcutaneous heart sounds of cardiac movement and intracoronary turbulence due to obstructive coronary disease could potentially change this. The aim of this study was thus to test the diagnostic accuracy of a new portable acoustic device for detection of CAD.
Methods:
We included 1675 patients consecutively with low to intermediate likelihood of CAD who had been referred for cardiac CT angiography. If significant obstruction was suspected in any coronary segment, patients were referred to invasive angiography and fractional flow reserve (FFR) assessment. Heart sound analysis was performed in all patients. A predefined acoustic CAD-score algorithm was evaluated; subsequently, we developed and validated an updated CAD-score algorithm that included both acoustic features and clinical risk factors. Low risk is indicated by a CAD-score value ≤20.
Results:
Haemodynamically significant CAD assessed from FFR was present in 145 (10.0%) patients. In the entire cohort, the predefined CAD-score had a sensitivity of 63% and a specificity of 44%. In total, 50% had an updated CAD-score value ≤20. At this cut-off, sensitivity was 81% (95% CI 73% to 87%), specificity 53% (95% CI 50% to 56%), positive predictive value 16% (95% CI 13% to 18%) and negative predictive value 96% (95% CI 95% to 98%) for diagnosing haemodynamically significant CAD.
Conclusion:
Sound-based detection of CAD enables risk stratification superior to clinical risk scores. With a negative predictive value of 96%, this new acoustic rule-out system could potentially supplement clinical assessment to guide decisions on the need for further diagnostic investigation.
Trial Registration Number:
ClinicalTrials.gov identifier NCT02264717; Results.
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