Prospective validation of an acoustic-based system for the detection of obstructive coronary artery disease in a high-prevalence population

Abstract

Recent guidelines recommend a risk-adjusted, non-invasive work-up in patients presenting with chest discomfort to exclude coronary artery disease (CAD). However, a risk-adjusted diagnostic approach remains challenging in clinical practice. An acoustic detection device for analyzing micro-bruits induced by stenosis-generated turbulence in the coronary circulation has shown potential for ruling out CAD in patients with low-to-intermediate likelihood. We examined the diagnostic value of this acoustic detection system in a high-prevalence cohort. In total, 226 patients scheduled for clinically indicated invasive coronary angiography (ICA) were prospectively enrolled at two centers and examined using a portable, acoustic detection system. The acoustic analysis was performed in double-blinded fashion prior to quantitative ICA and following percutaneous coronary intervention (PCI). An acoustic detection result (CAD score) was obtained in 94% of all patients. The mean baseline CAD score was 41.2 ± 11.9 in patients with obstructive CAD and 33.8 ± 13.4 in patients without obstructive CAD (p < 0.001). ROC analysis revealed an AUC of 0.661 (95% CI 0.584–0.737). Sensitivity was 97.6% (95% confidence interval (CI) 91.5–99.7%), specificity was 14.5% (CI 9.0–21.7%), negative predictive value was 90.5% (CI 69.6–98.8%), and positive predictive value was 41.7% (CI 34.6–49.0%). Following PCI, the mean CAD score decreased from 40.5 ± 11.2 to 38.3 ± 13.7 (p = 0.039). Using an acoustic detection device identified individuals with CAD in a high-prevalence cohort with high sensitivity but relatively low specificity. The negative predictive value was within the predicted range and may be of value for a fast rule-out of obstructive CAD even in a high-prevalence population.

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Acknowledgements

We thank Elizabeth Martinson, PhD, of the KHFI Editorial Office for her editorial assistance.

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(I) Conception and design: all authors; (II) administrative support: all authors; (III) provision of study materials or patients: MR, SDK, SES, BSL, HN, TB, CWH; (IV) collection and assembly of data: MR, SDK, SES, BSL; (V) data analysis and interpretation: MR, SDK, SES; (VI) manuscript writing: all authors; (VII) final approval of manuscript: all authors.

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Correspondence to Matthias Renker.

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Conflict of interest

SES is a minor shareholder and a part-time consultant of Acarix A/S. BSL is an industrial student at Acarix A/S. CWH and MB received advisory and speaker’s fees from Acarix A/S. MR, SDK, JSW, OD, UF, WK, HN, and TB have no conflicts of interest to declare.

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Renker, M., Kriechbaum, S.D., Schmidt, S.E. et al. Prospective validation of an acoustic-based system for the detection of obstructive coronary artery disease in a high-prevalence population. Heart Vessels (2021). https://doi.org/10.1007/s00380-021-01800-7

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Keywords

  • Coronary artery disease
  • Heart sounds
  • Invasive coronary angiography
  • Phonocardiography