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

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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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Author notes

  1. Matthias Renker and Steffen D. Kriechbaum contributed equally to this manuscript.

Authors and Affiliations

  1. Department of Cardiology, Kerckhoff Heart and Thorax Center, German Center for Cardiovascular Research (DZHK), Partner Site Rhein-Main, Benekestr. 2-8, 61231, Bad Nauheim, Germany

    Matthias Renker, Steffen D. Kriechbaum, Jan S. Wolter, Ulrich Fischer-Rasokat, Won-Keun Kim, Christoph Liebetrau & Christian W. Hamm

  2. Department of Health Science and Technology, Aalborg University, Aalborg, Denmark

    Samuel E. Schmidt & Bjarke S. Larsen

  3. Medical Clinic I, Division of Cardiology and Angiology, Giessen Campus, University Hospital of Giessen and Marburg, Giessen, Germany

    Oliver Dörr, Holger Nef, Timm Bauer & Christian W. Hamm

  4. Department of Cardiology, Hospital Unit West, Herning, Denmark

    Morten Bøttcher

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  1. Matthias Renker
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  2. Steffen D. Kriechbaum
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Contributions

(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 36, 1132–1140 (2021). https://doi.org/10.1007/s00380-021-01800-7

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