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Digital acoustical analysis of normal and bimodal Björk-Shiley 60 ° convexo-concave heart valves

  • Gerald A. Kien
    Correspondence
    Address for reprints: Gerald A. Kien, PhD, 102 South Hills, Barrington, Illinois 60010.
    Affiliations
    From International Acoustics Incorporated, Palatine, Illinois, USA

    From the Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland, USA
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  • Bradley Jeffries
    Affiliations
    From International Acoustics Incorporated, Palatine, Illinois, USA

    From the Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland, USA
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  • Hart V. Katz
    Affiliations
    From International Acoustics Incorporated, Palatine, Illinois, USA

    From the Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland, USA
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  • Bruce A. Herman
    Affiliations
    From International Acoustics Incorporated, Palatine, Illinois, USA

    From the Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland, USA
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  • Ronald F. Carey
    Affiliations
    From International Acoustics Incorporated, Palatine, Illinois, USA

    From the Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland, USA
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  • Daniel J. Chwirut
    Affiliations
    From International Acoustics Incorporated, Palatine, Illinois, USA

    From the Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland, USA
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  • Harry F. Bushar
    Affiliations
    From International Acoustics Incorporated, Palatine, Illinois, USA

    From the Food and Drug Administration Center for Devices and Radiological Health, Rockville, Maryland, USA
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      Abstract

      Fracture of the outlet strut of the Björk-Shiley 60 ° convexo-concave (BS60CC) valve has been attributed to a bimodal closing pattern in certain valves in which the closing disk rotates about the inlet strut, causing upward displacement of the outlet strut and its eventual fracture. This article reports the in vivo studies of the normal BS60CC valve and the in vitro studies of the normal and bimodal BS60CC valves, using a digitial acoustical signal processing technique, in which the individual collisions (impact history) of the occluder disk with the components of the valve body are revealed during each closing cycle. In vitro analysis of the closing acoustical signals of normal BS60CC valves showed impact history cluster width (IHCW) means of 2.07 ± 0.85 ms (standard error), not significantly different from those of 1.86 ± 0.58 ms (standard error) observed in 38 clinically normal patients with BS60CC valves (p >0.1). The bimodal valves showed IHCW of 6.14 ± 0.98 ms (standard error), in vitro, which was significantly greater than those observed in the normal in vitro valve group and in the normal patient population (p < 0.0001).
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