In vitro fluid dynamic evaluation of the Carbomedics bileaflet heart valve prosthesis in the aortic and mitral positions.

Since the introduction of bileaflet heart valve prostheses their clinical use has continued to escalate. The first of this valve type was the Standard St. Jude Medical (SSJM) prosthetic heart valve in 1977. The Carbomedics prosthetic heart valve (CPHV), introduced in the late 1980s, was intended to improve on the design of the SSJM bileaflet valve. The design changes in the CPHV valve, relative to the SSJM valve, may have the potential to affect its flow fields. This study, using flow visualization laser Doppler velocity measurements and color Doppler flow mapping, was intended to evaluate how these changes affect the flow fields in the near vicinity of the CPHV valve. The study was conducted in an in vitro pulse duplicator system. In the flow visualization study, the flow fields observed with the CPHV valve were quantitatively similar to those seen with the SSJM valve. Centralized jet-like flows with flow separation/stagnation were observed in the illuminated planes. The jet-like flows from the two lateral orifices were broader than that observed from the central orifice for both the CPHV and the SSJM valves. This fact implied that the major part of the volumetric flow was through the two lateral orifices, rather than the central orifice. In the laser Doppler velocity measurements, it was found that the flow field downstream of the SSJM valve was slightly more evenly distributed than that with the CPHV valve. In addition, the extent of the flow separation regions with the CPHV valve were slightly larger than with the SSJM valve. The slight differences in velocity profiles between the SSJM and the CPHV valves were due to the differences in leaflet opening angle. However, the levels of flow turbulence with the CPHV and the SSJM valves were found to be of the same order of magnitude. The results of the flow visualization and LDA velocity and turbulence measurements obtained in the study indicate that the differences in flow fields in the immediate vicinity of the CPHV valve relative to the SSJM valve are insignificant.