The expanded polytetrafluoroethylene (ePTFE) heart valve can serve as a viable option for prosthetic aortic valve. In this study, an ePTFE bi-leaflet valve design for aortic valve replacement (AVR) is presented, and the performance of the proposed valve was assessed numerically and experimentally. The valve was designed using CAE software. The dynamic behavior of the newly designed bi-leaflet valve under time-varying physiological pressure loading was first investigated by using commercial finite element code. Then, in-vitro tests were performed to validate the simulation and to assess the hemodynamic performance of the proposed design. A tri-leaflet ePTFE valve was tested in-vitro under the same conditions as a reference. The maximum leaflet coaptation area of the bi-leaflet valve during diastole was 216.3 mm2. When fully closed, no leakage gap was observed and the free edges of the molded valve formed S-shaped lines. The maximum Von Mises stress during a full cardiac cycle was 4.20 MPa. The dynamic performance of the bi-leaflet valve was validated by the in-vitro test under physiological aortic pressure pulse. The effective orifice area (EOA), mean pressure gradient, regurgitant volume, leakage volume and energy loss of the proposed valve were 3.14 cm2, 8.74 mmHg, 5.93 ml/beat, 1.55 ml/beat and 98.99 mJ, respectively. This study reports a novel bi-leaflet valve design for AVR. The performance of the proposed valve was numerically and experimentally assessed. Compared with the reference valve, the proposed design exhibited better structural and hemodynamic performances, which improved valve competency. Moreover, the performance of the bi-leaflet design is comparable to commercialized valves available on the market. The results of the present study provide a viable option for the future clinical applications.

The increased understanding of right heart diseases has led to more aggressive interventions to manage functional tricuspid regurgitation (FTR). In some cases of FTR, prosthetic valve replacement is typically considered when concomitant organic components or significant geometrical distortions are involved in the pathology of the tricuspid valve. However, little is known of the performance of current devices in the right heart circulation. In this study, a novel in vitro mock circulatory system that incorporated a realistic tricuspid valve apparatus in a patient-specific silicon right ventricle (RV) was designed and fabricated. The system was calibrated to emulate severe FTR, enabling the investigation of RV hemodynamics in pre- and post-implantation of tri-leaflet tissue implant and bi-leaflet mechanical implant. 2D particle imaging velocimetry was performed to visualize flow and quantify relevant hemodynamic parameters. While our results showed all prosthetic implants improved cardiac output, these implants also subjected the RV to increased turbulence level. Our study also revealed that the implants did not create the optimal behavior of fluid transfer in the RV as we expected. Among the implants tested, tissue implant created the most dominant vortices, which persisted throughout diastole; its observed strong negative vortex could lead to increase energy expenditure due to undesired fluid direction. In contrast, both native valve and mechanical implant had both weaker vortex formation as well as more significant vortex dissipation. Interestingly, the vortex dissipation of native valve was associated with streamlined flow pattern that tended towards the pulmonary outlet, while the mechanical implant generated more regions of flow stagnation within the RV. These findings heighten the imperative to improve designs of current heart valves to be used in the right circulation.

There has been a resurgence of interest in the treatment of severe functional tricuspid regurgitation (FTR) due to the awareness of its poor outcomes and potential percutaneous therapies. Kay bicuspidization has been adapted in percutaneous therapies but its clinical outcome remains uncertain. The present study evaluates the efficacy of Kay repair in a novel ex vivo pulsatile system. Porcine tricuspid valve (TV) (n = 3) was extracted and incorporated into a patient-specific silicon right ventricle (RV) emulating severe FTR, on which Kay repair was subsequently performed. TV area metrics and RV hemodynamic assessment by means of stereo-scopic particle image velocimetry were quantified in both FTR and post-repair conditions. Bicuspidization led to significant increase in cardiac output although the overall increment due to this approach alone was generally small, possibly due to existence of residual TR and the large reduction in TV opening area. Kinetic energy and viscous loss levels were increased post-repair, especially during diastolic filling. Main vortex structures generally maintained post-procedural. However, there was enhanced swirling motion in larger RV domain. Although this might reduce mural-thrombus risk, the relatively more complex vortex phenomenon likely resulted in elevated viscous loss observed and may potentially impact long-term adaptation. The RV hemodynamic alteration after tricuspid repair could be used to predict the success of these future transcatheter solutions.

Severe tricuspid regurgitation (TR) is life-threatening but is often undertreated. Many patients with severe TR are denied heart valve replacement surgery because their old age or comorbidities predispose them to a higher risk of surgical complications associated with open-heart surgery. With the advent of transcatheter technology, it is now possible to deliver the valve to the desired location without the need for open-heart surgery. However, presently, there is no commercially available transcatheter tricuspid valve. This may be due to the complex tricuspid valve anatomy, which lacks an anchorage zone for the percutaneous valves. In view of this drawback, we have recently developed and tested two percutaneous caval heart valves that are designed to deploy at the vena cava and atrium junction. The hemodynamic characteristics of these valves are tested in a mock circulatory system with patient-specific silicone atrium and vena cava, which emulates the physiological pressure and flow conditions at the right side of the human heart. Particle imaging velocimetry results showed that flow velocity and the associated Reynolds shear stress (RSS) and the turbulent kinetic energy (TKE) downstream of the valves increased after the implantation of the valves. A maximum flow velocity of 0.94 m/s was observed at the region downstream of the percutaneous valve at the superior vena cava (SVC). Maximum RSS value of 2076.1 dynes/cm(2) was observed downstream of the valve at the inferior vena cava during the deceleration phase while maximum TKE measured was 572.6 J/m(3) at the upstream of the valve in the SVC during the peak flow phase. While these values appear high, they are significantly lower than those reported in prosthetic mitral and aortic valves. Hence, caval stented valves can be potentially considered as a minimally invasive option to treat TR.

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