A low-cost bioprosthetic semilunar valve for research, disease modelling and surgical training applications

This paper provides detailed instructions for constructing low-cost bioprosthetic semilunar valves for animal research and clinical training. This work fills an important gap between existing simulator training valves and clinical valves by providing fully functioning designs that can be employed in ex vivo and in vivo experiments and can also be modified to model valvular disease.

Valves are constructed in 4 steps consisting of creating a metal frame, covering it with fabric and attaching a suture ring and leaflets. Computer-aided design files are provided for making the frame from wire or by metal 3D printing. The covering fabric and suturing ring are made from materials readily available in a surgical lab, while the leaflets are made from pericardium. The entire fabrication process is described in figures and in a video. To demonstrate disease modelling, design modifications are described for producing paravalvular leaks, and these valves were evaluated in porcine ex vivo (n = 3) and in vivo (n = 6) experiments.

Porcine ex vivo and acute in vivo experiments demonstrate that the valves can replicate the performance of clinical valves for research and training purposes. Surgical implantation is similar, and echocardiograms are comparable to clinical valves. Furthermore, valve leaflet function was satisfactory during acute in vivo tests with little central regurgitation, while the paravalvular leak modifications consistently produced leaks in the desired locations.

The detailed design procedure presented here, which includes a tutorial video and computer-aided design files, should be of substantial benefit to researchers developing valve disease models and to clinicians developing realistic valve training systems.