| Functional tricuspid regurgitation is a common tricuspid valve disease which is one of the primary causes leading to the increasing cardiovascular mortality.At present,surgical repair is the major treatment of functional tricuspid regurgitation such as annuloplasty,edge-to-edge repair and bicuspidization.However,these surgical treatments for functional tricuspid regurgitation is not ideal beacuse of a high recurrence rate of regurgitation,therefore,minimally-invasive techniques is desired.A novel valved plug device which has a bioprosthetic valve was proposed to treat functional tricuspid regurgitation in this paper.This novel valved plug device was implanted into the position of regurgitation tricuspid valve through a percutaneous catheter and it was not anchored in the annulus and did not interfere with the annulus dynamics and affect the tricuspid valve native structure.The valved plug repaired the tricuspid regurgitation since it opened and closed with the opening and closing of the native valve during a cardiac cycle.At the same time,the valved plug didn't block ventricular inflow channel in diastole.In this paper,the self-developed in-vitro right heart simulator was used to verify whether the concept of the valved plug is feasible and effective.It is mainly divided into the following parts:1.Firstly,pulsatile and static experiment test platform of right heart simulator which proved can simulated the right heart circulation system by a normal pig's tricuspid valve was designed and established in vitro.Two valved plugs in diameter 20 mm and 25 mm were made with 3D printing technique.The custom-made bioprosthetic valve was made of porcine pericardium fixed with glutaraldehyde,which was mounted inside the plug.Another two unvalved plugs were made with identical sizes as the valved plugs.The mild and severe tricuspid regurgitation was simulated with the 50% and 75% annulus dilation,respectively.Based on the pulsatile and static experiment and tricuspid regurgitation pathology,the performance of the tricuspid plug was investigated.2.The valved plugs and unvalved plugs were tested in the right heart simulator in order to understand its performance of repairing the tricuspid regurgitation.The results showed that: 1)Compared to the mild regurgitation,the integral of transvalvular pressure,cardiac output at severe regurgitation were reduced while the regurgitation volume,closing volume,leakage volume,effective orifice area and regurgitant effective orifice area were increased significantly.This result indicated that the right heart simulator were reliable,and there was a clear difference between mild and severe tricuspid regurgitation pathology.The results were consistent with the pathological phenomenon.2)According to compare the parameters before and afte repair,it is found that the integral of transvalvular pressure increased significantly after repaired with the four plugs,the cardiac output has significantly increased by 18%~61% after repair except using unvalved plugs in mild regurgitation.All the plugs reduced the regurgitation volume by 35%~56%.The regurgitant effective orifice area decreased by 45%~74% significantly after repaired except for using 20mm-diameter valved plug in mild regurgitation.Those data showed that all plugs were effective to reduce the regurgitation.3)By comparing the results between the valved plug and the unvalved plug,it can be seen that the effective orifice area in valved plugs was 15%~ 22% larger than that of unvalved plugs and the cardiac output was greater except for the repair in severe regurgitation.This result indicated that the valved plug showed better performance to treat the tricuspid regurgitation than the unvalved plug. |
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