In Silico and In Vitro Comparison of Seven Closed and Semi-Closed Leaflet Designs for Transcatheter Heart Valve...

Purpose: Transcatheter heart valve replacements (TVR) are typically designed in a closed shape with initial leaflet coaptation. However, recent studies suggest a semi-closed geometry without a predefined coaptation zone, relying on diastolic pressure and clinical oversizing of 10-20 % for closure. This approach may minimize pinwheeling, a phenomenon linked to early valve degeneration. Method: Seven valve geometries were assessed: one closed design (G0) and six semi-closed variations (G1-G6). The semi-closed designs differed in free edge shape (linear, concave, convex) and opening degree, defined as the relative distance from the leaflet to the valve center in the unloaded state. The opening degree was systematically increased across G1-G6, with G6 exhibiting the highest value. 30 mm valves were fabricated using porcine pericardium and self-expanding nitinol stents. Performance was assessed in a pulse duplicator system, evaluating transvalvular pressure gradient (TPG), effective orifice area (EOA), regurgitation fraction (RF) and a novel pinwheeling index (PI) which was validated by finite element simulations. Results: Finite element simulations demonstrated that semi-closed geometries achieve valve closure at a diameter reduction of >5%. In vitro tests confirmed these findings with more homogeneous coaptation and reduced pinwheeling. With increased opening degree the RF reduced significantly (RF_G0 = 18.54 ± 8.05%; RF_G6 = 8.22 ± 1.27%; p < 0.0001), while valve opening remained comparable (p = 0.4519). Conclusions: A semi-closed leaflet geometry enhances valve closure, reducing regurgitation and pinwheeling while preserving effective opening. With clinical oversizing, a higher opening degree improves coaptation and may enhance durability by mitigating structural deterioration, ultimately improving the long-term performance and lifespan of transcatheter valve replacements.