Abstract 4369453: Aortic Valve Neocuspidization Using Autologous Insertion Of Pulmonary Sinus ^Tm : A Proof Of Concept

Objectives: We developed and evaluated a novel aortic valve neocuspidization technique using autologous pulmonary sinuses in an ex-vivo porcine model. Human anatomical feasibility was assessed using retrospective 3D-echocardiographic data from children. Methods: Pulmonary sinuses harvested from porcine hearts were used to construct tri-leaflet valves, within native aortas (n=2, 26-28mm) or a Hemashield conduit (n=1, 26mm). Valves were subjected to hydrodynamic testing at varying cardiac outputs (CO) to simulate physiological aortic conditions. Separately, pulmonary sinus and aortic cusp dimensions were compared in 9 children (3-15y) with structurally normal valves using 3D-echocardiography to confirm anatomical feasibility. Results: All valves were able to sustain goal CO and MAP (100mmHg). The regurgitation fraction in Hemashield was 9-15% at 5L/min and 6-12% at 7L/min and in aorta, it was 11-21% and 5-15% at 5 and 7L/min, respectively, consistent with non-clinically significant regurgitation. Effective orifice area was 2.44cm 2 in Hemashield and 1.05-1.07cm 2 in native aortas. Peak pressure was 11-21mmHg (Hemashield) and 49-103mmHg (aorta). On pediatric 3D-echocardiographic analysis, there was a strong to excellent correlation between pulmonary sinus and aortic cusp dimensions: effective height (Correlation coefficient, r=0.83, p=0.006), geometric height (r =0.88, p=0.002), and intercommissural width (r=0.97, p<0.001). Conclusions: In an ex-vivo model, pulmonary sinuses functioned effectively as aortic neocusps with the expected afterload and CO. Pediatric 3D-echocardiography confirmed anatomical suitability. Given limited options in children, this technique may offer an alternative for aortic valve reconstruction using autologous tissue.