The Heart Valve Society

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Development of a Mitral Annuloplasty Ring with Preserved Dynamics of the Annular Height and Remodeling Capacity as Conventional Rigid and Semi Rigid Rings
Søren N. Skov, Diana M. Røpcke, Marcell J. Tjørnild, Christine Ilkjær, Jonas Rasmussen, Hans Nygaard, J M. Hasenkam, Morten O. Jensen, Sten L. Nielsen.
Aarhus University Hospital, Aarhus N, Denmark.

Introduction The native annular configuration changes from being nearly flat in the diastolic phase to a saddle shaped configuration in the systolic phase. Conventional rigid and semi-rigid remodeling rings are designed either in a flat configuration or fixed saddle shaped configuration. In this study we tested a novel remodeling annuloplasty ring with built-in septal-lateral fixation and commissural axial flexibility to maintain the annular saddle shape (Figure). The aim was to compare the biomechanical performance of the new remodeling annuloplasty ring compared to two conventional remodeling annuloplasty rings.
Methods The measurements were performed in-vivo using an 80 kg porcine model. 28 animals were randomized into four groups: A No ring, a novel remodeling ring, a semi-rigid ring (CE Physio ITM Ring) and a rigid ring group (CE ClassicTM Annuloplasty Ring). Force measurements were performed with a dedicated transducer to determine remodeling capacity of the annuloplasty rings. Geometry parameters were measured with sonomicrometry crystals implanted along the mitral annulus.
Results The novel remodeling, rigid and semi-rigid mitral annuloplasty rings significantly restricted dynamics of the mitral annular area, septal-lateral distance and segmental contraction and dilatation compared to the no ring group. The dynamics of the annular height was maintained for the novel ring but significantly decreased for the conventional rings compared to the no ring group (Figure). Mitral annular force measurements confirmed that the overall remodeling capacity of the novel ring was similar and even higher for the septal-lateral direction compared to the conventional rings (only significant for the semi-rigid ring).
Conclusion There were no differences in annular height between the novel remodeling ring and no ring group, indicating that the intended function of the new device was obtained. Force and geometry measurements confirmed a significant amount of remodeling capacity especially in the built-in fixation of the septal-lateral direction. The annular systolic saddle shape is essential to the mitral valve function and preservation of the cyclic change may be an important step towards an improved mitral valve reconstruction.


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