Comparison of the novel Medtentia double helix mitral annuloplasty system with the Carpentier-Edwards Physio annuloplasty ring: morphological and functional long-term outcome in a mitral valve insufficiency sheep model.

BACKGROUND: The prevalence of mitral regurgitation in cardiac diseases requires annuloplasty systems that can be implanted without excessive patient burden. This study was designed to examine the morphological and functional outcome of a new double helix mitral annuloplasty ring in an ovine model in comparison to the classical Carpentier-Edwards (CE) annuloplasty ring as measured by reduction of mitral regurgitation and tissue integration. The Medtentia annuloplasty ring (MAR) is a helical device that is rotated into the annulus self-restoring the valve geometry, enabling a faster fixation without the need of elaborate repair of the valve geometry. The ventricular part of the helical ring encircles the valve chords.

METHODS: Twenty adult sheep were overpaced until 2+ level mitral valve regurgitation was achieved. Seven animals per group received either the MAR or the CE ring. Implantation was performed on-pump in a beating heart through the left atrial appendix. The animals were sacrificed 3.6 ± 0.3 months after surgery following an echocardiography for assessing mitral regurgitation as primary endpoint. The annuloplasty rings with surrounding tissue were harvested for histological analyses as secondary endpoints. The remaining six sheep received the MAR system and were sampled seven, nine or 12 months after surgery.

RESULTS: Implantation time (p < 0.01) and perfusion time (p < 0.001) as clinical secondary endpoints were significantly shorter in the MAR group. Echocardiography follow-ups showed sufficient valve function repair in nearly all animals with a normalization of the ventricle diameters in both groups (group difference: p = 0.147). The weights of the hearts did not differ significantly. Histology revealed adequately covered atrial annuloplasty rings with functional endothelium and lack of excessive granulation tissue or fibrosis in all specimens. The ventricular projections of the MAR systems encircling the chordae tendineae were not completely covered with neointimal tissue, although in no case were microthrombi detected and no thromboembolic events were recorded.

CONCLUSIONS: The new MAR system is an easy to use annuloplasty system with a functional outcome comparable to that of the well-proven CE ring. Mitral valve regurgitation is effectively stopped both by restricting the pathological expansion of the annulus and by gathering the chords without thrombus formation.