Functional and structural effects of percutaneous edge-to-edge double-orifice repair under cardiac cycle in...

Percutaneous procedures for double-orifice mitral valve repair using the MitraClip device (clip) have been recently introduced as new treatment options as alternatives to medical management and open-heart surgery, especially for patients with high estimated operative risk. Similarly to the open-heart surgical technique, where suturing is used, the clip creates a double-orifice configuration that not only improves the closing function of the valve, but also significantly modifies its behaviour, particularly in the diastolic phase. While several clinical trials have been conducted, and are ongoing, in order to assess the safety and effectiveness of this technique, a deeper knowledge of the structural and functional effects on the valve, and of the cyclic loads transmitted to the clip itself, would allow a comparison with other repair techniques, and could serve as a foundation for possible further optimization of the clip design. The effects of the MitraClip device developed by Evalve Inc. were studied by means of a finite element model of the mitral valve, specifically developed to study the structural effects of the original, suture-based, edge-to-edge technique. A second model was developed in order to simulate the effects of a suture with similar extension from the leaflet edge in a direction to the annulus, in order to compare the two repair techniques. The mitral valve area and transvalvular pressure gradient predicted by the models for the clip and the suture are quite similar. Similar leaflet cyclic stresses, both in value and in location, were noted for the two mechanisms of linking the leaflets, while minor differences were found in the load transmitted to the suture and the clip, with slightly higher values for the clip. The model satisfactorily allowed functional parameters (valve area and transvalvular pressure gradient) and structural parameters (load, leaflet stress) to be determined. Overall, the structural effects of the clip and the suture are quite similar under the cyclic loading conditions imposed by the cardiac cycle.