Feasibility evaluation of the transapical saddle-shaped valved stent for transcatheter mitral valve implantation

Background and Aims of Study Transcatheter mitral valve implantation (TMVI) is a promising and minimally invasive treatment for high-risk mitral regurgitation. We aimed to investigate the feasibility of a novel self-expanding valved stent for TMVI via apical access. Methods We designed a novel self-expanding mitral valve stent system consisting of an atrial flange and saddle-shaped ventricular body connected by two opposing anchors and two opposing extensions. During valve deployment, each anchor was controlled by a recurrent string. TMVI was performed in 10 pigs using the valve prosthesis through apical access to verify technical feasibility. Echocardiography and ventricular angiography were used to assess hemodynamic data and valve function. Surviving pigs were killed 4 weeks later to confirm stent deployment. Results Ten animals underwent TMVI using the novel mitral valve stent. Optimal valve deployment and accurate anatomical adjustments were obtained in nine animals. Implantation failed in one case, and the animal died 1 day later due to stent mismatch. After stent implantation, the hemodynamic parameters of the other animals were stable, and valve function was normal. The mean pressure across the mitral valve and left ventricular outflow tract were 2.98 +/- 0.91 mmHg and 3.42 +/- 0.66 mmHg, respectively. Macroscopic evaluation confirmed the stable and secure positioning of the stents. No obvious valve displacement, embolism, or paravalvular leakage was observed 4 weeks postvalve implantation. Conclusions This study demonstrated that the novel mitral valve is technically feasible in animals. However, the long-term feasibility and durability of this valved stent must be improved and verified.