Mitral regurgitation is a common valvular disorder. Transcatheter edge-to-edge repair (TEER) is a minimally invasive technique which involves holding together the middle segments of the mitral valve leaflets, thereby reducing regurgitation. To date, MitraClip™ is the only Food and Drug Administration (FDA)-approved device for TEER. The MitraClip procedure is technically challenging, characterised by a steep learning curve. Training is generally performed on simplified models, which do not emphasise anatomical features, realistic materials, or procedural scenarios. The aim of this study is to propose a novel, 3D printed simulator, with a major focus on reproducing the anatomy and plasticity of all areas of the heart involved and specifically the ones of the mitral valve apparatus. A three-dimensional digital model of a heart was generated by segmenting computed tomography (CT). The model was subsequently modified for: (i) adding anatomical features not fully visible with CT; (ii) adapting the model to interact with the MitraClip procedural equipment; and (iii) ensuring modularity of the system. The model was manufactured with a Polyjet technology printer, with a differentiated material assignment among its portions. Polypropylene threads were stitched to replicate chordae tendineae. The proposed system was successfully tested with MitraClip equipment. The simulator was assessed to be feasible to practice in a realistic fashion, different procedural aspects including access, navigation, catheter steering, and leaflets grasping. In addition, the model was found to be compatible with clinical procedural imaging fluoroscopy equipment. Future studies will assess the effect of the proposed training system on improving TEER training.
Keywords: 3D printing; MitraClip procedure; Polyjet; mitral valve regurgitation; segmentation; simulation-based training; transcatheter edge-to-edge repair.