Demonstration of Use of a Novel 3D Printed Simulator for Mitral Valve Transcatheter Edge-to-Edge Repair (TEER)

Abstract

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.

The Application of Precision Medicine in Structural Heart Diseases: A Step towards the Future

“…Recently, a novel, 3D-printed simulator, focusing on reproducing the anatomy and plasticity of all areas of the left heart associated with the mitral valve apparatus, was created. The investigators aimed to create a realistic model, where different periprocedural aspects, such as vascular access, transseptal puncture, catheter movements, and leaflet grasping, will be feasible [58].…”

Three-dimensional printing in modelling mitral valve interventions

“…The investigators were able to perform four defined procedural steps on the static model (preparation, guide catheter insertion, clip positioning and implantation) under fluoroscopic guidance. Important limitations include the absence of TOE guidance which is crucial to procedural success in TEER as well as the static nature of platform which therefore fails to emulate the challenges of deploying repair devices on a beating heart [ 81 ]. These aspects of TEER simulation are increasingly recognised and early attempts at devising dynamic physical TEER simulators are now underway such as the proof-of-concept platform demonstrated by Zhu et al, which comprises a 3D printed ‘cardiac skeleton’ of structures relevant to TEER housed within a water tank, with ports for TOE evaluation and insertion of clip equipment.…”