RESUMEN
BACKGROUND: Training in transcatheter cardiovascular skills today represents a significant challenge because of the complexity of the interventions and an extensive use of multiple live imaging technologies. OBJECTIVES: We describe the design, the face validation, and content validation of a newly developed physical transseptal puncture (TSP) simulator using additive manufacturing techniques and novel imaging simulation solutions. METHODS: The TSP simulator contains a femoral vein catheterization pad, silicon phantoms of the venous system, a replaceable interatrial septum, and cameras to mimic live fluoroscopic and echocardiographic imaging. A validation study was conducted at the University Hospital of Zurich. A total of 14 interventional cardiologists and cardiac surgeons assessed the TSP simulator. Participants performed a TSP on the simulator using standard interventional tools. Face and content validity was demonstrated using a 5-point Likert scale. RESULTS: The TSP simulator is a new training tool for transcatheter cardiovascular interventions. All interventional cardiologists and cardiac surgeons completed the training exercise and scoring. Overall impression was rated (out of 5) 4.04 ± 1.03, haptic feedback scored 4.13 ± 0.82, and the realism of fluoroscopy simulation 4.39 ± 0.79. Usability was rated 4.50 ± 0.63 by the participants, indicating that the simulator could be suitable for training. CONCLUSION: We demonstrated face and content validity of a new simulator for transcatheter cardiovascular interventions. The TSP simulator's usability, haptic feedback, imaging solutions, and the overall impression of its usage were reported as very realistic. The TSP simulator represents a promising tool for simulation-based training using real interventional toolkits in a mimicked radiological environment.