Design and Validation of a Soft Robotic Simulator for Transseptal Puncture Training

Objective: Transseptal puncture (TP) is the technique used to access the left atrium of the heart from the right atrium during cardiac catheterization procedures. Through repetition, electrophysiologists and interventional cardiologists experienced in TP develop manual skills to navigate the transseptal catheter assembly to their target on the fossa ovalis (FO). Cardiology fellows and cardiologists that are new to TP currently train on patients to develop this skill, resulting in increased risk of complications. The goal of this work was to create low-risk training opportunities for new TP operators. Methods: We developed a Soft Active Transseptal Puncture Simulator (SATPS), designed to match the dynamics, static response, and visualization of the heart during TP. The SATPS includes three subsystems: (i) A soft robotic right atrium with pneumatic actuators mimics the dynamics of a beating heart. (ii) A fossa ovalis insert simulates cardiac tissue properties. (iii) A simulated intracardiac echocardiography environment provides live visual feedback. Subsystem performance was verified with benchtop tests. Face and content validity were evaluated by experienced clinicians. Results: Subsystems accurately represented atrial volume displacement, tenting and puncture force, and FO deformation. Passive and active actuation states were deemed suitable for simulating different cardiac conditions. Participants rated the SATPS as realistic and useful for training cardiology fellows in TP. Conclusion: The SATPS can help improve catheterization skills of novice TP operators. Significance: The SATPS could provide novice TP operators the opportunity to improve their TP skills before operating on a patient for the first time, reducing the likelihood of complications.