SeptalPro: Development and Usability Evaluation of a Force-Sensing Robotic Transseptal Puncture System for Cardiac Interventions.

Abstract

Objective: This study aimed to develop and evaluate the SeptalPro system, a novel robotic platform designed to enhance the precision, safety, and efficiency of transseptal puncture (TSP) procedures by integrating real-time remote control and force sensing.

Methods: The SeptalPro system was assessed using an anthropomorphic phantom in a simulated clinical environment. Four experienced cardiologists and one cardiology trainee participated in the study, performing manual and robot-assisted TSP procedures. The system's performance was evaluated using trajectory and motion smoothness metrics, as well as user feedback on the system's usability in a clinical environment.

Results: The robot-assisted approach demonstrated superior spatial control compared to the manual approach, with significantly shorter path lengths and reduced spatial dispersion for experienced operators. The SeptalPro system also achieved smoother and more efficient tool motions, as indicated by reduced mean motion jerk. User feedback indicated high satisfaction with the system's usability and potential clinical benefits.

Conclusion: SeptalPro represents a significant advancement in TSP, offering a promising solution to the challenges associated with the conventional manual approach. The robotic system demonstrated superior performance in terms of spatial control and motion smoothness compared to the manual approach.

Significance: This work establishes the first comprehensive framework for evaluating robotic TSP systems through integration of high-precision force sensing, clinically-validated performance metrics, and structured assessment protocols, providing essential foundations towards clinical translation of robotic assistance in TSP procedures.