Preclinical cardiac perforation reduction in leadless pacing: An update to the Micra leadless pacemaker delivery system.

ABSTRACT

BACKGROUND: Leadless pacemakers have been developed to avoid some of the complications that are associated transvenous pacemakers. Pericardial effusion is a rare complication of leadless pacemaker implantation, which may result from perforation of the delivery catheter. In this study, we describe preclinical perforation performance of an updated Micra delivery catheter. METHODS: To assess preclinical perforation performance of the updated delivery catheter, three analyses were performed. First, Finite Element Analysis (FEA) computational modeling was performed to estimate the target tissue stress during Micra delivery catheter tenting. Second, benchtop perforation forces of ovine tissue were recorded for the original and updated delivery catheters. Finally, a Monte-Carlo simulation combining human cadaveric Micra implant forces and human ventricular tissue perforation properties was performed to estimate clinical perforation performance. RESULTS: FEA modeling demonstrated a 66% reduction in target tissue stress when using the updated Micra delivery catheter (6.2 vs. 2.2 psi, Original vs. Updated Micra delivery catheter). Updated Micra delivery catheters required 20% more force to perforate porcine ventricular tissues in benchtop testing (µupd  = 26.9N vs. µorg  = 22.4N, p = .01). Monte-Carlo Simulation of catheter performance in human cadaveric tissues predicts 28.5% reduction of catheter-perforated cases with the updated delivery catheter. CONCLUSIONS: This study, using computer modelling and benchtop experimentation, has indicated that increased surface area and rounding of the updated Micra catheter tip significantly improves preclinical perforation performance. It will be important to evaluate the impact of these catheter design changes with robust registry data.