Leadless pacemakers had a 1.52% incidence of cardiac perforation compared to a mean of 0.82% for conventional pacemakers, suggesting a slightly higher risk likely due to a learning curve.
Meta-Analysis (n=60,744)
What is the incidence of cardiac perforation with leadless pacemaker systems compared to conventional pacemaker systems?
Leadless pacemakers appear to have a slightly higher risk of cardiac perforation compared to conventional pacemakers, which may reflect a learning curve with the novel technology.
Absolute Event Rate: 1.52% vs 0.82%
INTRODUCTION: Two leadless pacemaker (PM) systems were recently developed to avoid pocket- and lead-related complications. As leadless PMs are implanted with a large delivery catheter, cardiac perforation remains a major safety concern. We aimed to provide a literature review on incidence of cardiac perforation with conventional and with leadless PM systems. METHODS AND RESULTS: A systematic review over the last 25 years for studies reporting data on PM lead perforation was performed. Findings were synthesized descriptively. Where control groups were available, data were meta-analyzed to identify important clinical risk factors. A total of 28 studies comprising 60,744 patients undergoing conventional PM implantation were analyzed. The incidence of lead perforation ranged from 0% to 6.37% (mean 0.82%, weighted mean 0.31%, median of 0.40%). There was no significant difference in perforation risk between atrial and ventricular electrodes (POR 0.72, 95% confidence interval CI, 0.28-1.87, P = 0.50) and between MRI conditional and conventional leads (POR 5.93, 95% CI, 0.72-48.76, P = 0.10). The use of active fixation leads (POR 4.25, 95% CI, 1.00-17.95, P = 0.05) and utilization of DDD versus VVI PM systems (POR 3.50, 95% CI, 1.48-8.28, P < 0.01) were associated with higher rates of perforation. In the 2 leadless PM studies, the incidence of cardiac perforation was 1.52% for each. CONCLUSION: PM lead perforation rates vary in individual studies with an overall low incidence. Leadless PMs seem to be associated with a slightly higher perforation risk, most likely reflecting a learning curve effect of this novel technology.
Vámos et al. (Wed,) conducted a meta-analysis in Pacemaker implantation (n=60,744). Leadless pacemaker systems vs. Conventional pacemaker systems was evaluated on Incidence of cardiac perforation. Leadless pacemakers had a 1.52% incidence of cardiac perforation compared to a mean of 0.82% for conventional pacemakers, suggesting a slightly higher risk likely due to a learning curve.