Incidence of Cardiac Perforation With Conventional and With Leadless Pacemaker Systems: A Systematic Review and Meta-Analysis

J Cardiovasc Electrophysiol. 2017 Mar;28(3):336-346. doi: 10.1111/jce.13140. Epub 2017 Jan 11.


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.

Keywords: cardiac perforation; lead perforation; leadless pacemaker; pacemaker; pacemaker lead complication; pericardial effusion.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Aged
  • Aged, 80 and over
  • Cardiac Pacing, Artificial*
  • Equipment Design
  • Female
  • Heart Injuries / diagnosis
  • Heart Injuries / epidemiology*
  • Humans
  • Incidence
  • Male
  • Middle Aged
  • Odds Ratio
  • Pacemaker, Artificial / adverse effects*
  • Risk Assessment
  • Risk Factors
  • Treatment Outcome