title: Incidence of Cardiac Perforation With Conventional and With Leadless Pacemaker Systems: A Systematic Review and Meta-Analysis.
abstract: BACKGROUND
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Cardiology, University Hospital Frankfurt, Goethe University, Frankfurt Am Main, Germany.
authors.forename: Mate
authors.initials: M
authors.lastname: Vamos
authors.affiliation: Department of Cardiology, University Hospital Frankfurt, Goethe University, Frankfurt Am Main, Germany.
authors.forename: Julia W
authors.initials: JW
authors.lastname: Erath
authors.affiliation: Department of Cardiology, University Hospital Frankfurt, Goethe University, Frankfurt Am Main, Germany.
authors.forename: Alexander P
authors.initials: AP
authors.lastname: Benz
authors.affiliation: Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Bari
authors.affiliation: Department of Cardiology, Medical Centre, Hungarian Defence Forces, Budapest, Hungary.
authors.forename: Gabor Z
authors.initials: GZ
authors.lastname: Duray
authors.affiliation: Department of Cardiology, University Hospital Frankfurt, Goethe University, Frankfurt Am Main, Germany.
authors.forename: Stefan H
authors.initials: SH
authors.lastname: Hohnloser
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002304:Cardiac Pacing, Artificial; D004867:Equipment Design; D005260:Female; D006335:Heart Injuries / Q000175:diagnosis / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010138:Pacemaker, Artificial / Q000009:adverse effects*; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
keywords: cardiac perforation; lead perforation; leadless pacemaker; pacemaker; pacemaker lead complication; pericardial effusion