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Incidence of Cardiac Perforation With Conventional and With Leadless Pacemaker Systems: A Systematic Review and Meta‐Analysis
Author(s) -
VAMOS MATE,
ERATH JULIA W.,
BENZ ALEXANDER P.,
BARI ZSOLT,
DURAY GABOR Z.,
HOHNLOSER STEFAN H.
Publication year - 2017
Publication title -
journal of cardiovascular electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.193
H-Index - 138
eISSN - 1540-8167
pISSN - 1045-3873
DOI - 10.1111/jce.13140
Subject(s) - medicine , meta analysis , incidence (geometry) , perforation , cardiology , atrial fibrillation , mechanical engineering , physics , optics , punching , engineering
Meta‐Analysis of Pacemaker Lead Perforation 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.