A Meta-analysis of Major Complications between Traditional Pacemakers and Leadless Pacemakers

Abstract

Objectives: We aim to compare the major complications between leadless pacemakers and traditional pacemakers.Background: Leadless pacemakers, which are increasingly used in clinical practice, have several advantages compared with traditional pacemakers in avoiding pocket- and lead-related complications. However, the clinical effect of leadless pacemakers remains controversial.Methods: PubMed, Embase, the Cochrane Central Register of Controlled Trials (CENTRAL), the CNKI database, and the Wanfang database were searched from July 2013 to December 2019. Studies comparing leadless pacemakers and traditional pacemakers were included. The primary end point was major complications. The secondary end points were cardiac perforation/pericardial effusion, device revision or extraction, loss of device function, and death.Results: Six studies fulfilled the inclusion criteria. Only four of the six studies reported data on major complications. Leadless pacemakers were associated with a lower incidence of major complications (risk ratio 0.33, 95% confidence interval 0.25‐0.44, P<0.00001, I2=49%). We extracted data on cardiac perforation/pericardial effusion, device revision or extraction, loss of device function, and death from six studies. Our meta-analysis showed that leadless pacemakers have a higher risk of cardiac perforation or pericardial effusion (risk ratio 4.28, 95% confidence interval 1.66‐11.08, P=0.003, I2=0%). No statistically significant differences were found for mortality, device revision or extraction, and loss of device function.Conclusion: Compared with traditional pacemakers, leadless pacemakers have a significantly decreased risk of major complications, but have a higher risk of cardiac perforation or pericardial effusion.