Abstract

Background: Leadless pacemakers (LP) represent an emerging modality for treating bradyarrhythmias. We performed a meta-analysis and systematic review comparing safety and efficacy outcomes of Micra LP and transvenous pacemakers (TVP). Methods: A literature search was performed. The primary efficacy endpoints were successful implantation rate and acceptable capture threshold of <2V at 1 year. Primary safety outcomes were vascular injury, tamponade, device or lead dislodgement, pneumothorax, and major complications (needing intervention, prolonged hospital stay, readmission or death). A double-arm analysis was performed comparing LP and TVP. Data was pooled as mean differences (MD) or risk ratio (RR) including the 95% CI. Results: A total of 60 studies were included. There was no significant difference between the LP and TVP groups in terms of the rate of successful implantation (RR=1.02, P=0.95) and acceptable capture threshold (RR=0.90, P=0.11). LP was associated with a significantly lower incidence of major complications (RR = 0.54, [0.44, 0.67], P < 0.001) and dislodgment (RR= 0.31, [0.21, 0.46], P < 0.001). TVP had a significantly lower incidence of vascular injury (RR= 2.62, P=0.001) and a lower incidence of cardiac tamponade (RR= 2.29, P=0.001). There was no statistically significant difference regarding the incidence of infection (RR=0.76, P=0.6) and pneumothorax (RR= 0.58, P = 0.37). Conclusion: LP and TVP have equivalent implant success and long-term efficacy. LP had lower rates of major complications and dislodgement. TVP had lower rates of vascular injury and tamponade. Infection and pneumothorax rates were the same in both groups.

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