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Safety and efficacy of leadless pacemakers: A systematic review and meta-analysis
Hamidreza Soleimani1, Parham Dastjerdi2, Negin Sadat Hosseini Mohammadi2
1Department of Cardiology, School of Medicine, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
Background:
Leadless pacemakers (LPs) are emerging as a transformative alternative to traditional transvenous pacemakers (TVPs) for managing brady-arrhythmias. Unlike TVPs, LPs eliminate the need for leads and subcutaneous generator pockets, addressing complications.
Objective:
This meta-analysis aimed to evaluate the safety and efficacy of LPs, including Micra (Medtronic) and Aveir VR (Abbott) devices, in comparison to TVPs.
Method:
A systematic review and meta-analysis were conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Overall, 55 studies involving 286,349 patients met the inclusion criteria.
Results:
LPs demonstrated significantly lower risks of pneumothorax (relative risk [RR], 0.29; P = .019, event rate: 0.14% [LP] vs 0.93% [TVP], number needed to treat [NNT] = 128) and lead dislodgement (RR, 0.21; 95% confidence interval, 0.16-0.28; P < .0001, event rate: 0.36% [LP] vs 2.29% [TVP], NNT = 52) compared with TVPs, with negligible infection rates. However, LPs were associated with higher risks of cardiac tamponade (RR, 2.36; P = .007, event rate: 0.84% [LP] vs 0.46% [TVP], number needed to harm [NNH] = 265) and access site complications (RR, 2.82; P < .0001, event rate: 2.03% [LP] vs 0.62% [TVP], NNH = 71).
Conclusion:
LPs offer distinct advantages over TVPs, including reduced risks of certain complications and improved procedural efficiency.
