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SYSTEMATIC REVIEW article
Front. Cardiovasc. Med.
Sec. Cardiac Rhythmology
Volume 12 - 2025 | doi: 10.3389/fcvm.2025.1565821
Safety and Efficacy of Leadless Pacemakers: A Systematic Review and Meta-Analysis
Provisionally accepted
Hamidreza Soleimani 1
Parham Dastjerdi 2
Soroush Najdaghi 3
Negin Sadat Hosseini Mohammadi 2
Hedieh Shayesteh 2 Delaram Narimani Davani 3 Hirad Yarmohammadi 4 Masoud Eslami 1
Reza Mollazadeh 1*- 1 Tehran University of Medical Sciences, Tehran, Tehran, Iran
- 2 Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Alborz, Iran
- 3 Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Isfahan, Iran
- 4 Columbia College, Columbia University, New York City, New York, United States
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 such as lead dislodgement, pocket infections, and generator-related issues. This meta-analysis aimed to evaluate the safety and efficacy of LPs, including Micra (Medtronic) and Aveir VR (Abbott) devices, in comparison to TVPs.A systematic review and meta-analysis were conducted following PRISMA guidelines, with data sourced from PubMed, EMBASE, Scopus, and Cochrane databases. Eligible studies included both single-arm and comparative designs reporting clinical outcomes of LPs. Risk of bias was assessed using the ROBINS-I tool, and a random-effects model was applied for meta-analyses.Fifty-five studies involving 286,349 patients met the inclusion criteria. LPs demonstrated significantly lower risks of pneumothorax (Relative risk (RR): 0.29, 95% CI: 0.10-0.82, p = 0.019, I² = 40%, event rate: 0.14% (LP) vs. 0.93% (TVP), Number Needed to Treat (NNT) = 128) and lead dislodgement (RR: 0.21, 95% CI: 0.16-0.28, p < 0.0001, I² = 0%, event rate: 0.36% (LP) vs. 2.29% (TVP), NNT = 52) compared to TVPs, with negligible infection rates.However, LPs were associated with higher risks of cardiac tamponade (RR: 2.36, 95% CI:1.26-4.43, p = 0.007, I² = 50%, event rate: 0.84% (LP) vs. 0.46% (TVP), Number Needed to Harm (NNH) = 265) and access site complications (RR: 2.82, 95% CI: 1.79-4.44, p < 0.0001, I² = 71%, event rate: 2.03% (LP) vs. 0.62% (TVP), NNH = 71). For efficacy metrics, there was no statistically significant difference between LPs and TVPs in procedure duration, fluoroscopy time, impedance, or pacing capture threshold.LPs offer distinct advantages over TVPs, including reduced risks of certain complications and improved procedural efficiency.
Keywords: Leadless cardiac pacemaker, Transcatheter pacing system, complications, Safety, Efficacy PD, SN, NSHM: Collecting data DND writing the primary draft R.M, MEHRS: bringing the primary idea H.Y, RM: reviewing the draft. RM: submission
Received: 23 Jan 2025; Accepted: 04 Apr 2025.
Copyright: © 2025 Soleimani, Dastjerdi, Najdaghi, Hosseini Mohammadi, Shayesteh, Davani, Yarmohammadi, Eslami and Mollazadeh. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Reza Mollazadeh, Tehran University of Medical Sciences, Tehran, 1417863181, Tehran, Iran
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