Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2023;19(5):43-50.
doi: 10.2174/1573403X19666230331094647.

Leadless Pacemakers: State of the Art and Selection of the Ideal Candidate

Evan A Blank  1 , Mikhael F El-Chami  1 , Nanette K Wenger  2
Affiliations
Review

Leadless Pacemakers: State of the Art and Selection of the Ideal Candidate

Evan A Blank et al. Curr Cardiol Rev. 2023.

Abstract

The field of cardiac pacing has been defined by constant development to provide efficacious, safe, and reliable therapy. Traditional pacing utilizes transvenous leads, which dwell in the venous system and place patients at risk for complications, including pneumothorax, bleeding, infection, vascular obstruction, and valvular compromise. Leadless pacemakers have been developed to overcome many of the challenges of transvenous pacing while providing safe and effective pacing therapy for an increasing population of patients. The Medtronic Micra transcatheter pacing system was approved by the FDA in April of 2016 and the Abbott Aveir pacemaker was approved in April of 2022. Several additional leadless pacemakers are in various stages of development and testing. There exists limited guidance on the selection of the ideal candidate for leadless pacemakers. Advantages of leadless pacemakers include decreased infection risk, overcoming limited vascular access, and avoidance of interaction with the tricuspid valve apparatus. Disadvantages of leadless pacemakers include right ventricular-only pacing, unclear lifecycle management, cost, perforation risk, and lack of integration with defibrillator systems. This review aims to provide an overview of the current state of the art of leadless pacemakers, currently approved systems, clinical trials and real-world evidence, considerations for patient selection, and future directions of this promising technology.

Keywords: Leadless pacemaker; cardiac implantable electronic device; patient selection; safety; transvenous leads; transvenous pacemaker.

PubMed Disclaimer

Conflict of interest statement

Dr. Nanette Wenger is the editorial advisory board member for the journal Current Cardiology Reviews.

Figures

Fig. (1a)
Fig. (1a)
Micra transcatheter pacing system.
Fig. (1b)
Fig. (1b)
Aveir VR leadless pacemaker.
Fig. (2)
Fig. (2)
A Micra AV pacemaker is seen inserted through a bioprosthetic tricuspid valve for post-operative heart block.
See this image and copyright information in PMC

References

    1. Haydock P., Camm A.J. History and evolution of pacing and devices. Heart. 2022;108(10):794–799. doi: 10.1136/heartjnl-2021-320149. - DOI - PubMed
    1. Raatikainen M.J.P., Arnar D.O., Merkely B., et al. A Decade of Information on the Use of Cardiac Implantable Electronic Devices and Interventional Electrophysiological Procedures in the European Society of Cardiology Countries: 2017 Report from the European Heart Rhythm Association. Europace. 2017;19(S2):ii1–ii90. doi: 10.1093/europace/eux258. - DOI - PubMed
    1. Udo E.O., Zuithoff N.P.A., Van Hemel N.M., et al. Incidence and predictors of short- and long-term complications in pacemaker therapy: The FOLLOWPACE study. Heart Rhythm. 2012;9(5):728–735. doi: 10.1016/j.hrthm.2011.12.014. - DOI - PubMed
    1. Kirkfeldt R.E., Johansen J.B., Nohr E.A., Jorgensen O.D., Nielsen J.C. Complications after cardiac implantable electronic device implantations: An analysis of a complete, nationwide cohort in Denmark. Eur. Heart J. 2014;35(18):1186–1194. doi: 10.1093/eurheartj/eht511. - DOI - PMC - PubMed
    1. FDA approves first leadless pacemaker to treat heart rhythm disorders. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first-l....

MeSH terms