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

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.