Leadless Pacemaker Technologies: Patient Selection, Approach, and Outcomes
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Purpose of Review
Leadless cardiac pacemakers have recently entered clinical use for patients requiring single ventricular chamber pacing only. Two leadless systems have been utilized, the Nanostim leadless cardiac pacemaker and the Micra transcatheter pacing system. While currently limited to only a minority of pacemaker eligible patients, technical hurdles are expected to be overcome which will allow this technology to reach a much broader population. This review discusses the patient population for which these devices are indicated, the approach to device implantation and retrieval, and ongoing data on their long-term use.
Two major non-randomized clinical trials investigating the Nanostim and Micra leadless pacemaker systems were published in the New England Journal of Medicine in 2015 and 2016, respectively, with implant success rates of the active and passive fixation devices of 95.8 and 99.2%, respectively. The Nanostim and Micra demonstrated efficacy and safety, with major complication rates of 6.7 and 4% at 6 months, respectively, comparing favorably to historical transvenous pacemaker controls. Ongoing real-world registry data from Micra shows similar results, whereas Nanostim implantations have been halted due to an unexpected battery malfunction alert in late 2016. More data on device retrieval has become available, along with other strategies for end-of-life management.
Leadless pacemakers have emerged in clinical use based on their clinical outcomes and safety profile. These devices are expected to further revolutionize the field of cardiac pacing.
KeywordsLeadless pacemakers Outcomes Patient selection Techniques
Compliance with Ethical Standards
Conflict of Interest
Dr. Koene declared no conflict of interest. Dr. Cantillon reported consulting for Boston Scientific Corporation and Abbott Laboratories; membership on advisory committees for Boston Scientific Corporation and Abbott Laboratories; and teaching/speaking for Boston Scientific Corporation.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by any of the author.
Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance
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