The leadless cardiac pacemaker (LCP) shows promise as an alternative to conventional pacemaker systems, according to one-year follow-up data from the LEADLESS Trial, published April 13 in the Journal of the American College of Cardiology.

Researchers sought to assess the complication incidence, electrical performance and rate response characteristics of 31 patients 12 months after receiving an LCP in the apicoseptal region of the right ventricle. Overall results showed no pacemaker-related complications, nor did any patients develop pacemaker syndrome. In addition, there were no device embolizations, late perforations, or patients with a device-related infection. Further, researchers noted, the electrical performance measures of the LCP remained stable, and the rate response feature of the device was used and adequately functioning in 61 percent of patients.

Moving forward, researchers suggest that “larger studies are needed to evaluate the safety of the leadless device design and implantation procedure.” For example, a randomized, controlled trial comparing conventional and leadless pacing systems would provide necessary feedback on overall complications rates.  They also recommend a solid training program for new operating physicians to help minimize what they observed as a clear learning curve.

In an accompanying editorial comment, Michael R. Gold, MD, PhD, FACC, writes that evidence from this study “points toward a bright future for leadless pacing with the likely possibility that the devices of the future will be largely devoid of intravascular leads, and many will not require subcutaneous pulse generators.” He goes on to add that, “these devices should become the future of pacing in many types of devices rather than persist as a niche to compete in the single-chamber pacemaker market.” 

Keywords: Arrhythmias, Cardiac, Equipment Design, Follow-Up Studies, Heart Ventricles, Incidence, Pacemaker, Artificial

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