LEADLESS: The next generation pacemakers??

In LEADLESS 2 Trial, the investigators did a one year followup of 31 patients who had been implanted leadless pacemeaker in the Leadless trial. They noted the following result

Between 3 and 12 months of follow-up, there were no pacemaker-related adverse events reported. There were no device embolizations, late perforations, or patients with a device-related infection or infection of unknown origin.

The investigators concluded that the LCP showed “

very stable performance and reassuring safety results during intermediate-term follow-up” supporting the promise of this device as an alternative to conventional pacemaker systems. Comparative trials with longer follow-up are needed to further assess the performance of the LCP compared to lead-based pacemakers and to inform optimal case selection for each type of system.

Other Critics noted that the 1-year findings reported by the investigators shows “remarkably stable pacing parameters…” indicating a projected longevity of about 10 years, “even with 100% pacing.” The safety measures were also promising.

However, they noted that the sample in this study was small, the implantations were performed at a limited number of very experienced centers, and there were a few serious complications. Hence, Further study is needed.

With this trial, there is a growing excitement among the cardiologists for the leadless pacemakers, for the selected indications.

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