ORLANDO – A leadless transcatheter pacemaker rivals conventional transvenous pacemakers in terms of pacing capture and major complications, according to data presented at the American Heart Association scientific sessions and published simultaneously in the New England Journal of Medicine.
The prospective multicenter study involved 725 patients requiring ventricular pacing, of whom 719 were successful implanted with the leadless Micra Transcatheter Pacemaking System and followed for 6 months.
Of the 297 patients included in the primary efficacy analysis, 98.3% showed a 6-month pacing capture threshold of no greater than 2.0 V, with a mean pacing capture threshold at implantation of 0.63 V and 0.54 V at 6 months.
The leadless device also was associated with half the incidence of major complications, compared with data from a historical control cohort (4% vs. 7.4%; hazard ratio, 0.49; P = .001), as well as fewer hospitalizations and fewer system revisions due to complications.
“Complications that lead to death or that required invasive revision, termination of therapy, or hospitalization or extension of hospitalization occurred in 4% of the patients; this finding is in line with recent reports of transvenous systems and was significantly lower than the rate in the control group,” wrote Dr. Dwight Reynolds of the University of Oklahoma Health Sciences Center, Oklahoma City, and coauthors (N Engl J Med. Nov 9. doi: 10.1056/NEJMoa1511643).
The study was supported by Micra manufacturer Medtronic. Most authors reported personal fees, grants, and advisory board positions from private industry, including Medtronic. Two authors are Medtronic employees.