The leadless intracardiac transcatheter pacing system met safety and efficacy goals, with a safety profile similar to transvenous systems and low stable pacing thresholds.
Does a leadless transcatheter pacemaker provide safe and effective pacing compared to historical performance goals in patients with indications for single-chamber ventricular pacing?
725 patients with class I or II guideline-based indications for ventricular pacing (VVI), mean age 75.9, 58.8% male, multinational (19 countries). Key indications included bradycardia associated with persistent or permanent atrial tachyarrhythmia, sinus-node dysfunction, or atrioventricular block.
Leadless transcatheter single-chamber ventricular pacemaker implanted via the femoral vein.
No concurrent control group; evaluated against prespecified historical performance goals (83% for safety, 80% for efficacy) and a post hoc historical control cohort of 2,667 patients with transvenous pacemakers.
Two primary endpoints at 6 months: 1) Primary safety: freedom from system-related or procedure-related major complications. 2) Primary efficacy: percentage of patients with low and stable pacing capture thresholds (≤2.0 V at a pulse width of 0.24 msec and an increase of ≤1.5 V from the time of implantation).composite
A leadless transcatheter pacemaker demonstrated high implantation success, met prespecified safety and efficacy goals at 6 months, and had fewer major complications compared to a historical transvenous pacemaker cohort.
In this historical comparison study, the transcatheter pacemaker met the prespecified safety and efficacy goals; it had a safety profile similar to that of a transvenous system while providing low and stable pacing thresholds. (Funded by Medtronic; Micra Transcatheter Pacing Study ClinicalTrials.gov number, NCT02004873.).
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Dwight Reynolds
Gábor Zoltán Duray
Razali Omar
New England Journal of Medicine
The Ohio State University
University of Southampton
Amsterdam UMC Location University of Amsterdam
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Reynolds et al. (Mon,) reported a other. The leadless intracardiac transcatheter pacing system met safety and efficacy goals, with a safety profile similar to transvenous systems and low stable pacing thresholds.
www.synapsesocial.com/papers/69714deaf15775e61fbf1e3c — DOI: https://doi.org/10.1056/nejmoa1511643