Permanent Leadless Cardiac Pacing: Results of the LEADLESS Trial

Study Questions:

What is the safety and clinical performance of a novel, completely self-contained leadless cardiac pacemaker?


LEADLESS was a prospective, nonrandomized, single-arm, multicenter study of the safety and clinical performance of a completely self-contained leadless cardiac pacemaker. Thirty-three patients underwent implantation of the leadless cardiac pacemaker and were followed for 90 days. The primary safety endpoint was freedom from complications at 90 days. Secondary performance endpoints included implant success rate, implant time, and measures of device performance (pacing/sensing thresholds and rate-responsive performance).


The mean age of the patient cohort (n = 33) was 77 ± 8 years, and 67% of the patients were male (n = 22/33). The most common indication for cardiac pacing was permanent atrial fibrillation with atrioventricular block (n = 22, 67%). The implant success rate was 97% (n = 32). Five patients (15%) required the use of >1 leadless cardiac pacemaker during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as the result of a stroke. The overall complication-free rate was 94% (31/33). After 3 months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range.


The authors concluded that a completely self-contained, single-chamber leadless cardiac pacemaker has been shown to be safe and feasible.


This study suggests that leadless pacing is feasible and safe in a consecutive series of patients with an indication for single-chamber ventricular pacing. Despite improvements in lead design, lead malfunction is associated with significant adverse clinical outcomes, and remains the most common reason for surgical pacemaker revision. The absence of a transvenous lead and subcutaneous pulse generator represents a major paradigm shift in cardiac pacing.

Clinical Topics: Arrhythmias and Clinical EP, Implantable Devices, EP Basic Science

Keywords: Atrioventricular Block, Cardiac Pacing, Artificial

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