Permanent Leadless Cardiac Pacing: Results of the LEADLESS Trial
Background—Conventional cardiac pacemakers are associated with several potential short- and long-term complications related to either the transvenous lead or subcutaneous pulse generator. We tested the safety and clinical performance of a novel completely self-contained leadless cardiac pacemaker (LCP).
Methods and Results—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 LCP during the procedure. One patient developed right ventricular perforation and cardiac tamponade during the implant procedure, and eventually died as a result of 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 stably within the accepted range.
Conclusions—In a prospective non-randomized study, a completely self-contained single-chamber leadless cardiac pacemaker has shown to be safe and feasible. The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing.
Clinical Trial Registration Information—Clinicaltrials.gov. Identifier: NCT01700244.
- Received November 5, 2013.
- Revision received January 2, 2014.
- Accepted January 13, 2014.