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Clinical Articles, Lead Article

Leadless cardiac pacing appears safe

A self-contained, single-chamber leadless cardiac pacemaker (NanostimTM, St Jude Medical) has been shown to be safe and feasible, according to a prospective non-randomised study published recently in Circulation.1 The absence of a transvenous lead and subcutaneous pulse generator could represent a paradigm shift in cardiac pacing, say the authors.

The primary safety end point was freedom from complications at 90 days. Secondary performance end points 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 three months of follow-up, the measures of pacing performance (sensing, impedance, and pacing threshold) either improved or were stable within the accepted range.

References

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Nanostim(TM), St Jude Medical

1. Reddy VY, Knops RE, Sperzel J, et al. Permanent leadless cardiac pacing: results of the LEADLESS trial. Circulation 2014;129:1466–71. http://dx.doi.org/10.1161/​CIRCULATIONAHA.113.006987

Published on: May 28, 2014

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  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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