Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience

Circ Arrhythm Electrophysiol. 2016 Dec;9(12):e004626. doi: 10.1161/CIRCEP.116.004626.

Abstract

Background: Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans.

Methods and results: This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for <6 weeks (acute retrieval cohort), complete retrieval was achieved in 100% (n=5/5); for those implanted for ≥ 6 weeks (chronic retrieval cohort), retrieval was achieved in 91% (n=10/11) of patients. The mean duration of time from implant to retrieval attempt was 346 days (range, 88-1188 days) in the chronic retrieval cohort, and nearly two thirds (n=7; 63%) had been implanted for >6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure.

Conclusions: This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker.

Clinical trial registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02051972, NCT02030418, and NCT01700244.

Keywords: device removal; heart ventricles; humans; pacemaker, artificial; prostheses and implants.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Arrhythmias, Cardiac / therapy*
  • Device Removal*
  • Equipment Design
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Pacemaker, Artificial / adverse effects*
  • Patient Safety
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT02051972
  • ClinicalTrials.gov/NCT02030418
  • ClinicalTrials.gov/NCT01700244