Arrhythmias & electrophysiologyMeta-analysis
Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers
- Pooled analysis of prospective clinical trials
- multicentre
- international
Authors' conclusion
The safety and efficacy of chronic LP retrieval of an active helix-fixation device was demonstrated in an international clinical trial setting, with implant durations up to 9 years.
Study context
- Population
- Patients with an active helix-fixation leadless pacemaker (LEADLESS II phase 1 IDE, LEADLESS Observational, LEADLESS Japan trials) with an attempted leadless pacemaker (LP) retrieval ≥6 weeks post-implantation234 retrieval attempts
- Participants
- 233 patients
- Outcome
- Retrieval success rate of all attempted chronic LP retrievals
Pooled result
As reported in the abstract
Chronic LP retrieval success
Overall retrieval success rate (205 of 234 attempts)
87.6%
Failed retrievals due to inability to access LP docking button (25 of 29 attempts)
86.2%
Further pooled results
Time from implantation to attempted retrieval
- Mean time from implantation to attempted retrieval (range 0.2-9.0 years)
- 3.2 years
- Time to retrieval did not significantly influence retrieval success
- P = 0.71
Reason for failed retrieval
- Inability to access the LP docking button (25 of 29 failed attempts)
- 86.2%
Safety
Retrieval-related complications (adjudicated by independent CEC)
- 11 complications in 9 subjects (9 of 233 subjects)
- 3.9%
Original publication
Worldwide Chronic Retrieval Experience of Helix-Fixation Leadless Cardiac Pacemakers. J Am Coll Cardiol. Published 8 January 2025. doi:10.1016/j.jacc.2024.10.094
Summarised from the published abstract; every number is checked against it