Arrhythmias & electrophysiologyCohort study
Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry
- Prospective post-approval registry
- worldwide
- multicentre
- 179 centres in 23 countries
Authors' conclusion
Long-term outcomes with the Micra leadless pacemaker continue to demonstrate low rates of major complications and system revisions and an extremely low incidence of infection.
Study context
- Population
- Patients undergoing Micra leadless pacemaker implant attempts, enrolled July 2015–March 2018
- Participants
- 1,809 vs 2,667
- Exposure
- Micra leadless pacemaker vs transvenous pacemaker reference dataset
- Micran = 1,809
- Transvenousn = 2,667reference
- Outcome
- System- or procedure-related major complications and all-cause system revision rate
- Follow-up
- 60 months post-implant
Main finding
As reported in the abstract
Major complication rate (system- or procedure-related)
Hazard ratio
.47
95% CI .36-.61
P < 0.001
- Major complication rate at 60 months (Micra)
- 4.5% (95% CI 3.6%-5.5%)
Observational data: associations, not effects.
Further findings
System revision rate · 36 months
P < 0.001
All-cause system revision rate · 60 months
- All-cause system revision rate at 60 months (Micra)
- 4.9% (95% CI 3.9%-6.1%)
- Revisions for device upgrades
- 41.2%
- Revisions for elevated thresholds
- 30.6%
Safety
Micra removals due to infection
- No Micra removals due to infection over the duration of follow-up
Original publication
Leadless pacemakers at 5-year follow-up: the Micra transcatheter pacing system post-approval registry. Eur Heart J. Published 1 March 2024. doi:10.1093/eurheartj/ehae101
Summarised from the published abstract; every number is checked against it