Arrhythmias & electrophysiology
A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra atrioventricular (AV) post-approval registry
Main finding · Major complicationsResult — go to the resultHazard ratio 0.42 95% CI 0.28–0.61Authors' conclusion
The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.
Study context
- Population
- Real-world patients implanted with Micra AV at 97 centres in 19 countries796 implanted
- Participants
- 801 vs 2,667
- Exposure
- Micra AV vs Transvenous dual-chamber
- Micra AVn = 801
- Transvenous dual-chambern = 2,667reference
- Outcome
- Major complications and system revisions
- Follow-up
- 12 months
Methodological detailssingle-arm, worldwide, interim analysis, historical control cohort
- Single-arm
- Worldwide
- Interim analysis
- Historical control cohort
Main finding
Major complications
Hazard ratio
0.42
95% CI 0.28–0.61
P < 0.001
By group
Micra AV vs Transvenous dual-chamber
HR 0.42 (95% CI 0.28–0.61); P < 0.001
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | Micra AV | Transvenous dual-chamber | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| System revisions · 12 months · interim analysis | 1.5% | 5.5% | 0.25 (0.13–0.47) | P < 0.001 | |
| 0.10.31310Hazard ratio (log scale) |
- System revisions: largely driven by absence of lead dislodgments requiring revision
AV synchrony index (patients paced >90%)
- Median AV synchrony index in patients paced >90% (IQR 65.2%-86.4%)
- 79.4%
Successful implantation
- Device successfully implanted, 796 of 801 patients
- 99.4%
Safety
| Outcome | Micra AV | Transvenous dual-chamber | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major complications · 12 months · interim analysis | 3.7% | 8.8% | 0.42 (0.28–0.61) | P < 0.001 | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry. Heart Rhythm. Published 13 June 2024. doi:10.
Summarised from the published abstract; every number is checked against it