Arrhythmias & electrophysiology
Outcomes of patients implanted with an atrioventricular synchronous leadless ventricular pacemaker in the Medicare population
Authors' conclusion
Patients implanted with Micra AV had similar rates of complications at 30 days and significantly lower rates of complications and reinterventions at 6 months, despite being sicker than patients implanted with a transvenous pacemaker.
Study context
- Population
- US Medicare patients implanted with a pacemaker, February 5, 2020, through December 1, 2021
- Participants
- 7,471 vs 107,800
- Exposure
- Micra AV leadless pacemaker vs dual chamber transvenous pacemaker
- Micra AVn = 7,471
- Dual chamber transvenous pacemakern = 107,800reference
- Outcome
- Acute complications
- Follow-up
- 30 days
Methodological detailsdevice registry-linked Medicare claims data
- Device registry-linked Medicare claims data
Main finding
As reported in the abstract
Complications
Complications · 30 days
Adjusted rate
P < 0.0001
- Micra AV vs Dual chamber transvenous pacemaker: P = 0.61 — unadjusted
Observational data: associations, not effects.
Further findings
| Outcome | Adjusted HR (95% CI) | P value | |
|---|---|---|---|
| Complications · 6 months | 0.50 (0.43–0.57) | P < 0.0001 | |
| Reinterventions · 6 months | 0.46 (0.36–0.58) | P < 0.0001 | |
| 0.20.5125Adjusted hazard ratio (log scale) |
Baseline: end-stage renal disease and Charlson Comorbidity Index
End-stage renal disease
Mean Charlson Comorbidity Index Micra AV 4.9 · Dual chamber transvenous pacemaker 3.8
- Baseline: end-stage renal disease and Charlson Comorbidity Index: both P < .0001
All-cause mortality · 30 days and 6 months
- Higher with Micra AV, likely because of differences in underlying mortality risk
Original publication
Outcomes of patients implanted with an atrioventricular synchronous leadless ventricular pacemaker in the Medicare population. Heart Rhythm. Published 23 September 2023. doi:10. 1016/ j. hrthm. 2023. 09. 017
Summarised from the published abstract; every number is checked against it