Arrhythmias & electrophysiology
Six-month electrical performance of the first dual-chamber leadless pacemaker
Authors' conclusion
This first in-human evaluation of the new dual-chamber leadless pacemaker system demonstrated reliable electrical performance throughout the initial 6-month evaluation period.
Study context
- Population
- Patients meeting standard dual-chamber pacing indications implanted with the dual-chamber leadless pacemaker (DC-LP) system (Aveir DR, Abbott)complete 6-month data
- Participants
- 381 patients
- Exposure
- ALP vs VLP
- Outcome
- Chronic electrical performance: pacing capture threshold, sensed amplitude and pacing impedance
- Follow-up
- 0-6 months postimplant
Methodological detailsfirst in-human evaluation
- First in-human evaluation
Main finding
As reported in the abstract
Electrical metrics, implant to 1 month · implant to 1 month
| Group | Capture threshold (0.4-ms), implant → 1 month | Sensed amplitude | Impedance |
|---|---|---|---|
| ALP | 2.4 ± 1.5 V to 0.8 ± 0.8 V; P <.001 | 1.8 ± 1.3 mV to 3.4 ± 1.9 mV; P <.001 | 334 ± 68 Ω to 329 ± 52 Ω; P = .17 |
| VLP | 0.8 ± 0.6 V to 0.6 ± 0.4 V; P <.001 | 8.8 ± 4.0 mV to 11.7 ± 4.2 mV; P <.001 | 789 ± 351 Ω to 646 ± 190 Ω; P <.001 |
Capture threshold (0.4-ms), implant → 1 month
ALP2.4 ± 1.5 V to 0.8 ± 0.8 V; P <.001
VLP0.8 ± 0.6 V to 0.6 ± 0.4 V; P <.001
Sensed amplitude
ALP1.8 ± 1.3 mV to 3.4 ± 1.9 mV; P <.001
VLP8.8 ± 4.0 mV to 11.7 ± 4.2 mV; P <.001
Impedance
ALP334 ± 68 Ω to 329 ± 52 Ω; P = .17
VLP789 ± 351 Ω to 646 ± 190 Ω; P <.001
Observational data: associations, not effects.
Further findings
Electrical metrics by implant location
- No differences in electrical metrics among ALP or VLP implant locations
Original publication
Six-month electrical performance of the first dual-chamber leadless pacemaker. Heart Rhythm. Published 30 April 2024. doi:10. 1016/ j. hrthm. 2024. 04. 091
Summarised from the published abstract; every number is checked against it