Arrhythmias & electrophysiology

Six-month electrical performance of the first dual-chamber leadless pacemaker

Heart RhythmPublished Prospective single-arm study

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
GroupCapture threshold (0.4-ms), implant → 1 monthSensed amplitudeImpedance
ALP2.4 ± 1.5 V to 0.8 ± 0.8 V; P <.0011.8 ± 1.3 mV to 3.4 ± 1.9 mV; P <.001334 ± 68 Ω to 329 ± 52 Ω; P = .17
VLP0.8 ± 0.6 V to 0.6 ± 0.4 V; P <.0018.8 ± 4.0 mV to 11.7 ± 4.2 mV; P <.001789 ± 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

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