Arrhythmias & electrophysiology

Temperature-based rate response in a leadless pacemaker system

Heart RhythmPublished Prospective device study

Authors' conclusion

The temperature-based sensor in a dual-chamber leadless pacemaker system was shown to be effective at modulating pacing rate in response to increased metabolic demand for right ventricular and atrial devices.

Study context

Population
Patients implanted with a leadless pacemaker (VR-LP or dual-chamber DR-LP), 6 weeks after implantation
Outcome
Normalized slope of sensor-indicated rate vs metabolic workload; proportional if mean slope's 95% CI within 0.65–1.35
Follow-up
6 weeks after implantation
Methodological detailsexercise substudy of the LEADLESS II-Phase 2 and Aveir DR i2i studies, treadmill exercise protocol, prespecified acceptance range 0.65–1.35
  • Exercise substudy of the LEADLESS II-Phase 2 and Aveir DR i2i studies
  • Treadmill exercise protocol
  • Prespecified acceptance range 0.65–1.35

Main finding

As reported in the abstract

Normalised slope of sensor-indicated rate vs metabolic workload (rate-response slope)
GroupValueCIP (within acceptance criteria)
Ventricularmean 0.93 (SD 0.29)0.78-1.08P = .001
Atrialmean 0.91 (SD 0.28)0.78-1.05P < .001

Value

Ventricularmean 0.93 (SD 0.29)
Atrialmean 0.91 (SD 0.28)

CI

Ventricular0.78-1.08
Atrial0.78-1.05

P (within acceptance criteria)

VentricularP = .001
AtrialP < .001

Observational data: associations, not effects.

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

Temperature-based rate response in a leadless pacemaker system. Heart Rhythm. Published 22 November 2024. doi:10.1016/j.hrthm.2024.11.032

Summarised from the published abstract; every number is checked against it

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