Arrhythmias & electrophysiology
Pacing Performance of a Modular Communicative Leadless Pacing-Defibrillator System
Authors' conclusion
The performance of the modular pacing-defibrillator system at one year demonstrated a low complication rate and reliable pacing functionality.
Study context
- Population
- Patients with an ICD indication and at high risk for monomorphic ventricular tachycardia; pacemaker dependent patients were excludedLeadless pacemaker (LP) implant was attempted in 286 patients
- Participants
- 297 patients
- Outcome
- Primary safety endpoint 2: percentage of patients free from major LP-related complications
- Follow-up
- 12 months
Main finding
As reported in the abstract
Major LP-related complication free rate
97.2%
one-sided 97.5% LCL 94.5%
Further findings
Baseline characteristics
- Mean age
- 59±12 years
- Mean left ventricular ejection fraction
- 35.3±13.1%
- Female
- 17.5%
LP implant success
- LP implant successful, of 286 patients in whom it was attempted
- 100%
Secondary effectiveness endpoint: rate response performance of the LP under workload (slope of the normalized sensor rate versus the normalized workload)
- Slope of the normalized sensor rate versus the normalized workload
- 0.96 (95% LCL 0.91, 95% UCL 1.02)
- Within the performance goal range of 0.65-1.35
Pacing capture threshold ≤ 2V @ 0.4ms pulse width · 12 months
- Patients with a pacing capture threshold ≤ 2V @ 0.4ms pulse width
- 96.8%
Safety
- There were no LP-related complications following Implant
Original publication
Pacing Performance of a Modular Communicative Leadless Pacing-Defibrillator System. Europace. Published 5 November 2026. doi:10. 1093/ europace/ euag309
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