Arrhythmias & electrophysiology
A Dual-Chamber Leadless Pacemaker
Authors' conclusion
The dual-chamber leadless pacemaker system met the primary safety end point and provided atrial pacing and reliable atrioventricular synchrony for 3 months after implantation.
Study context
- Population
- Patients with a conventional indication for dual-chamber pacing
- Participants
- 300 patients
- Outcome
- Primary safety end point: freedom from complications (device- or procedure-related serious adverse events)
- Follow-up
- 90 days
Methodological detailsmulticentre
- Multicentre
Main finding
As reported in the abstract
Freedom from complications (primary safety end point met), performance goal 78% (P<0.001)
271
90.3%; 95% CI, 87.0 to 93.7
Adequate atrial capture threshold and sensing amplitude (first primary performance end point), performance goal 82.5% (P<0.001)
90.2%
95% CI 86.8 to 93.6
≥70% atrioventricular synchrony (second primary performance end point), performance goal 83% (P<0.001)
97.3%
95% CI 95.4 to 99.3
Observational data: associations, not effects.
Further findings
Implantation success (two functioning leadless pacemakers with implant-to-implant communication)
- Successful implantation
- 295 patients (98.3%)
Atrial capture threshold and P-wave amplitude
- Mean (±SD) atrial capture threshold
- 0.82±0.70 V
- Mean P-wave amplitude
- 3.58±1.88 mV
- P-wave amplitude <1.0 mV
- 21 patients (7%)
- Device revision for inadequate sensing among those with P-wave amplitude <1.0 mV
- 0
Safety
- Device- or procedure-related serious adverse events
- 35
- Patients with such events
- 29
Original publication
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