Atrioventricular Synchrony Delivered by a Dual-Chamber Leadless Pacemaker System

Area of Science:

• Cardiovascular medicine
• Biomedical engineering
• Implantable electronic devices

Background:

• A novel dual-chamber leadless pacemaker system utilizes wireless implant-to-implant (i2i) communication for atrioventricular (AV) synchronous pacing.
• Systematic evaluation of AV synchrony during ambulatory conditions is crucial for leadless pacing technologies.

Purpose of the Study:

• To assess the efficacy of a dual-chamber leadless pacemaker system in achieving and maintaining atrioventricular synchrony.
• To evaluate AV synchrony across diverse patient postures and activities.

Main Methods:

• A prospective, single-arm, multicenter clinical trial enrolled patients requiring dual-chamber pacing.
• Implanted leadless pacemaker systems were evaluated using 12-lead Holter ECGs at 3 months post-implantation.
• Atrioventricular synchrony was adjudicated based on a 300-millisecond PR interval, alongside assessment of i2i communication success rates.

Main Results:

• The study evaluated 384 patients, with 98% of beats demonstrating AV synchrony across all postures using the standard 300-millisecond limit.
• AV synchrony exceeded both atrial-to-ventricular and ventricular-to-atrial i2i communication success rates (94%) in 95% of patients.
• High AV synchrony (>95%) was maintained across all postures, activities, implantation indications, and heart rate ranges, including those exceeding 100 bpm.

Conclusions:

• The dual-chamber leadless pacemaker system effectively achieved high atrioventricular synchrony (98% of beats) at 3 months post-implantation.
• AV synchrony remained robust across various ambulatory scenarios and elevated heart rates (>100 bpm).
• This technology shows promise for leadless cardiac pacing with reliable AV synchrony.