Why the study?
While MARVEL demonstrated that accelerometer-based atrial sensing improves AV synchrony in patients with AV block and a Micra pacemaker at a single time point, its performance over time required assessment.
Does accelerometer-based atrial sensing maintain stable atrioventricular synchrony and signal amplitude over time in patients with AV block and a Micra pacemaker?
Does accelerometer-based atrial sensing maintain stable atrioventricular synchrony and signal amplitude over time in patients with AV block and a Micra pacemaker?
Accelerometer-based atrial sensing for atrioventricular synchronous pacing in leadless pacemakers maintains stable signal amplitude and performance over time, and behaves safely during atrial arrhythmias.
ACC-based AV synchrony appears stable over ≥6 months in Micra patients; leaves open durability and arrhythmia performance in larger prospective cohorts.
INTRODUCTION: The MARVEL study demonstrated at a single time point that accelerometer (ACC)-based atrial sensing improves atrioventricular (AV) synchrony (AVS) in patients with AV block and a Micra pacemaker (Medtronic, Minneapolis, MN, USA). The purpose of the MARVEL Evolve substudy was to assess the performance over time. METHODS: This prospective single-center study compared AVS and ACC signals at two visits ≥6 months apart. Custom software was temporarily downloaded into the Micra at each visit and AVS was measured during 30 min at rest. RESULTS: Nine patients from the MARVEL study were enrolled. The mean (±standard deviation) age was 82.3 ± 6.0 years old, 67% were male, and a Micra was implanted for 6.0 ± 6.4 months. High-degree AV block was present in four patients, whereas five with predominantly intrinsic conduction required intermittent pacing for bradycardia. The mean interval between visits was 7.1 ± 0.6 months. Seven patients had normal sinus node function at both visits and were included in a paired analysis. Both ACC signal amplitude (visit 2-visit 1 = 1.4 mG; 95% confidence interval [CI] [-25.8 to 28.4 mG]; P = 0.933) and AVS (visit 1: 90.8%, 95% CI [72.4, 97.4] and visit 2: 91.4%, 95% CI [63.8, 98.5]; P = 0.740) remained stable. Three patients had spontaneous atrial tachycardia. During atrial fibrillation, no atrial contraction was detected or tracked. During atrial flutter, intermittent tracking resulted in a ventricular rate of 60 ± 8 beats per minute (bpm); there was no ventricular pacing >100 bpm. CONCLUSION: ACC signals amplitude and performance of AVS pacing were stable over time. During atrial arrhythmias, the AV synchronous pacing mode behaved safely.
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Garweg et al. (2019) studied this question.