Abstract
Introduction: The Micra™ VR leadless pacemaker has demonstrated a high implant success rate and a low rate of complications in both investigational and real-world settings. Although the manufacturer’s product performance reporting suggests a high device survival rate, projected longevity based upon real-world usage has not been assessed. Objective: To summarize device electricals and battery longevity in Micra VR leadless pacemakers in nationwide practice. Methods: A retrospective analysis was performed using Micra VR remote transmissions from the CareLink de-identified database queried on 1 June 2022. A patient’s last transmission ≥ 30 days post-implant was used for analysis. Pacing percentage, electrical performance, and battery longevity were summarized. To standardize the analysis, projected battery longevity was computed by adding the number of years between implant and the device’s last transmission and the projected battery life remaining at last transmission based on device use conditions. Results: Transmissions from 26,698 patients qualified for analysis. Median time from implant to final transmission was 19.8 months (range 1-96.7). Mean pacing capture threshold (PCT) was 0.61 ± 0.50 V (standardized to 0.24 ms) with 92.1% of patients having a PCT ≤1.0 V. Mean pacing impedance and sensing amplitude were 567 ± 118 ohms and 13.7 ± 6.3 mV. Median pacing percentage was 82.3% (IQR: 25.7% - 98.6%) with 43.9% of patients paced >90%. Median projected battery longevity for the overall cohort was 13.7 years (IQR: 12.4 - 15.3 years) with 91.9% of devices exceeding 10 years (Figure). Among patients with >90% pacing burden (N=11,717), median projected battery longevity was 12.6 years (IQR: 11.6-13.4) with 87.2% of devices exceeding 10 years. Conclusions: Real-world performance of the Micra VR leadless pacemaker demonstrates favorable pacing parameters with 92.1% of patients having pacing thresholds of ≤1.0 V and a median projected battery longevity of 13.7 years.
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