Key result
The MicraVR transcatheter pacing system demonstrated stable long-term electrical parameters and battery longevity, with 0% device-related infections or system failures over a mean follow-up of 723 days.
Why the study?
While implantation safety and acute success of the MicraVR transcatheter pacing system have been demonstrated, few long-term real-life data exist.
Cohort (n=188)
Yes
Leadless transcatheter pacing demonstrates stable long-term electrical parameters and battery longevity with a low complication rate in a real-world cohort.
Supports MicraVR TPS use in AF bradycardia; extends acute safety data yet leaves long-term durability open.
AIMS: The MicraVR™ transcatheter pacing system (TPS) has been implemented into clinical routine for several years. The primary recipients are patients in need for VVI pacing due to bradycardia in the setting of atrial fibrillation (AF). Implantation safety and acute success have been proven in controlled studies and registries. So far only few long-term real-life data on TPS exist. We report indication, procedure and outcome data from two high-volume implanting German centers. METHODS: Between 2016 and 2019, 188 (of 303) patients were included. During follow-up (FU), TPS interrogation was performed after 4 weeks and thereafter every 6 months. RESULTS: Indication for TPS implantation in 159/188 (85%) patients was permanent or intermittent AV block III° in the setting of atrial fibrillation. The mean procedure duration was 50 min [35.0-70.0]. The average acute values after system release were: thresholds: 0.5V [0.38-0.74]/0.24ms; R-wave sensing: 10.0mV [8.1-13.5]; impedance: 650 Ohm [550-783]; RV-pacing demand: 16.9% [0.9-75.9]; and battery status: 3.15 V [3.12-3.16]. During FU of 723.4 ± 597.9 days, neither pacemaker failure nor infections were reported. Long-term FU revealed: thresholds: 0.5V [0.38-0.63]/0.24 ms; sensing: 12.3mV [8.9-17.2]; impedance: 570 Ohm [488-633]; RV-pacing demand: 87.1% [29.5-98.6]; and battery status 3.02 V [3.0-3.1]. Forty-three patients died from not-device-related causes. CONCLUSION: This to date largest German long-term dataset for MicraVR™ TPS implantation revealed stable device parameter. Foremost, battery longevity seems to fulfill predicted values despite a significant increase in RV-pacing demand over time and even in patients with consecutive AV-node ablation. Of note, no infections or system failure were observed.
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Sultan et al. (2023) conducted a cohort in Bradycardia requiring VVI pacing (primarily with atrial fibrillation) (n=188). MicraVR transcatheter pacing system was evaluated on Device-related infections or system failure during long-term follow-up. The MicraVR transcatheter pacing system demonstrated stable long-term electrical parameters and battery longevity, with 0% device-related infections or system failures over a mean follow-up of 723 days.
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