Abstract
BACKGROUND: Leadless ventricular pacemakers have been developed for single chamber VVIR and AV synchronous pacing applications. AIM: To assess the device longevity impact of battery/electronics enhancements of next-generation Micra leadless pacemakers, Micra VR2 and AV2, compared to Micra VR and AV. METHODS: Real-world pacing data gathered from the Micra IDE study, Medtronic's CareLink database, and historical pacemaker patient survival data from Medtronic's Device Registry were used to project device longevity and estimate the proportion of patients requiring lifetime device replacements. RESULTS: Based on data from 644 patients, the median projected longevity of Micra VR was 12.3 years and Micra VR2 was 16.7 years, with 91% of patients requiring a single VR2 device over their lifetime. Based on data from 999 patients, the median projected longevity of Micra AV was 10.8 years and Micra AV2 was 15.6 years, with 80% of patients requiring one AV2 device. The longevity improvements with Micra VR2 projected 8 fewer device replacements would be required across 100 patients. Similarly, 15 devices would be avoided when considering Micra AV versus AV2. CONCLUSIONS: Modeling of the Micra leadless pacemakers projected meaningful improvements in device longevity and an increase in the number of patients served with a single device.