Safety and performance of the Micra VR leadless pacemaker in Chinese patients: a post-market, prospective, observational, non-randomized study

Background and purpose: The real-world safety and performance of the Micra VR leadless pacemaker have been well-established by previous clinical trials. However, there is little clinical data from these studies specific to patients in China. The purpose of this study was to characterize the safety and performance of the Micra VR leadless pacemaker in a Chinese cohort. Methods: The primary endpoints of the Micra Acute Performance Greater China (MAP China) study were acute (≤30 days post-implant) and 12-month major complication rate following implantation of the Micra VR leadless pacemaker. Electrical performance was characterized from the time of implant through 12-month follow-up. Patient baseline and procedural characteristics and major complications were compared to the China pre-market and global Post-Approval Registry studies. Results: A total of 100 patients were enrolled and successfully implanted with the Micra VR system between June 2021 and October 2022 across 11 sites in mainland China. Average follow-up was 11.1 ± 4.1 months. One major complication was reported in 1 patient within 30 days from the time of implant for an acute and 12-month complication rate of 1.0% (95% confidence interval: 0.025%–5.446%). Risk of major complications was in line with the China pre-market and global Post-Approval Registry studies. Conclusion: The Micra VR leadless pacemaker had high implant success and low major complication rates in patients from China, in agreement with the China pre-market and global Post-Approval Registry studies.