Safety and Performance of the Micra VR Leadless Pacemaker in a Japanese Cohort ― Comparison With Global Studies ―
Kenji Andò, Kanki Inoue, Tomoo Harada, Satoshi Shizuta, Yukihiko Yoshida, Kengo Kusano, Tatsuya Onuki, Yuji Watari, Akio Fukui, Shingo Sasaki, Morio Shoda, Nobuhiro Nishii, Akira Shiose, Junya Hosoda, Chie Okai, Kurt Stromberg, Jeffrey A. Murphy, Thomas R. Holmes, Kyoko Soejima
Abstract
BACKGROUND: The Micra leadless pacemaker has demonstrated favorable outcomes in global trials, but its real-world performance and safety in a Japan-specific population is unknown. METHODS AND RESULTS: Micra Acute Performance (MAP) Japan enrolled 300 patients undergoing Micra VR leadless pacemaker implantation in 15 centers. The primary endpoint was the acute (30-day) major complication rate. The 30-day and 6-month major complication rates were compared to global Micra studies. All patients underwent successful implantation with an average follow-up of 7.23±2.83 months. Compared with previous Micra studies, Japanese patients were older, smaller, more frequently female, and had a higher pericardial effusion risk score. 11 acute major complications were reported in 10 patients for an acute complication rate of 3.33% (95% confidence interval: 1.61-6.04%), which was in line with global Micra trials. Pericardial effusion occurred in 4 patients (1.33%; 3 major, 1 minor). No procedure or device-related deaths occurred. Frailty significantly improved from baseline to follow-up as assessed by Japan Cardiovascular Health Study criteria. CONCLUSIONS: In a Japanese cohort, implantation of the Micra leadless pacemaker had a high success rate and low major complication rate. Despite the Japan cohort being older, smaller, and at higher risk, the safety and performance was in line with global Micra trials.