Department of Cardiology, Kokura Memorial Hospital.
Department of Cardiology, Sakakibara Heart Institute.
Circ J. 2023 Nov 24;87(12):1809-1816. doi: 10.1253/circj.CJ-23-0269. Epub 2023 Aug 2.
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.
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.
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.
无导线心脏起搏器 Micra 在全球试验中表现出良好的结果，但在日本特定人群中的实际表现和安全性尚不清楚。
Micra 急性性能（MAP）日本研究纳入了在 15 个中心接受 Micra VR 无导线起搏器植入的 300 例患者。主要终点是急性（30 天）主要并发症发生率。将 30 天和 6 个月的主要并发症发生率与全球 Micra 研究进行比较。所有患者均成功植入，平均随访 7.23±2.83 个月。与之前的 Micra 研究相比，日本患者年龄更大、体型更小、女性比例更高，心包积液风险评分更高。10 例患者发生 11 例急性主要并发症，急性并发症发生率为 3.33%（95%置信区间：1.61-6.04%），与全球 Micra 试验一致。4 例患者发生心包积液（1.33%；3 例主要，1 例次要）。无手术或器械相关死亡。根据日本心血管健康研究标准，虚弱程度从基线到随访显著改善。
在日本队列中，植入 Micra 无导线起搏器的成功率高，主要并发症发生率低。尽管日本队列患者年龄更大、体型更小、风险更高，但安全性和性能与全球 Micra 试验一致。
