Cha Myung-Jin, Park Seung-Jung, Cho Youngjin, Cho Min Soo, On Young Keun, Kim Ju Youn, Kim Tae-Hoon, Yu Hee Tae, Oh Yong-Seog, Lee So-Ryoung, Shim Jaemin, Choi Jong-Il, Choi Eue-Keun, Hwang Jongmin, Stromberg Kurt, Murphy Jeffrey, Fagan Dedra H, Joung Boyoung
Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Division of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Korean Circ J. 2025 Jun;55(6):526-537. doi: 10.4070/kcj.2024.0317. Epub 2025 Feb 13.
The Micra leadless pacemaker demonstrated a favorable safety and efficacy profile in global trials, but its performance and safety in a South Korean-specific population are unknown.
The prospective, single-arm Micra Acute Performance South Korean registry was designed to study the performance of the Micra VR leadless pacemaker in patients from South Korea. The primary objectives were to characterize the rate of acute (30 days) and longer-term (12 months) major complications. Electrical performance and quality of life at baseline and follow-up were also characterized.
A total of 100 enrolled patients underwent Micra VR implant at 8 centers in South Korea between July 2021 and February 2022 with 99% successfully implanted. Mean pacing capture threshold was 0.57±0.46 V at implant and remained stable through 12 months (0.65±0.44 V). Korean valuation of health status significantly increased from baseline (0.78±0.24) to 12 months (0.84±0.21) (p=0.016). Compared with global patients, South Korean patients were younger, had a lower body mass index, and fewer had a prior cardiovascular implantable electronic device (all p<0.01). During the follow-up period 1 major complication was reported (implant site hematoma) at 26 days post-implant. No pericardial effusion or tamponade events were observed. Through 12 months post-implant the major complication rate was 1.0% (95% confidence interval, 0.03%, 5.45%).
In a South Korean cohort, the Micra VR leadless pacemaker was implanted with a high success rate and low major complication rate.
Micra无导线起搏器在全球试验中显示出良好的安全性和有效性，但在韩国特定人群中的性能和安全性尚不清楚。
前瞻性单臂Micra急性性能韩国注册研究旨在研究Micra VR无导线起搏器在韩国患者中的性能。主要目标是确定急性（30天）和长期（12个月）主要并发症的发生率。还对基线和随访时的电性能和生活质量进行了评估。
2021年7月至2022年2月期间，共有100名入组患者在韩国的8个中心接受了Micra VR植入，成功率为99%。植入时平均起搏捕获阈值为0.57±0.46V，并在12个月内保持稳定（0.65±0.44V）。韩国健康状况评估从基线时的（0.78±0.24）显著提高到12个月时的（0.84±0.21）（p=0.016）。与全球患者相比，韩国患者更年轻，体重指数更低，既往植入心血管植入式电子设备的患者更少（所有p<0.01）。随访期间，报告了1例主要并发症（植入部位血肿），发生在植入后26天。未观察到心包积液或心包填塞事件。植入后12个月内，主要并发症发生率为1.0%（95%置信区间，0.03%，5.45%）。
在韩国队列中，Micra VR无导线起搏器植入成功率高，主要并发症发生率低。
