Department of Cardiology, Kyorin University Hospital.
Department of Cardiology, Showa University Hospital.
Circ J. 2017 Oct 25;81(11):1589-1595. doi: 10.1253/circj.CJ-17-0259. Epub 2017 May 30.
A global study designed to demonstrate the safety and efficacy of a transcatheter pacing system included 38 Japanese patients enrolled at 4 sites. Subgroup analysis to evaluate the performance of the leadless intracardiac transcatheter pacing system in Japanese patients was performed.Methods and Results:Safety and efficacy outcomes, patient and implant procedure characteristics, and patient and physician acceptability from the Japanese population were compared with those from outside Japan. Differences in patient characteristics, implant procedure characteristics and patient acceptability were observed. There were no major complications in Japanese patients and pacing thresholds remained low and stable throughout follow-up. There were no observable differences between Japanese patients and patients from outside Japan in the freedom from major complication rate at 12-months post-implant (100.0% vs. 95.7%, P=0.211) or physician acceptability.
Although some differences in specific baseline characteristics, such as body size and pacing indication, and in implant procedure characteristics, including anticoagulation strategy and hospitalization period, were observed in the Japanese patients, transcatheter pacemaker performance was similar to that in the global trial. (Clinical Trial Registration: ClinicalTrials.gov ID NCT02004873.).
一项旨在证明经导管起搏系统安全性和有效性的全球性研究纳入了 4 个地点的 38 名日本患者。对该无导线经导管心内起搏系统在日本患者中的表现进行了亚组分析。
对来自日本的患者的安全性和疗效结果、患者和植入程序特征以及患者和医生的可接受性与来自日本以外的患者进行了比较。观察到患者特征、植入程序特征和患者可接受性存在差异。在日本患者中没有发生重大并发症，起搏阈值在整个随访过程中保持较低且稳定。在植入后 12 个月时，主要并发症发生率的无重大并发症率（100.0%比 95.7%，P=0.211）或医生可接受性方面，日本患者与日本以外的患者之间没有观察到差异。
尽管在日本患者中观察到一些特定的基线特征（如体型和起搏适应证）和植入程序特征（包括抗凝策略和住院时间）存在差异，但经导管起搏器的性能与全球试验相似。（临床试验注册：ClinicalTrials.gov ID NCT02004873.）。
