Southampton General Hospital-University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
Centre Hospitalier Régional Universitaire de Tours-Hôpital Trousseau, Tours, France.
Heart Rhythm. 2017 Sep;14(9):1375-1379. doi: 10.1016/j.hrthm.2017.05.017. Epub 2017 May 11.
First-in-man studies of leadless pacemakers have demonstrated high rates of implant success, and safety and efficacy objectives were achieved. Outside of the investigational setting, there are concerns, particularly over cardiac effusion and perforation, device dislodgement, infection, telemetry, and battery issues.
The acute performance of the Micra transcatheter pacemaker from a worldwide Post-Approval Registry is reported.
The registry is an ongoing prospective single-arm observational study designed to assess the safety and effectiveness of Micra in the post-approval setting. The safety end point was system- or procedure-related major complications at 30 days post implant. We compared the major complication rate with that of the 726 patients from the investigational study. Electrical performance was also characterized.
The device was successfully implanted in 792 of 795 registry patients (99.6%) by 149 implanters at 96 centers in 20 countries. Through 30 days post implant, a total of 13 major complications occurred in 12 patients, for a major complication rate of 1.51% (95% confidence interval, 0.78%-2.62%). Major complications included cardiac effusion/perforation (1, 0.13%), device dislodgement (1, 0.13%), and sepsis (1, 0.13%). After adjusting for baseline differences, the rate of major complications in the registry trended lower than the investigational trial (odds ratio, 0.58, 95% confidence interval, 0.27-1.25; P = .16). Early pacing capture thresholds were low and stable.
Performance of the Micra transcatheter pacemaker in a real-world setting demonstrates a high rate (99.6%) of implant success and low rate (1.51%) of major complications through 30 days post implant. In particular, the rates of pericardial effusion, device dislodgement, and infection were low, reinforcing the positive results seen in the investigational study.
无导线起搏器的首例人体研究已经证明了其较高的植入成功率，并且达到了安全性和有效性目标。但在研究之外，人们仍存在一些担忧，特别是对心脏积液和穿孔、器械移位、感染、遥测和电池问题。
报告了无导线起搏器 Micra 从全球上市后注册研究中的急性表现。
该注册研究是一项正在进行的前瞻性单臂观察性研究，旨在评估 Micra 在上市后的安全性和有效性。安全性终点为植入后 30 天内与系统或手术相关的主要并发症。我们将主要并发症的发生率与研究中的 726 例患者进行了比较。还对电性能进行了特征描述。
在 20 个国家的 96 个中心，由 149 名植入者成功植入了 795 例注册患者中的 792 例（99.6%）。植入后 30 天内，共有 12 名患者发生 13 例主要并发症，发生率为 1.51%（95%置信区间，0.78%-2.62%）。主要并发症包括心脏积液/穿孔（1 例，0.13%）、器械移位（1 例，0.13%）和败血症（1 例，0.13%）。在调整了基线差异后，注册研究中的主要并发症发生率趋势低于研究（比值比，0.58，95%置信区间，0.27-1.25；P=0.16）。早期起搏捕获阈值较低且稳定。
无导线起搏器 Micra 在真实环境中的表现显示，植入成功率高（99.6%），植入后 30 天内主要并发症发生率低（1.51%）。特别是心包积液、器械移位和感染的发生率较低，这进一步证实了研究中的积极结果。
