Division of Cardiology, Section of Electrophysiology, Emory University, Atlanta, Georgia.
King Salman Heart Center - King Fahad Medical City, Riyadh, Saudi Arabia.
Heart Rhythm. 2018 Dec;15(12):1800-1807. doi: 10.1016/j.hrthm.2018.08.005. Epub 2018 Aug 10.
Early results of the Micra Investigational Device Exemption (IDE) study and Micra Post-Approval Registry (PAR) demonstrated excellent safety and efficacy performance; however, intermediate-term results across a large patient population in the real-world setting have not been evaluated.
We report updated performance of the Micra transcatheter pacemaker from a worldwide PAR and compare it with the IDE study as well as a transvenous historical control.
The safety objective of the analysis was system- or procedure-related major complications through 12 months postimplantation. We compared the major complication rate with that of the 726 patients from the IDE and with a reference data set of 2667 patients with transvenous pacemakers by using a Fine-Gray competing risk model.
The Micra device was successfully implanted in 1801 of 1817 patients (99.1%). The mean follow-up period was 6.8 ± 6.9 months. Through 12 months, the major complication rate was 2.7% (95% confidence interval [CI] 2.0%-3.7%). The risk of major complications for Micra PAR patients was 63% lower than that for patients with transvenous pacemakers through 12 months postimplantation (hazard ratio 0.37; 95% CI 0.27-0.52; P < .001). The major complication rate trended lower in the PAR than in the IDE study (hazard ratio 0.71; 95% CI 0.44-1.1; P = .160), driven by the lower pericardial effusion rate in the PAR. There were 3 cases of infection associated with the procedure, but none required device removal and there were no battery or telemetry issues. Pacing thresholds were low and stable through 12 months postimplantation.
Performance of the Micra transcatheter pacemaker in international clinical practice remains consistent with previously reported data. Major complications were infrequent and occurred 63% less often compared to transvenous systems.
Micra Transcatheter Pacing System Post-Approval Registry ClinicalTrials.gov identifier: NCT02536118; Micra Transcatheter Pacing Study ClinicalTrials.gov identifier: NCT02004873.
Micra 经导管心脏起搏器研究的早期结果和 Micra 上市后注册研究（PAR）显示了出色的安全性和有效性；然而，在现实环境中，尚未评估大型患者人群的中期结果。
我们报告了全球 Micra PAR 中经导管心脏起搏器的最新性能，并将其与 IDE 研究以及经静脉历史对照进行了比较。
分析的安全性目标是植入后 12 个月内与系统或程序相关的主要并发症。我们使用 Fine-Gray 竞争风险模型，将主要并发症发生率与 IDE 研究的 726 例患者和 2667 例经静脉起搏器患者的参考数据集进行比较。
1817 例患者中有 1801 例（99.1%）成功植入 Micra 装置。平均随访时间为 6.8 ± 6.9 个月。植入后 12 个月时，主要并发症发生率为 2.7%（95%置信区间 [CI] 2.0%-3.7%）。通过 12 个月，Micra PAR 患者发生主要并发症的风险比经静脉起搏器植入患者低 63%（风险比 0.37；95% CI 0.27-0.52；P <.001）。PAR 中的主要并发症发生率呈下降趋势，低于 IDE 研究（风险比 0.71；95% CI 0.44-1.1；P =.160），这主要是由于 PAR 中心包积液发生率较低。有 3 例与手术相关的感染病例，但均无需移除装置，也未出现电池或遥测问题。起搏阈值在植入后 12 个月内保持低且稳定。
国际临床实践中 Micra 经导管心脏起搏器的性能与先前报告的数据一致。主要并发症很少发生，且与经静脉系统相比发生率低 63%。
Micra 经导管心脏起搏系统上市后注册研究 ClinicalTrials.gov 标识符：NCT02536118；Micra 经导管心脏起搏研究 ClinicalTrials.gov 标识符：NCT02004873。
