Aims Clinical trials have demonstrated the safety and efficacy of the Micra leadless VVI pacemaker; however, longer-term outcomes in a large, real-world population with a contemporaneous comparison to transvenous VVI pacemakers have not been examined. We compared reinterventions, chronic complications, and all-cause mortality at 2 years between leadless VVI and transvenous VVI implanted patients. Methods and results The Micra Coverage with Evidence Development study is a continuously enrolling, observational, cohort study of leadless VVI pacemakers in the US Medicare fee-for-service population. Patients implanted with a leadless VVI pacemaker between March 9, 2017, and December 31, 2018, were identified using Medicare claims data linked to manufacturer device registration data (n = 6219). All transvenous VVI patients from facilities with leadless VVI implants during the study period were obtained directly from Medicare claims (n = 10 212). Cox models were used to compare 2-year outcomes between groups. Compared to transvenous VVI, patients with leadless VVI had more end-stage renal disease (12.0% vs. 2.3%) and a higher Charlson comorbidity index (5.1 vs. 4.6). Leadless VVI patients had significantly fewer reinterventions [adjusted hazard ratio (HR) 0.62, 95% confidence interval (CI) 0.45–0.85, P = 0.003] and chronic complications (adjusted HR 0.69, 95% CI 0.60–0.81, P < 0.0001) compared with transvenous VVI patients. Adjusted all-cause mortality at 2 years was not different between the two groups (adjusted HR 0.97, 95% CI 0.91–1.04, P = 0.37). Conclusion In a real-world study of US Medicare patients, the Micra leadless VVI pacemaker was associated with a 38% lower adjusted rate of reinterventions and a 31% lower adjusted rate of chronic complications compared with transvenous VVI pacing. There was no difference in adjusted all-cause mortality at 2 years.

中文翻译：

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Micra CED 研究中的无引线与经静脉单腔心室起搏：2 年随访

目的 临床试验证明了 Micra 无引线 VVI 起搏器的安全性和有效性；然而，尚未对大量现实世界人群的长期结果与经静脉 VVI 起搏器进行同期比较。我们比较了无引线 VVI 和经静脉 VVI 植入患者的再干预、慢性并发症和 2 年全因死亡率。方法和结果 Micra 覆盖率与证据开发研究是一项针对美国医疗保险付费服务人群中无引线 VVI 起搏器的持续入组、观察性队列研究。使用与制造商设备注册数据相关联的医疗保险索赔数据来识别 2017 年 3 月 9 日至 2018 年 12 月 31 日期间植入无引线 VVI 起搏器的患者 (n = 6219)。研究期间来自配备无引线 VVI 植入物的设施的所有经静脉 VVI 患者均直接从 Medicare 索赔中获得（n = 10 212）。Cox 模型用于比较各组之间的 2 年结果。与经静脉 VVI 相比，无引线 VVI 患者有更多的终末期肾病（12.0% vs. 2.3%）和更高的 Charlson 合并症指数（5.1 vs. 4.6）。无引线 VVI 患者的再干预次数显着减少 [调整后风险比 (HR) 0.62，95% 置信区间 (CI) 0.45–0.85，P = 0.003] 和慢性并发症（调整后 HR 0.69，95% CI 0.60–0.81，P < 0.0001） ）与经静脉 VVI 患者相比。两组间调整后的 2 年全因死亡率没有差异（调整后 HR 0.97，95% CI 0.91–1.04，P = 0.37）。结论 在一项针对美国 Medicare 患者的真实世界研究中，与经静脉 VVI 起搏相比，Micra 无引线 VVI 起搏器的再干预调整率降低了 38%，慢性并发症调整率降低了 31%。2 年调整后全因死亡率没有差异。