Micra AV 无导线起搏器在 Micra AV CED 研究中的 2 年结果。
Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study.
机构信息
Department of Medicine, Division of Cardiology, Emory University School of Medicine, 100 Woodruff Circle, 550 Peachtree Street NE, Atlanta, GA 30308, USA.
Medtronic, Inc., Minneapolis, MN, USA.
出版信息
Europace. 2024 Nov 1;26(11). doi: 10.1093/europace/euae273.
AIMS
Leadless pacing is a safe and effective alternative to transvenous pacing for bradycardia. Micra AV is a leadless, single-device solution that provides atrioventricular synchronous ventricular pacing therapy. Early results from the Micra AV CED study showed reductions in short-term complications associated with the Micra AV leadless pacemaker among US Medicare patients. The objective of this study is to compare chronic complications, re-interventions, and all-cause mortality at 2 years between patients implanted with a Micra AV leadless pacemaker and a traditional dual-chamber transvenous (DC-TV) pacemaker.
METHODS AND RESULTS
Patients implanted with a Micra AV leadless pacemaker (n = 7552) or a DC-TV pacemaker (n = 110 558) in 2020 and 2021 were identified using device registration-linked Medicare administrative claims data. Competing risk models compared the unadjusted and propensity score overlap weight-adjusted complication, re-intervention, and all-cause mortality rates of Micra AV and DC-TV patients at 2 years. Micra AV patients had significantly more comorbidities (end-stage renal disease 14.9 vs. 2.0%, P < 0.0001; renal dysfunction 47.9 vs. 34.2%, P < 0.0001; diabetes 46.2 vs. 38.3%, P < 0.001; congestive heart failure 41.4 vs. 30.6%, P < 0.0001). Two years post-implant, Micra AV patients had lower complication rates [adjusted 5.3 vs. 9.6%, hazard ratio (HR): 0.54, 95% confidence interval (CI) 0.49-0.61, P < 0.0001] and lower re-intervention rates (adjusted 3.5 vs. 5.6%, HR: 0.62, 95% CI 0.54-0.72, P < 0.0001) than DC-TV patients. Upgrades to cardiac resynchronization therapy were low in both groups (adjusted 1.6 vs. 1.7%, P = 0.40), as were Micra AV upgrades to a dual-chamber system (adjusted 1.4%). All-cause mortality rates remained higher in Micra AV than in DC-TV patients (unadjusted HR: 2.48, 95% CI 2.35-2.62, P < 0.0001; adjusted HR: 1.53, 95% CI 1.44-1.62, P < 0.0001).
CONCLUSION
Patients implanted with Micra AV had lower complications and re-intervention rates at 2 years than patients implanted with a traditional DC-TV pacemaker. All-cause mortality remained higher in Micra AV patients, likely due to their higher comorbidity burden and other differences in baseline characteristics.
CLINICAL TRIAL REGISTRATION
ClinicalTrials.gov ID NCT04235491.
目的
无导线起搏是治疗心动过缓的一种安全有效的经静脉起搏替代方法。Micra AV 是一种无导线、单器械解决方案，可提供房室同步心室起搏治疗。来自 Micra AV CED 研究的早期结果表明，在美国医疗保险患者中，与 Micra AV 无导线起搏器相关的短期并发症减少。本研究的目的是比较植入 Micra AV 无导线起搏器和传统双腔经静脉（DC-TV）起搏器的患者在 2 年时的慢性并发症、再干预和全因死亡率。
方法和结果
使用设备注册链接的医疗保险行政索赔数据，确定了 2020 年和 2021 年植入 Micra AV 无导线起搏器（n=7552）或 DC-TV 起搏器（n=110558）的患者。竞争风险模型比较了 Micra AV 和 DC-TV 患者在 2 年时未调整和倾向评分重叠权重调整后的并发症、再干预和全因死亡率。Micra AV 患者合并症更多（终末期肾病 14.9% vs. 2.0%，P<0.0001；肾功能不全 47.9% vs. 34.2%，P<0.0001；糖尿病 46.2% vs. 38.3%，P<0.001；充血性心力衰竭 41.4% vs. 30.6%，P<0.0001）。植入后 2 年，Micra AV 患者的并发症发生率较低[调整后 5.3% vs. 9.6%，风险比（HR）：0.54，95%置信区间（CI）0.49-0.61，P<0.0001]和再干预率较低（调整后 3.5% vs. 5.6%，HR：0.62，95%CI 0.54-0.72，P<0.0001）比 DC-TV 患者。两组心脏再同步治疗升级率均较低（调整后 1.6% vs. 1.7%，P=0.40），Micra AV 升级为双腔系统的比例也较低（调整后 1.4%）。全因死亡率在 Micra AV 患者中仍高于 DC-TV 患者（未调整 HR：2.48，95%CI 2.35-2.62，P<0.0001；调整 HR：1.53，95%CI 1.44-1.62，P<0.0001）。
结论
植入 Micra AV 的患者在 2 年时的并发症和再干预率低于植入传统 DC-TV 起搏器的患者。全因死亡率在 Micra AV 患者中仍然较高，可能是由于他们的合并症负担更高和其他基线特征的差异。
临床试验注册
ClinicalTrials.gov ID NCT04235491。
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