Two-year outcomes of Micra AV leadless pacemakers in the Micra AV CED study.

IF 7.9 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

Europace Pub Date : 2024-11-01 DOI:10.1093/europace/euae273

Mikhael F El-Chami, Lucas Higuera, Colleen Longacre, Kurt Stromberg, George Crossley, Jonathan P Piccini

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引用次数: 0

Abstract

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.

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Micra AV CED 研究中 Micra AV 无引线起搏器的两年疗效。

背景和目的：无导联起搏是经静脉起搏治疗心动过缓的一种安全有效的替代方法。Micra AV 是一种无导联、单设备解决方案，可提供房室同步心室起搏治疗。Micra AV CED 研究的早期结果显示，Micra AV 无导联起搏器可减少美国医疗保险患者的短期并发症。本研究的目的是比较植入 Micra AV 无导联起搏器和传统双腔经静脉（DC TV）起搏器的患者两年后的慢性并发症、再介入治疗和全因死亡率：利用与设备注册挂钩的医疗保险行政索赔数据，确定了 2020 年和 2021 年植入 Micra AV 无导联起搏器（N=7,552）或 DC TV 起搏器（N=110,558）的患者。竞争风险模型比较了 Micra AV 和 DC TV 患者两年内未经调整和倾向得分重叠加权调整的并发症、再介入和全因死亡率：结果：Micra AV 患者的合并症明显较多（终末期肾病 14.9% 对 2.0%，P 值结论：Micra AV 患者的合并症明显较多（终末期肾病 14.9% 对 2.0%，P 值结论）：与植入传统 DC-TV 起搏器的患者相比，植入 Micra AV 的患者两年后的并发症和再介入率更低。Micra AV患者的全因死亡率仍然较高，这可能是由于他们的合并症负担较重以及基线特征的其他差异：试验注册：ClinicalTrials.gov ID NCT04235491。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Europace 医学-心血管系统

CiteScore

10.30

自引率

8.20%

发文量

851

审稿时长

3-6 weeks

期刊介绍： EP - Europace - European Journal of Pacing, Arrhythmias and Cardiac Electrophysiology of the European Heart Rhythm Association of the European Society of Cardiology. The journal aims to provide an avenue of communication of top quality European and international original scientific work and reviews in the fields of Arrhythmias, Pacing and Cellular Electrophysiology. The Journal offers the reader a collection of contemporary original peer-reviewed papers, invited papers and editorial comments together with book reviews and correspondence.