Outcomes of Micra Leadless Pacemaker Implants in Centers With and Without Cardiac Surgery.

IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Gianluca Manzo, Gabriele Giannola, Gerardo Nigro, Giulio Zucchelli, Antonino Nicosia, Pietro Palmisano, Luca Bontempi, Miguel Viscusi, Mattia Liccardo, Marcello Piacenti, Giuseppe Coppola, Mario Volpicelli, Giovanni Morani, Sem Briongos, Saverio Iacopino
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引用次数: 0

Abstract

Background: Micra leadless pacemaker offers an alternative to traditional transvenous pacemakers by eliminating the risks associated with leads and device pockets. Due to the technical demands of a leadless transcatheter pacemaker, concerns initially limited the procedure to centers with on-site cardiac surgery (CS) capabilities. However, growing evidence supports its safe implementation in noncardiac surgical centers, though data comparing outcomes in these settings remain limited.

Aims: This analysis aims to evaluate the safety and feasibility of Micra leadless pacemaker implantation in centers with and without CS, assessing acute complications, device performance, and patient follow-up.

Methods: A retrospective analysis was conducted on 1899 patients who received a Micra pacemaker from May 2015 to September 2024 at 23 centers. Patients were divided into two groups: those implanted in centers with CS (CS, n = 1025) and those without (No-CS, n = 874). The primary endpoint was acute complications within 15 days postimplant, while secondary endpoints included device performance and clinical follow-up at 12 months.

Results: The overall acute complication rate was low at 0.6%, with no significant difference between the CS (0.5%) and No-CS groups (0.8%; p = 0.391). Procedural times were slightly shorter in No-CS centers (41.2 ± 19.8 vs. 46.1 ± 19.3 min; p < 0.001), and both groups showed comparable device performance and patient outcomes over the follow-up period.

Conclusion: The Micra leadless pacemaker can be safely and effectively implanted in centers without CS capabilities, broadening access to this technology across diverse clinical settings.

Micra无铅心脏起搏器植入中心与不进行心脏手术的结果。
背景:Micra无导线起搏器通过消除与导线和设备口袋相关的风险,提供了传统经静脉起搏器的替代方案。由于无导线经导管起搏器的技术要求,人们最初将该程序限制在具有现场心脏手术(CS)能力的中心。然而,越来越多的证据支持其在非心脏外科中心的安全实施,尽管比较这些设置的结果的数据仍然有限。目的:本分析旨在评估Micra无导线起搏器在中心植入有无CS的安全性和可行性,评估急性并发症、设备性能和患者随访。方法:对2015年5月至2024年9月在23个中心接受Micra起搏器治疗的1899例患者进行回顾性分析。患者分为两组:植入CS的患者(CS, n = 1025)和未植入CS的患者(No-CS, n = 874)。主要终点是移植后15天内的急性并发症,次要终点包括器械性能和12个月的临床随访。结果:总体急性并发症发生率较低,为0.6%,CS组(0.5%)与no -CS组(0.8%;p = 0.391)。无cs中心手术时间稍短(41.2±19.8 vs 46.1±19.3 min);结论:Micra无铅起搏器可以安全有效地植入没有CS功能的中心,扩大了该技术在不同临床环境中的应用范围。
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
CiteScore
5.20
自引率
14.80%
发文量
433
审稿时长
3-6 weeks
期刊介绍: Journal of Cardiovascular Electrophysiology (JCE) keeps its readership well informed of the latest developments in the study and management of arrhythmic disorders. Edited by Bradley P. Knight, M.D., and a distinguished international editorial board, JCE is the leading journal devoted to the study of the electrophysiology of the heart.
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