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
{"title":"Micra无铅心脏起搏器植入中心与不进行心脏手术的结果。","authors":"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","doi":"10.1111/jce.16701","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Aims: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The Micra leadless pacemaker can be safely and effectively implanted in centers without CS capabilities, broadening access to this technology across diverse clinical settings.</p>","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.3000,"publicationDate":"2025-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Outcomes of Micra Leadless Pacemaker Implants in Centers With and Without Cardiac Surgery.\",\"authors\":\"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\",\"doi\":\"10.1111/jce.16701\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Aims: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>The Micra leadless pacemaker can be safely and effectively implanted in centers without CS capabilities, broadening access to this technology across diverse clinical settings.</p>\",\"PeriodicalId\":15178,\"journal\":{\"name\":\"Journal of Cardiovascular Electrophysiology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2025-04-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cardiovascular Electrophysiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1111/jce.16701\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cardiovascular Electrophysiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1111/jce.16701","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
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。
Outcomes of Micra Leadless Pacemaker Implants in Centers With and Without Cardiac Surgery.
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.
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.