Comparison of 30-day complications between a tine-based and a screw-in helix fixation single-chamber ventricular leadless pacemaker: Results of a propensity score–matched analysis from a multicenter, nationwide registry

IF 5.7 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Heart rhythm Pub Date : 2025-08-01 Epub Date: 2025-03-10 DOI:10.1016/j.hrthm.2025.03.1881
Pietro Palmisano MD , Giovanni Rovaris MD , Domenico Giovanni Della Rocca MD, PhD , Paolo Della Bella MD, PhD , Ennio Carmine Luigi Pisanò MD , Lorenzo Mazzocchetti MD , Zefferino Palamà MD , Gabriele Dell’Era MD , Antonio Strangio MD , Antonio Dello Russo MD, PhD , Vincenzo Paolo Caccavo MD , Antonio Curcio MD, PhD , Cosimo Mandurino MD , Giorgio Spiniello MD , Domenico Gianfrancesco MD , Giovanni Caroli MD , Massimo Grimaldi MD , Giovanni Volpato MD , Fabio Megna MD , Giuseppe Patti MD, PhD , Antonino Nicosia MD
{"title":"Comparison of 30-day complications between a tine-based and a screw-in helix fixation single-chamber ventricular leadless pacemaker: Results of a propensity score–matched analysis from a multicenter, nationwide registry","authors":"Pietro Palmisano MD ,&nbsp;Giovanni Rovaris MD ,&nbsp;Domenico Giovanni Della Rocca MD, PhD ,&nbsp;Paolo Della Bella MD, PhD ,&nbsp;Ennio Carmine Luigi Pisanò MD ,&nbsp;Lorenzo Mazzocchetti MD ,&nbsp;Zefferino Palamà MD ,&nbsp;Gabriele Dell’Era MD ,&nbsp;Antonio Strangio MD ,&nbsp;Antonio Dello Russo MD, PhD ,&nbsp;Vincenzo Paolo Caccavo MD ,&nbsp;Antonio Curcio MD, PhD ,&nbsp;Cosimo Mandurino MD ,&nbsp;Giorgio Spiniello MD ,&nbsp;Domenico Gianfrancesco MD ,&nbsp;Giovanni Caroli MD ,&nbsp;Massimo Grimaldi MD ,&nbsp;Giovanni Volpato MD ,&nbsp;Fabio Megna MD ,&nbsp;Giuseppe Patti MD, PhD ,&nbsp;Antonino Nicosia MD","doi":"10.1016/j.hrthm.2025.03.1881","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Medtronic Micra VR and Abbott Aveir VR are 2 single-chamber ventricular leadless pacemakers (L-PMs) currently available in clinical practice. They differ in their design, fixation mechanism (tine-based fixation for Micra VR, screw-in helix fixation for Aveir VR), and implantation technique. Few comparative safety data are available for these L-PMs.</div></div><div><h3>Objective</h3><div>We aimed to compare the rate of acute procedure-related complications of patients undergoing Aveir VR vs Micra VR implantation.</div></div><div><h3>Methods</h3><div>A prospective, multicenter, observational registry enrolled consecutive patients who underwent Aveir VR or Micra VR implantation. The rate and nature of device-related complications at 30-day follow-up were analyzed and compared between the groups. Individual 1:1 propensity score matching of baseline characteristics was performed.</div></div><div><h3>Results</h3><div>A total of 1141 patients (75.9 ± 14.8 years; 60.2% male) were enrolled: 211 Aveir VR and 930 Micra VR. Propensity score matching yielded 189 matched pairs. In the matched cohort, the risk of device-related complications at 30 days of follow-up of the 2 L-PMs was similar (2.1% vs 2.1%; <em>P</em> = 1). Device migration (1.6% vs 0.5%; <em>P</em> = .315) and vascular complications (0.5% vs 1.1%; <em>P</em> = .562) were the most frequent complications, with no significant differences between the groups. Cardiac perforation was rare (1 case in the Micra VR group, no cases in the Aveir VR group).</div></div><div><h3>Conclusion</h3><div>The risk of acute device-related complications associated with Aveir VR and Micra VR L-PM implantation was similar. These findings suggest that despite differences in design, fixation mechanism, and implantation technique, these 2 devices appear to have a similar short-term safety profile.</div></div>","PeriodicalId":12886,"journal":{"name":"Heart rhythm","volume":"22 8","pages":"Pages e431-e437"},"PeriodicalIF":5.7000,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Heart rhythm","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1547527125021034","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/3/10 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0

Abstract

Background

Medtronic Micra VR and Abbott Aveir VR are 2 single-chamber ventricular leadless pacemakers (L-PMs) currently available in clinical practice. They differ in their design, fixation mechanism (tine-based fixation for Micra VR, screw-in helix fixation for Aveir VR), and implantation technique. Few comparative safety data are available for these L-PMs.

Objective

We aimed to compare the rate of acute procedure-related complications of patients undergoing Aveir VR vs Micra VR implantation.

Methods

A prospective, multicenter, observational registry enrolled consecutive patients who underwent Aveir VR or Micra VR implantation. The rate and nature of device-related complications at 30-day follow-up were analyzed and compared between the groups. Individual 1:1 propensity score matching of baseline characteristics was performed.

Results

A total of 1141 patients (75.9 ± 14.8 years; 60.2% male) were enrolled: 211 Aveir VR and 930 Micra VR. Propensity score matching yielded 189 matched pairs. In the matched cohort, the risk of device-related complications at 30 days of follow-up of the 2 L-PMs was similar (2.1% vs 2.1%; P = 1). Device migration (1.6% vs 0.5%; P = .315) and vascular complications (0.5% vs 1.1%; P = .562) were the most frequent complications, with no significant differences between the groups. Cardiac perforation was rare (1 case in the Micra VR group, no cases in the Aveir VR group).

Conclusion

The risk of acute device-related complications associated with Aveir VR and Micra VR L-PM implantation was similar. These findings suggest that despite differences in design, fixation mechanism, and implantation technique, these 2 devices appear to have a similar short-term safety profile.
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
基于时间和螺旋固定单室无铅起搏器30天并发症的比较。来自多中心全国登记的倾向匹配分析结果。
背景:美敦力Micra VR和雅培Aveir VR是目前临床应用的两种单室心室无铅起搏器(l - pm)。它们在设计、固定机制(Micra VR是基于时间的固定,Aveir VR是螺旋固定)和植入技术上有所不同。这些lpm的相对安全性数据很少。目的:比较Aveir VR与Micra VR植入患者急性手术相关并发症的发生率。方法:前瞻性、多中心、观察性登记纳入了接受Aveir VR或Micra VR植入的连续患者。分析比较两组患者术后30天器械相关并发症的发生率和性质。进行基线特征的个体1:1倾向匹配。结果:共纳入1141例患者(75.9±14.8岁,男性60.2%),其中Aveir VR 211例,Micra VR 930例。倾向匹配产生了189对匹配的配对。在匹配的队列中,两名l - pm患者随访30天发生器械相关并发症的风险相似(2.1 vs 2.1%;p = 1.000)。设备迁移(1.6% vs. 0.5%;P =0.315)和血管并发症(0.5 vs. 1.1%;P =0.562)为最常见的并发症,两组间差异无统计学意义。心脏穿孔罕见(Micra VR组1例,Aveir VR组无一例)。结论:Aveir VR和Micra VR l - pm植入的急性器械相关并发症风险相似。这些发现表明,尽管在设计、固定机制和植入技术上存在差异,但这两种装置似乎具有相似的短期安全性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 去求助
来源期刊
Heart rhythm
Heart rhythm 医学-心血管系统
CiteScore
10.50
自引率
5.50%
发文量
1465
审稿时长
24 days
期刊介绍: HeartRhythm, the official Journal of the Heart Rhythm Society and the Cardiac Electrophysiology Society, is a unique journal for fundamental discovery and clinical applicability. HeartRhythm integrates the entire cardiac electrophysiology (EP) community from basic and clinical academic researchers, private practitioners, engineers, allied professionals, industry, and trainees, all of whom are vital and interdependent members of our EP community. The Heart Rhythm Society is the international leader in science, education, and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education, and optimal health care policies and standards.
期刊最新文献
Editorial Board Risk of delayed atrioventricular block in patients without procedural conduction disturbances during transcatheter aortic valve replacement Flecainide sensitizes conduction to hyponatremia through an ephaptic mechanism Left atrial posterior volume and posterior-anterior volume ratio as predictive factors for atrial fibrillation recurrence: Insights from regional atrial remodeling Simplified 3-ganglionated plexus ablation for the treatment of recurrent vasovagal syncope and functional bradyarrhythmia
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1