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Navigating the Lead Paradox: Successful Co-Implantation of Cardiac Contractility Modulation Device and a Micra Leadless Pacemaker 导航导线悖论:心脏收缩调节装置和Micra无导线起搏器的成功联合植入。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-09 DOI: 10.1111/jce.70244
Gabriele Pavani, Paolo Garrone, Gianpaolo Varalda, Antonino Previti, Matteo Bianco, Alessandra Chinaglia

Background

Wild-type transthyretin cardiac amyloidosis (ATTRwt-CA) can lead to refractory heart failure. A “lead paradox” occurs when patients with a Micra leadless pacemaker require lead-based Cardiac Contractility Modulation (CCM) therapy.

Case Summary

We detail the first co-implantation of CCM and Micra devices in a 78-year-old male with ATTRwt-CA and NYHA III heart failure. A multi-view fluoroscopic technique ensured spatial separation, while specific device programming mitigated electrical crosstalk post-procedure.

Conclusion

At 1 year, the patient stabilized to NYHA Class II without further hospitalizations. This dual-device strategy is a feasible and safe technical roadmap for this complex clinical problem.

背景:野生型转甲状腺素型心脏淀粉样变性(ATTRwt-CA)可导致难治性心力衰竭。当使用Micra无铅起搏器的患者需要铅基心脏收缩调节(CCM)治疗时,就会出现“铅悖论”。病例总结:我们详细介绍了一例78岁男性attrt - ca和NYHA III型心力衰竭患者CCM和Micra装置的首次联合植入。多视图透视技术确保了空间分离,而特定的设备编程减轻了术后的电串扰。结论:1年后,患者稳定为NYHA II级,无需进一步住院治疗。对于这一复杂的临床问题,这种双装置策略是一种可行且安全的技术路线图。
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引用次数: 0
A Simple Method Is Used to Identify PVI-Responsive Patients With Persistent Atrial Fibrillation: Electrical Cardioversion and Noninduction Before Procedure. 一种简单的方法来识别pvi反应的持续性心房颤动患者:术前电复律和非诱导。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-09 DOI: 10.1111/jce.70240
Hai-Yang Xie, Yuyang Chen, Yong Xie, Jianhua Wu, Jiajie Li, Shuming Liang, Weicheng Chen, Hongdao Li, Yuan Chen, Wei Tang, Yanfang Ye, Feifan Ouyang, Jingfeng Wang, Shuanglun Xie

Background: Pulmonary vein isolation (PVI) demonstrates less efficacy in persistent atrial fibrillation (PersAF) compared to paroxysmal AF. Although recent multiple-center RCTs have shown that additional ablation, except for the ethanol intervention of the Marshall vein, has not significantly benefited in persistent AF. Therefore, the most important issue is how to identify PVI-responsive PersAF.

Objectives: This exploratory cohort study assessed a novel direct current cardioversion-electrophysiological study (DC-EPS) protocol before ablation, and evaluated whether inducibility can be guided by a PVI procedure.

Methods: In this prospective cohort study, patients were classified as Protocol-Negative (AF non-inducible post-cardioversion) and Protocol-Positive group (failed cardioversion, spontaneous AF recurrence within 5 min, or induced AF). PVI alone was done in the Protocol-Negative group, while PVI with adjunctive line ablation (Roof/MI/CTI lines) was performed in the Protocol-Positive group. The procedure success endpoint is freedom from atrial arrhythmias > 30 s without antiarrhythmic drugs within 12 months.

Results: Over the 12-month follow-up, 41 of 48 patients (85.4%) in the Protocol-Negative group and 37 of 61 patients (60.7%) in the Protocol-Positive group remained free from ATA. Arrhythmia-free survival was significantly higher in the Protocol-Negative group (HR = 0.326; 95% CI, 0.140-0.756; p = 0.009). After multivariable adjustment, the recurrence risk remained lower in Protocol-Negative patients (adjusted HR 0.328, 95% CI 0.138-0.779, p = 0.012). Protocol-Negative patients exhibited preserved cardiac architecture (left atrial volume: 134.5 vs. 151.8 mL, p = 0.022) and less fibrosis (low-voltage area: 0 vs. 1.3 cm², p < 0.001).

Conclusions: Patients with DC-EPS-defined Protocol-Negativity have an excellent PVI responder. These findings suggest that PV antrum isolation may be enough in the initial procedure, and require a multi-center RCT for further investigation.

背景:与阵发性房颤相比,肺静脉隔离(PVI)对持续性房颤(PersAF)的疗效较差。尽管最近的多中心随机对照试验显示,除了马歇尔静脉的乙醇干预外,额外的消融对持续性房颤没有显著的益处。因此,最重要的问题是如何识别PVI应答的PersAF。目的:本探索性队列研究评估了一种新的消融前直流电复心电生理研究(DC-EPS)方案,并评估了PVI程序是否可以引导诱导。方法:在这项前瞻性队列研究中,患者被分为方案阴性组(心律转复后非诱导性房颤)和方案阳性组(心律转复失败、5分钟内房颤自发性复发或诱发性房颤)。方案阴性组仅行PVI,方案阳性组行PVI合并辅助线消融(Roof/MI/CTI线)。手术成功终点为12个月内无房性心律失常,无抗心律失常药物。结果:在12个月的随访中,方案阴性组48例患者中有41例(85.4%)未发生ATA,方案阳性组61例患者中有37例(60.7%)未发生ATA。方案阴性组无心律失常生存率显著高于对照组(HR = 0.326; 95% CI, 0.140-0.756; p = 0.009)。多变量调整后,方案阴性患者的复发风险仍然较低(调整后HR 0.328, 95% CI 0.138 ~ 0.779, p = 0.012)。方案阴性患者表现出保留的心脏结构(左心房容积:134.5 vs 151.8 mL, p = 0.022)和较少的纤维化(低压面积:0 vs 1.3 cm²,p)结论:dc - eps定义的方案阴性患者具有出色的PVI反应。这些结果表明,在初始手术中,PV窦室隔离可能就足够了,需要多中心随机对照试验进行进一步研究。
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引用次数: 0
Pacemaker and ICD Programming Adherence With Evidence-Based Recommendations 心脏起搏器和ICD规划遵循循证建议。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-09 DOI: 10.1111/jce.70242
Alexander Smith, Matthew Ortman, John Andriulli, Andrea M. Russo

Introduction

Despite data-driven 2015 expert consensus statement (consensus) guidelines on recommended PPM and ICD parameters, patients often fall short of optimal device programing. The purpose of this retrospective, observational, single-center study is to review device implant registry data both before and after the consensus update to determine whether there is an improvement in adherence to consensus-recommended device programming over time.

Methods

McKesson software was used to identify all patients pre- (1/1/2012–12/31/2013) and post- (1/1/2020–12/31/2022) consensus who underwent a single, dual, or BiV device implant and had at least one follow-up appointment in the electronic medical record. Groups were evaluated for adherence to consensus recommendations based on the type of device. BiV devices were evaluated based on the percent of total pacing, with > 98% pacing being considered compliant with the consensus. Single and dual-chamber ICDs were evaluated based on bradycardia and tachyarrhythmia programming parameters as outlined in the 2015 consensus document and the 2019 manufacturer-specific update. Due to significant implantation rates at our institution, and to maintain consistency, only Medtronic devices were evaluated in this study.

Results

In the BiV group, before the consensus, 41 (85.4%) patients were > 98% paced, compared with only 69 (58.0%) patients post-consensus. Forty-five (93.7%) patients were at least 90% paced in the pre-consensus group, compared with 109 (91.6%) in the post-consensus group. In the ICD group, bradycardia-pacing settings were similar in both groups (34/89.5% vs. 73/90.1%, p = 0.91). There was a trend toward improved adherence to tachyarrhythmia therapies post-consensus (15/39.5% vs. 37/45.7%, p = 0.52). Nonadherence was driven by 1:1 SVT logic initiation. If this parameter was excluded, both groups increased significantly (37/97.4% vs. 78/96.3%, p = 0.76).

Conclusions

This study adds to the growing body of literature showing a persistent disconnect between data-driven recommendations and real-world clinical practice. Larger studies are needed to better understand physician barriers to these guideline-driven recommendations.

导言:尽管2015年专家共识声明(共识)指南中推荐了PPM和ICD参数,但患者往往无法获得最佳的设备编程。这项回顾性、观察性、单中心研究的目的是回顾共识更新前后的器械植入注册数据,以确定是否随着时间的推移,对共识推荐的器械规划的依从性有所提高。方法:使用McKesson软件识别所有接受单、双或BiV装置植入并在电子病历中至少有一次随访预约的患者(2012年1月1日- 2013年12月31日)和之后(2020年1月1日- 2022年12月31日)。根据器械类型评估各组对共识建议的依从性。BiV装置是根据总起搏的百分比进行评估的,其中bb0 - 98%的起搏被认为符合共识。单室和双室icd根据2015年共识文件和2019年制造商特定更新中概述的心动过缓和心动过速编程参数进行评估。由于我们机构的植入率很高,为了保持一致性,本研究仅评估美敦力设备。结果:在BiV组中,共识前,41例(85.4%)患者有> - 98%的节奏,而共识后只有69例(58.0%)患者。共识前组有45例(93.7%)患者至少达到90%,而共识后组有109例(91.6%)。在ICD组,两组的心动过缓设置相似(34/89.5% vs. 73/90.1%, p = 0.91)。共识后对速性心律失常治疗的依从性有提高的趋势(15/39.5% vs. 37/45.7%, p = 0.52)。非依从性由1:1 SVT逻辑启动驱动。如果排除该参数,两组均显著升高(37/97.4% vs. 78/96.3%, p = 0.76)。结论:这项研究增加了越来越多的文献,表明数据驱动的建议与现实世界的临床实践之间存在持续的脱节。需要更大规模的研究来更好地了解医生对这些指南驱动的建议的障碍。
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引用次数: 0
Author Response to: Expanding the Biophysical Insights Into Esophageal Heating During Radiofrequency Ablation. 作者回应:扩大对射频消融期间食管加热的生物物理见解。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-09 DOI: 10.1111/jce.70241
Pierre C Qian
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引用次数: 0
Prognostic Impact of Early Recurrence Following Pulsed Field Ablation: A Meta-Analysis 脉冲场消融后早期复发对预后的影响:荟萃分析。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-09 DOI: 10.1111/jce.70245
Esteban Arevalo, Cesar Erazo, Frans Serpa, André Rivera, Jakrin Kewcharoen, Rahul Bhardwaj, Jalaj Garg

Introduction

The conventional 3-month blanking period after atrial fibrillation (AF) ablation has been applied irrespective of energy modality. Pulsed field ablation (PFA), a nonthermal technique, may elicit different tissue responses, questioning the appropriateness of this timeframe. We performed a meta-analysis to evaluate whether early recurrence of atrial tachyarrhythmia (ERAT) after PFA predicts late recurrence (LRAT) and to assess the duration of the traditional blanking period.

Methods

We systematically searched PubMed, Embase, and Cochrane Library through April 2025 for studies reporting ERAT and LRAT following PFA for AF.

Results

Nine studies (N = 3384) met the inclusion criteria. ERAT within 3 months post-PFA occurred in 14% of patients. Patients with ERAT had significantly higher odds of LRAT (pooled OR: 8.66; 95% CI: 5.69–13.18; p < 0.001). Importantly, ERAT in the first month was not predictive of LRAT (OR: 1.30; p = 0.52), whereas ERAT in Months 2–3 strongly predicted LRAT.

Conclusion

ERAT after PFA is a strong predictor of LRAT, especially if occurring beyond the first month. These findings challenge the traditional 3-month blanking period for PFA and support shortening or individualizing this window. A tailored post-PFA surveillance approach focusing on arrhythmias beyond 1 month may improve timely interventions and long-term outcomes. Prospective studies are needed to refine blanking period duration for PFA.

导读:心房颤动(AF)消融后传统的3个月的空白期已被应用于任何能量模式。脉冲场消融(PFA)是一种非热技术,可能会引起不同的组织反应,质疑这个时间框架的适用性。我们进行了一项荟萃分析,以评估PFA后房性心动过速(ERAT)的早期复发是否预示着晚期复发(LRAT),并评估传统空白期的持续时间。方法:我们系统地检索了PubMed、Embase和Cochrane图书馆,检索了截至2025年4月报道af的PFA后ERAT和LRAT的研究。结果:9项研究(N = 3384)符合纳入标准。14%的患者在pfa后3个月内发生了ERAT。ERAT患者发生LRAT的几率明显更高(合并OR: 8.66; 95% CI: 5.69-13.18; p)结论:PFA后的ERAT是LRAT的一个强有力的预测因子,特别是如果发生在第一个月以后。这些发现挑战了传统的3个月的PFA空白期,并支持缩短或个性化这一窗口。针对超过1个月的心律失常,量身定制的pfa后监测方法可能改善及时干预和长期预后。需要前瞻性研究来完善PFA的空白期持续时间。
{"title":"Prognostic Impact of Early Recurrence Following Pulsed Field Ablation: A Meta-Analysis","authors":"Esteban Arevalo,&nbsp;Cesar Erazo,&nbsp;Frans Serpa,&nbsp;André Rivera,&nbsp;Jakrin Kewcharoen,&nbsp;Rahul Bhardwaj,&nbsp;Jalaj Garg","doi":"10.1111/jce.70245","DOIUrl":"10.1111/jce.70245","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>The conventional 3-month blanking period after atrial fibrillation (AF) ablation has been applied irrespective of energy modality. Pulsed field ablation (PFA), a nonthermal technique, may elicit different tissue responses, questioning the appropriateness of this timeframe. We performed a meta-analysis to evaluate whether early recurrence of atrial tachyarrhythmia (ERAT) after PFA predicts late recurrence (LRAT) and to assess the duration of the traditional blanking period.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We systematically searched PubMed, Embase, and Cochrane Library through April 2025 for studies reporting ERAT and LRAT following PFA for AF.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Nine studies (<i>N</i> = 3384) met the inclusion criteria. ERAT within 3 months post-PFA occurred in 14% of patients. Patients with ERAT had significantly higher odds of LRAT (pooled OR: 8.66; 95% CI: 5.69–13.18; <i>p</i> &lt; 0.001). Importantly, ERAT in the first month was not predictive of LRAT (OR: 1.30; <i>p</i> = 0.52), whereas ERAT in Months 2–3 strongly predicted LRAT.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>ERAT after PFA is a strong predictor of LRAT, especially if occurring beyond the first month. These findings challenge the traditional 3-month blanking period for PFA and support shortening or individualizing this window. A tailored post-PFA surveillance approach focusing on arrhythmias beyond 1 month may improve timely interventions and long-term outcomes. Prospective studies are needed to refine blanking period duration for PFA.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":"37 2","pages":"429-433"},"PeriodicalIF":2.6,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145944052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan. 消融导管批准滞后:欧盟、美国和日本监管时间表的比较分析。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-09 DOI: 10.1111/jce.70248
Gaku Oguri, Katsuhito Fujiu, Norihiko Takeda

Introduction: Approval timelines for ablation catheters differ across major markets, potentially delaying clinical access. This study aimed to quantify approval lags for contemporary ablation catheters across the EU, the US, and Japan.

Methods: We retrospectively identified therapeutic ablation catheters with documented approval dates in the European Union, the United States, and Japan using data from PMDA, FDA, and European notified-body/manufacturer sources. Non-therapeutic accessories were excluded. Month-level approval lags were calculated for each regional pair.

Results: Twenty-six devices met the inclusion criteria. Mean approval lags were 46.2 months for Japan versus EU, 16.7 months for Japan versus US, and 29.5 months for EU versus US. Medians were lower across all comparisons owing to several long-lag outliers. Legacy cryoablation catheters showed the greatest delays, whereas recent pulsed-field ablation systems were approved in closer temporal proximity across regions.

Conclusion: Substantial cross-regional heterogeneity in ablation-catheter approvals persists, but recent PFA devices demonstrate that near-synchronous submissions can narrow the gap. Regulatory convergence and coordinated sponsor strategies may further accelerate patient access.

导读:各主要市场对消融导管的审批时间有所不同,这可能会延迟其临床应用。本研究旨在量化欧盟、美国和日本当代消融导管的审批滞后。方法:我们使用来自PMDA、FDA和欧洲公告机构/制造商来源的数据,回顾性地确定了欧盟、美国和日本有批准日期的治疗性消融导管。排除非治疗性附件。计算每个区域对的月级审批滞后。结果:26台器械符合纳入标准。日本与欧盟的平均审批滞后时间为46.2个月,日本与美国的平均审批滞后时间为16.7个月,欧盟与美国的平均审批滞后时间为29.5个月。由于几个长滞后异常值,所有比较的中位数都较低。传统的冷冻消融导管显示出最大的延迟,而最近的脉冲场消融系统被批准在更近的时间范围内跨越区域。结论:消融导管批准的跨地区异质性仍然存在,但最近的PFA设备表明,近乎同步的申请可以缩小差距。监管趋同和协调的赞助商策略可能会进一步加速患者获得。
{"title":"Approval Lag for Ablation Catheters: A Comparative Analysis of Regulatory Timelines in the European Union, United States, and Japan.","authors":"Gaku Oguri, Katsuhito Fujiu, Norihiko Takeda","doi":"10.1111/jce.70248","DOIUrl":"https://doi.org/10.1111/jce.70248","url":null,"abstract":"<p><strong>Introduction: </strong>Approval timelines for ablation catheters differ across major markets, potentially delaying clinical access. This study aimed to quantify approval lags for contemporary ablation catheters across the EU, the US, and Japan.</p><p><strong>Methods: </strong>We retrospectively identified therapeutic ablation catheters with documented approval dates in the European Union, the United States, and Japan using data from PMDA, FDA, and European notified-body/manufacturer sources. Non-therapeutic accessories were excluded. Month-level approval lags were calculated for each regional pair.</p><p><strong>Results: </strong>Twenty-six devices met the inclusion criteria. Mean approval lags were 46.2 months for Japan versus EU, 16.7 months for Japan versus US, and 29.5 months for EU versus US. Medians were lower across all comparisons owing to several long-lag outliers. Legacy cryoablation catheters showed the greatest delays, whereas recent pulsed-field ablation systems were approved in closer temporal proximity across regions.</p><p><strong>Conclusion: </strong>Substantial cross-regional heterogeneity in ablation-catheter approvals persists, but recent PFA devices demonstrate that near-synchronous submissions can narrow the gap. Regulatory convergence and coordinated sponsor strategies may further accelerate patient access.</p>","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145944068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
EPI-VT Score Methodology and Interpretation. EPI-VT评分方法和解释。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-09 DOI: 10.1111/jce.70235
Moneeb Khalaph
{"title":"EPI-VT Score Methodology and Interpretation.","authors":"Moneeb Khalaph","doi":"10.1111/jce.70235","DOIUrl":"10.1111/jce.70235","url":null,"abstract":"","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145944095","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Road to Hell Is Paved With Plugged Ports—Leadless EGM Findings and Their Potential Clinical Implications 通往地狱之路是由堵塞的端口铺成的——无铅EGM的发现及其潜在的临床意义。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2026-01-09 DOI: 10.1111/jce.70249
Maciej Dyrbuś, Anna Kurek, Joanna Machowicz, Mariusz Gąsior, Mateusz Tajstra
{"title":"The Road to Hell Is Paved With Plugged Ports—Leadless EGM Findings and Their Potential Clinical Implications","authors":"Maciej Dyrbuś,&nbsp;Anna Kurek,&nbsp;Joanna Machowicz,&nbsp;Mariusz Gąsior,&nbsp;Mateusz Tajstra","doi":"10.1111/jce.70249","DOIUrl":"10.1111/jce.70249","url":null,"abstract":"","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":"37 2","pages":"416-419"},"PeriodicalIF":2.6,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145944050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Implantation Success, Electrical Performance, and Safety of an Active Fixation Stylet-Driven Lead for LBBAP in Clinical Practice: A Multicenter Experience. LBBAP植入成功、电性能和临床实践中主动固定风格驱动导联的安全性:多中心经验。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-27 DOI: 10.1111/jce.70237
Amato Santoro, Matteo Ziacchi, Raimondo Calvanese, Antonio Rapacciuolo, Mario Volpicelli, Luca Poggio, Pasquale Nocerino, Davide Castagno, Valter Bianchi, Paolo Liberato Magliano, Gabriele Dell'Era, Cosimo Mandurino, Gianluca Mirizzi, Gianluca Savarese, Leonardo Marinaccio, Carmelo La Greca, Gregorio Covino, Gianluca Zingarini, Marco Varalda, Francesco Vitali, Claudia Baiocchi, Monica Campari, Sergio Valsecchi, Matteo Bertini

Background: Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy. However, its feasibility and safety using conventional stylet-driven leads (SDL) such as INGEVITY+ remain under investigation.

Objective: To evaluate the clinical performance, safety, and follow-up outcomes of LBBAP using the INGEVITY+ lead in a real-world electrophysiology setting.

Methods: From 2021 to 2024, 207 consecutive patients underwent LBBAP implant attempts using the INGEVITY+ lead across 19 centers. Of these, 146 had bradycardia indications, and 61 had heart failure indications. A control group of 200 patients received standard right ventricular (RV) pacing with the same lead. Procedural outcomes, electrical parameters, complications, and mid-term lead performance were assessed.

Results: LBBAP was successfully achieved in 201 (97%) cases. Procedural and fluoroscopy times were slightly longer for LBBAP than for RV pacing. Acute complications included one helix fracture, one atrioventricular block, and one septal perforation. During a median follow-up of 9 months, no lead fractures were reported; lead dislodgment occurred in three cases. Kaplan-Meier analysis showed no significant difference in time to first lead-related complication between the LBBAP and RV pacing groups (hazard ratio: 4.69, 95%CI: 0.63-34.90, p = 0.139). Electrical performance remained stable, with 98% of retained leads maintaining capture thresholds ≤ 2 V and 92% with sensed amplitudes ≥ 5 mV.

Conclusions: LBBAP using the INGEVITY + SDL is feasible and safe in clinical practice, with excellent implant success and stable mid-term electrical performance. These findings support its use as a viable conduction system pacing strategy.

背景:左束分支区域起搏(LBBAP)已成为一种很有前途的生理起搏策略。然而,使用INGEVITY+等传统样式驱动引线(SDL)的可行性和安全性仍在研究中。目的:评估在真实电生理环境下使用INGEVITY+导联进行LBBAP的临床表现、安全性和随访结果。方法:从2021年到2024年,连续207例患者在19个中心使用INGEVITY+导线进行LBBAP种植尝试。其中,146人有心动过缓的迹象,61人有心力衰竭的迹象。对照组200例患者接受相同导联的标准右心室起搏。评估手术结果、电参数、并发症和中期导联表现。结果:201例(97%)患者成功完成LBBAP治疗。LBBAP的程序和透视时间略长于RV起搏。急性并发症包括螺旋骨折1例,房室传导阻滞1例,室间隔穿孔1例。在中位随访9个月期间,无铅骨折报告;3例发生铅脱出。Kaplan-Meier分析显示LBBAP和RV起搏组发生首导联相关并发症的时间差异无统计学意义(风险比:4.69,95%CI: 0.63-34.90, p = 0.139)。电学性能保持稳定,98%的保留引线保持捕获阈值≤2v, 92%的检测幅度≥5mv。结论:使用INGEVITY + SDL的LBBAP在临床实践中是可行和安全的,种植成功率高,中期电学性能稳定。这些发现支持其作为一种可行的传导系统起搏策略。
{"title":"Implantation Success, Electrical Performance, and Safety of an Active Fixation Stylet-Driven Lead for LBBAP in Clinical Practice: A Multicenter Experience.","authors":"Amato Santoro, Matteo Ziacchi, Raimondo Calvanese, Antonio Rapacciuolo, Mario Volpicelli, Luca Poggio, Pasquale Nocerino, Davide Castagno, Valter Bianchi, Paolo Liberato Magliano, Gabriele Dell'Era, Cosimo Mandurino, Gianluca Mirizzi, Gianluca Savarese, Leonardo Marinaccio, Carmelo La Greca, Gregorio Covino, Gianluca Zingarini, Marco Varalda, Francesco Vitali, Claudia Baiocchi, Monica Campari, Sergio Valsecchi, Matteo Bertini","doi":"10.1111/jce.70237","DOIUrl":"https://doi.org/10.1111/jce.70237","url":null,"abstract":"<p><strong>Background: </strong>Left bundle branch area pacing (LBBAP) has emerged as a promising physiological pacing strategy. However, its feasibility and safety using conventional stylet-driven leads (SDL) such as INGEVITY+ remain under investigation.</p><p><strong>Objective: </strong>To evaluate the clinical performance, safety, and follow-up outcomes of LBBAP using the INGEVITY+ lead in a real-world electrophysiology setting.</p><p><strong>Methods: </strong>From 2021 to 2024, 207 consecutive patients underwent LBBAP implant attempts using the INGEVITY+ lead across 19 centers. Of these, 146 had bradycardia indications, and 61 had heart failure indications. A control group of 200 patients received standard right ventricular (RV) pacing with the same lead. Procedural outcomes, electrical parameters, complications, and mid-term lead performance were assessed.</p><p><strong>Results: </strong>LBBAP was successfully achieved in 201 (97%) cases. Procedural and fluoroscopy times were slightly longer for LBBAP than for RV pacing. Acute complications included one helix fracture, one atrioventricular block, and one septal perforation. During a median follow-up of 9 months, no lead fractures were reported; lead dislodgment occurred in three cases. Kaplan-Meier analysis showed no significant difference in time to first lead-related complication between the LBBAP and RV pacing groups (hazard ratio: 4.69, 95%CI: 0.63-34.90, p = 0.139). Electrical performance remained stable, with 98% of retained leads maintaining capture thresholds ≤ 2 V and 92% with sensed amplitudes ≥ 5 mV.</p><p><strong>Conclusions: </strong>LBBAP using the INGEVITY + SDL is feasible and safe in clinical practice, with excellent implant success and stable mid-term electrical performance. These findings support its use as a viable conduction system pacing strategy.</p>","PeriodicalId":15178,"journal":{"name":"Journal of Cardiovascular Electrophysiology","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145846673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Acute Efficacy of Pulsed-Field Ablation of the Mitral Isthmus Using a Pentaspline Catheter and Two Different Ablation Settings 使用Pentaspline导管和两种不同消融设置脉冲场消融二尖瓣峡部的急性疗效。
IF 2.6 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2025-12-27 DOI: 10.1111/jce.70236
Josef Hornof, Marek Hozman, Dalibor Heřman, Oleksii Romanenko, Sabri Hassouna, Jana Veselá, Věra Filipcová, Lukáš Povišer, Jakub Karch, Jana Hozmanová, Lucie Znojilová, Anna Molová, Vojtěch Pěnkava, Pavel Osmančík

Introduction

There is limited data regarding the use of pulsed-field ablation (PFA) for mitral isthmus (MI) ablation in patients with non-paroxysmal atrial fibrillation (AF). Our aim was to assess the acute efficacy of MI ablation using a pentaspline PFA catheter with two different ablation settings.

Methods

Patients with AF undergoing ablation were consecutively enrolled. All patients underwent pulmonary vein isolation and left atrial posterior wall ablation. MI ablation was performed in up to 4 series (9 PFA applications each) in Cohort A, or in up to 3 series (20 PFA applications each) in Cohort B. Each series was followed by a 20-min observation period to verify the durability of the MI block. The primary endpoints were a first-pass MI block and a final MI block after all ablation series.

Results

Between September 2024 and June 2025, 70 patients were enrolled: 30 in Cohort A and 40 in Cohort B. A first-pass MI block was achieved in 10 (33.3%) patients in Cohort A and 28 (70%) patients in Cohort B (p = 0.003). A final MI block was present in 27 (90%) and 35 (87.5%) patients in Cohort A and B, respectively (p = 1.00). The median reconduction time was 6 min (IQR 2.8–9.4) in Cohort A and 5 min (IQR 2.6–8.7) in Cohort B. No major complications occurred.

Conclusion

Using series of 20 PFA applications increased the success rate of a first-pass MI block to 70%. An observation period is recommended to verify the durability of MI block in PFA.

Clinical Trial Registration: NCT06803238.

关于脉冲场消融(PFA)在非阵发性心房颤动(AF)患者二尖瓣峡(MI)消融中的应用数据有限。我们的目的是评估使用两种不同消融设置的pentaspline PFA导管进行心肌梗死消融的急性疗效。方法:连续纳入房颤消融患者。所有患者均行肺静脉隔离和左心房后壁消融。在队列A中进行了多达4个系列(每个9个PFA应用)的心肌梗死消融,或在队列b中进行了多达3个系列(每个20个PFA应用)的心肌梗死消融,每个系列都有20分钟的观察时间,以验证心肌梗死阻滞的持久性。主要终点是所有消融系列后的首次心肌梗死阻断和最终心肌梗死阻断。结果:在2024年9月至2025年6月期间,纳入了70例患者:A队列30例,B队列40例。A队列10例(33.3%)患者和B队列28例(70%)患者实现了首次通过心肌梗死阻断(p = 0.003)。在队列A和B中,分别有27例(90%)和35例(87.5%)患者出现了最终的心肌梗死阻滞(p = 1.00)。A组中位再传导时间为6 min (IQR 2.8 ~ 9.4), b组中位再传导时间为5 min (IQR 2.6 ~ 8.7),无重大并发症发生。结论:使用20组PFA应用将首次通过MI阻滞的成功率提高到70%。建议采用观察期来验证PFA中MI块的耐久性。临床试验注册:NCT06803238。
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引用次数: 0
期刊
Journal of Cardiovascular Electrophysiology
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