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Longer and better lives for patients with atrial fibrillation: the 9th AFNET/EHRA consensus conference 让心房颤动患者活得更长、活得更好:第 9 届 AFNET/EHRA 共识会议
Pub Date : 2024-04-09 DOI: 10.1093/europace/euae070
Dominik Linz, Jason G Andrade, Elena Arbelo, Giuseppe Boriani, Guenter Breithardt, A John Camm, Valeria Caso, Jens Cosedis Nielsen, Mirko De Melis, Tom De Potter, Wolfgang Dichtl, Søren Zoega Diederichsen, Dobromir Dobrev, Nicolas Doll, David Duncker, Elke Dworatzek, Lars Eckardt, Christoph Eisert, Larissa Fabritz, Michal Farkowski, David Filgueiras-Rama, Andreas Goette, Eduard Guasch, Guido Hack, Stéphane Hatem, Karl Georg Haeusler, Jeff S Healey, Hein Heidbuechel, Ziad Hijazi, Lucas H Hofmeister, Leif Hove-Madsen, Thomas Huebner, Stefan Kääb, Dipak Kotecha, Katarzyna Malaczynska-Rajpold, José Luis Merino, Andreas Metzner, Lluís Mont, Ghulam Andre Ng, Michael Oeff, Abdul Shokor Parwani, Helmut Puererfellner, Ursula Ravens, Michiel Rienstra, Prashanthan Sanders, Daniel Scherr, Renate Schnabel, Ulrich Schotten, Christian Sohns, Gerhard Steinbeck, Daniel Steven, Tobias Toennis, Stylianos Tzeis, Isabelle C van Gelder, Roderick H van Leerdam, Kevin Vernooy, Manish Wadhwa, Reza Wakili, Stephan Willems, Henning Witt, Stef Zeemering, Paulus Kirchhof
Aims Recent trial data demonstrate beneficial effects of active rhythm management in patients with atrial fibrillation (AF) and support the concept that a low arrhythmia burden is associated with a low risk of AF-related complications. The aim of this document is to summarize the key outcomes of the 9th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Methods and results Eighty-three international experts met in Münster for 2 days in September 2023. Key findings are as follows: (i) Active rhythm management should be part of the default initial treatment for all suitable patients with AF. (ii) Patients with device-detected AF have a low burden of AF and a low risk of stroke. Anticoagulation prevents some strokes and also increases major but non-lethal bleeding. (iii) More research is needed to improve stroke risk prediction in patients with AF, especially in those with a low AF burden. Biomolecules, genetics, and imaging can support this. (iv) The presence of AF should trigger systematic workup and comprehensive treatment of concomitant cardiovascular conditions. (v) Machine learning algorithms have been used to improve detection or likely development of AF. Cooperation between clinicians and data scientists is needed to leverage the potential of data science applications for patients with AF. Conclusions Patients with AF and a low arrhythmia burden have a lower risk of stroke and other cardiovascular events than those with a high arrhythmia burden. Combining active rhythm control, anticoagulation, rate control, and therapy of concomitant cardiovascular conditions can improve the lives of patients with AF.
目的 最近的试验数据表明,积极的心律管理对心房颤动(房颤)患者有益,并支持心律失常负担低与房颤相关并发症风险低相关联的理念。本文件旨在总结心房颤动网络(AFNET)和欧洲心脏节律协会(ERA)第 9 次 AFNET/EHRA 共识会议的主要成果。方法和结果 803 位国际专家于 2023 年 9 月在明斯特举行了为期两天的会议。主要结论如下(i) 积极的心律管理应成为所有合适的房颤患者默认的初始治疗方法的一部分。(ii) 经设备检测的房颤患者房颤负担较轻,中风风险较低。抗凝可以预防一些中风,但也会增加大出血,但不致命。(iii) 需要开展更多研究,以改善心房颤动患者的中风风险预测,尤其是心房颤动负荷较低的患者。生物分子、遗传学和影像学可对此提供支持。(iv) 心房颤动的出现应引发系统的检查和对并发心血管疾病的综合治疗。(v) 机器学习算法已被用于改善心房颤动的检测或可能的发展。临床医生和数据科学家之间需要开展合作,以发挥数据科学在心房颤动患者中的应用潜力。结论 与心律失常负荷高的患者相比,心房颤动和心律失常负荷低的患者发生中风和其他心血管事件的风险较低。将积极的节律控制、抗凝、心率控制和合并心血管疾病的治疗结合起来,可以改善房颤患者的生活。
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引用次数: 0
Accurate diagnosis of apical hypertrophic cardiomyopathy using explainable advanced ECG analysis 利用可解释的高级心电图分析准确诊断心尖肥厚型心肌病
Pub Date : 2024-04-08 DOI: 10.1093/europace/euae093
Rebecca K Hughes, George D Thornton, James W Malcolmson, Iain Pierce, Shafik Khoury, Amanda Hornell, Kristopher Knott, Gabriella Captur, James C Moon, Todd T Schlegel, Martin Ugander
Background and aims Typical electrocardiogram (ECG) features of apical hypertrophic cardiomyopathy (ApHCM) include tall R waves and deep or giant T-wave inversion in the precordial leads, but these features are not always present. The ECG is used as the gatekeeper to cardiac imaging for diagnosis. We tested whether explainable advanced ECG (A-ECG) could accurately diagnose ApHCM. Methods A-ECG analysis was performed on standard resting 12-lead ECGs in patients with ApHCM (n = 75 overt, n = 32 relative [<15mm hypertrophy]), a subgroup of which underwent cardiovascular magnetic resonance, n = 92), and comparator subjects (n = 2449), including healthy volunteers (n = 1672), patients with coronary artery disease (n = 372), left ventricular electrical remodelling (n = 108), ischemic (n = 114) or non-ischemic cardiomyopathy (n = 57), and asymmetrical septal hypertrophy (ASH) HCM (n = 126). Results Multivariable logistic regression identified four A-ECG measures that together discriminated ApHCM from other diseases with high accuracy (area under the receiver operating characteristics curve (AUC) [bootstrapped 95% confidence interval] 0.982 [0.965–0.993]. Linear discriminant analysis also diagnosed ApHCM with high accuracy (AUC 0.989 [0.986–0.991]). Conclusion Explainable A-ECG has excellent diagnostic accuracy for ApHCM, even when the hypertrophy is relative, with A-ECG analysis providing incremental diagnostic value over imaging alone. The electrical (ECG) and anatomical (wall thickness) disease features do not completely align, suggesting future diagnostic and management strategies may incorporate both features.
背景和目的 心尖肥厚型心肌病(ApHCM)的典型心电图(ECG)特征包括心前区导联的高R波和深型或巨型T波倒置,但这些特征并不总是存在。心电图是心脏成像诊断的 "守门员"。我们测试了可解释的高级心电图(A-ECG)能否准确诊断 ApHCM。方法 对 ApHCM 患者(n = 75 例明显肥厚,n = 32 例相对肥厚 [&lt.15mm])的标准静息 12 导联心电图进行 A-ECG 分析;15mm肥厚])(其中一个亚组进行了心血管磁共振检查,n = 92),以及对比受试者(n = 2449),包括健康志愿者(n = 1672)、冠状动脉疾病患者(n = 372)、左室电重塑患者(n = 108)、缺血性(n = 114)或非缺血性心肌病患者(n = 57),以及不对称室间隔肥厚(ASH)HCM 患者(n = 126)。结果 多变量逻辑回归确定了四种 A-ECG 测量方法,这些方法可将 ApHCM 与其他疾病高度准确地区分开来(接收器操作特征曲线下面积 (AUC) [自引导 95% 置信区间] 0.982 [0.965-0.993])。线性判别分析诊断 ApHCM 的准确率也很高(AUC 0.989 [0.986-0.991])。结论 可解释的 A-ECG 对 ApHCM 具有极高的诊断准确性,即使肥厚是相对的,A-ECG 分析也比单纯的影像学诊断具有更高的诊断价值。疾病的电学特征(心电图)和解剖学特征(心肌壁厚度)并不完全一致,这表明未来的诊断和管理策略可能会结合这两个特征。
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引用次数: 0
Application of a circular-shaped pulsed field ablation catheter with magnetic sensors for pulmonary vein isolation: a multi-centre clinical study report 带磁性传感器的环形脉冲场消融导管在肺静脉隔离中的应用:多中心临床研究报告
Pub Date : 2024-04-08 DOI: 10.1093/europace/euae068
Yan Wang, Heng Li Lai, Qi Chen, Hao Liu, Qi Ming Liu, Wei Bin Huang, Yu Tao, Qingmei Xiong, Ning Zhou, Chunxia Zhao, Jie Qiu, Ziqin Xu, Dao Wen Wang
Aims A few studies have reported the effect and safety of pulsed field ablation (PFA) catheters for ablating atrial fibrillation (AF), which were mainly based on basket-shaped or flower-shaped designs. However, the clinical application of a circular-shaped multi-electrode catheter with magnetic sensors is very limited. To study the efficacy and safety of a PFA system in patients with paroxysmal AF using a circular-shaped multi-electrode catheter equipped with magnetic sensors for pulmonary vein isolation (PVI). Methods and results A novel proprietary bipolar PFA system was used for PVI, which utilized a circular-shaped multi-electrode catheter with magnetic sensors and allowed for three-dimensional model reconstruction, mapping, and ablation in one map. To evaluate the efficacy, efficiency, and safety of this PFA system, a prospective, multi-centre, single-armed, pre-market clinical study was performed. From July 2021 to December 2022, 151 patients with paroxysmal AF were included and underwent PVI. The study examined procedure time, immediate success rate, procedural success rate at 12 months, and relevant complications. In all 151 patients, all the pulmonary veins were acutely isolated using the studied system. Pulsed field ablation delivery was 78.4 ± 41.8 times and 31.3 ± 16.7 ms per patient. Skin-to-skin procedure time was 74.2 ± 29.8 min, and fluoroscopy time was 13.1 ± 7.6 min. The initial 11 (7.2%) cases underwent procedures with deep sedation anaesthesia, and the following cases underwent local anaesthesia. In the initial 11 cases, 4 cases (36.4%) presented transient vagal responses, and the rest were all successfully preventatively treated with atropine injection and rapid fluid infusion. No severe complications were found during or after the procedure. During follow-up, 3 cases experienced atrial flutter, and 11 cases had AF recurrence. The estimated 12-month Kaplan–Meier of freedom from arrhythmia was 88.4%. Conclusion The PFA system, comprised of a circular PFA catheter with magnetic sensors, could rapidly achieve PVI under three-dimensional guidance and demonstrated excellent safety with comparable effects.
目的 少数研究报告了脉冲场消融(PFA)导管消融心房颤动(AF)的效果和安全性,这些导管主要采用篮形或花形设计。然而,带有磁传感器的圆形多电极导管的临床应用却非常有限。目的 研究在阵发性房颤患者中使用配备磁性传感器的环形多电极导管进行肺静脉隔离(PVI)的 PFA 系统的有效性和安全性。方法和结果 采用一种新型专有双极 PFA 系统进行 PVI,该系统利用配备磁传感器的环形多电极导管,可在一张图上完成三维模型重建、绘图和消融。为评估该 PFA 系统的疗效、效率和安全性,进行了一项前瞻性、多中心、单臂、上市前临床研究。从 2021 年 7 月到 2022 年 12 月,151 名阵发性房颤患者接受了 PVI。研究考察了手术时间、即刻成功率、12 个月的手术成功率以及相关并发症。在所有 151 名患者中,使用所研究的系统对所有肺静脉进行了急性隔离。每位患者的脉冲场消融次数为 78.4 ± 41.8 次,消融时间为 31.3 ± 16.7 毫秒。皮肤接触手术时间为(74.2±29.8)分钟,透视时间为(13.1±7.6)分钟。最初的 11 个病例(7.2%)进行了深度镇静麻醉,随后的病例进行了局部麻醉。在最初的 11 个病例中,有 4 个病例(36.4%)出现了一过性迷走神经反应,其余病例均在注射阿托品和快速输液后得到了成功的预防性治疗。术中和术后均未发现严重并发症。随访期间,3 例出现心房扑动,11 例房颤复发。估计 12 个月内无心律失常的 Kaplan-Meier 比率为 88.4%。结论 PFA 系统由带有磁性传感器的环形 PFA 导管组成,可在三维引导下快速实现 PVI,并具有出色的安全性和可比效果。
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引用次数: 0
2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation 2024 欧洲心脏节律协会/心脏节律协会/亚太心脏节律协会/拉丁美洲心脏节律协会关于心房颤动导管和手术消融的专家共识声明
Pub Date : 2024-04-08 DOI: 10.1093/europace/euae043
Stylianos Tzeis, Edward P Gerstenfeld, Jonathan Kalman, Eduardo B Saad, Alireza Sepehri Shamloo, Jason G Andrade, Chirag R Barbhaiya, Tina Baykaner, Serge Boveda, Hugh Calkins, Ngai-Yin Chan, Minglong Chen, Shih-Ann Chen, Nikolaos Dagres, Ralph J Damiano, Tom De Potter, Isabel Deisenhofer, Nicolas Derval, Luigi Di Biase, Mattias Duytschaever, Katia Dyrda, Gerhard Hindricks, Meleze Hocini, Young-Hoon Kim, Mark la Meir, Jose Luis Merino, Gregory F Michaud, Andrea Natale, Isabelle Nault, Santiago Nava, Takashi Nitta, Mark O’Neill, Hui-Nam Pak, Jonathan P Piccini, Helmut Pürerfellner, Tobias Reichlin, Luis Carlos Saenz, Prashanthan Sanders, Richard Schilling, Boris Schmidt, Gregory E Supple, Kevin L Thomas, Claudio Tondo, Atul Verma, Elaine Y Wan, Daniel Steven, Michael-Joseph Agbayani, T Jared Bunch, Aman Chugh, Juan Carlos Díaz, James V Freeman, Carina Abigail Hardy, Hein Heidbuchel, Sofian Johar, Dominik Linz, Bart Maesen, Peter A Noseworthy, Seil Oh, Andreu Porta-Sanchez, Tatjana Potpara, Gerardo Rodriguez-Diez, Frederic Sacher, Piotr Suwalski, Serge A Trines
In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .
在过去的三十年里,心房颤动(房颤)消融术已成为治疗最常见心律失常的一种安全有效的循证疗法。2007 年,第一份联合专家共识文件发布,为参与心房颤动导管或手术消融的医护人员提供了指导。随着研究证据的不断增加和技术的不断进步,导管和手术房颤消融领域的发展日新月异,因此强调有必要定期更新这一合作伙伴关系的版本,并分别于 2012 年和 2017 年发布了这一版本。在上一份共识发布七年后的今天,我们认为有必要更新一份文件,为考虑进行或正在进行导管或手术房颤消融的患者的选择和管理定义一个现代框架。该共识是欧洲心脏节律协会、美国心脏节律协会、亚太心脏节律协会和拉丁美洲心脏节律协会等心脏电生理学协作协会的共同努力成果。
{"title":"2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation","authors":"Stylianos Tzeis, Edward P Gerstenfeld, Jonathan Kalman, Eduardo B Saad, Alireza Sepehri Shamloo, Jason G Andrade, Chirag R Barbhaiya, Tina Baykaner, Serge Boveda, Hugh Calkins, Ngai-Yin Chan, Minglong Chen, Shih-Ann Chen, Nikolaos Dagres, Ralph J Damiano, Tom De Potter, Isabel Deisenhofer, Nicolas Derval, Luigi Di Biase, Mattias Duytschaever, Katia Dyrda, Gerhard Hindricks, Meleze Hocini, Young-Hoon Kim, Mark la Meir, Jose Luis Merino, Gregory F Michaud, Andrea Natale, Isabelle Nault, Santiago Nava, Takashi Nitta, Mark O’Neill, Hui-Nam Pak, Jonathan P Piccini, Helmut Pürerfellner, Tobias Reichlin, Luis Carlos Saenz, Prashanthan Sanders, Richard Schilling, Boris Schmidt, Gregory E Supple, Kevin L Thomas, Claudio Tondo, Atul Verma, Elaine Y Wan, Daniel Steven, Michael-Joseph Agbayani, T Jared Bunch, Aman Chugh, Juan Carlos Díaz, James V Freeman, Carina Abigail Hardy, Hein Heidbuchel, Sofian Johar, Dominik Linz, Bart Maesen, Peter A Noseworthy, Seil Oh, Andreu Porta-Sanchez, Tatjana Potpara, Gerardo Rodriguez-Diez, Frederic Sacher, Piotr Suwalski, Serge A Trines","doi":"10.1093/europace/euae043","DOIUrl":"https://doi.org/10.1093/europace/euae043","url":null,"abstract":"In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140566145","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of Three-dimensional Electroanatomic Mapping for Epicardial Access: Needle Tracking, Elctrographic Characteristics and Clinical Application 使用三维电解剖图进行心外膜入路:针跟踪、电子扫描特征和临床应用
Pub Date : 2024-04-08 DOI: 10.1093/europace/euae089
Ronghui Yu, Nian Liu, Binquan You, Haixiong Wang, Yanfei Ruan, Songnan Wen, Peter J Weiss, Michael Zawaneh, Wilber Su, Roderick Tung, Xin Zhao, Wei Wang, Ribo Tang, Rong Bai
Background and Aims Pericardiocentesis is usually completed under fluoroscopy. The electroanatomic mapping (EAM) system allows visualizing puncture needle tip (NT) while displaying the electrogram recorded from NT, making it possible to obtain epicardial access (EA) independent of fluoroscopy. This study was designed to establish and validate a technique by which EA is obtained under guidance of 3-dimensional (3D) EAM combined with NT electrogram. Methods 3D shell of the heart was generated and the NT was made trackable in the EAM system. Unipolar NT electrogram was continuously monitored. Penetration into pericardial sac was determined by an increase in NT potential amplitude and an injury current. A long guidewire of which the tip was also visible in the EAM system was advanced to confirm EA. Results EA was successfully obtained without complication in 13 pigs and 22 patients. In the animals, NT potential amplitude was 3.2± 1.0 mV when it was located in mediastinum, 5.2±1.6 mV when in contact with fibrous pericardium and 9.8±2.8 mV after penetrating into pericardial sac (all p≤0.001). In human subjects, it measured 1.54±0.40 mV, 3.61±1.08 mV and 7.15±2.88 mV respectively (all p<0.001). Fluoroscopy time decreased in every 4-5 cases (64±15, 23±17 and 0 second for animals 1-4, 5-8, 9-13 respectively, p=0.01; 44±23, 31±18; 4±7 seconds for patients 1-7, 8-14, 15-22 respectively, p<0.001). In 5 pigs and 7 patients, EA was obtained without X-ray exposure. Conclusions By tracking NT in the 3D EAM system and continuously monitoring the NT electrogram, it is feasible and safe to obtain EA with minimum or no fluoroscopic guidance.
背景和目的 心包穿刺术通常在透视下完成。电解剖图(EAM)系统可在显示穿刺针针尖(NT)的同时显示从 NT 记录的电图,从而可以在不进行透视的情况下获得心外膜通路(EA)。本研究旨在建立和验证一种技术,在三维(3D)EAM 结合 NT 电图的引导下获得 EA。方法 生成心脏的三维外壳,并在 EAM 系统中跟踪 NT。持续监测单极 NT 电图。通过 NT 电位振幅的增加和损伤电流来确定是否穿透心包囊。推进一根长导丝(其尖端在 EAM 系统中也可见)以确认 EA。结果 在 13 头猪和 22 位患者身上成功进行了 EA,未出现并发症。在动物身上,NT 电位振幅位于纵隔时为 3.2±1.0 mV,接触纤维心包时为 5.2±1.6 mV,穿透心包囊后为 9.8±2.8 mV(均 p≤0.001)。人体受试者的测量值分别为 1.54±0.40 mV、3.61±1.08 mV 和 7.15±2.88 mV(均 p<0.001)。透视时间在每 4-5 个病例中均有所缩短(动物 1-4、5-8、9-13 分别为 64±15、23±17 和 0 秒,p=0.01;患者 1-7、8-14、15-22 分别为 44±23、31±18 和 4±7 秒,p<0.001)。5 头猪和 7 名患者的 EA 无需 X 光照射即可获得。结论 通过在三维 EAM 系统中跟踪 NT 并持续监测 NT 电图,在最低限度或无需透视引导的情况下获得 EA 是可行且安全的。
{"title":"Use of Three-dimensional Electroanatomic Mapping for Epicardial Access: Needle Tracking, Elctrographic Characteristics and Clinical Application","authors":"Ronghui Yu, Nian Liu, Binquan You, Haixiong Wang, Yanfei Ruan, Songnan Wen, Peter J Weiss, Michael Zawaneh, Wilber Su, Roderick Tung, Xin Zhao, Wei Wang, Ribo Tang, Rong Bai","doi":"10.1093/europace/euae089","DOIUrl":"https://doi.org/10.1093/europace/euae089","url":null,"abstract":"Background and Aims Pericardiocentesis is usually completed under fluoroscopy. The electroanatomic mapping (EAM) system allows visualizing puncture needle tip (NT) while displaying the electrogram recorded from NT, making it possible to obtain epicardial access (EA) independent of fluoroscopy. This study was designed to establish and validate a technique by which EA is obtained under guidance of 3-dimensional (3D) EAM combined with NT electrogram. Methods 3D shell of the heart was generated and the NT was made trackable in the EAM system. Unipolar NT electrogram was continuously monitored. Penetration into pericardial sac was determined by an increase in NT potential amplitude and an injury current. A long guidewire of which the tip was also visible in the EAM system was advanced to confirm EA. Results EA was successfully obtained without complication in 13 pigs and 22 patients. In the animals, NT potential amplitude was 3.2± 1.0 mV when it was located in mediastinum, 5.2±1.6 mV when in contact with fibrous pericardium and 9.8±2.8 mV after penetrating into pericardial sac (all p≤0.001). In human subjects, it measured 1.54±0.40 mV, 3.61±1.08 mV and 7.15±2.88 mV respectively (all p<0.001). Fluoroscopy time decreased in every 4-5 cases (64±15, 23±17 and 0 second for animals 1-4, 5-8, 9-13 respectively, p=0.01; 44±23, 31±18; 4±7 seconds for patients 1-7, 8-14, 15-22 respectively, p<0.001). In 5 pigs and 7 patients, EA was obtained without X-ray exposure. Conclusions By tracking NT in the 3D EAM system and continuously monitoring the NT electrogram, it is feasible and safe to obtain EA with minimum or no fluoroscopic guidance.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"86 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140566278","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Impact of atrial fibrillation phenotype and left atrial volume on outcome after pulmonary vein isolation 心房颤动表型和左心房容积对肺静脉隔离术后疗效的影响
Pub Date : 2024-04-08 DOI: 10.1093/europace/euae071
Laurève Chollet, Salik ur Rehman Iqbal, Severin Wittmer, Gregor Thalmann, Antonio Madaffari, Nikola Kozhuharov, Oskar Galuszka, Thomas Küffer, Christoph Gräni, Nicolas Brugger, Helge Servatius, Fabian Noti, Andreas Haeberlin, Laurent Roten, Hildegard Tanner, Tobias Reichlin
Aims Pulmonary vein isolation (PVI) is increasingly performed in patients with atrial fibrillation (AF). Both AF phenotype and left atrial (LA) volume have been shown to influence ablation outcome. The inter-relationship of the two is incompletely understood. We aimed to investigate the impact of AF phenotype vs. LA volume on outcome after PVI. Methods and results In a retrospective analysis of a prospective registry of patients undergoing a first PVI, the association of AF phenotype and LA volume index (LAVI) was assessed as well as their impact on AF recurrence during follow-up. Overall, 476 patients were enrolled (median age 63 years, 29% females, 65.8% paroxysmal AF). Obesity, hypertension, chronic kidney disease, and heart failure were all significantly more frequent in persistent AF. After 1 year, single-procedure, freedom from arrhythmia recurrence was 61.5%. Patients with paroxysmal AF had better outcomes compared with patients with persistent AF (65.6 vs. 52.7%, P = 0.003), as had patients with no/mild vs. moderate/severe LA dilation (LAVI <42 mL/m2 67.1% vs. LAVI ≥42 mL/m2 53%, P < 0.001). The combination of both parameters refined prediction of 1-year recurrence (P < 0.001). After adjustment for additional clinical risk factors in multivariable Cox proportional hazard analysis, both AF phenotype and LAVI ≥42 mL/m2 contributed significantly towards the prediction of 1-year recurrence. Conclusion Atrial fibrillation phenotype and LA volume are independent predictors of outcome after PVI. Persistent AF with no/mild LA dilation has a similar risk of recurrence as paroxysmal AF with a moderate/severe LA dilation and should be given similar priority for ablation.
目的 越来越多的心房颤动(AF)患者接受肺静脉隔离术(PVI)。房颤表型和左心房(LA)容积都被证明会影响消融结果。但两者之间的相互关系尚不完全清楚。我们旨在研究房颤表型与 LA 容积对 PVI 术后结果的影响。方法和结果 在对首次接受 PVI 患者的前瞻性登记进行的回顾性分析中,我们评估了房颤表型和 LA 容积指数(LAVI)之间的关系,以及它们对随访期间房颤复发的影响。共有 476 名患者(中位年龄 63 岁,29% 为女性,65.8% 为阵发性房颤)接受了该研究。肥胖、高血压、慢性肾病和心力衰竭在持续性房颤中的发病率都明显较高。一年后,单次手术后心律失常复发率为 61.5%。阵发性房颤患者的预后优于持续性房颤患者(65.6% 对 52.7%,P = 0.003),无/轻度 LA 扩张患者的预后优于中度/重度 LA 扩张患者(LAVI <42 mL/m2 67.1% 对 LAVI ≥42 mL/m2 53%,P < 0.001)。这两个参数的组合改进了对1年复发的预测(P &p;lt;0.001)。在多变量考克斯比例危险分析中对其他临床危险因素进行调整后,房颤表型和 LAVI ≥42 mL/m2 对预测 1 年复发有显著作用。结论 心房颤动表型和 LA 容积是预测 PVI 术后结果的独立因素。无/轻度 LA 扩张的持续性房颤与中度/重度 LA 扩张的阵发性房颤具有相似的复发风险,因此应给予相似的消融优先权。
{"title":"Impact of atrial fibrillation phenotype and left atrial volume on outcome after pulmonary vein isolation","authors":"Laurève Chollet, Salik ur Rehman Iqbal, Severin Wittmer, Gregor Thalmann, Antonio Madaffari, Nikola Kozhuharov, Oskar Galuszka, Thomas Küffer, Christoph Gräni, Nicolas Brugger, Helge Servatius, Fabian Noti, Andreas Haeberlin, Laurent Roten, Hildegard Tanner, Tobias Reichlin","doi":"10.1093/europace/euae071","DOIUrl":"https://doi.org/10.1093/europace/euae071","url":null,"abstract":"Aims Pulmonary vein isolation (PVI) is increasingly performed in patients with atrial fibrillation (AF). Both AF phenotype and left atrial (LA) volume have been shown to influence ablation outcome. The inter-relationship of the two is incompletely understood. We aimed to investigate the impact of AF phenotype vs. LA volume on outcome after PVI. Methods and results In a retrospective analysis of a prospective registry of patients undergoing a first PVI, the association of AF phenotype and LA volume index (LAVI) was assessed as well as their impact on AF recurrence during follow-up. Overall, 476 patients were enrolled (median age 63 years, 29% females, 65.8% paroxysmal AF). Obesity, hypertension, chronic kidney disease, and heart failure were all significantly more frequent in persistent AF. After 1 year, single-procedure, freedom from arrhythmia recurrence was 61.5%. Patients with paroxysmal AF had better outcomes compared with patients with persistent AF (65.6 vs. 52.7%, P = 0.003), as had patients with no/mild vs. moderate/severe LA dilation (LAVI <42 mL/m2 67.1% vs. LAVI ≥42 mL/m2 53%, P < 0.001). The combination of both parameters refined prediction of 1-year recurrence (P < 0.001). After adjustment for additional clinical risk factors in multivariable Cox proportional hazard analysis, both AF phenotype and LAVI ≥42 mL/m2 contributed significantly towards the prediction of 1-year recurrence. Conclusion Atrial fibrillation phenotype and LA volume are independent predictors of outcome after PVI. Persistent AF with no/mild LA dilation has a similar risk of recurrence as paroxysmal AF with a moderate/severe LA dilation and should be given similar priority for ablation.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140566280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
First-in-Human Clinical Series of a Novel Conformable Large-Lattice Pulsed Field Ablation Catheter for Pulmonary Vein Isolation 用于肺静脉隔离的新型可变形大晶格脉冲场消融导管的首次人体临床系列研究
Pub Date : 2024-04-08 DOI: 10.1093/europace/euae090
Vivek Y Reddy, Elad Anter, Petr Peichl, Gediminas Rackauskas, Jan Petru, Moritoshi Funasako, Jacob S Koruth, Germanas Marinskis, Mohit Turagam, Audrius Aidietis, Josef Kautzner, Andrea Natale, Petr Neuzil
Background/Aims Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8-Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. Methods After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 secs per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2 and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. Results At three centers, PVI was performed by five operators in 85 patients using PULSE1 (n=30), PULSE2 (n=20), and PULSE3 (n=35). Acute PVI was achieved in 100% of PVs using 3.9±1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5±21.6, 10.0 ± 6.0, 19.1±9.3 and 5.7±3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. Conclusion PVI utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.
背景/目的 脉冲场消融术(PFA)与传统的心房颤动(AF)热消融术相比具有显著优势。这项首次用于治疗阵发性房颤(PAF)的单臂人体试验评估了 8 尺、大晶格、适形单射 PFA 导管和专用电解剖图系统的效率、安全性、肺静脉隔离(PVI)耐久性和一年的临床疗效。方法 在绘制出肺静脉解剖图后,PFA 导管提供单极双相脉冲串(每次 5-6 秒;每个肺静脉 4 次)。测试了三种波形:PULSE1、PULSE2 和 PULSE3。随访包括心电图、6 个月和 12 个月的 Holters 以及无症状和预定的经皮声波监测。主要和次要疗效终点分别是急性 PVI 和封堵后房性心律失常复发。在消融术后 75 天内进行有创重塑。结果 在三个中心,五名操作者使用 PULSE1(30 例)、PULSE2(20 例)和 PULSE3(35 例)对 85 例患者进行了 PVI。每个 PV 使用 3.9±1.4 次 PFA,100% 的 PV 实现了急性 PVI。整个手术过程、转运消融、PFA 导管停留和透视时间分别为 56.5±21.6、10.0±6.0、19.1±9.3 和 5.7±3.9 分钟。未发生预定义的主要安全事件。重新映射后,总静脉和 PULSE3 队列中每条静脉的 PVI 持久性分别为 90% 和 99%。一年内无房性心律失常的 Kaplan-Meier 估计值为 81.8%(95% CI 70.2-89.2%),PULSE3 组为 100%(95% CI 80.6-100%)。结论 利用可适形单发 PFA 导管进行 PVI 治疗 PAF 是高效、安全和有效的,在重新映射后可显示出持久的病变。
{"title":"First-in-Human Clinical Series of a Novel Conformable Large-Lattice Pulsed Field Ablation Catheter for Pulmonary Vein Isolation","authors":"Vivek Y Reddy, Elad Anter, Petr Peichl, Gediminas Rackauskas, Jan Petru, Moritoshi Funasako, Jacob S Koruth, Germanas Marinskis, Mohit Turagam, Audrius Aidietis, Josef Kautzner, Andrea Natale, Petr Neuzil","doi":"10.1093/europace/euae090","DOIUrl":"https://doi.org/10.1093/europace/euae090","url":null,"abstract":"Background/Aims Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8-Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. Methods After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 secs per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2 and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. Results At three centers, PVI was performed by five operators in 85 patients using PULSE1 (n=30), PULSE2 (n=20), and PULSE3 (n=35). Acute PVI was achieved in 100% of PVs using 3.9±1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5±21.6, 10.0 ± 6.0, 19.1±9.3 and 5.7±3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. Conclusion PVI utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140566268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Same-day discharge after atrial fibrillation ablation under a nurse-coordinated standardized protocol 在护士协调的标准化方案下,心房颤动消融术后当天出院
Pub Date : 2024-04-04 DOI: 10.1093/europace/euae083
Teresa Espinosa, Anna Farrus, Montserrat Venturas, Alba Cano, Sara Vazquez-Calvo, Margarida Pujol-Lopez, Frida Eulogio-Valenzuela, Jean-Baptiste Guichard, Pasquale V Falzone, Freddy R Graterol, Xavier Freixa, Jose M Tolosana, Eduard Guasch, Andreu Porta-Sanchez, Elena Arbelo, Josep Brugada, Marta Sitges, Lluis Mont, lvo Roca-Luque, Till F Althoff
Background and aims Same-day discharge (SDD) after atrial fibrillation (AF) ablation is an effective means to spare healthcare resources. However, safety remains a concern, and besides structural adaptations, SDD requires more efficient logistics and coordination. Therefore, we implemented a streamlined, nurse-coordinated SDD program following a standardized protocol. Methods As dedicated SDD coordinator a nurse specialized in ambulatory cardiac interventions was in charge of the full SDD protocol, including eligibility, patient-flow, in-hospital logistics, patient education and discharge as well as early post-discharge follow-up by smartphone-based virtual visits. Patients planned for AF ablation were eligible if LVEF ≥35%, basic support at home and accessibility of the hospital within 60min were warranted. Results 420 consecutive patients were screened by the SDD coordinator of whom 331 were eligible for SDD. Reasons for exclusion were living remotely (29, 6.9%), lack of support at home (19, 4.5%) or LVEF <35% (17, 4.0%). Of the eligible patients 300 (91%) were successfully discharged the same day. There was no major post-SDD complication. Rates of unplanned medical attention (19, 6.3%) and 30d-readmission (5, 1.6%) were extremely low and driven by femoral access site complications. Those were significantly reduced upon introduction of compulsory ultrasound-guided puncture after the initial 150 SDD patients (p=0.0145). Standardized SDD-coordination resulted in efficient workflows and reduced the total workload of the medical staff. Conclusions SDD after AF ablation following a nurse-coordinated standardized protocol is safe and efficient. The concept of ambulatory cardiac intervention nurses functioning as dedicated coordinators may be key in the forthcoming transition of hospitals to SDD. Ultrasound-guided femoral puncture virtually eliminated relevant femoral access site complications and should be a prerequisite for SDD.
背景和目的 心房颤动(房颤)消融术后当天出院(SDD)是节省医疗资源的有效手段。然而,安全性仍然是一个令人担忧的问题,除了结构上的调整外,SDD 还需要更高效的后勤和协调。因此,我们按照标准化方案实施了一项简化的、由护士协调的 SDD 计划。方法 由一名专门从事非住院心脏介入治疗的护士担任 SDD 专职协调员,负责整个 SDD 方案,包括资格审查、患者流程、院内后勤、患者教育、出院以及出院后通过智能手机虚拟访问进行早期随访。计划进行房颤消融术的患者,如果 LVEF ≥35%、在家中有基本支持且能在 60 分钟内到达医院,则符合条件。结果 SDD 协调员筛选了 420 名连续患者,其中 331 人符合 SDD 条件。排除的原因包括居住地偏远(29 人,占 6.9%)、家中缺乏支持(19 人,占 4.5%)或 LVEF <35% (17 人,占 4.0%)。符合条件的患者中有 300 人(91%)在当天顺利出院。手术后未出现重大并发症。计划外就医率(19 例,6.3%)和 30d 再次入院率(5 例,1.6%)极低,均由股骨通道部位并发症引起。在最初的 150 名 SDD 患者之后,引入强制超声引导穿刺后,这些并发症明显减少(p=0.0145)。标准化的 SDD 协调带来了高效的工作流程,减少了医务人员的总工作量。结论 心房颤动消融术后按照护士协调的标准化方案进行 SDD 既安全又高效。非住院心脏介入护士作为专职协调员的概念可能是医院即将向 SDD 过渡的关键。超声引导下的股骨穿刺几乎消除了股骨入路部位的相关并发症,应成为 SDD 的先决条件。
{"title":"Same-day discharge after atrial fibrillation ablation under a nurse-coordinated standardized protocol","authors":"Teresa Espinosa, Anna Farrus, Montserrat Venturas, Alba Cano, Sara Vazquez-Calvo, Margarida Pujol-Lopez, Frida Eulogio-Valenzuela, Jean-Baptiste Guichard, Pasquale V Falzone, Freddy R Graterol, Xavier Freixa, Jose M Tolosana, Eduard Guasch, Andreu Porta-Sanchez, Elena Arbelo, Josep Brugada, Marta Sitges, Lluis Mont, lvo Roca-Luque, Till F Althoff","doi":"10.1093/europace/euae083","DOIUrl":"https://doi.org/10.1093/europace/euae083","url":null,"abstract":"Background and aims Same-day discharge (SDD) after atrial fibrillation (AF) ablation is an effective means to spare healthcare resources. However, safety remains a concern, and besides structural adaptations, SDD requires more efficient logistics and coordination. Therefore, we implemented a streamlined, nurse-coordinated SDD program following a standardized protocol. Methods As dedicated SDD coordinator a nurse specialized in ambulatory cardiac interventions was in charge of the full SDD protocol, including eligibility, patient-flow, in-hospital logistics, patient education and discharge as well as early post-discharge follow-up by smartphone-based virtual visits. Patients planned for AF ablation were eligible if LVEF ≥35%, basic support at home and accessibility of the hospital within 60min were warranted. Results 420 consecutive patients were screened by the SDD coordinator of whom 331 were eligible for SDD. Reasons for exclusion were living remotely (29, 6.9%), lack of support at home (19, 4.5%) or LVEF <35% (17, 4.0%). Of the eligible patients 300 (91%) were successfully discharged the same day. There was no major post-SDD complication. Rates of unplanned medical attention (19, 6.3%) and 30d-readmission (5, 1.6%) were extremely low and driven by femoral access site complications. Those were significantly reduced upon introduction of compulsory ultrasound-guided puncture after the initial 150 SDD patients (p=0.0145). Standardized SDD-coordination resulted in efficient workflows and reduced the total workload of the medical staff. Conclusions SDD after AF ablation following a nurse-coordinated standardized protocol is safe and efficient. The concept of ambulatory cardiac intervention nurses functioning as dedicated coordinators may be key in the forthcoming transition of hospitals to SDD. Ultrasound-guided femoral puncture virtually eliminated relevant femoral access site complications and should be a prerequisite for SDD.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"49 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140566322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Area-weighted unipolar voltage to predict heart failure outcomes in patients with ischaemic cardiomyopathy and ventricular tachycardia 预测缺血性心肌病和室性心动过速患者心衰预后的区域加权单极电压
Pub Date : 2024-02-03 DOI: 10.1093/europace/euad346
Robert Rademaker, Yoshi Kimura, Marta de Riva Silva, Hans C Beukers, Sebastiaan R D Piers, Adrianus P Wijnmaalen, Olaf M Dekkers, Katja Zeppenfeld
Aims Patients with ischaemic cardiomyopathy (ICM) referred for catheter ablation of ventricular tachycardia (VT) are at risk for end-stage heart failure (HF) due to adverse remodelling. Local unipolar voltages (UV) decrease with loss of viable myocardium. A UV parameter reflecting global viable myocardium may predict prognosis. We evaluate if a newly proposed parameter, area-weighted unipolar voltage (awUV), can predict HF-related outcomes [HFO; HF death/left ventricular (LV) assist device/heart transplant] in ICM. Methods and results From endocardial voltage maps of consecutive patients with ICM referred for VT ablation, awUV was calculated by weighted interpolation of local UV. Associations between clinical and mapping parameters and HFO were evaluated and validated in a second cohort. The derivation cohort consisted of 90 patients [age 68 ±8 years; LV ejection fraction (LVEF) 35% interquartile range (IQR) (24–40)] and validation cohort of 60 patients [age 67 ± 9, LVEF 39% IQR (29–45)]. In the derivation cohort, during a median follow-up of 45 months [IQR (34–83)], 36 (43%) patients died and 23 (26%) had HFO. Patients with HFO had lower awUV [4.51 IQR (3.69–5.31) vs. 7.03 IQR (6.08–9.2), P < 0.001]. A reduction in awUV [optimal awUV (5.58) cut-off determined by receiver operating characteristics analysis] was a strong predictor of HFO (3-year HFO survival 97% vs. 57%). The cut-off value was confirmed in the validation cohort (2-year HFO-free survival 96% vs. 60%). Conclusion The newly proposed parameter awUV, easily available from routine voltage mapping, may be useful at identifying ICM patients at high risk for HFO.
目的 被转诊进行室性心动过速(VT)导管消融术的缺血性心肌病(ICM)患者由于重塑不良而面临终末期心力衰竭(HF)的风险。局部单极电压(UV)会随着存活心肌的丧失而降低。反映整体存活心肌的 UV 参数可预测预后。我们评估了一个新提出的参数--区域加权单极电压(awUV)能否预测 ICM 中与高频相关的预后[HFO;高频死亡/左心室(LV)辅助装置/心脏移植]。方法和结果 根据转诊进行 VT 消融的连续 ICM 患者的心内膜电压图,通过对局部 UV 进行加权插值计算 awUV。在第二个队列中评估并验证了临床参数和映射参数与 HFO 之间的关联。衍生队列由 90 名患者组成[年龄 68 ± 8 岁;左心室射血分数(LVEF)35%,四分位数间距(IQR)(24-40)],验证队列由 60 名患者组成[年龄 67 ± 9 岁,左心室射血分数(LVEF)39%,四分位数间距(IQR)(29-45)]。在中位随访 45 个月[IQR(34-83)]的衍生队列中,36 例(43%)患者死亡,23 例(26%)患者出现 HFO。HFO 患者的 awUV 较低 [4.51 IQR (3.69-5.31) vs. 7.03 IQR (6.08-9.2),P < 0.001]。awUV的降低[通过接收器操作特性分析确定的最佳awUV(5.58)截断值]是预测HFO的有力指标(3年HFO存活率为97% vs. 57%)。该临界值在验证队列中得到了证实(2 年无 HFO 生存率为 96% 对 60%)。结论 新提出的参数 awUV 很容易从常规电压图谱中获得,可用于识别 HFO 高风险 ICM 患者。
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引用次数: 0
‘Single-shot’ pulmonary vein isolation using a novel lotos pulsed field ablation catheter: a preclinical evaluation of the feasibility, safety and 30-day efficacy 使用新型 Lotos 脉冲场消融导管进行 "单次 "肺静脉隔离:对可行性、安全性和 30 天疗效的临床前评估
Pub Date : 2023-12-16 DOI: 10.1093/europace/euad362
Sijia Pu, Fangzhou Liu, Yuhan Chen, Cihua Luo, Peng Li, Yanlin Chen, Lu Fu, Huiyi Liu, Xingdong Ye, Shulin Wu, Yumei Xue, Weidong Lin
Aims Pulsed field ablation (PFA) is emerging as a nonthermal, tissue-specific technique for pulmonary vein isolation (PVI) in atrial fibrillation therapy. This preclinical study aimed to investigate the feasibility and safety of PVI using a novel PFA system including a nanosecond-scale PFA generator, a novel lotos PFA catheter, and a customized 12-French steerable sheath. Methods and Results A total of 11 Yorkshire swine were included in this study, with 4 in the acute cohort and 7 in the chronic cohort. Under general anesthesia, transseptal puncture and pulmonary vein (PV) angiography was initially performed. The PFA catheter was navigated to position at the right and left PV antrum after the electroanatomic reconstruction of left atrium. Biphasic PFA applications were performed on PVs in both the spindle-shaped and lotos-shaped poses. PVI and PFA-associated safety was assessed 30 minutes after ablation in both cohorts and 30 days later in the chronic cohort. Detailed necropsy and histopathology were performed. Additional intracardiac echocardiography and coronary angiogram were evaluated for safety. All target pulmonary veins (n = 20) were successfully isolated on the first attempt. No spasm of coronary artery or microbubble was seen during the procedure. Eleven of 12 PVs (91.6%) remained isolation at 30-day invasive study. No evidence of PV stenosis was observed in any targets. However, transient diaphragm capture occurred in 17.6%. Histopathological examinations showed no evidence of collateral injury. Conclusion This study provides scientific evidence demonstrating the safety and efficacy of the novel PFA catheter and system for single-shot PVI, which shows great potential.
目的 脉冲场消融(PFA)正在成为心房颤动治疗中肺静脉隔离(PVI)的一种非热组织特异性技术。这项临床前研究旨在调查使用新型 PFA 系统(包括纳秒级 PFA 发生器、新型 Lotos PFA 导管和定制的 12 法分可转向鞘)进行 PVI 的可行性和安全性。方法和结果 本研究共纳入 11 头约克夏猪,其中 4 头为急性组,7 头为慢性组。在全身麻醉的情况下,首先进行经皮穿刺和肺静脉血管造影。在对左心房进行电解剖重建后,将 PFA 导管导航至左右肺静脉窦的位置。在纺锤形和洛托斯形的 PV 上进行了双相 PFA 应用。在两组患者中,消融后 30 分钟对 PVI 和 PFA 相关安全性进行评估,在慢性组患者中,消融后 30 天对 PVI 和 PFA 相关安全性进行评估。进行了详细的尸体解剖和组织病理学检查。另外还对心内超声心动图和冠状动脉造影进行了安全性评估。所有目标肺静脉(n = 20)均在首次尝试时成功分离。手术过程中未发现冠状动脉痉挛或微泡。在为期 30 天的侵入性研究中,12 条肺静脉中有 11 条(91.6%)仍保持分离状态。未在任何目标中观察到 PV 狭窄的证据。然而,17.6%的目标发生了短暂的膈肌捕获。组织病理学检查未发现侧支损伤的证据。结论 这项研究提供了科学证据,证明新型 PFA 导管和系统用于单次 PVI 的安全性和有效性,显示出巨大的潜力。
{"title":"‘Single-shot’ pulmonary vein isolation using a novel lotos pulsed field ablation catheter: a preclinical evaluation of the feasibility, safety and 30-day efficacy","authors":"Sijia Pu, Fangzhou Liu, Yuhan Chen, Cihua Luo, Peng Li, Yanlin Chen, Lu Fu, Huiyi Liu, Xingdong Ye, Shulin Wu, Yumei Xue, Weidong Lin","doi":"10.1093/europace/euad362","DOIUrl":"https://doi.org/10.1093/europace/euad362","url":null,"abstract":"Aims Pulsed field ablation (PFA) is emerging as a nonthermal, tissue-specific technique for pulmonary vein isolation (PVI) in atrial fibrillation therapy. This preclinical study aimed to investigate the feasibility and safety of PVI using a novel PFA system including a nanosecond-scale PFA generator, a novel lotos PFA catheter, and a customized 12-French steerable sheath. Methods and Results A total of 11 Yorkshire swine were included in this study, with 4 in the acute cohort and 7 in the chronic cohort. Under general anesthesia, transseptal puncture and pulmonary vein (PV) angiography was initially performed. The PFA catheter was navigated to position at the right and left PV antrum after the electroanatomic reconstruction of left atrium. Biphasic PFA applications were performed on PVs in both the spindle-shaped and lotos-shaped poses. PVI and PFA-associated safety was assessed 30 minutes after ablation in both cohorts and 30 days later in the chronic cohort. Detailed necropsy and histopathology were performed. Additional intracardiac echocardiography and coronary angiogram were evaluated for safety. All target pulmonary veins (n = 20) were successfully isolated on the first attempt. No spasm of coronary artery or microbubble was seen during the procedure. Eleven of 12 PVs (91.6%) remained isolation at 30-day invasive study. No evidence of PV stenosis was observed in any targets. However, transient diaphragm capture occurred in 17.6%. Histopathological examinations showed no evidence of collateral injury. Conclusion This study provides scientific evidence demonstrating the safety and efficacy of the novel PFA catheter and system for single-shot PVI, which shows great potential.","PeriodicalId":11720,"journal":{"name":"EP Europace","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138741681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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