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使用新型环形阵列脉冲场消融导管进行肺静脉隔离和非肺静脉部位消融的初步真实世界经验。

Initial Real-World Experiences of Pulmonary Vein Isolation and Ablation of Non-Pulmonary Vein Sites Using a Novel Circular Array Pulsed Field Ablation Catheter.

作者信息

Yogarajah Joerg, Hutter Julie, Kahle Patrick, Beaujean Philipp, Tomic Marko, Hain Andreas, Sossalla Samuel, Kuniss Malte, Neumann Thomas

机构信息

Department of Cardiology, Kerckhoff Heart and Thorax Center, Campus Kerckhoff, Justus Liebig University Giessen, 61231 Bad Nauheim, Germany.

Department of Cardiology, Medical Clinic I, Justus Liebig University Giessen, 35392 Giessen, Germany.

出版信息

J Clin Med. 2024 Nov 19;13(22):6961. doi: 10.3390/jcm13226961.

Abstract

Various pulsed field ablation (PFA) systems are currently being developed. Recently, a novel CE-approved circular array PFA catheter (PulseSelect™ PFA System, Medtronic, Minneapolis, MN, USA) was introduced. Data on this commercially available system are sparse. The aim was to elucidate real-world data assessing the feasibility, safety, and acute efficacy of pulmonary vein isolation (PVI) and ablation beyond PVI with this novel ablation system. Consecutive patients with paroxysmal and persistent atrial fibrillation (AF) undergoing first-time ablation with the circular PFA catheter were enrolled in this study. In patients with persistent AF and left atrial (LA) enlargement (LA area > 20 cm), additional left atrial roof ablation (LARA) was performed. Those with concomitant typical atrial flutter received adjunctive cavo-tricuspid isthmus (CTI) ablation. A total of 100 AF patients were included (29% female, 50% persistent AF). Of these, 33 patients (33%) underwent adjunctive LARA, 1 patient (1%) received posterior wall isolation, and 6 patients (6%) required additional CTI ablation. The skin-to-skin procedural time averaged 66.3 ± 13.8 min, while the fluoroscopy time and dose area product were 13.7 ± 4.7 min and 6.8 ± 4.9 Gycm, respectively. Acute PVI was achieved in 100% of pulmonary veins. A bidirectional conduction block of the LARA and CTI lines was confirmed in all patients, and no major adverse events were reported. These real-world data demonstrate the feasibility, safety, and acute efficacy of PVI and ablation beyond PVI using a novel circular array PFA catheter in patients with atrial fibrillation and flutter. The system can easily be integrated with standard PVI workflows. Further and larger studies are warranted to assess the clinical long-term effectiveness and safety of this PFA system.

摘要

目前正在研发各种脉冲场消融(PFA)系统。最近,一款新的获得CE认证的环形阵列PFA导管(PulseSelect™ PFA系统,美敦力公司,美国明尼阿波利斯,MN)被推出。关于这个商业可用系统的数据很少。目的是阐明评估使用这种新型消融系统进行肺静脉隔离(PVI)以及PVI以外消融的可行性、安全性和急性疗效的真实世界数据。本研究纳入了连续使用环形PFA导管进行首次消融的阵发性和持续性心房颤动(AF)患者。对于持续性AF和左心房(LA)扩大(LA面积>20 cm)的患者,进行额外的左心房顶部消融(LARA)。伴有典型心房扑动的患者接受辅助性三尖瓣峡部(CTI)消融。共纳入100例AF患者(女性占29%,持续性AF占50%)。其中,33例患者(33%)接受了辅助性LARA,1例患者(1%)接受了后壁隔离,6例患者(6%)需要额外的CTI消融。皮肤到皮肤的手术时间平均为66.3±13.8分钟,而透视时间和剂量面积乘积分别为13.7±4.7分钟和6.8±4.9 Gycm。100%的肺静脉实现了急性PVI。所有患者均证实LARA和CTI线双向传导阻滞,且未报告重大不良事件。这些真实世界数据证明了在心房颤动和扑动患者中使用新型环形阵列PFA导管进行PVI以及PVI以外消融的可行性、安全性和急性疗效。该系统可以很容易地与标准PVI工作流程整合。有必要进行进一步的大规模研究来评估这种PFA系统的临床长期有效性和安全性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4325/11594633/ba0af9201ad6/jcm-13-06961-g001.jpg

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