Application of a circular-shaped pulsed field ablation catheter with magnetic sensors for pulmonary vein isolation: a multi-centre clinical study report

被引：5

作者：

Wang, Yan ^{[1
]}

Lai, Heng Li ^{[2
]}

Chen, Qi ^{[3
]}

Liu, Hao ^{[4
]}

Liu, Qi Ming ^{[5
]}

Huang, Wei Bin ^{[6
]}

Tao, Yu ^{[2
]}

Xiong, Qingmei ^{[3
]}

Zhou, Ning ^{[1
]}

Zhao, Chunxia ^{[1
]}

Qiu, Jie ^{[1
]}

Xu, Ziqin ^{[1
]}

Wang, Dao Wen ^{[1
]}

机构：

[1] Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Div Cardiol,Dept Internal Med, Jiefang Ave 1095, Wuhan 430030, Peoples R China

[2] Jiangxi Prov Peoples Hosp, Div Cardiol, Nanchang, Peoples R China

[3] Nanchang Univ, Affiliated Hosp 2, Dept Cardiovasc Med, Nanchang, Peoples R China

[4] Guangxi Med Univ, Affiliated Hosp 2, Div Cardiol, Nanning, Peoples R China

[5] Xiamen Univ, Affiliated Zhongshan Hosp, Div Cardiol, Xiamen, Peoples R China

[6] Cent South Univ, Xiangya Hosp 2, Div Cardiol, Changsha, Peoples R China

来源：

EUROPACE | 2024年 / 26卷 / 04期

关键词：

Atrial fibrillation; Catheter ablation; Pulmonary vein isolation; Pulsed field ablation; Electroporation; IRREVERSIBLE ELECTROPORATION; OUTCOMES;

D O I：

10.1093/europace/euae068

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. Graphical Abstract

引用

页数：9

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