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.

中文翻译：

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磁传感器圆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

目的 一些研究报道了脉冲场消融（PFA）导管用于消融心房颤动（AF）的效果和安全性，这些导管主要基于篮形或花形设计。然而，带有磁传感器的圆形多电极导管的临床应用非常有限。使用配备磁性传感器的圆形多电极导管进行肺静脉隔离 (PVI)，研究 PFA 系统对阵发性 AF 患者的有效性和安全性。方法和结果一种新颖的专有双极 PFA 系统用于 PVI，该系统利用带有磁传感器的圆形多电极导管，并允许在一张图中进行三维模型重建、绘图和消融。为了评估该 PFA 系统的功效、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名阵发性房颤患者被纳入并接受了PVI。该研究考察了手术时间、即刻成功率、12 个月时的手术成功率以及相关并发症。使用所研究的系统，对所有 151 名患者的所有肺静脉进行了急性隔离。每名患者的脉冲场消融次数为 78.4 ± 41.8 次，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 例（7.2%）病例接受了深度镇静麻醉，随后的病例接受了局部麻醉。最初11例中，4例（36.4%）出现短暂迷走神经反应，其余均通过阿托品注射和快速输液预防性治疗成功。手术期间或手术后未发现严重并发症。随访期间出现房扑3例，房颤复发11例。估计 12 个月 Kaplan-Meier 的无心律失常率为 88.4%。结论 PFA系统由带有磁传感器的圆形PFA导管组成，可以在三维引导下快速实现PVI，并且表现出良好的安全性和可比的效果。