新型国产脉冲电场消融系统治疗阵发性心房颤动安全性和可行性的初期研究

Safety and Feasibility of Treating Paroxysmal Atrial Fibrillation Patients With a Novel Domestic Pulsed Field Ablation System:a Pilot Study

目的:射频及冷冻能源均是应用于心房颤动(房颤)经导管消融的成熟能源,而脉冲电场消融(PFA)则应用脉冲电场使组织产生不可逆性电穿孔,是目前应用于房颤经导管消融的新型能源,本研究旨在评估一种新型国产PFA系统在阵发性房颤经导管消融中的安全性和可行性。方法:本研究是一项多中心、前瞻性、单臂、观察性研究中牵头单位的初期结果,纳入了2022年6月至8月在云南省阜外心血管病医院心律失常中心首次接受PFA治疗的阵发性房颤患者,全部患者在消融前后分别进行左心房三维电解剖标测,术后48 h内进行头颅MRI检查。结果:本研究共纳入10例患者,其中7例为男性,年龄为(53.3±9.6)岁。共对40支肺静脉进行PFA治疗,其中左上、左下、右上、右下肺静脉的消融时间分别为(47.1±18.6)s、(33.6±10.7)s、(42.7±14.1)s、(37.1±10.4)s。手术时间为(89.5±22.9)min,左心房操作时间为(59.9±17.6)min,照射剂量为(23.1±11.9)mGy。全部(100%)肺静脉均达到肺静脉隔离的手术终点,无围术期并发症出现。结论:新型PFA系统治疗阵发性房颤患者的即刻成功率高、无围术期并发症发生,但该结果仍需大样本及长期随访结果加以验证。

Objectives:Radiofrequency-and cryo-ablation are the usual catheter ablation options for patients with atrial fibrillation(AF).Pulsed field ablation(PFA)can achieve irreversible electroporation,and is a promising energy for AF ablation.The present study aimed to assess the safety and feasibility of a novel domestic PFA system in the catheter ablation of patients with paroxysmal AF(PAF).Methods:The present study was a multi-center prospective single-arm observational study performed in the initiated institution.We enrolled PAF patients who received initial PFA procedure in Cardiac Arrhythmia Center of Fuwai Yunnan Cardiovascular Hospital between June and August 2022.Electroanatomic mapping of left atrium was performed pre-and postablation.Brain MRI was performed within 48 hours after the procedure.Results:A total of 10 patients were enrolled,7 patients were male,and the average age was(53.3±9.6)years old.PFA was performed in 40 pulmonary veins(PVs).The average ablation time of left superior PV,left inferior PV,right superior PV and right inferior PV was(47.1±18.6)s,(33.6±10.7)s,(42.7±14.1)s and(37.1±10.4)s,respectively.The average procedural duration was(89.5±22.9)min.The average left atrial dwelling time was(59.9±17.6)min.The average radiation dose was(23.1±11.9)mGy.PV isolation was achieved in all PVs(100%).No peri-procedural complication was observed.Conclusions:The novel domestic PFA system could achieve a high acute success rate without peri-procedural complication in patients with PAF.Further studies with larger patient cohort and long-term follow-up are warranted to validate the efficacy of this system in treating PAF patients.