Luo Qingzhi, Li Xiang, Xie Yun, Bao Yangyang, Wei Yue, Lin Changjian, Liu Zhuhui, Zhang Ning, Ling Tianyou, Chen Kang, Pan Wenqi, Wu Liqun, Jin Qi
Department of Cardiovascular Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Ruijin Er Road, Shanghai, 200025, China.
Sci Rep. 2025 Feb 20;15(1):6181. doi: 10.1038/s41598-025-90920-5.
This study aimed to evaluate the long-term efficacy and clinical outcomes of catheter ablation performed with cryoballoon (CRYO) in comparison with robotic magnetic navigation (RMN) in patients with persistent atrial fibrillation (PersAF). A total of 200 patients with symptomatic PersAF were prospectively enrolled and non-randomly assigned (1:1) to the CRYO or RMN guided-ablation group undergoing pulmonary vein isolation (PVI) and additional linear ablation if necessary and then followed up over 5 years. The primary endpoint was freedom from atrial tachyarrhythmias (ATs) recurrence following a 3-month blanking period after the initial procedure. The secondary endpoints consisted of all-cause and cardiovascular rehospitalizations, rates of electrical cardioversion (EC) and re-do ablation, new-onset neurological event, major bleeding event and the difference in CHADS-VASc score at 5-year compared with baseline. After a median follow-up period of 60 months, 184 patients (93 in RMN, 91 in CRYO) completed the follow-up. Freedom from recurrent ATs was achieved in 44 out of 93 patients in the RMN group and 37 out of 91 patients in the CRYO group (47.3% vs. 40.7%, P = 0.32). There were no significant differences in the risk of all-cause and cardiovascular rehospitalizations, rates of EC and re-do ablation, new-onset neurological event, and major bleeding event at 5 years. Anticoagulation (OAC) discontinuation was relatively common after ablation, since 48.4% of patients with a CHADS-VASc score ≥ 2 were not on OAC therapy. CRYO is comparable to RMN-guided ablation with respect to long-term freedom from ATs in patients with PersAF. Discontinuation of OAC after ablation is not rare even in patients at risk of stroke for continued OAC therapy.
本研究旨在评估与机器人磁导航(RMN)相比,冷冻球囊(CRYO)导管消融术治疗持续性心房颤动(PersAF)患者的长期疗效和临床结局。共前瞻性纳入200例有症状的PersAF患者,并将其非随机分配(1:1)至CRYO或RMN指导下的消融组,进行肺静脉隔离(PVI),必要时进行额外的线性消融,然后随访5年。主要终点是初始手术后3个月空白期后无房性快速性心律失常(ATs)复发。次要终点包括全因和心血管再住院率、电复律(EC)和再次消融率、新发神经系统事件、大出血事件以及5年时与基线相比CHADS-VASc评分的差异。中位随访期60个月后,184例患者(RMN组93例,CRYO组91例)完成随访。RMN组93例患者中有44例、CRYO组91例患者中有37例实现了无ATs复发(47.3%对40.7%,P = 0.32)。5年时全因和心血管再住院风险、EC和再次消融率、新发神经系统事件以及大出血事件方面无显著差异。消融后抗凝(OAC)停药相对常见,因为CHADS-VASc评分≥2的患者中有48.4%未接受OAC治疗。对于PersAF患者,CRYO在长期无ATs方面与RMN指导下的消融相当。即使在有持续OAC治疗的卒中风险患者中,消融后停用OAC也并不罕见。