不对称双相脉冲场消融治疗阵发性心房颤动：临床评估。
完整摘要 · 中文译文
背景：脉冲场消融（PFA）是一种用于心房颤动的非热、组织选择性治疗。在本研究中，我们评估了一种新型不对称双相PFA系统的安全性和有效性，该系统结合了独特的脉冲参数配置与专用的可调六分支导管。 方法：这项前瞻性、多中心、单臂研究在中国开展。药物难治性阵发性房颤患者使用具有新型参数配置的1，000 V不对称双相PFA系统接受肺静脉隔离（PVI）。主要有效性终点为空白期后12个月内无房性心律失常复发。主要安全性终点为预定义的严重不良事件。次要安全性终点为溶血和沉默性脑病灶（SCLs）。 结果：在120例入组患者中，105例接受了消融并完成了12个月随访，而15例患者在PFA操作前退出。所有420条目标静脉均成功实现急性PVI。在12个月时，无房性心律失常复发的Kaplan-Meier估计值为69.5%（95% CI，60.1-77.5%）。观察到的12个月有效性处于既往PFA技术研究报告的范围之内。在安全性方面，主要操作并发症——包括肺静脉狭窄、膈神经损伤、房食管瘘、卒中和急性肾损伤（AKI）——完全未发生。然而，一名患者（0.95%）出现了短暂性冠状动脉痉挛，并经冠状动脉内血管扩张剂成功缓解。此外， 在两名患者（1.9%）中检测到无症状脑病变（SCLs）。虽然实验室溶血是常见发现，但未导致肾功能损害。 结论：该不对称双相脉冲场消融（PFA）系统实现了完全的急性肺静脉隔离（PVI），12个月有效性处于既往PFA技术研究报道的范围内。其安全性特征良好，SCLs极少且无溶血相关急性肾损伤（AKI）。 临床试验注册：https://www.chictr.org.cn/showproj.html?proj=134973，注册号ChiCTR2200062157。
完整摘要 · 英文原文
BACKGROUND: Pulsed field ablation (PFA) is a non-thermal, tissue-selective therapy for atrial fibrillation. In this study, we evaluated the safety and efficacy of a novel asymmetric biphasic PFA system, which combines a unique pulse-parameter configuration with a dedicated, adjustable six-spline catheter. METHODS: This prospective, multicenter, single-arm study was conducted in China. Patients with drug-refractory paroxysmal AF underwent pulmonary vein isolation (PVI) using a 1,000 V asymmetric biphasic PFA system with a novel parameter configuration. The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence through 12 months post-blanking. The primary safety endpoint was predefined serious adverse events. The secondary safety endpoint was hemolysis and silent cerebral lesions (SCLs). RESULTS: Among 120 enrolled patients, 105 underwent ablation and completed the 12-month follow-up, while 15 patients withdrew before the PFA operation. Acute PVI was successfully achieved in all 420 targeted veins. At 12 months, the Kaplan-Meier estimate of freedom from atrial arrhythmia recurrence was 69.5% (95% CI, 60.1-77.5%). The observed 12-month effectiveness was within the range reported in previous studies of PFA technologies. Regarding safety, major procedural complications-including pulmonary vein stenosis, phrenic nerve injury, atrioesophageal fistula, stroke, and acute kidney injury (AKI)-were entirely absent. However, one patient (0.95%) experienced a transient coronary vasospasm that was successfully resolved with an intracoronary vasodilator. Additionally, SCLs were detected in two patients (1.9%). While laboratory hemolysis was a common finding, it did not lead to renal impairment. CONCLUSIONS: This asymmetric biphasic PFA system achieved complete acute PVI and 12-month effectiveness was within the range reported in previous studies of PFA technologies. It showed a favorable safety profile, with few SCLs and no hemolysis-related AKI. CLINICAL TRIAL REGISTRATION: https://www.chictr.org.cn/showproj.html?proj=134973, identifier ChiCTR2200062157.