高重复频率纳秒脉冲场消融治疗阵发性心房颤动：SCENA-AF试验的12个月结局

摘要(中文译文)

纳米秒脉冲场消融可能带来减少肌肉收缩等潜在益处，有望使手术能够在局部麻醉下进行。评估一种新型高重频纳秒脉冲场消融治疗阵发性心房颤动的12个月安全性和有效性。前瞻性、多中心、单臂试验SCENA-AF研究（纳秒脉冲消融治疗心房颤动的安全性和有效性临床评价）在中国11个中心开展。年龄18至80岁、有症状且药物难治的阵发性心房颤动患者使用商业化纳秒脉冲场消融系统接受肺静脉隔离。主要有效性终点为消融后91至365天内，在不使用I类和III类抗心律失常药物的情况下，无记录的持续至少30秒的心房颤动、心房扑动或房性心动过速。主要安全性终点为手术期间及12个月随访期间无器械相关或手术相关死亡、卒中、短暂性脑缺血发作或其他重大并发症。在166例接受PFA手术的入组患者中，162例完成了随访。目标静脉的急性肺静脉隔离成功率为100%。12个月时，88.49%（95% CI，82.54%-92.50%）达到主要有效性终点。未发生器械相关或手术相关死亡、卒中或短暂性脑缺血发作。值得注意的是，92.77%的手术是在局部麻醉和清醒镇静下完成的。手术特异性严重不良事件发生率为2.41%，且仅限于已缓解的穿刺部位血肿或假性动脉瘤。未观察到临床溶血体征或症状。这种新型高重频纳秒脉冲场消融在阵发性心房颤动治疗中显示出较高的12个月有效性和良好的安全性。大多数手术能够在局部麻醉和清醒镇静下完成，极少需要全身麻醉，这凸显了该技术的潜在优势。www.clinicaltrials.gov；唯一标识符：NCT06039722。

Abstract

Nanosecond pulsed field ablation, which offers potential benefits, such as reduced muscle contraction, may enable procedures to be performed under local anesthesia.To evaluate the 12-month safety and efficacy of a novel high-repetition frequency nanosecond pulsed field ablation for treating paroxysmal atrial fibrillation. The prospective, multicenter, single-arm trial SCENA-AF study (Safety-and-effectiveness Clinical Evaluation of Nanosecond-pulse Ablation for Atrial Fibrillation) was conducted across 11 Chinese centers. Symptomatic drug-refractory patients with paroxysmal atrial fibrillation aged 18 to 80 years underwent pulmonary vein isolation using a commercial nanosecond pulsed field ablation system. The primary efficacy end point was freedom from documented atrial fibrillation, atrial flutter, or atrial tachycardia ≥30 seconds from 91 to 365 days postablation without use of class I and III antiarrhythmic drugs. The primary safety end point was freedom from device- or procedure-related death, stroke, transient ischemic attacks, or other major complications during the procedure and 12-month follow-up. Of the 166 enrolled patients who underwent the PFA procedures, 162 completed follow-up. Acute pulmonary vein isolation success was 100% for targeted veins. At 12 months, 88.49% (95% CI, 82.54%-92.50%) met the primary efficacy end point. No device- or procedure-related death, stroke, or transient ischemic attacks occurred. Notably, 92.77% of procedures were performed under local anesthesia and conscious sedation. Procedure-specific serious adverse events occurred in 2.41% of patients and were limited to access-site hematomas or pseudoaneurysms that resolved. No clinical hemolysis signs or symptoms were observed. The novel high-repetition-frequency nanosecond pulsed field ablation demonstrated high 12-month efficacy and a favorable safety profile for paroxysmal atrial fibrillation treatment. The ability to perform most procedures under local anesthesia with conscious sedation, with general anesthesia rarely needed, highlights a potential advantage of this technology. www.clinicaltrials.gov; Unique identifier: NCT06039722.

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