脉冲场与常规热消融治疗阵发性心房颤动:复发性心房心律失常负担。
Pulsed Field vs Conventional Thermal Ablation for Paroxysmal Atrial Fibrillation: Recurrent Atrial Arrhythmia Burden.
机构信息
Helmsley Electrophysiology Center, Mount Sinai Fuster Heart Hospital, New York, New York, USA.
Massachusetts General Hospital, Boston, Massachusetts, USA.
出版信息
J Am Coll Cardiol. 2024 Jul 2;84(1):61-74. doi: 10.1016/j.jacc.2024.05.001. Epub 2024 May 18.
BACKGROUND
The ADVENT randomized trial revealed no significant difference in 1-year freedom from atrial arrhythmias (AA) between thermal (radiofrequency/cryoballoon) and pulsed field ablation (PFA). However, recent studies indicate that the postablation AA burden is a better predictor of clinical outcomes than the dichotomous endpoint of 30-second AA recurrence.
OBJECTIVES
The goal of this study was to determine: 1) the impact of postablation AA burden on outcomes; and 2) the effect of ablation modality on AA burden.
METHODS
In ADVENT, symptomatic drug-refractory patients with paroxysmal atrial fibrillation underwent PFA or thermal ablation. Postablation transtelephonic electrocardiogram monitor recordings were collected weekly or for symptoms, and 72-hour Holters were at 6 and 12 months. AA burden was calculated from percentage AA on Holters and transtelephonic electrocardiogram monitors. Quality-of-life assessments were at baseline and 12 months.
RESULTS
From 593 randomized patients (299 PFA, 294 thermal), using aggregate PFA/thermal data, an AA burden exceeding 0.1% was associated with a significantly reduced quality of life and an increase in clinical interventions: redo ablation, cardioversion, and hospitalization. There were more patients with residual AA burden <0.1% with PFA than thermal ablation (OR: 1.5; 95% CI: 1.0-2.3; P = 0.04). Evaluation of outcomes by baseline demographics revealed that patients with prior failed class I/III antiarrhythmic drugs had less residual AA burden after PFA compared to thermal ablation (OR: 2.5; 95% CI: 1.4-4.3; P = 0.002); patients receiving only class II/IV antiarrhythmic drugs pre-ablation had no difference in AA burden between ablation groups.
CONCLUSIONS
Compared with thermal ablation, PFA more often resulted in an AA burden less than the clinically significant threshold of 0.1% burden. (The FARAPULSE ADVENT PIVOTAL Trial PFA System vs SOC Ablation for Paroxysmal Atrial Fibrillation [ADVENT]; NCT04612244).
背景
ADVENT 随机试验显示,在 1 年内,热(射频/冷冻球囊)消融与脉冲场消融(PFA)在避免房性心律失常(AA)复发方面无显著差异。然而,最近的研究表明,消融后 AA 负荷是预测临床结局的更好指标,优于 30 秒 AA 复发的二分法终点。
目的
本研究旨在确定:1)消融后 AA 负荷对结局的影响;2)消融方式对 AA 负荷的影响。
方法
在 ADVENT 中,患有阵发性房颤且药物难治性的有症状患者接受了 PFA 或热消融。消融后每周或根据症状进行远程心电图监测记录,6 个月和 12 个月时进行 72 小时动态心电图监测。AA 负荷通过动态心电图监测和远程心电图监测记录的 AA 百分比计算。在基线和 12 个月时进行生活质量评估。
结果
在 593 例随机患者(PFA 组 299 例,热消融组 294 例)中,使用 PFA/热消融的汇总数据,AA 负荷超过 0.1%与生活质量显著降低和临床干预增加相关:再次消融、电复律和住院。与热消融相比,PFA 组的 AA 负荷<0.1%的患者更多(OR:1.5;95%CI:1.0-2.3;P=0.04)。根据基线人口统计学特征评估结局显示,与热消融相比,既往接受 I 类/III 类抗心律失常药物治疗失败的患者在接受 PFA 后 AA 负荷更低(OR:2.5;95%CI:1.4-4.3;P=0.002);消融前仅接受 II 类/IV 类抗心律失常药物治疗的患者,两组之间 AA 负荷无差异。
结论
与热消融相比,PFA 更常导致 AA 负荷低于临床显著阈值 0.1%。(FARAPULSE ADVENT 关键性试验:PFA 系统与 SOC 消融治疗阵发性房颤 [ADVENT];NCT04612244)。