Kim Daehoon, Yu Hee Tae, Shim Jaemin, Park Junbeom, Baek Yong-Soo, Park Sang Won, Kim Dae-Kyeong, Park Young-Ah, Kim Tae-Hoon, Uhm Jae-Sun, Joung Boyoung, Lee Moon-Hyoung, Pak Hui-Nam
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine and Yonsei University Health System, Seoul, Republic of Korea (D.K., H.T.Y., T.-H.K., J.-S.U., B.J., M.-H.L., H.-N.P.).
Division of Cardiology, Department of Internal Medicine, Korea University College of Medicine and Korea University Anam Hospital, Seoul, Republic of Korea (J.S.).
Circ Arrhythm Electrophysiol. 2025 Jan;18(1):e013408. doi: 10.1161/CIRCEP.124.013408. Epub 2024 Dec 19.
Pulmonary vein isolation (PVI) alone is less effective in patients with persistent atrial fibrillation (AF) compared with those with paroxysmal AF. We investigate whether additional linear ablation from the superior vena cava to the right atrial septum and cavotricuspid isthmus ablation improves the rhythm outcome of patients with persistent AF undergoing cryoballoon PVI (Cryo-PVI).
In this investigator-initiated, multicenter, randomized clinical trial, 289 patients with persistent AF refractory to antiarrhythmic drug therapy were randomized 1:1 to either Cryo-PVI with additional right atrium (RA) linear ablation or Cryo-PVI alone. The primary end point was any documented atrial arrhythmia lasting ≥30 seconds after a 3-month blanking period after ablation. The secondary end points were atrial arrhythmia recurrence or antiarrhythmic drug use after a 3-month blanking period, complications, and total procedure time.
During the median follow-up of 24 months (median age, 63 years; 23.9% women), the atrial arrhythmia recurrence was less frequent in the additional RA ablation group (n=50, 37.5%) than in the Cryo-PVI alone group (n=69, 53.1%; absolute difference, -15.6% [95% CI, -27.9% to -3.4%]; hazard ratio, 0.66 [95% CI, 0.46-0.94]). Antiarrhythmic drugs were prescribed after the 3-month period to 72 (49.3%) patients in the additional RA ablation group and 79 (55.2%) patients in the Cryo-PVI alone group. No difference was found in complication rate between the 2 groups. Total procedure time was longer in the additional RA ablation group (median, 88 versus 72 minutes; <0.001).
Additional RA linear ablation beyond Cryo-PVI improved the ablation outcome compared with that of PVI alone in persistent AF patients.
与阵发性心房颤动（AF）患者相比，单纯肺静脉隔离（PVI）对持续性AF患者的疗效较差。我们研究了从上腔静脉至右心房间隔的额外线性消融以及腔静脉三尖瓣峡部消融是否能改善接受冷冻球囊PVI（冷冻PVI）的持续性AF患者的节律结局。
在这项由研究者发起的多中心随机临床试验中，289例对抗心律失常药物治疗无效的持续性AF患者按1:1随机分为接受额外右心房（RA）线性消融的冷冻PVI组或单纯冷冻PVI组。主要终点是消融后3个月空白期后记录到的持续≥30秒的任何房性心律失常。次要终点是3个月空白期后的房性心律失常复发或抗心律失常药物使用情况、并发症及总手术时间。
在中位随访24个月期间（中位年龄63岁；女性占23.9%），额外RA消融组（n = 50，37.5%）的房性心律失常复发频率低于单纯冷冻PVI组（n = 69，占53.1%；绝对差异为-15.6% [95% CI，-27.9%至-3.4%]；风险比为0.66 [95% CI，0.46 - 0.94]）。3个月后，额外RA消融组72例（49.3%）患者和单纯冷冻PVI组79例（55.2%）患者使用了抗心律失常药物。两组并发症发生率无差异。额外RA消融组的总手术时间更长（中位时间分别为88分钟和72分钟；P < 0.001）。
与单纯PVI相比，在持续性AF患者中，冷冻PVI联合额外RA线性消融改善了消融结局。
