Department of Cardiovascular Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.
Department of Cardiology, Fujian Provincial Hospital, Fuzhou, People's Republic of China.
Pacing Clin Electrophysiol. 2022 Sep;45(9):1015-1023. doi: 10.1111/pace.14556. Epub 2022 Jul 28.
Cryoballoon ablation (CBA) is one of the most commonly used technologies designed for pulmonary vein isolation (PVI) for paroxysmal atrial fibrillation (PAF), although the dosing of CBA remains controversial. We evaluated the long-term efficacy and safety of a novel individualized strategy of CBA compared to radiofrequency ablation (RFA) for patients with PAF.
In this observational study, symptomatic patients with drug-refractory paroxysmal AF were prospectively consented and enrolled in four centers, being assigned either to the CBA or RFA arm for ablation. In the CBA group, we used a time to isolation (TTI) - based dosing protocol. The primary endpoint was the recurrence of atrial arrhythmia >30 s following a 90-day blanking period. The secondary endpoint was procedure-related complications and procedure parameters.
A total of 500 patients were recruited in either the CBA group (n = 247) or the RFA group (n = 253) between January 2017 and July 2018. After a median follow-up of 778 days, the atrial tachyarrhythmia-free survival was 71.7% in the CBA group and 67.0% in the RFA group. CBA and RFA displayed similar major or minor complication occurrence, while the former had a significantly shorter procedure duration (82.5 min vs. 141.1 min, p < .001) and left atrial dwell time (60.1 min vs. 109.9 min, p < .001) but longer fluoroscopy exposure (13.8 min vs. 8.1 min, p < .001).
Compared to RFA, our TTI-based CBA dosing protocol showed comparable efficacy and safety, with a significantly reduced procedure duration in patients with PAF.
冷冻球囊消融(CBA)是用于治疗阵发性心房颤动(PAF)的肺静脉隔离(PVI)的最常用技术之一,尽管 CBA 的剂量仍存在争议。我们评估了一种新的个体化 CBA 策略与射频消融(RFA)治疗 PAF 患者的长期疗效和安全性。
在这项观察性研究中,我们前瞻性地同意并招募了患有药物难治性阵发性 AF 的有症状患者,并将他们分配到 CBA 或 RFA 消融组。在 CBA 组中,我们使用基于隔离时间(TTI)的剂量方案。主要终点是在 90 天空白期后出现>30 秒的心房心律失常复发。次要终点是与程序相关的并发症和程序参数。
2017 年 1 月至 2018 年 7 月期间,共有 500 例患者分别入组 CBA 组(n=247)或 RFA 组(n=253)。中位随访 778 天后,CBA 组和 RFA 组的无房性心动过速生存分别为 71.7%和 67.0%。CBA 和 RFA 的主要或次要并发症发生率相似,而前者的手术时间(82.5 分钟 vs. 141.1 分钟,p<.001)和左心房停留时间(60.1 分钟 vs. 109.9 分钟,p<.001)明显较短,但透视曝光时间(13.8 分钟 vs. 8.1 分钟,p<.001)较长。
与 RFA 相比,我们基于 TTI 的 CBA 剂量方案在 PAF 患者中显示出相似的疗效和安全性,且手术时间明显缩短。