Schiavone Marco, Bianchi Stefano, Malacrida Maurizio, Fassini Gaetano, Ricciolino Riccardo, Pecora Domenico, Pelargonio Gemma, Iacopino Saverio, Ducceschi Valentino, Maggio Ruggero, Bianchini Lorenzo, La Greca Carmelo, Rossi Pietro, Bencardino Gianluigi, Moltrasio Massimo, Di Belardino Natale, Pepi Patrizia, Rossi Luca, Santagostino Matteo, Tondo Claudio, De Simone Antonio
Department of Clinical Electrophysiology & Cardiac Pacing, Centro Cardiologico Monzino, IRCCS, Milan, Italy.
Center of Excellence in Cardiovascular Sciences, Ospedale Isola Tiberina - Gemelli Isola, Rome, Italy.
Heart Rhythm. 2025 May;22(5):1134-1141. doi: 10.1016/j.hrthm.2024.08.040. Epub 2024 Aug 22.
No data have been reported on cooling characteristics and the impact of variant pulmonary vein (PV) anatomy on atrial fibrillation (AF) recurrences after POLARx cryoballoon (CB) ablation.
The purpose of this study was to analyze the impact of PV anatomy variants and cooling characteristics after CB ablation from a large multicenter prospective registry.
The primary end point was defined as 1-year absence of any atrial tachyarrhythmias (ATAs: AF/atrial flutter/atrial tachycardia). Correlation between ATA recurrences and anatomy variants/cooling characteristics were evaluated. The secondary outcome was the rate of major periprocedural complications.
A total of 429 consecutive patients diagnosed with paroxysmal AF (83.4%) or persistent AF (peAF; 16.6%) were enrolled. Twenty-eight patients (6.6%) exhibited an anatomical variant (common ostium: 4.0%; adjunctive PV: 2.6%). Nadir temperature, thaw time, and total deflation time were different between standard PVs and PV variants. After the blanking period, over a mean of 431 ± 99 days of follow-up, 63 patients (14.7%) suffered an ATA recurrence. Patients with recurrences had both a shorter thaw time (18.5 ± 7 seconds vs 19.8 ± 7 seconds; P = .0012) and a shorter total deflation time, whereas time to isolation was longer (57.4 ± 42 seconds vs 49.1 ± 33 seconds; P = .04). Patients with anatomy variants showed a similar ATA recurrence rate (5 of 28 [17.9%]) to the standard PV anatomy group (58 of 401 [14.5%]) (P = .584), with a hazard ratio (HR) of 1.43 (95% confidence interval [CI] 0.49-4.13; log-rank, P = .4384). After adjusting for confounders, heart failure (HR 4.12; 95% CI 1.75-9.73; P = .0013) and peAF (HR 1.81; 95% CI 1.03-3.18; P = .0433) remained associated with ATA recurrence during follow-up.
The POLARx CB system demonstrated long-term efficacy, along with a safe profile, in both patients with paroxysmal AF and those with peAF, regardless of the presence PV variants. Time to isolation was longer in patients with ATA recurrences during follow-up.
Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA).
gov identifier: NCT03793998. Registration date: January 4, 2019.
关于冷冻球囊（CB）消融术后肺静脉（PV）解剖变异对房颤（AF）复发的影响及冷却特性，尚无相关数据报道。
本研究旨在通过一个大型多中心前瞻性注册研究，分析CB消融术后PV解剖变异和冷却特性的影响。
主要终点定义为1年无任何房性快速性心律失常（ATA：AF/心房扑动/房性心动过速）。评估ATA复发与解剖变异/冷却特性之间的相关性。次要结局是围手术期主要并发症的发生率。
共纳入429例连续诊断为阵发性AF（83.4%）或持续性AF（peAF；16.6%）的患者。28例患者（6.6%）表现出解剖变异（共同开口：4.0%；附加PV：2.6%）。标准PV和PV变异之间的最低温度、解冻时间和总放气时间不同。在空白期后，平均随访431±99天，63例患者（14.7%）发生ATA复发。复发患者的解冻时间（18.5±7秒对19.8±7秒；P = 0.0012）和总放气时间均较短，而隔离时间较长（57.4±42秒对49.1±33秒；P = 0.04）。解剖变异患者的ATA复发率（28例中的5例[17.9%]）与标准PV解剖组（401例中的58例[14.5%]）相似（P = 0.584），风险比（HR）为1.43（95%置信区间[CI] 0.49 - 4.13；对数秩检验，P = 0.4384）。在调整混杂因素后，心力衰竭（HR 4.12；95% CI 1.75 - 9.73；P = 0.0013）和peAF（HR 1.81；95% CI 1.03 - 3.18；P = 0.0433）在随访期间仍与ATA复发相关。
无论是否存在PV变异，POLARx CB系统在阵发性AF患者和peAF患者中均显示出长期疗效和安全的特征。随访期间ATA复发的患者隔离时间较长。
现实世界实践中使用高密度标测系统进行心律失常导管消融（CHARISMA）。
gov标识符：NCT03793998。注册日期：2０19年1月4日。
