Maria Cecilia Hospital, Cotignola, Ravenna, Italy.
Laboratorio Di Elettrofisiologia, Clinica San Michele, Maddaloni, Caserta, Italy.
J Interv Card Electrophysiol. 2022 Sep;64(3):641-648. doi: 10.1007/s10840-021-01063-2. Epub 2021 Dec 2.
A new cryoballoon (CB) technology (POLARx™; Boston Scientific) for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF) has recently been introduced. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB.
We assessed the first 69 consecutive patients indicated for AF ablation who underwent PV isolation by means of a novel CB system. Procedural metrics were prospectively recorded.
A total of 274 PVs were targeted in 69 patients. PV isolation was achieved in all patients by means of cryoablation alone. The median time to isolation (TTI) was 44 [31-68] s (median temperature at TTI = - 49 [- 53 to - 41] °C). The median duration of CB ablation was 180 [180 to 240] s. The median nadir temperature was - 56.0 [- 61 to - 52] °C, and the median thaw time to 0 °C was 18 [15-21] s. The median grade of PV occlusion was 4 [3 to 4]. On the basis of ROC analysis, we defined the following cut-off values for acute PV isolation: - 56 °C for nadir temperature (sensitivity = 73.3%, specificity = 64.6%, AUC = 0.716; positive predictive value = 88.1%), 30 s for TTT (60.2%, 53.3%, 0.578; 79.7%), thaw time > 17 s (65.3%, 70.0%, 0.709; 86.9%), and grade of PV occlusion = 4 (79.4%, 66.7%, 0.738; 88.5%). No major procedure-related adverse events were observed at 30-day post-procedure.
The new POLARx™ CB appears to be effective and safe. A nadir temperature of - 56 °C, a thaw time to 0 °C ≥ 17 s, and complete PV occlusion were the best predictors of acute PV isolation.
Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/Identifier : NCT03793998. Registration date: January 4, 2019.
一种新的冷冻球囊（CB）技术（Polarx™；波士顿科学公司）最近已被引入用于治疗心房颤动（AF）患者的肺静脉（PV）隔离。本研究旨在评估使用这种新的 CB 时导致急性 PV 隔离的程序和生物物理参数。
我们评估了 69 例接受 AF 消融的连续患者，这些患者通过一种新的 CB 系统进行了 PV 隔离。前瞻性记录了程序指标。
在 69 例患者中总共靶向了 274 个 PV。所有患者均通过冷冻消融单独实现了 PV 隔离。隔离时间中位数（TTI）为 44 [31-68] s（TTI 时的中位温度为-49[-53 至-41]°C）。CB 消融的中位持续时间为 180 [180 至 240] s。中位最低温度为-56.0[-61 至-52]°C，中位解冻至 0°C 时间为 18 [15-21] s。中位 PV 闭塞程度为 4 [3 至 4]。基于 ROC 分析，我们为急性 PV 隔离定义了以下截断值：最低温度为-56°C（敏感性=73.3%，特异性=64.6%，AUC=0.716；阳性预测值=88.1%）、TTI 为 30 s（60.2%、53.3%、0.578；0.779）、解冻时间>17 s（65.3%、70.0%、0.709；0.797）和 PV 闭塞程度=4（79.4%、66.7%、0.738；0.885）。术后 30 天未观察到与手术相关的主要不良事件。
新型 Polarx™ CB 似乎是有效且安全的。最低温度为-56°C、解冻至 0°C 的时间≥17 s 以及完全的 PV 闭塞是急性 PV 隔离的最佳预测指标。
高密度标测系统在真实世界实践中的心律失常导管消融（CHARISMA）。网址：http://clinicaltrials.gov/标识符：NCT03793998。注册日期：2019 年 1 月 4 日。
