Dataset related to the article "Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry"

This record contains raw data related to the article "Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry".

Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Clinical trial registration: 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.

本数据集包含与论文《使用新型冷冻球囊（cryoballoon, CB）技术实现有效急性肺静脉隔离的关键特征：来自CHARISMA注册研究的洞察》相关的原始数据。

**摘要**

**研究目的**：近期一款新型冷冻球囊（cryoballoon, CB）技术（POLARx™；波士顿科学（Boston Scientific））已被应用于心房颤动（atrial fibrillation, AF）患者的肺静脉（pulmonary vein, PV）隔离术。本研究旨在评估使用该新型CB时，可实现急性肺静脉隔离的操作及生物物理参数。

**研究方法**：我们前瞻性记录了首批69例拟行心房颤动消融术、并通过新型CB系统实施肺静脉隔离的连续患者的操作相关指标。

**研究结果**：共为69例患者的274条肺静脉实施了靶向隔离操作，所有患者仅通过冷冻消融即实现肺静脉隔离。实现隔离的中位时间（time to isolation, TTI）为44[31~68]秒，实现隔离时的中位温度为-49[-53~-41]℃。CB消融的中位持续时间为180[180~240]秒，中位最低温度为-56.0[-61~-52]℃，中位升温至0℃的解冻时间为18[15~21]秒。肺静脉闭塞的中位分级为4[3~4]。通过受试者工作特征（Receiver Operating Characteristic, ROC）分析，我们确定了急性肺静脉隔离的以下临界值：最低温度-56℃（敏感度=73.3%，特异度=64.6%，曲线下面积（area under the curve, AUC）=0.716；阳性预测值=88.1%）、30秒的TTT（60.2%，53.3%，0.578；79.7%）、解冻时间＞17秒（65.3%，70.0%，0.709；86.9%）以及肺静脉闭塞分级=4（79.4%，66.7%，0.738；88.5%）。术后30天随访未观察到重大操作相关不良事件。

**研究结论**：新型POLARx™冷冻球囊展现出良好的有效性与安全性。最低温度达-56℃、升温至0℃的解冻时间≥17秒以及完全肺静脉闭塞，是预测急性肺静脉隔离成功的最佳指标。

**临床试验注册信息**：真实世界下使用高密度标测系统行心律失常导管消融术（CHARISMA）。网址：http://clinicaltrials.gov/ 标识符：NCT03793998。注册日期：2019年1月4日。