Purpose

The aim was to report procedural and technical differences of a novel cryoballoon (NCB) ablation catheter for pulmonary vein isolation (PVI) compared to the standard cryoballoon (SCB) catheter.

Methods

Consecutive patients with atrial fibrillation (AF) undergoing PVI using the NCB and the SCB were included. Procedural parameters, technical differences, acute efficacy, and safety are reported.

Results

Eighty patients (age 66 ± 10 years, ejection fraction 57 ± 10%, left atrial volume index 40 ± 6 ml/m²) were studied. With the NCB, 156 of 158 PVs (99%) were isolated compared to isolation of 159 of 159 PVs (100%) with the SCB. The median number of freezes in the NCB and the SCB group was 6 (IQR 5–8) and 5 (IQR 4–7), respectively (p = 0.051), with 73% and 71% of the PVs isolated with a single freeze, respectively. Nadir temperature and temperature at isolation were − 59 ± 6 °C and − 45 ± 17 °C in the NCB group and − 46 ± 7 °C and − 32 ± 23 °C in the SCB group, respectively (both p < 0.001) with no difference in time to isolation (TTI). Procedural differences were observed for the total procedure time (84 ± 29 min in the NCB group and 65 ± 17 min in the SCB group, p = 0.003). There was a peri-procedural stroke in one patient in the NCB group. Differences in catheter design were observed that may account for the differences in temperature recordings and ice cap formation.

Conclusions

Acute efficacy and TTI were similar with the NCB compared to the SCB. Measured temperatures were lower with the NCB, most likely due to differences in catheter design.

中文翻译：

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两种不同冷冻球囊消融系统在心房颤动患者中的技术和程序比较

目的

目的是报告用于肺静脉隔离 (PVI) 的新型冷冻球 (NCB) 消融导管与标准冷冻球 (SCB) 导管相比的程序和技术差异。

方法

包括使用 NCB 和 SCB 进行 PVI 的连续房颤 (AF) 患者。报告了程序参数、技术差异、急性疗效和安全性。

结果

研究了 80 名患者（年龄 66 ± 10 岁，射血分数 57 ± 10%，左心房容积指数 40 ± 6 ml/m ²）。使用 NCB，158 个 PV 中的 156 个（99%）被隔离，而 SCB 的 159 个 PV 中的 159 个（100%）被隔离。NCB 和 SCB 组的中位数冻结次数分别为 6 (IQR 5-8) 和 5 (IQR 4-7) ( p  = 0.051)，其中 73% 和 71% 的 PV 被单次冻结分离， 分别。NCB 组的最低温度和隔离温度分别为 - 59 ± 6 °C 和 - 45 ± 17 °C，SCB 组分别为 - 46 ± 7 °C 和 - 32 ± 23 °C（均p < 0.001)，隔离时间 (TTI) 没有差异。观察到总手术时间的程序差异（NCB 组为 84 ± 29 分钟，SCB 组为 65 ± 17 分钟，p  = 0.003）。NCB 组的一名患者发生围手术期卒中。观察到导管设计的差异，这可能解释了温度记录和冰帽形成的差异。

结论

与 SCB 相比，NCB 的急性疗效和 TTI 相似。NCB 测得的温度较低，这很可能是由于导管设计的差异。