Purpose

Pulmonary vein isolation (PVI) with radiofrequency (RF) catheter ablation is an effective treatment option for patients with paroxysmal AF. However, traditional point by point RF ablation can be time consuming and technically challenging. To simplify the ablation procedure, without compromising procedure outcome, several “single shot” ablation systems have been developed. The multi-electrode RF Balloon catheter HELIOSTAR is a 28-mm compliant balloon compatible with the CARTO 3D electroanatomical mapping system; an optimized step-by-step workflow to perform PVI is described.

Methods

Procedures are performed under general anesthesia with unique transseptal puncture. To evaluate the optimal electrode-tissue contact and best RF Balloon positioning, the following baseline indicators should be fulfilled: inflation index > 0.8, impedance range close to 100 Ohms with a variability of less than 20 Ohms across electrodes, temperature variability on all electrodes < 3 °C with a maximum temperature of 31 °C.

Results

RF delivery along the posterior wall is programmed to 20 s or shorter in case of esophageal temperature rise (> 2 °C compared to baseline) and 60 s for all the other segments. Target parameters for PVI are 1) time to isolation less than 12 s; 2) impedance drop > 12 Ohms; 3) temperature rise > 6 °C.

Conclusions

Standardized workflow for RF Balloon is mandatory to achieve efficacy and safety with this new promising technology. In the absence of international guidelines, a single high-volume center procedural strategy is described for PVI.

中文翻译：

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射频球囊肺静脉隔离的优化临床工作流程

目的

肺静脉隔离 (PVI) 与射频 (RF) 导管消融术是阵发性 AF 患者的有效治疗选择。然而，传统的逐点射频消融可能既耗时又具有技术挑战性。为了在不影响手术结果的情况下简化消融程序，已经开发了几种“单次”消融系统。多电极射频球囊导管 HELIOSTAR 是一款 28 毫米顺应球囊，与 CARTO 3D 电解剖标测系统兼容；描述了执行 PVI 的优化分步工作流程。

方法

手术在全身麻醉下通过独特的经中隔穿刺进行。为了评估最佳电极-组织接触和最佳 RF Balloon 定位，应满足以下基线指标：膨胀指数 > 0.8，阻抗范围接近 100 欧姆，电极间的变异性小于 20 欧姆，所有电极的温度变异性 < 3 °C，最高温度为 31 °C。

结果

在食管温度升高（与基线相比 > 2 °C）的情况下，沿后壁的 RF 传递被编程为 20 秒或更短，所有其他段为 60 秒。PVI 的目标参数是 1) 隔离时间小于 12 秒；2) 阻抗下降 > 12 欧姆；3) 温升 > 6 °C。

结论

RF Balloon 的标准化工作流程对于使用这种新的有前途的技术实现有效性和安全性是必不可少的。在缺乏国际指南的情况下，针对 PVI 描述了单一的大容量中心程序策略。