Cardioangiologisches Centrum Bethanien, Frankfurt, Germany.
Universitätsklinikum Frankfurt, Medizinische Klinik 3- Klinik für Kardiologie, Frankfurt, Germany.
J Cardiovasc Electrophysiol. 2022 Jul;33(7):1371-1379. doi: 10.1111/jce.15519. Epub 2022 May 8.
The iCLAS ultra-low temperature cryoablation (ULTC) system has recently been brought to the market. A combination of a newly exploited cryogen and interchangeable stylet enables flexible and continuous lesion creation in atrial fibrillation (AF) ablation. The use of an esophageal warming balloon is recommended when using the system to reduce the potential for collateral esophageal injury.
To describe the initial clinical experience when using ULTC in the AF treatment without general anesthesia (GA).
Consecutive patients undergoing AF ablation using ULTC under deep sedation without GA were enrolled. We assessed the procedural data focusing on "single-shot isolation" defined as successful pulmonary vein (PV) isolation after the first application. Esophagogastroduodenoscopy was systematically performed the day after ablation.
A total of 27 AF patients (67% paroxysmal AF) were analyzed. Onehundred four out of 106 PVs (98.1%) were isolated solely using ULTC. The mean procedure time was 79 ± 30 min. The mean number of applications per PV was 2.6 ± 1.0. Single-shot isolation was achieved in 57 PVs (54%) varying across PVs from left superior to inferior PVs (40%-64%). The single procedure 6-month recurrence-free rate was 84%. No major complication (cerebrovascular event, pericardial effusion/tamponade, esophageal damage on esophagogastroduodenoscopy) occurred. A single transient phrenic nerve palsy occurred during the right superior PV ablation, which had recovered by the 3-month follow-up appointment.
AF ablation using the novel ULTC system seemed feasible without GA and enabled a >50% single-shot isolation rate. The promising safety profile has to be confirmed in large-scale studies.
iCLAS 超低温冷冻消融（ULTC）系统最近已推向市场。一种新开发的冷冻剂和可互换的导丝的结合使房颤（AF）消融中的灵活连续的病变形成成为可能。当使用该系统时，建议使用食管加热球囊以减少潜在的食管旁损伤。
描述在无全身麻醉（GA）的情况下使用 ULTC 治疗 AF 的初步临床经验。
连续纳入在深度镇静下接受 AF 消融的患者，无需 GA。我们评估了侧重于“单次隔离”的程序数据，定义为第一次应用后成功的肺静脉（PV）隔离。消融后第二天系统地进行食管胃十二指肠镜检查。
共分析了 27 例 AF 患者（67%为阵发性 AF）。106 个 PV 中有 104 个（98.1%）仅使用 ULTC 进行隔离。平均手术时间为 79±30 分钟。每个 PV 的平均应用次数为 2.6±1.0。57 个 PV （54%）实现单次隔离，左优势到下 PV （40%-64%）各不相同。单次手术 6 个月无复发率为 84%。无主要并发症（脑血管事件、心包积液/填塞、食管损伤）发生。在右优势 PV 消融期间发生一过性膈神经麻痹，在 3 个月的随访时已恢复。
使用新型 ULTC 系统进行 AF 消融似乎在无 GA 的情况下是可行的，并且能够实现>50%的单次隔离率。在大规模研究中需要证实有前景的安全性。
