Ablation of atrial fibrillation with cryoballoon or duty-cycled radiofrequency pulmonary vein ablation catheter: a randomized controlled study comparing the clinical outcome and safety; the AF-COR study
Ablation of atrial fibrillation with cryoballoon or duty-cycled radiofrequency pulmonary vein ablation catheter: a randomized controlled study comparing the clinical outcome and safety; the AF-COR study
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DOI：
10.1093/europace/eut104
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发表时间：
2013-11-01
期刊：
影响因子：
6.1
通讯作者：
Blomstrom-Lundqvist, Carina
中科院分区：
文献类型：
--
作者：
Malmborg, Helena;Lonnerholm, Stefan;Blomstrom-Lundqvist, Carina
促进房颤（AF）消融手术的迫切需要导致开发了专门设计为肺静脉隔离（PVI）一次性工具的新型消融导管。本研究的目的是比较使用不同能量源的两种导管的有效性、安全性和手术时间。110例转诊接受阵发性或持续性房颤消融的患者随机接受冷冻球囊或环形多极工作循环射频肺静脉消融导管（PVAC）治疗。冷冻球囊组和PVAC组分别有98例和93例患者实现了完全肺静脉隔离，并发症发生率分别为8例和2例（P 0.2）。冷冻球囊组46例患者在单次消融术后完全无AF，12个月后为34例（P 0.2）。手术时间相当，但冷冻球囊的透视时间（32 16 min）短于PVAC手术（47 17 min）（P 0.001）。消融术后，两组患者的生活质量（QoL）和肺动脉高压相关症状均得到显著改善。除了冷冻球囊的荧光透视时间更短外，两种导管均被证明在实现急性肺静脉隔离方面有效且安全。随访时，两组间无房颤和临床成功率无统计学显著差异。生活质量增加到相同的水平，为一般瑞典人口在这两个群体。
The urge to facilitate the atrial fibrillation (AF) ablation procedure has led to the development of new ablation catheters specifically designed as one-shot tools for pulmonary vein isolation (PVI). The purpose of this study was to compare the efficacy, safety, and procedure times for two such catheters using different energy sources.One hundred and ten patients, referred for ablation of paroxysmal or persistent AF, were randomized to treatment with either the cryoballoon or the circular multipolar duty-cycled radiofrequency-based pulmonary vein ablation catheter (PVAC). Complete PVI was achieved in 98 vs. 93 patients in the cryoballoon and PVAC group, respectively, with complication rates of 8 vs. 2 (P 0.2). Complete freedom from AF, without antiarrhythmic drugs, after one single ablation procedure was seen in 46 in the cryoballoon vs. 34 after 12 months (P 0.2). Procedure times were comparable, but fluoroscopy time was shorter for the cryoballoon (32 16 min) than for the PVAC procedures (47 17 min) (P 0.001). A significant improvement of quality of life (QoL) and arrhythmia-related symptoms was seen in both groups after ablation.Both catheters proved comparably effective and safe in achieving acute PVI, apart from the shorter fluoroscopy times achieved with the cryoballoon. At follow-up, there was no statistically significant difference between the groups regarding freedom from AF and clinical success. The QoL increased to the same levels as for the general Swedish population in both groups.