Department of Cardiology and Internal Intensive Care Medicine, Heart Center Munich-Bogenhausen, Munich Municipal Hospital Group, Englschalkinger Str. 77, 81925 Munich, Germany
Department of Cardiology and Internal Intensive Care Medicine, Heart Center Munich-Bogenhausen, Munich Municipal Hospital Group, Englschalkinger Str. 77, 81925 Munich, Germany.
Europace. 2014 Oct;16(10):1434-42. doi: 10.1093/europace/euu162. Epub 2014 Jul 3.
Cryoballoon (CB) ablation with the second-generation cryoballoon (CBG2) seems to be more effective than its predecessor [first-generation cryoballoon (CBG1)], but phrenic nerve palsies were observed more frequently. The aim of this study was to compare the safety and efficacy of CBG1 and CBG2 in a substudy of the prospective multicentre, multinational FREEZE Cohort Study.
Periprocedural data were analysed, and a total of 532 patients with paroxysmal atrial fibrillation (AF) were examined (n = 224 for CBG1 and n = 308 for CBG2). Procedure time decreased significantly from 149 to 130 min when comparing CBG1 with CBG2 (P < 0.0001), and pulmonary vein isolation (PVI) was achieved in 97.8 and 97.6% of PVs with CBG1 and CBG2 (P = 0.77), respectively. The need for dual-balloon usage within a procedure dropped (20.1 vs. 9.0%, P < 0.001), and the fluoroscopy time was reduced when operating the CBG2. Atrial fibrillation recurrence rates until discharge were similar (5.0 vs. 5.8%, P = 0.69). Comparable low rates of major complications were observed with both CBs, and there was a non-significant trend for more phrenic nerve palsies.
Second-generation cryoballoon demonstrated a high rate of acute PVI in a significant faster procedure, which also utilized less radiation exposure and less dual-balloon usage during an average procedure. The safety profile remains favourable with a non-significant trend for more phrenic nerve palsies. If the enhancements lead to a higher clinical benefit has to be determined. The 1-year outcome data from the ongoing FREEZE Cohort Study comparing radiofrequency and CB ablation will shed some light on that issue.
NCT01360008.
与第一代冷冻球囊（CBG1）相比，第二代冷冻球囊（CBG2）的冷冻球囊消融似乎更有效，但膈神经麻痹的发生率更高。本研究旨在比较 CBG1 和 CBG2 在前瞻性多中心、多国 FREEZE 队列研究的亚研究中的安全性和疗效。
分析了围手术期数据，共检查了 532 例阵发性心房颤动（AF）患者（CBG1 组 224 例，CBG2 组 308 例）。与 CBG1 相比，CBG2 的手术时间从 149 分钟显著缩短至 130 分钟（P<0.0001），CBG1 和 CBG2 分别实现了 97.8%和 97.6%的肺静脉隔离（P=0.77）。在一个手术中需要双球囊的情况减少（20.1%比 9.0%，P<0.001），并且使用 CBG2 时透视时间减少。直到出院时，房颤复发率相似（5.0%比 5.8%，P=0.69）。两种冷冻球囊的主要并发症发生率均较低，膈神经麻痹的发生率呈非显著增加趋势。
第二代冷冻球囊在明显更快的手术中显示出较高的急性 PVI 率，同时在平均手术中也减少了辐射暴露和双球囊的使用。安全性仍然良好，膈神经麻痹的发生率呈非显著增加趋势。如果这些改进带来更高的临床获益，还有待确定。正在进行的 FREEZE 队列研究比较射频消融和冷冻球囊消融的 1 年结果数据将对此问题有所启示。
NCT01360008。
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