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冷冻球囊与射频消融治疗心房颤动的比较:基于 ESC-EHRA 心房颤动消融长期注册登记研究和瑞典导管消融注册登记研究的结局和安全性分析。

Cryoballoon vs. radiofrequency ablation for atrial fibrillation: a study of outcome and safety based on the ESC-EHRA atrial fibrillation ablation long-term registry and the Swedish catheter ablation registry.

机构信息

Department of Medical Sciences, Uppsala University, Uppsala, Sweden.

Arrhythmia Section, Cardiology Department, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.

出版信息

Europace. 2019 Apr 1;21(4):581-589. doi: 10.1093/europace/euy239.

Abstract

AIMS

Pulmonary vein isolation (PVI), the standard for atrial fibrillation (AF) ablation, is most commonly applied with radiofrequency (RF) energy, although cryoballoon technology (CRYO) has gained widespread use. The aim was to compare the second-generation cryoballoon and the irrigated RF energy regarding outcomes and safety.

METHODS AND RESULTS

Of 4657 patients undergoing their first AF ablation, 982 with CRYO and 3675 with RF energy were included from the Swedish catheter ablation registry and the Atrial Fibrillation Ablation Long-Term registry of the European Heart Rhythm Association of the European Society of Cardiology. The primary endpoint was repeat AF ablation. The major secondary endpoints included procedural duration, tachyarrhythmia recurrence, and complication rate. The re-ablation rate after 12 months was significantly lower in the CRYO vs. the RF group, 7.8% vs. 11%, P = 0.005, while freedom from arrhythmia recurrence (30 s duration) did not differ between the groups, 70.2 % vs. 68.2%, P = 0.44. The result was not influenced by AF type and lesion sets applied. In the Cox regression analysis, paroxysmal AF had significantly lower risk for re-ablation with CRYO, hazard ratio 0.56 (P = 0.041). Procedural duration was significantly shorter with CRYO than RF, (mean ± SD) 133.6 ± 45.2 min vs. 174.6 ± 58.2 min, P < 0.001. Complication rates were similar; 53/982 (5.4%) vs. 191/3675 (5.2%), CRYO vs. RF, P = 0.806.

CONCLUSION

The lower re-ablation rates and shorter procedure times observed with the cryoballoon as compared to RF ablation may have important clinical implications when choosing AF ablation technique despite recognized limitations with registries.

摘要

目的

肺静脉隔离(PVI)是房颤(AF)消融的标准方法,最常应用射频(RF)能量,但冷冻球囊技术(CRYO)已广泛应用。本研究旨在比较第二代冷冻球囊和灌流 RF 能量在疗效和安全性方面的差异。

方法和结果

在瑞典导管消融登记处和欧洲心脏病学会的欧洲心律协会房颤消融长期登记处,纳入了 4657 例首次接受 AF 消融的患者,其中 982 例接受了 CRYO 消融,3675 例接受了 RF 消融。主要终点是再次行 AF 消融。主要次要终点包括手术时间、快速性心律失常复发和并发症发生率。12 个月时,CRYO 组的再消融率明显低于 RF 组,分别为 7.8%和 11%,P=0.005,而两组心律失常复发(持续 30 s)的无复发率无差异,分别为 70.2%和 68.2%,P=0.44。该结果不受 AF 类型和应用的消融策略影响。在 Cox 回归分析中,阵发性 AF 接受 CRYO 治疗的再消融风险显著降低,风险比 0.56(P=0.041)。CRYO 组的手术时间明显短于 RF 组,(平均±标准差)分别为 133.6±45.2 min 和 174.6±58.2 min,P<0.001。并发症发生率相似;53/982(5.4%)与 191/3675(5.2%),CRYO 与 RF,P=0.806。

结论

与 RF 消融相比,冷冻球囊的再消融率较低,手术时间较短,尽管注册研究存在局限性,但在选择 AF 消融技术时可能具有重要的临床意义。

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