Luik Armin, Kunzmann Kevin, Hörmann Patrick, Schmidt Kerstin, Radzewitz Andrea, Bramlage Peter, Schenk Thomas, Schymik Gerhard, Merkel Matthias, Kieser Meinhard, Schmitt Claus
Medizinische Klinik IV, Städtisches Klinikum Karlsruhe, Academic Teaching Hospital of the University of Freiburg, Karlsruhe, Germany.
Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
BMC Cardiovasc Disord. 2017 May 25;17(1):135. doi: 10.1186/s12872-017-0566-6.
Effective treatment of paroxysmal atrial fibrillation (AF) is essential for reducing the risk of stroke and heart failure. Cryoballoon (CB) ablation has been developed as an alternative to the use of radiofrequency (RF) energy for electrical isolation of the pulmonary veins. Herein, we provide long-term data regarding the efficacy of CB ablation in comparison to RF.
FreezeAF was a randomised non-inferiority study comparing CB ablation with RF ablation for the treatment of patients with drug-refractory paroxysmal AF. Procedural success for the long-term follow-up (30 months) was defined as freedom from AF with an absence of persistent complications.
Of the 315 patients that were randomised and received catheter ablation, 292 (92.7%) completed the 30-month follow-up (147 in the RF group and 145 in the CB group). The baseline characteristics of the RF and CB groups were similar. Single-procedure success was achieved by 40% of patients in the RF group and 42% of the CB group (p < 0.001 for non-inferiority). When including re-do procedures in the analysis, the multiple procedure success rate was 72% in the RF group and 76% in the CB group.
The data provide long-term evidence that CB ablation is non-inferior to RF ablation, with high proportions of patients reporting freedom from AF 30 months after the index procedure.
ClinicalTrials.gov Identifier: NCT00774566 ; first registered October 16, 2008; first patient included October 20, 2008.
有效治疗阵发性心房颤动（AF）对于降低中风和心力衰竭风险至关重要。冷冻球囊（CB）消融术已被开发出来，作为使用射频（RF）能量进行肺静脉电隔离的替代方法。在此，我们提供关于CB消融术与RF消融术疗效的长期数据。
FreezeAF是一项随机非劣效性研究，比较CB消融术与RF消融术治疗药物难治性阵发性AF患者的效果。长期随访（30个月）的手术成功率定义为无AF且无持续性并发症。
在315例随机接受导管消融的患者中，292例（92.7%）完成了30个月的随访（RF组147例，CB组145例）。RF组和CB组的基线特征相似。RF组40%的患者和CB组42%的患者单次手术成功（非劣效性p<0.001）。在分析中纳入再次手术时，RF组的多次手术成功率为72%，CB组为76%。
这些数据提供了长期证据，表明CB消融术不劣于RF消融术，在首次手术后30个月，高比例患者报告无AF。
ClinicalTrials.gov标识符：NCT00774566；首次注册于2008年10月16日；首例患者纳入于2008年10月20日。
