Background

Pulmonary vein isolation (PVI) using the second-generation cryoballoon (CB2) for atrial fibrillation (AF) treatment has demonstrated encouraging procedural success rates and mid-term results. However, long-term follow-up data on outcome is sparse. The current study is reporting on five-year clinical outcomes following CB2-based PVI in patients with paroxysmal AF (PAF) and persistent AF (PersAF).

Methods

A total of 139 patients underwent index CB2-based PVI patients (PAF: n = 105, 76% and PersAF: n = 34, 34%) in two electrophysiology centers. Freeze-cycle duration was 240 s. After successful PVI a bonus freeze-cycle of the same duration was applied in the first 71 patients while the bonus-freeze was omitted in 68 following patients. Three patients (2.2%) were lost to follow-up.

Results

After a median follow-up duration of 60 months (interquartile range: 46, 72 months) 74/136 (54.4%) patients remained in stable sinus rhythm (PAF: 62/104, 59.6%; PersAF: 15/32, 46.9%). Significant differences were observed concerning 5-year clinical outcome between PAF and PersAF patients (p = 0.0315). After a mean of 1.32 ± 0.6 procedures (2nd and 3rd procedure by radiofrequency ablation) and a median follow-up duration of 60 (37, 68) months 90/136 (66.2%) patients remained in stable sinus rhythm (PAF: 72/104 (69.2%), PersAF: 21/32 (65.6%), p = 0.0276). For the comparison of bonus-freeze vs no-bonus-freeze protocols no differences were observed (53.5% vs 57.4%, p = 0.650).

Conclusions

The five-year single-procedure success rate for CB2-based PVI was 54.4% and increased to 66.2% following repeat RF-based procedures. No differences were detected comparing bonus-freeze and no-bonus-freeze protocols.

中文翻译：

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基于第二代冷冻气球的肺静脉隔离：五年随访的经验教训。

背景

使用第二代冷冻球囊（CB2）进行房颤（AF）治疗的肺静脉隔离（PVI）已显示出令人鼓舞的程序成功率和中期结果。但是，有关结果的长期随访数据很少。当前的研究报道了阵发性房颤（PAF）和持续性房颤（PersAF）患者基于CB2的PVI术后的五年临床结果。

方法

在两个电生理中心，共有139例患者接受了基于CB2指数的PVI患者（PAF：n = 105，76％，PersAF：n = 34，34％）。冻结周期持续时间为240 s。在成功进行PVI后，对前71名患者应用了相同持续时间的额外冷冻周期，而在随后的68位患者中省略了额外冷冻。三名患者（2.2％）失去随访。

结果

中位随访时间为60个月（四分位间距：46、72个月）后，有74/136（54.4％）的患者保持稳定的窦性心律（PAF：62/104，59.6％; PersAF：15/32，46.9％ ）。在PAF和PersAF患者的5年临床结局方面观察到了显着差异（p = 0.0315）。经过平均1.32±0.6的手术（射频消融的第二和第三次手术）和60（37，68）个月的中位随访时间90/136（66.2％）患者保持稳定的窦性心律（PAF：72 / 104（69.2％），PersAF：21/32（65.6％），p = 0.0276）。对于奖金冻结与无奖金冻结协议的比较，未观察到差异（53.5％对57.4％，p = 0.650）。

结论

基于CB2的PVI的五年单程成功率是54.4％，并在重复基于RF的程序后提高到66.2％。比较红利冻结和无红利冻结方案，没有发现差异。