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两代冷冻球囊消融术单次治疗后的两年临床结果比较。

Two-year clinical outcome after a single cryoballoon ablation procedure: A comparison of first- and second-generation cryoballoons.

机构信息

Clinique Ambroise-Paré, 25-27 boulevard Victor-Hugo, 92200 Neuilly-sur-Seine, France; Cardiology department and Paris Cardiovascular Research Centre, European Georges-Pompidou Hospital, Paris, France.

Cardiology Department, Pasteur University Hospital, Nice, France.

出版信息

Arch Cardiovasc Dis. 2017 Oct;110(10):543-549. doi: 10.1016/j.acvd.2017.01.015. Epub 2017 Sep 25.

Abstract

BACKGROUND

The ablation of paroxysmal atrial fibrillation (PAF) by cryoballoon has increased dramatically in recent years. However, there are few data comparing first- and second-generation cryoballoons.

AIM

To compare safety and mid-term (2-year) efficacy of first- and second-generation cryoballoons in PAF ablation, using cryoballoon size tailored to pulmonary vein anatomy.

METHODS

In this single-centre study, we included the last 50 consecutive PAF patients who underwent cryoballoon-based pulmonary vein isolation using the first-generation cryoballoon (CB-1) and the first 50 patients using the second-generation cryoballoon (CB-2). The choice of 23 or 28mm cryoballoon was driven by patient anatomy. After discharge, follow-up was with systematic outpatient visits at 3, 6, 9, 12 and 24 months, including 12-lead electrocardiogram, Holter monitoring and telephone interviews, plus additional electrocardiograms, as required, in case of symptoms. Arrhythmia recurrence was defined as a documented atrial tachycardia or fibrillation episode>30seconds after a 3-month blanking period.

RESULTS

At 24 months, freedom from arrhythmia after a single procedure was similar for both generations of cryoballoon (72.0% and 72.0% for CB-1 and CB-2, respectively; P=0.95). Mean procedure and fluoroscopy times were longer in the CB-1 group than in the CB-2 group: 139±37.8 vs 95.2±21.3minutes and 10.2±7.2 vs 5.1±2.4minutes, respectively (P<0.02 for both). Transient right phrenic nerve palsy occurred only in the CB-1 group (five patients, 9.8%).

CONCLUSIONS

CB-1 and CB-2 showed similar efficacy for PAF ablation, with similar arrhythmia recurrence 24 months after a single ablation procedure. However, our findings suggest that CB-2 may have more effective cooling capabilities, enabling shorter procedure and fluoroscopy times.

摘要

背景

近年来,冷冻球囊消融阵发性心房颤动(PAF)的应用显著增加。然而,比较第一代和第二代冷冻球囊的数据很少。

目的

使用针对肺静脉解剖结构定制的冷冻球囊大小,比较第一代和第二代冷冻球囊在 PAF 消融中的安全性和中期(2 年)疗效。

方法

在这项单中心研究中,我们纳入了最后 50 例连续接受基于冷冻球囊的肺静脉隔离治疗的 PAF 患者,其中 25 例使用第一代冷冻球囊(CB-1),另外 25 例使用第二代冷冻球囊(CB-2)。23 或 28mm 冷冻球囊的选择取决于患者的解剖结构。出院后,通过 3、6、9、12 和 24 个月的系统门诊随访,包括 12 导联心电图、动态心电图监测和电话访谈,并根据需要在出现症状时额外进行心电图检查。心律失常复发定义为在 3 个月的空白期后记录到的心房心动过速或颤动发作持续>30 秒。

结果

在 24 个月时,两种冷冻球囊在单次消融后的无心律失常率相似(CB-1 组为 72.0%,CB-2 组为 72.0%;P=0.95)。CB-1 组的平均手术和透视时间均长于 CB-2 组:分别为 139±37.8 分钟和 95.2±21.3 分钟,10.2±7.2 分钟和 5.1±2.4 分钟(均 P<0.02)。暂时性右侧膈神经麻痹仅发生在 CB-1 组(5 例,9.8%)。

结论

CB-1 和 CB-2 在 PAF 消融中的疗效相似,单次消融后 24 个月的心律失常复发率相似。然而,我们的发现表明 CB-2 可能具有更有效的冷却能力,能够缩短手术和透视时间。

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