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随机对照试验:使用一氧化二氮与氩气基冷冻消融的同时迷宫手术。

Randomized Trial of Concomitant Maze Procedure Using Nitrous Oxide- Versus Argon-Based Cryoablation.

机构信息

Departments of Thoracic and Cardiovascular Surgery and Statistics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Departments of Thoracic and Cardiovascular Surgery and Statistics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

出版信息

Ann Thorac Surg. 2019 Jul;108(1):30-36. doi: 10.1016/j.athoracsur.2019.01.005. Epub 2019 Feb 1.

Abstract

BACKGROUND

Currently, two types of cryoprobes are available: nitrous oxide (NO)-based and argon gas-based. However, few studies have compared the outcomes obtained with these two cryoprobe types. The aim of this study was to compare the early outcomes of a concomitant maze procedure using NO-based cryoablation (the NO group) versus argon gas-based cryoablation (the argon group) in patients with persistent atrial fibrillation (AF).

METHODS

This study was a single-center, prospective, randomized controlled clinical trial. Sixty patients were randomly assigned to receive a concomitant maze procedure using NO-based cryoablation (n = 30) or argon gas-based cryoablation (n = 30) for persistent AF. Patients were followed up at 3, 6, and 12 months by electrocardiography, 24-hour Holter monitoring, and transthoracic echocardiography.

RESULTS

No important intergroup differences were observed in terms of preoperative variables, morbidity, or mortality. During 1 year of follow-up, normal sinus rhythm was maintained in 26 patients in the NO group and 26 patients in the argon group (86.7% versus 86.7%, p = 1.000). Freedom from atrial arrhythmia events at 12 months was observed in 84.5% ± 4.7% without intergroup differences. Early AF episode before discharge was correlated with atrial arrhythmia events during follow-up (hazard ratio 7.89, 95% confidence interval: 1.75 to 35, p = 0.007). The NO group showed earlier recovery of left atrial activity compared with the argon group (p = 0.043); however, this difference disappeared after 6 months.

CONCLUSIONS

Both procedures have similar 1-year sinus rhythm maintenance rates. Left atrial contractile activity tends to return earlier in the NO group.

摘要

背景

目前有两种类型的冷冻探针可供使用:一氧化二氮(NO)基和氩气基。然而,很少有研究比较这两种冷冻探针类型的结果。本研究旨在比较使用 NO 基冷冻消融(NO 组)与氩气基冷冻消融(氩气组)对持续性心房颤动(AF)患者同期迷宫手术的早期结果。

方法

这是一项单中心、前瞻性、随机对照临床试验。60 名患者被随机分配接受使用 NO 基冷冻消融(n=30)或氩气基冷冻消融(n=30)进行持续性 AF 的同期迷宫手术。通过心电图、24 小时 Holter 监测和经胸超声心动图在 3、6 和 12 个月对患者进行随访。

结果

在术前变量、发病率或死亡率方面,两组之间没有观察到重要的组间差异。在 1 年的随访期间,NO 组有 26 例患者和氩气组有 26 例患者维持窦性心律(86.7%对 86.7%,p=1.000)。12 个月时无房性心律失常事件的无事件率为 84.5%±4.7%,两组间无差异。出院前早期 AF 发作与随访期间的房性心律失常事件相关(危险比 7.89,95%置信区间:1.75 至 35,p=0.007)。与氩气组相比,NO 组左房活动的恢复更早(p=0.043);然而,这种差异在 6 个月后消失。

结论

两种方法 1 年的窦性心律维持率相似。NO 组左房收缩活动的恢复往往更早。

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