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第二代与第一代冷冻球囊治疗心房颤动的安全性和有效性:当前证据的荟萃分析

Safety and efficacy of second-generation versus first-generation cryoballoons for treatment of atrial fibrillation: a meta-analysis of current evidence.

作者信息

Pandya Bhavi, Sheikh Azfar, Spagnola Jonathan, Bekheit Soad, Lafferty James, Kowalski Marcin

机构信息

Department of Internal Medicine, Staten Island University Hospital, 475 Seaview Avenue, Staten Island, NY, 10305, USA.

Department of Cardiology, Staten Island University Hospital, 475 Seaview Avenue, Staten Island, NY, 10305, USA.

出版信息

J Interv Card Electrophysiol. 2016 Jan;45(1):49-56. doi: 10.1007/s10840-015-0075-4. Epub 2015 Nov 18.

Abstract

BACKGROUND

The newer second-generation cryoballoons (CB-2 or Arc-Adv-CB) have been shown to achieve significantly lower temperature and faster pulmonary vein isolation (PVI) time in comparison with first-generation cryoballoons (CB-1 or Arc-CB). To test the premise that second-generation cryoballoons can improve clinical outcomes in comparison to first-generation cryoballoons in terms of safety and efficacy, we pooled data for systemic review and meta-analyses from all available literature comparing their clinical performance.

METHODS

The Cochrane Library, PubMed, Google Scholar, and studies presented at various meetings were searched for any published literature comparing safety and efficacy of the second-generation cryoballoons (Arctic Front Advance cryoballoons) with first-generation cryoballoons (Arctic Front Cryoballoons). A total of ten published studies, with 2310 patients, were included in this meta-analysis with 957 patients in second-generation cryoballoon group and 1237 patients in first-generation cryoballoon group.

RESULTS

The pooled analysis showed significant superiority of second-generation cryoballoons in terms of less procedure time, less fluoroscopic time, and fewer incidences of arrhythmia recurrences compared to first-generation cryoballoons at the cost of higher incidence of persistent and transient phrenic nerve palsy. The differences in the rate of pericardial effusion and incidence of access site complications were not statistically significant.

CONCLUSIONS

Second-generation cryoballoons are associated with a shorter procedure time and fluoroscopy time, along with lower arrhythmia recurrence rates, reflecting higher procedure efficacy when compared to first-generation cryoballoons. However, they are also associated with a higher incidence of transient and persistent phrenic nerve palsies with a non-significant difference in rates of access site complications and pericardial effusion.

摘要

背景

与第一代冷冻球囊(CB-1或Arc-CB)相比,新型第二代冷冻球囊(CB-2或Arc-Adv-CB)已被证明能达到显著更低的温度和更快的肺静脉隔离(PVI)时间。为了验证与第一代冷冻球囊相比,第二代冷冻球囊在安全性和有效性方面可改善临床结局这一前提,我们汇总了所有比较其临床性能的现有文献数据进行系统评价和荟萃分析。

方法

检索Cochrane图书馆、PubMed、谷歌学术以及在各种会议上发表的研究,以查找任何比较第二代冷冻球囊(北极锋高级冷冻球囊)与第一代冷冻球囊(北极锋冷冻球囊)安全性和有效性的已发表文献。本荟萃分析共纳入10项已发表研究,涉及2310例患者,其中第二代冷冻球囊组957例患者,第一代冷冻球囊组1237例患者。

结果

汇总分析显示,与第一代冷冻球囊相比,第二代冷冻球囊在手术时间更短、透视时间更短以及心律失常复发发生率更低方面具有显著优势,但代价是持续性和短暂性膈神经麻痹的发生率更高。心包积液发生率和穿刺部位并发症发生率的差异无统计学意义。

结论

与第一代冷冻球囊相比,第二代冷冻球囊手术时间和透视时间更短,心律失常复发率更低,反映出更高的手术疗效。然而,它们也与短暂性和持续性膈神经麻痹的发生率较高相关,穿刺部位并发症发生率和心包积液发生率差异无统计学意义。

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