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第二代冷冻球囊消融治疗持续性心房颤动:一项更新的荟萃分析。

Second generation cryoballoon ablation for persistent atrial fibrillation: an updated meta-analysis.

机构信息

Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.

出版信息

Clin Res Cardiol. 2018 Feb;107(2):182-192. doi: 10.1007/s00392-017-1171-5. Epub 2017 Oct 26.

Abstract

BACKGROUND

Catheter ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). The cornerstone of AF ablation is pulmonary vein isolation (PVI). The second-generation cryoballoon (2G-CB) has shown non-inferiority to radiofrequency (RF) ablation in paroxysmal AF in several trials. Growing evidence suggests that 2G-CB is also effective in patients with persistent AF (perAF). The aim of this study was to summarize and analyze available data on safety and mid-term (≥ 12 months) efficacy of PVI using 2G-CB in patients with perAF.

METHODS

We did a search in PubMed, Web of Science, Cochrane Library, and clinicaltrials.gov in December 2016 for studies of 2G-CB ablation for perAF. Studies reporting clinical success rates at a follow-up (FU) of ≥ 12 months were included. Success was defined as freedom from any atrial arrhythmia lasting > 30 s after an initial blanking period of 3 months. Acute success and complication rates were also assessed. Data were analyzed applying random-effects model.

RESULTS

A total of 917 patients from 11 studies meeting study inclusion criteria were analyzed. After a mean FU of 16.7 ± 3.0 months, 68.9% were free from recurrences [95% confidence interval (CI) 63.4-74.7%]. Overall acute success rate was 99.7% (95% CI 99.2-100%). Complications occurred in 5.5% (95% CI 2.4-9.6%). Vascular access complications were the most frequent 3.3% (95% CI 1.5-5.6%). The rate of phrenic nerve palsy/injury was 2.09% (95% CI 0.8-3.9%). No death, stroke or myocardial infarction was reported.

CONCLUSION

The 2G-CB seems to be safe and effective in the treatment of perAF in the mid-term.

摘要

背景

导管消融是治疗有症状心房颤动(房颤)患者的一种既定治疗选择。房颤消融的基石是肺静脉隔离(PVI)。第二代冷冻球囊(2G-CB)在几项临床试验中已证明在阵发性房颤中不劣于射频(RF)消融。越来越多的证据表明,2G-CB 对持续性房颤(perAF)患者也有效。本研究的目的是总结和分析目前使用 2G-CB 进行 PVI 治疗 perAF 的安全性和中期(≥12 个月)疗效的可用数据。

方法

我们于 2016 年 12 月在 PubMed、Web of Science、Cochrane Library 和 clinicaltrials.gov 中搜索了 2G-CB 消融治疗 perAF 的研究。包括随访(FU)≥12 个月的临床成功率报告的研究。成功定义为初始空白期为 3 个月后,无任何持续时间>30 秒的房性心律失常。还评估了急性成功率和并发症发生率。数据应用随机效应模型进行分析。

结果

共有 11 项符合研究纳入标准的研究的 917 例患者纳入分析。在平均 FU 16.7±3.0 个月后,68.9%的患者无复发[95%置信区间(CI)63.4-74.7%]。总体急性成功率为 99.7%(95% CI 99.2-100%)。并发症发生率为 5.5%(95% CI 2.4-9.6%)。血管通路并发症最常见,为 3.3%(95% CI 1.5-5.6%)。膈神经麻痹/损伤的发生率为 2.09%(95% CI 0.8-3.9%)。无死亡、卒中和心肌梗死报告。

结论

2G-CB 在中期治疗 perAF 似乎是安全有效的。

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