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第二代冷冻球囊与接触力射频消融治疗心房颤动的比较:来自随机对照试验的证据的更新荟萃分析。

Second-generation cryoballoon versus contact force radiofrequency ablation for atrial fibrillation: an updated meta-analysis of evidence from randomized controlled trials.

机构信息

The First College of Clinical Medicine, Zhejiang Chinese Medical University, Hangzhou, China.

Department of Cardiology, Qingdao Hospital of Traditional Chinese Medicine (Qingdao Hiser Hospital), Qingdao, 266000, China.

出版信息

Sci Rep. 2021 Sep 9;11(1):17907. doi: 10.1038/s41598-021-96820-8.

Abstract

Catheter ablation has been recommended for patients with symptomatic atrial fibrillation (AF), with pulmonary vein isolation being the cornerstone of the ablation procedure. Newly developed technologies, such as cryoballoon ablation with a second-generation cryoballoon (CB2) and the contact force radiofrequency (CF-RF) ablation, have been introduced in recent years to overcome the shortcomings of the widely used RF ablation approach. However, high-quality results comparing CB2 and CF-RF remain controversial. Thus, we conducted this meta-analysis to assess the efficacy and safety between CB2 and CF-RF using evidence from randomized controlled trials (RCTs). Databases including Embase, PubMed, the Cochrane Library, and ClinicalTrials.gov were systematically searched from their date of inception to January 2021. Only RCTs that met the inclusion criteria were included for analysis. The primary outcome of interest was freedom from atrial tachyarrhythmia (AT) during follow-up. Secondary outcomes included procedure-related complications, procedure time and fluoroscopy time. Six RCTs with a total of 987 patients were finally enrolled. No significant differences were found between CB2 and CF-RF in terms of freedom from AT (relative risk [RR] = 1.03, 95% confidence interval [CI] 0.92-1.14, p = 0.616) or total procedural-related complications (RR = 1.25, 95% CI 0.69-2.27, p = 0.457). CB2 treatment was associated with a significantly higher risk of phrenic nerve palsy (PNP) than CF-RF (RR = 4.93, 95% CI 1.12-21.73, p = 0.035). The occurrences of pericardial effusion/tamponade and vascular complications were comparable between the CB2 and CF-RF treatments (RR = 0.41, p = 0.398; RR = 0.82, p = 0.632). In addition, CB2 treatment had a significantly shorter procedure time than CF-RF (weighted mean difference [WMD] = - 20.75 min, 95% CI - 25.44 ~ - 16.05 min, P < 0.001), whereas no difference was found in terms of fluoroscopy time (WMD = 4.63 min, p = 0.179). CB2 and CF-RF treatment are comparable for AF patients regarding freedom from AT and procedure-related complications. Compared to CF-RF, CB2 treatment was associated with a shorter procedure time but a higher incidence of PNP. Further large-scale studies are warranted to compare these two techniques and provide an up-to-date recommendation.

摘要

导管消融已被推荐用于有症状的心房颤动 (AF) 患者,肺静脉隔离是消融程序的基石。近年来,新开发的技术,如第二代冷冻球囊消融 (CB2) 和接触力射频 (CF-RF) 消融,已被引入,以克服广泛使用的射频消融方法的缺点。然而,比较 CB2 和 CF-RF 的高质量结果仍存在争议。因此,我们进行了这项荟萃分析,使用来自随机对照试验 (RCT) 的证据来评估 CB2 和 CF-RF 的疗效和安全性。从数据库包括 Embase、PubMed、Cochrane 图书馆和 ClinicalTrials.gov 系统地搜索了从成立日期到 2021 年 1 月的数据。只有符合纳入标准的 RCT 才被纳入分析。主要观察终点是随访期间无房性快速性心律失常 (AT)。次要观察终点包括与操作相关的并发症、操作时间和透视时间。最终纳入了 6 项共 987 例患者的 RCT。CB2 和 CF-RF 在无 AT 方面(RR=1.03,95%CI 0.92-1.14,p=0.616)或总操作相关并发症(RR=1.25,95%CI 0.69-2.27,p=0.457)方面无显著差异。与 CF-RF 相比,CB2 治疗与膈神经麻痹(PNP)的风险显著增加(RR=4.93,95%CI 1.12-21.73,p=0.035)。心包积液/填塞和血管并发症的发生在 CB2 和 CF-RF 治疗之间无差异(RR=0.41,p=0.398;RR=0.82,p=0.632)。此外,CB2 治疗的手术时间明显短于 CF-RF(加权均数差 [WMD]=-20.75 分钟,95%CI -25.44~-16.05 分钟,P<0.001),而透视时间无差异(WMD=4.63 分钟,p=0.179)。CB2 和 CF-RF 治疗在 AF 患者的无 AT 和操作相关并发症方面是可比的。与 CF-RF 相比,CB2 治疗与较短的手术时间相关,但膈神经麻痹的发生率较高。需要进一步的大规模研究来比较这两种技术,并提供最新的推荐意见。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6e4f/8429450/1cf407324b5f/41598_2021_96820_Fig1_HTML.jpg

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