Department of Cardiology, University Hospital Frankfurt, Frankfurt-am Main, Germany.
Department of Health Policy, London School of Economics and Political Science, London, UK.
Clin Res Cardiol. 2018 Aug;107(8):658-669. doi: 10.1007/s00392-018-1232-4. Epub 2018 Mar 21.
The aim of this study was to evaluate the clinical efficacy and safety outcomes of the treatment with cryoballoon (CB) compared to the treatment with traditional irrigated radiofrequency ablation (RF) for pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (pAF) and refractory to antiarrhythmic drug therapy (AAD).
We conducted a systemic review to find and include more than two randomized controlled trials (RCTs) with at least 20 patients in each of the CB and RF groups. Thereafter, we performed a meta-analysis to compare the treatment with CB and RF in primary outcomes including 1 year free from AF, complications and re-ablation procedures. Additionally, we evaluated procedure time and fluoroscopy duration in both groups. Risk of bias in the individual studies and across studies was assessed using Cochrane methods.
Two reviewers extracted study data and assessed risk of bias. Primary outcome data were extracted from the time point 1 year after the procedure. The random-effects model was used to calculate the odds ratio with 95% confidence interval.
Data sources utilized were PubMed and CENTRAL databases up to 16 June 2016.
Included studies were RCTs in adults with pAF and refractory to AAD in which CB therapy, including 1st and 2nd generation CB, was compared to the traditional irrigated RF therapy. Clinical outcomes assessed in each RCT were 1 year AF-free survival, complication rates, re-ablations, fluoroscopy time and procedure time.
The systematic review identified four randomized controlled trials that reported on comparative clinical outcomes involving 1284 patients. Our meta-analysis demonstrated that CB ablation had a non-significant higher success rate than RF therapy (OR 1.13; 95% CI 0.72-1.77). However, our study showed a relatively higher rate of complications in the CB group (OR 1.20; 95% CI 0.58-2.52). Furthermore, CB treatment was associated with a non-significant, shorter procedure time and marginally prolonged fluoroscopy time in comparison to RF treatment.
Our systemic review and meta-analysis revealed further evidence that cryoballoon ablation is an equally effective alternative procedure to the standard radiofrequency treatment with a slightly, non-significant higher freedom from AF 1 year after the ablation and a shorter procedure time.
本研究旨在评估与传统的冷盐水灌注定点消融（RF）相比，冷冻球囊（CB）治疗阵发性心房颤动（pAF）和抗心律失常药物治疗（AAD）无效患者的临床疗效和安全性结局。
我们进行了系统评价，以找到并纳入超过两项随机对照试验（RCT），每个 CB 和 RF 组至少有 20 名患者。然后，我们进行了荟萃分析，以比较 CB 和 RF 治疗的主要结局，包括 1 年无 AF、并发症和再消融程序。此外，我们还评估了两组的手术时间和透视时间。使用 Cochrane 方法评估个体研究和跨研究的偏倚风险。
两名审查员提取研究数据并评估偏倚风险。主要结局数据从术后 1 年的时间点提取。使用随机效应模型计算比值比及其 95%置信区间。
数据来源是截至 2016 年 6 月 16 日的 PubMed 和 CENTRAL 数据库。
纳入的研究是在对 AAD 无效的成年 pAF 患者中进行的 RCT，其中 CB 治疗，包括第一代和第二代 CB，与传统的冷盐水灌注定点消融治疗进行了比较。每个 RCT 评估的临床结局是 1 年无 AF 生存率、并发症发生率、再消融率、透视时间和手术时间。
系统评价确定了四项比较临床结局的随机对照试验，涉及 1284 名患者。我们的荟萃分析表明，CB 消融的成功率略高于 RF 治疗（比值比 1.13；95%置信区间 0.72-1.77）。然而，我们的研究显示 CB 组的并发症发生率相对较高（比值比 1.20；95%置信区间 0.58-2.52）。此外，与 RF 治疗相比，CB 治疗的手术时间略短，透视时间略长。
我们的系统评价和荟萃分析进一步表明，冷冻球囊消融是标准射频治疗的有效替代方法，消融后 1 年的 AF 无复发率略高，手术时间略短，但无统计学意义。
