Background

Atrial fibrillation (AF) represents a frequent complication in patients after interventional closure of patent foramen ovale (PFO). We aimed to compare the incident rate and risk of AF between Amplatzer PFO and GORE (Helex and CARDIOFORM Septal Occluder) device by analyzing the data from randomized trials.

Methods

We included all randomized studies which reported the rate of AF after PFO closure using Amplatzer or GORE occluder in patients suffering cryptogenic stroke and compared the risk of AF between the two devices. PubMed and Cochrane library were searched for eligible studies published until July 2020.

Results

Rate of all cases of incident AF from randomized trials with Amplatzer in the interventional group was 3.93% (30/763) vs. 1.46% (11/751) in the respective medical group (RR of 2.57, 95% CI 1.31–5.03, p = 0.006). The incidence of incident AF from randomized trial with GORE device was 6.57% (29/441) vs. 0.44% (1/223) in the respective medical group (RR of 14.66, 95% CI 2.01–106.95, p = 0.008). The p for interaction between the two devices regarding risk of AF was 0.10.

Conclusions

The results suggest lower risk expressed by lower rate of incident AF after PFO closure using Amplatzer PFO Occluder when compared with GORE Occluder. However, these findings are derived from secondary analyses and should be scrutinized using appropriate screening tool for AF following PFO closure in adequately powered randomized clinical trial with a head-to-head design that compares the two devices.

中文翻译：

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卵圆孔未闭闭合后与器械相关的心房颤动风险：系统评价和荟萃分析

背景

心房颤动 (AF) 是卵圆孔未闭 (PFO) 介入性闭合术后患者的常见并发症。我们旨在通过分析随机试验的数据来比较 Amplatzer PFO 和 GORE（Helex 和 CARDIOFORM 间隔封堵器）装置之间的 AF 发生率和风险。

方法

我们纳入了所有报告在隐源性卒中患者中使用 Amplatzer 或 GORE 封堵器闭合 PFO 后 AF 发生率的随机研究，并比较了两种装置之间的 AF 风险。在 PubMed 和 Cochrane 图书馆中搜索了截至 2020 年 7 月发表的符合条件的研究。

结果

在介入组中使用 Amplatzer 进行的随机试验的所有 AF 事件发生率分别为 3.93% (30/763) 和 1.46% (11/751) 在各自的医疗组中 (RR 为 2.57, 95% CI 1.31–5.03, p  = 0.006)。GORE 装置随机试验的 AF 事件发生率为 6.57% (29/441) 与 0.44% (1/223) 在各自的医疗组中（RR 为 14.66，95% CI 2.01–106.95，p  = 0.008）。两种设备之间关于 AF 风险的交互作用的 p 为 0.10。

结论

结果表明，与 GORE 封堵器相比，使用 Amplatzer PFO 封堵器封堵 PFO 后发生 AF 的风险较低。然而，这些发现来自二次分析，应在 PFO 闭合后使用适当的 AF 筛查工具进行仔细检查，该试验采用头对头设计，比较两种设备。