Vukadinović Davor, Scheller Bruno, Ukena Christian, Ewen Sebastian, Mahfoud Felix, Böhm Michael
Klinik Für Innere Medizin III, Kardiologie, Angiologie Und Internistische Intensivmedizin, Universitätsklinikum Des Saarlandes, Universität Des Saarlandes, Saarland University, Kirrberger Strasse, 66421, Homburg/Saar, Germany.
Clin Res Cardiol. 2022 May;111(5):583-587. doi: 10.1007/s00392-021-01964-2. Epub 2021 Nov 10.
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.
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.
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.
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.
心房颤动（AF）是卵圆孔未闭（PFO）介入封堵术后患者常见的并发症。我们旨在通过分析随机试验数据，比较Amplatzer PFO封堵器和GORE（Helex和CARDIOFORM房间隔封堵器）封堵器术后AF的发生率和风险。
我们纳入了所有报道使用Amplatzer或GORE封堵器封堵PFO后AF发生率的随机研究，这些研究的对象为不明原因卒中患者，并比较了两种封堵器术后AF的风险。检索了PubMed和Cochrane图书馆，查找截至2020年7月发表的符合条件的研究。
介入组中使用Amplatzer封堵器的随机试验中，所有新发AF病例的发生率为3.93%（30/763），而相应药物治疗组为1.46%（11/751）（相对风险为2.57，95%置信区间为1.31 - 5.03，p = 0.006）。使用GORE封堵器的随机试验中，新发AF的发生率为6.57%（29/441），而相应药物治疗组为0.44%（1/223）（相对风险为14.66，95%置信区间为2.01 - 106.95，p = 0.008）。两种封堵器在AF风险方面的交互作用p值为0.10。
结果表明，与GORE封堵器相比，使用Amplatzer PFO封堵器封堵PFO后，AF发生率较低，提示风险较低。然而这些发现来自二次分析，应在足够样本量的、比较这两种封堵器的头对头设计的随机临床试验中，使用适当的PFO封堵术后AF筛查工具进行仔细审查。
