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对比 Figulla Flex® 和 Amplatzer™ 封堵器在房间隔缺损封堵中的应用:一项荟萃分析。

Comparison of Figulla Flex® and Amplatzer™ devices for atrial septal defect closure: A meta-analysis.

机构信息

Instituto de Ciencias del Corazón (ICICOR), Hospital Clínico Universitario de Valladolid, Valladolid, Spain, Spain.

出版信息

Cardiol J. 2020;27(5):524-532. doi: 10.5603/CJ.a2020.0058. Epub 2020 Apr 24.

Abstract

BACKGROUND

Atrial septal defect (ASD) is one of the most common congenital heart diseases. Percutaneous closure is the preferred treatment, but certain complications remain a concern. The most common devices are AMPLATZER™ (ASO) (St. Jude Medical, St. Paul, MN, USA) and Figulla Flex® septal occluders (FSO) (Occlutech GmbH, Jena, Germany). The present study aimed to assess main differences in outcomes.

METHODS

A systematic search in Pubmed and Google scholarship was performed by two independent reviewers for any study comparing ASO and FSO. Searched terms were "Figulla", "Amplatzer", and "atrial septal defect". A random-effects model was used.

RESULTS

A total of 11 studies including 1770 patients (897 ASO; 873 FSO) were gathered. Baseline clinical and echocardiographic characteristics were comparable although septal aneurysm was more often reported in patients treated with ASO (32% vs. 25%; p = 0.061). Success rate (94% vs. 95%; OR: 0.81; 95% CI: 0.38-1.71; p = 0.58) and peri-procedural complications were comparable. Procedures were shorter, requiring less fluoroscopy time with an FSO device (OR: 0.59; 95% CI: 0.20-0.97; p = 0.003). Although the global rate of complications in long-term was similar, the ASO device was associated with a higher rate of supraventricular arrhythmias (14.7% vs. 7.8%, p = 0.009).

CONCLUSIONS

Percutaneous closure of ASD is a safe and effective, irrespective of the type of device. No differences exist regarding procedural success between the ASO and FSO devices but the last was associated to shorter procedure time, less radiation, and lower rate of supraventricular arrhythmias in follow-up. Late cardiac perforation did not occur and death in the follow-up was exceptional.

摘要

背景

房间隔缺损(ASD)是最常见的先天性心脏病之一。经皮闭合是首选治疗方法,但某些并发症仍令人担忧。最常用的装置是 AMPLATZER™(ASO)(圣犹达医疗公司,明尼苏达州圣保罗市,美国)和 Figulla Flex® 间隔封堵器(FSO)(Occlutech GmbH,耶拿,德国)。本研究旨在评估主要结局的差异。

方法

两名独立审查员在 Pubmed 和 Google 学术上进行了系统搜索,以查找比较 ASO 和 FSO 的任何研究。搜索词为“Figulla”、“Amplatzer”和“房间隔缺损”。使用随机效应模型。

结果

共纳入 11 项研究,包括 1770 例患者(ASO 组 897 例,FSO 组 873 例)。尽管在接受 ASO 治疗的患者中更常报告房间隔瘤(32% vs. 25%;p = 0.061),但基线临床和超声心动图特征具有可比性。成功率(94% vs. 95%;OR:0.81;95%CI:0.38-1.71;p = 0.58)和围手术期并发症相似。FSO 装置的手术时间更短,需要更少的透视时间(OR:0.59;95%CI:0.20-0.97;p = 0.003)。尽管长期并发症的总体发生率相似,但 ASO 装置与更高的室上性心律失常发生率相关(14.7% vs. 7.8%,p = 0.009)。

结论

经皮 ASD 闭合是一种安全有效的方法,与装置类型无关。ASO 和 FSO 装置在手术成功率方面无差异,但后者与手术时间更短、辐射量更少和随访时室上性心律失常发生率更低相关。随访中未发生迟发性心脏穿孔,死亡罕见。

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