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

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

Alvaro Aparisi  1 , Roman J Arnold  1 , Hipólito Gutiérrez  1 , Ana Revilla  1 , Ana Serrador  1 , Benigno Ramos  1 , Tania Rodriguez-Gabella  1 , Alberto Campo  1 , Carlos Baladrón  1 , Itziar Gómez  1 , Manuel Carrasco-Moraleja  1 , José A San Roman  1 , Ignacio J Amat-Santos  2
Affiliations
Meta-Analysis

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

Alvaro Aparisi et al. Cardiol J. 2020.

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.

Keywords: Amplatzer; Figulla; atrial septal defect.

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Conflict of interest statement

Conflict of interest: None declared

Figures

Figure 1
Figure 1
Amplatzer septal occluder (A) and Figulla Flex II (B, C) showing main differential features of Figulla Flex including the lack of screw attachment (replaced by a ball, B) and the smooth left atrial disc (C).
Figure 2
Figure 2
Flow chart showing search results and selection of the studies included in the meta-analysis.
Figure 3
Figure 3
Forest plot reflecting procedural and follow-up outcomes of the patients included in the meta-analysis. *Vertical line represents “no difference” point between the Amplatzer and Figulla groups; Horizontal lines 95% confidence interval (CI). Squares represent odds ratio for each study (the size of each square denotes the proportion of information given by each study). Diamonds represent pooled odds ratios from all studies.
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