open access

Vol 27, No 5 (2020)
Original articles — Interventional cardiology
Published online: 2020-04-17
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Comparison of Figulla Flex® and Amplatzer™ devices for atrial septal defect closure: A meta-analysis

Alvaro Aparisi, Roman J. Arnold, Hipólito Gutiérrez, Ana Revilla, Ana Serrador, Benigno Ramos, Tania Rodriguez-Gabella, Alberto Campo, Carlos Baladrón, Itziar Gómez, Manuel Carrasco-Moraleja, José A. San Roman, Ignacio J. Amat-Santos
DOI: 10.5603/CJ.a2020.0058
·
Pubmed: 32329042
·
Cardiol J 2020;27(5):524-532.

open access

Vol 27, No 5 (2020)
Original articles — Interventional cardiology
Published online: 2020-04-17

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.

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.

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Keywords

Figulla, Amplatzer, atrial septal defect

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About this article
Title

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

Journal

Cardiology Journal

Issue

Vol 27, No 5 (2020)

Pages

524-532

Published online

2020-04-17

DOI

10.5603/CJ.a2020.0058

Pubmed

32329042

Bibliographic record

Cardiol J 2020;27(5):524-532.

Keywords

Figulla
Amplatzer
atrial septal defect

Authors

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

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