Related Experiment Video
Updated: Dec 23, 2025
Echocardiographic Evaluation of Atrial Communications before Transcatheter Closure
Published on: February 8, 2022
Comparison of Figulla Flex® and Amplatzer™ devices for atrial septal defect closure: A meta-analysis
Alvaro Aparisi1, Roman J Arnold1, Hipólito Gutiérrez1
1Instituto de Ciencias del Corazón (ICICOR), Hospital Clínico Universitario de Valladolid, Valladolid, Spain, Spain.
Insights
This study compared AMPLATZER™ (ASO) and Figulla Flex® (FSO) devices for atrial septal defect (ASD) closure. While both are effective, FSO devices offer shorter procedure times and fewer long-term arrhythmias.
Area of Science:
- Cardiology
- Medical Devices
- Congenital Heart Disease
Background:
- Atrial septal defect (ASD) is a common congenital heart disease.
- Percutaneous closure is the preferred treatment for ASD.
- Complications associated with ASD closure devices remain a concern.
Purpose of the Study:
- To compare the outcomes of AMPLATZER™ (ASO) and Figulla Flex® (FSO) septal occluders for percutaneous ASD closure.
- To assess differences in procedural success, complications, and long-term outcomes between ASO and FSO devices.
Main Methods:
- A systematic literature search was conducted in PubMed and Google Scholar.
- Studies comparing ASO and FSO devices for ASD closure were included.
- A random-effects model was used for meta-analysis.
Main Results:
- 11 studies with 1770 patients (897 ASO, 873 FSO) were analyzed.
- Procedural success rates were comparable (94% vs. 95%).
- FSO devices were associated with shorter procedure times and less fluoroscopy.
- ASO devices showed a higher rate of long-term supraventricular arrhythmias (14.7% vs. 7.8%).
Conclusions:
- Percutaneous ASD closure with ASO and FSO devices is safe and effective.
- No significant difference in procedural success between ASO and FSO devices.
- FSO devices offer advantages in procedure time, radiation exposure, and long-term arrhythmia rates.
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.
