Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis

Heaton, Joseph; Okoh, Alexis K.; Suh, Seungmo; Öztürk, Ebru; Salemi, Arash; Waxman, Sergio; Tayal, Rajiv

doi:10.1016/j.carrev.2021.06.002

Cited by 4 publications

(2 citation statements)

References 31 publications

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“…The advent of the Amplatzer Septal occluder (Abbott) in 1997 enabled catheter interventional closure of a secundum ASD in most patients. A recently published systematic review and meta-analysis, including 2,972 patients, reported safe use with adverse event rates for 1 in 20 patients (17). Studies documented significantly lower morbidity and shorter hospital stay after interventional ASD-closure with the Amplatzer ASD occluder compared to surgical ASD-closure (8,18).…”

Section: Advantages/featuresmentioning

confidence: 99%

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

Fritz¹,

Engelhardt²,

Grohmann³

et al. 2022

Cardiovasc Diagn Ther

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Background: The last decades have brought remarkable improvements in treatment strategy and occluder modification of secundum atrial septal defect (ASD) closure. Approval, efficacy and safety of ASD closure devices have previously been demonstrated. This study investigated the clinical efficacy and safety of the LifeTech CeraFlex TM ASD occluder for interventional closure of secundum ASD with a 6-month follow-up (FU). Methods: Procedure specific data was collected on patients considered for ASD closure with the CeraFlex TM occluder between April 2016 and December 2019 in three German centers. Efficacy and safety were assessed after device closure, at discharge, and at 6-month FU. Results: The primary endpoint (successful ASD closure without severe complications) was reached by 102/103 patients (99%). Device embolization occurred in two patients (one early and one late embolization). After early snare-retrieval of an embolized device, this ASD was closed surgically and in the other patient with late device embolization the defect was closed with a larger CeraFlex TM occluder. The secondary endpoint (clincal efficacy after 6 months) was reached by 94/98 patients since new onset of arrhythmia occurred in four patients. Three patients had withdrawn their study-participation and one patient had moderate residual shunt, but not related to the occluder. Incomplete right bundle branch block (iRBBB) was seen in 31 patients. At last FU only 17 patients had remaining iRBBB documenting effective volume unloading of the right ventricle. Conclusions: Catheter interventional closure of secundum ASDs with the CeraFlex TM ASD occluder was feasible, safe and effective in this study.

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Section: Advantages/featuresmentioning

confidence: 99%

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

Fritz¹,

Engelhardt²,

Grohmann³

et al. 2022

Cardiovasc Diagn Ther

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“…One of the devices to remain on the market is the Amplatzer septal occluder (ASO), which was first introduced in humans in 1995 [8] and has been implanted more than 200,000 times. It has been shown that transcatheter closure results in the normalization of cardiac size and function [9][10][11], and short-and intermediate-term studies have shown the ASO to be safe and effective [12][13][14][15]. Furthermore, it has been demonstrated that the transcatheter mortality and morbidity in this procedure are lower than the surgical approach [2,[16][17][18][19].…”

Section: Introductionmentioning

confidence: 99%

The Prevalence of and Predisposing Factors for Late Atrial Arrhythmias after Transcatheter Closure of Secundum Atrial Septal Defects in Children

Abu-Tair

Martín²,

Wiethoff³

et al. 2023

JCM

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Background: A 24 h Holter study in children after transcatheter secundum ASD (ASD II) closure was conducted to detect the prevalence of defects and/or device-related late atrial arrhythmias (LAAs). ASD II closure with an Amplatzer septal occluder (ASO) is an established procedure. Little is known about LAAs after device implantation. Methods: The eligible participants were children who had undergone ASO implantation, with a follow-up of ≥5 years, as well as one pre- and at least one post-procedural Holter ECG. Results: In total, 161 patients (mean age: 6.2 ± 4.3 years), with a mean follow-up of 12.9 ± 3.1 years (range 5–19), were included. A median of four Holter ECGs per patient were available. LAAs occurred before intervention in four patients (2.5%), and it was peri-interventional in four patients (2.5%), sustained in three patients (1.9%), and developed in three patients (1.9%). In patients with pre- and peri-interventional LAAs, the Qp/Qs ratio was higher (6.4 ± 3.9 vs. non-AA: 2.0 ± 1.1 (p = 0.002)) and the IAS/ASO ratio was lower (1.18 ± 0.27 vs. non-AA: 1.7 ± 0.4 (p < 0.001)). The patients with LAAs differed from those without LAAs in their Qp/Qs (6.8 ± 3.5 vs. 2.0 ± 1.3; p < 0.0001) and IAS/ASO ratios (1.14 ± 0.19 vs. 1.73 ± 0.45; p < 0.001). The patients with LAAs had a Qp/Qs ratio ≥2.94:1, and those who developed LAAs had an IAS/ASO ratio <1.15. Conclusions: LAAs occurred in 1.9% of patients and were sustained in another 1.9% of patients but persisted in those with large shunt defects and large occluders in relation to the atrial septal length. The predisposing factors for LAAs after ASD closure were a high Qp/Qs ratio, pre-existing atrial arrhythmias, and a low IAS/ASO ratio.

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Update in Pediatric Cardiology

Ashkanase,

Wong

2023

Update in Pediatrics

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Safety and Efficacy of the Amplatzer Septal Occluder: A Systematic Review and Meta-Analysis

Cited by 4 publications

References 31 publications

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

A multi-center trial on efficacy and safety of the LifeTech CeraFlexTM ASD occluder for transcatheter closure in patients with secundum atrial septal defects

The Prevalence of and Predisposing Factors for Late Atrial Arrhythmias after Transcatheter Closure of Secundum Atrial Septal Defects in Children

Update in Pediatric Cardiology

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