Safety of Occlutech Septal Occluder ACCELL Flex II for Transcatheter Closure of Secundum Atrial Septal Defects in Children: A Long-Term Follow-Up

Abstract

Objectives. To assess the long-term safety and efficacy of the Occlutech® ACCELL® Flex II device used for atrial septal defect (ASD) closure. This device differs from the regular device by having two very thin patches that are made of polyethylene terephthalate (PET). These patches enhance faster sealing of the defect. Background. Transcatheter closure has become the method of choice to manage most patients with secundum ASDs. There are different types of devices. The regular Occlutech device used to close an ASD is called the Occlutech Figulla Flex II. A newer modification of this device (Occlutech® ACCELL® Flex II) has been designed to eliminate/reduce thrombus formation and to enhance faster sealing. Methods. Thirty patients were followed up after occlusion of secundum ASD using the Occlutech® ACCELL® Flex II Device. The follow-up period ranged from 5.2–5.5 years with median of 5.3 years. Detailed history and full clinical examination, twelve-lead electrocardiogram (ECG), plain chest radiograph, and full 2D transthoracic echocardiography (TTE) were performed at discharge, at one month, six months, and yearly thereafter. Results. The mean age of the study group at the last follow-up was 10.4 ± 4.6 years, with 63.3% (nineteen patients) females. There were no residual shunts or complications encountered immediately after the procedure and at the latest follow-up. Conclusion. This study confirmed the transcatheter closure (TCC) of secundum ASDs using the Occlutech® ACCELL® Flex II device to be safe and effective with no complications detected in children and adolescents.

Transcatheter Occluder Devices for the Closure of Atrial Septal Defect in Children: How Safe and Effective Are They? A Systematic Review

“…Transcatheter device closure of young children requires more experience and skill [ 18 ]. According to the hemodynamics, defects in patients with ratio of pulmonary blood flow to systemic blood flow (Qp/Qs) >1.5 and/or dilated right atrium and ventricle are advised to be closed [ 8 , 18 , 24 , 25 , 29 ]. According to morphological features, patients must have adequate rims on echocardiographic evaluations [ 18 ].…”

“…Knop et al’s study found mild mitral valve insufficiency in two of 157 patients under three years of age with secundum ASD who were managed with either Amplatzer Multi-Fenestrated Septal Occluder or Cardi-O-Fix ASD Occluder [ 29 ]. Patients in El-Sisi et al’s study experienced the widest variety of valvular problems compared to the rest of the studies [ 24 ]. Among 30 patients aged 5-18 years who underwent transcatheter closure of secundum ASD using Occlutech ACCELL Flex II device, mild mitral and aortic regurgitation were seen in two children each that persisted till the last follow-up, at the time of which 11 more had mild tricuspid regurgitation and five more had mild pulmonary regurgitation [ 24 ].…”

“…Patients in El-Sisi et al’s study experienced the widest variety of valvular problems compared to the rest of the studies [ 24 ]. Among 30 patients aged 5-18 years who underwent transcatheter closure of secundum ASD using Occlutech ACCELL Flex II device, mild mitral and aortic regurgitation were seen in two children each that persisted till the last follow-up, at the time of which 11 more had mild tricuspid regurgitation and five more had mild pulmonary regurgitation [ 24 ]. Two of 62 children with occlusion failure in Jalal et al’s study had failed due to atrioventricular valve damage, and one patient developed mild mitral regurgitation after successful device closure [ 19 ].…”

“…Complications seen with the use of Cocoon Septal Occluder included arrhythmias and conduction abnormalities, vascular access site problems, migraine, and even device embolization in two patients [ 22 , 23 ]. Children in one study using Occlutech Septal Occluder mostly experienced valvular regurgitation [ 24 ]. Four out of 25 children in one study using Solysafe Septal Occluder experienced device embolization, stroke leading to hemiparesis, arrhythmias, or vascular access site problems [ 25 ].…”

“…Complete closure of ASD with the septal occluder devices was ≥ 94% in nine of the 21 studies at the end of their follow-ups [ 8 , 17 , 19 , 20 , 22 , 24 , 28 - 30 ]. The lower percentage of complete closure at last follow-up in the remaining studies is likely attributed to smaller sample size.…”