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.
Highlights
Atrial septal defects (ASDs) are common and account for about 6–10% of all congenital heart lesions [1].Due to its efficacy and reliability, transcatheter device closure of a secundum Atrial septal defect Amplatzer Septal Occluder (ASO) (ASD) had emerged to be the principal choice for management of secundum Atrial septal defect ASO (ASD)
E inherent advantages of transcatheter closure (TCC) of ASDs include the absence of a thoracotomy incision, no intensive care unit admission, less psychological impact, shorter hospital stay, and less need for blood transfusion. e absence of a myocardial scar may decrease the incidence of incisional dysrhythmias [1]. e ideal device should be repositionable, retrievable prior to release, and should facilitate complete closure with minimal risk of embolization
Occlutech unique patented braiding technology allows the device to be manufactured without a left-sided hub. e absence of a left disc hub minimizes the risk of thrombus formation, and it confers softness to the left disc; we believe it minimizes the incidence of device erosion. e device is pushed through the delivery catheter across the defect, one disc is deployed in the left atrium and the waist is deployed to “stent,” the defect itself, and the right atrial disc is deployed in the right atrium. e procedure is best performed under echocardiographic guidance [10]
Summary
Atrial septal defects (ASDs) are common and account for about 6–10% of all congenital heart lesions [1]. ® e standard Occlutech Figulla Flex II device (FSO; Occlutech GmbH, Jena, Germany) is a nitinol double-disk occluder that possesses these characteristics and is used frequently for closure of secundum ASDs [5,6,7,8,9]. E faster endothelialization of the device helps anchoring the device to the atrial septum and sealing of the residual shunt through the device which provides superior occlusion of the defect and minimizes the risk for left-to-right shunt after device implantation. The results from this study ® ® demonstrated that ACCELL Flex II occluders were safe and showed similar performance as uncoated occluders when implanted in pigs’ hearts. Two patients had sinus tachycardia, and the other patients showed normal ECG with no heart block or any arrhythmias or right ventricle
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