Recent Changes in Instructions for Use for the Amplatzer Atrial Septal Defect Occluder: How to Incorporate These Changes While Using Transesophageal Echocardiography or Intracardiac Echocardiography?

Abstract

The Amplatzer septal occluder is commonly used to close secundum atrial septal defects (ASDs). Recently, the manufacturer's recommendations have been modified with regard to contraindications for its use. These changes primarily focus on evaluation of the aortic rim (anterio-superior rim) with transesophageal echocardiography (TEE) and intracardiac echocardiography (ICE). In this editorial, we will review systematically all of the sequential views in TEE and ICE that are required for thorough assessment of the aortic rim and provide explanation of what constitutes deficiency of the aortic rim as seen on ICE.Keywords Secundum atrial septal defect Á Intracardiac echocardiography Á Transesophageal echocardiography Secundum ASD is a defect in the septum primum that results in a communication between left and right atria. The size of the defect is primarily based on the extent of septum primum deficiency. The septum secundum is always present in these patients and constitutes the atrial septal rims, although it could be deficient in some areas. When deficient, the defect can be very large and technically difficult to close. The secundum atrial septal defect (ASD) is surrounded by the aortic, superior, superior vena cava (SVC), posterior, inferior vena cava (IVC), and atrioventricular (AV) valve rims [1]. In general, excellent short-, mid-, and even late-term results have been reported with the percutaneous closure of ASD using the Amplatzer septal occluder (ASO) and other devices [10,12]. However, the procedure carries a risk of early and late complications, including thrombus formation, device embolization, wire fracture, nickel allergy, arrhythmias, cerebrovascular accident, and atrial wall with occasional aortic wall erosion. The worst of these complications is atrial wall erosion, also called ''perforation'' [2,6,7]. Based on the description of surgeons, the erosions occur in the anteriorsuperior region of the atrial wall, an area that corresponds to the aortic and the superior rim on echocardiography. Although the primary reason for erosion has been attributed to device over-sizing, there have been cases in which there was no apparent device oversizing, however device placement did result in erosion [8].More than 40 % of patients with ASD have an aortic rim \5 mm [11]. In a recent review of cases of erosions by St. Jude Medical (SJM), aortic rim deficiency was present in 88 % of the cases in which erosion occurred. This number is consistent with our previous study [2]. Based on this analysis, aortic rim absence was a strong predictor of erosion, and so SJM updated the instructions for use (IFU) in January 2012 [4]. The changes included contraindications to close ASD with echocardiographic evidence of absent or deficient anterior-superior rim (sufficient rim was defined as the presence of at least 5 mm of rim in multiple and sequential short-axis views as confirmed by ICE or TEE).In the original IFU, a 5 mm minimum rim was required for optimal closure of ASD for all rims except the aortic rim. The 5 mm s...

Closure of Secundum Atrial Septal Defects by Using the Occlutech Occluder Devices in More Than 1300 Patients: The IRFACODE Project: A Retrospective Case Series

“…Procedural data included the mode of sedation/anesthesia, the procedural and fluoroscopy time, the type of echocardiography used, and the specific characteristics of the ASD. A deficient aortic rim was defined as a distance ≤4 mm, while a “naked aorta” was defined when no aortic rim was present . An aneurysm was defined when the septum movement exceeded 10 mm.…”

Prevalence of Deficient Retro-Aortic Rim and Its Effects on Outcomes in Device Closure of Atrial Septal Defects

“…On procedural echocardiograms, septal length, retro-aortic rim, and maximal defect size were measured. Deficient retro-aortic rim was defined as a retro-aortic rim measuring less than or equal to 5 mm on any view on the echocardiogram as has been described previously[14, 16, 22]. Defect size during balloon inflation using stop-flow technique (which was used for all cases) was also measured, with device sizing based on this measurement.…”

Guidelines for the Echocardiographic Assessment of Atrial Septal Defect and Patent Foramen Ovale: From the American Society of Echocardiography and Society for Cardiac Angiography and Interventions

“…83,[90][91][92][93] The key ICE views used in the evaluation of the IAS as described are listed in Table 5. The currently available ICE systems and their present specifications are listed in Table 6.…”