Abstract
Objectives: To evaluate safety, efficacy, and technical advantages of Amplatzer™ Trevisio™ intravascular delivery system (ATIDS) in percutaneous atrial septal defect (ASD) closure in children.Background: The Trevisio™ is a novel delivery system designed for accurate and facilitated implantation of Amplatzer™ devices. There are no published clinical reports so far.Methods: During September 2020, 9 children with anatomically challenging ASDs underwent attempted transcatheter closure using ATIDS to deliver Amplatzer™ Septal occluders (ASO). All interventions were performed under general anesthesia, trans-esophageal echocardiography (TOE), and fluoroscopic guidance. Standard safety, immediate, and 60-days outcomes were prospectively assessed.Results: The median age was 8.1 (5.1–16.9) years and the median bodyweight was 30 (18–63) kg. Six patients had isolated secundum-type ASDs with absent anterosuperior rims including one with an aneurysmal septum. Three patients had unclassical defects associated with complex congenital heart anomalies. Eight devices were delivered from the femoral vein and the jugular vein was accessed in one patient with interrupted inferior caval vein and azygos continuation. All implantations were successful. The shape, position, and orientation of the ASO were identical before and after release on TOE and fluoroscopy. There was no device embolization or serious complication following closure. Complete shunt closure was confirmed on follow-up.Conclusions: We report the first clinical experience with ATIDS in transcatheter ASD pediatric closures. Safety and efficacy were witnessed in our case-series. The major advantage of reduced-tension deployment and reliable precision in device positioning is highly beneficial in challenging anatomies and unusual access.
Highlights
Since the first report of atrial septal defect (ASD) non-surgical closure in 1974, multiple occluders were tested in clinical studies [1,2,3]
During September 2020, all consecutive pediatric patients with anatomically challenging ASDs and scheduled for attempted transcatheter closure using the new AmplatzerTM TrevisioTM intravascular delivery system (ATIDS) to deliver AmplatzerTM Septal occluders (ASO) (AGA Medical Corp., MN, USA) at our institution were enrolled in this study and prospectively followed-up for 60 days
One patient with surgically-corrected double outlet right ventricle and straddling mitral valve had leftto-right shunt across a residual ASD initially created by balloon atrial septostomy in the neonatal period and left untreated until the age of 5 years
Summary
Since the first report of atrial septal defect (ASD) non-surgical closure in 1974, multiple occluders were tested in clinical studies [1,2,3]. It was not until the AmplatzerTM Septal Occluder (ASO) became available in the mid-1990s that transcatheter ASD closure became a routine procedure [4]. The ASO remains the most widely used device with proven long-term efficacy and safety in adult and pediatric patients [5, 6]. We report the first experience with the TrevisioTM delivery system in percutaneous ASD pediatric closures
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