Preliminary Experience With the New Amplatzer™ Trevisio™ Delivery System in Transcatheter Atrial Septal Defect Closures in Children

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.

FAST technique: fast atrial sheath traction technique for device closure of atrial septal defects

“…In self-centering devices, the recommended device size is the same or slightly larger than the balloon-sized diameter ( 20 ). However, it is also believed that ultrasound-guided sizing of ASD and device deployment provide a better success rate with relatively smaller-sized devices ( 17 , 21 ). As per our usual experience, we did not balloon-size the defects to avoid unintentional overstretching of the defect diameters.…”

“…Results: Seventeen patients (64.7% males) were involved with a median age of 9.8 years [interquartile range (IQR), 7.6-15.1] and a median weight of 34 kg (IQR,. The median ASD size on ultrasound was 19 mm (IQR,(16)(17)(18)(19)(20)(21)(22). Five (29.4%) patients had absent aortic rims, and three (17.6%) patients had an ASD size-tobody weight ratio higher than 0.9.…”

“…Five (29.4%) patients had absent aortic rims, and three (17.6%) patients had an ASD size-tobody weight ratio higher than 0.9. The median device size was 22 mm (IQR,(17)(18)(19)(20)(21)(22)(23)(24). The median difference between device size and ASD two-dimensional static diameter was 3 mm (IQR, 1-3).…”

3D model‐guided transcatheter closure of ascending aorta pseudoaneurysm with the novel Amplatzer Trevisio intravascular delivery system

“…[16][17][18][19] In addition, using soft and trackable delivery systems may be useful to correctly allocate the occluding device as well as to anticipate its final position before release. 20 We report on a case of AAP closure guided by 3D printed model using an Amplatzer Septal Occluder (ASO; Abbott, Plymouth MN) device implanted with the novel delivery cable Amplatzer Trevisio intravascular delivery system (ATIDS).…”

Combination of modified techniques for percutaneous closure of a large secundum atrial septal defect

“…A recently introduced novel delivery system, providing major flexibility and tension reduction, enables more predictable and efficient device closure of large atrial septal defects [ 6 ]. In cases when conventional technique and improved delivery system prove insufficient, a combination of modified techniques, such as balloon assistance and right upper pulmonary vein approach, enable successful device delivery even in a single attempt and exclude the need for significant device upsizing.…”