Transcatheter Closure of Atrial Septal Defects using the GORE® Septal Occluder in Children Less Than 10 kg of Body Weight

Abstract

The GORE(®) Septal Occluder (GSO) is a well-evaluated device for interventional ASD closure with closure rates comparable to the Amplatzer(®) Septal Occluder (ASO), but there are no published reports of its use in small children weighing less than 10 kg. This may be due to the necessity of a large-sized introducing sheath of at least 10 Fr and therefore the assumed risk of complications in vascular access. The GSO is an alternative option for interventional ASD closure in children weighing less than 10 kg. Fourteen infants and children with a median body weight 8900 g (range 6350-9650 g) underwent successful ASD closure using the GSO. The closure was performed under fluoroscopic and transthoracic echocardiographic guidance. Postprocedure, the vessels passed by the occluder and delivery catheter were examined by duplex sonography. The median ASD diameter was 11 mm (5-17 mm), and the median GSO size was 22.5 mm (15-30 mm), whereas the median ASO left disc size that would have been recommended was 25 mm (17-31 mm). All ASDs were successfully closed. During a median follow-up of 1.57 years (range 0.5-4.2), no complications like erosion, embolization, arrhythmias, or vascular injuries occurred. Although using a 10-Fr introducer sheath, no vascular complications were detected. Our data suggest that the small usable size as well as the soft and flexible design of the device allows successful use of the GSO in young children.

Multicenter midterm follow‐up results using the gore septal occluder for atrial septal defect closure in pediatric patients

“…Special considerations in young children have been reported in detail . Aside from these potential modifications in certain patients, the GSO was delivered using standard catheter techniques, deployed and released according to the company's instructions for use.…”

Here today, gone tomorrow: Outcomes of residual leak following secundum atrial septal defect closure with the GORE CARDIOFORM Septal Occluder

“…The GSO has been previously shown to be a safe and effective device for use in the closure of small‐ to medium‐sized secundum ASDs . Our review of the North American GSO pivotal and continued access cohort noted a residual leak at implantation in 17.56% of patients, the vast majority (87.6%) of which disappeared over the first year of follow‐up.…”

“…The wires create a double disc frame of 10 petals, five on either side of the septum. The device was available in sizes from 15 to 30 mm in 5 mm increments and could be used to close secundum defects up to 17–18 mm in size . The 15 mm device is no longer commercially available.…”

Transcatheter atrial septal defect closure in an infant (body weight 6.4 kg) using the GORE CARDIOFORM septal occluder (GCSO)

“…Data suggest that interventional ASD closure was safe and effective, resulting in significant clinical improvement [ 2 ]. Data from Wyss et al and Abu-Tair et al support these findings reporting 14 and 28 infants with a body weight < 10 kg respectively who underwent interventional ASD closure without any major complications [ 3 , 4 ].…”