Cocoon devices for transcatheter closure of atrial septal defect and patent ductus arteriosus in children

Abstract

Closure of the atrial septal defect (ASD) and patent ductus arteriosus (PDA) are among the most frequent cardiac interventional procedures. This was a prospective study, which started together with the implementation of a national program of pediatric interventional cardiology in Romania. We used Cocoon devices in 83 consecutive cases from 92 implantations for ASD and PDA. 27 cases were ASD closure and 56 cases PDA closure. Regarding the ASD closure, the median age was 8.5 years (range 3–25 years) and median weight 25 kg (range 11.5–63 kg). The mean follow-up was 17.4 ± 6.7 months (range 3–26 months). The mean ASD diameter by transesophageal echocardiography was 15.2 ± 4.1 mm (range 8–26 mm). The mean device diameter used was 17.3 ± 5.6 mm (range 8–32 mm). Regarding the PDA closure, the median age was 36 months (range 4–192 months) and median weight 14 kg (range 5–58 kg). The mean follow-up was 15 ± 8 months (range 3–28 months). The mean PDA minimum diameter was 2.5 ± 0.8 mm. The success implantation rate for both groups was 97.6% (2 cases of withdrawn for ASD and PDA), while the complication rate was 2.3% (including 2 ASD device embolization). In the first 24 hours, the closure rates were 96.3% for ASD, 98.2% for PDA, and 100% at 1-month follow-up for both procedures. On short and intermediate follow-up (3–28 months), no device-related complications were noted.The Cocoon devices are safe for transcatheter closure of both ASD and PDA, and the initial experience with their use in our emerging center is encouraging.

Transcatheter Occluder Devices for the Closure of Atrial Septal Defect in Children: How Safe and Effective Are They? A Systematic Review

“…Device embolization/occluder dislodgement is a rare but serious complication of device closure operations [ 20 ]. A total of 37 out of 4,278 children in eight of the studies experienced device embolization after transcatheter device closure of large defects or defects with insufficient septal rims either intra or postoperatively which had to be replaced or surgically removed with or without surgical patch closure of ASD [ 8 , 19 , 20 , 22 , 23 , 25 , 27 , 28 , 30 ]. The most cases of device embolization or migration were seen in Jalal et al’s study [ 19 ].…”

“…Peripheral vascular injury hematoma can be seen commonly due to the requirement of peripheral vascular (femoral vein) approach for transcatheter mode of device closure of ASD [ 20 ]. Hematoma at the access site (groin) was reported in three patients in Qiu et al’s study, two patients in Mahmoud et al’s study, and three patients in Han et al’s study, [ 8 , 20 , 23 ]. Ali et al’s study had one patient with rebleeding at the access site [ 28 ].…”

“…As the Amplatzer Septal Occluder was the most commonly employed device for the closure of ASD, it presented with the widest range of complications overall. Complications seen with the use of Cocoon Septal Occluder included arrhythmias and conduction abnormalities, vascular access site problems, migraine, and even device embolization in two patients [ 22 , 23 ]. Children in one study using Occlutech Septal Occluder mostly experienced valvular regurgitation [ 24 ].…”