International experience with the use of Cocoon septal occluder for closure of atrial septal defects

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

“…However, in Zhang et al's study, the child with deficient aortic rim was managed with a device equal in size to the defect and still developed aortic erosion, suggesting that absent aortic rim may be associated with higher risk of erosion than the use of an oversized device [ 16 ]. Thanopoulos et al’s study that used Cocoon Septal Occluder for the transcatheter closure of ASD in 1,835 children did not exclude children with isolated rim deficiencies, and states that risks and complications related to the procedure can be avoided if the investigator selects an appropriate implantation strategy for each individual patient [ 22 ]. Their study followed up the children for 2-14 years and did not observe cardiac erosion or any other major complication [ 22 ].…”

“…Thanopoulos et al’s study that used Cocoon Septal Occluder for the transcatheter closure of ASD in 1,835 children did not exclude children with isolated rim deficiencies, and states that risks and complications related to the procedure can be avoided if the investigator selects an appropriate implantation strategy for each individual patient [ 22 ]. Their study followed up the children for 2-14 years and did not observe cardiac erosion or any other major complication [ 22 ].…”

“…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 ].…”

“…They also found eight cases of arrhythmias after the procedure, three of which persisted till the last follow-up [ 19 ]. Thanopoulos et al’s study of 1,853 children undergoing device closure with Cocoon Septal Occluder noted 31 patients with atrial arrhythmias during the procedure which increased to 38 cases of minor atrial arrhythmias at six months of follow-up, and 16 cases of conduction block during the procedure, one of which was complete AV block, while the remaining were either first or second degree AVB (AVB I or II) [ 22 ]. Two more children in Cha et al’s study developed complete AV block, one of which was during the procedure, leading to occlusion failure [ 27 ].…”

“…Migraine was reported in two of the studies. In Thanopoulos et al’s study, 25 children developed mild to moderate migraine within 1-2 weeks of Cocoon Septal Occluder implantation and were managed with oral medications [ 22 ]. Fifteen children in Jalal et al’s study had migraine as a delayed complication after Amplatzer Septal Occluder implantation [ 19 ].…”