The Cocoon septal occluder (CSO) is a new generation double disk occluder device for catheter closure of secundum atrial septal defect (ASD). Initial clinical evaluations with the use of this device have shown quite satisfactory results but large follow-up studies are missing. In this international multicenter study we present procedural and follow-up data from 4008 patients with secundum ASD who underwent catheter closure with the use of CSO.
The study cohort consisted from 1853 pediatric and 2155 adult patients with secundum ASD treated with the CSO. Patients were enrolled retrospectively from 11 international centers and were followed for a mean period of 43 months (range 12 – 84 months), postprocedural. Clinical, electrocardiographic, echocardiographic, procedural and follow-up data were collected from each collaborating hospital.
The CSO was permanently implanted in 3983 (patients (99.4%). Echocardiographic evaluation at one-month follow-up revealed complete closure in 99. 6 % of those patients who had a device implanted. Thrombus formation in one adult patient was the only major device related procedural complication. During the follow-up period no patient developed cardiac erosions, allergic reactions to nickel or other major complication.
Implantation of CSO provided satisfactory procedural and follow – up results with high success and no device related cardiac erosions and nickel allergy.