Basil Vasilios D Thanopoulos1, Lars Soendergaard2, Hieu Lan Ngugen3, Maurizio Marasini4, Andreas Giannopoulos5, Georgios C Bompotis6, Tasalac Thonghong7, Kavassery Mahadevan Krishnamoorthy8, Sebastian Placid9, Dan Deleanou10, Konstantinos P Toutouzas11. 1. Department of Cardiology IASO Children's Hospital, Athens, Greece. Electronic address: vthanop@otenet.gr. 2. Department of Cardiology Copenhagen University Hospital, Rigshospitalet, Denmark. 3. Department of Cardiology Bach Mai Hospital, Hanoi, Viet Nam. 4. Pediatric Cardiology Unit Giannina Gaslini Hospital, Genova, Italy. 5. Department of Pediatric Cardiology AHEPA University General Hospital of Thessaloniki, Greece. 6. Department of Cardiology Papageorgiou General Hospital of Thessaloniki, Greece. 7. Department of Cardiology Chiang Mai University Hospital, Chiang Mai, Thailand. 8. Department of Cardiology Sree Chitra Tirunal Institute for Medical Sciences and Technology, Kerala, India. 9. Department of Cardiology Sakaharna Hrudayalaya Hospital, Kerala, India. 10. Institute for Cardiovascular Diseases C.C. Iliescu, Bucharest, Romania. 11. First Department of Cardiology Hippokration General Hospital, National and Kapodistrian University of Athens, Greece.
Abstract
BACKGROUND: The Cocoon septal occluder (CSO) is a new generation double disk occluder device for catheter closure of the 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. METHODS: The study cohort consisted of 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. RESULTS: 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 to procedural complication. During the follow-up period, no patient developed cardiac erosions, allergic reactions to nickel, or other major complications. CONCLUSIONS: Implantation of CSO provided satisfactory procedural and follow-up results with high success and no device-related cardiac erosions and nickel allergy.
BACKGROUND: The Cocoon septal occluder (CSO) is a new generation double disk occluder device for catheter closure of the 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. METHODS: The study cohort consisted of 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. RESULTS: 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 to procedural complication. During the follow-up period, no patient developed cardiac erosions, allergic reactions to nickel, or other major complications. CONCLUSIONS: Implantation of CSO provided satisfactory procedural and follow-up results with high success and no device-related cardiac erosions and nickel allergy.
Authors: Tejasvi Kashyap; Muhammad Sanusi; Elina S Momin; Asma A Khan; Vijayalakshmi Mannan; Muhammad Ahad Pervaiz; Aqsa Akram; Abeer O Elshaikh Journal: Cureus Date: 2022-05-27
Authors: Abhay A Divekar; Yousef M Arar; Stephen Clark; Animesh Tandon; Thomas M Zellers; Surendranath R Veeram Reddy Journal: Children (Basel) Date: 2022-04-02