{"title":"Safety and One-year Follow-Up Analysis of Percutaneous ASD Closure at a Tertiary Care Hospital.","authors":"Naga Raghunandan Thota, Kamalakar Kosaraju, John Satish Rudrapogu, Krishna Prasad Nevali, Thirupathi Rao Kondaveeti","doi":"10.1016/j.ihj.2025.03.011","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>This study was designed to evaluate the safety and effectiveness of the Cocoon Septal Occluder device (Vascular Innovations Co. Nonthaburi, Thailand) for transcatheter closure of isolated secundum type atrial septal defect (ASD) in Indian patients METHODS: This was a single-center, retrospective, observational study which included patients who underwent transcatheter closure of isolated secundum ASD using the Cocoon Septal Occluder between April 2014 and May 2023. Follow-up assessments up to one-year were conducted through review of hospital medical records, clinic visits, or via telephonic communication with primary care physicians.</p><p><strong>Results: </strong>A total of 400 patients were included in the study, consisting of 28 paediatric (aged ≤15 years, 8.14±4.41 years) and 372 adult patients (40.83±13.23 years). The mean defect diameter and device size were 16.75±5.85 mm and 20.43±6.24 mm for paediatric patients, and 21.62±6.87 mm and 24.94±7.28 mm for adult patients, respectively. The device was successfully implanted in all paediatric patients, achieving 100% closure of the defect with no complications, which persisted through one-year follow-up. In the adult cohort, complete ASD closure was achieved in 99.2% of patients, with two cases of device embolization and one case of device withdrawal. At one-year follow-up, adult patients experienced 0.3% late device embolization, 0.8% pericardial effusion/cardiac tamponade, 0.5% atrioventricular block, and 0.5% atrial flutter/fibrillation. No cases of endocarditis, haemolysis, nickel allergy, stroke/transient ischemic attack, or migraine were reported in either paediatric or adult patients.</p><p><strong>Conclusion: </strong>The results demonstrate that Cocoon Septal Occluder is safe and effective in closing isolated secundum ASD during one-year follow-up.</p>","PeriodicalId":13384,"journal":{"name":"Indian heart journal","volume":" ","pages":""},"PeriodicalIF":1.4000,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Indian heart journal","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1016/j.ihj.2025.03.011","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Aim: This study was designed to evaluate the safety and effectiveness of the Cocoon Septal Occluder device (Vascular Innovations Co. Nonthaburi, Thailand) for transcatheter closure of isolated secundum type atrial septal defect (ASD) in Indian patients METHODS: This was a single-center, retrospective, observational study which included patients who underwent transcatheter closure of isolated secundum ASD using the Cocoon Septal Occluder between April 2014 and May 2023. Follow-up assessments up to one-year were conducted through review of hospital medical records, clinic visits, or via telephonic communication with primary care physicians.
Results: A total of 400 patients were included in the study, consisting of 28 paediatric (aged ≤15 years, 8.14±4.41 years) and 372 adult patients (40.83±13.23 years). The mean defect diameter and device size were 16.75±5.85 mm and 20.43±6.24 mm for paediatric patients, and 21.62±6.87 mm and 24.94±7.28 mm for adult patients, respectively. The device was successfully implanted in all paediatric patients, achieving 100% closure of the defect with no complications, which persisted through one-year follow-up. In the adult cohort, complete ASD closure was achieved in 99.2% of patients, with two cases of device embolization and one case of device withdrawal. At one-year follow-up, adult patients experienced 0.3% late device embolization, 0.8% pericardial effusion/cardiac tamponade, 0.5% atrioventricular block, and 0.5% atrial flutter/fibrillation. No cases of endocarditis, haemolysis, nickel allergy, stroke/transient ischemic attack, or migraine were reported in either paediatric or adult patients.
Conclusion: The results demonstrate that Cocoon Septal Occluder is safe and effective in closing isolated secundum ASD during one-year follow-up.
期刊介绍:
Indian Heart Journal (IHJ) is the official peer-reviewed open access journal of Cardiological Society of India and accepts articles for publication from across the globe. The journal aims to promote high quality research and serve as a platform for dissemination of scientific information in cardiology with particular focus on South Asia. The journal aims to publish cutting edge research in the field of clinical as well as non-clinical cardiology - including cardiovascular medicine and surgery. Some of the topics covered are Heart Failure, Coronary Artery Disease, Hypertension, Interventional Cardiology, Cardiac Surgery, Valvular Heart Disease, Pulmonary Hypertension and Infective Endocarditis. IHJ open access invites original research articles, research briefs, perspective, case reports, case vignette, cardiovascular images, cardiovascular graphics, research letters, correspondence, reader forum, and interesting photographs, for publication. IHJ open access also publishes theme-based special issues and abstracts of papers presented at the annual conference of the Cardiological Society of India.