Observational studyIndian heart journal
Safety and one-year follow-up analysis of percutaneous ASD closure at a tertiary care hospital.
Observational study in Indian heart journal. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimThis 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.
methodsThis 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.
resultsA 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.
conclusionThe results demonstrate that Cocoon Septal Occluder is safe and effective in closing isolated secundum ASD during one-year follow-up.
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