# Safety and one-year follow-up analysis of percutaneous ASD closure at a tertiary care hospital

## TL;DR

A study shows the Cocoon Septal Occluder device is safe and effective for closing heart defects in both children and adults over one year.

## Contribution

The study provides safety and effectiveness data for the Cocoon Septal Occluder device in a large Indian patient cohort.

## Key findings

- 100% defect closure in pediatric patients with no complications at one-year follow-up.
- 99.2% complete ASD closure in adults with minimal complications like device embolization and cardiac issues.
- No major adverse events like endocarditis or stroke reported in either group.

## Abstract

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.

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.

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.

The results demonstrate that Cocoon Septal Occluder is safe and effective in closing isolated secundum ASD during one-year follow-up.

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