Author + information
- Santosh Sinha1,
- Mahmadula Razi1,
- Mukesh Jha1,
- Vikas Mishra1,
- Puneet Aggarwal1,
- Lokendra Rekwal1 and
- Anupam Singh1
To evaluate the feasibility, safety, and efficacy of a novel Cocoon duct occluder device for transcatheter closure (TCC) of large patent ductus arteriosus (PDA).
In this prospective, non-randomized study, consecutive patients with large PDA (narrowest diameter: ≥3.5/4.0 mm in symptomatic/asymptomatic respectively), who underwent TCC with Cocoon duct occluder at our institute between November, 2012 and June, 2016 were examined. TCC were performed using standard technique and devices were delivered antegadely via 6-10F long delivery sheaths. Device embolization, residual shunt, haemolysis, left pulmonary artery (LPA) stenosis, procedural and fluoroscopy time, and mortality were assessed. Patients were followed-up by transrthoracic echocardiography with colour Doppler imaging at 24 hours (D1), 1 month (D30), and 6 months (D180) after implantation.
A total of 57 patients (age: 11.7±2.8 years; weight: 22.3±3.5 kg) were enrolled. The mean narrowest diameter was 7.4±0.7 mm. PDA closure was performed successfully in each patient. Fluoroscopy and procedural time were 6.7±3.2 min and 23.9±2.7 min respectively. Post-procedural angiography revealed that 49 (85.9%) patients had immediate and complete closure, while 8 (14.1%) had residual shunt. Colour Doppler imaging at D1 revealed complete closure in 52 (91.3%) patients. At D30, complete closure was reported in all patients and was maintained at D180. Haemolysis, embolization, obstruction of LPA or descending aorta, and death were not reported till 6-month follow-up.
TCC using Cocoon duct occluder is feasible, safe, and effective in the management of patients with large PDA, with excellent results on short and medium- term follow-up. Key words: Congenital heart disease, Transcatheter closure, Cocoon duct occluder, Large patent ductus arteriosus.
STRUCTURAL: Congenital and Other Structural Heart Disease