Prospective evaluation of the feasibility, safety, and efficacy of Cocoon Duct Occluder for transcatheter closure of large patent ductus arteriosus: A single-center study with short- and medium-term follow-up results

Abstract

Objective: To evaluate the feasibility, safety, and efficacy of a novel Cocoon Duct Occluder device for the transcatheter closure (TCC) of large patent ductus arteriosus (PDA). Methods: In this prospective, non-randomized study, consecutive patients with large PDA (narrowest diameter: ≥3.5/4.0 mm in symptomatic/asymptomatic patients, respectively), who underwent TCC with Cocoon Duct Occluder at our institute between November, 2012 and June, 2016 were examined. TCC was performed using the standard technique, and devices were antegradely delivered via 6–10F delivery sheaths. Device embolization, residual shunt, hemolysis, left pulmonary artery (LPA) stenosis, procedural and fluoroscopy time, and mortality were assessed. Patients were followed-up by transthoracic echocardiography with color Doppler imaging at 24 h (D1), 1 month (D30), and 6 months (D180) after implantation. Results: 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. The PDA closure was successfully performed in each patient. Fluoroscopy and procedural time was 6.7±3.2 min and 23.9±2.7 min, respectively. Postprocedural angiography revealed that 49 (85.9%) patients had immediate and complete closure, whereas 8 (14.1%) had residual shunt. Color 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. Hemolysis, embolization, obstruction of LPA or descending aorta, and death were not reported till D180. Conclusion: 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.

Outcomes of transcatheter closure of patent ductus arteriosus with the off-label use of large occluders (≥16 mm)

“… 1 , 2 The natural history of PDA varies from an asymptomatic, incidentally detected defect to congestive heart failure, atrial arrhythmias, endocarditis, ductal aneurysm, pulmonary vascular disease, and Eisenmenger's syndrome. 4 The successful closure of PDA reduces mortality and decreases the incidence of endocarditis. Hence, surgical or transcatheter closure is indicated for all patients with PDA except those with small, silent defects and patients with irreversible pulmonary artery hypertension (PAH).…”

“… 1 Transcatheter closure has become the mainstay of treatment for PDA and surgical ligation is reserved for complex, large defects not suitable for device closure or PDA in very young infants and neonates. 4 , 5 Although percutaneous closure is the preferred treatment of PDA for most children as well as adults, many patients, especially adolescents and adults with very large defects, are subjected to surgery because of the lack of appropriate sized devices. 6 Most of the available literature of PDA device closure have established the efficacy of the Amplatzer duct occluders ( ADO and ADO II , AGA Medical Corporation, Golden Valley, Minnesota, USA ).…”

“…7 , 8 , 9 , 10 , 11 The largest available size of the ADO is 16/14 mm and can be used to close PDAs up to 11–12 mm in size. 4 , 7 However, larger devices are available from other manufacturers [i.e. Cera duct occluder, Lifetech Scientific, Shenzhen, China and Cocoon duct occluder, Vascular Innovations, Nonthaburi, Thailand ] and can be used for the closure of defects not amenable to ADO and ADO II.…”

“…Cera duct occluder, Lifetech Scientific, Shenzhen, China and Cocoon duct occluder, Vascular Innovations, Nonthaburi, Thailand ] and can be used for the closure of defects not amenable to ADO and ADO II. 4 , 12 There is limited data regarding the transcatheter closure of PDA with devices ≥16 mm. 4 , 13 , 14 We hereby report our experience of PDA device closure with the use of large devices, which are not FDA-approved.…”

“… 4 , 12 There is limited data regarding the transcatheter closure of PDA with devices ≥16 mm. 4 , 13 , 14 We hereby report our experience of PDA device closure with the use of large devices, which are not FDA-approved.…”