The new Occlutech® PDA occluder: Initial human experience

OBJECTIVES: To evaluate the feasibility, safety, and efficacy of the Occlutech(®) PDA occluder for closure of patent ductus arteriosus (PDA). BACKGROUND: The Occlutech(®) PDA occluder is novel, self‐shaping Nitinol wire device with PET (polyethylene terephthalate) patches integrated into the shank of the device to assure a better obturation of the ductus. The Occlutech(®) PDA occluder has undergone two design modifications. METHODS: A prospective, non‐randomized pilot study was started in November 2011. Thirty‐three patients were included until April 2013. Patients weighing <6 kg or those with associated cardiac anomalies that required surgery were excluded. All patients were followed up by transthoracic echocardiography at 24 hr, 30 days, 90 days, 180 days, and 360 days after implantation. Residual shunt, left pulmonary artery (LPA) and descending aortic velocities were among the parameters assessed. All occluders were delivered via 6–8 F long sheaths and PDA closures were performed following standard techniques. RESULTS: Thirty three patients (20 female/13 male), with a median age of 2 years (6 month to 38 years), and median weight of 9.3 kg (6–69.2 kg) were included. The narrowest median PDA diameter was 3mm (1.8–5.8 mm). All the 33 patients were closed successfully using Occlutech ductal occluder, 16 patients (48.4%) had immediate and complete closure on angiography. Within 24 hr, color Doppler revealed complete closure in 27patients (81.8%), 32patients (97%) at 30 days, and in 100% of patients at 90 days. All patients with a large PDA had immediate residual shunt which was closed at the 90‐day follow‐up. There was no device embolization, hemolysis, or obstruction to the LPA or descending aorta. CONCLUSION: The new Occlutech(®) PDA is safe and effective. In patients with a large PDA complete closure tended to take longer time. © 2015 Wiley Periodicals, Inc.