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.
MATERIALS AND METHODS: This was a multi-institutional, retrospective study involving all consecutive patients (>15 years old) with patent ductus arteriosus and severe pulmonary hypertension. Patients who had patent ductus arteriosus closure were divided into the Good (no death or hospital admissions due to worsening pulmonary hypertension) and the Poor Outcome groups and these groups were compared.
RESULTS: Thirty-seven patients [male: 9 (24.3%); mean age: 30.49 ± 9.56 years; median follow-up: 3 (IQR: 1.5,10) years] were included from four centers. Twenty-two patients who underwent patent ductus arteriosus closure, 15 (71.4%) had good outcomes while 7 (28.6%) had poor outcomes. Pulmonary vascular resistance index and pulmonary to systemic resistance ratio (Rp:Rs) were lower in the Good Outcome Group (14.35 ± 1.66 Wood units x m2 vs. 20.07 ± 2.44; p = 0.033 and 0.44 ± 0.16 vs. 1.08 ± 1.21; p = 0.042). Haemoglobin concentrations (<14.3 g/dL) were associated with good long-term outcomes in the Closed Group.
CONCLUSIONS: Patients with patent ductus arteriosus with severe pulmonary hypertension have a dismal outcome with or without closure. High haemoglobin levels at the time of occlusion predict a worse outcome for patients with patent ductus arteriosus and pulmonary hypertension.