INTRODUCTION AND OBJECTIVES:Percutaneous closure of patent ductus arteriosus (PDA) is a well-established technique. We evaluated the usefulness of the Amplatzer duct occluder for the percutaneous closure of patent ductus arteriosus in 29 children under 1 year of age. METHODS: The patients' mean age was 8.9+/-2.8 months and their mean weight was 6.4+/-1.5 kg. In addition, 24.1% of patients were aged 6 months or less and 17.2% weighed 5 kg or less. All completed follow-up (0.5-36 months). RESULTS: The minimum PDA diameter was 3.16+/-1.24 mm. The device was implanted successfully in 26 patients (89.6%). Failures were due to either the device migrating to the descending aorta, persistent moderate leakage, or to difficulty in the advancement of the device. No deaths were associated with the procedure. Three major complications occurred in two patients (10.3%). Aortography showed initial total occlusion in 65.5% of patients. At 3-month follow-up, total occlusion was observed in 96.1% of patients. Ultimately, closure was achieved successfully in 25 of the 29 patients (86.2%). During follow-up, four patients exhibited mild left pulmonary artery stenosis and one exhibited mild stenosis of the descending aorta. CONCLUSIONS: In children under 1 year of age, percutaneous closure of patent ductus arteriosus using an Amplatzer occluder was a safe and effective procedure. It is possible that improvements in the design of the occluder could decrease the complication rate.
RCT Entities:
INTRODUCTION AND OBJECTIVES: Percutaneous closure of patent ductus arteriosus (PDA) is a well-established technique. We evaluated the usefulness of the Amplatzer duct occluder for the percutaneous closure of patent ductus arteriosus in 29 children under 1 year of age. METHODS: The patients' mean age was 8.9+/-2.8 months and their mean weight was 6.4+/-1.5 kg. In addition, 24.1% of patients were aged 6 months or less and 17.2% weighed 5 kg or less. All completed follow-up (0.5-36 months). RESULTS: The minimum PDA diameter was 3.16+/-1.24 mm. The device was implanted successfully in 26 patients (89.6%). Failures were due to either the device migrating to the descending aorta, persistent moderate leakage, or to difficulty in the advancement of the device. No deaths were associated with the procedure. Three major complications occurred in two patients (10.3%). Aortography showed initial total occlusion in 65.5% of patients. At 3-month follow-up, total occlusion was observed in 96.1% of patients. Ultimately, closure was achieved successfully in 25 of the 29 patients (86.2%). During follow-up, four patients exhibited mild left pulmonary artery stenosis and one exhibited mild stenosis of the descending aorta. CONCLUSIONS: In children under 1 year of age, percutaneous closure of patent ductus arteriosus using an Amplatzer occluder was a safe and effective procedure. It is possible that improvements in the design of the occluder could decrease the complication rate.