OBJECTIVE: Percutaneous closure of patent ductus arteriosus (PDA) is a well established technique. Our objective was to determine the safety and efficacy of the Amplatzer occluder for the treatment of PDA in children. METHODS: From November 2005 to June 2007 we reviewed the clinical records of 39 patients (23 girls and 16 boys), with a mean age of 19.8 +/- 13.7 months and weight 9.2 +/- 3.2 Kg, who underwent percutaneous closure of a PDA with an Amplatzer device. The forty one percent of the patients (16/39) were < or = 1 year of age, and 71.8 % (28/39) weighed < or = 10 Kg. The age of children with body weight < or = 10 Kg was 13.1 +/- 6.1 months (range 5-33 months). The morphology of the PDA was determined by a lateral aortogram and classified according to Krichenko. All the patients were followed-up with radiologic and echocardiographic control at 24 hours, 1, 3, 6 and 12 months postinsertion (median 20 months). RESULTS: The PDA diameter ranged between 2.0 mm to 12 mm (3.6 mm +/- 2.0 mm) in the 39 patients included. PDA types according to Krichenko were: type A = 25 (64.1%), type B = 1 (2.6%), type C = 5 (12.8%), type D = 2 (5.1%) and type E = 3 (7.7%). Three patients had a residual PDA post-surgical closure attempt. Qp/Qs ratio was 2.4 +/- 1.5 (range 1.0-6.7) and the relation PSP/PSS was 0.49 +/- 0.18 (range: 0.21-0.87). Pulmonary hypertension was present in 16 patients (41%). The Amplatzer occluder was implanted successfully in 36/39 patients (92.3%). The procedure failed in three cases: 1) difficulty to place the device due to wrong assessment of the ductus size; 2) difficulty to advance the device due to angulation (kinking) of the releasing system; 3) migration of the device to descending aorta. The mean time of fluoroscopy and for the entire procedure was 13.2 +/- 6.3 minutes and 65.3 +/- 21.9 minutes, respectively. There were no deaths with the procedure. Minor and mayor complications occurred in eight patients, all of them but one, in children with body weight < or = 10 Kg. In the 36 successful insertions an aortogram showed complete occlusion in 26 (66.7%), trivial leak through the occluder in 6 (15.45), mild leak in 4 (10.3%), and moderate leak in 2 (5.1%). A control echocardiogram 24 h after the insertion showed a successful rate of 82.1% (32/36). Complete occlusion of the PDA was obtained in 35/36 patients (97.2%) at 3 months follow-up study. In 4 patients the percutaneous occlusion technique did not result in PDA closure, and 3 of them underwent a surgical closure. On follow-up, 3 patients developed mild stenosis of the left pulmonary artery and two a mild pressure gradient in the descending aorta. CONCLUSIONS: Percutaneous closure of PDA with an Amplatzer is a safe and effective technique. In children with ductus arteriosus diameter > or = 2 mm the Amplatzer device should be recommended over surgical closure. The incidence of complications after the procedure is higher in patients under 10 kg of body weight.
OBJECTIVE: Percutaneous closure of patent ductus arteriosus (PDA) is a well established technique. Our objective was to determine the safety and efficacy of the Amplatzer occluder for the treatment of PDA in children. METHODS: From November 2005 to June 2007 we reviewed the clinical records of 39 patients (23 girls and 16 boys), with a mean age of 19.8 +/- 13.7 months and weight 9.2 +/- 3.2 Kg, who underwent percutaneous closure of a PDA with an Amplatzer device. The forty one percent of the patients (16/39) were < or = 1 year of age, and 71.8 % (28/39) weighed < or = 10 Kg. The age of children with body weight < or = 10 Kg was 13.1 +/- 6.1 months (range 5-33 months). The morphology of the PDA was determined by a lateral aortogram and classified according to Krichenko. All the patients were followed-up with radiologic and echocardiographic control at 24 hours, 1, 3, 6 and 12 months postinsertion (median 20 months). RESULTS: The PDA diameter ranged between 2.0 mm to 12 mm (3.6 mm +/- 2.0 mm) in the 39 patients included. PDA types according to Krichenko were: type A = 25 (64.1%), type B = 1 (2.6%), type C = 5 (12.8%), type D = 2 (5.1%) and type E = 3 (7.7%). Three patients had a residual PDA post-surgical closure attempt. Qp/Qs ratio was 2.4 +/- 1.5 (range 1.0-6.7) and the relation PSP/PSS was 0.49 +/- 0.18 (range: 0.21-0.87). Pulmonary hypertension was present in 16 patients (41%). The Amplatzer occluder was implanted successfully in 36/39 patients (92.3%). The procedure failed in three cases: 1) difficulty to place the device due to wrong assessment of the ductus size; 2) difficulty to advance the device due to angulation (kinking) of the releasing system; 3) migration of the device to descending aorta. The mean time of fluoroscopy and for the entire procedure was 13.2 +/- 6.3 minutes and 65.3 +/- 21.9 minutes, respectively. There were no deaths with the procedure. Minor and mayor complications occurred in eight patients, all of them but one, in children with body weight < or = 10 Kg. In the 36 successful insertions an aortogram showed complete occlusion in 26 (66.7%), trivial leak through the occluder in 6 (15.45), mild leak in 4 (10.3%), and moderate leak in 2 (5.1%). A control echocardiogram 24 h after the insertion showed a successful rate of 82.1% (32/36). Complete occlusion of the PDA was obtained in 35/36 patients (97.2%) at 3 months follow-up study. In 4 patients the percutaneous occlusion technique did not result in PDA closure, and 3 of them underwent a surgical closure. On follow-up, 3 patients developed mild stenosis of the left pulmonary artery and two a mild pressure gradient in the descending aorta. CONCLUSIONS: Percutaneous closure of PDA with an Amplatzer is a safe and effective technique. In children with ductus arteriosus diameter > or = 2 mm the Amplatzer device should be recommended over surgical closure. The incidence of complications after the procedure is higher in patients under 10 kg of body weight.