| ObjectiveTo assess the clinical efficacy and safety of the Amplatzer occluder for percutaneous closure of secundum atrial septal defect.MethodsBetween Aprial 2002 and July 2003, 50 patients recruited in the sector of congenital heart diseases of the Department of Cardiology the First Affiliated Hospital, Zhejiang University with secundum atrial septal defect (ASD)were selected for this study. They underwent transthoracic echocardiography (TTE) and transesophageal echocardiography (TEE) and met the following inclusion criteria: patients of both sexes and more than twenty years old; with left-to-right blood flow through the atrial septal defect; with the defect according to the following characteristics: diameter between 4-38mm, distance of at least 5mm between its rims and the atrioventricular valves, the origin of the coronary sinus (CS) and the inferior vena cava (IVC), in itsinferior portion, maintaining the same distance between its superior portion and the emergence of the right superior pulmonary vein (RSPV) and the superior vena cava (SVC). The antero-superior rim (related to the aorta in the transverse plane) could be deficient (< 5mm) or absent. Patients with the following characteristics were excluded from the study: secundum atrial septal defect with clinical signs of right-to-left blood flow (sat 02 < 94%); fixed pulmonary arterial hypertension and other heart associated defects requiring surgical correction.The Amplatzer occuder(Aga Medical corporation,Golden Valley,Mninn, USA) The metal used in its fabrication is a metallic alloy composed of nickel(55%) and titanium(45%),named nitinol.The prosthesis is formed by 2 retention disks linked by one waist in a single body.The disk are availble in sizes with unit variation at every 2 mm up to 38mm diameter. The prosthesis is filled with polyester fiber that is highly thrombogenic.The procedure of implantation was carried out fluoroscopy and TEE. The technique of implantation of the Amplatzer occluder was reported in the study by Fontes et al.Immediately after the ASO release ,a precise TEE examination was performed.The shape of the occluder was evaluated.A color Doppler signal width <2 was considered as a small residual shunt,2 to 4 mm as a moderate shunt,and>4mm as significant residual shunt. Relationships between the occluder and both atrioventricular valves were evaluated. Drainage of the caval vein, right pulmonary veins,and the coronary sinus were evaluated for obstruction.A physical examination, a 12-lead standard EKG, chest radiograph,and TTE were performed after 24-h ,during 1 -month and 6 month.Majior complications included cerebral embolism, cardiac perforation with tamoponade, endocarditis, repeat operation,death due to the procedure,cardiacarrthythmisa requiring permanent pacemaker placement or long-term antiarrhythmic medication,or device embolization requiring immediate surgical removal. Minor complications included device embolization with percutaneous retrieval,cardiac arrhythmia with treatment,phrenic nerve injury,access site hematoma,other vascular access site complications,retroperitoneal hematoma.ResultsFifty patients were selected for percutaneous occlusion of secundum atrial septal defect with the Amplatzer occluder. On echocardiography (TTE and TEE), the atrial septal defect appeared as a single orifice in 96.0% (48/50) of the patients, as 2 orifices in 2. The means diameters of the orifices were 6-34(19.70 to 5.12)mm . Fifty prostheses were implanted with technical success in 50 patients.Right after definitive deployment of the device, color Doppler TEE showed that 12 patients had residual flow, which was classified as small in 11 patients, moderate in 1. Residual interatrial shunts occurred in 4 patients at one month,2 patients at six month.On the echocardiogram,mean four-chamber right ventricular( RV )size and mean right ventricular outflow tract diameter (RVOTD) decreased significantly by one month to within normal limits (30.94±5.12vs 28.18±4.67mm,p<0.01,and 27.10±4.12 vs 25.50±3.70mm) and has progressive decreased at six month.
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