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Tex Heart Inst J ; 37(5): 531-7, 2010.
Article in English | MEDLINE | ID: mdl-20978563

ABSTRACT

Transcatheter closure of congenital heart defects with the use of septal occluders has been widely accepted as a preferred treatment; however, the high cost of these devices limits their clinical application in some countries. Few clinical data are available regarding lower-cost products. Accordingly, we evaluated the efficacy and safety of the Chinese-made Shanghai Shape Memory Alloy (SHSMA) occluder in patients with congenital heart defects. From December 2001 through December 2008, a total of 180 patients with congenital heart defects (ages, 3-68 yr; mean age, 17.35 ± 13.22 yr) underwent transcatheter closure with use of the SHSMA occluder: 73 had atrial septal defects; 64, ventricular septal defects; 40, patent ductus arteriosus; and 3, complex congenital defects. The mean diameters of the defects were 20 ± 7.6 mm (atrial septal), 4.9 ± 2.1 mm (ventricular septal), and 5.6 ± 2.2 mm (patent ductus arteriosus). The procedural success rates were 98.6% for atrial defects, 98.4% for ventricular defects, and 100% for patent ductus arteriosus and for complex defects. The overall incidences of sequelae were 5.5%, 9.4%, 2.5%, and 0, respectively. Six months postprocedurally, complete occlusion was associated with a significant decrease in the right ventricular Tei index in atrial septal defect patients (P < 0.05) and with improvement of body mass index in 11 children. These results suggest that the SHSMA occluder is a safe, effective device for the transcatheter closure of congenital heart defects. For confirmation, a randomized controlled trial with more patients and a longer follow-up period is warranted.


Subject(s)
Cardiac Catheterization/instrumentation , Heart Defects, Congenital/therapy , Septal Occluder Device , Adolescent , Adult , Aged , Cardiac Catheterization/adverse effects , Cardiac Catheterization/economics , Child , Child, Preschool , China , Cost Savings , Cost-Benefit Analysis , Female , Heart Defects, Congenital/diagnostic imaging , Hospital Costs , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Pilot Projects , Prosthesis Design , Radiography , Risk Assessment , Risk Factors , Septal Occluder Device/economics , Time Factors , Treatment Outcome , Young Adult
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