Transcatheter closure with use of the SHSMA occluder in 180 patients with congenital heart defects: preliminary results.
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.
Sun
Wan-Feng
WF
Department of Cardiology, Affiliated Yancheng Hospital, Southeast University, Yancheng 224001, People's Republic of China.
Dong
Zhi-Feng
ZF
Gong
Kaizheng
K
Zhang
Guo-Pei
GP
Cui
Ting
T
Xia
Yu-Dong
YD
Dong
Jing
J
Shen
Yuan
Y
D000293:Adolescent; D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000191:economics / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D002681:China; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D005260:Female; D006330:Heart Defects, Congenital / Q000000981:diagnostic imaging / Q000628:therapy*; D017721:Hospital Costs; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011474:Prosthesis Design; D011859:Radiography; D018570:Risk Assessment; D012307:Risk Factors; D055989:Septal Occluder Device / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult