[The development of a new perimembranous ventricular septal defect occluder].
OBJECTIVE
The aim of this study was to develop a new perimembranous VSD occluder and to evaluate it.


METHODS
The shape of VSD occluder was designed as fabric frame "I" shape that comprised two types: symmetric and asymmetric. The safety, efficacy, feasibility and complication were tested in 22 animal models and in 58 VSD patients in clinical trial. The device were compared with Amplatzer occluder in this study.


RESULTS
The new perimembranous VSD occluder was passed the national material test. In animal study, artificial VSD were all occluded by using the new devices with no complication in follow up except one pig expresented wound infection. In clinical trial, all 58 VSD cases were healing with the new device. One patient suffered with atria-ventricular block 5 days after procedure and was free from AV block with medicine therapy. Compared with Amplatzer perimembranous VSD occluder, the new devices had lower frequency of residual shunt.


CONCLUSIONS
The new perimembranous VSD occluder is a safe and effective perimembranous VSD interventional apparatus, and the effect of the new occluders seems not worse than that of the Amplatzer ones.
Zhang
Zhi-wei
ZW
Department of Pediatrics, Guangdong Cardiovascular Institute, Guangdong 510100, China.
Zeng
Guo-hong
GH
Lin
Shu-guang
SG
Fan
Rui-xin
RX
Li
Yu-fen
YF
Wang
Shu-shui
SS
Xie
Yu-mei
YM
Shi
Ji-jun
JJ
Li
Jun-jie
JJ
D000293:Adolescent; D000328:Adult; D000818:Animals; D021721:Balloon Occlusion / Q000295:instrumentation* / Q000379:methods; D006328:Cardiac Catheterization / Q000379:methods; D002648:Child; D002675:Child, Preschool; D004867:Equipment Design; D005260:Female; D006345:Heart Septal Defects, Ventricular / Q000601:surgery*; D006801:Humans; D008297:Male; D019919:Prosthesis Implantation; D013552:Swine; D016896:Treatment Outcome; D055815:Young Adult