Circulation, Vol 75, 583-592, Copyright © 1987 by American Heart Association
WJ Rashkind, CE Mullins, WE Hellenbrand and MA Tait
The first successful application of a transcatheter closure technique for
patent ductus arteriosus (PDA) suitable for use in infants and children was
performed by us in 1977. Since that time, there has been continued
improvement and simplification of the equipment as well as in the
implantation technique. Following a Food and Drug Administration protocol,
a multicenter study was conducted to test the safety and effectiveness of
this interventional method. The clinical results from three major regional
test centers (Philadelphia, Houston, and New Haven) are presented. One
hundred forty-six patients from a test population of 156 were treated for
PDA with use of the Rashkind PDA Occluder Systems. Successful closure was
accomplished in 94 (66%) of the total cases. Ten patients (7%) retained
residual ductal murmurs despite correct placement of the occlusion devices;
five additional patients (3%) were considered failures due to the presence
of abnormal Doppler flow patterns after the procedure. Postrelease
embolizations occurred in 19 (15%) instances. One patient required
emergency surgical intervention after attempted retrieval of an embolized
occluder. With the improvements in the manufacturing of the double-disk
occluder systems as well as the perfection of the transvenous delivery
technique, the incidences of closure failure and postrelease complications
have decreased. Since January 1984, 78% of all transcatheter closure
attempts were successful, with 10% embolization.
ARTICLES
Nonsurgical closure of patent ductus arteriosus: clinical application of the Rashkind PDA Occluder System
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