TRANSCATHETER OCCLUSION OF PATENT DUCTUS-ARTERIOSUS WITH A NEW DETACHABLE COIL SYSTEM (DUCTOCCLUD) - A MULTICENTER CLINICAL-TRIAL

A multicenter clinical trial of DuctOcclud, a new detachable coil for transcatheter occlusion of patent ductus arteriosus (PDA), was conduct ed. DuctOcclud was used in 35 patients (12 male and 23 female) for tra nscatheter occlusion of PDA between January, 1996, and April, 1997, Th e age of the patients ranged from 0.5 to 27.2 years (median 7.6 years) and weight from 6.3 to 70.0kg (median 23,0kg). The smallest diameter of PDA was 2.0+/-0.7 mm (range 1.0-3.3 mm). Pulmonary-systemic flow ra tio (Qp/Qs) was 1.3+/-0.3 (range 1.0-2.2), The coils were successfully implanted in 32 (91%) patients. Of 31 patients who were followed 6 mo nths after the procedure, 26 (84%) had no residual shunt and 5 (16%) h ad trivial residual shunt. One patient had infective endocarditis 1 mo nth after the procedure but recovered completely, There were no incide nces of coil embolization, hemolysis, late coil migration, or pulmonar y artery stenosis. We conclude that DuctOcclud is a safe and effective device of transcatheter occlusion of PDA.