TRANSCATHETER OCCLUSION OF PATENT DUCTUS-ARTERIOSUS WITH ADJUSTABLE BUTTONED DEVICE - INITIAL CLINICAL-EXPERIENCE

Background. Several devices are available for transcatheter occlusion of patent ductus arteriosus. Most of these devices either require comp licated intracardiac maneuvering, have not been tried in humans, or ne ed a large-sized sheath for implantation of the device. Methods and Re sults. During a 26-month period ending November 1992, 14 patients unde rwent transcatheter closure of patent ductus arteriosus with an adjust able buttoned device delivered via a 7F sheath under an institutional review board-approved custom-made device protocol. The children were 1 5 months to 8 years of age with weight range of 7.2 to 19 kg. The pate nt ductus arteriosus measured from 2 to 7.5 mm (median, 3 mm) at the n arrowest diameter and was conical, short, or tubular. They were occlud ed with devices measuring 15 to 20 mm. The ratio of pulmonary to syste mic flow decreased (P<.01) from 1.9+/-0.6 (mean+/-SD; range, 1.3 to 3. 2) to 1.05+/-0.1 (1 to 1.3). Continuous murmur of patent ductus arteri osus disappeared in all except 1 patient. Small residual shunts were d etected by color Doppler studies in 4 of 14 patients (29%). All patien ts were followed for 1 to 24 months (mean, 6+/-7 months). The device w as intact in all patients, and no breakage of the wires was noted. No shunts were seen in 12 of 14 patients (86%), and minute residual shunt s were seen in 2 children. No major complications were encountered. Co nclusions. It is concluded that transcatheter closure of patient ductu s arteriosus with the adjustable buttoned device is feasible and effec tive and can be accomplished via small 7F sheaths; a 7F sheath is adeq uate for all ductal sizes; and the adjustable length of the loop accom modated all types of patent ductus arteriosus. Clinical trials on a la rger number of patients are warranted.