Abstract

Between December 1987 and September 1991, 205 nonsurgical procedures for closure of patent ductus arteriosus were attempted in 182 infants, children, and young adults with use of the Rashkind double-disc ductal occluding device. The patients' ages ranged from 8 months to 26 years (median 5 years) with 18 aged less than 2 years. Their weights ranged from 7.4 to 55 kg (median 16 kg); in patients aged less than 2 years the mean weight was 10.2 +/- 1.5 kg, and in those aged more than 2 years mean weight was 19.5 +/- 9.6 kg. Successful occluder device implantation was achieved in 174 patients (96%) at the initial attempt. Device embolization to a pulmonary artery occurred in six patients; two of these devices were retrieved by grabber catheter and four at operation, all without adverse sequelae; there were two other technical failures. Follow-up studies included two-dimensional Doppler echocardiography with color flow mapping. The 6-week follow-up study revealed a small residual shunt in 27% (46/169) of patients. At the 6-month follow-up study, 22% (37/167) of the patients had a small residual shunt; this prevalence was 17% (24/145) in ducts with a narrowest diameter of less than 6 mm, and 59% (13/22) in ducts greater than 6 mm. Immediately after implantation of the occluder device and throughout the follow-up period, the mean narrowest ductal diameter of ducts with residual shunts was significantly larger than that of ducts in which total occlusion was achieved (range of p < 0.01 to 0.001). The use of the 17 mm occluder device, however, was significantly associated with an increased prevalence of residual shunt only immediately after implantation (p < 0.01). Implantation of a second occluder device was attempted in 21 patients with residual patent ductus together with a continuous murmur at the 6-month follow-up; embolization of one device to a pulmonary artery occurred immediately but it was retrieved by grabber catheter and another device was successfully implanted 1 month later. All 21 patients were seen for 6-month follow-up study, when only one (5%) had a small residual shunt that was subsequently successfully closed by the insertion of a third occluder device. Thus, after successful implantation of one or more occluder devices, complete closure of the ductus was achieved in 90% of all patients seen to date for their 6-month follow-up study. One patient had limited hemolysis. The maximum follow-up period is 50 months. These results confirm the efficacy, with low morbidity and no mortality, of the use of the Rashkind occluder device for nonsurgical closure of patent ductus arteriosus, especially in those with smaller diameters.

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