Comparison of two transcatheter closure methods of persistently patent arterial duct

A randomized trial of arterial duct occlusion with a double umbrella (DU) o r wire coil (WC) was undertaken for patients <18 years of age, weighing >10 kg with isolated ducts less than or equal to3 mm in diameter. Baseline, pr ocedural, and outcome characteristics were compared in on intention-to-trea t analysis according to randomization group. From 40 consecutively screened patients, 2 were not enrolled due to a ductal diameter of >3 mm on initial aortography, 38 patients were randomized to either the DU (n = 20) or WC ( n = 18) groups. The groups did not differ significantly with respect to age , weight, gender, duct size, type, or branch pulmonary artery diameters. Cr ossover occurred only in the DU group, where 4 patients (20%) had a ductal diameter of less than or equal to1 mm and could not be entered for umbrella placement. All remaining DU group patients had ductal diameters of greater than or equal to1.3 mm (p <0.0001). There were no embolizations or seconda ry implants in the DU group, but in the WC group there was 1 early and 1 la te embolization, with 6 patients (33%) with <greater than or equal to>2 coi ls. Mean times for the procedure (DU 68 +/- 19 minutes; WC 65 +/- 27 minute s; p = 0.70) and fluoroscopy (DU 14 +/- 4 minutes; WC 11 +/- 6 minutes; p = 0.22) did not differ significantly. Angiographic duct closure was document ed in 4 of 13 patients (31%) of the DU group and 4 of 18 patients (22%) of the WC group (p = 0.69). Combined with an echocardiogram, closure in 11 of 17 patients with DU (65%) and 13 of 18 patients with WC (72%) (p = 0.64) wa s documented before hospital discharge. One WC group patient received throm bolytic therapy for a femoral artery thrombus. Follow-up at a median of 6.5 months (range 3.2 to 37) showed closure by Doppler echocardiography in 15 of 19 patients with DU (79%) versus 14 of 18 patients with WC (78%) (p = 1. 0). Thus, with a tendency toward similar procedural characteristics and out comes, the higher cost of the DU system compared with coil implants favors the use of coils for closure of the small arterial duct. (C) 2001 by Excerp ta Medica, Inc.