title: Comparison of two transcatheter closure methods of persistently patent arterial duct.
abstract: A randomized trial of arterial duct occlusion with a double umbrella (DU) or wire coil (WC) was undertaken for patients <18 years of age, weighing >10 kg with isolated ducts < or = 3 mm in diameter. Baseline, procedural, and outcome characteristics were compared in an intention-to-treat 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. Crossover occurred only in the DU group, where 4 patients (20%) had a ductal diameter of < or = 1 mm and could not be entered for umbrella placement. All remaining DU group patients had ductal diameters of > or = 1.3 mm (p <0.0001). There were no embolizations or secondary implants in the DU group, but in the WC group there was 1 early and 1 late embolization, with 6 patients (33%) with > or = 2 coils. Mean times for the procedure (DU 68+/-19 minutes; WC 65+/-27 minutes; p = 0.70) and fluoroscopy (DU 14+/-4 minutes; WC 11+/-6 minutes; p = 0.22) did not differ significantly. Angiographic duct closure was documented 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) was documented before hospital discharge. One WC group patient received thrombolytic 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 outcomes, the higher cost of the DU system compared with coil implants favors the use of coils for closure of the small arterial duct.
authors.affiliation: Department of Pediatrics, The Hospital for Sick Children, University of Toronto School of Medicine, Ontario, Canada.
authors.forename: H
authors.initials: H
authors.lastname: Justino
authors.forename: R N
authors.initials: RN
authors.lastname: Justo
authors.forename: C
authors.initials: C
authors.lastname: Ovaert
authors.forename: A
authors.initials: A
authors.lastname: Magee
authors.forename: K J
authors.initials: KJ
authors.lastname: Lee
authors.forename: A
authors.initials: A
authors.lastname: Hashmi
authors.forename: D G
authors.initials: DG
authors.lastname: Nykanen
authors.forename: B W
authors.initials: BW
authors.lastname: McCrindle
authors.forename: R M
authors.initials: RM
authors.lastname: Freedom
authors.forename: L N
authors.initials: LN
authors.lastname: Benson
mesh_terms: D000704:Analysis of Variance; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D002675:Child, Preschool; D003251:Constriction, Pathologic / Q000209:etiology; D017023:Coronary Angiography; D004374:Ductus Arteriosus, Patent / Q000000981:diagnostic imaging / Q000628:therapy*; D015150:Echocardiography, Doppler; D004868:Equipment Failure; D006801:Humans; D007223:Infant; D019736:Prostheses and Implants / Q000009:adverse effects; D011651:Pulmonary Artery / Q000473:pathology; D016037:Single-Blind Method; D018709:Statistics, Nonparametric; D016896:Treatment Outcome