Initial experience with the new Amplatzer Duct Occluder II.
BACKGROUND
Different devices are used for transcatheter occlusion of patent ductus arteriosus (PDA), each with its own limitations and complications. We report our initial single-center experience with the new Amplatzer Duct Occluder II (ADO II), which has been designed to address some of these issues.


METHODS
From April until October 2008, 10 consecutive patients with PDA (minimal diameter > or = 2 mm) were enrolled for intention-to-treat with ADO II. The median age was 10.2 years (7 months to 51.4 years); the median weight was 35.5 kg (6.3-70 kg).


RESULTS
ADO II implantation was attempted in 10/10 patients. The mean PDA diameter was 3.1 mm (+/- 1.0 mm), and the mean device waist diameter was 4.0 mm (+/- 1.3 mm). In 1 patient, the ADO II encroached upon the left pulmonary artery, hence it was changed to an Amplatzer Duct Occluder I. In another patient, the shape and size of the duct necessitated the use of a Cook detachable coil. Complete angiographic closure was achieved in 8/8 ADO II implantations (100%) and in the patient with the coil. In the patient with an ADO I, complete echocardiographic closure was demonstrated at 24 hours. No device embolization or complications related to implantation occurred.


CONCLUSIONS
This initial experience demonstrates the feasibility and efficacy of the ADO II to occlude PDA with a minimum diameter > or = 2 mm. It is especially useful in smaller children with larger duct diameters. Longer-term follow up in a larger cohort of patients is required to establish safety and long-term results.
Dua
Jaspal
J
Policlinico San Donato, Department of Paediatric Cardiology and Adult with Congenital Heart Defeca, via Morandi 30, San Donato Milanese, Milan, 20097, Italy. jaspaldua@yahoo.com
Chessa
Massimo
M
Piazza
Luciane
L
Negura
Diana
D
Micheletti
Angelo
A
Bussadori
Claudio
C
Butera
Gianfranco
G
Carminati
Mario
M
D000328:Adult; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods; D002648:Child; D002675:Child, Preschool; D004374:Ductus Arteriosus, Patent / Q000000981:diagnostic imaging / Q000628:therapy*; D004452:Echocardiography; D004867:Equipment Design / Q000009:adverse effects; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D008875:Middle Aged; D012189:Retrospective Studies; D055989:Septal Occluder Device / Q000009:adverse effects; D016896:Treatment Outcome