Clinical evaluation of the new Amplatzer duct occluder II for patent arterial duct occlusion.
BACKGROUND
Several devices such as coils and Amplatzer duct occluder (ADO) are used for catheter closure of patent arterial ducts (PDA). These carry a high success rate but residual shunts, suboptimal device orientation, and technical problems are encountered. The Amplatzer duct occluder II (ADO II) is designed to address these limitations.


OBJECTIVE
To evaluate the technical features of the new ADO II device for PDA closure and document the immediate/early closure rate, complications and device behavior during implantation.


METHODS
Prospective, two center study from February 2008 to January 2009. Twenty-seven patients (18 females) received the ADO II. The median age was 22 months (range: 7 months-68 years) and the median weight was 11.7 kg (range: 6.9-108). The median PDA diameter was 2.6 mm (range: 1-4.4). The approach was arterial in 13 and venous in 14 patients. Follow-up included echocardiography at 1 day and 1 month postimplantation.


RESULTS
All implantations were technically successful with immediate complete angiographic closure in 21 and trivial contrast flow in six patients. The median procedure time was 43 min (range: 15-82) and the fluoroscopy time was 6 min (range: 2.2-26.5). Echocardiography confirmed no residual shunts on the following day. There were no complications.


CONCLUSIONS
The new ADO II is a versatile and very effective device for closure of PDAs of various shapes, lengths, and up to diameters of 5.5 mm. The disc articulations, high early closure rate, arterial or venous approach options, and small diameter delivery catheter are all beneficial features.
Bhole
V
V
Heart Unit, Birmingham Children's Hospital, Birmingham, United Kingdom.
Miller
P
P
Mehta
C
C
Stumper
O
O
Reinhardt
Z
Z
De Giovanni
J V
JV
D000293:Adolescent; D000328:Adult; D000368:Aged; D001835:Body Weight; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D017023:Coronary Angiography; D004374:Ductus Arteriosus, Patent / Q000000981:diagnostic imaging / Q000628:therapy*; D004739:England; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D011446:Prospective Studies; D011474:Prosthesis Design; D055989:Septal Occluder Device; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography; D055815:Young Adult