The new occlutech duct occluder: immediate results, procedural challenges, and short-term follow-up.
OBJECTIVE
The aim of this study was to assess the immediate and short-term results of transcatheter closure of patent ductus arteriosus (PDA) using the Occlutech duct occluder (ODO).


BACKGROUND
The ODO is a new self-expanding nitinol device. Its body is wider at the pulmonary artery end than the aortic end. It is available in longer lengths than the Amplatzer duct occluder.


METHODS
Twenty-two ODO implants were attempted in successive children referred for transcatheter device occlusion of PDAs ≥1 mm in diameter.


RESULTS
Median patient age was 2.4 years (range, 0.7-17.5 years), median weight was 13.1 kg (range, 6.3-40 kg), and median PDA diameter was 1.9 mm (range, 1-4.3 mm). Twenty-one out of 22 patients (95%) had successful ODO implantation. One device was withdrawn before release because it did not reach the pulmonary artery end of a long duct. Median procedure time was 40 minutes (range, 26-60 minutes) and fluoroscopy time was 4.5 minutes (range, 2.7-13.3 minutes). Occlusion rates were 19/21 (90%) at the end of the procedure, 20/21 (95%) at 24-48 hours post procedure, and 21/21 (100%) on echocardiography at a median follow-up of 4 weeks (range, 2-16 weeks). There were no device-related complications. Two infants had femoral artery occlusion, successfully treated by heparinization and thrombolysis.


CONCLUSIONS
This first formal clinical evaluation of the ODO indicates that it is safe and effective in occluding small-to-moderate size ducts, up to a diameter of 4.3 mm. The device produced equivalent results to the Amplatzer duct occluder. Further evaluation is required to assess whether its shape and longer length make it superior for closing large and long ducts.
Consultant Paediatric Cardiologist, East Midlands Congenital Heart Centre, Glenfield Hospital, Groby Road, Leicester, United Kingdom, LE3 9QP. akd11@leicester.ac.uk.
Vikram
V
Kudumula
Demetris
D
Taliotis
Christopher
C
Duke
D000293:Adolescent; D006328:Cardiac Catheterization / Q000379:methods*; D002648:Child; D002675:Child, Preschool; D004374:Ductus Arteriosus, Patent / Q000175:diagnosis / Q000601:surgery*; D004452:Echocardiography; D005260:Female; D005471:Fluoroscopy; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011474:Prosthesis Design; D012189:Retrospective Studies; D055989:Septal Occluder Device; D025321:Surgery, Computer-Assisted / Q000379:methods*; D013997:Time Factors