Transcatheter closure of the patent ductus arteriosus using the new Amplatzer duct occluder: initial clinical applications in children.

BACKGROUND

In spite of recent advances in transcatheter management, the occlusion of certain anatomic types of patent ductus arteriosus (PDA), especially in infants and small children, remains a challenge. The aim of the study was to report initial human experience with transcatheter closure of PDA in 25 patients using the new Amplatzer duct occluder (ADO II) (AGA Medical, Golden Valley, MN).

METHODS

The median age of the patients was 3.2 years (range 0.1-5 years), and the median weight was 10.5 kg (range 3-18 kg). The device used is a modified ADO II made of fabric-free fine Nitinol wire net into 2 very-low-profile disks with an articulated connecting waist. Both disks are 6 mm larger than the diameter of the connecting waist. Connecting waist diameters range from 3 to 6 mm.

RESULTS

The mean PDA diameter was 3.6+/-1.3 mm (range 0.6-5 mm). The mean device diameter (waist diameter) was 4.3+/-1.4 mm (range 3-6 mm). Complete echocardiographic closure of the ductus at 1-month follow-up was observed in 24 (96%) of 25 patients. Immediately after the procedure, there was a mild left pulmonary stenosis (Doppler gradient of 15 mm Hg) in 2 of 25 patients. No other complications were observed.

CONCLUSIONS

The ADO II is a promising addition to our armamentarium for PDA closure. Further studies are required to document its efficacy, safety, and long-term results.