Clinical Evaluation of the new Amplatzer Duct Occluder II (ADOII)
Background: Several devices including coils and Amplatzer Duct Occluder (ADO) are used for catheter closure of patent arterial ducts (PDA). These devices generally carry a high success rate but residual shunts, sub-optimal device orientation and technical problems can be overcome by better designed devices. The new ADOII is designed with these in mind.
Objectives: The aim of this study was to evaluate the safety and efficacy of the ADO II for closure of PDA.
Methods: This was a prospective multicentre study from February 2008 to January 2009. Twenty-seven patients (17 females) received the ADO II, The median age was 22 months(Range: 7 months – 68 years) and the median weight was 11.7(6.9 – 110) Kg. The mean PDA diameter was 3 (1 – 4.4)mm. The approach was arterial in 13(48%) and venous in 14(52%) patients. Follow-up included echocardiography at 1 day and 1 month post-implantation
Results: All implantations were technically successful. Angiography soon after device release showed complete closure in 20(77%) and trivial contrast flow in 6 patients with complete occlusion on echocardiography by the next day. The median procedure time was 41 (15 – 82)minutes and the fluoroscopy time 6(2.2 – 26.5)minutes. There were no complications.
Conclusion: The ADO II is a versatile and very effective device for catheter closure of PDA up to diameters of 5.5 mm. The articulations, high early closure rate, arterial/venous approach options and small diameter delivery catheter (4-5F) are all beneficial features of this new device.