Experimental evaluation of a new articulated Amplatzer ductal occluder device without fabric.

Objectives: To describe a new percutaneous PDA device.

Background: The ADO II was developed by AGA Medical for closure of small-moderate sized PDAs via a small delivery catheter from an antegrade or retrograde catheter approach. The objective of this study was to evaluate the technical feasibility, safety, and efficacy of the ADO II in a canine PDA model.

Methods: The ADO-II consists of multi-layer nitinol wire braid with symmetric retention disks and an articulating connecting center waist, without sewn-in polyester, that can be delivered though a 4-5F catheter. A PDA was surgically created in nine dogs. Transcatheter occlusion of the PDA was performed using the ADO II. Angiographic and hemodynamic data were obtained at 7, 30, 60, and 90 days post-procedure. The devices were then harvested for pathology.

Results: Devices were placed transarterially (n = 8) and transvenously (n = 1). All PDAs were occluded and there were no significant pressure gradients (P > 0.05) at the immediate and 90 post-implant evaluations. Pathology found endothelial coverage on all aortic and pulmonary disks, except at the tip of the microscrew. There were no procedural complications. One canine was euthanized 4 hr after device implant because of a clinical deterioration. The staff veterinarian and pathologist concluded that the animal's illness was not device related.

Conclusions: The Amplatzer ADO II devices can be safely deployed in animal models of PDAs, with complete resolution of the PDA shunt. The lower profile and symmetry of the ADO II allows for venous or arterial approach and smaller delivery catheter size. The ADO-II is expected to be a preferred alternative for closure of small-moderate PDAs.