Coil on the loop and selectively enhanced stiffness for improved control: feasibility study in the neonatal ovine model of the large patent ductus arteriosus

Abstract

Rationale and objectives: Several devices have been suggested and tested for interventional closure of the persistent ductus arteriosus. Coils were found effective only in small ducts due to their lack of maneuverability and physical limitation of grip forces leading to risk of embolization. The authors evaluated the feasibility to place single coils with selectively enhanced stiffness into high shunting ductus arteriosus, the coils being deployed and controlled through a veno-arterial loop in a bovine model.

Methods: "Double-cone" shaped, stainless steel coils with enhanced stiffness of the outer rings were mounted on either end on a nitinol core wire. A snap-in mechanism attaches the coil to this delivery wire and is freed by a pusher system of coiled steel wire that is advanced over the core wire. Forming a veno-arterial loop across the patent ductus allows for repositioning into the pulmonary artery or aortic catheter. A chronic lamb model of large patent ductus arteriosus (PDAs) (> or = 9 mm) was used in which ductus patency was secured by a protocol of repetitive angioplasties. Different systems (n = 10) were placed having retrieved the previous coil by a snare after definitive release.

Results: Placement of coils was possible in all 10 attempts. The coils were pulled back into the catheters between five and eight times before definitive release.

Conclusions: The device allows controlled placement of single coils in our model of large PDAs and may lead the way to overcome previous limitations of coils. Clinical trials are warranted.