Transvenous double-balloon occlusion of the persistent ductus arteriosus: an experimental study.

A new method of transvenous catheter closure has been developed for closure of a persistent ductus arteriosus (PDA), especially in infants and children. The device consists of a 5F or 6F triple-lumen catheter which carries a detachable silicone double-balloon at the tip. After expanding the distal positioning balloon, the proximal occlusion balloon is placed in the PDA and filled to the required size with radiopaque silicone. As the silicone cures inside the balloon, a solid plug occludes the PDA after it is detached from the catheter. In 21 beagles a short segment of subclavian artery was interposed between the main pulmonary artery and the descending aorta, simulating a PDA. The procedure was tested on these models and proved to be suitable. Within one month the plug was covered with fibrous tissue at the pulmonary and aortic ends, thus ensuring permanent occlusion. The long-term follow-up extended for up to two years and confirmed the biocompatibility of the silicone plug.