Creation of an intra-atrial communication with a new Amplatzer shunt prosthesis: preliminary results in a swine model.

A nitinol shunt device was applied in six minipigs to create a precise intra-atrial shunt. This self-expanding shunt device consists of two retention disks of 2-8 mm, a 4 mm connecting waist with a 10 mm eccentric hole. It requires a 7 Fr introducer sheath. The device is attached to the delivery cable with a microscrew. Placement technique is identical to that of Amplatzer septal occluder. Balloon dilation was performed immediately and 1 month after placement. One animal died from general anesthesia before device placement. Left atrial angiography showed a patent intra-atrial shunt in 5/5 pigs immediately and 4/4 in 1- to 3-month follow up. Postmortem examination demonstrated patent shunts partially or completely neoendothelialized. The shunt device was found to be an effective and safe way to create a permanent atrial communication.