Experimental evaluation of a modified Amplatzer duct occluder

The purpose of this study was to evaluate a new device specifically designed for patent ductus arteriosus (PDA) occlusion based on PDA anatomy. Percutaneous closure of aortopulmonary shunts was attempted in 10 dogs. Shunts were surgically created in the location and orientation of PDA. The occlusion prosthesis consisted of a cylindrical frame filled with polyester and a 32° angled retention disk. The delivery system of the device included a 6 Fr thin-walled Teflon introducing sheath, an antirotating delivery catheter, and cable. Complete occlusion of the shunt was obtained in nine animals. One animal died before device placement. Temporary hemolysis occurred in one dog after device placement. The disk of device was completely covered by smooth glistening neoendothelium at 1-3 months postmortem examination. None of the devices protruded into the lumen of the aorta. The device is an improvement over the standard Amplatzer duct occluder. The angled retention disk lies flatly against the aortic wall, avoiding turbulence or an aortic pressure gradient.