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Abstracts: ASAIO Cardiac Abstracts

EVALUATION OF A NEW DOUBLE RING NITINOL DEVICE FOR CLOSURE OF PATENT FORAMEN OVAL IN AN ANIMAL MODEL

Silva, Ana C2,3; Solano, Omar4; Gutierrez, Edgar4; Garcia-Torres, Alberto E1; Ronderos, Miguel1; Freudenthal, Franz5; Briceno, Juan Carlos2,3

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Shape memory devices are effective in the treatment of intracardiac defects. The aim of this study was to evaluate the efficacy of closure of patent foramen oval (PFO) of a new double ring nitinol device. The device was implanted in 13-kg piglets (n=12). Efficacy of liberation, implantation and adequacy of closure were assessed. The animals were monitored for up to 75 days and an echocardiogram was performed before autopsy. The device was liberated and implanted successfully in all animals. Full closure of the FOP was demonstrated in all animals. One animal died immediately after the procedure and another 1 day after the procedure. Cause of dead does not appear to be device-related. Monitoring period lasted 15 days (n=3), 45 days (n=3) or 75 days (n=4). Echocardiographical examination showed that adequate FOP closure was preserved through the monitoring period in all animals. All autopsies presented proper positioning of the device without obstruction of vital structures, residual defects or atrial thrombus. The older implanted devices presented adequate epitelization of both rings and semidetachment to interatrial septum. The other implanted devices presented adequate epitelization of the right ring, less epitelization of the left ring and less detachment to interatrial septum. The new device presented a very high efficacy of liberation, implantation and adequacy of closure through catheterization in an animal model of FOP.

Copyright © 2005 by the American Society for Artificial Internal Organs