Author/Editor     Pavčnik, Dušan; Takulve, Kurt; Uchida, Barry T; Pavčnik-Arnol, Maja; VanAlstine, William; Keller, Frederick; Roesch, Josef
Title     Biodisk: a new device for closure of patent foramen ovale: a feasibility study in swine
Type     članek
Source     Catheter Cardiovasc Interv
Vol. and No.     Letnik 75, št. 6
Publication year     2010
Volume     str. 861-7
Language     eng
Abstract     Purpose: To evaluate the feasibility, effectiveness, and safety of a porcine small intestinal submucosa (SIS)-covered Biodisk (BD) for the closure of patent foramen ovale (PFO) in swine. Methods: Twelve piglets (9-30 kg) with PFO ranging in size from 6 to 12 mm were used for the in vivo testing. The BD device consisted of two basic nitinol wire components covered with platinum coil, a flexible SIS-covered ring, and an anchor. The BD was advanced through an 8-Fr sheath from the femoral vein. Nine acute animals were used to test the BD for deployment, stability, immediate shunt closure, and device repositioning before or after its detachment. To assess retrievability, four devices were deployed and intentionally embolized into the RA (n = 2) and LA (n = 2). The effectiveness of the device was evaluated by angiocardiography. EKG was recorded before and after PFO closure for 3 hr. From the 12 animals, nine were acute and three were followed; one for 6 weeks, one for 12 weeks, and one for 16 weeks. Results: Successful device implantation was achieved in all animals with no shunting of contrast media observed during follow-up in. One animal needed to have device repositioned for complete PFO occlusion because of suboptimal placement at the first attempt. The device was easily placed and retrieved before detachment in all nine animals in the acute study. None of the BDs spontaneously embolized during release or on follow-up. EKG did not demonstrate arrhythmias during or after treatment. Four intentionally embolized BDs were easily retrieved with an Amplatz goose neck snare. Macroscopic and histologic evaluation of the three long-term animals showed that devices were well incorporated in the atrial septum with complete shunt closure. The SIS showed progressive remodeling with the host cells. There was also progressive endothelization of the BD device. Conclusion: The BD device deployment is feasible, safe, and effective. (Abs. trunc. at 2000 ch.)
Descriptors     HEART SEPTAL DEFECTS, ATRIAL
HEART CATHETERIZATION
INTESTINAL MUCOSA
ELECTROCARDIOGRAPHY
DISEASE MODELS, ANIMAL
ANIMALS
EQUIPMENT DESIGN
FEASIBILITY STUDIES
SWINE
EMBOLISM
FOLLOW-UP STUDIES