Animal experimental implantation of an atrial septal defect occluder system

Citation
Ab. Thomsen et al., Animal experimental implantation of an atrial septal defect occluder system, HEART, 80(6), 1998, pp. 606-611
Citations number
15
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Cardiovascular & Respiratory Systems","Cardiovascular & Hematology Research
Journal title
HEART
ISSN journal
1355-6037 → ACNP
Volume
80
Issue
6
Year of publication
1998
Pages
606 - 611
Database
ISI
SICI code
1355-6037(199812)80:6<606:AEIOAA>2.0.ZU;2-5
Abstract
Objective-To establish the implantation technique for the atrial septal def ect occluder system (ASDOS) device in an experimental animal model and to d etermine long term mechanical stability of the device and its in vivo prope rties in terms of biocompatibility and tissue reaction. Materials and methods-An atrial septal defect was created and the device im planted in 17 pigs (mean weight 30 kg). The implantation technique was refi ned and modified because of initial technical and anatomical complications during nine acute pilot studies. The technique proved to be feasible in eig ht subsequent survival studies. Four pigs were electively killed three mont hs after implantation (group 1). The remaining four pigs were killed six mo nths after implantation (group 2). Results-Necropsy showed all devices were embedded in soft tissue three mont hs after implantation. Microscopic examination of atrial septal tissue show ed an acute granulomatous inflammatory reaction in group 1 and fibrosis in group 2. The intensity of the inflammatory reaction around the device was c learly milder in group 2, indicating a decline in the inflammatory response with time. Clinical and biochemical investigations indicated acceptable bi ocompatibility of the device. Conclusion-The implantation technique for the ASDOS device in a chronic pig model has been established. Biocompatibility of the device was acceptable.