Bloch Thomsen A, Schneider M, Baandrup U, Stenbøg E V, Hasenkam J M, Bagger J P, Hausdorf G
Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Denmark.
Heart. 1998 Dec;80(6):606-11. doi: 10.1136/hrt.80.6.606.
To establish the implantation technique for the atrial septal defect occluder system (ASDOS) device in an experimental animal model and to determine long term mechanical stability of the device and its in vivo properties in terms of biocompatibility and tissue reaction.
An atrial septal defect was created and the device implanted in 17 pigs (mean weight 30 kg). The implantation technique was refined and modified because of initial technical and anatomical complications during nine acute pilot studies. The technique proved to be feasible in eight subsequent survival studies. Four pigs were electively killed three months after implantation (group 1). The remaining four pigs were killed six months after implantation (group 2).
Necropsy showed all devices were embedded in soft tissue three months after implantation. Microscopic examination of atrial septal tissue showed an acute granulomatous inflammatory reaction in group 1 and fibrosis in group 2. The intensity of the inflammatory reaction around the device was clearly milder in group 2, indicating a decline in the inflammatory response with time. Clinical and biochemical investigations indicated acceptable biocompatibility of the device.
The implantation technique for the ASDOS device in a chronic pig model has been established. Biocompatibility of the device was acceptable.
在实验动物模型中建立房间隔缺损封堵器系统（ASDOS）装置的植入技术，并确定该装置的长期机械稳定性及其在生物相容性和组织反应方面的体内特性。
制造房间隔缺损并将该装置植入17头猪（平均体重30千克）体内。由于在9项急性先导研究期间出现了最初的技术和解剖学并发症，对植入技术进行了改进和改良。该技术在随后的8项存活研究中被证明是可行的。4头猪在植入后3个月被选择性处死（第1组）。其余4头猪在植入后6个月被处死（第2组）。
尸检显示植入3个月后所有装置均嵌入软组织中。房间隔组织的显微镜检查显示，第1组有急性肉芽肿性炎症反应，第2组有纤维化。第2组装置周围的炎症反应强度明显较轻，表明炎症反应随时间下降。临床和生化检查表明该装置的生物相容性可接受。
已在慢性猪模型中建立了ASDOS装置的植入技术。该装置的生物相容性可接受。
