Study on the biocompatibility of self-made nitinol alloy ventricular septal defect occluder / 第二军医大学学报

ABSTRACT

Objective: To evaluate the biocompatibility of self made nitinol alloy ventricular septal defect occluder. Methods: Six nitinol alloy ventricular septal defect occluder were implanted in the ventricular septum by catheter in 6 normal anaesthetized open chest pigs, and the animals were observed for 45 to 120 d(2 animals). Results: One deaths resulted from hemorrhage and another from embolization of occluder in abdominal aorta during the placement procedure. Successful placement of the occluder was achieved in 4 animals. Four animals were killed at 45, 60 and 120 d. Postmortem gross and microscopic examination of 4 devices 45 to 120 d after placement showed that both the right and left ventricular discs of the occluder were completely covered by a smooth, shiny, glistening thin layer of neoendocardium, and the surface of neoendocardium was covered by a monolayer of endothelium like cells. The inflammatory infiltrate around the occluder was found at 45 d, and disappeared and fibrosis formed at 120 d. These appeared as a repair process of the injury. Embolization in lung,liver, spleen, kidney, intestinal and colon were not found. Conclusion: These suggest that the self made nitinol alloy ventricular septal defect occluder has good biocompatibility. [