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Study of biodegradable occluder of atrial septal defect in a porcine model
Author(s) -
Li BoNing,
Xie YuMei,
Xie ZhaoFeng,
Chen XianMiao,
Zhang Gui,
Zhang DeYuan,
Liu XiangDong,
Zhang ZhiWei
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.27852
Subject(s) - medicine , percutaneous , animal model , histopathology , surgery , cardiology , biomedical engineering , pathology
Objective To evaluate the safety and feasibility of a modified poly( l ‐lactic acid) (PLLA) atrial septal defect (ASD) occluder. Methods Forty‐five piglets were divided into two groups: an experimental group ( n = 27) and a control group ( n = 18). The experimental group underwent percutaneous implantation of a modified PLLA ASD device while the control group underwent percutaneous implantation of a widely used metal ASD device. X‐ray imaging, transthoracic echocardiography (TTE), electrocardiogram (ECG), histopathology and electron microscopic examination were performed at 7 days, 1, 3, 6, and 12 months after implantation. Results Twenty‐seven experimental piglets and 18 control piglets were all successfully implanted with modified biodegradable and metal ASD devices, respectively. While both devices exhibited very good occluding effects, the modified PLLA ASD devices were completely endothelialized at 3 months after implantation, and the endothelialization appeared to be more complete compared to the control group. Degradation of the PLLA devices was noted at 12 months follow‐up with no loss of integrity at the atrial septum. Conclusion This animal model with implanting of the occluders was effective and not associated with complications. The modified PLLA ASD devices are more controllable and practical than our previous devices. The implanted devices demonstrated good endothelialization and degradability in short and moderate term follow‐up. Long‐term studies are now underway to further evaluate the biodegradability of this novel device.