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用于房间隔缺损和动脉导管未闭封堵的自膨胀纳米铂涂层镍钛诺装置:猪模型

Self-expanding nanoplatinum-coated nitinol devices for atrial septal defect and patent ductus arteriosus closure: a swine model.

作者信息

Lertsapcharoen Pornthep, Khongphatthanayothin Apichai, La-orkhun Vidhavas, Supachokchaiwattana Pentip, Charoonrut Phingphol

机构信息

Division of Pediatric Cardiology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.

出版信息

Indian Heart J. 2006 Jul-Aug;58(4):315-20.

PMID:19039147
Abstract

OBJECTIVES

Our purpose was to evaluate self-expanding nanoplatinum-coated nitinol devices for transcatheter closure of atrial septal defects and patent ductus arteriosus in a swine model. The devices were braided from platinum-activated nitinol wires and filled with polyester to enhance thrombogenicity. The platinum activation of the nitinol wires was carried out with the help of Nanofusion technology. The coating of platinum covers the exposed surface of the nitinol wires and prevents the release of nickel into the blood stream after the implantation of the device but does not affect its shape memory, which makes the device self-expanding after it is loaded from the catheter.

METHODS AND RESULTS

Atrial septal defects were created in 12 piglets by balloon dilation of the patent foramen ovale. The size of the device was selected on the basis of the diameter of the balloon and the size of the defect, measured by transthoracic echocardiography. The devices were successfully deployed in all 12 piglets under fluoroscopic study. Transthoracic color Doppler echocardiograms showed complete closure of the atrial septal defect within 15 minutes of device implantation. Twelve patent ductus arteriosus closure devices were deployed in the right or left subclavian arteries in 10 piglets. Angiograms showed complete occlusion of the subclavian arteries within a few minutes of device deployment. In the atrial septal defect cases, the autopsy findings showed complete organizing fibrin thrombus formation and complete neo-endothelialization on the outer surface of the devices within one week and six weeks of implantation, respectively.

CONCLUSION

The use of self-expanding nanoplatinum-coated nitinol devices for the transcatheter closure of atrial septal defects and patent ductus arteriosus is feasible. The excellent occlusion result and complete neo-endothelialization of the devices in the swine model is an indication of the potential of these devices in human application.

摘要

目的

我们的目的是在猪模型中评估用于经导管闭合房间隔缺损和动脉导管未闭的自膨胀纳米铂涂层镍钛诺装置。这些装置由铂激活的镍钛诺丝编织而成,并填充聚酯以增强血栓形成性。镍钛诺丝的铂激活借助纳米融合技术进行。铂涂层覆盖镍钛诺丝的暴露表面,防止装置植入后镍释放到血流中,但不影响其形状记忆,这使得装置从导管加载后能自膨胀。

方法与结果

通过对卵圆孔未闭进行球囊扩张,在12只仔猪中制造房间隔缺损。根据球囊直径和缺损大小选择装置尺寸,经胸超声心动图测量缺损大小。在透视研究下,所有12只仔猪的装置均成功植入。经胸彩色多普勒超声心动图显示装置植入后15分钟内房间隔缺损完全闭合。在10只仔猪的右或左锁骨下动脉中植入了12个动脉导管未闭闭合装置。血管造影显示装置植入后几分钟内锁骨下动脉完全闭塞。在房间隔缺损病例中,尸检结果显示分别在植入后1周和6周时,装置外表面有完全组织化的纤维蛋白血栓形成和完全的新内皮化。

结论

使用自膨胀纳米铂涂层镍钛诺装置经导管闭合房间隔缺损和动脉导管未闭是可行的。在猪模型中装置优异的闭塞结果和完全的新内皮化表明这些装置在人类应用中的潜力。

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