Department of Veterinary Pathobiology, Texas A&M University, College Station, Texas 77843, USA.
ASAIO J. 2013 Sep-Oct;59(5):486-92. doi: 10.1097/MAT.0b013e31829bdffd.
A left atrial pressure (LAP) monitoring system was developed for guiding the management of patients with heart failure. The LAP sensor is implanted into the left atrium via transseptal catheterization and affixed to the interatrial septum by nitinol anchors. The long-term safety of permanent implantation of the LAP sensor in patients was evaluated based on the comparative pathology in animals. Tissue specimens of the LAP sensor from 7 patients, 49 canines, and 14 ovine were examined for thrombosis and tissue overgrowth. Implant duration ranged from 22 to 1,686 days. Gross examination showed minimal-to-moderate tissue overgrowth with no evidence of migration, erosion, or perforation. There was no excessive host-to-device reaction or active thrombogenesis in any of the subjects that followed the antithrombotic therapy protocol. Micro-computed tomography scanning confirmed the structural integrity of the device. Low vacuum scanning electron microscopy and histology showed neoendocardial tissue overgrowth with no inflammation or fibrin. The pathology of both animal models was found to closely approximate the pathology in humans and favorably supports the long-term safety of the device.
我们研发了一种左心房压力（LAP）监测系统，用于指导心力衰竭患者的治疗管理。通过经房间隔穿刺术将 LAP 传感器植入左心房，并通过镍钛诺锚将其固定在房间隔上。我们通过动物对比病理学评估了 LAP 传感器在患者体内长期植入的安全性。对 7 名患者、49 只犬和 14 只绵羊的 LAP 传感器组织标本进行了血栓形成和组织过度生长的检查。植入时间从 22 天到 1686 天不等。大体检查显示，组织过度生长程度较轻到中度，没有迁移、侵蚀或穿孔的证据。在遵循抗血栓治疗方案的所有患者中，均未观察到过度的宿主-器械反应或活跃的血栓形成。微计算机断层扫描确认了设备的结构完整性。低真空扫描电子显微镜和组织学显示，心内膜新生组织过度生长，无炎症或纤维蛋白。两种动物模型的病理学与人类的病理学非常相似，这有力地支持了该设备的长期安全性。
