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Biocompatibility assessment of a long-term wearable artificial pump-lung in sheep

机译：绵羊长期可穿戴人工泵肺的生物相容性评估

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The purpose of this study was to assess the biocompatibility of a newly developed long-term wearable artificial pump-lung (APL) in a clinically relevant ovine animal model. The wearable APL device was implanted in five sheep through left thoracotomy. The device was connected between the right atrium and pulmonary artery and evaluated for 30 days. Three sheep were used as the sham control. Platelet activation was assessed by measuring platelet surface P-selectin (CD62P) expression with flow cytometry and plasma soluble P-selectin with an enzyme-linked immunosorbent assay. Thrombotic deposition on the device components and hollow fiber membranes were analyzed with digital imaging and scanning electron microscopy. Surface P-selectin of the APL and sham groups changed significantly over the study period, but without significant differences between the two groups. Soluble P-selectin for the two groups peaked in the first 24h after the surgery. Soluble P-selectin of the APL group remained slightly elevated over the study period compared to the presurgical baseline value and was slightly higher compared to that of the sham group. Plasma free hemoglobin remained in the normal ranges in all the animals. In spite of the surgery-related alteration in laboratory tests and elevation of platelet activation status, the APL devices in all the animals functioned normally (oxygen transfer and blood pumping) during the 30-day study period. The device flow path and membrane surface were free of gross thrombus. Electron microscopy images showed only scattered thrombi on the fibers (membrane surface and weft). In summary, the APL exhibited excellent biocompatibility. Two forms of platelet activation, surgery-related and device-induced, in the animals implanted with the wearable APL were observed. The limited device-induced platelet activation did not cause gross thrombosis and impair the long-term device performance.
机译：这项研究的目的是评估临床上相关的绵羊动物模型中新开发的长期可穿戴人工泵肺（APL）的生物相容性。可穿戴式APL设备通过左胸廓切开术植入了五只绵羊。该设备连接在右心房和肺动脉之间，并进行了30天的评估。使用三只绵羊作为假对照。通过使用流式细胞仪测量血小板表面P-选择素（CD62P）的表达和通过酶联免疫吸附法测定血浆可溶性P-选择素来评估血小板活化。用数字成像和扫描电子显微镜分析了在设备部件和中空纤维膜上的血栓沉积。在研究期间，APL和假手术组的表面P-选择素发生了显着变化，但两组之间没有显着差异。两组的可溶性P-选择素在手术后的最初24小时达到高峰。与手术前的基线值相比，APL组的可溶性P-选择素在研究期内仍略有升高，而与假手术组相比则略高。在所有动物中，血浆游离血红蛋白保持在正常范围内。尽管在实验室测试中与手术有关的改变以及血小板活化状态的升高，在30天的研究期内，所有动物中的APL设备均正常运行（氧气转移和血液泵送）。装置的流路和膜表面无血栓形成。电子显微镜图像仅显示纤维上的分散血栓（膜表面和纬线）。总之，APL表现出优异的生物相容性。在植入了可穿戴APL的动物中，观察到了两种形式的血小板活化：手术相关的和器械诱导的。有限的设备诱发的血小板活化不会导致血栓形成，也不会损害长期的设备性能。

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