Wang Yaxin, Smith P Alex, Handy Kelly M, Conger Jeffrey L, Spangler Taylor, Lin Frank, Chen Chen, Costas Gil, Elgalad Abdelmotagaly, Sampaio Luiz C
Annu Int Conf IEEE Eng Med Biol Soc. 2020 Jul;2020:2589-2593. doi: 10.1109/EMBC44109.2020.9176569.
Left ventricular assist devices (LVADs) are used to treat patients with severe (New York Heart Association class IV) heart failure. Thrombosis and bleeding are severe LVAD-related complications; thus, an effective anticoagulation regimen is crucial for successful postoperative management. The CH-VAD™ (CH Biomedical, Inc.) is a small, implantable, full-support (>5 L/min) LVAD with a centrifugal flow pump that has a fully magnetically levitated rotor, which confers superior hemocompatibility. In this study, the CH-VAD™ was implanted in two calves to evaluate its hemocompatibility and to establish an anticoagulation regimen for future GLP (good laboratory practice) studies. Heparin infusion was used during the surgery, and during postoperative management, the proper dosage of warfarin was given orally to maintain an international normalized ratio (INR) between 2.0 and 3.0. Pump performance, animal condition, and hematology results were recorded throughout the study (approximately 60 days). The results show that under the established anticoagulation regimen, the CH-VAD™ was well tolerated in the bovine model, with no significant thrombus or thromboembolic lesion formation in distal end organs. Low plasma free hemoglobin levels suggest that the device did not cause hemolysis. These results and the experience gained pave the way for future GLP studies.
左心室辅助装置（LVADs）用于治疗重度（纽约心脏协会IV级）心力衰竭患者。血栓形成和出血是与LVAD相关的严重并发症；因此，有效的抗凝方案对于术后成功管理至关重要。CH-VAD™（CH生物医学公司）是一种小型、可植入、全支持（>5升/分钟）的LVAD，带有离心式血泵，其转子完全磁悬浮，具有卓越的血液相容性。在本研究中，将CH-VAD™植入两只小牛体内，以评估其血液相容性，并为未来的GLP（良好实验室规范）研究制定抗凝方案。手术期间使用肝素输注，术后管理期间，口服适当剂量的华法林以维持国际标准化比值（INR）在2.0至3.0之间。在整个研究过程（约60天）中记录泵的性能、动物状况和血液学结果。结果表明，在既定的抗凝方案下，CH-VAD™在牛模型中耐受性良好，远端器官未形成明显血栓或血栓栓塞性病变。低血浆游离血红蛋白水平表明该装置未引起溶血。这些结果以及所获得的经验为未来的GLP研究铺平了道路。
