Short-term in vivo preclinical biocompatibility evaluation of FW-II axial blood pump in a sheep model.

We investigated the outcome of FW-II axial pump on healthy sheep (weight, 60-70 kg) for 2 weeks by perioperatively hematological and chemical tests, and circulating activated platelet and leukocyte-platelet aggregates measurements by flow cytometry assays. Complete necropsy and histopathological examinations and thorough pump inspection were performed at study termination for evidence of thrombi. In this experimental series, one sheep died of pulmonary edema, the other four sheep reached the scheduled endpoint of 14 days without device-related problems, and flow range was maintained at 2.5-4.0 L/min. The number of red blood cells and platelets decreased within first 3 days but increased gradually after the first postoperative week. In all animals, serum glutamic oxaloacetic transaminase increased significantly after surgery but gradually returned to normal limits within 2 weeks. Platelet activation, granulocyte-platelet aggregates, and monocyte-platelet aggregates reached the peak at postoperative day 2. Postexplant examinations indicated round thrombus in the hub areas of pumps. No evidence of ischemia or infarction was found in the explanted hearts, livers, spleens, kidneys, and brains of the five animals. Our results demonstrate that FW-II ventricular assist device (VAD) is a promising device for left ventricular (LV) support with moderate anticoagulation.