Complications common to ventricular assist device support are rare with 90days of DeBakey VAD (R) support in calves

The DeBakey VAD (R) is a miniaturized, electromagnetically driven axial flo w pump intended for long-term ventricular assist. Safety and performance da ta from six calves implanted with the complete DeBakey VAD (R) system are r eported elsewhere; here we describe complications and necropsy findings for these same six animals, all of which survived 90 days. The study was condu cted according to a uniform protocol, which included anticoagulation and an tibiotic prophylaxis. Clinical complications tracked included bleeding, car diovascular abnormalities (e.g., arrhythmias, tachycardia unrelated to pain , bradycardia), hemolysis, hepatic dysfunction, renal dysfunction, thromboe mbolism (neurologic or peripheral), or infection. Each adverse event was re trospectively categorized with regard to severity (mild, moderate, severe) and relationship to device. Clinical findings were confirmed by necropsy. T here was no evidence of systemic infection, thromboembolism, hemolysis, or renal or hepatic dysfunction in these six animals during the study period. A single adverse event was noted in each of two of the calves. Both events were considered mild according to the predefined criteria. Bleeding related to the surgical implantation procedure and requiring reoperation occurred in one animal. The other animal had evidence of a superficial infection at the exit site of the cables on the left lateral thoracic wall; the infectio n did not extend into the thoracic cavity. Chronic, healed small renal infa rct scars were present in several animals. Mild valvular endocardiosis was observed in two calves and mild fibroelastosis was present in the endocardi um at the site of the inflow cannula in three calves; however, these lesion s were not considered clinically significant No other gross or histologic a bnormalities were noted at necropsy. In conclusion, calves implanted with t he complete DeBakey VAD (R) for 90 days demonstrated few complications and had no significant necropsy findings. Complications common to ventricular a ssist device (VAD) support (i.e., hemolysis, infection, bleeding, thromboem bolism) were rare during long-term support (90 days) with the DeBakey VAD.