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

The DeBakey VAD (R) is a miniaturized, electromagnetically driven axial flow pump intended for long-term ventricular assist. Safety and performance data from six calves implanted with the complete DeBakey VAD (R) system are reported elsewhere; here we describe complications and necropsy findings for these same six animals, all of which survived 90 days. The study was conducted according to a uniform protocol, which included anticoagulation and antibiotic prophylaxis. Clinical complications tracked included bleeding, cardiovascular abnormalities (e.g., arrhythmias, tachycardia unrelated to pain, bradycardia), hemolysis, hepatic dysfunction, renal dysfunction, thromboembolism (neurologic or peripheral), or infection. Each adverse event was retrospectively categorized with regard to severity (mild, moderate, severe) and relationship to device. Clinical findings were confirmed by necropsy. There 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 infection did not extend into the thoracic cavity. Chronic, healed small renal infarct scars were present in several animals. Mild valvular endocardiosis was observed in two calves and mild fibroelastosis was present in the endocardium at the site of the inflow cannula in three calves; however, these lesions were not considered clinically significant No other gross or histologic abnormalities were noted at necropsy. In conclusion, calves implanted with the complete DeBakey VAD (R) for 90 days demonstrated few complications and had no significant necropsy findings. Complications common to ventricular assist device (VAD) support (i.e., hemolysis, infection, bleeding, thromboembolism) were rare during long-term support (90 days) with the DeBakey VAD.