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Ex Vivo Phase 1 Evaluation of the DeBakey/NASA Axial Flow Ventricular Assist Device
Author(s) -
Kawahito Koji,
Damm George,
Benkowski Robert,
Aber Gregory,
Bacak James,
Tasai Kimitaka,
Shimono Takatsugu,
Takatani Setsuo,
Nosé Yukihiko,
Noon George P.,
DeBakey Michael E.
Publication year - 1996
Publication title -
artificial organs
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.684
H-Index - 76
eISSN - 1525-1594
pISSN - 0160-564X
DOI - 10.1111/j.1525-1594.1996.tb04417.x
Subject(s) - ventricular assist device , thrombus , centrifugal pump , cannula , medicine , continuous flow , cardiology , biomedical engineering , hemolysis , impeller , hemodynamics , surgery , materials science , heart failure , engineering , mechanical engineering , biochemical engineering
A small ventricular assist device intended for long‐term implantation has been developed by a cooperative effort between the Baylor College of Medicine and the NASA/Johnson Space Center. To date, in vitro tests have been performed to address hemolysis and pump performance issues. In this Phase 1 study, we assessed the durability and atraumatic features aiming for 2 day implantation. Eight pumps were implanted in 2 calves as paracorporeal left ventricular assist devices. The pump running times ranged from 18 to 203 h (78.1 ± 23.7; mean ± SEM). All the pump implantations were terminated because of thrombus formation. Plasma‐free hemoglobin levels were below 13.7 mg/dl, except for 1 case complicated by inflow cannula obstruction. The pump speed was maintained between 10,100 and 11,400 rpm. Pump outputs were from 3.6 to 5.2 L/min. The electrical power required by the system ranged between 9 and 12 W. Clinically there was no detectable organ dysfunction noted, and postmortem evaluation demonstrated no pump related adverse effects in either calf except for small kidney infarctions. Thrombus deposition was observed mainly at the hub portions and the flow straightener.