Long-term in vivo left ventricular assist device study for 284 days with Gyro PI pump.
A totally implantable centrifugal artificial heart has been developed. The plastic prototype, the Gyro PI 601, passed 2 day hemodynamic tests as a functional total artificial heart (TAH), 2 week screening tests for anti-thrombogenecity, and a 1 month system feasibility study. Based upon these results, a metallic prototype, the Gyro PI 700 series, was subjected to long-term in vivo left ventricular assist device (LVAD) studies of over 1 month. The Gyro PI 700 series has the same inner dimension and same characteristics of the Gyro PI 601 such as an eccentric inlet port, a double pivot bearing system, and a magnet coupling system. The PI metallic pump is also driven with the Vienna DC brushless motor actuator like the PI 601. The pump-actuator package was implanted in 3 calves in the preperitoneal space, bypassing from the left ventricular (LV) apex to the descending aorta. Case 1 achieved a 284 day survival. Case 2 was euthanized early at 72 postoperative days as a result of the functional obstruction of the inlet port due to the excessive growth of the calf. There was no blood clot inside the pumps of either case. Case 3 is on-going (22 days on July 24, 1998). During these periods, all cases showed no physiological abnormalities. In conclusion, the PI 700 series pump has excellent results as a long-term implantable LVAD.
Ohtsuka
G
G
Department of Surgery, Baylor College of Medicine, Houston, Texas, USA.
Nakata
K
K
Yoshikawa
M
M
Takano
T
T
Glueck
J
J
Sankai
Y
Y
Takami
Y
Y
Mueller
J
J
Sueoka
A
A
Letsou
G
G
Schima
H
H
Schmallegger
H
H
Wolner
E
E
Koyanagi
H
H
Fujisawa
A
A
Baldwin
J C
JC
Nosé
Y
Y
D000818:Animals; D001013:Aorta, Thoracic / Q000601:surgery; D001806:Blood Urea Nitrogen; D001831:Body Temperature / Q000502:physiology; D002417:Cattle; D003404:Creatinine / Q000097:blood; D004867:Equipment Design; D005240:Feasibility Studies; D006354:Heart, Artificial; D006353:Heart-Assist Devices; D006439:Hemodynamics / Q000502:physiology; D006454:Hemoglobins / Q000032:analysis; D007770:L-Lactate Dehydrogenase / Q000097:blood; D007958:Leukocyte Count; D008137:Longitudinal Studies; D008280:Magnetics / Q000295:instrumentation; D008670:Metals; D010969:Plastics; D013499:Surface Properties; D015996:Survival Rate; D013927:Thrombosis / Q000209:etiology; D016277:Ventricular Function, Left / Q000502:physiology*
D006454:Hemoglobins; D008670:Metals; D010969:Plastics; D003404:Creatinine; D007770:L-Lactate Dehydrogenase