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The Journal of Thoracic and Cardiovascular Surgery, Vol 95, 191-200, Copyright © 1988 by The American Association for Thoracic Surgery and The Western Thoracic Surgical Association
DJ Farrar, P Litwak, JH Lawson, RS Ward, KA White, AJ Robinson, R Rodvien and JD Hill
To reduce the risk of thromboembolic complications in prosthetic blood
pumps, we have developed a new segmented polyurethane elastomer. This
material is unique because its mechanical properties for long-term
durability and surface properties for biocompatibility have been separated
and developed in two distinct materials. Improved thromboresistance is then
obtained by a 1% concentration of a new polymeric surface-modifying
additive blended with the base polyurethane before fabrication of the blood
pump. To evaluate this material in vivo, we performed 10 implants, in
calves, of the Pierce-Donachy prosthetic ventricle with blood-pumping sacs
and cannulas fabricated from the new surface-modifying additive copolymer
blend (Thoratec's BPS- 215M). In four control implants the blood sacs and
cannulas were fabricated from Ethicon's Biomer segmented polyurethane,
which is the present clinical standard for most artificial hearts and
circulatory support devices. The blood pumps were connected from the apex
of the left ventricle to the descending aorta in male Holstein calves
weighing 82 to 108 kg and were driven pneumatically in the full-to-empty
mode with flows averaging 5 to 6 L/min. Each calf was medicated with
aspirin and dipyridamole throughout the study period and was electively put
to death after 4 weeks for evaluation of explanted blood sacs and for
examination of the kidneys for infarction. All 10 explanted blood sacs made
with the surface-modifying additive copolymer blend were shiny and
completely free of thrombus. Three of the four explanted Biomer blood sacs
showed visible red thrombus, and all four showed small areas of white
thrombus. The average surface area of the Biomer blood sacs covered with
thrombus was 45 +/- 32 mm2. Use of a semiquantitative scale to assess renal
infarction demonstrated that nine of 10 animals with a surface-modifying
additive copolymer blend blood sac had infarction less severe than the mean
infarct score of the animals with a Biomer sac. The surface-modifying
additive copolymer blend has excellent mechanical and physical properties
necessary for use in artificial heart blood pumps. From these experiments,
we conclude that the surface-modified polyurethane blend is superior to
Biomer polyurethane in blood compatibility and in freedom from
thromboembolic risk. This material is now approved by the Food and Drug
Administration for investigational device exemption studies in the
Pierce-Donachy prosthetic ventricle.
ARTICLES
In vivo evaluations of a new thromboresistant polyurethane for artificial heart blood pumps
Department of Cardiovascular Surgery, Pacific Presbyterian Medical Center, San Francisco, CA 94120.
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