| Development of a disposable magnetically levitated centrifugal blood pump (MedTech Dispo) intended for bridge-to-bridge applications--two-week in vivo evaluation. | |
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MedLine Citation:
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PMID: 20928936 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Last year, we reported in vitro pump performance, low hemolytic characteristics, and initial in vivo evaluation of a disposable, magnetically levitated centrifugal blood pump, MedTech Dispo. As the first phase of the two-stage in vivo studies, in this study we have carried out a 2-week in vivo evaluation in calves. Male Holstein calves with body weight of 62.4–92.2 kg were used. Under general anesthesia, a left heart bypass with a MedTech Dispo pump was instituted between the left atrium and the descending aorta via left thoracotomy. Blood-contacting surface of the pump was coated with a 2-methacryloyloxyethyl phosphorylcholine polymer. Post-operatively, with activated clotting time controlled at 180–220 s using heparin and bypass flow rate maintained at 50 mL/kg/min, plasma-free hemoglobin (Hb), coagulation, and major organ functions were analyzed for evaluation of biocompatibility. The animals were electively sacrificed at the completion of the 2-week study to evaluate presence of thrombus inside the pump,together with an examination of major organs. To date, we have done 13 MedTech Dispo implantations, of which three went successfully for a 2-week duration. In these three cases, the pump produced a fairly constant flow of 50 mL/Kg/min. Neurological disorders and any symptoms of thromboembolism were not seen. Levels of plasma-free Hb were maintained very low. Major organ functions remained within normal ranges. Autopsy results revealed no thrombus formation inside the pump. In the last six cases, calves suffered from severe pneumonia and they were excluded from the analysis. The MedTech Dispo pump demonstrated sufficient pump performance and biocompatibility to meet requirements for 1-week circulatory support. The second phase (2-month in vivo study) is under way to prove the safety and efficacy of MedTech Dispo for 1-month applications. |
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Authors:
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Eiki Nagaoka; Takeshi Someya; Takashi Kitao; Taro Kimura; Tomohiro Ushiyama; Wataru Hijikata; Tadahiko Shinshi; Hirokuni Arai; Setsuo Takatani |
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Publication Detail:
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Type: Evaluation Studies; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Artificial organs Volume: 34 ISSN: 1525-1594 ISO Abbreviation: Artif Organs Publication Date: 2010 Sep |
Date Detail:
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Created Date: 2010-10-06 Completed Date: 2011-01-13 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7802778 Medline TA: Artif Organs Country: United States |
Other Details:
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Languages: eng Pagination: 778-83 Citation Subset: IM |
Copyright Information:
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© 2010, Copyright the Authors. Artificial Organs © 2010, International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc. |
Affiliation:
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Department of Cardiothoracic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University, Tokyo, Japan. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Animals Cattle Coated Materials, Biocompatible Disposable Equipment* Heart-Assist Devices* / adverse effects Hemoglobins / metabolism Magnetics* Male Materials Testing Methacrylates Models, Animal Phosphorylcholine / analogs & derivatives Prosthesis Design Thrombosis / blood, etiology, prevention & control Time Factors |
| Chemical | |
Reg. No./Substance:
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0/Coated Materials, Biocompatible; 0/Hemoglobins; 0/Methacrylates; 107-73-3/Phosphorylcholine; 67881-98-5/2-methacryloyloxyethyl phosphorylcholine |
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