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Chronic Ovine Studies Demonstrate Low Thromboembolic Risk in the Penn State Infant Ventricular Assist Device.
Lukic, Branka; Clark, J Brian; Izer, Jenelle M; Cooper, Timothy K; Finicle, Heidi A; Cysyk, Johua; Doxtater, Bradly; Yeager, Eric; Reibson, John; Newswanger, Raymond K; Leibich, Patrick; Bletcher, Kirby; Weiss, William J.
Afiliación
  • Lukic B; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Clark JB; Pediatric Cardiothoracic Surgery, The Pennsylvania State University, College of Medicine, Penn State Children's Hospital, Hershey, PA.
  • Izer JM; Department of Comparative Medicine, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Cooper TK; Department of Comparative Medicine, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Finicle HA; Present address: Integrated Research Facility at Fort Detrick, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Fort Detrick, Frederick, Maryland.
  • Cysyk J; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Doxtater B; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Yeager E; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Reibson J; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Newswanger RK; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Leibich P; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Bletcher K; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
  • Weiss WJ; From the Department of Surgery, The Pennsylvania State University, College of Medicine, Hershey, PA.
ASAIO J ; 65(4): 371-379, 2019.
Article en En | MEDLINE | ID: mdl-30681440
Mechanical circulatory support for children under 6 years of age remains a challenge. This article describes the preclinical status and the results of recent animal testing with the Penn State Infant Left Ventricular Assist Device (VAD). The objectives have been to 1) demonstrate acceptably low thromboembolic risk to support Food and Drug Administration approval, 2) challenge the device by using minimal to no anticoagulation in order to identify any design or manufacturing weaknesses, and 3) improve our understanding of device thrombogenicity in the ovine animal model, using multicomponent measurements of the coagulation system and renal ischemia quantification, in order to better correlate animal results with human results.The Infant VAD was implanted as a left VAD (LVAD) in 18-29 kg lambs. Twelve LVAD and five surgical sham animals were electively terminated after approximately 30 or 60 days. Anticoagulation was by unfractionated heparin targeting thromboelastography R times of 2x normal (n = 6) or 1x normal (n = 6) resulting in negligible heparin activity as measured by anti-Xa assay (<0.1 IU/ml). Platelet inhibitors were not used.There were no clinically evident strokes or evidence of end organ dysfunction in any of the 12 electively terminated LVAD studies. The degree of renal ischemic lesions in device animals was not significantly different than that found in five surgical sham studies, demonstrating minimal device thromboembolism.In summary, these results in a challenging animal test protocol support the conclusion that the Penn State Infant VAD has a low thromboembolic risk and may allow lower levels of anticoagulation.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tromboembolia / Corazón Auxiliar / Insuficiencia Cardíaca Tipo de estudio: Etiology_studies / Guideline / Risk_factors_studies Límite: Animals / Female / Humans / Infant / Male Idioma: En Revista: ASAIO J Asunto de la revista: TRANSPLANTE Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tromboembolia / Corazón Auxiliar / Insuficiencia Cardíaca Tipo de estudio: Etiology_studies / Guideline / Risk_factors_studies Límite: Animals / Female / Humans / Infant / Male Idioma: En Revista: ASAIO J Asunto de la revista: TRANSPLANTE Año: 2019 Tipo del documento: Article Pais de publicación: Estados Unidos