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Mechanical Circulatory Support in End-Stage Heart Failure pp 371–380Cite as

The Berlin Heart EXCOR Experience in the USA

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Abstract

Heart transplantation is the final therapeutic option in children with end-stage heart failure due to cardiomyopathy or congenital heart disease. Approximately 11,000–14,000 children are admitted to the hospital with heart failure [1] each year in the USA. A proportion of these patients will require heart transplantation due to end-stage heart failure. Prior to FDA approval of the Berlin Heart EXCOR, there was no reliable mechanical circulatory support option for children. Historically, children with end-stage heart failure were bridged to transplant with extracorporeal membrane oxygenation (ECMO). The outcomes of this approach were suboptimal as only ~47% of patients bridged to transplant survived to hospital discharge [2]. Early experience with the off-label use of adult ventricular assist devices (VADs) in children was promising as 76% survived to transplant; however, the outcomes in children <10 years of age and with congenital heart disease were less encouraging [3]. The Food and Drug Administration (FDA) granted a humanitarian device exemption (HDE) for the continuous-flow DeBakey VAD Child in 2004; however, use of the device in children was limited by concerns about device fit within the chest wall of small children and thrombotic complications [4].

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Author information

Authors and Affiliations

  1. Department of Pediatric Cardiology, The Heart Institute, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH, USA

    Chet R. Villa

  2. Department of Cardiothoracic Surgery, The Heart Institute, Cincinnati Children’s Hospital Medical Center, University of Cincinnati College of Medicine, 3333 Burnet Ave MLC 2004, Cincinnati, OH, 45229, USA

    David L. S. Morales MD

Authors
  1. Chet R. Villa
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  2. David L. S. Morales MD
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Correspondence to David L. S. Morales MD .

Editor information

Editors and Affiliations

  1. San Camillo-Forlanini Hospital, Rome, Italy

    Andrea Montalto

  2. Cardiac Surgery, S.Orsola-Malpighi Hospital, Bologna, Italy

    Antonio Loforte

  3. San Camillo-Forlanini Hospital, Rome, Italy

    Francesco Musumeci

  4. Deutsches Herzzentrum Berlin, Berlin, Germany

    Thomas Krabatsch

  5. Department of Cardiovascular and Thoracic Surgery, University of Louisville, Louisville, Kentucky, USA

    Mark S. Slaughter

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© 2017 Springer International Publishing Switzerland

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Villa, C.R., Morales, D.L.S. (2017). The Berlin Heart EXCOR Experience in the USA. In: Montalto, A., Loforte, A., Musumeci, F., Krabatsch, T., Slaughter, M. (eds) Mechanical Circulatory Support in End-Stage Heart Failure. Springer, Cham. https://doi.org/10.1007/978-3-319-43383-7_37

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  • DOI: https://doi.org/10.1007/978-3-319-43383-7_37

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-43381-3

  • Online ISBN: 978-3-319-43383-7

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