Postapproval Outcomes: The Berlin Heart EXCOR Pediatric in North America

Robert D.B. Jaquiss, Tilman Humpl, Charles E. Canter, David L.S. Morales, David N. Rosenthal, Charles D. Fraser

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

The Berlin Heart EXCOR Pediatric Ventricular Assist Device (BH) was approved for use in the United States in December 2011, based on a prospective investigational device exemption (IDE) trial. Strict exclusion criteria for the trial selected a low-risk "ideal" cohort. We sought to determine whether postapproval usage of the BH in a "real world" cohort of recipients would result in similar outcomes. Preimplant diagnostic information was collected for all patients. Efficacy was evaluated by comparison of all children (efficacy group, n = 247) implanted between FDA approval and April 2015 to those in the IDE trial (IDE, n = 48), with regard to achievement of one of four end-states: transplanted, successful weaning, death/unsuccessful weaning, or still-on-device. Safety outcomes were compared between IDE patients and a subset of postapproval patients (safety group, n = 39) for whom adjudicated adverse events were tracked in a regulator-mandated dataset. Diagnostic categories were similar between groups: IDE (congenital 19%, dilated cardiomyopathy/myocarditis/other 81%) versus Efficacy Group (congenital 24%, dilated cardiomyopathy/myocarditis/other 75%). Patients in the IDE cohort were larger (median 14.8 kg, range 3.6-58.1 kg vs. 10.7 kg, 2.9-112.0 kg, p = 0.02). More IDE patients were successfully supported than in the efficacy group cohort (90% vs. 77%, p = 0.05). Proportions with bleeding and stroke were similar between the IDE and safety group cohorts (46% vs. 41%, p = 0.65; 29% vs. 33%, p = 0.68, respectively). With usage of the BH in a less-ideal population, rates of bridge to transplant and weaning have declined slightly, but remain encouragingly high. Bleeding and neurologic event rates have not increased.

Original languageEnglish (US)
Pages (from-to)193-197
Number of pages5
JournalASAIO Journal
Volume63
Issue number2
DOIs
StatePublished - Jan 1 2017

Keywords

  • Berlin Heart
  • pediatric
  • ventricular assist device

ASJC Scopus subject areas

  • Biophysics
  • Bioengineering
  • Biomaterials
  • Biomedical Engineering

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  • Cite this

    Jaquiss, R. D. B., Humpl, T., Canter, C. E., Morales, D. L. S., Rosenthal, D. N., & Fraser, C. D. (2017). Postapproval Outcomes: The Berlin Heart EXCOR Pediatric in North America. ASAIO Journal, 63(2), 193-197. https://doi.org/10.1097/MAT.0000000000000454