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Postapproval Outcomes: The Berlin Heart EXCOR Pediatric in North America

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

doi: 10.1097/MAT.0000000000000454
Pediatric Circulatory Support

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.

From the *Duke Children’s Hospital, Durham, North Carolina; The Hospital for Sick Children, Toronto, Ontario, Canada; St. Louis Children’s Hospital, St. Louis, Missouri; §Cincinnati Children’s Hospital, Cincinnati, Ohio; Stanford University, Palo Alto, California; and Texas Children’s Hospital, Houston, Texas.

Submitted for consideration June 2016; accepted for publication in revised form September 2016.

Disclosures: The authors have no conflicts of interest to report.

Presented at International Society for Heart Lung Transplantation Meeting 2015, Nice, France.

Correspondence: Robert D. B. Jaquiss, DUMC 3474, Durham, NC 27110. Email robert.jaquiss@duke.edu.

Copyright © 2017 by the American Society for Artificial Internal Organs