title: Closing in on the PumpKIN Trial of the Jarvik 2015 Ventricular Assist Device.
abstract: The Infant Jarvik ventricular assist device (VAD; Jarvik Heart, Inc., New York, NY) has been developed to support the circulation of infants and children with advanced heart failure. The first version of the device was determined to have elevated hemolysis under certain conditions. The objective of this work was to determine appropriate modifications to the Infant Jarvik VAD that would result in acceptably low hemolysis levels. In vitro hemolysis testing revealed that hemolysis was related to the shape of the pump blade tips and a critical speed over which hemolysis would occur. Various design modifications were tested and a final design was selected that met the hemolysis performance goal. The new version was named the Jarvik 2015 VAD. Chronic in vivo tests, virtual fit studies, and a series of other performance tests were carried out to assess the device's performance characteristics. In vivo test results revealed acceptable hemolysis levels in a series of animals and virtual fit studies showed that the device would fit into children 8 kg and above, but could fit in smaller children as well. Additional FDA-required testing has been completed and all of the data are being submitted to the FDA so that a clinical trial of the Jarvik 2015 VAD can begin. Development of a Jarvik VAD for use in young children has been challenging for various reasons. However, with the hemolysis issue addressed in the Jarvik 2015 VAD, the device is well-poised for the start of the PumpKIN clinical trial in the near future.
authors.affiliation: Division of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, MD. Electronic address: baldwint@nhlbi.nih.gov.
authors.forename: J Timothy
authors.initials: JT
authors.lastname: Baldwin
authors.affiliation: Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX; Congenital Heart Surgery, Texas Children's Hospital, Houston, TX.
authors.forename: Iki
authors.initials: I
authors.lastname: Adachi
authors.affiliation: Jarvik Heart, Inc., New York, NY.
authors.forename: John
authors.initials: J
authors.lastname: Teal
authors.affiliation: Department of Pediatrics (Cardiology), Stanford University, Palo Alto, CA.
authors.forename: Christopher A
authors.initials: CA
authors.lastname: Almond
authors.affiliation: Division of Cardiothoracic Surgery, Duke University School of Medicine, Duke University Medical Center, Durham, NC.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Jaquiss
authors.affiliation: Department of Pediatrics, University of Alberta, Edmonton, Alberta, Canada.
authors.forename: M Patricia
authors.initials: MP
authors.lastname: Massicotte
authors.affiliation: Geno, LLC., Cocoa, FL.
authors.forename: Kurt
authors.initials: K
authors.lastname: Dasse
authors.affiliation: New England Research Institutes, Inc. (NERI), Watertown, MA.
authors.forename: Flora S
authors.initials: FS
authors.lastname: Siami
authors.affiliation: New England Research Institutes, Inc. (NERI), Watertown, MA.
authors.forename: Victor
authors.initials: V
authors.lastname: Zak
authors.affiliation: Division of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, MD.
authors.forename: Jonathan R
authors.initials: JR
authors.lastname: Kaltman
authors.affiliation: Department of Pediatrics, Division of Pediatric Cardiology, Emory University School of Medicine, Atlanta, GA.
authors.forename: William T
authors.initials: WT
authors.lastname: Mahle
authors.affiliation: Jarvik Heart, Inc., New York, NY.
authors.forename: Robert
authors.initials: R
authors.lastname: Jarvik
mesh_terms: D002648:Child; D002675:Child, Preschool; D004867:Equipment Design; D006333:Heart Failure / Q000628:therapy*; D006353:Heart-Assist Devices; D006461:Hemolysis; D006801:Humans; D007223:Infant