title: Adverse events in children implanted with ventricular assist devices in the United States: Data from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS).
abstract: Ventricular assist devices (VADs) have been used in children on an increasing basis in recent years. One-year survival rates are now >80% in multiple reports. In this report we describe adverse events experienced by children with durable ventricular assist devices, using a national-level registry (PediMACS, a component of INTERMACS) METHODS: PediMACS is a national registry that contains clinical data on patients who are <19 years of age at the time of VAD implantation. Data collection concludes at the time of VAD explantation. All FDA-approved devices are included. PediMACS was launched on September 1, 2012, and this report includes all data from launch until August 2014. Adverse events were coded with a uniform, pre-specified set of definitions.
  
  
  
  This report comprises data from 200 patients with a median age of 11 years (range 11 days to 18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy (n = 146, 73%), myocarditis (n = 17, 9%), congenital heart disease (n = 35, 18%) and other (n = 2, 1%). Pulsatile-flow devices were used in 91 patients (45%) and continuous-flow devices in 109 patients (55%). Actuarial survival was 81% at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction (n = 79), infection (n = 78), neurologic dysfunction (n = 52) and bleeding (n = 68). Together, these accounted for 277 events, 66% of the total. Although 38% of patients had no reported adverse event and 16% of patients had ≥5 adverse events. Adverse events occurred at all time-points after implantation, but were most likely to occur in the first 30 days. For continuous-flow devices, there were broad similarities in adverse event rates between this cohort and historic rates from the INTERMACS population.
  
  
  
  In this study cohort, the overall rate of early adverse events (within 90 days of implantation) was 86.3 events per 100 patient-months, and of late adverse events it was 20.4 events per 100 patient-months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurologic dysfunction, bleeding and infection. For continuous-flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurologic dysfunction and respiratory failure. Compared with an adult INTERMACS cohort, the overall rate and distribution of adverse events appears similar.
authors.affiliation: Department of Pediatric (Cardiology), Stanford University, Palo Alto, California, USA. Electronic address: davidnr@stanford.edu.
authors.forename: David N
authors.initials: DN
authors.lastname: Rosenthal
authors.affiliation: Department of Pediatric (Cardiology), Stanford University, Palo Alto, California, USA.
authors.forename: Christopher S
authors.initials: CS
authors.lastname: Almond
authors.affiliation: Department of Pediatric Cardiac Surgery, Duke University School of Medicine, Durham, North Carolina, USA.
authors.forename: Robert D
authors.initials: RD
authors.lastname: Jaquiss
authors.affiliation: Children's Hospital Heart Institute, Children's Hospital Colorado, Aurora, Colorado, USA.
authors.forename: Christine E
authors.initials: CE
authors.lastname: Peyton
authors.affiliation: Department of Pediatrics, University of Colorado, Aurora, Colorado, USA.
authors.forename: Scott R
authors.initials: SR
authors.lastname: Auerbach
authors.affiliation: Department of Pediatric Cardiothoracic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Morales
authors.affiliation: Department of Pediatric Cardiothoracic Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Deirdre J
authors.initials: DJ
authors.lastname: Epstein
authors.affiliation: Department of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA; Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama, USA.
authors.forename: Ryan S
authors.initials: RS
authors.lastname: Cantor
authors.affiliation: Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Kormos
authors.affiliation: Department of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA.
authors.forename: David C
authors.initials: DC
authors.lastname: Naftel
authors.affiliation: Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: Ryan J
authors.initials: RJ
authors.lastname: Butts
authors.affiliation: Department of Pediatrics (Critical Care Section), Medical College of Wisconsin and Children's Hospital of Wisconsin, Milwaukee, Wisconsin, USA.
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Ghanayem
authors.affiliation: Department of Cardiothoracic Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA.
authors.forename: James K
authors.initials: JK
authors.lastname: Kirklin
authors.affiliation: Department of Cardiology, Boston Children's Hospital, Boston, Massachusetts, USA.
authors.forename: Elizabeth D
authors.initials: ED
authors.lastname: Blume
mesh_terms: D000293:Adolescent; D002648:Child; D006333:Heart Failure; D006353:Heart-Assist Devices; D006801:Humans; D011673:Pulsatile Flow; D012042:Registries; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D014481:United States
keywords: heart failure; mechanical circulatory support; pediatrics; pedimacs; registry; ventricular assist device