title: A multicenter analysis of clinical hemolysis in patients supported with durable, long-term left ventricular assist device therapy.
abstract: BACKGROUND
  Despite the beneficial effects of mechanical circulatory support (MCS), the majority of patients ultimately will have an adverse event. Although hemolysis is common among temporary devices, the incidence and clinical significance of hemolysis in patients managed with long-term, durable left ventricular assist device (LVAD) therapy is largely unknown.
  
  
  METHODS
  Data were obtained from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). All adults who received a continuous-flow LVAD (CF-LVAD) between June 2006 and March 2012 were included. A hemolytic event was defined as a plasma-free hemoglobin >40 mg/dl in association with clinical signs of hemolysis occurring at least 72 hours after LVAD implant. Descriptive statistics, time-dependent analyses and multivariable modeling were employed for statistical purposes.
  
  
  RESULTS
  A total of 4,850 patients followed for a mean of 11.1 months comprised the final study population. There were 340 hemolytic events in 260 patients. Freedom from hemolysis was 97% at 3 months, 94% at 1 year and 91% at 2 years. Mean time from implant to first hemolysis event was 7.4 months. Younger age (<60 years) was independently associated with greater hemolysis (p < 0.001). Thrombotic device malfunction, device exchange and mortality were all significantly higher after hemolysis, with the greatest risk for each occurring within 6 months.
  
  
  CONCLUSIONS
  Hemolysis is not a rare event after CF-LVAD implantation and is associated with an early increase in morbidity and death. Future study should focus on other device and implant characteristics that may lead to hemolytic events, as well as appropriate strategies for managing affected patients.
authors.affiliation: Division of Cardiology, UNC Center for Heart and Vascular Care, Chapel Hill, North Carolina. Electronic address: katzj@med.unc.edu.
authors.forename: Jason N
authors.initials: JN
authors.lastname: Katz
authors.affiliation: Division of Cardiology, UNC Center for Heart and Vascular Care, Chapel Hill, North Carolina; McAllister Heart Institute, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Brian C
authors.initials: BC
authors.lastname: Jensen
authors.affiliation: Division of Cardiology, UNC Center for Heart and Vascular Care, Chapel Hill, North Carolina.
authors.forename: Patricia P
authors.initials: PP
authors.lastname: Chang
authors.affiliation: Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Susan L
authors.initials: SL
authors.lastname: Myers
authors.affiliation: Department of Surgery, University of Michigan, Ann Arbor, Michigan.
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.affiliation: Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: James K
authors.initials: JK
authors.lastname: Kirklin
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000097:blood / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006461:Hemolysis / Q000502:physiology*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012042:Registries; D012189:Retrospective Studies; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D014481:United States / Q000453:epidemiology
keywords: hemolysis; outcomes; survival; thrombosis; ventricular assist device