title: High early event rates in patients with questionable eligibility for advanced heart failure therapies: Results from the Medical Arm of Mechanically Assisted Circulatory Support (Medamacs) Registry.
abstract: The prognosis of ambulatory patients with advanced heart failure (HF) who are not yet inotrope dependent and implications for evaluation and timing for transplant or destination therapy with a left ventricular assist device (DT-LVAD) are unknown. We hypothesized that the characteristics defining eligibility for advanced HF therapies would be a primary determinant of outcomes in these patients.
  
  
  
  Ambulatory patients with advanced HF (New York Heart Association class III-IV, Interagency Registry for Mechanically Assisted Circulatory Support profiles 4-7) were enrolled across 11 centers from May 2013 to February 2015. Patients were stratified into 3 groups: likely transplant eligible, DT-LVAD eligible, and ineligible for both transplant and DT-LVAD. Clinical characteristics were collected, and patients were prospectively followed for death, transplant, and left ventricular assist device implantation.
  
  
  
  The study enrolled 144 patients with a mean follow-up of 10 ± 6 months. Patients in the ineligible cohort (n = 43) had worse congestion, renal function, and anemia compared with transplant (n = 51) and DT-LVAD (n = 50) eligible patients. Ineligible patients had higher mortality (23.3% vs 8.0% in DT-LVAD group and 5.9% in transplant group, p = 0.02). The differences in mortality were related to lower rates of transplantation (11.8% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p = 0.02) and left ventricular assist device implantation (15.7% in transplant group vs 2.0% in DT-LVAD group and 0% in ineligible group, p < 0.01).
  
  
  
  Ambulatory patients with advanced HF who were deemed ineligible for transplant and DT-LVAD had markers of greater HF severity and a higher rate of mortality compared with patients eligible for transplant or DT-LVAD. The high early event rate in this group emphasizes the need for timely evaluation and decision making regarding lifesaving therapies.
authors.affiliation: Division of Cardiology, University of Colorado, Aurora, Colorado. Electronic address: Amrut.Ambardekar@ucdenver.edu.
authors.forename: Amrut V
authors.initials: AV
authors.lastname: Ambardekar
authors.affiliation: Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Rhondalyn C
authors.initials: RC
authors.lastname: Forde-McLean
authors.affiliation: Division of Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California.
authors.forename: Michelle M
authors.initials: MM
authors.lastname: Kittleson
authors.affiliation: Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Garrick C
authors.initials: GC
authors.lastname: Stewart
authors.affiliation: Department of Internal Medicine, Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan.
authors.forename: Maryse
authors.initials: M
authors.lastname: Palardy
authors.affiliation: Department of Internal Medicine, Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Jennifer T
authors.initials: JT
authors.lastname: Thibodeau
authors.affiliation: Division of Cardiology, Duke University Medical School, Durham, North Carolina.
authors.forename: Adam D
authors.initials: AD
authors.lastname: DeVore
authors.affiliation: Division of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Maria M
authors.initials: MM
authors.lastname: Mountis
authors.affiliation: Division of Cardiology, University of Iowa, Iowa City, Iowa.
authors.forename: Linda
authors.initials: L
authors.lastname: Cadaret
authors.affiliation: Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Teuteberg
authors.affiliation: Division of Cardiovascular Diseases, Birmingham, Alabama.
authors.forename: Salpy V
authors.initials: SV
authors.lastname: Pamboukian
authors.affiliation: Division of Cardiothoracic Surgery, and Department of Epidemiology, School of Public Health, University of Alabama at Birmingham, Birmingham, Alabama.
authors.forename: Ryan S
authors.initials: RS
authors.lastname: Cantor
authors.affiliation: Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.
authors.forename: JoAnn
authors.initials: J
authors.lastname: Lindenfeld
mesh_terms: D006333:Heart Failure; D016027:Heart Transplantation; D006353:Heart-Assist Devices; D006801:Humans; D012042:Registries; D016896:Treatment Outcome
keywords: cardiac transplantation; destination therapy; mechanical support; patient selection; ventricular assist device