title: Outcomes in advanced heart failure patients with left ventricular assist devices for destination therapy.
abstract: BACKGROUND
  The HeartMate II (HMII) destination therapy (DT) trial demonstrated significant improvements in outcomes in continuous-flow left ventricular assist devices compared with patients implanted with the pulsatile-flow HeartMate XVE. The primary hypothesis of the current study is that trial patients enrolled after the initial data cohort would have better clinical outcomes.
  
  
  RESULTS
  Two hundred eighty-one patients who underwent HMII for DT from May 2007 to March 2009 (Mid Trial [MT] group) were compared with the initial 133 HMII patients from March 2005 to May 2007 (Early Trial [ET] group). Patient entry criteria were the same during the 2 time periods. Survival, adverse events, and quality of life were compared between the 2 groups. Baseline characteristics were similar between the groups. Compared with the ET group, patients in the MT group had reduced adverse event rates for bleeding requiring transfusions (1.66 versus 1.13 events per patient-year, P<0.001), sepsis (0.38 versus 0.27, P=0.025), device-related infections (0.47 versus 0.27, P<0.001), and hemorrhagic stroke (0.07 versus 0.03, P=0.01). Other event rates were similar between groups including ischemic stroke (0.06 versus 0.05 events per patient-year, P=0.57). Survival at 1 year in the MT group was 73% versus 68% in the ET group (P=0.21). Additionally, there was a significant reduction in deaths caused by hemorrhagic stroke (P=0.01). Quality of life improvements were significant in both the groups (P<0.001).
  
  
  CONCLUSIONS
  The benefit of DT therapy with the HMII is confirmed in subsequent trial patients, with improved adverse event rates and a strong trend for improvements in survival. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00121485.
authors.affiliation: Division of Cardiac Surgery, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA. park.soon@mayo.edu
authors.forename: Soon J
authors.initials: SJ
authors.lastname: Park
authors.forename: Carmelo A
authors.initials: CA
authors.lastname: Milano
authors.forename: Antone J
authors.initials: AJ
authors.lastname: Tatooles
authors.forename: Joseph G
authors.initials: JG
authors.lastname: Rogers
authors.forename: Robert M
authors.initials: RM
authors.lastname: Adamson
authors.forename: D Eric
authors.initials: DE
authors.lastname: Steidley
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Ewald
authors.forename: Kartik S
authors.initials: KS
authors.lastname: Sundareswaran
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
mesh_terms: D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006352:Heart Ventricles / Q000503:physiopathology* / Q000601:surgery; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D012189:Retrospective Studies; D013318:Stroke Volume; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology