title: Results of the destination therapy post-food and drug administration approval study with a continuous flow left ventricular assist device: a prospective study using the INTERMACS registry (Interagency Registry for Mechanically Assisted Circulatory Support).
abstract: OBJECTIVE
  A post-approval (PA) study for destination therapy (DT) was required by the Food and Drug Administration (FDA) to determine whether results with the HeartMate (HM) II (Thoratec, Pleasanton, California) left ventricular assist device (LVAD) in a commercial setting were comparable to results during the DT multicenter pivotal clinical trial.
  
  
  BACKGROUND
  New device technology developed in the clinical research setting requires validation in a real-world setting.
  
  
  METHODS
  The PA study was a prospective evaluation of the first 247 HM II patients identified pre-operatively as eligible for DT in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry. Patients were enrolled from January to September 2010 at 61 U.S. centers and followed for 2 years. A historical comparison group included patients (n = 133 at 34 centers) enrolled in the primary data cohort in the DT pivotal trial (TR). Survival rates and adverse events for the PA group were obtained from the INTERMACS registry.
  
  
  RESULTS
  Baseline characteristics were similar for PA versus TR. Forty-five percent of PA patients were in INTERMACS profiles 1 to 2 and 28% were in profile 3. Adverse events in the PA group were similar or lower than those in the TR group, including improvements in device-related infection (0.22 vs. 0.47) and post-operative bleeding requiring surgery (0.09 vs. 0.23) events per patient-year. Kaplan-Meier survival at 2 years was 62% (PA group) versus 58% (TR group). PA group survival at 1 and 2 years was 82 ± 5% and 69 ± 6% for INTERMACS profiles 4 to 7 (n = 63) versus 72 ± 3% and 60 ± 4% for profiles 1 to 3 (n = 184). The median length of stay after surgery was reduced by 6 days in the PA group versus the TR group.
  
  
  CONCLUSIONS
  Results in a commercial patient care setting for the DT population supported the original pivotal clinical trial findings regarding the efficacy and risk profile of the HM II LVAD. Survival was best in patients who were not inotrope-dependent (INTERMACS profiles 4 to 7).
authors.affiliation: Columbia University Medical Center-New York Presbyterian Hospital, New York, New York. Electronic address: Upj1@columbia.edu.
authors.forename: Ulrich P
authors.initials: UP
authors.lastname: Jorde
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Sudhir S
authors.initials: SS
authors.lastname: Kushwaha
authors.affiliation: Advocate Christ Medical Center, Oak Lawn, Illinois.
authors.forename: Antone J
authors.initials: AJ
authors.lastname: Tatooles
authors.affiliation: Columbia University Medical Center-New York Presbyterian Hospital, New York, New York.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.affiliation: Advocate Christ Medical Center, Oak Lawn, Illinois.
authors.forename: Geetha
authors.initials: G
authors.lastname: Bhat
authors.affiliation: INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma.
authors.forename: James W
authors.initials: JW
authors.lastname: Long
authors.affiliation: INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma.
authors.forename: Douglas A
authors.initials: DA
authors.lastname: Horstmanshof
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Kormos
authors.affiliation: University of Pittsburgh, Pittsburgh, Pennsylvania.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Teuteberg
authors.affiliation: University of Louisville, Louisville, Kentucky.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.affiliation: University of Louisville, Louisville, Kentucky.
authors.forename: Emma J
authors.initials: EJ
authors.lastname: Birks
authors.affiliation: Thoratec Corporation, Pleasanton, California.
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.affiliation: Mayo Clinic, Rochester, Minnesota.
authors.forename: Soon J
authors.initials: SJ
authors.lastname: Park
mesh_terms: D000328:Adult; D002140:California / Q000453:epidemiology; D018795:Device Approval; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012042:Registries; D015996:Survival Rate / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration
keywords: assist device; destination therapy; heart failure