title: Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support).
abstract: OBJECTIVE
  The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication.
  
  
  BACKGROUND
  After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication.
  
  
  METHODS
  The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry.
  
  
  RESULTS
  Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline.
  
  
  CONCLUSIONS
  The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results.
authors.affiliation: Heart Failure and Cardiac Transplant Medicine, Department of Cardiovascular Medicine, Kaufman Center for Heart Failure, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA. starlir@ccf.org
authors.forename: Randall C
authors.initials: RC
authors.lastname: Starling
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Boyle
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Gonzalez-Stawinski
authors.forename: Ranjit
authors.initials: R
authors.lastname: John
authors.forename: Ulrich
authors.initials: U
authors.lastname: Jorde
authors.forename: Stuart D
authors.initials: SD
authors.lastname: Russell
authors.forename: John V
authors.initials: JV
authors.lastname: Conte
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
authors.forename: Edwin C
authors.initials: EC
authors.lastname: McGee
authors.forename: William G
authors.initials: WG
authors.lastname: Cotts
authors.forename: David
authors.initials: D
authors.lastname: DeNofrio
authors.forename: Duc Thinh
authors.initials: DT
authors.lastname: Pham
authors.forename: David J
authors.initials: DJ
authors.lastname: Farrar
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001243:Assisted Circulation / Q000295:instrumentation / Q000592:standards*; D002648:Child; D002675:Child, Preschool; D018795:Device Approval / Q000592:standards*; D005260:Female; D005500:Follow-Up Studies; D016027:Heart Transplantation / Q000295:instrumentation / Q000592:standards*; D006353:Heart-Assist Devices / Q000592:standards*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D011446:Prospective Studies; D012042:Registries / Q000592:standards*; D014481:United States; D018487:Ventricular Dysfunction, Left / Q000601:surgery / Q000628:therapy; D055815:Young Adult