title: Lessons learned from the first fully magnetically levitated centrifugal LVAD trial in the United States: the DuraHeart trial.
abstract: BACKGROUND
  The DuraHeart is a continuous centrifugal-flow left ventricular assist device that uses active magnetic levitation for impeller positioning designed for improved hemocompatibility and durability. This study reviews the results of the US trial with specific attention to hemolysis, thrombotic complications, and pump failure.
  
  
  METHODS
  The US SUSTAIN trial was a multicenter, prospective, single-arm observational study in advanced heart failure patients listed for transplantation. Follow-up was complete in 100% of the patients at 6 months.
  
  
  RESULTS
  Sixty-three patients were enrolled at 23 centers. Forty-six patients (73%) reached the primary end points of survival to transplantation, alive on the original device at 180 days and listed for transplantation, or explant for recovery. Median duration of support was 267 days (range, 10 to 952 days) with a total support time of 46 patient-years. There was no clinical hemolysis reported during the study. Mean lactate dehydrogenase values peaked at day 4 and significantly decreased during support (435±236 U/L and 297±142 U/L on day 3 and day 180, respectively). There were no cases of pump thrombosis reported, and 3 cases of pump thrombus "in transit" (0.06 events/patient-year) were observed. There were 6 (10%) cases of magnetic levitation system failure, all secondary to cable wire fractures (0.12 events/patient-year). All patients were hemodynamically stable with the backup hydrodynamic mode. Major adverse events included gastrointestinal bleeding (0.52 events/patient-year), ischemic and hemorrhagic strokes (0.17 events/patient-year and 0.09 events/patient-year, respectively), and driveline infections (0.67 events/patient-year).
  
  
  CONCLUSIONS
  The DuraHeart demonstrated good hemocompatibility; however, the reliability of full magnetic levitation systems should be a high priority in future pump designs.
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address: moazamn@ccf.org.
authors.forename: Nader
authors.initials: N
authors.lastname: Moazami
authors.affiliation: Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Steffen
authors.affiliation: Division of Cardiothoracic Surgery, Columbia University, New York, New York.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.affiliation: Division of Cardiology, Columbia University, New York, New York.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Jorde
authors.affiliation: Division of Cardiothoracic Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania.
authors.forename: Stephen
authors.initials: S
authors.lastname: Bailey
authors.affiliation: Division of Cardiology, Allegheny General Hospital, Pittsburgh, Pennsylvania.
authors.forename: Srinivas
authors.initials: S
authors.lastname: Murali
authors.affiliation: Division of Cardiac Surgery, Newark Beth Israel Medical Center, Newark, New Jersey.
authors.forename: Margarita T
authors.initials: MT
authors.lastname: Camacho
authors.affiliation: Division of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey.
authors.forename: Mark
authors.initials: M
authors.lastname: Zucker
authors.affiliation: Terumo Heart, Inc, Ann Arbor, Michigan.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Marascalco
authors.affiliation: Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto, Ontario, Canada.
authors.forename: Vivek
authors.initials: V
authors.lastname: Rao
authors.affiliation: Department of Cardiology, Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors.forename: David
authors.initials: D
authors.lastname: Feldman
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006333:Heart Failure / Q000601:surgery*; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D060328:Magnetic Phenomena; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D055815:Young Adult