title: Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF: A Multicenter Study.
abstract: BACKGROUND
  The HeartMate 3 left ventricular assist system (LVAS) is intended to provide long-term support to patients with advanced heart failure. The centrifugal flow pump is designed for enhanced hemocompatibility by incorporating a magnetically levitated rotor with wide blood-flow paths and an artificial pulse.
  
  
  OBJECTIVE
  The aim of this single-arm, prospective, multicenter study was to evaluate the performance and safety of this LVAS.
  
  
  METHODS
  The primary endpoint was 6-month survival compared with INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)-derived performance goal. Patients were adults with ejection fraction ≤ 25%, cardiac index ≤ 2.2 l/min/m(2) without inotropes or were inotrope-dependent on optimal medical management, or listed for transplant.
  
  
  RESULTS
  Fifty patients were enrolled at 10 centers. The indications for LVAS support were bridge to transplantation (54%) or destination therapy (46%). At 6 months, 88% of patients continued on support, 4% received transplants, and 8% died. Thirty-day mortality was 2% and 6-month survival 92%, which exceeded the 88% performance goal. Support with the fully magnetically levitated LVAS significantly reduced mortality risk by 66% compared with the Seattle Heart Failure Model-predicted survival of 78% (p = 0.0093). Key adverse events included reoperation for bleeding (14%), driveline infection (10%), gastrointestinal bleeding (8%), and debilitating stroke (modified Rankin Score > 3) (8%). There were no pump exchanges, pump malfunctions, pump thrombosis, or hemolysis events. New York Heart Association classification, 6-min walk test, and quality-of-life scores showed progressive and sustained improvement.
  
  
  CONCLUSIONS
  The results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363).
authors.affiliation: Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic; Second Department of Surgery, Department of Cardiovascular Surgery, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic. Electronic address: ivan.netuka@ikem.cz.
authors.forename: Ivan
authors.initials: I
authors.lastname: Netuka
authors.affiliation: Clinical Affairs, St. Jude Medical, Burlington, Massachusetts.
authors.forename: Poornima
authors.initials: P
authors.lastname: Sood
authors.affiliation: National Research Cardiac Surgery Center, Astana, Kazakhstan.
authors.forename: Yuriy
authors.initials: Y
authors.lastname: Pya
authors.affiliation: Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
authors.forename: Daniel
authors.initials: D
authors.lastname: Zimpfer
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, German Heart Center, Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Krabatsch
authors.affiliation: Heart Center Leipzig, Department of Cardiac Surgery, University of Leipzig, Leipzig, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Garbade
authors.affiliation: Toronto General Hospital, Toronto, Canada.
authors.forename: Vivek
authors.initials: V
authors.lastname: Rao
authors.affiliation: Thoracic and Cardiovascular Surgery Clinic, Bad Oeynhausen, Germany.
authors.forename: Michiel
authors.initials: M
authors.lastname: Morshuis
authors.affiliation: Cardiothoracic Surgical Unit, The Alfred Hospital, Melbourne, Australia.
authors.forename: Silvana
authors.initials: S
authors.lastname: Marasco
authors.affiliation: Department of Cardiovascular Surgery Freiburg, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.affiliation: Clinical Affairs, St. Jude Medical, Burlington, Massachusetts.
authors.forename: Laura
authors.initials: L
authors.lastname: Damme
authors.affiliation: Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
authors.forename: Jan D
authors.initials: JD
authors.lastname: Schmitto
mesh_terms: D000368:Aged; D002316:Cardiotonic Agents / Q000627:therapeutic use; D004867:Equipment Design; D005260:Female; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000601:surgery; D016027:Heart Transplantation / Q000706:statistics & numerical data; D006352:Heart Ventricles / Q000503:physiopathology*; D006353:Heart-Assist Devices; D006439:Hemodynamics; D006801:Humans; D008134:Long-Term Care / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D013318:Stroke Volume; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D002316:Cardiotonic Agents
keywords: HeartMate 3; hemolysis; pump; quality of life; thrombosis