title: Heartmate 3 fully magnetically levitated left ventricular assist device for the treatment of advanced heart failure -1 year results from the Ce mark trial.
abstract: BACKGROUND
  The HeartMate 3 Left Ventricular Assist System (LVAS) (St. Jude Medical Inc., St Paul, MN) with full magnetic levitation allows for wide and consistent blood flow paths and an artificial pulse designed for enhanced hemocompatibility. The HeartMate 3 received market approval in the European Union in 2015 following completion of a multicenter study. After reaching the 6-month study endpoint, patients continue to be followed for 2 years with the 1-year results presented herein.
  
  
  METHODS
  A prospective, non-randomized study included adults with advanced heart failure and ejection fraction (EF) ≤ 25%, cardiac index (CI) ≤ 2.2 L/min/m2 while not on inotropes, or inotrope dependent, or on optimal medical management for 45/60 days.
  
  
  RESULTS
  Fifty patients-54% bridge to transplant (BTT) and 46% destination therapy (DT)-were enrolled and implanted with the HeartMate 3. At baseline, 92% of the patients were INTERMACS profiles 2-4, with cardiac index 1.8 + 0.5 L/min/m2and 58% were supported with inotropes. At 1 year, 74% of the patients remain on support, 18% expired, 6% transplanted, and 2% explanted. The adverse events include 12% gastrointestinal bleeding, 16% driveline infections, 18% strokes, and 2% outflow graft thrombosis. There was no hemolysis, pump thrombosis or pump malfunction through 1 year. The six-minute walk test distance increased from a mean of 273 m to 371 m (P <0.0001). EQ-5D quality-of-life score increased from a mean of 52.7 to 70.8 (P = 0.0006).
  
  
  CONCLUSIONS
  The 1-year HeartMate 3 LVAS results show survival and adverse-event profile are similar to other approved devices, with no pump thrombosis or pump failure. Patient's functional status and quality of life significantly improved over time.
  
  
  BACKGROUND
  Clinicaltrials.gov registration number: NCT02170363 . Registered June 19, 2014.
authors.affiliation: German Heart Center, Deutsches Herzzentrum Berlin, Augustenburger Platz 1, D-13353, Berlin, Germany. krabatsch@dhzb.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Krabatsch
authors.affiliation: Institute for Clinical and Experimental Medicine, Vídenská 1958/9 Praha 4, Prague, Czech Republic.
authors.forename: Ivan
authors.initials: I
authors.lastname: Netuka
authors.affiliation: Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
authors.forename: Jan D
authors.initials: JD
authors.lastname: Schmitto
authors.affiliation: University of Vienna, Waehringer Guertel 18-20, A-1090, Vienna, Austria.
authors.forename: Daniel
authors.initials: D
authors.lastname: Zimpfer
authors.affiliation: Heart Center Leipzig, Struempellstrasse 39, 04289, Leipzig, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Garbade
authors.affiliation: Toronto General Hospital, 4N-464 200 Elizabeth St.,, Toronto, ON, M5G 2C4, Canada.
authors.forename: Vivek
authors.initials: V
authors.lastname: Rao
authors.affiliation: Herz- und Diabeteszentrum NRW, Georgstr. 11, 32545, Bad Oeynhausen, Germany.
authors.forename: Michiel
authors.initials: M
authors.lastname: Morshuis
authors.affiliation: University Heart Center Freiburg-Bad Krozingen, Hugstetterstr 55, D-79106, Freiburg, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.affiliation: The Alfred Hospital, 55 Commercial Road, Prahran, VIC, 3181, Melbourne, Australia.
authors.forename: Silvana
authors.initials: S
authors.lastname: Marasco
authors.affiliation: St. Jude Medical, 11 Da Vincilaan, Zaventem, 1935, Belgium.
authors.forename: Laura
authors.initials: L
authors.lastname: Damme
authors.affiliation: National Research Cardiac Surgery Center, 010000, 38 Turan St., Astana, Kazakhstan.
authors.forename: Yuriy
authors.initials: Y
authors.lastname: Pya
mesh_terms: D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006353:Heart-Assist Devices; D006439:Hemodynamics / Q000502:physiology*; D006801:Humans; D059346:Magnets; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D013997:Time Factors; D016896:Treatment Outcome
keywords: Heart failure; HeartMate 3; LVAS; Magnetic levitation