title: Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes.
abstract: OBJECTIVE
  The objective of this study was to describe the operative experience and 30-day outcomes of patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS) during the Conformité Européenne (CE) Mark clinical trial.
  
  
  METHODS
  Adult patients met inclusion and exclusion criteria defining advanced-stage heart failure and included the indications of bridge to transplant and destination therapy. Operative parameters, outcomes, adverse events, physical status and quality-of-life parameters were assessed in the first 30 days after LVAS implant.
  
  
  RESULTS
  Fifty patients were implanted with the HeartMate 3 at 10 centres in 6 countries. The 30-day survival rate was 98%. The median operative and cardiopulmonary bypass times were 200 (range: 95-585) min and 84 (range: 47-250) min, respectively. Patients required transfusion with packed red blood cells (3.6 ± 2.3 units), fresh frozen plasma (6.5 ± 5 units) and platelets (2 ± 1 units). Six patients (12%) required reoperation for postoperative bleeding and 10 patients (20%) did not require blood transfusion. The median intensive care time was 6 days (range: 1-112 days) and the total hospital stay was 28 days (range: 14-116 days). The most common adverse events were bleeding (15, 30%), arrhythmia (14, 28%) and infection (10, 20%). There were 2 (4%) strokes.
  
  
  CONCLUSIONS
  The 30-day outcomes following implantation of the HeartMate 3 demonstrates excellent survival with low adverse event rates. The LVAD performed as intended with no haemolysis or device failure.
  
  
  BACKGROUND
  NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark).
authors.affiliation: University of Vienna, Vienna, Austria daniel.zimpfer@meduniwien.ac.at.
authors.forename: Daniel
authors.initials: D
authors.lastname: Zimpfer
authors.affiliation: Institute for Clinical and Experimental Medicine, Prague, Czech Republic.
authors.forename: Ivan
authors.initials: I
authors.lastname: Netuka
authors.affiliation: Hannover Medical School, Hannover, Germany.
authors.forename: Jan D
authors.initials: JD
authors.lastname: Schmitto
authors.affiliation: National Research Cardiac Surgery Center, Astana, Kazakhstan.
authors.forename: Yuriy
authors.initials: Y
authors.lastname: Pya
authors.affiliation: Heart Center Leipzig, Leipzig, Germany.
authors.forename: Jens
authors.initials: J
authors.lastname: Garbade
authors.affiliation: Thoracic and Cardiovascular Surgery Clinic, Bad Oeynhausen, Germany.
authors.forename: Michiel
authors.initials: M
authors.lastname: Morshuis
authors.affiliation: University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany.
authors.forename: Friedhelm
authors.initials: F
authors.lastname: Beyersdorf
authors.affiliation: The Alfred Hospital, Melbourne, Australia.
authors.forename: Silvana
authors.initials: S
authors.lastname: Marasco
authors.affiliation: Toronto General Hospital, Toronto, Canada.
authors.forename: Vivek
authors.initials: V
authors.lastname: Rao
authors.affiliation: St. Jude Medical Inc., St. Paul, MN, USA.
authors.forename: Laura
authors.initials: L
authors.lastname: Damme
authors.affiliation: St. Jude Medical Inc., St. Paul, MN, USA.
authors.forename: Poornima
authors.initials: P
authors.lastname: Sood
authors.affiliation: German Heart Center, Berlin, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Krabatsch
mesh_terms: D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D014943:Global Health; D006333:Heart Failure / Q000401:mortality / Q000503:physiopathology / Q000601:surgery*; D006352:Heart Ventricles / Q000503:physiopathology* / Q000601:surgery; D006353:Heart-Assist Devices; D006801:Humans; D015994:Incidence; D007902:Length of Stay / Q000639:trends; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000453:epidemiology* / Q000601:surgery; D011446:Prospective Studies; D011788:Quality of Life; D012086:Reoperation; D015996:Survival Rate / Q000639:trends; D013997:Time Factors
keywords: 30-Day outcomes; Advanced heart failure; HeartMate 3; Magnetically levitated rotor