ADVANCE (HeartWare) trial - Summary & Results
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ADVANCE (HeartWare) trial - Summary & Results

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http://www.theheart.org/web_slides/1171463.do ...

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A study designed to compare HeartWare, a novel left ventricular assist device (LVAD), with the only other widely used LVAD, Thoratec's HeartMate II, as a bridge to heart transplant

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ADVANCE (HeartWare) trial - Summary & Results ADVANCE (HeartWare) trial - Summary & Results Presentation Transcript

  • ADVANCE (HeartWare)
  • ADVANCE (HeartWare)K D Aaronson (University of Michigan, Ann Arbor)American Heart Association 2010 Scientific Sessions• A study designed to compare HeartWare, a novel left ventricular assist device (LVAD), with the only other widely used LVAD, Thoratecs HeartMate II, as a bridge to heart transplant• Population and treatment: 140 patients who received HeartWare were compared with patients in the Interagency Registry for Mechanical Assisted Circulatory Support• Outcomes: Primary end point: Success, defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days Secondary end points: A comparison of survival between treatment and control groups, and functional and quality-of-life outcomes, as well as adverse events
  • ADVANCE: Results• HeartWare VAD met the criterion of noninferiority to the control (p<0.001) but not superiority: The treatment-group success was 92.0% Control-group success was 90.1%• There appears to be less bleeding and infection with the new device• The incidence of stroke was higher than might have been expected with the smaller size of the device
  • ADVANCE: Commentary*"A landmark trial in the long road of optimizing LVAD usage, we await the long-termresults with interest." - Dr Magdi Yacoub"Certainly the noninferiority data are persuasive and demonstrate that we may haveyet another platform we can use." - Dr Clyde Yancy"In the next two or three years . . . there is going to be a clinical trial of a factor Xaor thrombin inhibitor in the presence of a VAD compared with warfarin." - Dr Alfred A Bove*All comments from ADVANCE: New LVAD equivalent to HeartMate II, nonrandomized study shows (http://www.theheart.org/article/1147661.do)
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