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ADVANCE (HeartWare) trial - Summary & Results


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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

  1. 1. ADVANCE (HeartWare)
  2. 2. 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
  3. 3. 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
  4. 4. 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 (
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