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

1. ADVANCE (HeartWare)

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, Thoratec's 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. 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. ADVANCE: Commentary*
"A landmark trial in the long road of optimizing LVAD usage, we await the long-term
results with interest."
- Dr Magdi Yacoub
"Certainly the noninferiority data are persuasive and demonstrate that we may have
yet 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 Xa
or 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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