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ADVANCE: Experimental LVAD comparable to approved bridge-to-transplant devices
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American Heart Association Scientific Sessions 2010
CHICAGO — A novel ventricular assist device implanted in patients with advanced HF waiting for transplants was associated with outcomes comparable to those of currently approved bridge-to-transplant devices, according to early results from a nonrandomized study.
Researchers for the ADVANCE study enrolled 140 patients with HF from the United Network for Organ Sharing’s heart-transplant waiting list scheduled to receive the HeartWare left ventricular assist device (HVAD), and 499 comparable control patients with HF on nationwide waiting lists to receive an HVAD. The primary outcome measure was survival and success defined as survival (on the originally implanted device, transplant or explant for ventricular recovery) at 180 and 360 days after implantation. Secondary measures included a comparison of survival between treatment and control groups, as well as functional quality of life outcomes and adverse events in the treatment group.
According to the study results, 92.0% of patients in the treatment group achieved success vs. 90.1% in the control group, with 0.9% difference in the 95% upper confidence limit. This was less than the prespecified 15% noninferiority margin, suggesting that the success in the treatment group was noninferior to the control group (P<.001). The secondary outcome comparison of survival was similar between groups. Patients in the HVAD treatment group also were able to walk 113 meters farther in a six minute walk test than control patients.
“The success rate with this novel device was quite high, survival was quite good, there was a favorable adverse events profile and there were marked improvements in functional class and quality of life similar to what we achieve with cardiac transplantation,” Keith Aaronson, MD, associate professor of internal medicine at the University of Michigan Medical Center in Ann Arbor, said at a press conference. “This provides a new opportunity for patients who require ventricular support as a means to get to a heart transplant.”
Dr. Aaronson reports having received research support from HeartWare, Thoratec and Terumo, and is on the clinical steering committee for HeartWare. - by Eric Raible
For more information:
- Aaronson K. LBCT I, Abstract 21723. Presented at: American Heart Association Scientific Sessions 2010; Nov.13-17; Chicago.
The main positive point of this trial is adding an attractive new device with a lot of potential [as a treatment option], for all of the reasons the authors have mentioned. It is small, simple to insert and it does not require a pocket. Importantly, there are also technical innovations in this particular device (a third generation VAD) which could hopefully translate into clinical benefit. This is only the beginning, however, as these are early results.
- Magdi H. Yacoub, MD
Harefield Hospital,
Middlesex, United Kingdom
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