30 Oct Reversal of Heart Failure Using Left Ventricular Assist Devices
MedicalResearch.com Interview with:
Stavros G. Drakos, MD, PhD, FACC
Professor of Cardiology
Univ. of Utah Healthcare & Medical School and the Salt Lake VA Medical Center.
Dr. Drakos is Medical Director of the University’s Cardiac Mechanical Support/Artificial Heart Program
Co-Director Heart Failure & Transplant and Director of Research for the Division of Cardiology
MedicalResearch.com: What is the background for this study?
Response: Heart transplantation and LVADs are first line therapies for advanced chronic heart failure. There were some earlier anecdotal observations and single center small studies from several programs in the US and overseas that left ventricular assist devices (LVADs) significantly reduce the strain on failing hearts and in some cases, using LVADs for limited periods of time has allowed hearts to “rest” and remodel their damaged structures. As a result of these repairs, described as “reverse remodeling,” heart function can improve to the point that the LVAD can be removed.
The new study sought to broaden the reach of the research with a multicenter trial involving physicians and scientists at the University of Utah Health, the University of Louisville, University of Pennsylvania, the Albert Einstein College of Medicine/Montefiore Medical Center, the Cleveland Clinic, and the University of Nebraska Medical Center.
MedicalResearch.com: What are the main findings?
Response: The researchers recruited 40 advanced heart failure patients between the ages of 18 to 59 who were so severely ill that they required surgical implantation of a LVAD pump to remain alive.
a) 5% of all enrolled end-stage chronic Heart Failure (HF) patients achieved cardiac (heart) recovery and were able to undergo LVAD removal. This high rate of heart recovery is even more impressive if you consider that all patients had baseline chronic disease with severe cardiac dysfunction and cardiac chamber dilation resistant to medical therapy and requiring mechanical support. These findings are exciting because they reveal the plasticity of the heart muscle and its ability to recover even from very severe advanced heart failure and shows that reversal of severe heart failure is possible using this strategy.
b)The sustainability of heart recovery was 90% at one year after the LVAD removal and 77% at 2 and 3 years. This was a very interesting finding especially if you consider that these patients were in the terminal stage of heart failure which we know that has a survival rate of only 20% within 2 years.
c) Excellent reproducibility with successful LVAD explantations taking place in similar rates in all participating US tertiary medical centers.
MedicalResearch.com: What should readers take away from your report?
Response: Reversal of even advanced chronic heart failure can occur in a significant proportion of patients using mechanical support combined with specific pharmacological therapy aimed to improve their heart function. Patients with advanced chronic heart failure resistant to usual medical therapies with deteriorating heart function receiving mechanical support as a bridge to transplant or as destination therapy can recover the heart function enough to have the pump removed freeing up the precious donor heart for another individual.
We would like physicians to use such a protocol to try and recover the heart function of patients receiving mechanical support, particularly those with non ischemic cardiomyopathy studied in this study.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: This multi-center study builds on and validates more than a decade of research conducted by physician-scientists at the University of Utah. These patients receiving this protocol and successfully recovering provide a model of the reversal of human heart failure for us to be able to study novel mechanisms that might occur in heart failure reversal. Encouraged by these results our research teams have already been performing additional studies both in the clinic and in the lab to identify the biological mechanisms that drove this remarkably favorable response. In particular, we have been focused on identifying the metabolic and other pathways that drive this favorable myocardial response. Based on recent findings our team also published in Circulation, specific metabolic pathways appear to play a key role in the restructuring and remodeling that occurs. This line of investigations could lead to novel drug targets and the future goal is also to recover more failing hearts possibly without the help of surgeries/LVAD but just with drugs that will be able to activate these mechanisms.
MedicalResearch.com: Is there anything else you would like to add?
Response: Overall the standard of care for these end-stage heart failure patients is heart transplantation. But as we know we have limited availability of organ donors and so a very high number of heart failure patients are on waiting lists for a compatible donor. Also some patients are not suitable for heart transplantation. The therapy tested in this multicenter study provides an important new avenue because the ones that can recover can continue enjoying their lives with their native (recovered) heart and we can allocate the precious donor hearts to another patient in need that cannot recover their heart. Long term quality of life has been shown to be good for these recovered and explanted patients. So we feel that for patients receiving LVADs as a bridge to heart transplantation or as destination therapy physicians should use protocols such as this to try and recover the underlying heart function particularly in patients with non ischemic cardiomyopathy (normal heart arteries) as were studied in this study.
We are also proud of the way that the specialized doctors and teams in these well known institutions worked so collaboratively in this study to test and apply this protocol subsequently resulting in a high rate of recovery seen with this protocol and hopefully furthering the field.
A Prospective Multicentre Study of Myocardial Recovery Using Left Ventricular Assist Devices (REmission from Stage D Heart Failure: RESTAGE-HF): Medium Term and Primary Endpoint Results
Emma J. Birks , Stavros G. Drakos , Snehal R. Patel , Brian D. Lowes , Craig H. Selzman , Randall C. Starling , Jaimin Trivedi , Mark S. Slaughter , Pavan Atluri , Daniel Goldstein , Simon Maybaum , John Y. Um , Kenneth B. Margulies , Josef Stehlik , Christopher Cunningham , David J. Farrar , and Jesus E. Rame
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