17 Nov Fully Magnetized HeartMate 3 LVAD Eliminates Pump Clots
MedicalResearch.com Interview with:
Mandeep R. Mehra, MD, FACC, FESC, FHFSA, FRCP
Medical Director, Brigham and Women’s Hospital Heart and Vascular Center
Executive Director, Center for Advanced Heart Disease
Professor of Medicine, Harvard Medical School
Editor in Chief, The Journal of Heart and Lung Transplantation
Brigham and Women’s Hospital
MedicalResearch.com: What is the background for this study?
Response: 10% of patients with heart failure and a reduced ejection fraction transition into Advanced Stages of disease where they become unresponsive to life prolonging traditional medications. Such patients typically require intravenous inotropic therapy to preserve cardiac function but most remain profoundly limited in their quality of life. In such cases a heart transplant is desirable but this is an option for only a few patients.
Left Ventricular Assist Devices (LVADs) have become the mainstay for treating such patients either while they await a transplant or as a permanent option. However, there are challenges leading to infections, strokes, bleeding and most importantly pump malfunction due to thrombosis of the LVAD itself. The HeartMate 3 LVAD is a centrifugal pump that is designed to overcome the problem of pump thrombosis by virtue of 3 engineering attributes:
(a) A frictionless rotor that is based on a fully magnetically levitated platform
(b) wide blood flow passages that reduce red cell destruction and
(c) an artificial intrinsic pulse that prevents stasis of blood within the pump.
MedicalResearch.com: What are the main findings?
Response: The MOMENTUM 3 trial tested the engineering attributes of the HeartMate 3 pump in the clinical context by conducting a randomized trial against the HeartMate II LVAD by including a population of advanced heart failure patients deemed candidates for such therapy irrespective of the need for transplantation. Thus, the study tested an established device against the first US experience with the new LVAD.
The first primary end point of this study was assessed in 294 patients who reached 6 months of follow up for survival free of a disabling stroke or need for surgical reoperation to replace or remove the pump. We found that the HeartMate 3 outperformed the HeartMate II and demonstrated superiority, largely driven by the reduced need for reoperations for pump malfunction. We noted no case of pump thrombosis in the HeartMate 3 device while this occurred with a 10% incidence in the HeartMate II group. The new device performed as well as the established device in terms of improving functional capacity, quality of life and other adverse effects including strokes and bleeding related complications.
MedicalResearch.com: What should readers take away from your report?
Response: The MOMENTUM 3 trial demonstrates that advanced engineering has led to a superior device that performs well clinically by eliminating one challenge of such therapy, pump thrombosis. This should infuse confidence in the therapy, its application and its future potential for our patients suffering from Advanced stages of Heart Failure.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The encouraging initial results at 6 months in MOMENTUM 3 are being evaluated within the trial in a larger group of patients followed to 2 years. This future analysis will define the durability of these early important findings, including the constellation of adverse effects that accumulate over a longer term experience. We anticipate that this device will become the predicate device for our patients in the near term, however, progress in this field will need to continue to eliminate other complications such as infections. This will be achieved by developing a fully internalized power source so that these devices do not require a drive-line to exit the body for connection to an external power source.
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A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure
Mandeep R. Mehra, M.D., Yoshifumi Naka, M.D., Nir Uriel, M.D., Daniel J. Goldstein, M.D., Joseph C. Cleveland, Jr., M.D., Paolo C. Colombo, M.D., Mary N. Walsh, M.D., Carmelo A. Milano, M.D., Chetan B. Patel, M.D., Ulrich P. Jorde, M.D., Francis D. Pagani, M.D., Keith D. Aaronson, M.D., David A. Dean, M.D., Kelly McCants, M.D., Akinobu Itoh, M.D., Gregory A. Ewald, M.D., Douglas Horstmanshof, M.D., James W. Long, M.D., and Christopher Salerno, M.D., for the MOMENTUM 3 Investigators*
November 16, 2016DOI: 10.1056/NEJMoa1610426
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