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NIH Awards SBU Professor Of Biomedical Engineering $7.5 Million For Advanced Research on Cardiovascular Devices

NIH Awards SBU Professor Of Biomedical Engineering $7.5 Million For Advanced Research on Cardiovascular Devices

Dr. Danny Bluestein Receives NIBIB Grant to Eliminate Need for Anticoagulation With Devices

Danny Bluestein, Ph.D., Professor of Biomedical Engineering at Stony Brook University, has been awarded a five-year, $7.5 million grant by the National Institutes of Health. The award marks the first time a Stony Brook professor has received a Phase II Quantum Grant, given by The National Institute of Biomedical Imaging and Bioengineering (NIBIB), a division of the NIH, to make a profound improvement—or quantum leap forward—in health care. Dr. Bluestein’s project involves testing and optimizing the designs of various cardiovascular devices with the goal to eliminate the need for anticoagulation therapy for patients with these devices. 

Millions of cardiovascular disease patients worldwide are implanted with prosthetic devices. While these devices save lives, they promote blood clot formation and patients are required to take anticoagulants, which may slow the rate at which the patient’s blood clots. There are numerous conditions for which cardiovascular patients take anticoagulants. Most patients with prosthetic heart valves, left ventricular assist devices (LVADs), and biventricular assist devices (BiVADs), need to take anticoagulants. The downsides to this class of drugs are that blood clot formation is not eliminated and there is a risk for dangerous and potentially deadly bleeds if therapy is not properly monitored.

“Dr. Bluestein’s work is certain to contribute to our understanding of cardiovascular disease and pave new ways of treating heart dysfunction,” says Clinton T. Rubin, Ph.D., Director of the Center for Biotechnology, Distinguished SUNY Professor, and Chair of the Department of Biomedical Engineering at SBU. 

“The Quantum award recognizes the potential of this research to revolutionize cardiovascular care for millions of patients,” says Kenneth Kaushansky, M.D., Senior Vice President, Health Sciences, and Dean, SBU School of Medicine. “Dr. Bluestein’s work stands out as the kind of translational research that is necessary to advance cardiovascular care even more than it has already progressed within the past decade.”

“We developed a Device Thrombogenicity Emulator (DTE) that measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device, as extracted from sophisticated numerical simulations,” says Dr. Bluestein. “The DTE measures the formation of blood clots in an emulated device environment, facilitating the optimization of these devices without the need to build expensive prototypes and test them before optimization is achieved.

“This has a tremendous potential to significantly reduce the ensuing healthcare costs while improving the quality of life for patients with implanted devices,” he explains, likening the concept to wind tunnels used for aeronautic and automotive testing.
During Phase I of the project, Dr. Bluestein and his colleagues developed and tested the DTE, which reduced the need for anticoagulation in laboratory models. During Phase II, he expects to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices, where clots can form.

“Within the DTE, we can tweak the geometry of the device’s design to optimize it and minimize or eliminate these hot spots,” he notes.

According to Dr. Bluestein, the researchers recently demonstrated in numerical simulations and in the DTE (where clot formation is also measured) that an optimized design of the HeartAssist5, the modern DeBekay LVAD, clot formation was reduced by an order of magnitude. Concurrent animal experiments using the optimized device were conducted by Micromed Inc.—the company that manufactures the device—and the results indicates that its recipients may not require anticoagulation.
Dr. Bluestein is working with various institutions and companies to use the DTE to test and optimize the designs of various prosthetic heart valves, LVADs, BiVADs and the only Food and Drug Administration (FDA)-approved total artificial heart. He envisions the methodology as becoming an FDA standard for testing such medical devices.

“The work of Dr. Bluestein and colleagues contributes enormously to the bridging of our College of Engineering and Applied Sciences to the School of Medicine,” states Yacov Shamash, Ph.D., Vice President for Economic Development, and Dean of the College of Engineering and Applied Science at SBU. “We are excited to see this marriage of engineering and medicine that should lead to great advances in health care.”

The Quantum Grants Program of NIBIB challenges the research community to propose projects that have an innovative, highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge. The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies. 

Collaborators on Dr. Bluestein’s project include the Sarver Heart Center at the University of Arizona in Tucson, along with a consortium of four industrial partners: SynCardia Systems, Inc.; MicroMed Cardiovascular, Inc.; Medtronic-ATS Medical Inc., and Innovia LLC. Co-investigators at Stony Brook include Department of Medicine Professor Jolyon Jesty, and Professor Shmuel Einav of the College of Engineering and Applied Science. 

Dr. Bluestein, Director of the Biofluids Laboratory in the SBU Biomedical Engineering Department, has been with the department since 1996.  In 1992, he received his Ph.D. in Mechanical and Biomedical Engineering from Tel Aviv University in Tel Aviv, Israel, where he also earned an M.S. in Mechanical Engineering in 1985.  He received a B.S. in Aeronautical Engineering from the Technion-Israel Institute of Technology in 1981.  

In 2010, Professor Bluestein was elected into the American Institute for Medical and Biological Engineering’s (AIMBE) College of Fellows, in recognition of his exceptional leadership and achievements in medical and biological engineering.

The Department of Biomedical Engineering at Stony Brook University is one of 25 departments within the School of Medicine and is part of the College of Engineering and Applied Sciences. Established in 2000, the department includes more than 60 faculty training students in undergraduate, MS and PhD programs. Areas of research emphasis include Biomechanics & Biomaterials, Bioelectricity & Bioimaging, Tissue Engineering, Bioinstrumentation and Biosignal Processing, and Cell & Molecular Bioengineering.

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