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
Wednesday, October 13, 2010
Hemostatic Powder Market - Cook Rollout of Endoscopic Application
Novel application of powder could eventually replace endoscopic surgical procedure
TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.
TORONTO, Ont., October 13, 2010 — A new material similar to that used by the U.S. Military to treat traumatic injuries is showing promise as the next novel treatment for bleeding ulcers, a condition that commonly affects up to 15 per cent of adults, according to Hong Kong physician Dr. James Lau. Dr. Lau is presenting his findings today on this world-first research at the 23rd International Course on Therapeutic Endoscopy. The course is a world-renowned international conference on the latest innovations in endoscopy organized and hosted by St. Michael's Hospital.
"Nearly 5 to 10 per cent of patients who have a bleeding ulcer experience additional bleeding despite our best treatment efforts," said Dr. Lau, a physician at the Prince of Wales Hospital and professor at the Chinese University of Hong Kong. "However, our findings suggest a new approach with a powder that could ultimately prove to be more effective for patients and result in fewer complications."
A preliminary study on the safety of using a proprietary powder from Cook Medical, by Lau and colleagues, found it was beneficial in treating 95 per cent of patients with bleeding peptic ulcers. A peptic ulcer is an oval sore that develops when the lining of the stomach or duodenum is eaten away by stomach acid and digestive juices. First-line treatment involves the use of an endoscope, or a flexible tube, inserted through the mouth into the small intestine and stomach, to treat and repair bleeding ulcers. This is often done by injecting drugs into a blood vessel at the ulcer base or clipping or sealing the ulcer with a probe that generates heat.
In the study, researchers administered the powder through the channel of an endoscope. The powder was applied to the ulcer in one to two short bursts until bleeding stopped. They found the bleeding was successfully stopped in 95 per cent of cases and there was no recurrent bleeding or complications 30 days after treatment. The preliminary findings suggest the powder has high success rates and, most importantly, the technique of applying the powder is simple.
The findings signal future potential uses of the hemostatic powder to treat bleeding ulcers. Dr. Lau's findings is one of many innovative research studies being shared with colleagues around the world through an international conference at the Four Season Hotel in Toronto hosted by endoscopy experts at St. Michael's Hospital.
The Advanced Diagnostic and Therapeutic Endoscopy unit at St. Michael's is a center of excellence in therapeutic interventional and palliative endoscopy. Known worldwide as leaders in the field of endoscopy, physicians on the team have made groundbreaking discoveries and are performing some of the country's only and most innovative endoscopy techniques that allow for the early diagnosis and treatment of cancer.
St. Michael's Hospital provides compassionate care to all who walk through its doors. The Hospital also provides outstanding medical education to future health care professionals in more than 23 academic disciplines. Critical care and trauma, heart disease, neurosurgery, diabetes, cancer care, and care of the homeless are among the Hospital's recognized areas of expertise. Through the Keenan Research Centre and the Li Ka Shing Knowledge Institute, research at St. Michael's Hospital is recognized and put into practice around the world. Founded in 1892, the Hospital is fully affiliated with the University of Toronto.
Heart Surgery Transfusions - at best a waste of resources
"We don't know whether the variability is potentially harming patients," said lead author Elliott Bennett-Guerrero, M.D., director of Perioperative Clinical Research at Duke Clinical Research Institute and Professor of Anesthesiology/Critical Care. "Even if more liberal transfusion is not harmful to patients, it may represent a significant waste of scarce resources and money."
The researchers didn't find any link between patient mortality rates after surgery and whether the hospital was a high-transfusion site or a low-transfusion site, Bennett-Guerrero said.
The work was published in the Journal of the American Medical Association (JAMA) online on Oct. 12.
"To our knowledge there has never been a published large randomized trial in surgical patients looking at the impact of blood transfusion to determine whether we should be more restrictive or liberal with these transfusions," Bennett-Guerrero said. "Despite the fact that we spend billions of dollars on health care and research, we spend comparatively little on clinical effectiveness trials, which are gaining recognition as an informed way to change clinical practice."
Even when centers performing fewer operations were excluded, the researchers found that transfusion rates among the patients at hospitals ranged from 7.8 percent to 92.8 percent for red blood cells, 0 percent to 97.5 percent for fresh-frozen plasma, and 0.4 percent to 90.4 percent for platelets. The average cost of a unit of RBCs including direct and indirect costs was $761 in a 2010 study published in Transfusion journal.
The team, which included researchers from other institutions, found variation in RBC use based on geographic region, as well as higher RBC usage at academic hospitals and hospitals that performed the fewest number of coronary artery bypass graft (CABG) operations. Taken together, however, these three characteristics only accounted for 11.1 percent of variation in red-blood cell use.
The research team assessed data from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database kept by the Duke Clinical Research Institute, which captures clinical information from the majority of U.S. cardiac surgical procedures (up to 80 percent of all surgical data available).
The patients included in the study all had the same operation, a first-time, isolated coronary artery bypass graft (CABG), and all were on a heart-lung pump during surgery.
Differences in surgical techniques may help explain some of the variability. "There is a reasonable chance that some patients are getting transfused more because they are bleeding more during surgery, which could be linked to differences in surgical technique among the doctors," Bennett-Guerrero said.
Another likely difference is simply the transfusion culture at an institution. This may also have to do with early medical education and training, as some institutions pass along a pro-transfusion culture to those in training, he said.
argely circumstantial evidence suggests excessive blood transfusion for a patient may be harmful, Bennett Guerrero says. Everyone agrees that transfusion is needed when an injured person has lost most of their blood or has severe anemia. "It is difficult to get agreement, however, in situations where the patient has moderate blood loss or anemia," he said. "No one has yet proven that more liberal transfusion is harmful, and in the absence of results from high-quality randomized clinical studies, it is not surprising that there is variation in transfusion rates."
This work was supported by the Society of Thoracic Surgeons through the National Adult Cardiac Surgery Database and the Duke Clinical Research Institute.
Other authors include Yue Zhao and Sean M. O'Brien of the biostatistics division and Eric D. Peterson in the cardiology division of the Duke Clinical Research Institute; T.B. Ferguson of the Department of Cardiovascular Sciences, at the East Carolina Heart Institute, in Greenville, N.C.; James S. Gammie of the Division of Cardiac Surgery at the University of Maryland Medical Center in Baltimore; and senior author Howard K. Song of the Division of Cardiothoracic Surgery, Oregon Health and Science University in Portland.
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