ADDISON, Texas, June 20 /PRNewswire/ -- The National Heart, Lung, and Blood Institute (NHLBI), of the National Institutes of Health, awarded a nearly $6 million contract over five years to the University of Alabama at Birmingham, with principal investigator Dr. James K. Kirklin, to establish an interagency registry of mechanical circulatory support devices (MCSD) for the treatment of advanced heart failure.
The co-principal investigators are Dr. Robert Kormos, University of Pittsburgh Medical Center, and Dr. Lynne Warner Stevenson, Brigham and Women’s Hospital and Harvard Medical School. Patient and device data will be collected through the United Network of Organ Sharing (UNOS), taking advantage of its substantial experience in data collection. UNOS has conducted a voluntary MCSD database within the International Society for Heart and Lung Transplantation (ISHLT) since 2002.
Kirklin and his co-investigators drew upon the expertise of a consortium of experts on mechanical circulatory support and advanced heart failure within the ISHLT to generate their proposal to NHLBI. The new NIH-sponsored database will benefit from the data and analyses generated by the existing ISHLT database; but this new federal initiative will encourage active participation from U.S. Centers implanting these devices, governmental agencies and the MCSD industry.
The nearly 70 institutions involved in the collaborative project are currently utilizing MCSDs for the treatment of end stage heart failure. The Registry is designed to advance MCSD therapy by aiding in the development of technology and reporting standards, and ultimately improving patient outcomes for those with advanced heart failure. According to the NHLBI, it is anticipated that the registry will collect data, blood and tissue samples from approximately 2,000 new patients per year for a period of five years.
Data analysis will be performed at the University of Alabama at Birmingham under the direction of the principal investigator Dr. Kirklin, Professor of Surgery, Director of Cardiothoracic Transplantation, and Dr. David Naftel, head statistician for the project. The Registry will be guided by committees composed of experts within this field, members of industry and representatives from the NIH, the Food and Drug Administration (FDA), and the Centers for Medicare and Medicaid Services (CMS).
MCSD Technology
MCSDs are used to stabilize adults with heart disease and act as a mechanical “bridge” for patients waiting for a donor heart, or in some cases as permanent implantation or “destination therapy” for advanced heart failure. The use of MCSDs is increasing as the supply of donor organs remains low, meeting a small percentage of the actual need for transplants. However, there are serious and sometimes life-threatening complications associated with MCSD implantation. The Registry will provide a platform for the introduction of new technology to reduce these complications, and act as a laboratory for investigation into the physiology of mechanical circulatory support, device- patient interactions, and the potential for myocardial recovery in patients with advanced heart failure.
“Our goal is to provide a scientific platform from which to advance the application of MCSD therapy from its current use as a bridge to cardiac transplantation toward a chronic, permanent therapy for selected patients with advanced heart failure,” continued Dr. Kirklin. “We hope to use the knowledge gained from the Registry to improve the lives of these patients.”
Data Collection and Reporting
Patient and device data will be collected through the United Network of Organ Sharing (UNOS). “We see this registry as a continuation of our management of clinical data that will benefit patient care directly,” said Berkeley Keck, RN, M.P.H., Assistant Executive Director for Information Technology at UNOS. “We have been involved in transplant data for nearly 20 years and have worked closely with ISHLT for much of that time. The use of MCSDs as a destination therapy expands upon the number of people who may benefit from this form of treatment.”
The Registry will also be utilized to promote standards for current clinical device application through collaboration with NHLBI, CMS and the FDA. The Federal agencies will collaborate in monitoring the Registry to develop standardized reporting of patient characteristics, indications, implantation procedures and adverse events.
This project is funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. N01-HV-58198. The total contract, $6,338,903 over five years, will be financed 100 percent by Federal money.
About ISHLT
The International Society for Heart and Lung Transplantation (ISHLT) is a not-for-profit organization dedicated to the advancement of the science and treatment of end-stage heart and lung diseases. Created in 1981, the Society now includes more than 2,200 members from 45-plus countries, representing a variety of disciplines involved in the management and treatment of end-stage heart and lung disease.
ISHLT has a voluntary MCSD database, which has been collecting data since 2002 to help identify patient populations who may benefit from MCSD implantation. It is designed to capture worldwide data for patients receiving cardiac assist devices and currently contains information on nearly 770 patients and more than 925 devices at 46 institutions in the U.S. ISHLT uses the database to track and predict patient outcomes by generating predictive models and assessing the mechanical and biological reliability of current and future devices.
ISHLT also maintains the International Heart and Lung Transplant Registry, a one-of-a-kind registry that has been collecting data since 1983 from 223 hospitals from 18 countries. For more information, visit www.ishlt.org .
Contact: Lauren Mason
Phone: (210) 857-2521 E-mail: lmason@masonpr.com
International Society for Heart and Lung Transplantation
CONTACT: Lauren Mason, +1-210-857-2521, or lmason@masonpr.com , forInternational Society for Heart and Lung Transplantation
Web site: http://www.ishlt.org/