MADRID, Spain, April 7 /PRNewswire/ -- A recent study shows promise for cardiac transplant patient monitoring with new non-invasive procedures to help predict organ rejection. Mandeep R. Mehra, M.D., head of the Division of Cardiology at the University of Maryland School of Medicine (Baltimore, MD), presents the study results tomorrow at the 26th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) in a session focused on clinical heart transplantation.
Data from the study show that a gene expression pattern in heart transplant patients, initially validated to detect the absence of ongoing acute cellular rejection, can actually anticipate acute cellular rejection.
Biopsies are the current standard for monitoring transplant recipients, but the procedure has several limitations. With nearly 5,000 cardiac transplants performed worldwide each year, it is believed that new monitoring methods will alleviate the need for tens of thousands of biopsies and the patient discomfort that accompanies the procedure. Biopsies are invasive and expensive procedures, which only detect organ rejection in patients after damage to the heart tissue has occurred. Both from a clinical perspective and addressing patient quality-of-life, these limitations emphasize the need for improved monitoring and diagnostic tools for heart transplant recipients.
The prospective study examined the messenger RNA gene expression patterns of 104 heart transplant recipients at least one-month post transplant who showed no signs of current rejection on biopsy. The primary end point was the ability of the molecular gene expression pattern to predict the development of moderate to severe cellular rejection within 12 weeks of follow-up. Of the sample, 39 patients developed acute cellular rejection within 12 weeks, and on average, higher gene test scores were noted for those future rejectors compared to those who remained rejection-free, demonstrating the predictive power of the test.
Importantly, the genes actively predictive of rejection were those that are modified by corticosteroids, a backbone of immunosuppressive drug therapy in transplantation. Similarly, following treatment of rejection, the gene expression patterns showed improvement toward the baseline. These findings were examined further in a series of 192 representative patients and demonstrated a negative predictive value of 98.9 percent for a gene expression pattern score that indicated quiescence.
These findings could allow for better refinement in immunosuppressive therapy management thereby decreasing the rates of biopsy and might improve rejection-related outcomes.
This study was sponsored by XDx whose laboratory provides the gene expression testing service, the AlloMap(TM) test, used in this investigation. The AlloMap test was developed utilizing samples and clinical data from the Cardiac Allograft Rejection Gene expression Observational study. The CARGO study was conducted by XDx in collaboration with leading heart transplant centers including: University of Maryland, Ochsner Clinic, University of California at Los Angeles, Columbia University, Drexel University, Temple University, Cleveland Clinic, Stanford University, University of Pittsburgh and University of Florida.
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 maintains two vital databases. The International Heart and Lung Transplant Registry is a one-of-a-kind registry that has been collecting data since 1983 from 223 hospitals from 18 countries. The ISHLT Mechanical Circulatory Device (MCSD) database has been collecting data since 2002 with the aim of identifying patient populations who may benefit from MCSD implantation; generating predictive models for outcomes; and assessing the mechanical and biological reliability of current and future devices. For more information, visit http://www.ishlt.org .
Contact: Melissa Aguillon
Phone: (210) 745-2611
E-mail: maguillon@masonpr.com
International Society for Heart and Lung TransplantationCONTACT: Melissa Aguillon, +1-210-745-2611, or maguillon@masonpr.com , forInternational Society for Heart and Lung Transplantation
Web site: http://www.ishlt.org/
