International Society for Heart and Lung Transplantation Release: Blood Test May Reduce Need For Biopsies and Immunosuppressive Therapy For Heart Transplant Patients

SAN FRANCISCO, April 26 /PRNewswire/ -- According to data presented today, non-invasive gene-based blood testing may help to reduce the need for biopsies and optimize the use of immunosuppressive therapy. Studies related to molecular expression testing will be presented today at the 27th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) at the Hilton San Francisco.

In today’s Concurrent Session 8 Find and Fight Rejection, researchers are presenting data demonstrating molecular testing may be helpful for reducing immunosuppression without the need for invasive biopsies, and, additional data suggesting gene analysis may allow for prediction of future occurrence of cardiac allograft rejection.

These studies suggest that molecular expression testing, currently used to detect the absence of moderate to severe rejection, may also help doctors optimize treatment regimens to meet the specific needs of individual heart transplant patients. Molecular testing works by distinguishing patterns of genes in circulating white blood cells (leukocytes), which are expressed differentially during rejection of foreign tissue compared to states of quiescence (or non-rejection).

“These data point to the potential clinical utility of molecular expression testing in monitoring rejection based on gene-expression profiling,” said Mario C. Deng, M.D., Director of Cardiac Transplantation Research, Columbia University Medical Center/New York Presbyterian Hospital, and Co-principal investigator in the Cardiac Allograft Gene Expression Observational (CARGO) study. “The fact that we can accomplish this non-invasively, without requiring a routine biopsy, is likely to impact the care and quality of life of many patients who have undergone solid heart transplantation.”

Until recently, heart muscle biopsy was the only method available to rule out heart transplant rejection and guide treatment with anti-rejection, or immunosuppressive, therapy. Aside from the invasive and painful nature of the procedure, a biopsy is only able to detect rejection after damage has already occurred to the heart tissue. Doctors initially perform biopsies weekly following heart transplantation, then every one to two months until the end of the first year. Depending on the heart transplant center’s protocol, biopsies may be performed every three to six months throughout a patient’s lifetime.

Alternatively, non-invasive molecular testing uses a routine blood sample, analyzes gene expression in white blood cells, and provides information on the functional status of the transplanted heart before tissue damage occurs.

Testing May Prove Useful in Weaning Patients from Immunosuppressants

Separately, two studies presented at the ISHLT meeting by Daniel Bernstein, M.D., Stanford University School of Medicine, Palo Alto, CA, (Abstract 170) and Robert Scott, M.D., Mayo Clinic Hospital, Scottsdale, AZ, (Abstract 250), demonstrate that the use of non-invasive molecular expression testing may be used to safely reduce the use of immunosuppressants, while decreasing the frequency of invasive biopsy and preventing organ rejection.

“The data in these studies show that molecular blood testing may help identify those patients in which it may be appropriate to decrease immunosuppressant therapy,” said Howard Eisen, M.D., head of the Division of Cardiology at the Drexel University College of Medicine and Hahnemann University Hospital (Philadelphia, PA) and a principal investigator. “While most heart patients will require a lifelong regimen of immunosuppressants, being able to better identify rejection will allow us to optimize treatment.”

ISHLT Meeting Highlights

Other studies to be presented at ISHLT on gene expression testing in heart transplantation include a study presented by Mandeep R. Mehra, M.D., Head of the Division of Cardiology at the University of Maryland, School of Medicine, Baltimore, MD, that shows induction therapy does not alter the results of gene expression testing in predicting cardiac allograft rejection. Induction therapy with immunosuppressants is used before and after heart transplant surgery to suppress the body’s immune system and prevent organ rejection. Dr. Mehra will also present a study showing that monitoring corticosteroid-regulated and alloimmune and inflammatory pathway genes may allow prediction of cardiac allograft rejection weeks to months prior to the crisis episode (Abstracts 131, 250).

Studies were sponsored by XDx, whose laboratory provides the AlloMap(R) molecular expression testing used in this investigation.

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 manages two vital databases. The International Heart and Lung 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. In Fall 2006, ISHLT released the first international guidelines for heart failure patient management. For more information, visits http://www.ishlt.org.

Contact: Lauren Mason

(210) 857-2521 lmason@masonpr.com

International Society for Heart and Lung Transplantation

CONTACT: Lauren Mason, +1-210-857-2521, lmason@masonpr.com, forInternational Society for Heart and Lung Transplantation

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