Molecular Testing to Monitor Heart Transplant Rejection

The results were presented at the annual meeting of the International Society for Heart and Lung Transplantation in San Francisco (ISHLT, CA, USA) in April 2004.

The trial was designed to evaluate the usefulness of a multi-gene molecular expression assay developed to identify the quiescent state after heart transplantation and determine the assay's ability to predict clinical outcomes. A major challenge facing doctors in managing transplant patients is finding the right balance of drug therapy, one that suppresses the patient's immune response enough to prevent rejection of the transplanted organ but not so much that the immune system no longer competently fights infection and cancer. When this balance is reached, the immune system is deemed "quiescent.”

Analysis of the eight-center trial showed that molecular testing using peripheral leukocyte gene expression was successful. For patients, the test could mean less discomfort during the constant monitoring for rejection and prolonged transplant success. The most common cause of death in the first year is acute cardiac rejection, when the patient's immune system attacks the heart as though it were a foreign object until it no longer functions properly. The current way of diagnosing acute rejection is a heart biopsy, which is invasive, uncomfortable and time consuming.

"This technology has many benefits,” said lead investigator Mandeep Mehra, M.D., FACC, a director of ISHLT and vice chairman, Ochsner Heart & Vascular Institute, New Orleans (LA, USA). "It can be used to identify patients' immunosuppresion regimens and provide a means to resolve uncertainties of a biopsy.”




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