Andrew Marsh, age 72 of Tinton Falls, NJ, is among 602 heart transplant recipients who took part in an important clinical research trial aimed at eliminating the pain and risk of complications associated with the invasive testing necessary to detect and prevent organ rejection.
Newark Beth Israel Medical Center's Heart Failure Treatment and Transplant Program is one of only 12 centers in the nation and the only program in New Jersey invited to participate in the Invasive Monitoring Attenuation through Gene Expression (IMAGE) trial. Results of the study were presented at the April 22 annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) in Chicago. The breakthrough study will also be published in the May 20 edition of the New England Journal of Medicine. The Journal published the study online as an "early release" to coincide with the data presentation at the ISHLT.
The IMAGE trial tested the effectiveness of a noninvasive gene expression test that is performed on a blood sample to detect the first signs of organ rejection. Traditionally, cardiologists perform a minimally invasive cardiac catheterization procedure and take several small tissue samples from the heart which are examined for possible rejection.
"Aside from being an uncomfortable procedure, the biopsy has its limitations," said David Baran, MD, Director of Heart Failure and Transplant Research at Newark Beth Israel Medical Center, an affiliate of the Saint Barnabas Health Care System. "We take tissue samples from three to four locations in the heart and there is always the chance that we can miss an area affected by rejection." Threading the catheter through one or more of the heart valves as necessary can also cause damage to the heart, he noted.
"It is the first time in four decades of performing heart transplants that doctors have had an alternative technique for accurately assessing immunosuppression and predicting rejection," added Dr. Baran. "This blood test has been validated by a well designed scientific study."
Like others in the research study, Mr. Marsh underwent biopsies during the first year after his heart transplant in 2007 and was then able to join the clinical study. "The biopsies were uncomfortable and inconvenient because I had to stay in bed for several hours to prevent bleeding after each catheterization," recalled Mr. Marsh. "It is certainly a lot easier to give blood. I have a lot of confidence in Dr. Baran so I was confident in a clinical study he offered."
The AlloMap Molecular Expression Testing, as the blood test is known, was cleared by the Food and Drug Administration in 2008 and this is the first clinical trial measuring patient outcomes. For more information about Newark Beth Israel Medical Center's Heart Failure Treatment and Transplant Program, please call 973-926-7205 or log on to www.saintbaranbas.com/heartcenters