NEWARK — David A. Baran, MD, Director of Heart Failure and Transplant Research at Newark Beth Israel Medical Center, presented results of his latest research at the International Society of Heart and Lung Transplant (ISHLT) annual meeting last month. During the three-day meeting he was also elected Chair of ISHLT’s Scientific Council on Heart Failure and Transplant Medicine.
Transplant physicians from around the world were interested in Dr. Baran’s five-year data resulting from a unique clinical trial being conducted only at Newark Beth Israel Medical Center that allows patients to maintain a transplanted heart with only one immunosuppressive medication and no steroid. Heart transplant recipients at other centers take a three-medication combination that includes a steroid.
Steroid medications have been the mainstay of immunosuppression since organ transplant began in the 1950s. Unfortunately, steroids are fraught with many serious and unpleasant side effects. Even at a minimum dose, many patients suffer the consequences of steroids which can include weight gain (20-50 lbs in a year), change of overall appearance, mood swings, depression, acne and hair growth, as well as the development of diabetes, osteoporosis and cataracts. Patients on steroids are also at risk for developing high blood pressure and high cholesterol.
Results of Dr. Baran’s successful protocol have been presented at several international meetings and will be published later this year.
Dr. Baran is also one of the authors of the Invasive Monitoring Attenuation through Gene Expression (IMAGE) trial that was presented at the same meeting and published in the May 20 edition of the New England Journal of Medicine. 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, a biopsy has limitations. Tissue samples are taken from three to four locations in the heart and there is always the chance that an area affected by rejection can be missed. Also, threading the catheter through one or more of the heart valves, as is necessary with catheterization, can cause damage to the heart. 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. It is the first time in four decades of performing heart transplants that doctors have an alternative technique for accurately assessing immunosuppression and predicting rejection.
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