New Blood Test May be as Effective as Biopsy for Detecting Signs of Organ Rejection
Results of the Invasive Monitoring Attenuation through Gene Expression (IMAGE) study show that a noninvasive blood test is as effective as biopsy for monitoring stable post-transplant patients
Within 10 days of receiving the news from her cardiologist that she needed a heart transplant, Annette Giarrente, a patient at Northwestern’s Bluhm Cardiovascular Institute, was wait-listed among top-priority patients, matched with a donor heart and implanted with her new heart. The then 54-year-old said she had literally days to absorb the idea of needing a heart transplant before getting the good news that she would soon receive her new heart.
“Everything happened so fast,” said Giarrente, now 57. She suffered from Cardiac Sarcoidosis, a little-known disease that causes granular clumps of cells similar to scar tissue to proliferate. “I had to quickly transition from the shock of hearing I needed a heart transplant to doing whatever I needed to do to survive and keep my new heart healthy.”
Keeping transplant patients healthy is also top priority for their physicians. Now techniques for monitoring the progression of post transplant patients may be made easier as indicated by the results of a new study know as the Invasive Monitoring Attenuation through Gene Expression (IMAGE) study—published online today in the New England Journal of Medicine. Results show that the noninvasive gene expression blood test called AlloMap® is as effective as biopsy for monitoring stable post-transplant patients. The news was also presented today at the International Society for Heart & Lung Transplantation (ISHLT) annual meeting in Chicago.
“This innovative test can help physicians identify which patients are at a low risk of rejection and can be managed without a surveillance biopsy,” said William Cotts, MD, medical director of Heart Transplantation and Mechanical Assistance at the Bluhm Cardiovascular Institute and site principal investigator for the study at Northwestern Memorial. The hospital was one of 12 centers that participated in the study. ‘This is the first evidence-based clinical confirmation that the blood test outcomes are comparable to biopsy outcomes.” Cotts is also Associate Professor of Medicine at Northwestern University Feinberg School of Medicine.
Each year in the United States, about 2,200 individuals receive heart transplants. Advances in immunosuppression have improved one-year survival rates to nearly 90 percent following cardiac transplantation, but the risk of rejection persists for several years post-transplantation. The primary method of monitoring a heart transplant recipient for rejection is to have a biopsy of the heart tissue which is performed by a catheter procedure. Recipients may have between 12 and 15 biopsies in the first year after transplant, and the procedure is associated with discomfort, inconvenience and some risks. In addition each biopsy may cost approximately $4,000 or more.
“The study results signal a significant improvement in post-transplant care for these patients,” said Edwin McGee Jr., MD, cardiothoracic surgeon, surgical director of Heart Transplantation and Mechanical Assistance at the Bluhm Cardiovascular Institute and Assistant Professor of Surgery at the Feinberg School of Medicine. ‘We pride ourselves on having the latest in clinical trials, assist devices and surgical techniques to offer our patients.” For the past two years Northwestern Memorial’s heart transplant program achieved the largest volumes and top-rated outcomes in Illinois—a ranking that places the program among the top 20 heart transplant programs nationally.
For Northwestern Memorial heart transplant recipient Stan Larson, the most important thing after receiving a new heart in March of 2008 was to keep himself healthy. “I went through biopsies because that’s what I needed to do to make sure my body wasn’t rejecting the organ,” said Larson. “But certainly having the option to undergo a simple blood test is much better than going through an invasive procedure.” Larson is entering his second year as a participant in the IMAGE study.
The IMAGE study was a multi-center trial involving 602 patients. Study results were presented during a plenary session at the International Society for Heart & Lung Transplantation (ISHLT) 30th Anniversary Meeting & Scientific Sessions in Chicago and coincide with publication in the New England Journal of Medicine. The Journal is publishing the study today online as an “early release” to coincide with the data presentation at ISHLT and will follow with publication in the June 17, 2010 print edition.
For more information about the Bluhm Cardiovascular Institute, please visit www.nmh.org/heart.