In what could be a major shift in the management of heart-transplant patients, a Stanford study published online in the New England Journal of Medicine today shows that doctors can safely use a blood test to cut back on routine biopsies.
Most transplant patients face a lifetime of heart biopsies, which involve snipping out tiny pieces of heart to check for possible organ rejection. If the procedure shows a heart is being rejected, doctors can adjust levels of immunosuppressive drugs, often saving lives. While the risk of complications from biopsies is low, it can be serious and the procedure can be uncomfortable and frightening for patients. (Senior author Hannah Valantine, MD, recently told me her patients hate it and are “anxious for weeks before.”)
The blood test, which was cleared by the FDA in 2008, uses genomics technology to present a snapshot of the immune status of the transplanted heart. If the patient is at low risk of heart rejection, he can skip the biopsy.
The Stanford study compared the blood test and biopsy and found:
Patients monitored with the non-invasive blood tests, as compared with those who underwent routine biopsies, had similar two-year rates of rejection, graft dysfunction, death or re-transplantation (14.5 percent vs. 15.3 percent). The number of biopsies needed in the blood test group was reduced by 73 percent, and a patient satisfaction survey showed that patients preferred the blood test approach to the biopsy.