April 23, 2010

Blood Test Meant To Analyze Genetic Activity Could Replace Biopsies After Heart Transplantation

BY Dr. Keith J. Kaplan

The New York Times (4/23, B5, Pollack) reports that "a blood test that analyzes genetic activity could let heart transplant patients avoid many of the invasive and uncomfortable biopsies now used to monitor whether their immune systems are rejecting their new organs," according to a study scheduled to be presented at the International Society for Heart and Lung Transplantation meeting and published online by the New England Journal of Medicine. The research "involved 602 patients at 13 American transplant centers who had received a transplant from six months to five years earlier." Half of the participants "were given periodic biopsies and the others the blood test," called AlloMap, "at the same frequency." 

The Wall Street Journal (4/23, Winslow) reports that just under 15% of patients who were given the test died or experienced complications during the follow-up period, compared to just over 15% of patients who were given biopsies.

The Los Angeles Times (4/22, Maugh) "Booster Shots" blog reported that "the primary limitations of the study were that it did not include patients in the first months immediately after their surgery and that it probably did not include patients who were at high risk of rejection, the authors said."

The Time (4/22, O'Callaghan) "Wellness" blog reported that AlloMap "was approved by the US Food and Drug Administration in September 2008 and assesses rejection risk by examining gene expression in patients' white blood cells." 

Reuters (4/23, Steenhuysen) quotes one of the researchers as saying, "This represents a major step forward in the way we manage a patient after heart transplants because we can now safely reduce the numbers of heart biopsies." 

MedPage Today (4/22, Phend) reported, "Rather than suggesting that the assay should become the standard, the real implication is the evidence the study offers questioning whether any routine screening is needed over the longer term after transplantation, [John A. Jarcho, MD, of Brigham and Women's Hospital] said" in an accompanying editorial. HeartWire (4/22, Stiles) and MedWire (4/22, Price) also covered the story.

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