April 22nd, 2010
Endomyocardial Biopsy versus Gene-Expression Profiling
Larry Husten, PHD
Endomyocardial Biopsy versus Gene-Expression Profiling: It may be possible to replace routine endomyocardial biopsy with gene-expression profiling in some cardiac-transplant patients, according to a new study presented at the annual meeting of the International Society for Heart and Lung Transplantation and published online in the New England Journal of Medicine. The IMAGE Study Group randomized 602 transplant patients at low risk for rejection and found no significant differences at one year in the primary composite outcome (rejection with hemodynamic compromise, graft dysfunction due to other causes, death, or retransplantation) or at two years in the rate of death.
In an accompany editorial, John Jarcho writes that the trial’s clinical significance is somewhat limited, due to the low-risk patient population and the wide confidence intervals used in the trial. Jarcho notes that the benefits of routine biopsies have never been demonstrated, and asks whether “it is time to perform a randomized trial that compares a strategy of continuing endomyocardial biopsies indefinitely with that of discontinuing routine endomyocardial biopsies at some specified interval.”
In an article in the New York Times by Andrew Pollack, study leader Michael Pham is quoted as saying the trial “will cause a paradigm shift in the way we look at monitoring for rejection.” The Times story points out that a biopsy costs $4,000 to $5,000 and the new test costs $3,000. Both tests may be frequently repeated.

wow
$3000 for this test… that is incredible. I just wonder how they price it — did they look at biopsy and figure they should beat it by 25%?