Abstract
Background: Gene Expression Profiling (GEP) has been used since 2005 to identify Orthotopic Heart Transplant (OHT) recipients at low risk of allograft rejection. A rise in GEP scores during the first year post OHT has been previously reported. The purpose of this study is to confirm and better characterize this effect of time post-transplant in a larger, unselected cohort. Methods: All commercially obtained GEP scores (XDx Inc., Brisbane, CA) collected between January 2005 and September 2011 were included. Clinical data were available for patient age, gender and dates of transplantation and tests. Results: There were 32,043 GEP tests from 9,272 patients at 108 transplant centers (mean age at testing 54.2 ± 14.7 yrs, 25% women). There was a significant effect of time post transplant on GEP, which rose from 24.7 ± 7.8 at 2-6 months to 28.8 ± 5.8 at 7-12 months (p<0.0001) and 29.6 ± 5.0 (p<0.0001) at 13-24 months, after which it remained stable. Conclusions: A rise in GEP scores is seen during the first year following OHT, which parallels the time frame of decreased corticosteroid dosing. Further study of this test characteristic may better inform clinical use of GEP testing in conjunction with endomyocardial biopsy.
Highlights
Allograft rejection is most frequently encountered during the first year after Orthotopic Heart Transplantation (OHT) and is one of the most common causes of early mortality
Gene Expression Profiling (GEP) testing is used clinically to aid in the identification of OHT recipients with stable allograft function who have a low probability of moderate to severe acute cellular rejection
In this retrospective analysis of 32,043 commercially obtained GEP tests, 25% were obtained in women, fifty-one percent of tests were obtained between 6 months and 5 years post OHT consistent with the time period evaluated in the IMAGE study, and almost 30% were in the first year following OHT, the time of greatest risk for rejection
Summary
Allograft rejection is most frequently encountered during the first year after Orthotopic Heart Transplantation (OHT) and is one of the most common causes of early mortality. GEP testing is used clinically to aid in the identification of OHT recipients with stable allograft function who have a low probability of moderate to severe acute cellular rejection. This test has been commercially available since January 2005 and is cleared by the Federal Drug Administration for use in patients age 15 and older at least 55 days post OHT. Gene Expression Profiling (GEP) has been used since 2005 to identify Orthotopic Heart Transplant (OHT) recipients at low risk of allograft rejection. The purpose of this study is to confirm and better characterize this effect of time post transplant in a larger, unselected cohort
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