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Gene Expression Profiling for Cardiac Transplant Recipients: Results from the Outcomes AlloMap® Registry

S. Hall1, G. Ewald2, P. Berman3, A. Kao4, T. Wolf-Doty5, J. Yee5, J. Kobashigawa6

1Baylor University Medical Center, Dallas, TX, 2Washington University, St. Louis, MO, 3Tampa General Hospital, Tampa, FL, 4Saint Luke's Mid America Heart Institute, Kansas City, MO, 5CareDx, Brisbane, CA, 6Cedars-Sinai Medical Center, Los Angeles, CA

Meeting: 2019 American Transplant Congress

Abstract number: B112

Keywords: Antibodies, Gene expression, Heart/lung transplantation, Risk factors

Session Information

Session Name: Poster Session B: Heart and VADs: All Topics

Session Type: Poster Session

Date: Sunday, June 2, 2019

Session Time: 6:00pm-7:00pm

 Presentation Time: 6:00pm-7:00pm

Location: Hall C & D

*Purpose: Transplant registries may facilitate collection of comprehensive and unbiased real-world data on short and long-term outcomes of patients. We share the results of patients managed with gene expression profiling (GEP) using the Outcomes AlloMap® Registry (OAR).

*Methods: This ongoing, prospective, observational registry study includes heart transplant recipients who received GEP testing as part of standard rejection surveillance. Baseline clinical risk factors, clinical status, medications, diagnostic test results and graft function were collected from 4/2013 to 9/2018 in 36 centers.

*Results: In 2190 patients (pts) with 13469 visits, baseline recipient demographics are Table 1. The first GEP test occurred in months post-transplant (m) ≥2-6 for 69%, m ≥6-12 for 17% and m ≥12 for 14%. The mean GEP score was 27 in m ≥2-6, 30 in m ≥6-12 and 31 in m ≥12. 707 pts (32%) discontinued steroids in the study with 12% in m ≥2-6, 58% in m ≥6-12, 30% in m ≥12. Of 5185 biopsies, 98 (2%) showed acute cellular rejection grade ≥2R; 34 (35%) occurred in m ≥2-6, 32 (33%) in m ≥6-12, 18 (18%) in m ≥12-36 and 3 (3%) in m ≥36. 139 cases of antibody mediated rejection (AMR); AMR 1 in 114 pts, AMR 2 in 24 pts, AMR 3 in 1 pt were reported. Interval hospitalizations reported in 9% of the visits (infections 23%, rejection 7%, non-transplant related cause 53%). There were 131 patients with episodes of cancer diagnosis (50% skin cancers, 12% lymphoma, 8% solid organ tumor) and 296 (3%) cases of new CMV infection. 198 pts reported cardiac allograft vasculopathy. 578 unique patients had ≥2 AlloMap Variability scores (AMV) with 22% of scores <0.5, 58% of scores 0.5-1.4 and 20% of scores >1.4 (calculated using 4 GEP scores occurring ≥315 days post-transplant, all scores within an 85-780 day time period).

*Conclusions: This report from OAR demonstrates that most patients begin surveillance with GEP in the first-year post-transplant. Cancer and infections tend to be more prevalent than acute rejection. AMV provides assessment of future events that may lend to optimization of patient management.

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To cite this abstract in AMA style:

Hall S, Ewald G, Berman P, Kao A, Wolf-Doty T, Yee J, Kobashigawa J. Gene Expression Profiling for Cardiac Transplant Recipients: Results from the Outcomes AlloMap® Registry [abstract]. Am J Transplant. 2019; 19 (suppl 3). https://atcmeetingabstracts.com/abstract/gene-expression-profiling-for-cardiac-transplant-recipients-results-from-the-outcomes-allomap-registry/. Accessed May 8, 2025.

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