Clinical Use of Gene-Expression Profiling to Monitor for Rejection After Cardiac Transplantation

Clinical Use of Gene-Expression Profiling to Monitor for Rejection After Cardiac Transplantation – Which Patients and When?

J. Teuteberg,¹ M. Shullo,¹ T. Wolf,² P. Prasad,² G. Ewald.³

¹University of Pittsburgh Medical Center, Pittsburgh, PA
²CareDx, Inc., Brisbane, CA
³Washington University, St. Louis, MO.

Meeting: 2015 American Transplant Congress

Abstract number: D249

Keywords: Genomic markers, Heart transplant patients

Session Information

Session Name: Poster Session D: "The Tell-Tale Heart": Allograft Rejection and Post-Transplant Monitoring

Session Type: Poster Session

Date: Tuesday, May 5, 2015

Session Time: 5:30pm-6:30pm

Presentation Time: 5:30pm-6:30pm

Location: Exhibit Hall E

Background: Gene-expression profiling (GEP), in place of endomyocardial biopsy, is increasing. GEP testing is intended for low-risk asymptomatic patients (pts); thus, the profile of pts offered testing, in the clinical setting, has not been fully characterized.

Methods: An ongoing, prospective, observational registry, the Outcomes AlloMap® Registry (OAR), includes heart transplant recipients, at 11 centers, receiving GEP testing during routine post-transplant surveillance. This registry database was queried for baseline clinical risk factors, interval clinical status, medications, diagnostic test results and graft function from 4/2013 to 10/2014. The GEP surveillance schedule was planned for 4.6 tests/pt in year 1, 3.2 tests/pt in year 2, 3.6 tests/pt in years 3 to 5.

Results: In 237 pts (651 visits), baseline recipient demographics were: mean age 56y (range 21-88), male (70%), Caucasian (72%), ischemic myopathy (41%), mechanical circulatory support (56%), CMV mismatch (D+/R-) (18%) and PRA >10% (11%). The mean ejection fraction was 60.1%, (SD 6.5). Baseline calcineurin inhibitor was tacrolimus (92%), cyclosporine (8%), and sirolimus (7%). 83% of pts received mycophenolate mofetil; 60% of pts received maintenance steroids. Mean overall steroid dose for pts was 5.9 mg/d (months 2-6), 4.4 mg/d (months 6-12), and 4.3 mg/d beyond month 12. 6, of 11 centers, included some surveillance biopsies coincident with GEP. The first GEP test occurred at months 2-6 (35%), months 6-12 (34%), and beyond month 12 (28%). Of 307 biopsies, 8 (3%) showed acute cellular rejection grade ≥2R. Two, of the 8 biopsies, occurred at months 2-3, and 6 biopsies occurred at months 6-12. 13 cases of antibody-mediated rejection (AMR 1, n=12; AMR 2, n=1) were reported. Interval hospitalizations were reported in 7% of the visits due to: infections (43%), surgical procedures (21%), or other miscellaneous reasons (36%); 12 (5%) new cases of CMV infection were observed.

Conclusion: Patients' baseline demographics and immunosuppressive regimen, in the OAR registry, were similar to those occurring in the overall transplant patient population; the vast majority of pts had normal graft function, and was on steroid dosage <10mg/d. Over one third of GEP testing occurred before month 6. Rate of biopsy-proven rejection was low.

To cite this abstract in AMA style:

Teuteberg J, Shullo M, Wolf T, Prasad P, Ewald G. Clinical Use of Gene-Expression Profiling to Monitor for Rejection After Cardiac Transplantation – Which Patients and When? [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/clinical-use-of-gene-expression-profiling-to-monitor-for-rejection-after-cardiac-transplantation-which-patients-and-when/. Accessed November 24, 2024.

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