Purpose: Gene expression profiling (GEP) offers a non-invasive alternative to surveillance with endomyocardial biopsies. We sought to assess the medium-term survival and graft function in patients managed with and without GEP in general clinical use compared to low-risk controls.

Methods: All patients with CTX at a single institution from 1/02 until 9/11. GEP was typically started after one year, all patients who had at least one GEP test were included in the GEP group. The control group consisted of low-risk patients who survived at least one year post-transplant and had no significant rejection in the first year. Controls were transplanted before GEP was available, declined GEP use or were not considered for testing.

Results: A total of 283 patients were included, 151 in the GEP group and 132 controls. Baseline characteristics were not different between groups: mean age 55 years, 77% male, 89% white, 55% ischemic, VAD 25%, CMV mismatch 23%, 18% with PRA > 20. Donor characteristics were not different: mean age 35 years, 77% white and ischemic time 190 minutes. The control group had fewer male donors 60% v. 72%, p=0.025, Induction use was more common in controls 77% (80% alemtuzumab) v. GEP 66% (73% alemtuzumab), p=0.044. Maintenance was not different for groups: 99% TAC, 99%MMF. The median time to first GEP was 496 days (range 143 to 1440), with a median number of GEP assessments of 3 (range 1-9). The 5 year survival was significantly higher for GEP group, 90% v. 78%, p=0.01. The 5 year freedom from EF < 50% was also significantly better in the GEP group, 92% v. 80%, p=0.01. Only one patient in each group died of graft failure after one year.

Conclusions: Medium-term survival and graft function were better in patients who had GEP for rejection surveillance than low-risk controls who had at least one year of rejection-free survival.

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