ALLOMAP® Protocol Post Heart Transplant Purpose for ALLOMAP testing ALLOMAP molecular expression testing is a blood test that measures specific gene expression patterns to help define and identify immune activity in the early rejection process in cardiac allograft recipients. ALLOMAP can also reduce the number of invasive biopsies in selected patients who meet the indications for ALLOMAP testing as identified below. Plan/Management Educate patient about the purpose of Allomap testing Explain scoring result and what it means Follow Allomap protocol based on score for further testing or treatment needs Indications for Use of Allomap 1. Patient is clinically stable a. b. c. d. e. Pt does not show signs/symptoms of cardiac allograft dysfunction LV EF > 40% Cardiac Index > 2L/min No history of grade 3A/2R rejection with in preceding 6 months No history of antibody mediated rejection with in preceding 6 months 2. Patient must be 15 years or older 3. Patient cannot be pregnant Early Testing Guidelines For those patient who have vascular access issues or are on chronic anti-coagulants requiring discontinuation of agents and/or bridging with Lovenox for catherization procedures will be given consideration for Allomap testing at 24 weeks if Prednisone dosage is <20mg per day. Other early Allomap testing reasons will be given consideration on an individual patient case basis. Contraindications for Allomap Testing 1. Prednisone or equivalent dosage > 20mg in the past 30 days 2. < 21 days post graft dysfunction 3. Significant change in immunosupression (> 25% increase or reduction of standard dose) 4. Patient has had change in immunosuppressive agent in last 12 months 5. Patient has had blood transfusion in last 30 days 6. Patient is/has taken Neupogen/ Leukine/ Procrit in past 30 days Physician Consult Always consult transplant physician regarding result and further treatment plan ALLOMAP Threshold Scores 6 months to 12 months 30 12 months- beyond 34 BIOPSY and ALLOMAP Testing For Cardiac Allograft Recipient Biopsy/Allomap Schedule for First Year of Transplant for those patients who qualify for early testing (55 days to 2 years) Week 1- RHC/bx Week 2- RHC/bx with clinic Week 3 Week 4-RHC/bx with clinic Week 5 Week 6-RHC/bx with clinic Week 7 Week 8-RHC/bx, baseline Allomap with clinic (if Prednisone dosage is 20mg once day or less) Week 12-RHC/bx with clinic Week 16-RHC/bx with clinic Week 20-RHC/bx with clinic Week 24-Allomap/ECHO with clinic Week 28-RHC/bx with clinic Week 32-Allomap/ECHO with clinic Week 36-RHC/bx with clinic Week 40-Allomap/ECHO with clinic Week 44-RHC/bx with clinic Week 48-Allomap/ECHO with clinic ** At any time if Allomap score is above threshold (30 month 6-12 and 34 month 12+) within the first year a biopsy will be performed. Biopsies will also be performed on any patients with a decline in ECHO function, symptoms of heart failure/cardiac dysfunction/rejection. At 12 months (week 52): beginning of year 2 Annual studies to include ECHO, LHC/RHC/bx and Allomap with clinic visit Month 3- Allomap/ECHO with clinic Month 6- RHC/bx with clinic Month 9- Allomap/ECHO with clinic At 24 months: beginning of year 3 Annual studies: Adenosine SPECT stress perfusion scan, Cardiac stress MRI, or Dobutamine stress ECHO based on the needs of the patient/ RHC/ bx Month 4- ECHO/Allomap with clinic Month 6- RHC/bx with clinic Month 8- ECHO/ Allomap with clinic At 36 months and beyond Annual studies: LHC/RHC/bx and/or Allomap alternating yearly with Adenosine SPECT stress perfusion scan, Cardiac stress MRI, or Dobutamine stress ECHO/ Allomap as indicated by individual patients needs Month 6-Allomap/ECHO ** At anytime the patient has a score above threshold of 35 with drop in EF on ECHO or exhibits symptoms of cardiac dysfunction, heart failure, or shows other signs of allograft rejection a biopsy will be done. For those patients who have started Allomap testing in later periods (3-5 years post transplant): Baseline Allomap/ECHO with clinic then Allomap testing every 4 months for 3 tests then every six months. References Yamani MH, Taylor DO, Haire C, Smedira N, Starling RC. Post-transplant ischemic injury is associated with up-regulated AlloMap gene expression. Clinical Transplant. 2007 Jul-Aug; 21(4):523-5. Yamani MH, Taylor DO, Rodreguiez ER, Cook DJ, Zhou L, Smedira N, Starling RC. Transplant Vasculopathy is associated with increased AlloMap gene expression score. Journal of Heart Lung Transplant. 2007 April;26(4):403-6.