ALLOMAP® Protocol

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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.
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