An audit of CMV disease in renal transplant recipients transplanted at the Queen Elizabeth Hospital...
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Transcript of An audit of CMV disease in renal transplant recipients transplanted at the Queen Elizabeth Hospital...
An audit of CMV disease in renal transplant recipients transplanted at the Queen Elizabeth Hospital Birmingham
Gemma Banham, Shazia Shabir, Richard Borrows
Cytomegalovirus infection
• Direct effects– Viral syndrome– Tissue invasive disease
• Indirect effects– Acute and chronic rejection– Post transplantation diabetes– Opportunistic infections
IMPACT Trial
Humar A et al. American Journal of Transplantation 2010; 10: 1228–1237Humar A et al, Transplantation 2010; 90: 1427–1431
RCT of oral prophylactic ganciclovir vs intravenous pre-emptive therapy
FULL ITT population D+/R- D+/R+ D-/R+
Kliem V et al, American Journal of Transplantation 2008; 8: 975–983
British Transplantation Society Guidelines (2011)
• CMV prophylaxis to seronegative recipients who receive a transplant from a seropositive donor (D+/R-)
• CMV prophylaxis where either the donor or recipient is seropositive if patient is treated with T-cell depleting antibodies
• Choice of prophylaxis strategies
• Audit standards1. Rate of CMV disease in 1st year in D+/R- patients <8%2. Rate of CMV disease in 1st year in D+/R+ patients <8%3. Rate of CMV disease in 1st year in D-/R+ patients <8%
Audit Methods• Patients transplanted at QEHB between 1st August 2007 and 30th June 2011• Patients identified from Surgery Department’s database • Total of 569 patients
CMV status (Donor/Recipient) Number (%)
D-/R- 150 (26.4)D-/R+ 121 (21.3)D+/R+ 178 (31.3)D+/R- 116 (20.4)
Unknown 4 (0.7)
• PICS microbiology tab for CMV PCR results• Electronic clinical notes for those with
CMV viraemia• Heartland’s Hospital Virology Department
results database • Stoke audit• NHS Blood and Transplant
Audit Questions?
1. Should we offer extended prophylaxis (200 days) to D+/R- recipients?
2. Should we offer prophylaxis to D+/R+ recipients?
3. Should we offer prophylaxis to D-/R+ recipients?
£1081.46 for 30 day supply of 900mg once daily dose
CMV Syndrome CMV Disease
Number at risk
0 100 200 300 365
150 137 127 119 111
121 104 96 94 89
116 109 86 75 67
178 128 115 107 105
Number at risk
0 100 200 300 365
150 140 130 121 113
121 110 104 102 97
116 110 98 91 85
178 154 143 136 133
Audit Standards
1. Rate of CMV disease in the first year post transplantation in D+/R- patients <8%
2. Rate of CMV disease in the first year post transplantation in D+/R+ patients <8%
3. Rate of CMV disease in the first year post transplantation in D-/R+ patients <8%
Early CMV in D+/R-
Creatinine clearance (ml/min)Cockcroft-Gault Formula
Recommended valganciclovir prophylaxis
>60 900mg once daily
40 - 59 450mg once daily
25 - 39 450mg alternate days
10 - 24 450mg twice weekly
<10 Not recommended
• 3/23 cases CMV syndrome during 1st 100 days• Subtherapeutic dose of valganciclovir in 2/3
Consequences of CMV Syndrome
Syndrome cases (%)D-/R-
3/150 (2.0)D-/R+
12/122 (9.9)D+/R+
39/178 (21.9)D+/R-
23/116 (19.8)Total
77/569 (13.5)Disease 1 (33.0) 2 (16.7) 5 (12.8) 4 (17.4) 12 (15.6)
Histology 0 (0.0) 2 (16.7) 2 (5.1) 1 (4.3) 5 (6.5)
Death during CMV episode 0 (0.0) 0 (0.0) 1 (2.6) 1 (4.3) 2 (2.6)
Viraemia level(median, range)
2.2x107, 1.6x106 - 3.1x107
1.1x104, 1025-1.9x105
1.3x104, 504- 1.7x108
3.1x105, 571- 7.7x106
2.2x104, 504- 1.7x108
Requiring treatment*- Total- Intravenous
3 (100.0)2 (66.7)
11 (91.7)2 (1.7)
37 (94.9) 12 (30.8)
21 (91.3)8 (34.8)
72 (93.5)24 (31.2)
Patients requiring CMV related hospitalisation - Total- QEHB- Stoke
3 (100.0)3 (100.0)
0 (0.0)
8 (66.7)8 (66.7)0 (0.0)
27 (69.2)23 (59.0)
4 (10.3)
17 (73.9)14 (60.9)
3 (13.0)
55 (71.4)48 (62.3)
7 (9.1)
Days in QEHB (median, range) 8, 6-10 21, 2-42 9, 2-48 10.5, 3-26 9, 2-48Total days in QEHB 24 175 343 168 710
*5 additional patients received treatment with no evidence of CMV Syndrome or Disease
Conclusions
• Meeting targets for CMV ‘Disease’• Large amounts CMV ‘Syndrome’ with significant
morbidity and cost• Highest burden in D+/R+, followed by D+/R- then D-/R+• Majority D+/R- disease is late• Early D+/R- disease may be due to inappropriate dosing
of valganciclovir
Acknowledgments
• Everyone at other transplant units • Kerry Tomlinson• Caroline Clark• Hari Krishnan• Husum Osman
Who should receive prophylaxis?
Number at risk
0 200 400 600 730
150 127 110 97 81
121 96 87 74 59
116 86 62 51 40
178 115 102 90 77