Expanded Criteria Recipients: Are there any Limits

Transcription

1 Expanded Criteria Recipients: Are there any Limits Andreas Paul, MD, MSc, FRCS Department of General-, Visceral- and Transplant Surgery, University Hospital Essen

2 Ruhr Area inhabitants University Hospital Essen Bed facility In-patients Out-patients Core areas: - Transplantation - Oncology - Cardiovascular disease Folie Paul

3 Organ Donation in Germany ~ 30% of donors 65 years ~ 60 % ECD for kidneys No NHBD Folie Paul

4 Dialysis and kidney transplantation in Germany In 2009 ~ patients on dialysis ~ patients listed for transplantation ~ waiting time: 5 6 years ~ transplants (living donors 21%) < 3 % pre-emtive transplants < 1 % dual transplants 5 - year graft survival deceased transplants: 70% 5 year graft survival living related transplants : 84% Folie Paul

5 High Risk Recipient No difference in acceptance policy for living related and deceased donor renal transplantation in Germany Definition¹:..a potential recipient of a kidney transplant who is at a significant risk of death complications or graft failure because of pre-existing co-morbidity or immunological status (statistically: outside the 95% CI for graft and patient survival) No precise definition No robust clinical data ¹Guidelines for Living Donor Kidney Transplantation in High Risk Adult Recipients ww.bts.org.uk Folie Paul

6 High risk kidney transplant recipient Level of evidence III Folie Paul

7 High Risk Recipient : Acceptance criteria¹ Absence of contraindications Realistic expectation of the patient surviving with a functioning transplant for at least 2 years (5 years) Pre-exsisting conditions should not be exacerbated by transplantation Measures to minimise peri- and post-operative complications Transplant technically possible ¹ww.bts.org.uk Folie Paul

8 High Risk Recipient : Acceptance criteria¹ Absence of contraindications Realistic expectation of the patient surviving with a functioning transplant for at least 2 years (5 years) Pre-exsisting conditions should not be exacerbated by transplantation Measures to minimise peri- and post-operative complications Transplant technically possible Gain in life-expectancy and / or quality of life Folie Paul

9 High Risk Recipient : Contraindications¹ Active ischemic heart disease or severe cardiomyopathy Active infection Recent history of cancer or other than nonmelanoma skin cancer Liver cirrhosis or advanced fibrosis Active substance abuse Active psychosis Incorrigible non-compliance ¹Scandling J.D Folie Paul

10 High Risk Recipient : Acceptance criteria¹ Absence of contraindications Realistic expectation of the patient surviving with a functioning transplant for at least 2 years (5 years) Pre-exsisting conditions should not be exacerbated by transplantation Measures to minimise peri- and post-operative complications Transplant technically possible Folie Paul

11 High Risk Recipient : Assessment Medical assessment: Heart disease Vascular disease Infection Cancer Liver disease Obesity Diabetes mellitus Coagulopathy Age Psychosocial situation and support best clinical judgement Education and assessment of motivation, (second opinion)» Decision: transplant versus dialysis Folie Paul

12 High Risk Recipient : ESP (n=1406) vs ETKAS (n=2133) , multicenter, registry data 20% mortality after 2 years in ESP Frei U. et al., Am J Transplant:8, 50-57;2008 Folie Paul

13 High Risk Recipient : Acceptance criteria¹ Absence of contraindications Realistic expectation of the patient surviving with a functioning transplant for at least 2 years (5 years) Pre-exsisting conditions should not be exacerbated by transplantation Measures to minimise peri- and post-operative complications Transplant technically possible Folie Paul

14 High Risk Recipient : Assessment of Co-morbid conditions Score Codition 1 Myocardial Infarction Heart failure Peripheral vascular disease Cerebrovascular disease Dementia Chronic pulmonary disease Connective tissue disorder Peptic ulcer disease Mild liver disease Diabetes 2 Hemiplegia Moderate or severe renal disease Diabetes with end-organ damage Any tumor, leucemia, lymphoma 3 Moderate or severe liver disease 6 Metastatic solid tumor AIDS Charlson Co-morbidity Index Charlson M.E. et al. J Chronic Dis 40: modified by Wu C. et al. J Am Soc Nephrol 16: , 2005 Folie Paul

15 High Risk Recipient : Assessment of Co-morbid conditions n=715, single center retrospective study, CCI:Charlson Co-morbidity Index Wu C. et al. J Am Soc Nephrol 16: , 2005 Folie Paul

16 High Risk Recipient : Assessment of Co-morbid conditions n=715, single center retrospective study, CCI:Charlson Co-morbidity Index Wu C. et al. J Am Soc Nephrol 16: , 2005 Folie Paul

17 High Risk Recipient : University of Essen Results Retrospective Analysis , n=332 D+R Non marginal D non marginal +R marginal D marginal + R non marginal No. of patient D+R marginal P-value Recipient age 42 ± ± ± ± 5.1 <0.01 Recipient comorbidity Art. hypertension 14 (10%) 5 (12%) 9 (13%) 4(5%) 0.33 Arteriosclerotic disease 15 (11%) 19 (46%) 7 (10%) 26(31%) <0.01 Haert insufficiency 10 (7%) 4 (10%) 2 (3%) 8(10%) 0.39 Diabetes mellitus 11 (8%) 14 (34%) 3 (4%) 15 (18%) <0.01 Hypercholesterolemia 18 (13%) 8 (20%) 14 (20%) 33 (40%) <0.01 Chronic obstructive lung disease 8 (6%) 2 (5%) 2 (3%) 5 (6%) 0.81 Duration of dialysis 72 (42) 67 (36) 86 (55) 63 (35) 0.01 First transplantation 101 (73%) 34 (83%) 50 (73%) 66 (79%) 0.8 High risk recipients: Age >60 years or 50 years with at least 1 risk factors: Coronary heart disease, PAD grade Ila or higher and / or diabetes mellitus Folie Paul M. Heuer et al., J Med Res:14, 1-4; 2009

18 High Risk Recipient : University of Essen Results 1 year patient survival: High risk patients versus non high risk patients 93,6% versus 98,1%, p=0.07 Marginal Donor High risk Recipient HLA mismatches Duration of Dialysis egfr at 1 week egfr at 1 month egfr at 12 months < < Folie Paul

19 High Risk Recipient : University of Essen Results Kidney transplantation from donors > 75 years, , n=51 %(x100) 1,0 0,9 0,8 0,7 0,6 0,5 0,4 0,3 0,2 0,1 0, graft survival Folie Paul

20 High Risk Recipient : University of Essen Results Kidney transplantation from donors > 75 years, , n=51 Alive (n=37) Deseased (n=14) P-value Donor data Age Donor (years) 80 (75-86) 78.5 (75-83) ICU stay (days) 2 (1-13) 3 (1-14) S-Kreatinin (mg/dl) 0.9 (0,4-2,4) 1.1 ( ) GFR (ml/min/1,73²) 68.8 (19,3-207) 61.3 ( ) Recipient data: Age Recipient (years) (52-82) 66,7 (59-71) Waiting Time (years) 2,5 (0,2-2,7) 4,0 (1,2 8,7) BMI 26 (19-36) 26.5 (21-35) CIT (hr) 14,1 (5,1-25,7) 15 (7,8-30,0) Co-Morbidity Index > 5 n=10 (27%) n= 7 (50%) Re-Transplant n=1 n= Doubel Transplant =7 n= PNF n= 6 n= DGF n= 8 n= Clavian Classification IIIb and higher n=16 n= Hospital stay (days) 24 (10-43) 51.5 (10-74) Folie Paul

21 High Risk Recipient : Acceptance criteria¹ Absence of contraindications Realistic expectation of the patient surviving with a functioning transplant for at least 2 years (5 years) Pre-exsisting conditions should not be exacerbated by transplantation Measures to minimise peri- and post-operative complications Transplant technically possible Folie Paul

22 High Risk Recipent : Technical Complications ESP n(%) patients (n=73) ETKAS n(%) patients (n=51) P (incidensce) Incidence Revision Incidence Revision Arterial anastomosis 5 (7) All Secondary haemorrhage 8 (1) 3 (4) 2 (4) 1(2) Wound infection 1 (1) None 1 (2) None Wound seperation Subcutaneous 1 (1) None 1 (2) None Fascial 7 (10) All 5 (10) All Incisional hernia 2 (3) All 2 (4) All Lymphocele 17 (23) 7 (10) 3 (6) None Epifascial seroma 5 (7) 1 (1) 2 (4) None Urinoma 1 (1) All 2 (4) 1 (2) Ureteral structure 1 (1) 1 (1) 4 (8) 3 (6) Conclusion: high surgical complication rate (ESP) but outcome not compromised Folie Paul Bentas W. et al., Nephrol. Dial. Transplant;23, , 2008

23 Classification of surgical complications Grade Definition Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopical interventions Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics, electrolytes, and physiotherapy. This group includes also woundinfections opened at the bedside Grade II Grade III Grade IIIa Grade IIIb Grade IV Grade IVa Grade IVb Grade V Suffix d Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusion and total parenteral nutrition are also included Requiring surgical, endoscopic or radiological interventions Interventions not under general anesthesia Interventions under general anesthesia Life threating complication (including CNS complications) Single organ dysfunction (including dialysis) Multiorgan dysfunction Death of a patient If the patient suffers from a complication at the time of discarche, the suffix d (for disability) is added to the respective grade of complication. This label indicates the need for a follow-up to fully evaluate the complication. Folie Paul Dindo D. et al., Annals of Surgery 2004, 240,

24 High Risk Recipient : University of Essen Results Kidney transplantation from donors > 75 years, , n=51 Recipient Data %(x100) 1,0 0,9 0,8 0,7 0,6 78% 0,5 64% 0,4 0,3 0,2 0,1 0, patient survival Age 66 (52-82) years M/F n=13/n=38 Waiting Time 3 (0.2-8,7) years BMI 26.5 (19-35) kg/m² CIT 13.3 (5.1-30) hr Co-morbidity 5 n=18 (35,3%) Re-Transplant n=6 Doubel Transplant n=11 DGF n=24 (47%) PNF n=12 (23,5%) Clavian Classification IIIb and higher n=25 (49%) Hospital stay 26 (10-74) days Folie Paul

25 High Risk Recipient : Acceptance criteria¹ Absence of contraindications Realistic expectation of the patient surviving with a functioning transplant for at least 2 years (5 years) Pre-exsisting conditions should not be exacerbated by transplantation Measures to minimise peri- and post-operative complications Transplant technically possible Folie Paul

26 High Risk Recipient : Technical Aspects Folie Paul

27 High Risk Recipient : Transplant technically possible Folie Paul

28 High Risk Recipient : Simultaneous implantation of vascular graft, , n=11 out of n=443 (2,5%) Özcelik A. et al. Transplant Proc 2008 Folie Paul

29 High Risk Recipient : Simultaneous implantation of vascular graft, , n=11 out of n=443 (2,5%) Patient Age PAD known Donor Age CIT (hr) Primary function Graft- loss Complication 1 65 yes no ja rejection 2 59 yes no Intraop yes yes no yes no Intraop amputation 5 45 yes yes no no yes no no 65 7 yes no no yes no no yes no yes 65 2,5 yes no yes yes no bleeding after biopsy Folie Paul Özcelik A. et al. Transplant Proc 2008

30 High Risk Recipient : Acceptance criteria¹ Absence of contraindications Realistic expectation of the patient surviving with a functioning transplant for at least 2 years (5 years) Pre-exsisting conditions should not be exacerbated by transplantation Measures to minimise peri- and post-operative complications Transplant technically possible Gain in life-expectancy and / or quality of life Folie Paul

31 Expanded Criteria Recipients: Are there any Limits? - Summary - Analysis of individual risk factors helpful Use of validated index more helpful Clinical judement of experianced transplant nephrologist/surgeon better Decision making together with well informed patient Predictors of outcome in patients at different risks to better define limits Scores better than best clinical practice? Folie Paul