Liver Transplant Outcomes in the United States : Effect of Preservation Solution
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Liver Transplant Outcomes in the United States : Effect of Preservation Solution DKFC Symposium July 16, 2012. John Fung, MD, PhD Cleveland Clinic. Disclosure: I have been a past consultant for both Dupont and Odyssey. Recent Retrospective Database Reviews.

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Liver Transplant Outcomes in the United States : Effect of Preservation SolutionDKFC SymposiumJuly 16, 2012

John Fung, MD, PhD

Cleveland Clinic

Disclosure: I have been a past consultant for both Dupont and Odyssey


Recent Retrospective Database Reviews

Theme of 3 studies: These results suggest that the increasing use of HTK for abdominal organ preservation should be reexamined


Liver Preservation


Liver Preservation

Indiana University, 2001 to 2008

All adult, deceased donor

n=1013

HTK 632, UW 381

Simultaneous, retrospective


Liver Preservation

Indiana University, 2001 to 2008

All adult, deceased donor

Simultaneous, retrospective

n=1013HTK 632 UW 381

Serum ALT

Serum Bilirubin


Using the SRTR Database

  • Only adult first liver-only transplants from 2002-2008 were included and only for those whom flush and storage solutions were the same

  • All patients had minimum one year follow up

  • 25,616 patients, 20,901 (82%) with UW and 4,715 (18%) with HTK

  • Mean follow-up: 2.7 ± 1.7 years (2.9 ± 1.7 for UW and 1.8 ± 1.1 for HTK)


Statistical Analysis

  • Three comparisons:

  • Unadjusted graft survival

  • Bootstrapping hazard modeling using risk factors for graft survival determined using non-proportional, multiphase, multivariable hazard methodology with >100 clinically relevant recipient, donor, and procedure variables

  • Propensity-matched comparison for 50 most important variables


Bootstrapping

  • A random sample of patients is drawn from the original data - patients are drawn one at a time, with replacement, until a new dataset of the same size has been created

  • When the new dataset has been created, the stepwise regression technique is run again to see what significant predictors it finds and the process is repeated multiple times

  • The bootstrap percentage is the percent of runs in which the variable appeared, so the higher the percentage, the more certain is the impact of that variable - those appearing in >50% of runs were considered reliably statistically significant at p<0.001


Adjusting for Multiple Tests

Use p = 0.05 / no. of tests


Results

  • Validation of reported significant recipient factors of graft failure in the early and later phases after DDLT

  • OPS did not appear as a statistically significant predictor of graft failure

    • hospital death, re-transplant rates and relisting rates were not different


Unadjusted Patient and Graft Survival - HTK vs UW

Adult LTX from 2002-2008

UW n = 20,901 HTK n = 4,715

PS: p = 0.90 log rank test GS: p = 0.60 


Unadjusted Patient and Graft Survival - HTK vs UW

Adult LTX from 2002-2008: By DRI - 2.5

7,883 UW10,484 UW

1,826 HTK 2,314 HTK

DRI < 2.5 p = 0.20 log rank test DRI >2.5: p = 0.20 


Unadjusted Patient and Graft Survival - HTK vs UW

Adult LTX from 2002-2008: By CIT - 8 hrs (non-DCD)

14,053 UW6,119 UW

3,279 HTK 1,177 HTK

CIT < 8 hr p = 0.70 log rank test CIT >8 hr: p = 0.50 


Unadjusted Patient and Graft Survival - HTK vs UW

Adult LTX from 2002-2008: By CIT - 12 hrs (non-DCD)

19,082 UW1,090 UW

4,253 HTK 203 HTK

CIT < 12 hr p = 0.80 log rank test CIT >12 hr: p = 0.60 


Risk Factors for Graft Failure - Early Phase


Risk Factors for Graft Failure - Constant Phase


Limitations of the Hopkins UNOS Analysis

  • Used case-wise deletion of missing data, i.e. used only patients for whom all variables were reported - the actual number of cases deleted not provided

  • Last case included was 2/28/08 - the paper was submitted on 7/17/08.  Allowing a minimum of 45 days to analyze and write the paper, the latest data cutoff was 6/1/08. Using UNOS timelines for a 6/1/08 cutoff, there would only have been data for transplants performed before 11/1/07 


Unadjusted 1-year Graft Survival Rates by Year of Transplant


SRTR Data, 2000-2010, N=55110, Age 18+

By Years and Preservation Solution: 2001-2005 vs 2006-2010 and UW vs HTK

HTK 2006-10

Liver Transplant Graft Survival

UW 2006-10

HTK 2000-5

UW 2000-5

SRTR Data, 2000-2010, N=55110, Age 18+

By Years and Preservation Solution: 2001-2005 vs 2006-2010 and UW vs HTK


SRTR Data, 2000-2010, N=55110, Age 18+

By Years and Preservation Solution: 2001-2005 vs 2006-2010 and UW vs HTK

HTK 2006-10

Liver Transplant Patient Survival

UW 2006-10

HTK 2000-5

UW 2000-5

SRTR Data, 2000-2010, N=55110, Age 18+

By Years and Preservation Solution: 2001-2005 vs 2006-2010 and UW vs HTK


Comparing HTK Users - 2010 UNOS Report - ADDLT


Comparing UW Users – 2010 UNOS Report - ADDLT


Conclusions

  • Discrepancies between published reports and clinical experience:

    • Flawed analysis

    • Learning curve

    • Changing practices

  • Excellent outcomes can be obtained with either solution


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