CUSTODIOL HTK Solution        Heart       Pancreas        Kidney       Liver

Kidney Transplantation

HTK was associated with a significant risk reduction on the incidence of DGF.5

• Graft survival did not significantly differ by preservation solution
- but in living donor patients, HTK showed a trend toward improved long-term graft survival over UW solution.5

• ...with cold ischemia times over 24 hours, there is not detriment associated with HTK use.5

• Despite a numerically higher incidence of DGF in the HTK group, Cox multivariable regression analysis shows a reduction in DGF with
HTK preservation. This may reflect an era effect, where the HTK variable represents not only preservation solution, but a reference to
year of operation.5

Prolonged Cold Preservation of Kidney Allografts6

• The only significant variable in the multivariate analysis was the preservation solution, with UW having a greater tendency towards DGF.6

• The patient demographics revealed no significant difference between the two groups, however there was longer CIT and WIT in the HTK group.6

• There was a trend toward improved graft survival in HTK.6

• To date, HTK Solution is at least comparable to UW for cold preservation of renal allografts. We report that with prolonged cold ischemia times (greater than 24 hr). HTK is not inferior to UW as previously suggested by other authors and may in fact provide better protection for the prevention of delayed graft function compared to UW solution.6

References

1. Data on file. Essential Pharmaceuticals, LLC.

2. Erhard J, Lange R, Scherer R, et al. Comparison of histidine-tryptophan- ketoglutarate (HTK) solution versus University of Wisconsin (UW) solution for organ preservation in human liver transplantation. A prospective, randomized study. Transplant Int. 1994;7:177-181

3. Gebhard MM,, Kirlum HJ, Schlegel C. Organ preservation with the solution HTK. In: Hesse UJ, de Hemptinne B, eds. Organ Preservation with HTK and UW Solution: Update on Clinical Use and Experimental Studies. Lengerich, Germany: Pabst Science Publishers; 1999:75-87.

4. Ringe B, Braun F, Moritz M, Zeldin G, Soriano H, Meyers W. Safety and efficacy of living donor liver preservation with HTK solution. Transplant Proc. 2005;37:316-319.

5. Lynch RJ, Kubus J, Chenault RH, Pelletier SJ, Campbell DA, and Englesbe MJ. Comparison of Histidine-Trytophan-ketogluterate and University of Wisconsin Preservation in renal Transplantation. American Journal of Transplantation. 2008;8:567-573.

6. Agarwal A, Murdock P, Fridell JA. Comparison of histidine-tryptophan- ketoglutarate (HTK) solution and University of Wisconsin solution in prolonged cold preservation of kidney allografts. Transplantation. 2006;81:480-482.

7. Agarwal A, Powelson JA, Goggins WC, Milgrom ML, and Fridell JA. Organ preservation with histidine-tryptophan-ketoglutarate solution in clinical pancreas transplantation: an update of the Indiana University Experience. Transplant Proceedings. 2008;40:498-501

8. Pokorny H, Grünberger T, Rockenschaub S, et al. Liver transplantation with HTK perfused organs—a multicenter study. Transplantation. 2002;74:36-37. Abstract

9. Welling TH, Heidt DG, Englesbe MJ, Magee JC, et al. Biliary complications following liver transplantation in the model for end-stage liver disease era: effect of donor, recipient, and technical factors. Liver Transpl. 2008;14:73-80

10. Mangus RS, Fridell JA, Vianna RM, Milgrom MA, et al. Comparison of histidine-tryptophan-ketoglutarate solution (HTK) and University of Wisconsin solution (UW) in extended criteria liver donors. Liver Transpl. 2008;14:365-373.5. (Brown)

11. Becker T, Ringe B, Nyibata M, Meyer zu Vilsendorf A, Schrem H, Lück R, et al. Pancreas transplantation with histidine-tryptophanketoglutarate (HTK) solution and University of Wisconsin (UW) solution: is there a difference? Journal of the Pancreas (Online) 2007;8(3):304-311.

12. Potdar S, Malck S, Eghtesad B, et al: Initial experience using histidine- tryptophan-ketogluterate solution in clinical pancreas transplantation. Clin Transplant 18:661, 2004

13. Englesbe MJ, Moyer A, Kim DY et al: Early Pancreas transplant outcomes with histidine-tryptophan-ketogluterate preservation: a multicenter study. Transplantation 82:136, 2006

14. Weiselthaler GM, Chevtchik O, Konestschny R, et al. Improved graft function using a new myocardial preservation solution: Celsior. Preliminary data from a randomized prospective study. Transplant Proc. 1999;31:2067-2068.

15. CUSTODIOL® [package insert]. Newtown, PA: Essential Pharmaceuticals, LLC;2006.

16. Ackerman J, Gross W, Mory M, Schaefer M, Gebhard, MM. Celsior versus Custodiol® : Early postichemic recovery after cardioplegia and ischemia at 5°C. Ann Thorac Surg. 2002;74:522-529.