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Report of the International Pancreas Transplant Registry
Report of the International Pancreas Transplant Registry A.C. Gruessner, D.E.R. Sutherland, and R.W.G. Gruessner
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S of December 31, 1996, a total of 9012 pancreas transplants have been reported to the International Pancreas Transplant Registry (IPTR). Of these transplants, 6,640 (74%) were performed in the United States, and 2,372 (26%) outside the United States. Since 1995, over 1000 pancreas transplants per year have been reported from the United States alone. As of December 31, 1996, there were 101 pancreas transplant centers in the United States, and 87 outside. All US pancreas transplants must be reported to the United Network for Organ Sharing (UNOS) through a subcontract with the IPTR. Transplants performed outside the United States, however, are only reported on a voluntary basis; the records, therefore, are incomplete. The following analysis is limited to transplants done in the United States between October 1, 1987 and July 31, 1997. Overall patient survival rates have continuously improved over the years (based on comparisons among 1987 to 1989, 1990 to 1991, 1992 to 1993, and 1994 to 1997). By recipient category, 1-year patient survival with a cadaver donor increased as follows: for simultaneous pancreas– kidney (SPK) recipients (n 5 4,952), from 90% (1987 to 1989) to 94% (1994 to 1997) (P 5 .002); for pancreas after kidney (PAK) recipients (n 5 446), from 90% to 95% (P 5 not significant [NS]). For pancreas transplant alone (PTA) recipients (n 5 259), 1-year patient survival has remained at 93%. Similarly, overall graft survival rates have significantly increased over time. One-year pancreas graft survival for SPK recipients (n 5 4,952) with cadaver donors increased from 74% (1987 to 1989) to 82% (1994 to 1997) (P 5 .0001); 1-year kidney graft survival increased from 86% to 89% (P 5 .004). For technically successful SPK transplants with a cadaver donor (n 5 4,361), the number of pancreas graft losses due to rejection at one year decreased from 6% to 2% (P 5 .0001). For PAK recipients with a cadaver donor (n 5 446), 1-year pancreas graft survival increased from 56% to 70% (P # .008). For technically successful PAK transplants with a cadaver donor (n 5 331), the number of graft losses due to rejection at 1 year decreased from 25% to 10% (P # .01). For PTA recipients (n 5 259), 1-year graft survival increased from 46% to 74% (P # .0001). For technically successful PTA transplants with a cadaver donor (n 5 192), the number of graft losses due to rejection at 1 year decreased from 38% to 7% (P # .01). By 0041-1345/98/$19.00 PII S0041-1345(97)01242-6 242
recipient category, pancreas graft survival remains significantly higher for SPK recipients. Between January 1, 1994 and July 31, 1997, 1-year graft survival was as follows: SPK, 82%; PAK, 70%; and PTA, 74% (P 5 .0001). As with primary transplants, 1-year graft survival has improved for retransplant recipients over time: from 54% (1987 to 1989) to 67% (1994 to 1997). Although the most common technique for managing pancreas exocrine secretions has been bladder drainage (BD), interest in enteric drainage (ED) was revived in 1995. Before 1995, only 3% (1989) to 6% (1994) of all pancreas transplants used ED; in 1995, the percentage increased to 16%; in 1996, to 31%. Similarly, the number of pancreas transplant centers using ED increased from 4 (1988) to 14 (1994) to 19 (1995) to 33 (1996). With both BD and ED, 1-year graft survival for SPK recipients has significantly increased over time: from 75% (BD) and 29% (ED) (1987 to 1989) to 83% (BD) and 79% (1994 to 1997) (P 5 .0001 [BD] and P 5 .001 [ED]). With ED, results were slightly better for SPK recipients when a Roux-en-Y loop was used: between January 1, 1994 and July 31, 1997, 1-year graft survival with BD (n 5 1,898) was 83%; with ED with Roux-en-Y (n 5 192), 80%; with ED without Roux-en-Y (n 5 226), 77% (overall P , .1). The difference was not significant for BD versus ED with Roux-en-Y (P 5 .35) or for ED with versus without Roux-en-Y (P 5 .36). But the difference was significant for BD versus ED without Rouxen-Y (P 5 .01). For SPK recipients, 1-year kidney graft survival was not different for recipients with BD versus ED (89% each) (P 5 .8). With BD, the technical failure (eg, graft loss from thrombosis, infection, pancreatitis, leak, bleeding) rate has also decreased over time. By recipient category, the technical failure rate decreased as follows: for SPK recipients, from 16% (1987 to 1989) to 7% (1994 to 1997) (P 5 .001); for PAK recipients, from 16% to 13% (P 5 .006); for PTA recipients, from 18% to 10% (P 5 .29). Of all causes of technical failure, graft thrombosis has remained the most common. For the years 1994 to 1997, the incidence of graft
From the Department of Surgery (A.C.G., D.E.R.S., R.W.G.S.), University of Minnesota, Minneapolis, Minnesota. Address reprint requests to Dr Angelika C. Gruessner, University of Minnesota, Department of Surgery, 420 Delaware St. S.E., Minneapolis, MN 55455. © 1998 by Elsevier Science Inc. 655 Avenue of the Americas, New York, NY 10010 Transplantation Proceedings, 30, 242–243 (1998)
INTERNATIONAL PANCREAS TRANSPLANT REGISTRY
thrombosis was as follows: SPK, 5.5%; PAK, 10.2%; and PTA, 6.7%. Of note, the incidence decreased over time for SPK (1987 to 1989, 8%; 1994 to 1997, 5.5%) and PTA (1987 to 1989, 13.3%; 1994 to 1997, 6.7%) recipients. For 1994 to 1997, the overall technical failure rate was slightly higher for pancreas transplants with ED. By recipient category, the technical failure rate for SPK recipients was 7.4% (BD) versus 10.6% (ED) (P 5 .06); for PAK recipients, 12.9% (BD) versus 11.1% (ED) (P 5 .79); and for PTA recipients, 9.9% (BD) versus 15.8% (ED) (P 5 .43). By univariate analysis, risk factors for graft thrombosis were donor age above 45 years (overall P 5 .001) and cerebrocardiovascular cause of donor death (overall P 5 .001), irrespective of the recipient category. Preservation time (#20 versus .20 h) had no significant impact on the incidence of graft thrombosis. By univariate analysis, risk factors for posttransplant infections were donor age over 45 years (overall P 5 .001), cerebrocardiovascular cause of donor death (overall P 5 .03), and preservation time of 20 hours or more (overall P 5 .001). By multivariate analysis (Cox regression), risk factors for decreased patient and graft survival and for graft loss from rejection were studied in all three recipient categories. Variables included donor age (per 20-year increments), recipient age (per 20-year increments), donor cause of death (cerebrocardiovascular versus traumatic), HLA mismatch (number of mismatches), preservation time (per 10-hour increments), transplant number (primary versus retransplant), use of anti–T-cell therapy for induction (versus none), use of tacrolimus (versus cyclosporine), and use of mycophenolate mofetil (MMF) (versus azathioprine). For SPK recipients with BD, risk factors for decreased patient survival were older recipient age (RR 5 1.56; P 5 .0001), older donor age (RR 5 1.26; P 5 .001), longer preservation time (RR 5 .82; P 5 .017), and lack of anti–T-cell therapy (RR 5 .83; P 5 .16); for decreased pancreas graft survival, older donor age (RR 5 1.27; P 5 .0001), older recipient age (RR 5 1.23; P 5 .001), retransplant (RR 5 1.62; P 5 .05), cerebrocardiovascular cause of donor death (RR 5 1.24; P 5 .003), lack of anti–T-cell therapy (RR 5 .78; P 5 .003), lack of MMF (RR 5 .64; P 5 .004), and HLA mismatch (RR 5 .93; P 5 .17); for graft loss from rejection, retransplant (RR 5 2.52; P 5 .03), cerebrocardiovascular cause of donor death (RR 5 1.39; P 5 .02), lack of anti–T-cell therapy (RR 5 .77; P 5 .14),
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lack of tacrolimus (RR 5 .64; P 5 .16), and lack of MMF (RR 5 .18; P 5 .02). For SPK recipients with ED, risk factors for patient survival were lack of tacrolimus (RR 5 .49; P 5 .19) and lack of MMF (RR 5 .44; P 5 .19); for pancreas graft survival, cerebrocardiovascular cause of donor death (RR 5 1.45; P 5 .13), lack of tacrolimus (RR 5 .62; P 5 .08), and lack of MMF (RR 5 .53; P 5 .03). For PAK recipients with BD, risk factors for patient survival were older recipient age (RR 5 1.67; P 5 .07), retransplant (RR 5 2.08; P 5 .02), longer preservation time (RR 5 .68; P 5 .15), lack of tacrolimus (RR 5 .24; P 5 .18); for pancreas graft survival, older donor age (RR 5 1.39; P 5 .002), HLA mismatch (RR 5 1.39; P 5 .002), longer preservation time (RR 5 1.22; P 5 .1), older recipient age (RR 5 .77; P 5 .07), retransplant (RR 5 1.46; P 5 .014), lack of tacrolimus (RR 5 .41; P 5 .002); for graft loss from rejection, HLA mismatch (RR 5 1.56; P 5 .007), older recipient age (RR 5 .66; P 5 .075), retransplant (RR 5 1.58; P 5 .05), lack of tacrolimus (RR 5 .47; P 5 .087). For PTA recipients with BD, risk factors for patient survival were older donor age (RR 5 1.88; P 5 .049), older recipient age (RR 5 1.83; P 5 .14), lack of anti–T-cell therapy (RR 5 .2; P 5 .006), and lack of tacrolimus (RR 5 2.42; P 5 .14); for pancreas graft survival, older donor age (RR 5 1.31; P 5 .05), HLA mismatch (RR 5 .93; P 5 .17), lack of anti–T-cell therapy (RR 5 .69; P 5 .2); for graft loss from rejection, older donor age (RR 5 1.32; P 5 .14), HLA mismatch (RR 5 1.92; P 5 .005), and lack of tacrolimus (RR 5 .33; P 5 .09). The following conclusions can be drawn from this IPTR analysis: (1) Patient and graft survival rates for both primary and pancreas retransplants continue to improve. (2) By recipient category, pancreas graft survival remains highest for SPK recipients; however, 1-year graft survival for solitary pancreas (PAK, PTA) recipients now exceeds 70%. (3) The number of transplant centers using ED has increased; so has the number of pancreas transplants using ED. One-year graft survival rates for SPK recipients are not different for BD versus ED with Roux-en-Y. (4) Graft losses from rejection and from technical failures have significantly decreased over time. (5) According to uni- and multivariate analyses, older donor and recipient age as well as cerebrocardiovascular cause of donor death are the most common risk factors for decreased patient and graft survival. (6) The use of new immunosuppressants (tacrolimus, MMF) appears to further improve outcome.
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S of December 31, 1996, a total of 9012 pancreas transplants have been reported to the International Pancreas Transplant Registry (IPTR). Of these transplants, 6,640 (74%) were performed in the United States, and 2,372 (26%) outside the United States. Since 1995, over 1000 pancreas transplants per year have been reported from the United States alone. As of December 31, 1996, there were 101 pancreas transplant centers in the United States, and 87 outside. All US pancreas transplants must be reported to the United Network for Organ Sharing (UNOS) through a subcontract with the IPTR. Transplants performed outside the United States, however, are only reported on a voluntary basis; the records, therefore, are incomplete. The following analysis is limited to transplants done in the United States between October 1, 1987 and July 31, 1997. Overall patient survival rates have continuously improved over the years (based on comparisons among 1987 to 1989, 1990 to 1991, 1992 to 1993, and 1994 to 1997). By recipient category, 1-year patient survival with a cadaver donor increased as follows: for simultaneous pancreas– kidney (SPK) recipients (n 5 4,952), from 90% (1987 to 1989) to 94% (1994 to 1997) (P 5 .002); for pancreas after kidney (PAK) recipients (n 5 446), from 90% to 95% (P 5 not significant [NS]). For pancreas transplant alone (PTA) recipients (n 5 259), 1-year patient survival has remained at 93%. Similarly, overall graft survival rates have significantly increased over time. One-year pancreas graft survival for SPK recipients (n 5 4,952) with cadaver donors increased from 74% (1987 to 1989) to 82% (1994 to 1997) (P 5 .0001); 1-year kidney graft survival increased from 86% to 89% (P 5 .004). For technically successful SPK transplants with a cadaver donor (n 5 4,361), the number of pancreas graft losses due to rejection at one year decreased from 6% to 2% (P 5 .0001). For PAK recipients with a cadaver donor (n 5 446), 1-year pancreas graft survival increased from 56% to 70% (P # .008). For technically successful PAK transplants with a cadaver donor (n 5 331), the number of graft losses due to rejection at 1 year decreased from 25% to 10% (P # .01). For PTA recipients (n 5 259), 1-year graft survival increased from 46% to 74% (P # .0001). For technically successful PTA transplants with a cadaver donor (n 5 192), the number of graft losses due to rejection at 1 year decreased from 38% to 7% (P # .01). By 0041-1345/98/$19.00 PII S0041-1345(97)01242-6 242
recipient category, pancreas graft survival remains significantly higher for SPK recipients. Between January 1, 1994 and July 31, 1997, 1-year graft survival was as follows: SPK, 82%; PAK, 70%; and PTA, 74% (P 5 .0001). As with primary transplants, 1-year graft survival has improved for retransplant recipients over time: from 54% (1987 to 1989) to 67% (1994 to 1997). Although the most common technique for managing pancreas exocrine secretions has been bladder drainage (BD), interest in enteric drainage (ED) was revived in 1995. Before 1995, only 3% (1989) to 6% (1994) of all pancreas transplants used ED; in 1995, the percentage increased to 16%; in 1996, to 31%. Similarly, the number of pancreas transplant centers using ED increased from 4 (1988) to 14 (1994) to 19 (1995) to 33 (1996). With both BD and ED, 1-year graft survival for SPK recipients has significantly increased over time: from 75% (BD) and 29% (ED) (1987 to 1989) to 83% (BD) and 79% (1994 to 1997) (P 5 .0001 [BD] and P 5 .001 [ED]). With ED, results were slightly better for SPK recipients when a Roux-en-Y loop was used: between January 1, 1994 and July 31, 1997, 1-year graft survival with BD (n 5 1,898) was 83%; with ED with Roux-en-Y (n 5 192), 80%; with ED without Roux-en-Y (n 5 226), 77% (overall P , .1). The difference was not significant for BD versus ED with Roux-en-Y (P 5 .35) or for ED with versus without Roux-en-Y (P 5 .36). But the difference was significant for BD versus ED without Rouxen-Y (P 5 .01). For SPK recipients, 1-year kidney graft survival was not different for recipients with BD versus ED (89% each) (P 5 .8). With BD, the technical failure (eg, graft loss from thrombosis, infection, pancreatitis, leak, bleeding) rate has also decreased over time. By recipient category, the technical failure rate decreased as follows: for SPK recipients, from 16% (1987 to 1989) to 7% (1994 to 1997) (P 5 .001); for PAK recipients, from 16% to 13% (P 5 .006); for PTA recipients, from 18% to 10% (P 5 .29). Of all causes of technical failure, graft thrombosis has remained the most common. For the years 1994 to 1997, the incidence of graft
From the Department of Surgery (A.C.G., D.E.R.S., R.W.G.S.), University of Minnesota, Minneapolis, Minnesota. Address reprint requests to Dr Angelika C. Gruessner, University of Minnesota, Department of Surgery, 420 Delaware St. S.E., Minneapolis, MN 55455. © 1998 by Elsevier Science Inc. 655 Avenue of the Americas, New York, NY 10010 Transplantation Proceedings, 30, 242–243 (1998)
INTERNATIONAL PANCREAS TRANSPLANT REGISTRY
thrombosis was as follows: SPK, 5.5%; PAK, 10.2%; and PTA, 6.7%. Of note, the incidence decreased over time for SPK (1987 to 1989, 8%; 1994 to 1997, 5.5%) and PTA (1987 to 1989, 13.3%; 1994 to 1997, 6.7%) recipients. For 1994 to 1997, the overall technical failure rate was slightly higher for pancreas transplants with ED. By recipient category, the technical failure rate for SPK recipients was 7.4% (BD) versus 10.6% (ED) (P 5 .06); for PAK recipients, 12.9% (BD) versus 11.1% (ED) (P 5 .79); and for PTA recipients, 9.9% (BD) versus 15.8% (ED) (P 5 .43). By univariate analysis, risk factors for graft thrombosis were donor age above 45 years (overall P 5 .001) and cerebrocardiovascular cause of donor death (overall P 5 .001), irrespective of the recipient category. Preservation time (#20 versus .20 h) had no significant impact on the incidence of graft thrombosis. By univariate analysis, risk factors for posttransplant infections were donor age over 45 years (overall P 5 .001), cerebrocardiovascular cause of donor death (overall P 5 .03), and preservation time of 20 hours or more (overall P 5 .001). By multivariate analysis (Cox regression), risk factors for decreased patient and graft survival and for graft loss from rejection were studied in all three recipient categories. Variables included donor age (per 20-year increments), recipient age (per 20-year increments), donor cause of death (cerebrocardiovascular versus traumatic), HLA mismatch (number of mismatches), preservation time (per 10-hour increments), transplant number (primary versus retransplant), use of anti–T-cell therapy for induction (versus none), use of tacrolimus (versus cyclosporine), and use of mycophenolate mofetil (MMF) (versus azathioprine). For SPK recipients with BD, risk factors for decreased patient survival were older recipient age (RR 5 1.56; P 5 .0001), older donor age (RR 5 1.26; P 5 .001), longer preservation time (RR 5 .82; P 5 .017), and lack of anti–T-cell therapy (RR 5 .83; P 5 .16); for decreased pancreas graft survival, older donor age (RR 5 1.27; P 5 .0001), older recipient age (RR 5 1.23; P 5 .001), retransplant (RR 5 1.62; P 5 .05), cerebrocardiovascular cause of donor death (RR 5 1.24; P 5 .003), lack of anti–T-cell therapy (RR 5 .78; P 5 .003), lack of MMF (RR 5 .64; P 5 .004), and HLA mismatch (RR 5 .93; P 5 .17); for graft loss from rejection, retransplant (RR 5 2.52; P 5 .03), cerebrocardiovascular cause of donor death (RR 5 1.39; P 5 .02), lack of anti–T-cell therapy (RR 5 .77; P 5 .14),
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lack of tacrolimus (RR 5 .64; P 5 .16), and lack of MMF (RR 5 .18; P 5 .02). For SPK recipients with ED, risk factors for patient survival were lack of tacrolimus (RR 5 .49; P 5 .19) and lack of MMF (RR 5 .44; P 5 .19); for pancreas graft survival, cerebrocardiovascular cause of donor death (RR 5 1.45; P 5 .13), lack of tacrolimus (RR 5 .62; P 5 .08), and lack of MMF (RR 5 .53; P 5 .03). For PAK recipients with BD, risk factors for patient survival were older recipient age (RR 5 1.67; P 5 .07), retransplant (RR 5 2.08; P 5 .02), longer preservation time (RR 5 .68; P 5 .15), lack of tacrolimus (RR 5 .24; P 5 .18); for pancreas graft survival, older donor age (RR 5 1.39; P 5 .002), HLA mismatch (RR 5 1.39; P 5 .002), longer preservation time (RR 5 1.22; P 5 .1), older recipient age (RR 5 .77; P 5 .07), retransplant (RR 5 1.46; P 5 .014), lack of tacrolimus (RR 5 .41; P 5 .002); for graft loss from rejection, HLA mismatch (RR 5 1.56; P 5 .007), older recipient age (RR 5 .66; P 5 .075), retransplant (RR 5 1.58; P 5 .05), lack of tacrolimus (RR 5 .47; P 5 .087). For PTA recipients with BD, risk factors for patient survival were older donor age (RR 5 1.88; P 5 .049), older recipient age (RR 5 1.83; P 5 .14), lack of anti–T-cell therapy (RR 5 .2; P 5 .006), and lack of tacrolimus (RR 5 2.42; P 5 .14); for pancreas graft survival, older donor age (RR 5 1.31; P 5 .05), HLA mismatch (RR 5 .93; P 5 .17), lack of anti–T-cell therapy (RR 5 .69; P 5 .2); for graft loss from rejection, older donor age (RR 5 1.32; P 5 .14), HLA mismatch (RR 5 1.92; P 5 .005), and lack of tacrolimus (RR 5 .33; P 5 .09). The following conclusions can be drawn from this IPTR analysis: (1) Patient and graft survival rates for both primary and pancreas retransplants continue to improve. (2) By recipient category, pancreas graft survival remains highest for SPK recipients; however, 1-year graft survival for solitary pancreas (PAK, PTA) recipients now exceeds 70%. (3) The number of transplant centers using ED has increased; so has the number of pancreas transplants using ED. One-year graft survival rates for SPK recipients are not different for BD versus ED with Roux-en-Y. (4) Graft losses from rejection and from technical failures have significantly decreased over time. (5) According to uni- and multivariate analyses, older donor and recipient age as well as cerebrocardiovascular cause of donor death are the most common risk factors for decreased patient and graft survival. (6) The use of new immunosuppressants (tacrolimus, MMF) appears to further improve outcome.