- Email: [email protected]
The Fate of Organs Refused Locally and Transplanted Elsewhere
OUTCOMES
The Fate of Organs Refused Locally and Transplanted Elsewhere R. Cadillo-Chávez, E.A. Santiago-Delpı´n, Z. González-Caraballo, L. Morales-Otero, M. Saade, J. Davis, and D. Heinrichs ABSTRACT The number of kidney allografts procured from deceased donors has been fairly constant in the past few years, while organs from living donors steadily increase. In our program, existing protocols refused some kidneys which were subsequently accepted and transplanted at other hospitals. Thus, a review of our criteria to accept kidneys became necessary. Methods. We studied the outcome of all kidneys refused by us but transplanted in other programs between 2002 and 2004. The data analyzed included ID no. donor, transplant center, procurement date, donor age, ischemic times, recipient alive or dead, creatinine level (when it was offered), initial function, hypertension, diabetes mellitus, biopsy, reason why the kidney was not accepted in our program, kidney functioning or lost, and cause of graft failure. The chi-square, Fisher, and t tests were used to analyze our data; P values of ⬍.05 were regarded as significant. Results. Originally 137, we excluded kidneys exported due to mandatory sharing (26 of 137 ⫽ 18.97%) and multiorgan placement (10 of 137 ⫽ 7.3%). Thus, 101 kidneys were not accepted by us because they did not meet the existing criteria of our program, but were accepted elsewhere. Reasons for nonacceptance were divided into donor quality, donor social history, donor age, donor size/weight, positive serological test, as well as organ preservation time, organ anatomical damage, elevated creatinine, abnormal urinalysis, abnormal biopsy, and decreased urine output. Donor issues were 66 of 101 (65.3%) with a graft loss of 13.6%, and organ issues were 35 of 101 (34.7%) with a graft loss of 66.6%. Donor quality totaled 24 of 66 (36.4%) and donor social history totaled 20 of 66 (30.3%); these were the most common causes for kidney nonacceptance related to donor issues. Reasons related to organ quality included elevated creatinine (15 of 35 ⫽ 42.9%; graft loss,
From the Puerto Rico Transplant Program, Auxilio Mutuo Hospital, Department of Surgery, University of Puerto Rico, and LifeLink of Puerto Rico, San Juan, Puerto Rico. 0041-1345/06/$–see front matter doi:10.1016/j.transproceed.2006.02.039 892
Address reprint requests to E.A. Santiago-Delpı´n, Puerto Rico Transplant Program, P.O. Box 362403, San Juan, PR 00936. E-mail: [email protected] © 2006 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 38, 892– 894 (2006)
FATE OF ORGANS REFUSED LOCALLY
893
46.6%), and abnormal biopsy (9 of 35 ⫽ 25.7%; graft loss, 11.1%) and organ anatomical damage (4 of 35 ⫽ 11.4%; graft loss, 75%) (P ⫽ .42). Graft loss was more frequent with creatinine levels above 2.4 mg/dL (P ⬍ .001, RR gf ⫽ 1.5). Long-term fate of these 101 kidneys transplanted elsewhere: 82 (81.2%) were still working while 19 (18.8%) were lost. The causes of graft loss were renal artery thrombosis (42.1%), renal venous thrombosis (26.3%), death for other reasons (15.8%), graft never worked (10.5%), and ESRD (5.7%). The results suggest that the criteria for refusal related to donor issues, including hypertension, diabetes mellitus, donor age and donor size, should be revised owing to the low percentage of graft loss. Other donor issues such as positive serological test and donor social history (drug use, alcoholism) represent a serious potential risk for the health of recipients; for this reason, considering these persons as possible donors is very difficult irrespective of the graft outcome. Kidney refusals related to organ issues (especially elevated creatinine and anatomical damage) due to the very high percentage of graft loss should be considered high risk and probably be excluded. The increase in the demand of kidneys to be transplanted is a very important reason for a continuous and systematic review of donor exclusion criteria in every transplant program. The results presented here have helped us to improve both our outcomes and utilizations based on scientific evidence.
D
ONATION OF organs from deceased donors is still far from attaining the number of needed organs. As a result, there has been an unprecedented increase in living donation, but even combined with organs from deceased donors, this is still not sufficient to meet transplant needs. It appears to be important not only to continue efforts to increase donation, but to achieve the maximum utilization of cadaveric organ donation.1,2 Strategies for the latter have resulted in an expanded criteria for the use of these donors, including organs from non-heart-beating cadaver donors.1– 4 Puerto Rico has experienced one of the highest increases in cadaveric organ donation in recent years,5 even though not all cadaver donor offers were accepted. The present study was planned to critically assess the outcome of kidneys that were refused by our program but transplanted in other programs. This scrutiny was made with the intention to identify areas in which we could maximize the utilization of donor organs.
PATIENTS AND METHODS We analyzed the outcome of all kidneys refused by our transplant center but transplanted in other programs between 2002 and 2004. The data analyzed included identification number of the donor (subsequently blinded), transplant center, procurement date, donor date, ischemic times, recipient alive or dead, creatinine level at the time of the kidney offer, and initial function. Through our organ procurement agency we obtained information on the status of the recipient and the fate of the organ. Donor comorbidities included the presence of hypertension or diabetes, biopsy, reason why the kidney was not accepted in our program, current status of the kidney whether functioning or not, and cause of graft failure. The Fischer exact test and the t test were used to analyze our data, and a P value of .05 was regarded as significant.
RESULTS
A total of 101 kidneys were not accepted by our center for transplantation because they did not meet the existing
criteria of our program. Originally 137, we excluded kidneys exported due to mandatory sharing or multiorgan placement. Reasons for not acceptance were divided into several categories: donor quality, donor social history, donor age, donor size/weight, and positive serological tests. Other factors were organ preservation time, organ anatomical damage, elevated creatinine, abnormal urinalysis, abnormal biopsy, and decreased urinary output. Donor issues caused nonacceptance in 66 of 101 (65.3%), and these had a graft loss in the recipient of 13.6%. Issues relating to the organ and the quality of the organ were 35 of 101 (34.7%), with a graft loss of 34.28%. Of those in the donor issue category, donor quality and donor social history encompassed 29.1% and 5%, respectively, and were the most common causes for kidney nonacceptance related to donor issues. Percentage of grafts lost associated with donor, cardiac arrest, diabetic, hypertension, and drug use were 37.5%, 0%, 37.5%, and 5%, respectively (Table 1). Reasons related to organ quality included elevated creatinine (15 of 35; graft loss, 46.6%), abnormal biopsy (9 of 35; graft loss, 11%), and anatomical damage (4 of 35; graft loss, 75%). Graft loss was more frequent with creatinine levels above 2.4 (P ⬍ .001, relative risk 1.5) (Table 2). The long-term fate of these 101 transplanted organs was 82%, of Table 1. Donor Quality Graft
Cardiac arrest Diabetes HBP Cancer Positive U/A High WBC U/C(⫹)
Yes
No
%
3 0 3 0 0 0 1
5 2 5 1 1 2 1
37.5 0 37.5 0 0 0 50
894
CHAVEZ, DELPIN, CARABALLO ET AL Table 2. Organ Factors Graft Lost
Organ preservation Organ anatomical damage Elevated creatinine Abnormal urinalysis Abnormal biopsy Decreased urine output TOTAL
Yes
No
%
1 3 7 1 1 0 13
3 1 8 1 8 1 23
25 75 46.6 50 11.1 0 100
organs still working; 18% had been lost. Causes of graft loss were renal artery thrombosis in 42%, renal venous thrombosis in 26%, death for other reasons in 15%, graft never worked 10%, and development of end-stage renal disease, 5.7%. DISCUSSION
The successful results achieved in organ transplantation in recent years and its establishment as the treatment of choice of end-stage disease of several organs have resulted in a worldwide explosion of referrals for organ transplantation. In the United States, UNOS has reported an exponential increase of patients in the waiting list, while organ donation fails to increase correspondingly. Puerto Rico used to have one of the lowest donation rates in the United States, but the development of a formal organ procurement organization, LifeLink of Puerto Rico, and the institution of strategies to deal with the low donation rate, resulted in an increase of 1225% in cadaver donation, with a corresponding increase in both cadaver organ transplantation (556%) and overall transplantation rate of 250%.6 However, offers from our organ procurement organization were frequently rejected because of a number of factors that the program had established as their minimal criteria for acceptance. The purpose of our study was to identify areas in which we could improve utilization of the local cadaver organs. Organs refused because of donor social history, including the possibility of transmission of a disease, was established
as a criteria because the majority of the patients in our waiting list refused to receive an organ with a risk of infection. It will be difficult to deal with this cause of refusal because of ethical and legal reasons, even though the results of this study show minimal organ loss. However, insight has been gained in the use of other marginal donors. Donors with hypertension and diabetes whose organs were transplanted successfully elsewhere continued to work well. Conversely, organs refused by us because of anatomical damage were lost with an alarmingly high percentage as were those in which the final creatinine of the donor was high. From this study one can conclude that it is safe to transplant organs from donors with expanded criteria, an abnormal biopsy, and donor social history if the intended recipient accepts such a donation. However, there is considerable risk in our data in using organs with a high donor creatinine level or with anatomical damage. Based on these findings we have liberalized our acceptance policy of most donors except those with high risk of disease transmission, while focusing criteria of organ quality more on anatomy and creatinine than on other factors. Finally, the increased demand of kidneys to be transplanted is a highly important reason for a continuous and systematic review of donor exclusion criteria in every transplant program. The results presented here have helped our program to improve both our outcomes and utilization based on scientific evidence. REFERENCES 1. Lee C, Scandling J, Pavlakis M, et al: A review of the kidney that nobody wanted. Transplantation 65:213, 1998 2. Jacobbi LM, McBride VA, Etherede EE: The risk, benefits and cost of expanding donor criteria. Transplantation 60:1491, 1995 3. Spees EK, Orlowski JP, Temple DM: The successful use of marginal cadaveric donor kidneys. Transplant Proc 22:1382, 1990 4. Alfrey EL, Lee C, Scandling JD: When should expanded criteria donor kidneys be used for single versus dual kidney transplants? Transplantation 64:1142, 1997 5. Santiago-Delpı´n E, González-Caraballo Z, Morales-Otero L, et al: In Terasaki PI, Cecka JM (eds): Clinical Transplants 2003. Los Angeles, Calif: UCLA Immunogenetics Center; 2004, p 155 6. Saade M, Davis J, Torres E, et al: A marked increase in organ donation in Puerto Rico. Transplant Proc 37:3618, 2005
The Fate of Organs Refused Locally and Transplanted Elsewhere R. Cadillo-Chávez, E.A. Santiago-Delpı´n, Z. González-Caraballo, L. Morales-Otero, M. Saade, J. Davis, and D. Heinrichs ABSTRACT The number of kidney allografts procured from deceased donors has been fairly constant in the past few years, while organs from living donors steadily increase. In our program, existing protocols refused some kidneys which were subsequently accepted and transplanted at other hospitals. Thus, a review of our criteria to accept kidneys became necessary. Methods. We studied the outcome of all kidneys refused by us but transplanted in other programs between 2002 and 2004. The data analyzed included ID no. donor, transplant center, procurement date, donor age, ischemic times, recipient alive or dead, creatinine level (when it was offered), initial function, hypertension, diabetes mellitus, biopsy, reason why the kidney was not accepted in our program, kidney functioning or lost, and cause of graft failure. The chi-square, Fisher, and t tests were used to analyze our data; P values of ⬍.05 were regarded as significant. Results. Originally 137, we excluded kidneys exported due to mandatory sharing (26 of 137 ⫽ 18.97%) and multiorgan placement (10 of 137 ⫽ 7.3%). Thus, 101 kidneys were not accepted by us because they did not meet the existing criteria of our program, but were accepted elsewhere. Reasons for nonacceptance were divided into donor quality, donor social history, donor age, donor size/weight, positive serological test, as well as organ preservation time, organ anatomical damage, elevated creatinine, abnormal urinalysis, abnormal biopsy, and decreased urine output. Donor issues were 66 of 101 (65.3%) with a graft loss of 13.6%, and organ issues were 35 of 101 (34.7%) with a graft loss of 66.6%. Donor quality totaled 24 of 66 (36.4%) and donor social history totaled 20 of 66 (30.3%); these were the most common causes for kidney nonacceptance related to donor issues. Reasons related to organ quality included elevated creatinine (15 of 35 ⫽ 42.9%; graft loss,
From the Puerto Rico Transplant Program, Auxilio Mutuo Hospital, Department of Surgery, University of Puerto Rico, and LifeLink of Puerto Rico, San Juan, Puerto Rico. 0041-1345/06/$–see front matter doi:10.1016/j.transproceed.2006.02.039 892
Address reprint requests to E.A. Santiago-Delpı´n, Puerto Rico Transplant Program, P.O. Box 362403, San Juan, PR 00936. E-mail: [email protected] © 2006 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710 Transplantation Proceedings, 38, 892– 894 (2006)
FATE OF ORGANS REFUSED LOCALLY
893
46.6%), and abnormal biopsy (9 of 35 ⫽ 25.7%; graft loss, 11.1%) and organ anatomical damage (4 of 35 ⫽ 11.4%; graft loss, 75%) (P ⫽ .42). Graft loss was more frequent with creatinine levels above 2.4 mg/dL (P ⬍ .001, RR gf ⫽ 1.5). Long-term fate of these 101 kidneys transplanted elsewhere: 82 (81.2%) were still working while 19 (18.8%) were lost. The causes of graft loss were renal artery thrombosis (42.1%), renal venous thrombosis (26.3%), death for other reasons (15.8%), graft never worked (10.5%), and ESRD (5.7%). The results suggest that the criteria for refusal related to donor issues, including hypertension, diabetes mellitus, donor age and donor size, should be revised owing to the low percentage of graft loss. Other donor issues such as positive serological test and donor social history (drug use, alcoholism) represent a serious potential risk for the health of recipients; for this reason, considering these persons as possible donors is very difficult irrespective of the graft outcome. Kidney refusals related to organ issues (especially elevated creatinine and anatomical damage) due to the very high percentage of graft loss should be considered high risk and probably be excluded. The increase in the demand of kidneys to be transplanted is a very important reason for a continuous and systematic review of donor exclusion criteria in every transplant program. The results presented here have helped us to improve both our outcomes and utilizations based on scientific evidence.
D
ONATION OF organs from deceased donors is still far from attaining the number of needed organs. As a result, there has been an unprecedented increase in living donation, but even combined with organs from deceased donors, this is still not sufficient to meet transplant needs. It appears to be important not only to continue efforts to increase donation, but to achieve the maximum utilization of cadaveric organ donation.1,2 Strategies for the latter have resulted in an expanded criteria for the use of these donors, including organs from non-heart-beating cadaver donors.1– 4 Puerto Rico has experienced one of the highest increases in cadaveric organ donation in recent years,5 even though not all cadaver donor offers were accepted. The present study was planned to critically assess the outcome of kidneys that were refused by our program but transplanted in other programs. This scrutiny was made with the intention to identify areas in which we could maximize the utilization of donor organs.
PATIENTS AND METHODS We analyzed the outcome of all kidneys refused by our transplant center but transplanted in other programs between 2002 and 2004. The data analyzed included identification number of the donor (subsequently blinded), transplant center, procurement date, donor date, ischemic times, recipient alive or dead, creatinine level at the time of the kidney offer, and initial function. Through our organ procurement agency we obtained information on the status of the recipient and the fate of the organ. Donor comorbidities included the presence of hypertension or diabetes, biopsy, reason why the kidney was not accepted in our program, current status of the kidney whether functioning or not, and cause of graft failure. The Fischer exact test and the t test were used to analyze our data, and a P value of .05 was regarded as significant.
RESULTS
A total of 101 kidneys were not accepted by our center for transplantation because they did not meet the existing
criteria of our program. Originally 137, we excluded kidneys exported due to mandatory sharing or multiorgan placement. Reasons for not acceptance were divided into several categories: donor quality, donor social history, donor age, donor size/weight, and positive serological tests. Other factors were organ preservation time, organ anatomical damage, elevated creatinine, abnormal urinalysis, abnormal biopsy, and decreased urinary output. Donor issues caused nonacceptance in 66 of 101 (65.3%), and these had a graft loss in the recipient of 13.6%. Issues relating to the organ and the quality of the organ were 35 of 101 (34.7%), with a graft loss of 34.28%. Of those in the donor issue category, donor quality and donor social history encompassed 29.1% and 5%, respectively, and were the most common causes for kidney nonacceptance related to donor issues. Percentage of grafts lost associated with donor, cardiac arrest, diabetic, hypertension, and drug use were 37.5%, 0%, 37.5%, and 5%, respectively (Table 1). Reasons related to organ quality included elevated creatinine (15 of 35; graft loss, 46.6%), abnormal biopsy (9 of 35; graft loss, 11%), and anatomical damage (4 of 35; graft loss, 75%). Graft loss was more frequent with creatinine levels above 2.4 (P ⬍ .001, relative risk 1.5) (Table 2). The long-term fate of these 101 transplanted organs was 82%, of Table 1. Donor Quality Graft
Cardiac arrest Diabetes HBP Cancer Positive U/A High WBC U/C(⫹)
Yes
No
%
3 0 3 0 0 0 1
5 2 5 1 1 2 1
37.5 0 37.5 0 0 0 50
894
CHAVEZ, DELPIN, CARABALLO ET AL Table 2. Organ Factors Graft Lost
Organ preservation Organ anatomical damage Elevated creatinine Abnormal urinalysis Abnormal biopsy Decreased urine output TOTAL
Yes
No
%
1 3 7 1 1 0 13
3 1 8 1 8 1 23
25 75 46.6 50 11.1 0 100
organs still working; 18% had been lost. Causes of graft loss were renal artery thrombosis in 42%, renal venous thrombosis in 26%, death for other reasons in 15%, graft never worked 10%, and development of end-stage renal disease, 5.7%. DISCUSSION
The successful results achieved in organ transplantation in recent years and its establishment as the treatment of choice of end-stage disease of several organs have resulted in a worldwide explosion of referrals for organ transplantation. In the United States, UNOS has reported an exponential increase of patients in the waiting list, while organ donation fails to increase correspondingly. Puerto Rico used to have one of the lowest donation rates in the United States, but the development of a formal organ procurement organization, LifeLink of Puerto Rico, and the institution of strategies to deal with the low donation rate, resulted in an increase of 1225% in cadaver donation, with a corresponding increase in both cadaver organ transplantation (556%) and overall transplantation rate of 250%.6 However, offers from our organ procurement organization were frequently rejected because of a number of factors that the program had established as their minimal criteria for acceptance. The purpose of our study was to identify areas in which we could improve utilization of the local cadaver organs. Organs refused because of donor social history, including the possibility of transmission of a disease, was established
as a criteria because the majority of the patients in our waiting list refused to receive an organ with a risk of infection. It will be difficult to deal with this cause of refusal because of ethical and legal reasons, even though the results of this study show minimal organ loss. However, insight has been gained in the use of other marginal donors. Donors with hypertension and diabetes whose organs were transplanted successfully elsewhere continued to work well. Conversely, organs refused by us because of anatomical damage were lost with an alarmingly high percentage as were those in which the final creatinine of the donor was high. From this study one can conclude that it is safe to transplant organs from donors with expanded criteria, an abnormal biopsy, and donor social history if the intended recipient accepts such a donation. However, there is considerable risk in our data in using organs with a high donor creatinine level or with anatomical damage. Based on these findings we have liberalized our acceptance policy of most donors except those with high risk of disease transmission, while focusing criteria of organ quality more on anatomy and creatinine than on other factors. Finally, the increased demand of kidneys to be transplanted is a highly important reason for a continuous and systematic review of donor exclusion criteria in every transplant program. The results presented here have helped our program to improve both our outcomes and utilization based on scientific evidence. REFERENCES 1. Lee C, Scandling J, Pavlakis M, et al: A review of the kidney that nobody wanted. Transplantation 65:213, 1998 2. Jacobbi LM, McBride VA, Etherede EE: The risk, benefits and cost of expanding donor criteria. Transplantation 60:1491, 1995 3. Spees EK, Orlowski JP, Temple DM: The successful use of marginal cadaveric donor kidneys. Transplant Proc 22:1382, 1990 4. Alfrey EL, Lee C, Scandling JD: When should expanded criteria donor kidneys be used for single versus dual kidney transplants? Transplantation 64:1142, 1997 5. Santiago-Delpı´n E, González-Caraballo Z, Morales-Otero L, et al: In Terasaki PI, Cecka JM (eds): Clinical Transplants 2003. Los Angeles, Calif: UCLA Immunogenetics Center; 2004, p 155 6. Saade M, Davis J, Torres E, et al: A marked increase in organ donation in Puerto Rico. Transplant Proc 37:3618, 2005