Pursuing expanded criteria donors as candidates for kidney donation after circulatory death Of the 119 310 people on the national transplant waiting list, 97 280 people are waiting for kidneys. There simply are not enough organs to meet the demand. Recognizing that 64% of the people waiting for kidney transplants are at least 50 years old, this organ procurement organization embarked on a study to evaluate the potential of increasing the number of viable kidneys available for transplant by pursuing expanded criteria donors as donation after circulatory death (ECD/DCD) candidates. Pursuing ECD/DCD donors resulted in 24 additional donors (50-67 years old), 48 kidneys recovered, 30 kidneys transplanted into 26 recipients (44-74 years old), 7 kidneys placed for research, and 11 kidneys discarded, yielding an overall 62% transplant rate, 15% research rate, and 23% discard rate. The overall discard rate including all donors in all classifications during the study period was 13.1% (122 discards from 928 kidneys) compared with 12.6% (111 discards from 880 kidneys) when the study set was excluded. Although ECD/DCD donors still had the highest discard rates of all the groups, the 0.5% increase in the overall discard rate due to pursuing ECD/DCD kidneys was considered insignificant when compared with the benefit of the 30 additional kidneys transplanted. Including potential ECD/DCD patients in the donor pool increases the number of viable kidneys available for transplant without significantly increasing the overall kidney discard rates. (Progress in Transplantation. 2014;24:206-210) ©2014 NATCO, The Organization for Transplant Professionals doi: http://dx.doi.org/10.7182/pit2014439
A
ccording to data from the Organ Procurement and Transplantation Network,1 when this article was written, 119 310 people were on the national transplant waiting list. Of this number, 97 280 people were waiting for kidneys. There is national recognition that there simply are not enough organs, especially kidneys, to meet the demand. From 1995 to 2003, several initiatives were designed to improve organ donation rates (eg, public education, minority education, and involving key medical professionals to ensure that all potential donors are identified and referred in a timely manner), which had resulted in 2% to 4% annual growth in the number of deceased donors.2 In 2003, The US Organ Donation Breakthrough Collaborative was started at the request of the Secretary of the US Department of Health and Human Services and included participation of the 300 US hospitals identified as having the largest organ donor potential
206
Ginger T. DeLario, PhD, MT (ASCP), CPTC, CTOP II, Jim Quetschenbach, RN, BSN, CPTC, Donna Croezen, RN, MSN, CPTC, Danielle Niedfeldt, RN, BSN, JD, CPTC, Julie Landon, RN, CPTC Carolina Donor Services, Durham, North Carolina Corresponding author: Ginger T. DeLario, PhD, MT (ASCP), CPTC, CTOP II, Carolina Donor Services, 3621 Lyckan Parkway, Durham, NC 27707 (e-mail: gdelario@carolinadonorservices .org) To purchase electronic or print reprints, contact: American Association of Critical-Care Nurses 101 Columbia, Aliso Viejo, CA 92656 Phone (800) 899-1712 (ext 532) or (949) 448-7370 (ext 532) Fax (949) 362-2049 E-mail [email protected]
and the 43 organ procurement organizations (OPOs) associated with them.2,3 The efforts of the Collaborative proved successful in the first year, with a 14.1% increase in the number of organ donors within the participating hospitals. With continued spread of those efforts to include 500 of the nation’s hospitals and 50 OPOs (2003-2006), the number of total US organ donors increased 22.5%.2,4 One of the high-leverage changes suggested during the Collaborative was implementation of donation after circulatory death (DCD).3 Although many hospitals and OPOs across the United States were not routinely pursuing DCD donors, this was not a revolutionary practice. Before the ad hoc committee of Harvard Medical School defined brain death criteria for the neurological determination of death in 1968,5 early organ recoveries involving deceased donors could occur only after cessation of circulatory and respiratory
Progress in Transplantation, Vol 24, No. 2, June 2014
Pursuing expanded criteria donors as candidates for kidney donation after circulatory death functions or circulatory determination of death.6 However, with brain-dead donors practically eliminating warm ischemic time, resulting in higher quality organs and appearing to provide an adequate supply of organs, DCD organ recoveries decreased substantially across the United States.6 Even though the Collaborative was successful in increasing and sustaining overall rates of organ donation from deceased donors, including an increase in DCD donors, as the number of candidates listed for transplant continues to increase, the number of available donors has remained relatively static. In the past 6 years (2007-2012), the total number of organ donors was 85 900, of which 79 836 were kidney donors (43 769 deceased donors and 36 067 living donors) for a mean of 14 316 total organ donors, of which 13 306 were kidney donors (7295 deceased donors and 6011 living donors), per year.1 During this same period (2007-2012), 43 026 people died while waiting for a transplant; 27 446 of those people were waiting for a kidney transplant.1 Although those numbers seem tragic enough, that total may even be deflated, as it does not include the number of people who die before they are ever listed or the 22 296 people (12 124 potential kidney recipients) removed from the waiting list because they were too sick to receive a transplant. Deaths occurring in those 2 groups are not tracked by the United Network for Organ Sharing, and the true total number of people dying without ever receiving a transplant is not documented.1 Carolina Donor Services is one of the 2 OPOs in the state of North Carolina, serving more than 100 hospitals (4 of which are transplant centers) in 77 counties of North Carolina and Danville, Virginia. This OPO aggressively pursues donation on all medically suitable brain-dead standard criteria donors and expanded criteria donors (ECD) equally. The Organ Procurement and Transplantation Network, for the purposes of kidney allocation, defines an ECD as any donor more than 60 years old or donors 50 to 59 years old with 2 of the following comorbid conditions: history of hypertension, most recent serum level of creatinine at the time of allocation greater than 1.5 mg/dL (to convert to micromoles per liter, multiply by 88.4), or death resulting from cerebrovascular accident. Standard criteria donors are defined as all other donors.7 Before this study, for those patients not declared brain dead, DCD was considered for standard criteria patients, but rarely pursued for expanded criteria patients. Recognizing that of the 97 280 people waiting for kidney transplants, 64% are at least 50 years old (41887 patients between the ages of 50 and 64 and 20 029 patients 65 years old and older),1 many of whom would most likely classify as ECD should they themselves become donors, this OPO embarked on a study to evaluate the potential of increasing the number of viable kidneys available for transplant by pursuing ECD/DCD candidates. Progress in Transplantation, Vol 24, No. 2, June 2014
Methods Before beginning the study, the study coordinator interviewed 2 of the most historically aggressive kidney transplant surgeons within our donor service area. The surgeons were asked for upper age limits and upper creatinine ranges and any other criteria that would prevent them from considering an expanded criteria patient as a candidate for DCD kidney donation. Based on the feedback received, staff at this OPO evaluated all medically suitable non–brain-dead patients who were less than 70 years old, had adequate urinary output, and had a creatinine level of 1.5 mg/dL or less for DCD potential. As a general rule, the OPO no longer used the potential donor’s ECD status as a strike against donation. If a non–brain-dead patient’s medical status would be acceptable as a brain-dead donor if deterioration to brain death were to occur, and cardiopulmonary arrest within 60 minutes after extubation was expected, then the patient was pursued as a potential DCD donor. During the course of this study, only kidneys were recovered from these ECD/DCD donors. Although studies have also shown that ECD kidneys that are sampled by biopsy have a higher discard rate than do ECD kidneys that are not sampled by biopsy,8 staff at this OPO, believing that sound medical judgment is dependent on obtaining the most information available, extended our normal practice of taking biopsy specimens from all ECD donor kidneys to the ECD/DCD study set. Likewise, several studies have shown that the use of pulsatile perfusion in ECD kidneys decreases the rate of delayed graft function8,9 and increases the utilization rates of ECD kidneys.10 It is the practice of this OPO to pump all kidneys from ECD donors and DCD donors on the LifePort Kidney Transporter manufactured by Organ Recovery Systems unless specifically requested otherwise by the accepting transplant surgeon or when pumping would interfere with transportation arrangements made when exporting a kidney outside of the donor service area. This practice was applied to the study set. Results During the 6-month study period (July 1-December 31, 2010), 6 potential ECD/DCD donors were identified. After authorization for donation had been obtained, during the 12-hour period awaiting results of serological tests, 2 donors deteriorated neurologically and were converted to brain-dead organ donors. Although those donors do not calculate into any of the statistical figures reported here, the study is credited for producing 2 additional donors that would not have been pursued if the study protocol had not been in place, as support would have been withdrawn before the further neurological decline. Four patients (50-60 years old) became actual ECD/DCD donors, with 8
207
DeLario et al Table 1 Study results (July 1, 2010-December 31, 2010)
Study period July-December 2010
ECD/DCD donors
Kidneys recovered
Kidneys transplanted
Transplant rate, %
Kidneys for research
Research rate, %
Kidneys discarded
Discard rate, %
4
8
5
62
0
0
3
38
Abbreviation: ECD/DCD, expanded criteria donation/donation after circulatory death.
kidneys recovered, 5 transplanted into 4 recipients (5073 years old), and 3 discarded (Table 1). The circumstances surrounding the 3 discarded kidneys during the study period seemed unrelated to the donors’ ECD/DCD classification. Two of the discarded kidneys were from a hepatitis B core antibodypositive donor and were provisionally accepted for transplant but were deemed nontransplantable after cancer was discovered during the organ recovery in the operating room. The third discarded kidney was from a high-risk, hepatitis C–positive donor. Rejection codes recorded in the United Network for Organ Sharing’s DonorNet system suggest that the donor’s high-risk status and positive serological test results contributed more to the inability to allocate that organ for transplant than the ECD/DCD status contributed. The other kidney from that same donor was transplanted. Local policies restrict the placement of organs with positive serological profiles for research. These policies, combined with the low number of ECD/DCD donors during the study period, may have contributed to the high discard rate (38%). To determine if the discard rate was acceptable when the 5 transplantable kidneys gained was considered, the overall OPO kidney discard rate including all donors in all classifications during the study period was calculated (10.8%, 20 discards in 186 kidneys recovered) and compared with the overall kidney discard rate when the study set was excluded (9.6%, 17 discards in 178 kidneys recovered). Study results were reviewed by the OPO’s Quality Council. The difference of 1.2% was deemed insignificant. This OPO implemented permanent practice changes by pursing ECD/DCD donors and tracking data for 24 subsequent months (January 1, 2011-December 31, 2012). During this tracking period after the study, a total of 20 ECD/DCD donors (11 in
2011, 52-72 years old, and 9 in 2012, 53-64 years old) yielded 40 kidneys recovered (22 in 2011 and 18 in 2012), 25 kidneys transplanted (16 in 2011 and 9 in 2012) into 22 recipients (44-74 years old), 7 kidneys placed for research (2 in 2011 and 5 in 2012), and 8 kidneys discarded (4 in 2011 and 4 in 2012; Table 2). Again, to determine if the discard rate was acceptable when the 25 transplantable kidneys gained in the 2 years after the study are considered, the overall kidney discard rate including all donors in all classifications was calculated: 13.7% (102 discards from 742 kidneys recovered), compared with 13.4% with the study set removed (94 discards from 702 kidneys). The difference of 0.3% was deemed insignificant. When the results from the study period and the observation period after the study, July 1, 2010, to December 31, 2012, are combined, pursuing ECD/ DCD donors resulted in 24 additional donors (ages 50-67), 48 kidneys recovered, 30 kidneys transplanted into 26 recipients (44-74 years old), 7 kidneys placed for research, and 11 kidneys discarded (Table 3). When all data from the 6-month study and the 24month observation period after the study are combined, the overall discard rate including all donors in all classifications was 13.1% (122 discards from 928 kidneys) compared with 12.6% (111 discards from 880 kidneys) when the study set is excluded. Although ECD/DCD donors still have the highest discard rates of all the groups, the 0.5% increase in the overall discard rate due to pursuing ECD/DCD kidneys was considered insignificant when compared with the benefit of the 30 additional kidneys transplanted. When considering reproducibility of results, it should be noted that this OPO serves aggressive local transplant surgeons. Of the 30 kidneys transplanted, 83% were transplanted locally, whereas 17% were
Table 2 Tracking period after study (January 1, 2011-December 31, 2012) ECD/DCD donors
Kidneys recovered
Kidneys transplanted
Transplant rate, %
Kidneys for research
2011
11
22
16
73
2012
9
18
9
50
Totals
20
40
25
62
Observation period
Research rate, %
Kidneys discarded
Discard rate, %
2
9
4
18
5
28
4
22
7
18
8
20
Abbreviation: ECD/DCD, expanded criteria donation/donation after circulatory death.
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Pursuing expanded criteria donors as candidates for kidney donation after circulatory death Table 3 Overall ECD/DCD results (July 1, 2010-December 31, 2012)
Study and observation period July 2010-December 2012
Overall ECD/DCD Kidneys Kidneys donors recovered transplanted 24
48
30
Transplant rate, %
Kidneys for research
Research rate
Kidneys discarded
Discard rate, %
62
7
15
11
23
Abbreviation: ECD/DCD, expanded criteria donation/donation after circulatory death.
transplanted outside of our donor service area. Likewise, this OPO also has established relationships with aggressive local researchers. All 7 of the kidneys placed for research in the study set were placed with local researchers. Research placement was not attempted for the 11 discarded kidneys, as authorization for research placement was not granted for 9 of the kidneys, and the remaining 2 had positive serological profiles. Access to aggressive transplant programs, relationships with aggressive research programs, and unpredictable research authorization rates should be considered variables that could affect overall discard rates. Although patients’ outcomes are of paramount importance, those outcomes were not used as measures of success for this study. However, the following outcomes are reported: 26 recipients received the 30 kidneys that were transplanted during the study and the observation period after the study, 1 recipient was less than 50 years old, 7 recipients were 50 to 59 years old, 12 recipients were 60 to 69 years old, and 6 recipients were 70 years old or older. Four recipients received 2 kidneys. Fourteen recipients experienced delayed graft function that required dialysis the first week after transplant. At the time of this publication, 3 recipients had experienced graft failure, whereas 23 recipients still have functioning grafts and are free from dialysis.11 Discussion Delayed graft function, defined as the need for dialysis within the first week after transplant, occurs in approximately 25% of deceased donor transplants.12 Studies have shown that both DCD and ECD kidneys are associated with higher rates of delayed graft function than are standard criteria kidneys.9,13,14 Results of most studies indicate that delayed graft function is associated with increased risk of acute rejection, poorer long-term graft survival, and adverse immediate posttransplant effects including increased cost due to lengthened hospital stays and dialysis. 1 2 , 1 3 , 1 5 Although lengthened hospital stays and inpatient dialysis have definite cost implications that should not be ignored, the burden of these short-term costs may be far outweighed by the decrease in dialysis cost in the long term. Moreover, kidney transplant offers a substantial survival benefit for dialysis patients who are Progress in Transplantation, Vol 24, No. 2, June 2014
on the waiting list. 16-18 Despite the expected higher incidence of delayed graft function and early graft loss, dialysis patients who are on the waiting list have longer life expectancies after DCD and ECD kidney transplant than do transplant candidates who continue on dialysis treatment.14,16,19 Conclusion Studies relating to the outcomes for recipients receiving ECD/DCD kidneys are limited. Data available from 2003 to 2010, before this study period, show inferior outcomes for ECD/DCD kidneys as compared with any other donor group.20 Continued study of these outcomes is needed. However, the United States has a critical organ shortage. There simply are not enough organs available to meet the needs of the patients waiting for lifesaving transplants. Moreover, 64% of the patients waiting for kidney transplants today are more than 50 years old, and many would be classified as expanded criteria recipients themselves. Criteria to be considered by transplant surgeons when determining the optimal recipients for ECD/DCD kidneys is outside of the scope of this publication and beyond the responsibility of the OPOs. However, in order to increase the number of kidneys available for transplant, OPOs must be aggressive in the pursuit of every potential donor, while maintaining focus on ethical and financial implications of such pursuits and balancing the associated risk and benefits. Including potential ECD/DCD patients in the donor pool increases the number of viable kidneys available for transplant without significantly increasing the overall kidney discard rates. Financial Disclosures None reported. References 1. US Department of Health and Human Services. http://optn .transplant.hrsa.gov. Accessed April 25, 2014. 2. Marks WH, Wagner D, Pearson TC, et al. Organ donation and utilization, 1995-2004: entering the collaborative era. Am J Transplant. 2006;6(5 pt 2):1101-1110. 3. Shafer TJ, Wagner D, Chessare J, Zampiello FA, McBride V, Perdue J. Organ donation breakthrough collaborative: increasing organ donation through system redesign. Crit Care Nurse. 2006;26(2):33-42,44-48. 4. Shafer TJ, Wagner D, Chessare J, et al. US Organ Donation Breakthrough Collaborative increases organ donation. Crit Care Nurs Q. 2008;31(3):190-210.
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DeLario et al 5. A definition of irreversible coma. Report of the Ad Hoc Committee of the Harvard Medical School to examine the Definition of Brain Death. JAMA. 1968;205(6):337-340. 6. Moser M, Sharpe M, Weernink C, et al. Five-year experience with donation after cardiac death kidney transplantation in a Canadian transplant program: factors affecting outcomes. Can Urol Assoc J. 2012;6(6):448-452. 7. Organ Procurement and Transplantation Network. Policy Management. Policy 3.5.1. http://optn.transplant.hrsa.gov /policiesAndBylaws. Accessed March 24, 2013. 8. Sung RS, Christensen LL, Leichtman AB, et al. Determinants of discard of expanded criteria donor kidneys: impact of biopsy and machine perfusion. Am J Transplant. 2008;8(4):783-792. 9. Matsuoka L, Shah T, Aswad S, et al. Pulsatile perfusion reduces the incidence of delayed graft function in expanded criteria donor kidney transplantation. Am J Transplant. 2006; 6(6):1473-1478. 10. United Network for Organ Sharing. DonorNet Portal Reporting Site. https://www.portal.unos.org. Accessed April 5, 2013. 11. Schold JD, Kaplain B, Howard RJ, Reed AI, Foley DP, MeierKriesche HU. Are we frozen in time? Analysis of the utilization and efficacy of pulsatile perfusion in renal transplantation. Am J Transplant. 2005;5(7):1681-1688. 12. Irish WD, Ilsley JN, Schnitzler MA, Feng S, Brennan DC. A risk prediction model for delayed graft function in the current era of deceased donor renal transplantation. Am J Transplant. 2010;10(10):2279-2286.
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13. Hall IE, Yarlagadda SG, Coca SG, et al. IL-18 and urinary NGAL predict dialysis and graft recovery after kidney transplantation. J Am Soc Nephrol. 2010;21(1):189-187. 14. Saidi RF, Elais N, Kawai T, et al. Outcome of kidney transplantation using expanded criteria donors and donation after cardiac death kidneys: realities and costs. Am J Transplant. 2007;7(12):2769-2774 15. Shoskes DA, Cecka JM. Deleterious effects of delayed graft function in cadaveric renal transplant recipients independent of acute rejection. Transplantation. 1998;66(12):1697-1701. 16. Snoeijs MG, Schaubel DE, Hene R, et al. Kidneys from donors after cardiac death provide survival benefit. J Am Soc Nephrol. 2010;21(6):1015-1021. 17. Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999;341(23):1725-1730. 18. Oniscu GC, Brown H, Forsythe JL. Impact of cadaveric renal transplantation on survival in patients listed for transplantation. J Am Soc Nephrol. 2005;16(6):1859-1865. 19. Merion RM, Ashby VB, Wolfe RA, et al. Deceased-donor characteristics and the survival benefit of kidney transplantation. JAMA. 2005;294(21):2726-2733. 20. Farney AC, Hines MH, al-Geizawi S, Rogers J, Stratta RJ. Lessons learned from a single center’s experience with 134 donation after cardiac death donor kidney transplants. J Am Coll Surg. 2011;212(4):440-451.
Progress in Transplantation, Vol 24, No. 2, June 2014
A
ccording to data from the Organ Procurement and Transplantation Network,1 when this article was written, 119 310 people were on the national transplant waiting list. Of this number, 97 280 people were waiting for kidneys. There is national recognition that there simply are not enough organs, especially kidneys, to meet the demand. From 1995 to 2003, several initiatives were designed to improve organ donation rates (eg, public education, minority education, and involving key medical professionals to ensure that all potential donors are identified and referred in a timely manner), which had resulted in 2% to 4% annual growth in the number of deceased donors.2 In 2003, The US Organ Donation Breakthrough Collaborative was started at the request of the Secretary of the US Department of Health and Human Services and included participation of the 300 US hospitals identified as having the largest organ donor potential
206
Ginger T. DeLario, PhD, MT (ASCP), CPTC, CTOP II, Jim Quetschenbach, RN, BSN, CPTC, Donna Croezen, RN, MSN, CPTC, Danielle Niedfeldt, RN, BSN, JD, CPTC, Julie Landon, RN, CPTC Carolina Donor Services, Durham, North Carolina Corresponding author: Ginger T. DeLario, PhD, MT (ASCP), CPTC, CTOP II, Carolina Donor Services, 3621 Lyckan Parkway, Durham, NC 27707 (e-mail: gdelario@carolinadonorservices .org) To purchase electronic or print reprints, contact: American Association of Critical-Care Nurses 101 Columbia, Aliso Viejo, CA 92656 Phone (800) 899-1712 (ext 532) or (949) 448-7370 (ext 532) Fax (949) 362-2049 E-mail [email protected]
and the 43 organ procurement organizations (OPOs) associated with them.2,3 The efforts of the Collaborative proved successful in the first year, with a 14.1% increase in the number of organ donors within the participating hospitals. With continued spread of those efforts to include 500 of the nation’s hospitals and 50 OPOs (2003-2006), the number of total US organ donors increased 22.5%.2,4 One of the high-leverage changes suggested during the Collaborative was implementation of donation after circulatory death (DCD).3 Although many hospitals and OPOs across the United States were not routinely pursuing DCD donors, this was not a revolutionary practice. Before the ad hoc committee of Harvard Medical School defined brain death criteria for the neurological determination of death in 1968,5 early organ recoveries involving deceased donors could occur only after cessation of circulatory and respiratory
Progress in Transplantation, Vol 24, No. 2, June 2014
Pursuing expanded criteria donors as candidates for kidney donation after circulatory death functions or circulatory determination of death.6 However, with brain-dead donors practically eliminating warm ischemic time, resulting in higher quality organs and appearing to provide an adequate supply of organs, DCD organ recoveries decreased substantially across the United States.6 Even though the Collaborative was successful in increasing and sustaining overall rates of organ donation from deceased donors, including an increase in DCD donors, as the number of candidates listed for transplant continues to increase, the number of available donors has remained relatively static. In the past 6 years (2007-2012), the total number of organ donors was 85 900, of which 79 836 were kidney donors (43 769 deceased donors and 36 067 living donors) for a mean of 14 316 total organ donors, of which 13 306 were kidney donors (7295 deceased donors and 6011 living donors), per year.1 During this same period (2007-2012), 43 026 people died while waiting for a transplant; 27 446 of those people were waiting for a kidney transplant.1 Although those numbers seem tragic enough, that total may even be deflated, as it does not include the number of people who die before they are ever listed or the 22 296 people (12 124 potential kidney recipients) removed from the waiting list because they were too sick to receive a transplant. Deaths occurring in those 2 groups are not tracked by the United Network for Organ Sharing, and the true total number of people dying without ever receiving a transplant is not documented.1 Carolina Donor Services is one of the 2 OPOs in the state of North Carolina, serving more than 100 hospitals (4 of which are transplant centers) in 77 counties of North Carolina and Danville, Virginia. This OPO aggressively pursues donation on all medically suitable brain-dead standard criteria donors and expanded criteria donors (ECD) equally. The Organ Procurement and Transplantation Network, for the purposes of kidney allocation, defines an ECD as any donor more than 60 years old or donors 50 to 59 years old with 2 of the following comorbid conditions: history of hypertension, most recent serum level of creatinine at the time of allocation greater than 1.5 mg/dL (to convert to micromoles per liter, multiply by 88.4), or death resulting from cerebrovascular accident. Standard criteria donors are defined as all other donors.7 Before this study, for those patients not declared brain dead, DCD was considered for standard criteria patients, but rarely pursued for expanded criteria patients. Recognizing that of the 97 280 people waiting for kidney transplants, 64% are at least 50 years old (41887 patients between the ages of 50 and 64 and 20 029 patients 65 years old and older),1 many of whom would most likely classify as ECD should they themselves become donors, this OPO embarked on a study to evaluate the potential of increasing the number of viable kidneys available for transplant by pursuing ECD/DCD candidates. Progress in Transplantation, Vol 24, No. 2, June 2014
Methods Before beginning the study, the study coordinator interviewed 2 of the most historically aggressive kidney transplant surgeons within our donor service area. The surgeons were asked for upper age limits and upper creatinine ranges and any other criteria that would prevent them from considering an expanded criteria patient as a candidate for DCD kidney donation. Based on the feedback received, staff at this OPO evaluated all medically suitable non–brain-dead patients who were less than 70 years old, had adequate urinary output, and had a creatinine level of 1.5 mg/dL or less for DCD potential. As a general rule, the OPO no longer used the potential donor’s ECD status as a strike against donation. If a non–brain-dead patient’s medical status would be acceptable as a brain-dead donor if deterioration to brain death were to occur, and cardiopulmonary arrest within 60 minutes after extubation was expected, then the patient was pursued as a potential DCD donor. During the course of this study, only kidneys were recovered from these ECD/DCD donors. Although studies have also shown that ECD kidneys that are sampled by biopsy have a higher discard rate than do ECD kidneys that are not sampled by biopsy,8 staff at this OPO, believing that sound medical judgment is dependent on obtaining the most information available, extended our normal practice of taking biopsy specimens from all ECD donor kidneys to the ECD/DCD study set. Likewise, several studies have shown that the use of pulsatile perfusion in ECD kidneys decreases the rate of delayed graft function8,9 and increases the utilization rates of ECD kidneys.10 It is the practice of this OPO to pump all kidneys from ECD donors and DCD donors on the LifePort Kidney Transporter manufactured by Organ Recovery Systems unless specifically requested otherwise by the accepting transplant surgeon or when pumping would interfere with transportation arrangements made when exporting a kidney outside of the donor service area. This practice was applied to the study set. Results During the 6-month study period (July 1-December 31, 2010), 6 potential ECD/DCD donors were identified. After authorization for donation had been obtained, during the 12-hour period awaiting results of serological tests, 2 donors deteriorated neurologically and were converted to brain-dead organ donors. Although those donors do not calculate into any of the statistical figures reported here, the study is credited for producing 2 additional donors that would not have been pursued if the study protocol had not been in place, as support would have been withdrawn before the further neurological decline. Four patients (50-60 years old) became actual ECD/DCD donors, with 8
207
DeLario et al Table 1 Study results (July 1, 2010-December 31, 2010)
Study period July-December 2010
ECD/DCD donors
Kidneys recovered
Kidneys transplanted
Transplant rate, %
Kidneys for research
Research rate, %
Kidneys discarded
Discard rate, %
4
8
5
62
0
0
3
38
Abbreviation: ECD/DCD, expanded criteria donation/donation after circulatory death.
kidneys recovered, 5 transplanted into 4 recipients (5073 years old), and 3 discarded (Table 1). The circumstances surrounding the 3 discarded kidneys during the study period seemed unrelated to the donors’ ECD/DCD classification. Two of the discarded kidneys were from a hepatitis B core antibodypositive donor and were provisionally accepted for transplant but were deemed nontransplantable after cancer was discovered during the organ recovery in the operating room. The third discarded kidney was from a high-risk, hepatitis C–positive donor. Rejection codes recorded in the United Network for Organ Sharing’s DonorNet system suggest that the donor’s high-risk status and positive serological test results contributed more to the inability to allocate that organ for transplant than the ECD/DCD status contributed. The other kidney from that same donor was transplanted. Local policies restrict the placement of organs with positive serological profiles for research. These policies, combined with the low number of ECD/DCD donors during the study period, may have contributed to the high discard rate (38%). To determine if the discard rate was acceptable when the 5 transplantable kidneys gained was considered, the overall OPO kidney discard rate including all donors in all classifications during the study period was calculated (10.8%, 20 discards in 186 kidneys recovered) and compared with the overall kidney discard rate when the study set was excluded (9.6%, 17 discards in 178 kidneys recovered). Study results were reviewed by the OPO’s Quality Council. The difference of 1.2% was deemed insignificant. This OPO implemented permanent practice changes by pursing ECD/DCD donors and tracking data for 24 subsequent months (January 1, 2011-December 31, 2012). During this tracking period after the study, a total of 20 ECD/DCD donors (11 in
2011, 52-72 years old, and 9 in 2012, 53-64 years old) yielded 40 kidneys recovered (22 in 2011 and 18 in 2012), 25 kidneys transplanted (16 in 2011 and 9 in 2012) into 22 recipients (44-74 years old), 7 kidneys placed for research (2 in 2011 and 5 in 2012), and 8 kidneys discarded (4 in 2011 and 4 in 2012; Table 2). Again, to determine if the discard rate was acceptable when the 25 transplantable kidneys gained in the 2 years after the study are considered, the overall kidney discard rate including all donors in all classifications was calculated: 13.7% (102 discards from 742 kidneys recovered), compared with 13.4% with the study set removed (94 discards from 702 kidneys). The difference of 0.3% was deemed insignificant. When the results from the study period and the observation period after the study, July 1, 2010, to December 31, 2012, are combined, pursuing ECD/ DCD donors resulted in 24 additional donors (ages 50-67), 48 kidneys recovered, 30 kidneys transplanted into 26 recipients (44-74 years old), 7 kidneys placed for research, and 11 kidneys discarded (Table 3). When all data from the 6-month study and the 24month observation period after the study are combined, the overall discard rate including all donors in all classifications was 13.1% (122 discards from 928 kidneys) compared with 12.6% (111 discards from 880 kidneys) when the study set is excluded. Although ECD/DCD donors still have the highest discard rates of all the groups, the 0.5% increase in the overall discard rate due to pursuing ECD/DCD kidneys was considered insignificant when compared with the benefit of the 30 additional kidneys transplanted. When considering reproducibility of results, it should be noted that this OPO serves aggressive local transplant surgeons. Of the 30 kidneys transplanted, 83% were transplanted locally, whereas 17% were
Table 2 Tracking period after study (January 1, 2011-December 31, 2012) ECD/DCD donors
Kidneys recovered
Kidneys transplanted
Transplant rate, %
Kidneys for research
2011
11
22
16
73
2012
9
18
9
50
Totals
20
40
25
62
Observation period
Research rate, %
Kidneys discarded
Discard rate, %
2
9
4
18
5
28
4
22
7
18
8
20
Abbreviation: ECD/DCD, expanded criteria donation/donation after circulatory death.
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Pursuing expanded criteria donors as candidates for kidney donation after circulatory death Table 3 Overall ECD/DCD results (July 1, 2010-December 31, 2012)
Study and observation period July 2010-December 2012
Overall ECD/DCD Kidneys Kidneys donors recovered transplanted 24
48
30
Transplant rate, %
Kidneys for research
Research rate
Kidneys discarded
Discard rate, %
62
7
15
11
23
Abbreviation: ECD/DCD, expanded criteria donation/donation after circulatory death.
transplanted outside of our donor service area. Likewise, this OPO also has established relationships with aggressive local researchers. All 7 of the kidneys placed for research in the study set were placed with local researchers. Research placement was not attempted for the 11 discarded kidneys, as authorization for research placement was not granted for 9 of the kidneys, and the remaining 2 had positive serological profiles. Access to aggressive transplant programs, relationships with aggressive research programs, and unpredictable research authorization rates should be considered variables that could affect overall discard rates. Although patients’ outcomes are of paramount importance, those outcomes were not used as measures of success for this study. However, the following outcomes are reported: 26 recipients received the 30 kidneys that were transplanted during the study and the observation period after the study, 1 recipient was less than 50 years old, 7 recipients were 50 to 59 years old, 12 recipients were 60 to 69 years old, and 6 recipients were 70 years old or older. Four recipients received 2 kidneys. Fourteen recipients experienced delayed graft function that required dialysis the first week after transplant. At the time of this publication, 3 recipients had experienced graft failure, whereas 23 recipients still have functioning grafts and are free from dialysis.11 Discussion Delayed graft function, defined as the need for dialysis within the first week after transplant, occurs in approximately 25% of deceased donor transplants.12 Studies have shown that both DCD and ECD kidneys are associated with higher rates of delayed graft function than are standard criteria kidneys.9,13,14 Results of most studies indicate that delayed graft function is associated with increased risk of acute rejection, poorer long-term graft survival, and adverse immediate posttransplant effects including increased cost due to lengthened hospital stays and dialysis. 1 2 , 1 3 , 1 5 Although lengthened hospital stays and inpatient dialysis have definite cost implications that should not be ignored, the burden of these short-term costs may be far outweighed by the decrease in dialysis cost in the long term. Moreover, kidney transplant offers a substantial survival benefit for dialysis patients who are Progress in Transplantation, Vol 24, No. 2, June 2014
on the waiting list. 16-18 Despite the expected higher incidence of delayed graft function and early graft loss, dialysis patients who are on the waiting list have longer life expectancies after DCD and ECD kidney transplant than do transplant candidates who continue on dialysis treatment.14,16,19 Conclusion Studies relating to the outcomes for recipients receiving ECD/DCD kidneys are limited. Data available from 2003 to 2010, before this study period, show inferior outcomes for ECD/DCD kidneys as compared with any other donor group.20 Continued study of these outcomes is needed. However, the United States has a critical organ shortage. There simply are not enough organs available to meet the needs of the patients waiting for lifesaving transplants. Moreover, 64% of the patients waiting for kidney transplants today are more than 50 years old, and many would be classified as expanded criteria recipients themselves. Criteria to be considered by transplant surgeons when determining the optimal recipients for ECD/DCD kidneys is outside of the scope of this publication and beyond the responsibility of the OPOs. However, in order to increase the number of kidneys available for transplant, OPOs must be aggressive in the pursuit of every potential donor, while maintaining focus on ethical and financial implications of such pursuits and balancing the associated risk and benefits. Including potential ECD/DCD patients in the donor pool increases the number of viable kidneys available for transplant without significantly increasing the overall kidney discard rates. Financial Disclosures None reported. References 1. US Department of Health and Human Services. http://optn .transplant.hrsa.gov. Accessed April 25, 2014. 2. Marks WH, Wagner D, Pearson TC, et al. Organ donation and utilization, 1995-2004: entering the collaborative era. Am J Transplant. 2006;6(5 pt 2):1101-1110. 3. Shafer TJ, Wagner D, Chessare J, Zampiello FA, McBride V, Perdue J. Organ donation breakthrough collaborative: increasing organ donation through system redesign. Crit Care Nurse. 2006;26(2):33-42,44-48. 4. Shafer TJ, Wagner D, Chessare J, et al. US Organ Donation Breakthrough Collaborative increases organ donation. Crit Care Nurs Q. 2008;31(3):190-210.
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DeLario et al 5. A definition of irreversible coma. Report of the Ad Hoc Committee of the Harvard Medical School to examine the Definition of Brain Death. JAMA. 1968;205(6):337-340. 6. Moser M, Sharpe M, Weernink C, et al. Five-year experience with donation after cardiac death kidney transplantation in a Canadian transplant program: factors affecting outcomes. Can Urol Assoc J. 2012;6(6):448-452. 7. Organ Procurement and Transplantation Network. Policy Management. Policy 3.5.1. http://optn.transplant.hrsa.gov /policiesAndBylaws. Accessed March 24, 2013. 8. Sung RS, Christensen LL, Leichtman AB, et al. Determinants of discard of expanded criteria donor kidneys: impact of biopsy and machine perfusion. Am J Transplant. 2008;8(4):783-792. 9. Matsuoka L, Shah T, Aswad S, et al. Pulsatile perfusion reduces the incidence of delayed graft function in expanded criteria donor kidney transplantation. Am J Transplant. 2006; 6(6):1473-1478. 10. United Network for Organ Sharing. DonorNet Portal Reporting Site. https://www.portal.unos.org. Accessed April 5, 2013. 11. Schold JD, Kaplain B, Howard RJ, Reed AI, Foley DP, MeierKriesche HU. Are we frozen in time? Analysis of the utilization and efficacy of pulsatile perfusion in renal transplantation. Am J Transplant. 2005;5(7):1681-1688. 12. Irish WD, Ilsley JN, Schnitzler MA, Feng S, Brennan DC. A risk prediction model for delayed graft function in the current era of deceased donor renal transplantation. Am J Transplant. 2010;10(10):2279-2286.
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13. Hall IE, Yarlagadda SG, Coca SG, et al. IL-18 and urinary NGAL predict dialysis and graft recovery after kidney transplantation. J Am Soc Nephrol. 2010;21(1):189-187. 14. Saidi RF, Elais N, Kawai T, et al. Outcome of kidney transplantation using expanded criteria donors and donation after cardiac death kidneys: realities and costs. Am J Transplant. 2007;7(12):2769-2774 15. Shoskes DA, Cecka JM. Deleterious effects of delayed graft function in cadaveric renal transplant recipients independent of acute rejection. Transplantation. 1998;66(12):1697-1701. 16. Snoeijs MG, Schaubel DE, Hene R, et al. Kidneys from donors after cardiac death provide survival benefit. J Am Soc Nephrol. 2010;21(6):1015-1021. 17. Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999;341(23):1725-1730. 18. Oniscu GC, Brown H, Forsythe JL. Impact of cadaveric renal transplantation on survival in patients listed for transplantation. J Am Soc Nephrol. 2005;16(6):1859-1865. 19. Merion RM, Ashby VB, Wolfe RA, et al. Deceased-donor characteristics and the survival benefit of kidney transplantation. JAMA. 2005;294(21):2726-2733. 20. Farney AC, Hines MH, al-Geizawi S, Rogers J, Stratta RJ. Lessons learned from a single center’s experience with 134 donation after cardiac death donor kidney transplants. J Am Coll Surg. 2011;212(4):440-451.
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