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Cost Evaluation of a Donation after Cardiac Death Program: How Cost per Organ Compares to Other Donor Types
Accepted Manuscript A Cost Evaluation of a Donation after Cardiac Death Program: How Cost per Organ Compares to Other Donor Types Jessica Lindemann, MD, Leigh Anne Dageforde, MD, MPH, Neeta Vachharajani, BS, Emily Stahlschmidt, BS, Diane Brockmeier, RN, BSN, MA, Jason R. Wellen, MD, MBA, FACS, Adeel Khan, MD, MPH, FACS, William C. Chapman, MD, FACS; MB, Majella Doyle, MD, MBA, FACS PII:
S1072-7515(18)30159-5
DOI:
10.1016/j.jamcollsurg.2018.02.005
Reference:
ACS 9074
To appear in:
Journal of the American College of Surgeons
Received Date: 3 January 2018 Revised Date:
14 February 2018
Accepted Date: 16 February 2018
Please cite this article as: Lindemann J, Dageforde LA, Vachharajani N, Stahlschmidt E, Brockmeier D, Wellen JR, Khan A, Chapman WC, Doyle M, A Cost Evaluation of a Donation after Cardiac Death Program: How Cost per Organ Compares to Other Donor Types, Journal of the American College of Surgeons (2018), doi: 10.1016/j.jamcollsurg.2018.02.005. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1 A Cost Evaluation of a Donation after Cardiac Death Program: How Cost per Organ Compares to Other Donor Types Jessica Lindemann, MDa; Leigh Anne Dageforde, MD, MPHa; Neeta Vachharajani, BSa; Emily
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Stahlschmidt, BSb; Diane Brockmeier, RN, BSN, MAb; Jason R Wellen, MD, MBA, FACSa; Adeel Khan, MD, MPH, FACSa; William C Chapman, MD, FACSa; MB Majella Doyle, MD,
a
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MBA, FACSa
Department of Surgery, Division of Abdominal Organ Transplantation, Washington University
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School of Medicine, St Louis, MO b
Mid America Transplant Services, St Louis, MO
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Disclosure Information: Nothing to disclose. Disclosures outside the scope of this work: Dr Chapman is a board member of Novartis and XOR Labs, and is an intellectual property owner of Pathfinder. Presented at the Western Surgical Association 125th Scientific Session, Scottsdale, AZ, November 2017.
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Corresponding Author Address: MB Majella Doyle, MD, MBA, FACS Department of Surgery Section of Abdominal Transplantation Washington University School of Medicine 660 S Euclid Ave Campus Box 8109 St Louis, MO 63110 Phone: (314) 362-2880 Email: [email protected]
Running Head: Costs of Donation after Cardiac Death
ACCEPTED MANUSCRIPT 2 Abstract BACKGROUND: Donation after cardiac death (DCD) is one method of organ donation. Nationally, more than half of evaluated DCD donors do not yield transplantable organs. There is
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no algorithm for predicting which DCD donors will be appropriate for organ procurement. DCD program costs from an organ procurement organization (OPO) accounting for all evaluated donors have not been reported.
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STUDY DESIGN: Hospital, transportation, and supply costs of potential DCD donors evaluated at a single OPO from January 2009 to June 2016 were collected. Average costs per donor and per
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organ were calculated. Cost of DCD donors that did not yield a transplantable organ were included in cost analyses resulting in total cost of the DCD program. DCD donor costs were compared to costs of in hospital donation after brain death (DBD) donors. RESULTS: There were 289 organs transplanted from 264 DCD donors evaluated. Average cost
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per DCD donor yielding transplantable organs was $9,306. However, 127 donors yielded no organs at an average cost of $8,794 per donor. The total cost of the DCD program was $32,020 per donor and $15,179 per organ. The average cost for an in hospital DBD donor was $33,546
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and $9,478 per organ transplanted. Average organ yield for DBD donors was 3.54 versus 2.21 for DCD donors (p<0.0001), making the cost per DBD organ 63% of the cost of a DCD organ.
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CONCLUSIONS: The average cost per DCD donor is comparable to DBD donors however, individual cost of DCD organs increases by almost forty percent when all costs of an entire DCD program are included.
Key Words: donation after cardiac death; cost; organ yield; organ procurement organization
ACCEPTED MANUSCRIPT 3 Abbreviations: DBD, donation after brain death; DCD, donation after cardiac death; ICER, incremental cost effectiveness ratio; OPC, organ procurement center; OPO, organ procurement organization; OR,
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operating room; OPTN, organ procurement and transplantation network; QALY, quality adjusted
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life year
ACCEPTED MANUSCRIPT 4 Introduction As of 2017, there are over 75,000 active and 116,000 total patients on the waiting list for organ transplantation in the United States (1). While the number of transplants performed each year
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continues to rise, a significant need remains as the number of patients on the waiting list
increases at a pace more rapid than the number of transplants performed (2). Donation after cardiac death (DCD) is one approach to abate the organ shortage, although organ yield per donor
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is generally expected to be less than for donation after brain death (DBD) donors. For potential donors with devastating neurologic injury with no anticipated recovery who do not meet brain
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death criteria, DCD is a way to still give families the option to participate in the organ donation process. In DCD, all life support is withdrawn from the patient by a physician not associated with the organ procurement team. Once there is cardiac death with no appreciated cardiac rhythm, the donor is declared dead by their physician. The time to initiation of organ
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procurement is determined on an organ procurement organization (OPO) basis. For our OPO the wait time is five minutes. Transplant centers generally have requirements for time from withdrawal to organ flush with preservation solution due to reports of potential organ damage
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leading to post transplant complications for prolonged warm ischemic times. According to national data from the Organ Procurement and Transplantation Network
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and Scientific Registry of Transplant Recipients 2015 Annual Data Report on DCD donors, organ yield per DCD donor in 2015 was 1.93 and per DBD donor was 3.25(3). For DCD donors, this yield per donor does not include those potential donors who undergo evaluation, but do not progress to donation for a variety of reasons. Some donors do not progress to donation because they do not progress to cardiac death within a time frame suitable for transplantation. Other organs may not be suitable for transplant once they are procured. When all potential DCD donors
ACCEPTED MANUSCRIPT 5 are accounted for, the organ yield per DCD donor decreases. Unfortunately, there is no established algorithm for predicting which potential DCD donors proceed to cardiac death within a suitable time frame to be appropriate for procurement. Despite the expected lower yield, the
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shortage of organs for transplantation is so great all potential donation options must be utilized. Several studies have considered the cost of DCD donation to the organ recipient and to society (4-6). However, these studies do not include cost of organ procurement, which can be
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significant and should also be taken into consideration. An OPO assumes responsibility for all costs of the potential donor starting at the time of consent for organ donation. This includes any
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clinical investigations, operating room charges, and ICU care. The percentage of the total charges paid by the OPO varies between individual OPOs. Individual charges per donor also vary greatly by donor and by hospital. All of these factors should be accounted for in a DCD donor cost analysis.
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The demand for organs for transplantation significantly exceeds supply of organs and organ procurement costs are high. To fully quantify cost associated with organ transplantation, cost of procurement should be investigated. However, DCD program costs from an OPO
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perspective accounting for all evaluated donors have not previously been reported. In addition, it is unknown how the cost of an entire DCD program compares with the cost of a DBD program.
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With this cost analysis, we aim to determine the total cost of a DCD program compared to in hospital DBD donation within a single OPO. Our OPO is unique in that we have an organ procurement center (OPC) where all DBD
donors are transferred soon after family consent for donation is obtained. All donor evaluations are performed at the OPC prior to procurement. In a previous publication, we found that it costs 50% less to transfer a potential DBD donor to the OPC than to perform the procurement at the
ACCEPTED MANUSCRIPT 6 original hospital(7). This is because fees for investigations for donor evaluation and ICU stay are lower at the OPC. We are also able to better maximize organ yield, effectively lowering cost per organ. However, there are three specific criteria that donors have to meet prior to transfer. The
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family needs to give consent to transfer the donor, the donor must be hemodynamically stable, defined as requiring two or less pressors, and the donor must weigh at least 35 pounds.
Additionally, there are some hospitals with policies that do not allow donors to be transferred for
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procurement.
For DBD donors who do not meet criteria for transfer because of instability, it is difficult
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to predict if there will be more or less associated procurement costs as compared to OPC DBD procurements. Unstable donors can be expedited to the OR for procurement, or procurement can be delayed while stabilization is attempted, resulting in the use of more resources in a donor with potentially lower than average yield. For the purpose of this analysis, only the costs of DBD
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donor procurements performed in hospital are used for comparison, as the procurement process for in hospital DBD donors is more similar to DCD donor procurement. Due to the nature of DCD donation, donors often undergo less evaluation and spend a shorter time in hospital prior to
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procurement than DBD donors. We hypothesized that this will result in generally lower cost per
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donor when compared to DBD donation.
Methods
Costs related to transportation, operating room (OR) supplies, investigations, and hospital fees for all DCD evaluations and donors at a single OPO were collected from January 2009 to June 2016. Costs were not adjusted for inflation. In the Mid America Transplant area, donor hospital charges are paid at a rate of 70% of the total, but can be as high as 100% of billed charges for
ACCEPTED MANUSCRIPT 7 other OPOs. Ground or air transportation was determined by distance from donor to hospital. Generally, ground transport was used for a donor within 90 miles and air transport was used for donors greater than 90 miles from the hospital where the transplant will be performed, per OPO
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policy. All DCD donors were procured in hospital and were not transferred to an OPC. DCD donors during the period of study were divided into four groups for the purpose of analysis: [1] potential donors evaluated, but turned down [2] those approved for donation, but did not expire
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within the specified time, which at our OPO has been approximately 20 minutes for liver and 60 minutes for kidney procurement [3] donors who proceeded to surgery, but had all organs
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discarded after procurement [4] donors with at least one organ procured and transplanted. Discarded organs included those organs procured, but used for research. For donors with at least one organ transplanted, there may have also been discarded organs. Discarded organs were those considered to be unsuitable for transplantation after they had been procured.
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Kidneys, livers and lungs either discarded or used for research have the same associated cost to the OPO as a transplanted organ. For this reason, cost was allocated equally to each kidney, liver and lung procured regardless of end use. However, in DCD donors, heart, small
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bowel and pancreas procurement is always performed with the intention for use in research and result in minimal cost to the OPO. Thus, the procurement of any heart, small bowel or pancreas
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was not included in the cost analysis. Kidneys procured en bloc and double lungs were counted as one organ as they are transplanted into a single recipient. For each of the four groups, total cost per group and average cost per donor were
calculated per year and over the course of the study. The potential donors evaluated, but turned down group and those approved for donation, but did not expire within the OPO specified time group were combined into one, as all potential donors did not progress to procurement. For the
ACCEPTED MANUSCRIPT 8 organs discarded group average cost per organ discarded was also determined. Total costs and average cost per organ transplanted were calculated per year and in total over the duration of the study for the organs transplanted group. To determine the effect of DCD program cost on cost
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per organ transplanted, calculations were performed twice. The first calculation included all costs from the DCD program; the second used only costs associated with donors who had at least one organ transplanted. Costs from all four groups of DCD donors were included in this analysis,
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which allowed for calculation of total costs of the DCD program for a single OPO.
Transportation and OR supply costs were calculated separately due to billing. The cost
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was then added to evaluation and hospital costs to obtain the total cost of each donor group. These totals were then used to calculate total cost per donor and per organ. Organ yield was calculated by dividing the total number of organs procured for transplant by the number of DCD donors. This was performed as a total over the duration of the study for the organs transplanted
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group only and then again for the DCD and DBD programs of the same OPO. A subanalysis of rapid DCD donors was performed to determine whether this type of donor might offer a potential opportunity for increasing DCD yield. A rapid DCD donor was
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defined as having a consent to OR time less than 8 hours. Organ yield was calculated as total organs transplanted per rapid DCD donor over the duration of the study.
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DCD donor costs were compared to average costs of in hospital DBD donors only from
the same OPO from 2009-2014 (7). All data were collected on an MS Access Database (Microsoft) and analyzed using GraphPad Prism software, version 5.0. Categorical variables were presented as numbers and percentages. Continuous variables (eg, costs) were presented as means. A p value <0.05 was considered statistically significant.
ACCEPTED MANUSCRIPT 9 Results Over the course of the study, 264 potential DCD donors were evaluated. Of those, 137 donors (52%) resulted in a total of 289 organs transplanted. The remaining 48% of potential donors (n=
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127) were evaluated, but did not have organs recovered for transplantation. Thirty eight were determined to be ineligible for donation and 77 progressed to surgery, but did not expire within the OPO designated time. Twelve had organs procured, but either all discarded or used for
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research. Of the 289 organs, there were 243 kidneys, 40 livers and 6 lungs transplanted (Figure 1).
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The average cost of evaluation of a DCD donor that did not progress to surgery was $8,794. DCD donors who proceeded to surgery, but did not expire had a higher average cost at $16,695 due to the additional transportation, OR and supply charges (Table 1). For DCD donors who yielded at least one transplantable organ, the average cost per donor was $19,630 and the
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average cost per organ was $9,306 (Table 1). For the organs discarded group of DCD donors, the cost per organ discarded was calculated to be about $2,600 less per organ than the organs transplanted group (Table 1).
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When costs from all groups were included to calculate cost per donor and cost per organ for the DCD donor program, the average cost of a DCD donor yielding at least one organ
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suitable for transplantation increased by 38.7% from $19,630 to $32,020. This resulted in an increase in cost per organ to $15,179 from $9,306 (Table 1). Cost of transportation and OR supplies together made up 40% of total costs of the DCD program. Air transport was more expensive than ground, costing nearly 4 times the amount per donor. Eighty eight donors required air transport, the majority of which were in the organs transplanted group (n=46), although there were 39 donors requiring air transportation that were either turned down or did
ACCEPTED MANUSCRIPT 10 not expire (Table 2). The remaining 176 donors were reached by ground transportation. For the discarded organs or those used for research that came from donors who also had organs procured for transplantation, transport and OR supplies per organ procured and discarded or transplanted
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was $3,811 (Table 2).
DCD organ yield over the course of the study was found to be 2.12 (SD ± 0.75) organs per donor, whereas DBD organ yield was significantly higher at 3.57 (SD ± 1.17, p <0.0001)
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organs per donor. DCD donor organ yield decreased to 1.10 when all DCD donors evaluated, including those that did not proceed to surgery, were included (Table 3). When DCD donor and
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in hospital DBD donor costs were compared over the same study period, costs were similar. Average in hospital DBD donor costs were $33,546 while DCD costs were $32,020 (Table 1). However, cost per organ transplanted differed by nearly $6,000, making the cost of an organ from DBD donation approximately 60% of the cost per DCD organ (Figure 2). When cost per
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organ transplanted was compared between in hospital DBD donor organs and only DCD donors who had at least one organ transplanted, the cost per organ was very similar between a DCD donor ($9,306/organ) versus for a DBD organ ($9,478/organ) (Figure 2).
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When a subanalysis of rapid DCD donors was performed, 34 of the 264 total donors (13%) met the rapid DCD donor criteria. There were 56 organs transplanted. This resulted in an
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organ yield of 1.65 per rapid DCD donor. Nearly all organs transplanted were kidneys (n=55) with only one liver transplantation. Nine kidneys were discarded, 2 kidneys used for research and another 5 livers were also used for research after all were found to be unsuitable for transplantation (Table 4).
Discussion
ACCEPTED MANUSCRIPT 11 DCD donation was similar in cost per donor when compared to in hospital DBD donation. The cost per DCD and DBD donors differed by approximately $1,500, with DCD donors being the slightly less costly of the two. There was less than a $200 difference in cost per organ in DCD
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and DBD donors when all DCD program costs were excluded. However, when cost per organ was compared using all DCD program costs, in hospital DBD organs were markedly less costly than DCD organs by more than $5,000 per organ. The cost per organ from a DCD donor was 60
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percent higher than from an in hospital DBD donor. This was the result of two important factors. Firstly, the organ yield from a DBD donor was nearly twice that of a DCD donor, significantly
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lowering cost per organ yielded for DBD organs. Secondly, nearly 40 percent of the DCD program costs were from donors who were evaluated but did not progress to donation. Transportation and OR supply costs made up a significant portion of all DCD program costs. Air transportation contributed the most with an average of $12,840 per donor, whereas
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ground transport was only $3,708, nearly four times less per donor. One third of all donors required air transportation, but represent nearly two thirds of the total transportation and OR supplies cost. Of the donors that required air transportation, 39 (44%) were donors that were
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either turned down or did not expire within the OPO designated time. This potential donor population represents an opportunity for cost savings for a DCD program
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Organ yield per DCD donor in this study was comparable to organ yield nationally over
the same time period (2). However, when all donors evaluated were included, organ yield fell from a 2.21 to 1.10 average over the duration of the study. The national number for all donors evaluated but not progressing is not available for comparison. As expected, the average cost per donor increased as donor interventions and clinical investigations increased. The difference in cost per donor between those DCD donors with organs discarded and those with organs
ACCEPTED MANUSCRIPT 12 transplanted was just over $1,300 despite requiring similar OR and hospital resources. This was likely secondary to differences in organ yield and transportation fees between the two groups. Rapid DCD donors made up 13% of all total donors and had an average organ yield of
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1.65 per donor, compared to a yield of 2.21 for DCD donors with at least one organ transplanted. This lower yield is largely due to the inability to wait for serology results to be completed for liver transplantation, essentially eliminating the use of livers from these donors. This represents
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an opportunity to potentially increase DCD donor yield, if rapid DCD donors could be converted to regular DCD donors to allow for serologies to be sent and results received.
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In this study, an organ discarded was defined as kidneys or livers discarded or used for research from DCD donors that had no organs transplanted. Due to the nature of DCD donation, heart, pancreas, and small bowel organs were excluded from organ discard calculations because they are rarely procured with intent to transplant. There were no lungs discarded or used for
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research from this donor group, but as they can be procured for transplant in DCD donors, they would have been included in the organs discarded total if present. The nature of DCD donation limits our ability to increase yield per donor in the same ways we can work to increase yield in
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DBD donors for three reasons: 1) often families want to move quicker to donation and will not wait for serologies to return thus limiting these “rapid” DCD procurements to kidney only rather
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than kidney and liver procurement, 2) traditionally heart and intestine are not used in the DCD setting, and 3) often centers have strict guidelines for at what timeframe after withdrawal of support the organs may be suitable for transplantation although some centers are willing to consider a longer warm time especially if oxygen saturation and blood pressure is maintained (7). Furthermore, only a few very selective programs are using pancreas and lungs, although lung and pancreas transplants with DCD donor organs are increasing (8-9).
ACCEPTED MANUSCRIPT 13 One strategy to address the problem of low yield and excess cost is to carefully consider resource allocation for donor evaluation. A possible solution to increase DCD organ yield and reduce program cost associated with evaluating potential DCD donors is the use of a prediction
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model. One such model, named the University of Wisconsin Donation after Cardiac Death
Evaluation Tool, was developed with the intention of identifying those donors most likely to expire by 60 and 120 minutes following withdrawal of life support. Initial data showed
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promising results. Using this tool they were able to predict suitability for DCD donation at 60 minutes 83.7% of the time and 74.4% of the time at 120 minutes (10). A second model, called
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DCD N for DCD donation in a neurocritical state, used a combination of physical exam findings and oxygenation index. It was found to have a sensitivity of 72% for predicting death at 60 minutes (11). A subsequent comparison study between the University of Wisconsin model, the DCD N model and the medical team’s prediction after assessment, found that the degree of
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sensitivity between the three was not significant enough for either model to be useful in clinical practice (12). Currently, there is no model for determination of suitability of DCD donation that is widely used or accepted in clinical practice. If one were to be developed, there is great
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potential for increased organ yield and cost reduction in DCD donation. There are some limitations to our study that should be recognized. This study is based on
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a single OPO experience. However, while the single center OPO is a limitation, cost data is difficult to obtain from OPOs and may vary by region and center. By using just one OPO we are consistent in our comparisons. We also did not have cost data for surgeon’s fees, however this fee is consistent across all donors regardless of organs procured and it was universally excluded from all donors for cost calculations.
ACCEPTED MANUSCRIPT 14 This OPO has a donor procurement center where the majority of DBD procurements occur. Donors at the center cost significantly less than in hospital DBD donors, therefore we only included in hospital DBD donor costs in our analysis. However, the cost of DBD donors
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evaluated, but do not progress to donation was not included because it is impossible to know which of the potential DBD donors who do not progress would have been procured in hospital versus at the OPC. From a previous publication, we found that only about 10% of DBD donors
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in our OPO are procured in hospital, so it would be inaccurate to attribute all of the cost for DBD donors who do not progress to the in hospital DBD donor costs (7). For a more complete
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comparison, the following data were extrapolated. From 2009-2014 there were 156 DBD donors evaluated, but did not progress to donation, which resulted in a total cost of $1,341,138 and an average cost per donor evaluated, but did not progress of $8,597. When this was added to the cost of the in hospital DBD donors, there was an increase in average total cost per donor to
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$34,861 compared to $32,020 per DCD donor. However, DCD donor organs remained more expensive with a cost per organ of $15,179 compared to the adjusted cost per DBD donor organ of $9,850.
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Finally, this study focuses only on DCD donor costs to the OPO, but the cost of organ transplantation extends beyond procurement to transplantation and ongoing medical care.
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Currently, there is no cost analysis that evaluates the total cost of organ transplantation per quality-adjusted life year (QALY) gained. A figure that is commonly used to benchmark costeffectiveness of a medical intervention is the incremental cost effectiveness ratio (ICER). This is the additional cost per QALY gained from a medical intervention. An ICER of $50,000/QALY is the generally accepted threshold for a cost-effective medical treatment in the US. However, that value was established in the early 1990’s after an influential cost-effective analysis of
ACCEPTED MANUSCRIPT 15 hemodialysis versus kidney transplant was published (13). Recently, a threshold of $100,000$150,000/QALY gained was recommended (14). A comprehensive cost-effective analysis,
being met, should be a focus of research in the future.
Conclusions
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including organ procurement costs for organ transplantation to evaluate whether this threshold is
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Overall, DCD donors did increase the organ supply by allowing for the transplantation of 289 organs; however, the increase in organs transplanted was not without a cost. Thirty nine percent
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of DCD program cost was attributable to DCD donors who did not yield organs suitable for transplantation. When total program costs were excluded, the cost per DCD donor organ transplanted was slightly less than cost per organ transplanted from an in hospital DBD donor. The development of a prediction model that will identify DCD donors most likely to progress to
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donation would significantly decrease the cost of a DCD donor program and make DCD donation equivalent in cost to DBD donation.
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Acknowledgements: The authors would like to acknowledge Rich Rothweiler from Mid
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America Transplant for his contribution.
ACCEPTED MANUSCRIPT 16 References: 1. Organ Procurement and Transplantation Network. Waiting list and donor numbers. Available at: http://optn.transplant.hrsa.gov/. Accessed on 4 September, 2017.
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2. Organ Procurement and Transplantation Network. National Data. Available at:
https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/. Accessed on 4 September, 2017.
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3. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of
Transplant Recipients (SRTR). OPTN/SRTR 2015 Annual Data Report. Rockville, MD:
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Department of Health and Human Services, Health Resources and Services Administration; 2016.
4. Saidi RF, Elias 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
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2007;7:2769-2774.
5. Dageforde LA, Feurer ID, Pinson CW, Moore DE. Is liver transplantation using organs donated after cardiac death cost effective or does it decrease waitlist death by increasing
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recipient death? HPB 2013;15:182-189.
6. van der Hilst CS, Ijtsma AJC, Bottema JT, et al. The price of donation after cardiac death in
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liver transplantation: a prospective cost effectiveness study. Transpl Int 2013;26:411-418. 7. Doyle MBM, Subramanian V, Vachharajani N, et al. Organ Donor Recovery Performed at an Organ Procurement Organization Based Facility Is an Effective Way to Minimize Organ Recovery Costs and Increase Organ Yield. J Am Coll Surg 2016;222:591-600.
ACCEPTED MANUSCRIPT 17 8. Cypel M, Levvey B, van Raemdonck D, et al. International Society for Heart and Lung Transplantation Donation After Circulatory Death Registry Report. Journal of Heart and Lung Transplantation 2015;34: 1278-1282.
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9. Kopp W, Lam HD, Schaapherder AM, et al. Pancreas transplantation with grafts from donors deceased after circulatory death (DCD): 5 years single center experience. Transplantation 2017; Sep 6. Epub ahead of print.
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10. Lewis J, Peltier J, Nelson H, et al. Development of the University of Wisconsin donation After Cardiac Death Evaluation Tool. Prog Transplant 2003;13:265-273.
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11. Rabinstein AA, Yee AH, Mandrekar J, et al. Prediction of potential for organ donation after cardiac death in patients in neurocritical state: a prospective observational study. Lancet Neurol 2012;11:414-419.
12. Pugin D, Hechinger S, Mamjou H, et al. Donation After Cardiac Death, Comparative of
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Scores to Predict Death. Transplant 2017;101:315-319.
13. Hornberger JC. The hemodialysis prescription and cost effectiveness. Renal Physicians Association Working Committee on Clinical Guidelines. J Am Soc Nephrol 1993;4:1021-1027.
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14. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness--the curious
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resilience of the $50,000-per-QALY threshold. N Engl J Med 2014;371:796-797.
ACCEPTED MANUSCRIPT 18 Table 1. Total Cost and Average Cost per Donor and per Organ for Each Category of Donation after Cardiac Death Donors Total organs, n
Total cost, $
Average cost per donor, $
Average cost per organ, $
Evaluated, no procurement*
115
-
1,011,353
8,794
-
Organs discarded†
12
30
200,341‡
16,695
6,678
Successful donors organs discarded§
48
56
485,662
10,118
8,673
Organs transplanted
137
289
2,689,314
19,630
9,306
DCD program DBD programǁ
264 102
289 361
4,386,672 3,421,692
32,020 33,546
15,179 9,478
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Total donors, n
Donor type
Total cost includes transportation, operating room supplies, investigations, hospital fees and personnel for each donor. Discarded organs include all organs procured but not used for transplantation. *
†
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Includes all potential DCD donors who were evaluated and determined to be ineligible to donate (n=38) and evaluated, but did not expire within the organ procurement organization designated time period (n=77).
Excludes the organs discarded or used for research from donors who also had organs procured for transplantation. Total cost includes only the cost of donors who had no organs procured for transplantation.
§
DCD donors with a combination of organs transplanted and discarded.
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‡
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Data of DBD donors from the same OPO over the course of the study.
DBD, donation after brain death; DCD, donation after cardiac death.
ACCEPTED MANUSCRIPT 19 Table 2. Transportation and Operating Room Supply Costs by Donation after Cardiac Death Donor Category Air transport
Donors per category, average cost
Ground transport
Average cost per donor, $
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Total, $ n
$
n
$
Turned down or did not expire (n=115 donors)
39
318,290
76
45,128
Organs discarded (n=12)
3
49,691
9
54,670
104,361
8,697
Organs transplanted (n=137)
46
761,928
91
552,779
1,314,707 [1,101,305]*
9,596 [3,811]*
-
-
12,840
*
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Average cost per donor, $
363,418
3,708
3,160
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Cost in brackets represents cost of transportation and operating room supplies per organ distributed among all organs (kidney, liver and lung) procured regardless of whether they were transplanted, discarded or used for research.
ACCEPTED MANUSCRIPT 20
Donor type DBD DCD DCD program DCD national†
Organ yield (SD) 3.57 (± 1.17)* 2.21 (± 0.75)* 1.10 (± 1.18) 1.93‡
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Table 3. Average Organ Yield of Donation after Cardiac Death and Donation after Brain Death Donors from the Mid America Transplant Organ Procurement Organization over the Course of the Study
p value <0.0001.
†
2016 DCD organ yield as calculated from the OPTN national database (2).
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*
‡
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Unable to calculate standard deviation for national DCD organ yield because yield per individual donor is not included in the OPTN national data.
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DBD, donation after brain death; DCD, donation after cardiac death; OPTN, organ procurement and transplantation network.
ACCEPTED MANUSCRIPT 21 Table 4. Disposition of Organs Procured from 34 Total Rapid Donation after Cardiac Death Donors
1 0 5 72 56 1.65
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55 9 2
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Number of organs
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Organ disposition Kidneys Transplanted Discarded Research Livers Transplanted Discarded Research Total organs procured, n Total organs transplanted, n Organ yield
ACCEPTED MANUSCRIPT 22 Figure Legends:
Figure 1. Donation after cardiac death (DCD) donor and organ distribution diagram. A total of
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264 donors were evaluated, 149 of which had at least 1 organ procured. Twelve donors had organs procured, but all discarded. From 137 DCD donors, a total of 289 organs were
transplanted. *Organs discarded include kidneys, livers and lungs discarded or used for research
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from all donors over the course of the study. Of the 86 organs discarded, 30 came from donors with no organs transplanted (24 kidneys, 6 livers). Seven organs not included: 5 hearts, 1
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pancreas, 1 small bowel.
Figure 2. Average total cost of procurement for each organ type. Comparison is made between cost of discarded organs, transplanted donation after brain death (DBD) and donation after
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cardiac death (DCD) organs. A transplanted organ from a DBD donor cost 60% of what a DCD
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transplanted organ costs when all DCD donor program costs are included.
ACCEPTED MANUSCRIPT 23 Precis The average cost per donation after cardiac death (DCD) donor is comparable to donation after
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costs of an entire DCD program are included.
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brain death donors; however, individual cost of DCD organs increases by almost 40% when all
ACCEPTED MANUSCRIPT
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Potential DCD donors evaluated n=264
Donors with organs procured n=149
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Evaluated but not procured n=115
Donors with all organs discarded n=12
Donor did not expire n=77
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Donor not eligible n=38
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86 organs discarded*: 46 kidneys, 38 livers, 2 lungs
Donors with organs transplanted n=137
289 organs transplanted: 243 kidneys, 40 livers, 6 lungs
ACCEPTED MANUSCRIPT
$15,179
$16,000
$12,000 $9,478
$10,000 $7,977 $8,000 $6,000 $4,000
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$2,000 $0
Transplanted DBD Transplanted DCD Transplanted DCD Organ Organ Organ Including All DCD Program Costs
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Discarded DCD Organ
$9,306
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Cost (US Dollars)
$14,000
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Organ Type
S1072-7515(18)30159-5
DOI:
10.1016/j.jamcollsurg.2018.02.005
Reference:
ACS 9074
To appear in:
Journal of the American College of Surgeons
Received Date: 3 January 2018 Revised Date:
14 February 2018
Accepted Date: 16 February 2018
Please cite this article as: Lindemann J, Dageforde LA, Vachharajani N, Stahlschmidt E, Brockmeier D, Wellen JR, Khan A, Chapman WC, Doyle M, A Cost Evaluation of a Donation after Cardiac Death Program: How Cost per Organ Compares to Other Donor Types, Journal of the American College of Surgeons (2018), doi: 10.1016/j.jamcollsurg.2018.02.005. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
ACCEPTED MANUSCRIPT 1 A Cost Evaluation of a Donation after Cardiac Death Program: How Cost per Organ Compares to Other Donor Types Jessica Lindemann, MDa; Leigh Anne Dageforde, MD, MPHa; Neeta Vachharajani, BSa; Emily
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Stahlschmidt, BSb; Diane Brockmeier, RN, BSN, MAb; Jason R Wellen, MD, MBA, FACSa; Adeel Khan, MD, MPH, FACSa; William C Chapman, MD, FACSa; MB Majella Doyle, MD,
a
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MBA, FACSa
Department of Surgery, Division of Abdominal Organ Transplantation, Washington University
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School of Medicine, St Louis, MO b
Mid America Transplant Services, St Louis, MO
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Disclosure Information: Nothing to disclose. Disclosures outside the scope of this work: Dr Chapman is a board member of Novartis and XOR Labs, and is an intellectual property owner of Pathfinder. Presented at the Western Surgical Association 125th Scientific Session, Scottsdale, AZ, November 2017.
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Corresponding Author Address: MB Majella Doyle, MD, MBA, FACS Department of Surgery Section of Abdominal Transplantation Washington University School of Medicine 660 S Euclid Ave Campus Box 8109 St Louis, MO 63110 Phone: (314) 362-2880 Email: [email protected]
Running Head: Costs of Donation after Cardiac Death
ACCEPTED MANUSCRIPT 2 Abstract BACKGROUND: Donation after cardiac death (DCD) is one method of organ donation. Nationally, more than half of evaluated DCD donors do not yield transplantable organs. There is
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no algorithm for predicting which DCD donors will be appropriate for organ procurement. DCD program costs from an organ procurement organization (OPO) accounting for all evaluated donors have not been reported.
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STUDY DESIGN: Hospital, transportation, and supply costs of potential DCD donors evaluated at a single OPO from January 2009 to June 2016 were collected. Average costs per donor and per
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organ were calculated. Cost of DCD donors that did not yield a transplantable organ were included in cost analyses resulting in total cost of the DCD program. DCD donor costs were compared to costs of in hospital donation after brain death (DBD) donors. RESULTS: There were 289 organs transplanted from 264 DCD donors evaluated. Average cost
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per DCD donor yielding transplantable organs was $9,306. However, 127 donors yielded no organs at an average cost of $8,794 per donor. The total cost of the DCD program was $32,020 per donor and $15,179 per organ. The average cost for an in hospital DBD donor was $33,546
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and $9,478 per organ transplanted. Average organ yield for DBD donors was 3.54 versus 2.21 for DCD donors (p<0.0001), making the cost per DBD organ 63% of the cost of a DCD organ.
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CONCLUSIONS: The average cost per DCD donor is comparable to DBD donors however, individual cost of DCD organs increases by almost forty percent when all costs of an entire DCD program are included.
Key Words: donation after cardiac death; cost; organ yield; organ procurement organization
ACCEPTED MANUSCRIPT 3 Abbreviations: DBD, donation after brain death; DCD, donation after cardiac death; ICER, incremental cost effectiveness ratio; OPC, organ procurement center; OPO, organ procurement organization; OR,
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operating room; OPTN, organ procurement and transplantation network; QALY, quality adjusted
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life year
ACCEPTED MANUSCRIPT 4 Introduction As of 2017, there are over 75,000 active and 116,000 total patients on the waiting list for organ transplantation in the United States (1). While the number of transplants performed each year
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continues to rise, a significant need remains as the number of patients on the waiting list
increases at a pace more rapid than the number of transplants performed (2). Donation after cardiac death (DCD) is one approach to abate the organ shortage, although organ yield per donor
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is generally expected to be less than for donation after brain death (DBD) donors. For potential donors with devastating neurologic injury with no anticipated recovery who do not meet brain
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death criteria, DCD is a way to still give families the option to participate in the organ donation process. In DCD, all life support is withdrawn from the patient by a physician not associated with the organ procurement team. Once there is cardiac death with no appreciated cardiac rhythm, the donor is declared dead by their physician. The time to initiation of organ
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procurement is determined on an organ procurement organization (OPO) basis. For our OPO the wait time is five minutes. Transplant centers generally have requirements for time from withdrawal to organ flush with preservation solution due to reports of potential organ damage
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leading to post transplant complications for prolonged warm ischemic times. According to national data from the Organ Procurement and Transplantation Network
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and Scientific Registry of Transplant Recipients 2015 Annual Data Report on DCD donors, organ yield per DCD donor in 2015 was 1.93 and per DBD donor was 3.25(3). For DCD donors, this yield per donor does not include those potential donors who undergo evaluation, but do not progress to donation for a variety of reasons. Some donors do not progress to donation because they do not progress to cardiac death within a time frame suitable for transplantation. Other organs may not be suitable for transplant once they are procured. When all potential DCD donors
ACCEPTED MANUSCRIPT 5 are accounted for, the organ yield per DCD donor decreases. Unfortunately, there is no established algorithm for predicting which potential DCD donors proceed to cardiac death within a suitable time frame to be appropriate for procurement. Despite the expected lower yield, the
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shortage of organs for transplantation is so great all potential donation options must be utilized. Several studies have considered the cost of DCD donation to the organ recipient and to society (4-6). However, these studies do not include cost of organ procurement, which can be
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significant and should also be taken into consideration. An OPO assumes responsibility for all costs of the potential donor starting at the time of consent for organ donation. This includes any
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clinical investigations, operating room charges, and ICU care. The percentage of the total charges paid by the OPO varies between individual OPOs. Individual charges per donor also vary greatly by donor and by hospital. All of these factors should be accounted for in a DCD donor cost analysis.
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The demand for organs for transplantation significantly exceeds supply of organs and organ procurement costs are high. To fully quantify cost associated with organ transplantation, cost of procurement should be investigated. However, DCD program costs from an OPO
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perspective accounting for all evaluated donors have not previously been reported. In addition, it is unknown how the cost of an entire DCD program compares with the cost of a DBD program.
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With this cost analysis, we aim to determine the total cost of a DCD program compared to in hospital DBD donation within a single OPO. Our OPO is unique in that we have an organ procurement center (OPC) where all DBD
donors are transferred soon after family consent for donation is obtained. All donor evaluations are performed at the OPC prior to procurement. In a previous publication, we found that it costs 50% less to transfer a potential DBD donor to the OPC than to perform the procurement at the
ACCEPTED MANUSCRIPT 6 original hospital(7). This is because fees for investigations for donor evaluation and ICU stay are lower at the OPC. We are also able to better maximize organ yield, effectively lowering cost per organ. However, there are three specific criteria that donors have to meet prior to transfer. The
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family needs to give consent to transfer the donor, the donor must be hemodynamically stable, defined as requiring two or less pressors, and the donor must weigh at least 35 pounds.
Additionally, there are some hospitals with policies that do not allow donors to be transferred for
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procurement.
For DBD donors who do not meet criteria for transfer because of instability, it is difficult
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to predict if there will be more or less associated procurement costs as compared to OPC DBD procurements. Unstable donors can be expedited to the OR for procurement, or procurement can be delayed while stabilization is attempted, resulting in the use of more resources in a donor with potentially lower than average yield. For the purpose of this analysis, only the costs of DBD
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donor procurements performed in hospital are used for comparison, as the procurement process for in hospital DBD donors is more similar to DCD donor procurement. Due to the nature of DCD donation, donors often undergo less evaluation and spend a shorter time in hospital prior to
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procurement than DBD donors. We hypothesized that this will result in generally lower cost per
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donor when compared to DBD donation.
Methods
Costs related to transportation, operating room (OR) supplies, investigations, and hospital fees for all DCD evaluations and donors at a single OPO were collected from January 2009 to June 2016. Costs were not adjusted for inflation. In the Mid America Transplant area, donor hospital charges are paid at a rate of 70% of the total, but can be as high as 100% of billed charges for
ACCEPTED MANUSCRIPT 7 other OPOs. Ground or air transportation was determined by distance from donor to hospital. Generally, ground transport was used for a donor within 90 miles and air transport was used for donors greater than 90 miles from the hospital where the transplant will be performed, per OPO
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policy. All DCD donors were procured in hospital and were not transferred to an OPC. DCD donors during the period of study were divided into four groups for the purpose of analysis: [1] potential donors evaluated, but turned down [2] those approved for donation, but did not expire
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within the specified time, which at our OPO has been approximately 20 minutes for liver and 60 minutes for kidney procurement [3] donors who proceeded to surgery, but had all organs
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discarded after procurement [4] donors with at least one organ procured and transplanted. Discarded organs included those organs procured, but used for research. For donors with at least one organ transplanted, there may have also been discarded organs. Discarded organs were those considered to be unsuitable for transplantation after they had been procured.
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Kidneys, livers and lungs either discarded or used for research have the same associated cost to the OPO as a transplanted organ. For this reason, cost was allocated equally to each kidney, liver and lung procured regardless of end use. However, in DCD donors, heart, small
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bowel and pancreas procurement is always performed with the intention for use in research and result in minimal cost to the OPO. Thus, the procurement of any heart, small bowel or pancreas
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was not included in the cost analysis. Kidneys procured en bloc and double lungs were counted as one organ as they are transplanted into a single recipient. For each of the four groups, total cost per group and average cost per donor were
calculated per year and over the course of the study. The potential donors evaluated, but turned down group and those approved for donation, but did not expire within the OPO specified time group were combined into one, as all potential donors did not progress to procurement. For the
ACCEPTED MANUSCRIPT 8 organs discarded group average cost per organ discarded was also determined. Total costs and average cost per organ transplanted were calculated per year and in total over the duration of the study for the organs transplanted group. To determine the effect of DCD program cost on cost
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per organ transplanted, calculations were performed twice. The first calculation included all costs from the DCD program; the second used only costs associated with donors who had at least one organ transplanted. Costs from all four groups of DCD donors were included in this analysis,
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which allowed for calculation of total costs of the DCD program for a single OPO.
Transportation and OR supply costs were calculated separately due to billing. The cost
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was then added to evaluation and hospital costs to obtain the total cost of each donor group. These totals were then used to calculate total cost per donor and per organ. Organ yield was calculated by dividing the total number of organs procured for transplant by the number of DCD donors. This was performed as a total over the duration of the study for the organs transplanted
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group only and then again for the DCD and DBD programs of the same OPO. A subanalysis of rapid DCD donors was performed to determine whether this type of donor might offer a potential opportunity for increasing DCD yield. A rapid DCD donor was
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defined as having a consent to OR time less than 8 hours. Organ yield was calculated as total organs transplanted per rapid DCD donor over the duration of the study.
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DCD donor costs were compared to average costs of in hospital DBD donors only from
the same OPO from 2009-2014 (7). All data were collected on an MS Access Database (Microsoft) and analyzed using GraphPad Prism software, version 5.0. Categorical variables were presented as numbers and percentages. Continuous variables (eg, costs) were presented as means. A p value <0.05 was considered statistically significant.
ACCEPTED MANUSCRIPT 9 Results Over the course of the study, 264 potential DCD donors were evaluated. Of those, 137 donors (52%) resulted in a total of 289 organs transplanted. The remaining 48% of potential donors (n=
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127) were evaluated, but did not have organs recovered for transplantation. Thirty eight were determined to be ineligible for donation and 77 progressed to surgery, but did not expire within the OPO designated time. Twelve had organs procured, but either all discarded or used for
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research. Of the 289 organs, there were 243 kidneys, 40 livers and 6 lungs transplanted (Figure 1).
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The average cost of evaluation of a DCD donor that did not progress to surgery was $8,794. DCD donors who proceeded to surgery, but did not expire had a higher average cost at $16,695 due to the additional transportation, OR and supply charges (Table 1). For DCD donors who yielded at least one transplantable organ, the average cost per donor was $19,630 and the
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average cost per organ was $9,306 (Table 1). For the organs discarded group of DCD donors, the cost per organ discarded was calculated to be about $2,600 less per organ than the organs transplanted group (Table 1).
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When costs from all groups were included to calculate cost per donor and cost per organ for the DCD donor program, the average cost of a DCD donor yielding at least one organ
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suitable for transplantation increased by 38.7% from $19,630 to $32,020. This resulted in an increase in cost per organ to $15,179 from $9,306 (Table 1). Cost of transportation and OR supplies together made up 40% of total costs of the DCD program. Air transport was more expensive than ground, costing nearly 4 times the amount per donor. Eighty eight donors required air transport, the majority of which were in the organs transplanted group (n=46), although there were 39 donors requiring air transportation that were either turned down or did
ACCEPTED MANUSCRIPT 10 not expire (Table 2). The remaining 176 donors were reached by ground transportation. For the discarded organs or those used for research that came from donors who also had organs procured for transplantation, transport and OR supplies per organ procured and discarded or transplanted
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was $3,811 (Table 2).
DCD organ yield over the course of the study was found to be 2.12 (SD ± 0.75) organs per donor, whereas DBD organ yield was significantly higher at 3.57 (SD ± 1.17, p <0.0001)
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organs per donor. DCD donor organ yield decreased to 1.10 when all DCD donors evaluated, including those that did not proceed to surgery, were included (Table 3). When DCD donor and
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in hospital DBD donor costs were compared over the same study period, costs were similar. Average in hospital DBD donor costs were $33,546 while DCD costs were $32,020 (Table 1). However, cost per organ transplanted differed by nearly $6,000, making the cost of an organ from DBD donation approximately 60% of the cost per DCD organ (Figure 2). When cost per
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organ transplanted was compared between in hospital DBD donor organs and only DCD donors who had at least one organ transplanted, the cost per organ was very similar between a DCD donor ($9,306/organ) versus for a DBD organ ($9,478/organ) (Figure 2).
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When a subanalysis of rapid DCD donors was performed, 34 of the 264 total donors (13%) met the rapid DCD donor criteria. There were 56 organs transplanted. This resulted in an
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organ yield of 1.65 per rapid DCD donor. Nearly all organs transplanted were kidneys (n=55) with only one liver transplantation. Nine kidneys were discarded, 2 kidneys used for research and another 5 livers were also used for research after all were found to be unsuitable for transplantation (Table 4).
Discussion
ACCEPTED MANUSCRIPT 11 DCD donation was similar in cost per donor when compared to in hospital DBD donation. The cost per DCD and DBD donors differed by approximately $1,500, with DCD donors being the slightly less costly of the two. There was less than a $200 difference in cost per organ in DCD
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and DBD donors when all DCD program costs were excluded. However, when cost per organ was compared using all DCD program costs, in hospital DBD organs were markedly less costly than DCD organs by more than $5,000 per organ. The cost per organ from a DCD donor was 60
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percent higher than from an in hospital DBD donor. This was the result of two important factors. Firstly, the organ yield from a DBD donor was nearly twice that of a DCD donor, significantly
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lowering cost per organ yielded for DBD organs. Secondly, nearly 40 percent of the DCD program costs were from donors who were evaluated but did not progress to donation. Transportation and OR supply costs made up a significant portion of all DCD program costs. Air transportation contributed the most with an average of $12,840 per donor, whereas
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ground transport was only $3,708, nearly four times less per donor. One third of all donors required air transportation, but represent nearly two thirds of the total transportation and OR supplies cost. Of the donors that required air transportation, 39 (44%) were donors that were
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either turned down or did not expire within the OPO designated time. This potential donor population represents an opportunity for cost savings for a DCD program
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Organ yield per DCD donor in this study was comparable to organ yield nationally over
the same time period (2). However, when all donors evaluated were included, organ yield fell from a 2.21 to 1.10 average over the duration of the study. The national number for all donors evaluated but not progressing is not available for comparison. As expected, the average cost per donor increased as donor interventions and clinical investigations increased. The difference in cost per donor between those DCD donors with organs discarded and those with organs
ACCEPTED MANUSCRIPT 12 transplanted was just over $1,300 despite requiring similar OR and hospital resources. This was likely secondary to differences in organ yield and transportation fees between the two groups. Rapid DCD donors made up 13% of all total donors and had an average organ yield of
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1.65 per donor, compared to a yield of 2.21 for DCD donors with at least one organ transplanted. This lower yield is largely due to the inability to wait for serology results to be completed for liver transplantation, essentially eliminating the use of livers from these donors. This represents
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an opportunity to potentially increase DCD donor yield, if rapid DCD donors could be converted to regular DCD donors to allow for serologies to be sent and results received.
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In this study, an organ discarded was defined as kidneys or livers discarded or used for research from DCD donors that had no organs transplanted. Due to the nature of DCD donation, heart, pancreas, and small bowel organs were excluded from organ discard calculations because they are rarely procured with intent to transplant. There were no lungs discarded or used for
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research from this donor group, but as they can be procured for transplant in DCD donors, they would have been included in the organs discarded total if present. The nature of DCD donation limits our ability to increase yield per donor in the same ways we can work to increase yield in
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DBD donors for three reasons: 1) often families want to move quicker to donation and will not wait for serologies to return thus limiting these “rapid” DCD procurements to kidney only rather
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than kidney and liver procurement, 2) traditionally heart and intestine are not used in the DCD setting, and 3) often centers have strict guidelines for at what timeframe after withdrawal of support the organs may be suitable for transplantation although some centers are willing to consider a longer warm time especially if oxygen saturation and blood pressure is maintained (7). Furthermore, only a few very selective programs are using pancreas and lungs, although lung and pancreas transplants with DCD donor organs are increasing (8-9).
ACCEPTED MANUSCRIPT 13 One strategy to address the problem of low yield and excess cost is to carefully consider resource allocation for donor evaluation. A possible solution to increase DCD organ yield and reduce program cost associated with evaluating potential DCD donors is the use of a prediction
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model. One such model, named the University of Wisconsin Donation after Cardiac Death
Evaluation Tool, was developed with the intention of identifying those donors most likely to expire by 60 and 120 minutes following withdrawal of life support. Initial data showed
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promising results. Using this tool they were able to predict suitability for DCD donation at 60 minutes 83.7% of the time and 74.4% of the time at 120 minutes (10). A second model, called
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DCD N for DCD donation in a neurocritical state, used a combination of physical exam findings and oxygenation index. It was found to have a sensitivity of 72% for predicting death at 60 minutes (11). A subsequent comparison study between the University of Wisconsin model, the DCD N model and the medical team’s prediction after assessment, found that the degree of
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sensitivity between the three was not significant enough for either model to be useful in clinical practice (12). Currently, there is no model for determination of suitability of DCD donation that is widely used or accepted in clinical practice. If one were to be developed, there is great
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potential for increased organ yield and cost reduction in DCD donation. There are some limitations to our study that should be recognized. This study is based on
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a single OPO experience. However, while the single center OPO is a limitation, cost data is difficult to obtain from OPOs and may vary by region and center. By using just one OPO we are consistent in our comparisons. We also did not have cost data for surgeon’s fees, however this fee is consistent across all donors regardless of organs procured and it was universally excluded from all donors for cost calculations.
ACCEPTED MANUSCRIPT 14 This OPO has a donor procurement center where the majority of DBD procurements occur. Donors at the center cost significantly less than in hospital DBD donors, therefore we only included in hospital DBD donor costs in our analysis. However, the cost of DBD donors
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evaluated, but do not progress to donation was not included because it is impossible to know which of the potential DBD donors who do not progress would have been procured in hospital versus at the OPC. From a previous publication, we found that only about 10% of DBD donors
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in our OPO are procured in hospital, so it would be inaccurate to attribute all of the cost for DBD donors who do not progress to the in hospital DBD donor costs (7). For a more complete
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comparison, the following data were extrapolated. From 2009-2014 there were 156 DBD donors evaluated, but did not progress to donation, which resulted in a total cost of $1,341,138 and an average cost per donor evaluated, but did not progress of $8,597. When this was added to the cost of the in hospital DBD donors, there was an increase in average total cost per donor to
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$34,861 compared to $32,020 per DCD donor. However, DCD donor organs remained more expensive with a cost per organ of $15,179 compared to the adjusted cost per DBD donor organ of $9,850.
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Finally, this study focuses only on DCD donor costs to the OPO, but the cost of organ transplantation extends beyond procurement to transplantation and ongoing medical care.
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Currently, there is no cost analysis that evaluates the total cost of organ transplantation per quality-adjusted life year (QALY) gained. A figure that is commonly used to benchmark costeffectiveness of a medical intervention is the incremental cost effectiveness ratio (ICER). This is the additional cost per QALY gained from a medical intervention. An ICER of $50,000/QALY is the generally accepted threshold for a cost-effective medical treatment in the US. However, that value was established in the early 1990’s after an influential cost-effective analysis of
ACCEPTED MANUSCRIPT 15 hemodialysis versus kidney transplant was published (13). Recently, a threshold of $100,000$150,000/QALY gained was recommended (14). A comprehensive cost-effective analysis,
being met, should be a focus of research in the future.
Conclusions
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including organ procurement costs for organ transplantation to evaluate whether this threshold is
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Overall, DCD donors did increase the organ supply by allowing for the transplantation of 289 organs; however, the increase in organs transplanted was not without a cost. Thirty nine percent
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of DCD program cost was attributable to DCD donors who did not yield organs suitable for transplantation. When total program costs were excluded, the cost per DCD donor organ transplanted was slightly less than cost per organ transplanted from an in hospital DBD donor. The development of a prediction model that will identify DCD donors most likely to progress to
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donation would significantly decrease the cost of a DCD donor program and make DCD donation equivalent in cost to DBD donation.
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Acknowledgements: The authors would like to acknowledge Rich Rothweiler from Mid
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America Transplant for his contribution.
ACCEPTED MANUSCRIPT 16 References: 1. Organ Procurement and Transplantation Network. Waiting list and donor numbers. Available at: http://optn.transplant.hrsa.gov/. Accessed on 4 September, 2017.
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2. Organ Procurement and Transplantation Network. National Data. Available at:
https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/. Accessed on 4 September, 2017.
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3. Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of
Transplant Recipients (SRTR). OPTN/SRTR 2015 Annual Data Report. Rockville, MD:
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Department of Health and Human Services, Health Resources and Services Administration; 2016.
4. Saidi RF, Elias 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
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2007;7:2769-2774.
5. Dageforde LA, Feurer ID, Pinson CW, Moore DE. Is liver transplantation using organs donated after cardiac death cost effective or does it decrease waitlist death by increasing
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recipient death? HPB 2013;15:182-189.
6. van der Hilst CS, Ijtsma AJC, Bottema JT, et al. The price of donation after cardiac death in
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liver transplantation: a prospective cost effectiveness study. Transpl Int 2013;26:411-418. 7. Doyle MBM, Subramanian V, Vachharajani N, et al. Organ Donor Recovery Performed at an Organ Procurement Organization Based Facility Is an Effective Way to Minimize Organ Recovery Costs and Increase Organ Yield. J Am Coll Surg 2016;222:591-600.
ACCEPTED MANUSCRIPT 17 8. Cypel M, Levvey B, van Raemdonck D, et al. International Society for Heart and Lung Transplantation Donation After Circulatory Death Registry Report. Journal of Heart and Lung Transplantation 2015;34: 1278-1282.
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9. Kopp W, Lam HD, Schaapherder AM, et al. Pancreas transplantation with grafts from donors deceased after circulatory death (DCD): 5 years single center experience. Transplantation 2017; Sep 6. Epub ahead of print.
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10. Lewis J, Peltier J, Nelson H, et al. Development of the University of Wisconsin donation After Cardiac Death Evaluation Tool. Prog Transplant 2003;13:265-273.
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11. Rabinstein AA, Yee AH, Mandrekar J, et al. Prediction of potential for organ donation after cardiac death in patients in neurocritical state: a prospective observational study. Lancet Neurol 2012;11:414-419.
12. Pugin D, Hechinger S, Mamjou H, et al. Donation After Cardiac Death, Comparative of
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Scores to Predict Death. Transplant 2017;101:315-319.
13. Hornberger JC. The hemodialysis prescription and cost effectiveness. Renal Physicians Association Working Committee on Clinical Guidelines. J Am Soc Nephrol 1993;4:1021-1027.
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14. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness--the curious
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resilience of the $50,000-per-QALY threshold. N Engl J Med 2014;371:796-797.
ACCEPTED MANUSCRIPT 18 Table 1. Total Cost and Average Cost per Donor and per Organ for Each Category of Donation after Cardiac Death Donors Total organs, n
Total cost, $
Average cost per donor, $
Average cost per organ, $
Evaluated, no procurement*
115
-
1,011,353
8,794
-
Organs discarded†
12
30
200,341‡
16,695
6,678
Successful donors organs discarded§
48
56
485,662
10,118
8,673
Organs transplanted
137
289
2,689,314
19,630
9,306
DCD program DBD programǁ
264 102
289 361
4,386,672 3,421,692
32,020 33,546
15,179 9,478
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SC
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Total donors, n
Donor type
Total cost includes transportation, operating room supplies, investigations, hospital fees and personnel for each donor. Discarded organs include all organs procured but not used for transplantation. *
†
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Includes all potential DCD donors who were evaluated and determined to be ineligible to donate (n=38) and evaluated, but did not expire within the organ procurement organization designated time period (n=77).
Excludes the organs discarded or used for research from donors who also had organs procured for transplantation. Total cost includes only the cost of donors who had no organs procured for transplantation.
§
DCD donors with a combination of organs transplanted and discarded.
ǁ
EP
‡
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Data of DBD donors from the same OPO over the course of the study.
DBD, donation after brain death; DCD, donation after cardiac death.
ACCEPTED MANUSCRIPT 19 Table 2. Transportation and Operating Room Supply Costs by Donation after Cardiac Death Donor Category Air transport
Donors per category, average cost
Ground transport
Average cost per donor, $
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Total, $ n
$
n
$
Turned down or did not expire (n=115 donors)
39
318,290
76
45,128
Organs discarded (n=12)
3
49,691
9
54,670
104,361
8,697
Organs transplanted (n=137)
46
761,928
91
552,779
1,314,707 [1,101,305]*
9,596 [3,811]*
-
-
12,840
*
SC
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Average cost per donor, $
363,418
3,708
3,160
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EP
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Cost in brackets represents cost of transportation and operating room supplies per organ distributed among all organs (kidney, liver and lung) procured regardless of whether they were transplanted, discarded or used for research.
ACCEPTED MANUSCRIPT 20
Donor type DBD DCD DCD program DCD national†
Organ yield (SD) 3.57 (± 1.17)* 2.21 (± 0.75)* 1.10 (± 1.18) 1.93‡
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Table 3. Average Organ Yield of Donation after Cardiac Death and Donation after Brain Death Donors from the Mid America Transplant Organ Procurement Organization over the Course of the Study
p value <0.0001.
†
2016 DCD organ yield as calculated from the OPTN national database (2).
SC
*
‡
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Unable to calculate standard deviation for national DCD organ yield because yield per individual donor is not included in the OPTN national data.
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EP
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DBD, donation after brain death; DCD, donation after cardiac death; OPTN, organ procurement and transplantation network.
ACCEPTED MANUSCRIPT 21 Table 4. Disposition of Organs Procured from 34 Total Rapid Donation after Cardiac Death Donors
1 0 5 72 56 1.65
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55 9 2
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Number of organs
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Organ disposition Kidneys Transplanted Discarded Research Livers Transplanted Discarded Research Total organs procured, n Total organs transplanted, n Organ yield
ACCEPTED MANUSCRIPT 22 Figure Legends:
Figure 1. Donation after cardiac death (DCD) donor and organ distribution diagram. A total of
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264 donors were evaluated, 149 of which had at least 1 organ procured. Twelve donors had organs procured, but all discarded. From 137 DCD donors, a total of 289 organs were
transplanted. *Organs discarded include kidneys, livers and lungs discarded or used for research
SC
from all donors over the course of the study. Of the 86 organs discarded, 30 came from donors with no organs transplanted (24 kidneys, 6 livers). Seven organs not included: 5 hearts, 1
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pancreas, 1 small bowel.
Figure 2. Average total cost of procurement for each organ type. Comparison is made between cost of discarded organs, transplanted donation after brain death (DBD) and donation after
TE D
cardiac death (DCD) organs. A transplanted organ from a DBD donor cost 60% of what a DCD
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EP
transplanted organ costs when all DCD donor program costs are included.
ACCEPTED MANUSCRIPT 23 Precis The average cost per donation after cardiac death (DCD) donor is comparable to donation after
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EP
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SC
costs of an entire DCD program are included.
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brain death donors; however, individual cost of DCD organs increases by almost 40% when all
ACCEPTED MANUSCRIPT
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Potential DCD donors evaluated n=264
Donors with organs procured n=149
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SC
Evaluated but not procured n=115
Donors with all organs discarded n=12
Donor did not expire n=77
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Donor not eligible n=38
AC C
EP
86 organs discarded*: 46 kidneys, 38 livers, 2 lungs
Donors with organs transplanted n=137
289 organs transplanted: 243 kidneys, 40 livers, 6 lungs
ACCEPTED MANUSCRIPT
$15,179
$16,000
$12,000 $9,478
$10,000 $7,977 $8,000 $6,000 $4,000
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$2,000 $0
Transplanted DBD Transplanted DCD Transplanted DCD Organ Organ Organ Including All DCD Program Costs
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Discarded DCD Organ
$9,306
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Cost (US Dollars)
$14,000
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Organ Type