The American Journal of Surgery (2015) -, -–-

Increasing organ donation after cardiac death in trauma patients Bellal Joseph, M.D.a,*, Mazhar Khalil, M.D.a, Viraj Pandit, M.D.a, Tahereh Orouji Jokar, M.D.a, Ali Cheaito, M.D.b, Narong Kulvatunyou, M.D.a, Andrew Tang, M.D.a, Terence O’Keeffe, M.D.a, Gary Vercruysse, M.D.a, Donald J. Green, M.D.a, Randall S. Friese, M.D.a, Peter Rhee, M.D.a a

Division of Trauma, Critical Care, Emergency Surgery, and Burns, Department of Surgery, University of Arizona, Tucson, AZ, USA; bDepartment of Surgery, University of California, Los Angeles, CA, USA

KEYWORDS: Organ donation; Donation after cardiac death; Donation after circulatory collapse; Trauma donors

Abstract BACKGROUND: Organ donation after cardiac death (DCD) is not optimal but still remains a valuable source of organ donation in trauma donors. The aim of this study was to assess national trends in DCD from trauma patients. METHODS: A 12-year (2002 to 2013) retrospective analysis of the United Network for Organ Sharing database was performed. Outcome measures were the following: proportion of DCD donors over the years and number and type of solid organs donated. RESULTS: DCD resulted in procurement of 16,248 solid organs from 8,724 donors. The number of organs donated per donor remained unchanged over the study period (P 5 .1). DCD increased significantly from 3.1% in 2002 to 14.6% in 2013 (P 5 .001). There was a significant increase in the proportion of kidney (2002: 3.4% vs 2013: 16.3%, P 5 .001) and liver (2002: 1.6% vs 2013: 5%, P 5 .041) donation among DCD donors over the study period. CONCLUSIONS: DCD from trauma donors provides a significant source of solid organs. The proportion of DCD donors increased significantly over the last 12 years. Ó 2015 Elsevier Inc. All rights reserved.

Advancements in transplant medicine and improved recipient outcomes have led to an increased demand for organ transplantation. The number of organ donors and transplantations in the United States has more than doubled There were no relevant financial relationships or any sources of support in the form of grants, equipment, or drugs. The authors declare no conflicts of interest. Presented at the 73rd Annual Meeting of the American Association for the Surgery of Trauma, September 10–13, 2014, Philadelphia, Pennsylvania. * Corresponding author. Tel.: 11-520-626-5056; fax: 11-520-626-5016. E-mail address: [email protected] Manuscript received December 23, 2014; revised manuscript February 6, 2015 0002-9610/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjsurg.2015.03.013

over the past few years; however, the demand of organs dwarfs the supply.1–3 Even though the brain dead donors contribute the majority of transplanted organs, they cannot account for annual organ requirement.4–6 As a result new avenues are currently being explored to increase organ donation among deceased donors, such as donation after cardiac death (DCD). DCD has always been a secondary source of organ donation. Its utility has always remained limited because of inherent concerns associated with an extended criteria donation, which include poor organ quality and adverse recipient outcomes. However with the establishment of donor management protocols and better organ preservation

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techniques, there has been a push for DCD. Since 2006, DCD has been actively promulgated as a promising option to overcome organ shortage and several institutions have implemented protocols to harvest DCD organs.7–9 However, this vital source of organs continues to be underutilized.10–14 Over the past decade, because of severe shortage of organs, the criteria for organ donation among trauma donors have been extended to include DCD as a potential source of organ donation. However, the true utilization of DCD in trauma patients remains unknown. Additionally, the impact of changing resuscitation practices and donor management protocols on the organs obtained from DCD is unclear. The aim of this study was to assess the national trends in DCD in trauma donors. We hypothesized that there is an increasing national trend in trauma organ donation after DCD over the years.

Data are reported as proportions for categorical variables. We utilized chi-square test to identify differences in proportions for categorical variables. Analysis of variance was utilized for trend analysis. P value less than .05 was considered as statistically significant. All statistical analyses were performed using Statistical Package for Social Sciences (SPSS, Version 21; IBM Corp., Armonk, NY). This study was reviewed by the institutional review board at the University of Arizona College of Medicine and was determined to be exempt from approval.

Methods We performed a 12-year (2002 to 2013) retrospective analysis of the United Network for Organ Sharing Database (UNOS). All the deceased trauma patients who donated solid organs were identified from UNOS and included in the study. We recorded the following data points from the UNOS database: mechanism of death, total number of trauma organ donors after cardiac death, total number of trauma organ donors after brain death, and number and type of organs donated. Trauma deaths were defined as the patients who died from blunt injury, drowning, drug intoxication, gunshot wound, stab wound, or traumatic brain injury. Blunt mechanism of injury was defined as motor vehicle collision, pedestrian struck, bicycle accidents, motorcycle collisions, and falls. DCD was defined as organ recovery process that occurred when death was defined as irreversible cessation of circulatory and respiratory functions. Donation after brain death (DBD) was defined as organ recovery process after declaration of death on brain-based definition of death. Solid organ donation was defined as donation of heart, lung, liver, kidney, pancreas, kidney– pancreas, and heart–lung. The UNOS database is the largest online database system which is used to collect, store, analyze, and publish all Organ Procurement and Transplant Network data that pertain to the patients on waiting list, organ matching, and transplantation. The UNOS database was launched on October 25, 1999 and contains data regarding every organ donated and transplanted in the United States since 1986. The primary outcome measures were number of organs donated and rate of organs donated per donor after cardiac death in trauma patients. We defined rate of organ donation as number of organs donated per donor and was calculated as a ratio of total number of DCD solid organs donated by the total number of DCD organ donors. Secondary outcome measures were number and type of solid organs donated.

Results A total of 120,512 eligible trauma organ donors were identified, of which 90,586 patients donated solid organs over the study period. Of all the trauma solid organ donors (n 5 90,586), 9.6% (n 5 8,724/90,586) donated after cardiac death. The proportion of patients who donated after cardiac death increased significantly from 3.1% (190/6,184) in 2002 to 14.6% (1,000/6,871) in 2013 (P % .001) (Fig. 1). When we looked at the number of organs donated during the study period, a total of 252,052 organs were donated by trauma donors. A total of 6.4% (16,258) of the donated organs were procured from trauma donors who donated after cardiac death. Over the study period, there was a significant increase in the number of organs procured after DCD from 2% (381/18,284) in 2002 to 9.5% (1,825/ 19,205) in 2013 (P 5 .001). Kidney (n 5 12,898) followed by the liver (n 5 2,868) were the most common solid organs donated. Table 1 demonstrates the number and type of organs donated over the study period. A total of 120,572 kidneys were donated over the study period. DCD kidneys accounted for 10.6% (n 5 12,898) of all donated kidneys. There was a significant increase in the number of DCD kidneys donated over the study period from 3.4% (291/8,539) in 2002 to 16.3% (1,520/9,314) in 2013 (P 5 .001). Fig. 2 demonstrates the trends in kidney donation in DCD and DBD donors over the study period.

Figure 1 Proportion of trauma donors who donated after cardiac death over the years.

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donation. Since 1968, when an ad hoc committee at Harvard Medical School proposed brain-based definition of death, the pool started shifting toward donors declared dead by brain-based criteria.15 Later in 1981, with universal acceptance of brain death as a definition of death in constitution, the DCD reached negligible levels.16 However, decades later when the organ shortage forced the medical community to look for alternatives, DCD arose as one of the feasible options. As a result, the Institute of Medicine encouraged DCD, which resulted in the establishment of polices by the centers for Medicare and Medicaid services and Joint Commission which required all hospitals to establish and implement protocols for recovering DCD organs.8,9 DCD is an acceptable mode of organ donation, and with the development of new donor optimization and organ preservation protocols, provide a great opportunity to overcome organ shortage. Saidi et al,1 in their study among all organ donors, demonstrated an increasing trend in organ donation after DCD. Similarly, Steinbrook2 also reported an increasing trend in DCD after 1995. However, these studies reported over all trends in DCD. No study specifically looked at the trends of DCD in trauma donors who form the largest pool of organ donors. During the study period, we observed a steady increase in DCD in trauma donors. The trends of our study suggest a gradual shift in organ donor pool toward DCD donation. During the study period, the number of donors increased both in donations after brain death and donations after cardiac death; however, the proportions indicate increasing contribution from DCD pool. This increasing trend reflects the results of persistent efforts on part of transplant collaborative and organ donation networks and improved DCD organ donation outcomes. However, on the other end of the spectrum, a very important concern arises with this increasing trend in DCD donors: whether this increase in DCD donors represents a different donor profile or these are potential DBD donors that are pushed for DCD. Because of limitations in the data, this question remains unanswered in this study. Future studies with special attention on this vital question

Despite rigorous advancements in organ procurement and transplantation, the patients in need of transplantation outnumber potential organ donor pools. Over the past few decades emphasis is to mainstream extended criteria donors such as DCD to overcome the organ void. Our study reports the national trends in DCD in trauma patients. The national efforts to enhance DCD were reflected in our results as we observed a significant increase in the number of donations after cardiac death in this pool of donors. Although the number of organs procured per donor remained unchanged, there was a significant increase in the kidney and liver donations from trauma patients after cardiac death over the study period. We believe that DCD in trauma patients requires more attention and further implementation of protocols may result in an increased donor supply. In the 1960s, before the wide acceptance of definition of brain death, DCD was the only acceptable source of organ

Figure 2 Proportion of trauma donors who donated kidneys after cardiac death over the years.

Table 1 Number and type of organs donated after DCD in trauma patients* Years

Kidney

Kidney–Pancreas

Liver

Lungs

Heart

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

291 392 537 754 980 1,130 1,258 1,313 1,401 1,698 1,624 1,520

6 13 22 20 19 22 27 35 33 25 15 13

79 111 185 271 289 307 277 289 269 269 263 259

1 3 6 8 12 9 20 31 14 19 21 31

0 0 1 0 0 3 0 0 1 0 0 0

DCD 5 donation after cardiac death. *No heart–lung donor over the study period.

During the study period, a total of 70,329 livers were donated. DCD accounted for 4% (n 5 2,868) of all the liver donations over the study period. There was a significant increase in the DCD liver donation over the study period from 1.6% (n 5 79/4,969) in 2002 to 5% (n 5 259/5,164) in 2013 (P 5 .041). Fig. 3 demonstrates the trends in liver donation in DCD and DBD donors over the study period. The overall organ donation rate over the 12-year period was 2.78 organs per donor. The mean rate of organ donation per donor was 2.88 (235,794/81,850) organs per donor in DBD and 1.86 (16,258/8,724) organs per donor in DCD. The rate of organ donation in brain dead donors (2.98 organs per donor in 2002 to 2.96 organs per donor in 2013, P 5 .6) and cardiac death donors (2 organs per donor in 2002 and 1.8 organs per donor in 2013, P 5 .1) remained unchanged over the study period. Fig. 4 demonstrates the mean number of organs donated per year over the years.

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Figure 3 Proportion of trauma donors who donated liver after cardiac death over the years.

would enhance the understanding of the donation profiles in trauma patients. Since its inception, DCD is very well received among transplantation world. One of the reasons for this gradual success in DCD procurement is clarity in definition of death.17 While there is a great degree of variability in the brain death definition, the definition of cardiac death is fairly standard.18 This provides organ procurement organizations, medical team, and family a standardized platform to proceed with organ donation. However, ethical concerns relating to this approach hinder its universal acceptance. Studies have found a great deal of variability in DCD protocol success among different OPOs.17 This disparity at regional level is multifactorial. Some of the reported concerns are secondary to ethical problems associated with DCD. Although a legion of medical and ethical literature considers DCD an acceptable practice, Mandell et al19 in a survey reported a significant concern among the healthcare providers regarding the morality of this practice, some even reporting a similarity between euthanasia and DCD practice. A potential area for improvement in DCD donors is number of organs donated per donor. Although the proportion of organs procured from patients after cardiac death is increasing, the number of organs procured per donor has remained unsteady over the years. Except for a peak in 2006, it remained fairly low compared with rate per donor in DBD. Studies reported a high discard rate in DCD donors which can contribute to the lower rate per donor.1 Furthermore, the adverse outcomes in DCD livers and extremely low availability of hearts and lungs pose a significant challenge to increase the rate per donor. Over the study period, the most significant trend was observed in DCD kidney donations. There was a marked improvement in the number of kidneys donated during the study period. One of the reasons for this growing trend in DCD kidney donation is good outcomes after DCD kidney transplantation.20,21 Furthermore, organ preservation techniques for DCD kidneys are showing promising results and expanding the feasibility of DCD kidney donation.22–24 The trends for DCD livers indicate an overall increase over the years. However, after reaching a peak in 2005, it

The American Journal of Surgery, Vol -, No -, - 2015 remained relatively stagnant. This plateau observed in DCD livers correlated with the variable outcomes of liver transplant after DCD.25–28 Furthermore, reluctance on part of receiving centers, strict selection criteria, and high incurring costs without significant benefits limit its utility as an additive pool of organs. Focused research on DCD organ optimization and standardization of donation protocols will potentially improve the overall situation of DCD donation. However, recent advancements in DCD liver preservation have proven to be beneficial.29 The outcomes reported for lung transplant are comparable with DBD.30–32 Because of the lack of hormonal and autonomic disturbances that follow brain death, DCD lungs provide better quality and function. Some studies report superior outcomes for DCD lungs compared with DBD lungs.33 During the study period, we observed a significant increase in DCD lung transplantation. However, the trend was faltering and remained inconsistent. Despite significant improvement in outcomes and organ preservation techniques, there remains an inconsistency.34–36 This discrepancy in outcomes and procurement for lungs after DCD needs further exploration. Despite these achievements in DCD donors, there still remain opportunities for improvement in this group. With continued efforts, extended criteria donor can account for up to 25% of all deceased organ donors.37 With increasing demand for transplantable organs, DCD assumes great importance. Identifying the areas requiring improvement, such as economic feasibility of this approach, continuous research and development in improving outcomes, and ethical concerns related to DCD, are some of the avenues that can improve the conversion rate. Perhaps, the most important area requiring focus is public concerns related to organ donation in general and DCD specifically. The greatest proportion of lost potential donors is secondary to denial of consent by the family. Collaboration of public media, civil society, and medical community at multiple levels is mandatory to streamline transplant request process and overcome ethical and moral concerns associated with organ donation.

Figure 4 years.

Mean number of organs donated per year over the

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This study comes with inherent limitations of a retrospective study and data should be interpreted in context of these limitations. Because of the retrospective nature of the study, donor characteristics cannot be identified. Furthermore, over the study period, donor management protocols and organ harvesting and preservation methods are significantly improved, which cannot be accounted for because of its retrospective nature of study.

Conclusion DCD is an acceptable practice that can significantly affect the organ donation pool. With the shifting paradigm toward DCD in trauma donors, further research on optimization and standardization of DCD will improve the organ donation rates in this group of donors.

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Increasing organ donation after cardiac death in trauma patients.

Organ donation after cardiac death (DCD) is not optimal but still remains a valuable source of organ donation in trauma donors. The aim of this study ...
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