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Donor Criteria in Lung Transplantation^*

An Issue Revisited

^* From the Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Transplant Program, University of Alabama-Birmingham, Birmingham, AL.

Correspondence to: David Weill, MD, FCCP, Division of Pulmonary, Allergy, and Critical Care Medicine, 1900 University Blvd, THT 215, Birmingham, AL; e-mail: dweill{at}uab.edu

	Abstract

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The availability of suitable lung donors is the major limitation to increasing the number of lung transplants performed. Donor criteria developed early in the lung transplant era have not been rigorously evaluated. Each of the "standard" lung donor criteria currently in use should be challenged by obtaining, analyzing, and using multicenter data from a well-designed database. Only in this way will our understanding of appropriate lung donor criteria advance and the pool of lungs available for transplantation increase.

Key Words: lung • organ donor • transplantation

	Introduction

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The expansion of lung transplantation as a therapy for end-stage lung disease is not limited by the number of potential recipients but rather by the availability of suitable donor organs. While certain geographic regions of this country, some countries in Europe, and Australia have adopted more aggressive donor management strategies that have resulted in more donor lungs, many areas with lung transplant programs have fewer than expected lung donors.¹ Consequently, patients listed for transplantation in these areas have longer waiting times and are, either potentially or in reality, exposed to greater waiting list mortality. In the United States and elsewhere, active, "aggressive" programs have been able to achieve more transplants by being willing to accept a greater percentage of donors who in the past would have been considered less than ideal. The tendency of a specific program toward aggressive donor management and acceptance, or the converse, becomes well-known throughout the various organ procurement organizations (OPOs) and leads to even more lung donor offers as the OPOs scramble to place organs. Many times, these organs go to the more aggressive centers. In this way, the OPOs motivated to place lungs are more likely to become matched with programs motivated to transplant lungs.

The question then becomes, how do we get all the lung transplant programs to become aggressive programs? First, the larger centers with experience transplanting lungs that do not fit the "classic," or currently prevailing, donor definition need to systematically document and report that experience, ideally through an international database. Hopefully this information would demonstrate that a wide variety of donor lungs could be used with good outcomes. Second, we need to ignore the classic criteria. Here is why:

At any given time, approximately 3,500 people in this country are waiting for a lung transplant. Unfortunately, only 7 to 22% of multiorgan donors are deemed suitable to become lung donors,¹ due to the fragility of the lungs in brain-dead patients and to the lung injury that occurs due to the trauma that often produces organ donors. Diminishing the donor pool even further is the wide regional variability in donor organ acceptance rates. Consequently, only 800 to 900 lung transplants are performed yearly, and waiting times for patients listed for a lung transplant continue to increase. Aside from persistent efforts by the OPOs to develop critical pathways for organ procurement and to increase donation consent rates, transplant centers should evaluate critically their own practices regarding donor assessment and employ evidence-based strategies to determine whether a specific lung donor is acceptable. Before that can be done, however, we need to review the current criteria and try to determine how they were developed.

The standard, or classic, lung donor criteria are well-known, if not closely followed, among lung transplant practitioners (Table 1 ). While some of these criteria certainly make good sense (ie, a clear chest radiograph, no bronchoscopic evidence of aspiration), nearly all the others are controversial, often ignored, and not based on convincing research data. For example, with regards to the level of acceptable oxygenation, Shumway and colleagues² reviewed donor selection for heart-lung transplantation in 1987. Forty heart-lung transplants were reviewed with respect to various donor parameters, most notably the concept that the PaO₂ should be > 100 mm Hg on a fraction of inspired oxygen of 0.4 and a positive end-expiratory pressure > 5 cm H₂O. Apparently, this criterion was justified by the authors’ noting that "these standards were not reached in one donor and the recipient died of lung failure at operation." The group concluded that "this experience suggests there is little justification for expansion of the donor criteria... because broadening the criteria would be likely to result in increased recipient morbidity and mortality." But would it? Do we have enough information, from this analysis or any others at single centers,^{3 4} to conclude anything about the precise relevance of the donor oxygenation parameter?

However, a more recent and larger study⁶ at our institution found no relationship between the donor-sputum Gram stain results and patient outcomes in an era when prophylactic, broad-spectrum antibiotic coverage was routinely used. Furthermore, we found no predictive value in the type or amount of bacteria seen, or by the presence or absence of WBCs in the donor sputum. Other programs have had similar experiences.^{7 8} We concluded that excluding donors with abnormal Gram stain results is unwarranted and will ultimately limit the number of lung transplants performed. Certainly, many other parts of the donor-evaluation process are controversial and are debated internally at most transplant centers, often in the middle of the night.

Because most in the community recognize that very conservative lung donor criteria will lead to fewer transplants, some have begun to "push the envelope" with regard to donor lung suitability, and have asked questions such as: how long is too long for mechanical ventilation of the donor; how many cigarettes smoked are too many; are lungs procured from donors who die from hanging usable; is recipient/donor cytomegalovirus status mismatching reasonable; and when is the ischemic time too long? Evidence-based answers to these and other questions must be available if we are to enlarge the currently available donor pool.

In trying to solve some of these conundrums, a great deal can be learned from the experience of heart transplantation, and, specifically, some of the answers provided by the Cardiac Transplant Research Database (CTRD). The CTRD was started in 1990 and gathers demographic data regarding cardiac transplant donors and recipients. The information obtained is then analyzed in regard to various events (death, rejection, infection) and their determinants. Rigorous analysis of the cardiac data has provided meaningful information about heart transplant outcomes; hopefully a similar strategy could one day be used to learn more about what works, and what does not work, in lung transplantation. For example, the CTRD uses data on > 1,700 transplant procedures from > 25 institutions to examine risk factors for death after primary transplantation. Recipient variables (such as age, hemodynamic status, and ventilator status) were analyzed, in addition to several donor variables (eg, the relationship between donor and recipient age, ischemic time, inotropic support, and diabetes) in the hopes of finding donor/recipient variables that in their interaction were associated with an increased risk for death. Depicted in Figure 1 is an example of how donor variables may interact, forming concentric circles that describe the probability of survival within 30 days following heart transplantation.⁹ One learns from these data that, as donor age and ischemic time increases, the probability of survival decreases. In this example, actual data-based evidence supports the assertion that a 50-year-old donor with 120 min of ischemic time has a 90% chance of surviving the first 30 days after a heart transplant. This information provides a powerful platform on which to base clinical decisions.

View larger version (33K): [in this window] [in a new window] [Download PPT slide]   Figure 1.. Probability of donor heart survival at 30 days receiving moderate inotropic support.

So now, the oft-asked question, where do we go from here? Before considering what to do in the future, we need to recognize what is apparent at this moment. First, it is unclear on what basis the original donor criteria were developed. Second, strict adherence to the classic or "standard" criteria will result in fewer transplants. The latter is not acceptable given that our recipient lists continue to grow and the likelihood of our patients surviving the waiting period diminishes unless we do something now to expand the donor pool. Long-term solutions such as xenotransplantation should continue to be explored, but our waiting patients need help now. Therefore, we are compelled to use the currently available donors more effectively and understand more completely which donor lungs are usable and which are not. The only way to accomplish this is through development, maintenance, and analysis of a true research-quality database devised for the purpose of answering these and other questions regarding what we do on a daily basis. Until this is done, making well-informed decisions about donor lung suitability will be more difficult, and the maximal number of donor organs will not be utilized. Our waiting patients deserve better.

	Footnotes

 
Abbreviations: CTRD = Cardiac Transplant Research Database; OPO = organ procurement organization

Received for publication November 28, 2001. Accepted for publication December 3, 2001.

	References

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1. United Network of Organ Sharing. Waiting list characteristics. Available at: http://www.unos.org. Accessed May 9, 2002.
2. Shumway, SJ, Hertz, MI, Petty, MG, et al (1994) Liberalization of donor criteria in lung and heart-lung transplantation. Ann Thorac Surg 57,92-95[Abstract]
3. Sundaresan, S, Semenkovich, J, Ochoa, L, et al (1995) Successful outcome of lung transplantation is not compromised by the use of marginal donor lungs. Thorac Cardiovasc Surg 109,1075-1080
4. Bhorade, SM, Vigneswaran, W, McCabe, MA, et al (2000) Liberalization of donor criteria may expand the donor pool without adverse consequence in lung transplantation. J Heart Lung Transplant 19,1200-1204
5. Zenati, M, Dowling, RD, Dummer, JS, et al (1990) Influence of the donor lung on development of early infections in lung transplant recipients. J Heart Transplant 9,502-509[Medline]
6. Weill, D, Dey, GC, Hicks, RA, et al (2002) A positive donor Gram stain does not predict outcome following lung transplantation. J Heart Lung Transplant 21,555-558[CrossRef][ISI][Medline]
7. Ciulli, F, Tamm, M, Dennis, C, et al (1993) Donor-transmitted bacterial infection in heart-lung transplantation. Transplant Proc 25,115-156
8. Gabbay, E, Williams, TJ, Griffiths, AP, et al (1999) Maximizing the utilization of donor organs offered for lung transplantation. Am J Respir Crit Care Med 160,265-271[Abstract/Free Full Text]
9. Young, JB, Naftel, DC, Bourge, RC, et al (1994) Matching the heart donor and heart transplant recipient: clues for successful expansion of the donor pool; a multivariable, multi-institutional report. J Heart Lung Transplant 13,353-365[ISI][Medline]
10. Novick, RJ, Bennett, LE, Meyer, DM, et al (1999) Influence of graft ischemic time and donor age on survival after lung transplantation. J Heart Lung Transplant 18,425-431[CrossRef][ISI][Medline]

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