Organ transplantation

Outcome of kidney transplant in primary, repeat, and kidney‐after‐nonrenal solid‐organ transplantation: 15‐year analysis of recent UNOS database

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Abstract

The number of nonrenal solid‐organ transplants increased substantially in the last few decades. Many of these patients develop renal failure and receive kidney transplantation. The aim of this study was to evaluate patient and kidney allograft survival in primary, repeat, and kidney‐after‐nonrenal organ transplantation using national data reported to United Network for Organ Sharing (UNOS) from January 2000 through December 2014. Survival time for each patient was stratified into the following: Group A (comparison group)—recipients of primary kidney transplant (178 947 patients), Group B—recipients of repeat kidney transplant (17 819 patients), and Group C—recipients of kidney transplant performed after either a liver, heart, or lung transplant (2365 patients). We compared survivals using log‐rank test. Compared to primary or repeat kidney transplant, patient and renal allograft survival was significantly lower in those with previous nonrenal organ transplant. Renal allograft and patient survival after liver, heart, or lung transplants are comparable. Death was the main cause of graft loss in patients who had prior nonrenal organ transplant.

China to Stop Using Prisoners’ Organs for Transplants.

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China will start phasing out its decades-long practice of using the organs of executed prisoners for transplant operations from November, a senior official said on Thursday, as it pushes to mandate the use of organs from ethical sources in hospitals.

China remains the only country in the world that still systematically uses organs extracted from executed prisoners in transplant operations, a practice that has drawn widespread international criticism. Many Chinese view the practice as a way for criminals to redeem themselves.

But officials have recently spoken out against the practice of harvesting organs from dead inmates, saying it “tarnishes the image of China.”

The health ministry will begin enforcing the use of organs from voluntary donors allocated through a fledging national program at a meeting set to be held in November, former deputy health minister Huang Jiefu, who still heads the ministry’s organ transplant office, told Reuters.

“I am confident that before long all accredited hospitals will forfeit the use of prisoner organs,” Huang said.

The first batch of all 165 Chinese hospitals licensed for transplants will promise to stop using organs harvested from death row inmates at the November meeting, he added. Huang did not specify the exact number.

MEETING “ACCEPTED ETHICAL STANDARDS”

An Australian-trained liver transplant surgeon, Huang said the China Organ Transplant Committee will ensure that the “source of the organs for transplantation must meet the commonly accepted ethical standards in the world.”

That effectively means the use of prisoner organs at approved hospitals will come to an end, but the timeframe remains indefinite, he added.

China has launched pilot volunteer organ donor programs in 25 provinces and municipalities with the aim of creating a nationwide voluntary scheme by the end of 2013.

By the end of 2012, about 64% of transplanted organs in China came from executed prisoners and the number has dipped to under 54% so far this year, according to figures provided by Huang.

At a meeting in August last year, Huang, deputy health minister at the time, told officials that top leaders had decided to reduce dependency on prisoners’ organs, according to a transcript of the meeting obtained by Reuters.

Rights groups say many organs are taken from prisoners without their consent or their family’s knowledge, something the government denies.

So far, more than 1,000 organ donors have come through the new system, benefiting at least 3,000 patients, Huang said.

Voluntary organ donation in China has already risen from 63 cases in all of 2010 to a current average of 130 per month so far this year, Huang added.

However, not all donated organs are currently allocated through the new program, leaving room for human interference, one of the main challenges the reform faces.

Supply still falls far short of demand due in part to the traditional Chinese belief that bodies should be buried or cremated intact. An estimated 300,000 patients are waitlisted every year for organ transplants and only about one in 30 ultimately will receive a transplant.

The shortage has driven a trade in illegal organ trafficking and in 2007 the government banned organ transplants from living donors, except spouses, blood relatives and step or adopted family members.

 

Source: Medscape.com

 

 

Source: http://www.sciencedirect.com

 

Rationing Lung Transplants — Procedural Fairness in Allocation and Appeals.

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Organ transplantation requires explicit rationing and relies on public trust and altruism to sustain the organ supply. The well-publicized cases of two pediatric candidates for lung transplants have shaken the transplant community with emergency legal injunctions arguing that current lung-allocation policy is “arbitrary and capricious.” Although the resulting transplantation seemingly provided an uplifting conclusion to an emotional public debate, this precedent may open the floodgates to litigation from patients seeking to improve their chances of obtaining organs. These cases questioned the potential disadvantaging of children and the procedural fairness in lung allocation. But legal appeals exacerbate inequities and undercut public trust in the organ-transplantation system.

The controversy began when the parents of Sarah Murnaghan, a critically ill 10-year-old awaiting a lung transplant for cystic fibrosis, appealed through her physicians to the Organ Procurement and Transplantation Network (OPTN) for an exception to the policy that restricts lung-transplant candidates younger than 12 years to receiving organs from donors younger than 12. When this appeal failed, the Murnaghans appealed to the media, politicians, and finally a federal judge to grant access to the larger pool of lungs from adult donors. They argued that mistreatment of pediatric candidates for transplants would probably result in Sarah’s death. The merits of the case were never argued, since during the 10-day temporary injunction, Murnaghan received two lung transplants from adult donors. She has had serious complications, including pneumonia, and required a tracheostomy.

In 2005, to improve equity and efficiency, the OPTN switched from prioritization based on waiting time, a first-come–first-served approach that often prioritized less-urgent cases for organs, to an approach that incorporated consideration of urgency. After a 5-year review, the OPTN had developed a lung allocation score (LAS) using medical factors that predict disease severity and the likelihood of dying on the waiting list.1 Such scores were assigned only to patients 12 or older, because there were insufficient data to support their applicability to younger populations, owing to their different diagnoses and limited outcomes data. Thus, patients younger than 12 were excluded from consideration for adolescent and adult donors’ lungs (which are allocated according to the LAS and geography) and limited to use of pediatric donors’ lungs, which are allocated according to two priority levels (different degrees of urgency based on medical criteria) and geography.

The LAS policy has increased lung-transplantation rates and reduced mortality on the waiting list among older patients.2 Pediatric patients, however, continue to have higher waiting-list mortality and are less likely to receive transplants.

Unadjusted Relative Risk of Dying While on the Waiting List or Becoming Too Sick to Receive a Lung Transplant (Panel A) and Relative Likelihood of Receiving a Lung Transplant (Panel B), According to Age Group, September 12, 2010 to March 11, 2013.), despite wider geographic sharing of pediatric organs and the use of urgency levels — primarily because there are few pediatric donors. The supporters of the “under-12 rule” argue that it promotes equity and efficiency because of its aggregate benefits. They also cite the problematic discrepancy in lung size between adult donors and pediatric recipients. Furthermore, as a treatment for cystic fibrosis (the most common diagnosis among pediatric candidates for lung transplants), transplantation has been shown in several retrospective studies to have only marginal benefit, owing to improvements in medical management (although some data suggest otherwise).3 Lung transplantation in pediatric patients is also associated with high postoperative morbidity and mortality, largely because of the recipients’ underlying diagnoses.

Nevertheless, appeals to list children for adult organs have merit. First, designating age 12 as the cutoff arbitrarily disadvantages some children because age is a poor proxy for size. Younger patients who meet the size requirements and could benefit from adult lungs should be considered eligible. Second, in allocating other organs, we often prioritize children, partly on the basis of “fair innings” considerations (equalizing people’s chances of living until a given age) and partly because of the unique importance for physical and cognitive development that a transplant may confer. These arguments also apply to lung transplantation. Third, transplanting lungs into children is similarly efficient to doing so in adults, since their graft-survival rates are similar. Lobar resection can facilitate transplantation of adult lungs into smaller pediatric patients — also with similar results.4 Finally, given the scarcity of pediatric lung transplants, the data necessary for optimal validation of the LAS in this population may never be available. Without conclusive data, we should err on the side of inclusion, not exclusion from access to a broader supply of lifesaving organs. Currently, only 30 children in the United States await lung transplants, and only 11 of them are 6 to 11 years of age. The change that would occur by allowing these children access would most likely have little effect on nonpediatric candidates.

In response to objections that children are unfairly disadvantaged, the OPTN will review its lung-allocation policy during the next year and allow expedited appeals to an expert lung-allocation board in the interim. Candidates approved during this period will gain access to the full pool of lungs on the basis of the LAS and geographic location, while maintaining their pediatric priority.

Are the organ-allocation and appeals processes fair? Despite this case, we believe they are. An ethical framework that is gaining traction in health policy, Accountability for Reasonableness (A4R), offers an approach for achieving fairness and legitimacy in allocating health resources.5 A4R requires transparency about the objectives of and evidence for decisions, consensus about the relevance of rationales used in resource allocation, a process for reevaluating and revising criteria in light of new evidence, and procedures for enforcing these conditions in the deliberative process. This approach claims that a fair deliberative process results in outcomes that are acceptable to all.

A4R has limitations in Murnaghan’s case, including those resulting from the limited data regarding lung-transplantation outcomes in the pediatric population. But generally, organ allocation follows A4R’s tenets: it is public, transparent, revisable, enforceable, and open to appeals, and it incorporates key stakeholders. Organ-allocation algorithms seek to balance equity and efficiency. Committees comprising medical and ethics experts, transplant recipients and donors, and other key stakeholders meet in a predictable and transparent way. They deliberate and issue reports and policy recommendations that are opened to public comment. Policies are enforced and revised regularly on the basis of new evidence.

Transplant candidates and their families go to great lengths to obtain lifesaving treatment. They should be assured of fair process and, in cases of error or newly available information, allowed to appeal decisions. Appeals waged through federal courts and the court of public opinion, however, undermine fairness. Judicial appeals grant discretionary access to wealthier people, exacerbating disparities and discrimination. Moreover, appeals are inefficient, complicating allocation and leading to longer allocation times, poorer matches due to expansion of criteria, and greater difficulty in managing the waiting list. Lawsuits also inappropriately saddle courts with decisions about health policy. Finally, appeals reduce transparency and predictability, undermining the public perception of fairness, which could reduce donation rates.

Although the OPTN’s allowance of appeals to an expert panel is preferable to judicial appeals, it is problematic. Relying on physicians to appeal on behalf of candidates leaves patients of lower socioeconomic status, those less informed about their options, and those lacking advocates vulnerable to worse treatment. Physicians may also fear that accepting the responsibility of mounting appeals means assuming greater risk of poor outcomes and subsequent audits, which may also result in disparities.

To prevent unequal treatment, absent better data, we believe the OPTN should expand its policy to automatically assign an LAS to pediatric candidates and put those meeting the size and LAS criteria for adult and adolescent organs on the waiting list. Lung transplants should be allocated on the basis of the LAS and size match, with consideration of lobar resection for small recipients of adult lungs. Children should retain preference for lungs from pediatric donors.

Overall, we believe that the organ-allocation process is fundamentally fair, in part because of procedures in place to revise and modify allocation. It is because of this fair process that errors can be discovered and addressed. Our proposed changes would provide more lifesaving lungs to children; they would also provide useful data for the 1-year policy review and could ensure equal treatment for all children awaiting lung transplants.

 

Source: NEJM

 

 

Transmission of Rabies Virus from an Organ Donor to Four Transplant Recipients.

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Rabies is an acute encephalitis caused by viruses in the genus Lyssavirus, family Rhabdoviridae, that is nearly uniformly fatal in unvaccinated hosts. Although the virus is present in animal reservoirs, infection in humans is rare in the United States, with only two cases reported in 20031,2 and no more than six cases reported in any year in the past decade.3 The primary mode of transmission is through the bite of an infected animal, most commonly a bat in the United States.4 Although transmission of rabies virus from corneal transplants has previously been described,5 to our knowledge, no cases ascribed to organ or vascular-tissue transplants have been reported.

In May 2004, physicians at a hospital in Texas diagnosed encephalitis in three recipients of a liver and two kidneys from a common organ donor. It was later discovered that encephalitis also developed in a fourth patient, who had received a vascular graft from the same donor during liver transplantation. All four patients became progressively obtunded, lapsed into coma, and died within 50 days after transplantation. The initial diagnostic evaluation revealed no cause of the encephalitis, and assistance was sought from the Centers for Disease Control and Prevention (CDC) and the Texas Department of State Health Services. We report the results of this investigation.

CASE REPORTS

Transplant Recipients

In May 2004, encephalitis was diagnosed in three recipients of a liver and two kidneys (Patients 2, 3, and 4 in Figure 1FIGURE 1The Clinical Course of Four Recipients of Rabies-Infected Tissue or Organs.) from a common organ donor. In all three patients, signs and symptoms of altered mental status and progressively worsening encephalitis developed within 30 days after transplantation. Major clinical events and immunosuppressive medications are summarized in Figure 1. All patients had rapid neurologic deterioration characterized by agitated delirium and seizures. Respiratory failure requiring intubation developed within 48 hours after the onset of neurologic symptoms. Examination of cerebrospinal fluid from the three patients showed pleocytosis, with an average of 18 cells per cubic millimeter (range, 7 to 35), and elevated protein levels (mean, 135 mg per deciliter; range, 17 to 331). Neurologic imaging in the week after the onset of symptoms showed no evidence of an acute cerebral process. Magnetic resonance imaging (MRI) performed later in the course of illness demonstrated diffuse signal abnormalities, most often in the temporal lobes, basal ganglia, brain stem, and hippocampi on T2-weighted and fluid-attenuated inversion recovery images (Figure 2FIGURE 2Axial Fluid-Attenuated Inversion Recovery MRI Scan Showing Profound Signal Abnormalities within the Bilateral Frontal and Temporal Lobes, Hippocampi, Basal Ganglia, and Medulla in Patient 2.). There was minimal enhancement after the administration of gadolinium. The patients died an average of 13 days after the onset of neurologic symptoms (range, 7 to 23).

Organ Donor

Four days before death, the organ donor was seen twice at an emergency department for nausea, vomiting, and difficulty swallowing. He was subsequently admitted to another hospital with altered mental status requiring intubation. Physical examination revealed a temperature of 38.1°C (100.5°F) and fluctuating blood pressures, including systolic measurements of more than 200 mm Hg. On admission, a urine toxicology screen was positive for cocaine and marijuana, and computed tomography of the brain demonstrated a subarachnoid hemorrhage. The hemorrhage progressed, and the neurologic symptoms, including seizures and coma, worsened. The patient was declared brain-dead within four days after presentation. Donor-eligibility screening and testing performed by an organ-procurement organization, including a review of premortem blood, urine, and sputum bacterial cultures, did not detect any signs or symptoms of infection precluding solid-organ donation. The patient’s kidneys, lungs, and liver were removed for transplantation; in addition, iliac arteries were harvested for potential use in vascular reconstruction during the liver transplantation. In part because of the positive toxicology result, nonorgan tissues (e.g., tendons) were not removed. During contact investigations conducted after the rabies diagnoses were made, friends of the donor indicated he had reported being bitten by a bat.

METHODS

Clinical and Epidemiologic Review

Medical records of the donor and infected transplant recipients were reviewed to characterize clinical courses and diagnostic evaluations. After the laboratory diagnosis of rabies infection in the three organ recipients, case finding was performed to search for other possible cases. Hospital autopsy records on patients with encephalitis were reviewed for pathological findings consistent with the presence of rabies. Also, charts of patients who had been on the same floor as a patient with rabies and who had also had a lumbar puncture or neurology consultation for altered mental status were examined for documented clinical findings consistent with the presence of rabies. Procedures for organ recovery and handling were also reviewed.

Laboratory Methods

Formalin-fixed, paraffin-embedded tissue specimens, obtained at autopsy, were stained with hematoxylin and eosin and various immunohistochemical stains according to a method described previously.6 For immunohistochemical assays, 3-μm tissue sections were deparaffinized, rehydrated, and digested in proteinase K. Tissue sections were incubated for 60 minutes at room temperature with a hyperimmune rabbit antiserum or mouse ascitic fluid with reactivity to rabies virus. After sequential application of the appropriate biotinylated linked antibody, avidin–alkaline phosphatase complex, and naphthol fast-red substrate, sections were counterstained in Meyer’s hematoxylin and mounted with the use of aqueous mounting medium. Serologic analyses, detection of viral antigen in tissue by means of fluorescence microscopy, and identification of rabies virus variants were performed as described previously.7,8 Controls included serum specimens from noninfected animals, tissues from humans with nonrabies encephalitides, and rabies-infected human tissues. Immunohistochemical assays for various other viral, rickettsial, and protozoan agents of encephalitis were also performed on tissues from recipients.

Vero E6 cells were inoculated with CSF and 10 percent tissue suspensions from three of the four rabies-infected recipients (Patients 2, 3, and 4). Suckling mice were inoculated intracranially and intraperitoneally with cerebrospinal fluid and 10 percent clarified homogenates of brain tissue, spinal cord, and kidney suspensions. Tissue cultures and suckling mice were observed daily for cytopathic effects and signs of illness, respectively. Tissues obtained from suckling mice that developed neurologic signs or died were fixed in 10 percent neutral buffered formalin or 2.5 percent buffered gluteraldehyde or were frozen for further evaluation. At 14 days, the Vero E6 cells were suspended in saline, fixed on glass slides, and tested for the presence of rabies virus antigen by means of a direct fluorescence antibody assay according to a previously described method.9 Immunohistochemical studies were performed as described above, and formalin-fixed tissues were embedded for examination by electron microscopy.

RESULTS

Review of Transplantation Records

All organs obtained from the donor were transplanted; the lung recipient died of intraoperative complications. Iliac arteries from the donor were not used during the liver transplantation in Patient 2 and were placed in a sterile container and stored for potential use in subsequent transplantation procedures. One day after the organs were transplanted, the iliac-artery segment was retrieved and used to construct a vascular graft for another liver-transplant procedure (in Patient 1).

Rabies Case Finding

In addition to the three initial cases noted by physicians, autopsy review identified a fourth patient (Patient 1 in Figure 1) in whom progressive, fatal encephalitis had developed after liver transplantation. This patient had received the vascular segment from the rabies-infected donor. A review of the medical records of patients who had been on the same floor as a patient with rabies and who had had a lumbar puncture or neurology consultation for altered mental status revealed no further cases of encephalitis consistent with the presence of rabies.

Pathological Findings

Histopathological evaluation of tissues from all four rabies-infected transplant recipients demonstrated diffuse, predominantly lymphohistiocytic, infiltrates and microglial nodules involving the cerebrum, brain stem, cerebellum, and spinal cord. Cytoplasmic inclusions consistent with Negri bodies were identified throughout the central nervous system (CNS), particularly in the Purkinje cells of the cerebellum and in neurons of the frontal cortex, thalamus, hippocampus, midbrain, and pons (Figure 3AFIGURE 3Histopathological Findings in Patient 4.). Lymphohistiocytic infiltrates involving the peripheral nerves, heart, and kidneys were also noted in some patients. Electron microscopy of the midbrain of Patient 4 demonstrated abundant rhabdovirus particles (Figure 3B). Intracytoplasmic rabies virus antigens were detected on immunohistochemical staining in neurons from multiple areas of the CNS (Figure 3C); in peripheral nerves of the transplanted kidneys, liver, and arterial graft (Figure 4FIGURE 4Immunohistochemical Staining (Red) of Rabies Virus Antigens in Peripheral Nerves of the Liver (Panels A and B), Kidney (Panel C), and Arterial-Graft Transplants (Panel D).); and in renal tubular epithelium, smooth muscle, histiocytes, and vascular endothelium. No tissues were positive for enteroviruses, human herpesviruses 1 and 2, West Nile and other flaviviruses, eastern equine encephalomyelitis virus, lymphocytic choriomeningitis virus, Cache Valley virus, henipaviruses, measles virus, spotted fever and typhus group rickettsiae, Toxoplasma gondii, or Trypanosoma cruzion immunohistochemical analysis. Direct fluorescence antibody staining also demonstrated rabies virus antigens in CNS tissues from all recipients.

Serologic Analyses and Viral Identification

Antibodies (IgM and IgG) reactive to rabies virus were present in the donor’s serum at the time of death. Antibodies were also present in three of the four recipients in samples obtained on postoperative days 35 and 36; both IgM and IgG antibodies were present in one kidney recipient (Patient 3) and the recipient of the donor’s liver (Patient 2), whereas only IgG antibodies were present in the patient who received the arterial segment (Patient 1). Antigenic typing revealed a previously characterized rabies virus variant associated with bats.

Cell Culture and Mouse Inoculations

All suckling mice had neurologic abnormalities or had died seven to eight days after inoculation. Thin-section electron microscopy of CNS tissue demonstrated rhabdovirus particles, and IHC testing detected rabies virus antigens in mouse CNS tissues. Cultures of Vero E6 cells inoculated with brain, spinal cord, and kidney from a kidney recipient demonstrated rabies virus antigen on staining with DFA.

DISCUSSION

This report describes the transmission of rabies virus through the transplantation of solid organs and vascular material. Four patients who received transplants — three organs and one vascular segment — from a donor with unrecognized rabies infection subsequently died of rabies. The transmission of rabies from corneal transplants has been described previously.5

Rabies is seldom included in the differential diagnosis of encephalitis in the absence of a documented exposure or suggestive history.8,10 The symptoms in the cases reported here, including fever, changes in mental status, and autonomic instability, were, in retrospect, consistent with a diagnosis of rabies. However, the diagnosis was complicated by the absence of a history of exposure at presentation and by the number of other potential causes of illness in these immunosuppressed patients. A history of a bat bite in the donor was discovered during contact interviews only after rabies had been diagnosed, and the investigation initiated. The diagnosis in the donor was further complicated by the presence of a subarachnoid hemorrhage in the setting of hypertension and a positive toxicology screen for cocaine. It is not known whether rabies infection was the cause of the subarachnoid hemorrhage, since this finding has not been noted in previous reports.11-13

Signs of rabies developed in all four transplant recipients within 30 days after infection. According to previous reports, symptoms developed within 30 days after an animal bite in only 25 percent of patients.10 It is unknown whether the shorter incubation period in these patients was due to the immunosuppression, the route of transmission, or both. The effect of immunosuppression on rabies infection is currently not well understood. In reports of rabies transmission from corneal transplants in patients who were not immunosuppressed and did not receive postexposure prophylaxis, symptoms developed an average of 26 days after transplantation,14-17 suggesting that implantation of material from infected donors may lead to a shorter incubation period. Three of our patients presented with commonly described symptoms of tremors and changes in mental status, whereas the fourth presented with abdominal and flank pain, which may have been neuropathic, and changes in mental status occurred about 48 hours later. The rapidly progressive encephalitis, with death occurring an average of 13 days after the onset of symptoms, is consistent with the course in other reports.4

There is only one reported case of recovery from clinical rabies by a patient who had not received preexposure or postexposure prophylaxis against rabies.18 However, administration of postexposure prophylaxis with rabies immune globulin and vaccine is highly effective in preventing infection after exposure. In a previous report, administration of postexposure prophylaxis probably prevented infection in a patient who had received a cornea from a donor with rabies.19

This report and another, describing the transmission of West Nile virus through solid-organ transplantation,20 underscore the potential for transmission of unexpected infectious diseases through organ transplantation. Recognition and prevention of transplant-transmitted infections may be improved in various ways, including enhanced donor screening and testing, the development of standardized procedures related to storage and use of donor vascular segments, as well as methods to track their use or nonuse, and enhanced means of detection and diagnosis of illnesses in recipients.

To minimize the risk of transmitting infections during organ transplantation, the Organ Procurement and Transplantation Network (OPTN) has established standards that require organ-procurement organizations to assess the risks of infectious diseases through screening questions and blood testing for selected bloodborne viral pathogens and syphilis.21 Questions about potential exposure to rabies are generally not included, and laboratory testing for rabies infection is not performed. Organs can be procured from donors who are febrile, provided that the medical director of the organ-procurement organization and the transplantation physicians agree that the cause of the fever does not pose an unacceptable risk to the recipient. Given the growing importance of emerging and reemerging infectious diseases, the ability of general improvements in the donor-screening process, rather than disease-specific measures, to increase organ safety should be evaluated. A proposed revision of OPTN policies would expand the list of potentially transmittable diseases and conditions that clinicians should consider in determining a donor’s eligibility.22 The revision emphasizes that when any of these conditions is known or suspected in a donor, this information should be conveyed immediately to the organ-procurement organization as well as to all transplantation centers that received organs from the donor.

The successful use of donor arterial conduits has been reported in liver transplantation23-26 and in the management of vascular complications in recipients of both hepatic transplants27,28 and renal transplants.29 As with organs, these vessel segments have the potential to transmit infection. A careful accounting of and an ability to track donated material, such as vessel conduits, are essential in efforts to link unexplained illnesses or deaths to a common organ donor and will increase the probability of quickly identifying all recipients who may be at risk from donor infections. Proposed revisions of the policies of both OPTN22 and the Joint Commission on Accreditation of Healthcare Organizations30 may help address the storage of vessel conduits and documentation of their use or nonuse.

Our investigation underscores the challenge in detecting and diagnosing infections that occur in recipients of organs or tissues from a common donor. The potential for disease transmission from a donor as a cause of illness or death may not be considered in the evaluation of an individual recipient. In this investigation, and in the previous report of the transmission of West Nile virus through transplantation, the ability to connect illnesses to a common organ donor was facilitated by the fact that multiple recipients were hospitalized at the same facility. Improved national detection of unexpected or serious outcomes among transplant recipients may facilitate the discovery of transplant-related transmission of emerging and unusual pathogens by allowing connections to common donors to be made. The ability to make retrospective diagnoses of infections in organ donors when unexplained deaths or illnesses occur in recipients is hampered by the limited availability of donor samples, particularly tissue; currently, only serum samples from organ donors are retained for any length of time. Investigations into possible transplantation-associated infections would be facilitated by the availability of selected, archived tissue samples from the donor and by autopsy reports and materials. An improved diagnostic ability may have important implications for other patients who received material from the donors and for contacts of the patients and donors.

As organ and tissue transplantation becomes more common, the potential risks of disease transmission may increase. Cases of transplantation-associated infections provide important opportunities to review practices in an attempt to enhance the safety of transplantation without affecting the organ supply. The Department of Health and Human Services, including the CDC, is working with other partners in the organ- and tissue-transplantation community to review donor-screening practices, the use of retained vascular segments, and surveillance of recipients for illness. Clinicians who care for organ-transplant recipients should continue to be aware of the potential for disease transmission through transplantation and the challenges in recognizing atypical presentations of infections in this immunosuppressed population. Clinicians should report unexpected outcomes or unexplained illnesses in transplant recipients to their local organ- and tissue-procurement organization.

We are indebted to the state health departments in Oklahoma and Alabama, to the Southwest Transplant Alliance, and to the staff of the Baylor University Medical Center for their assistance with this investigation.

Source: NEJM

 

Ensuring fair allocation of organs.

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Last week, the NHS Blood and Transplant organisation (NHSBT) published a new strategy on organ transplantation for the UK until 2020, with the support of UK health ministers. The aims of the strategy are to increase consent rates for organ donation, raise deceased donor rates, boost the number of organs transplanted from donors, and increase the number of patients receiving transplants. Launching the strategy during National Transplant Week, the Director of Organ Donation and Transplantation at NHSBT, Sally Johnson, called for debate on attitudes to organ donation: “Almost everyone would take an organ if they needed one—but only 57% of families agreed to donation when they were asked…is it fair to take if you won’t give?”

Specific actions are recommended in the strategy to improve knowledge of organ transplantation, ease registration for donation, and increase adherence to the donor’s wishes—in many cases, family members are unaware of the prospective donor’s wish to donate, or override that decision. Methods of providing support within hospitals are outlined to ensure that each donor can give as many organs as possible, and that surgeons have more options to preserve organs and that they adhere to evidence-based policies for organ allocation.

The most radical action proposed in the NHSBT strategy is to promote national debate on whether those on the Organ Donor Register should receive higher priority if they need to be placed on the transplant waiting list than those who have not registered to donate their organs. Such nationwide prioritisation is in place in Israel and Singapore.

The law in Israel came into force in 2010, and was born out of an acute organ shortage. In addition to organs prioritised for those with donor cards, transplant candidates can move up the priority list if they have a first-degree relative who has signed a donor card, donated an organ after death, or is an eligible live non-directed donor. Preliminary data from 2011 showed that deceased and living organ donation had risen compared with previous years. Critics have pointed out that clinical need should be the only factor determining organ allocation, and also that this system unfairly favours those with large families.

The United Network for Organ Sharing prioritises living donors of organs to receive a transplant from a dead donor, should they need one. In the USA, an organisation called LifeSharers facilitates donation between members—members commit to organ donation on their death, and other members are given priority to receive the organs.

In Wales, presumed consent for organ donation will come into force in 2015, after a 2 year public education programme to explain that people can register to donate, or opt out of donation. If they do neither, individuals will be presumed to have consented to donate their organs after death. The expectation is that the number of donors will substantially increase in Wales. Consultation on a similar opt-out system has also begun in Northern Ireland. Similar presumed consent systems are in place in Spain and Belgium.

In China, efforts are being made to ensure fair allocation of organs by enforcing use of a computerised system for organ distribution—the China Organ Transplant Response System—which ranks patients by disease severity, waiting time, and location. The source of organs, though, is still a major concern, with many still being from executed prisoners. Trafficking of organs, and payment for organs, are still major barriers to a fair system of transplantation in some countries.

Experts in organ transplantation met in Madrid on June 27—28 to share best practice in blood transfusion and transplantation in Europe, in an event partly sparked by recent scandals in Germany where there have been cases of falsification of patients’ data on transplant waiting lists to shorten waiting list times or to misdirect organs.

There are many frameworks within which organ transplantation can operate, but at the heart of any system must be trust. Dying patients must be able to trust their families to respect their wishes to donate, and their doctors to provide the best end-of-life care possible. Patients in need of a transplant must be able to trust in an ethical and fair organ supply, and that their doctors will provide the highest standards of clinical care. Patients who receive transplants must adhere to often punishing immunosuppression regimens and treatment to maximise the life of their new organs.

Clinical need should be the main determinant of organ receipt. Whether clinical need should be the only factor is a matter for debate. Is it fair to take an organ if you won’t give? Let the UK, and broader international, debate begin.

Source: Lancet

 

AMs to vote on ‘presumed consent’ organ donation plans.

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Wales could become the only UK country with an opt-out organ donation system if politicians vote to change the law.

organ

The Welsh government wants to introduce a system where individuals will be presumed to have consented for their organs to be donated after death unless they have specifically objected.

But opponents want families to be able to stop a donation if their relative did not express an opinion either way.

Ministers want to increase the number of donors for transplant by a quarter.

There has been opposition to the changes from Christian churches and from within the Muslim and Jewish communities.

It would mean a change from the current opt-in system, where would-be donors have to sign a register.

A statement from faith leaders and health professionals – signed by the Archbishop of Wales Dr Barry Morgan and others – calls for a so-called “soft opt-out scheme” in the Human Transplantation Bill.

They say it would give deceased patients’ families a say on donation if their relative had neither opted in or out.

A joint statement says that failure to make changes to the bill would be “inhuman, unfeeling before the suffering of relatives, and a danger to the public trust and support which are necessary for the practice of organ donation to flourish”.

If passed by assembly members on Tuesday, the presumed consent system could come into force by 2015.

The Welsh government hopes legislation will lead to a rise in the numbers of donors.

As currently happens, organs could go to recipients anywhere in the UK, not just in Wales, although evidence from other countries with an opt-out system indicates that the rise is small with around 15 additional donors provided each year and approximately 45 extra organs.

According to the NHS Blood and Transplant service, fewer than 5,000 people die every year in the UK in circumstances that would allow them to donate successfully.

Added to that, when compatibility, organ suitability, location, time scales and consent are taken into account it means that not everyone who wants to donate actually does.

It is estimated there are around 250 people on a waiting list for a transplant at any one time – 33 people in Wales died in 2012/13 whilst waiting.

Health Minister Mark Drakeford told BBC Wales: “The legislation makes it absolutely clear that if you are uncomfortable with being an organ donor you have an absolute right in the simplest way possible to opt out of the system.

Publicise the system

“You put your name on the organ donor register saying you don’t want to be a donor and that is the end of the matter.

“There is nothing to be scared of in this legislation.”

The presumed consent law would apply to over-18s who die in Wales if they have lived in Wales for more than 12 months.

People will be able to sign up to the organ donor register so their wishes will be known if they die outside Wales.

ORGAN DONATION FIGURES

  • The aim of the Bill is to increase the number of organs available from Wales, potentially by 25%
  • On latest figures this would see the number of donors rise from around 65 donors to 80.
  • The average number of transplants anticipated from 15 additional donors would be approximately 26 kidneys, 10 livers, two hearts and four lungs
  • Just over 30% of organs donated in Wales are transplanted into people living in Wales

If the law is changed, ministers will have a duty to publicise the system and almost £8m will be spent over 10 years.

The bill would involve transferring some powers from the UK government to Welsh ministers.

The Kidney Wales Foundation (KWF) has campaigned for a law change on organ donation and described the bill as “progressive law”.

Roy Thomas, KWF chief executive, said: “The Welsh government has seen this bill scrutinised properly and several detailed consultations have been undertaken with the Welsh public.

“This law is further progress and evidence shows it will increase donation rates.”

Meanwhile, in Northern Ireland a public consultation is under way about adopting an opt-out system. In Scotland, ministers have said the option was “not completely off the agenda” but they have argued that progress has been made under the current system.

The Department of Health said a taskforce had recommended against moving to an opt-out system for England in 2008.

A spokesman added: “We are working closely with the Welsh government to ensure their policy does not negatively impact on our work to promote voluntary organ donations.”

Source: BBC

 

 

Sarah Murnaghan gets lung transplant.

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A severely ill 10-year-old girl to whom a US judge granted a prime spot on the adult transplant list despite her youth has received a new set of lungs.

Sarah Murnaghan’s family said they were “thrilled” the six-hour surgery to implant adult lungs went smoothly and that she had done “extremely well”.

The family had challenged a US policy relegating under-12s to the bottom of the adult organ donation list.

Analysts have warned the judge’s decision set a dangerous precedent.

The Obama administration declined to intervene in Sarah’s case, arguing transplant policy should be made by doctors and scientists rather than the government.

Children under 12 have priority for paediatric lung donations, but far fewer paediatric lungs are donated than adult lungs.

‘Close to the end’

Sarah’s surgery began around 11:00 local time (15:00 GMT) on Wednesday in Philadelphia.

“Her doctors are very pleased with both her progress during the procedure and her prognosis for recovery,” the family said in a statement about seven hours later.

Her aunt Sharon Ruddock told reporters the lungs had been resized to fit her small body, but her recovery time would probably be extensive because the girl had been unconscious and breathing through a tube since Saturday as her condition deteriorated.

Complications from lung transplants can include rejection of the new lungs and infection.

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It’s important that people understand that money, visibility, being photogenic… are factors that have to be kept to a minimum”

Dr Arthur Caplan,Bioethicist

Since Sarah’s case came to light, the national organisation that sets organ transplant policy has created a special appeal and review system for young patients.

About 30 children under the age of 11 are on the waiting list for a lung transplant, according to the Organ Procurement and Transplantation Network, out of a total of 1,650 potential lung recipients.

Last week, US District Judge Michael Baylson, who is independent of the Obama administration, ruled Sarah and another child at Children’s Hospital in Philadelphia, 11-year-old Javier Acosta, eligible for a better spot on the adult list.

He found that the US policy amounted to improper age discrimination.

Both children suffer from with cystic fibrosis, a chronic lung disease. Sarah’s condition had worsened significantly in the last 18 months, diminishing her lung capacity to 30%.

Last month she was admitted to the intensive care unit in hospital. Doctors told the Murnaghans that if Sarah were an adult, she would probably be at “the very top” of the lung transplant list.

Ms Ruddock said she was sure that had Sarah not been put on the adult list, “we would have lost her”.

“She was very close to the end,” she said.

US patients on organ waiting lists as of 12 June 2013

  • Kidney: 96,555
  • Pancreas: 1,180
  • Kidney/Pancreas: 2,089
  • Liver: 15,736
  • Intestine: 264
  • Heart: 3,506
  • Lung: 1,650
  • Heart/Lung: 46

Source: Organ Procurement and Transplantation Network

Some analysts warned the intervention of politicians and judges in the cases would set a dangerous precedent.

Dr Arthur Caplan, a bioethicist at New York University Langone Medical Center, said children fared worse than adults after lung transplants, one of the reasons for the existing policy.

“In general, the road to a transplant is still to let the system decide who will do best with scarce, lifesaving organs,” Dr Caplan said.

“And it’s important that people understand that money, visibility, being photogenic… are factors that have to be kept to a minimum if we’re going to get the best use out of the scarce supply of donated cadaver organs.”

Before Sarah, only one lung transplant from a donor older than 18 to a recipient younger than 12 had taken place in the US since 2007, according to US government data.

Source: BBC

9-month pregnant woman gets new liver.

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A 19-year-old woman who suffered from acute liver failure during pregnancy was saved after a 12-hour transplant surgery here. The child was also delivered successfully which is rare, claim doctors.
The surgery took place at Sir Ganga Ram hospital(SGRH).The patient, Swati Kumari, suffered from acute liver failure in the 38th week of pregnancy due to hepatitis E infection, said the doctors. She was admitted to a hospital in her hometown Patna with severe jaundice and referred to SGRH later.

“The problem in her case was that she required urgent liver transplantation as a life-saving procedure, however, that could put the unborn child at risk of anaesthesia and death. If we had decided to conduct the delivery then the patient would have been at risk of severe uncontrolled bleeding because of thinning blood,” said Dr Naimish Mehta, the liver transplant surgeon.

The woman went into spontaneous labour on the second day of her admission and gave birth to the child. But then went into deep coma which could lead to death.

“A healthy person’s brain activity measures greater than 90 on Bi-Index Spectrography (BIS). In patients who are under anaesthesia it reduces to 40-60. But, when BIS shows reading of less than 40, then tests for brain death are advised. In Swati’s case, the BIS reading was 17-18 which is very low. We were in a quandary whether to perform a transplant to save her or not.

Finally, on the family’s permission, a 12-hour long transplant procedure was conducted. The girl’s mother donated part of her liver,” said Mehta.

Dr Jayshree Sood, head of the department of anaesthesia said the patient regained consciousness within 48 hours of surgery. “The first thing she asked after gaining consciousness was about the child. It’s her first baby,” said Reena Devi, the patient’s mother. Both the child and the mother are doing fine post-surgery, said the doctors.

Health experts say hepatitis E infection is the most common cause of liver failure in pregnancy and is dangerous for both mother and child with a mortality rate from 60 to 100%. “We received four similar cases in the last three years. In three cases, only the mother survived,” said Dr Mehta.

He added that hepatitis E virus is transmitted through contaminated food and water. “During pregnancy, the immunity levels are low and chances of infection causing severe complications such as liver failure increase. One must take precautions such as drinking clean water, avoiding food from outside and not having fruits without washing them properly. Maintaining hygienic practices such as hand washing , particularly before handling food is helpful,” said a senior gastroenterologist.

Source: TOI

Organs Wasted in Kidney Transplant Network .

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The current system of allocating kidneys is flawed, with organs being discarded that might otherwise have benefited people — and the problem is growing — the New York Times reports.

The paper says that in 2011, some 2600 of 15,000 kidneys recovered for transplantation were discarded — many because recipients could not be found in time (the article notes that “it is not precisely clear” how many discarded kidneys might actually have been useful). The number of kidneys discarded has grown over 75% in the past decade, “more than twice as fast as the increase in kidney recoveries,” according to the Times.

Federal efforts to monitor the quality of transplantation programs may also inadvertently contribute to the problem. The effort to keep success rates high has made transplant surgeons “far more selective about the organs and patients they accepted, leading to more discards.”

New proposals for kidney allocation have been put forward, but remain similar to the system already in place.

Source:New York Times