ORGAN PROCUREMENT METHODS

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Key words: organ procurement, kidney transplant, informed consent. Corresponding ... tissues or organs from a donor to a ... increase the pool of transplantable.

Revista Română de Bioetică, Vol. 11, Nr.4, octombrie - decembrie 2013

ORGAN PROCUREMENT METHODS: A COMPARATIVE APPROACH OF ETHICAL ISSUES IN DIFFERENT CENTERS Raluca Dumea*, Cristina Gavrilovici**, Dimitrie Siriopol*, Simona Hogas*, Mihaela Blaj***, Mihaela-Dora Donciu*, Adrian Covic* Abstract During the past years the number of organ donors in Romania has declined after a slow but steady increase since 2000. Improving consent rate for solid organ donation from deceased donor is a key component of strategies to increase de availability of organs for transplantation. In our country, the law is currently clear on what forms consent may take, during life or after death - through family approval. The factors determining such actions include both positive altruistic motives and negative psychological responses. The national program of organ donation is an opt-in system. Without having a centralized program of organ donors, which makes the request consent for donation more difficult, some potential organs for transplant can be lost because of lack of consent. The present article largely discusses: the strategies and policies for organ procurement in our country and two other countries, with important transplant rates, even if they have different systems of donation. We analyzed the survival of patients in our evidence (University Hospital “Dr. C. I. Parhon”), the overall graft survival at 1, 5 and 10 years is superior to the average literature-survival (US and Canadian statistics). The high percentage of living-donor transplants could explain the better outcomes in our unit. While the total number of deceased donors and transplants has been relatively stable in the last three years, the number of patients on the active transplant list is greater each year. Organ shortage remains one of the main challenges in organ transplantation. An adequate organization seems to be the clue to increase deceased donation activity in a sustained way. The public should be prepared to understand and accept the presumed consent. Key words: organ procurement, kidney transplant, informed consent Corresponding Author – Cristina Gavrilovici : [email protected] * Nephrology,UMF "Gr.. T. Popa ", Iași, Universitary Hospital "Dr. CI. Parhon", Iaşi, România ** Center for Ethics and Health Policy, UMF Gr.T.Popa, Iași, România *** Department of Anesthesia and Intensive Care, Universitary Hospital "St. Spiridon” Iaşi, România

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Introduction End-stage renal disease (ESRD) can be ultimately defined by the requirement for life-saving dialysis or kidney transplantation. The incidence and prevalence of th is disease are still increasing markedly world wide (1). Transplantation is defined as the transfer (engraft ment) of hu man cells, tissues or organs from a donor to a recipient with the aim of restoring function(s) in the body (2). The o rgan transplant gives a uniquely modern perspective to perennial questions on body and identity, illness and health, death and survival. (3) Renal transplantation is associated with a survival advantage and improved quality of life for the majority of patients with ESRD (4). Huge med ical advances in research immunology and clinical transplantation led to immediate palpable consequences: the lives of many potential recipients could be either saved or vastly improved, g iven appropriate transplantation conditions and necessary channels of consent (5). At the same t ime, the demand for organs for transplantation continues to vastly exceed the limited supply capacity all over the world (6). Despite encouraging educational programs, the wait ing list for organ transplantation progressively grows, as the nu mber of donated organs remains low (7). Currently, “the donation gap” remains the leading obstacle to transplantation (8). An inability to address transplantation needs and disparities in donation, added to the unequal distribution of wealth in the world, represent the root causes for many patients dying or having a poor quality of life and for unacceptable practices, such as organ trafficking and transplant tourism (9).

Donation rates from living and deceased donors have remained relatively unchanged over the last 10 years (10), despite the strategies to increase the pool of transplantable organs by progressively using unrelated liv ing donation (11), expanded-criteria organs (12), A BOincompatib le transplants (13), and liv ing-donor paired exchange programs (14). Therefore, in addition to improvements in maximal utilization of organs fro m deceased donors, strategies to enhance living organ donation have become essential. Living-donor transplants are clearly associated with improved outcomes (15), allo wing for p re-emptive transplantation, which is associated with further imp roved survival (16). With increasing public awareness of deficiency of organ donation and the transplantation benefits from livingdonors, there was an increase in kidney donation in the last decade (17). Nevertheless, the (low) consent rate for organ donation, either from potential donors themselves or next of kin, is regarded as one of the main bottlenecks behind the chronic shortage of transplantable donor organs (18). Therefore, it was proposed to change or adjust the consent system. Innovative schemes, such as paired kidney exchange, altruistic donation, donor chains and list exchange programs, have contributed to increased living-donor kidney transplants (19). Irrespectively of the consent system, most people do not reg ister their wishes (whether consent or refusal), consequently the pool of potential donors in a p resumed consent system far exceeds the pool of potential donors in an explicit consent system (20). Certain lawmakers feared 102

that switching to a presumed consent system would lead to a decline in legal certainty and public trust in the procurement system. (21) Organ donation brings the issue of respect as unique being or member of a society, the question is also which is better, presumed or expressed consent. Ethical issues are discussed in relation to the expression of consent, as a personal decision or fro m relatives, considering cultural values, relig ious or social attitudes, serving utilitarian reasons (22). The large spectrum of moral assumptions over this topic stems from a d iversity of social and sociological factors, cultures and religions (23). This paper is an attempt to objectively analyse some of these fundamental assumptions. After a short description of the legal framework, necessary for a good comprehension of the Romanian model of organ transplantation, our intention is to perfo rm an analysis of various procurement methods, highlighting their ethical or social implications, also using examples of different international o rgan procurement strategies.

therapeutic alternative or a therapeutic method of comparable effectiveness. According to Law no. 95/2006 (24), family consent is a mandatory condition for organ donation fro m brain-dead patients. In contrast, 21 of 27 European Un ion countries included in their legislation the presumed consent. In November 2007, 7 members of the Ro manian Parliament had a legislative initiat ive for complet ion of the Law no. 95/ 2006 concerning the Healthcare System (24, 25). A mong various proposal an amend ment intended to replace the informed consent by the presumed consent for organ donation was introduced, so that any person who during his/hers life time never expressed the refusal to donate organs after death, implicitly agrees with organ donation. In May 2008, the Ro manian government expressed an official point of view (26) in favour of the informed consent, recommending at the same time a wider documentation, consultation of the civil society and the introduction of a National Donor Registry. The main pros (beyond the profound humanitarian goal of saving more lives) for changing the existing legislation were: the low rate of o rgan donation with long waiting lists, enhancement of organ procurement, avoidance of wasting valuable organs, reducing the stress imposed to the family when giving the donation consent, tuning with the recent medical scientific progress, and avoiding unnecessary bureaucracy. The main cons were related to ethical issues: potential violat ion of human rights, denial of brain death, unethical advantage of public ignorance, unethical use of underprivileged people with huge negative effects on

Legislati ve provision for organ procurement in Romania In Ro man ia, the importance of regulating public procurement became obvious only after the polit ical changes following the fall of co mmunist regimes in Europe. The Transplant Agency is a public institution with the status of legal entity under the Ministry of Health, regulating all activit ies related to transplantation of organs, tissues and human cells, and ensuring that patients have equal access to transplant services. Transplantation is performed only if there is no 103

public opinion, and ult imately public mistrust in transplant programs. At present, transplantation fro m liv ing-donor can be performed with the written consent of the container after it has been informed of the potential risks and consequences, that she/he can change one’s mind until the donation Any constriction is forbidden, donation should be humanitarian and altruistic – in other words, there are no restrictions concerning the identity of recip ient, or the relation between them. An independent commission controls whether the donation is a humanitarian, altru istic act and is not subject to material transactions. One needs to be aware of the insistence on the word “altru istic” in the legislation. It emphasizes the ethical dimension of the donation act, by carefully d istinguishing it fro m other (supposedly non-altruistic and therefore non-ethical) types of donation. By all legal definitions (American, European or Ro manian laws), all organ donations need to be altruistic in order to be acceptable. “Altruism”, together with “voluntary” or “informed consent”, is part of the basic princip les that make the donation act possible in the first place. Organ procurement fro m inco mpetent persons is strictly forbidden. Article 10 of the law explains the conditions of extraction fro m body: sampling is possible if the consent of the person before death was expressed in accordance with the current law. If, during life, the deceased expressed his option against donation through an act of refusal in handwritten form or another legal form, ext raction is not carried out. If consent is absent, the donation is possible, if family does not preclude, or the legal representative of the deceased does not oppose (26).

Strategies for org an procurement worldwi de There are t wo main methods for determining voluntary consent: "opt in" (only those who have given exp licit consent are donors) and "opt out" (anyone who has not refused is a donor). The Opt out System Under a system of "opting out" or "presumed consent", every person liv ing in that country is deemed to have given their imp licit consent to organ donation, unless they have specifically "opted out" by recording in writing their unwillingness to give organs (22). Proponents of the “opt out” policy counted on European experience, where several countries seem to favour the idea. Nations with the highest per capita organ donation rates in the world are Spain, Austria and Belgiu m, countries that have seen improvement in their donor rates after the enactment of the “opt out” laws. One fear with the presumed consent is that people will not get round to registering an objection and the subsequent expectation that organ donation should take place could lead to unnecessary distress to their relatives and widespread adverse publicity. If an individual does not register an objection, it is possible that his/her silence may indicate a lack of understanding rather than agreement with the policy. It is because of such concerns that in the majo rity of countries operating an opt-out system, health care pro fessionals still consult the family to establish consent (22,27). Advocates of the opt-out system 104

point out to the enormously increased number of potential donors as one the main benefit. Today, many organs are buried or cremated, when it is possible that they could have been used to save a life. A system of presumed consent would enable those who object to organ donation to have their views respected while at the same t ime pushing for the maximu m possible donation rate from a given population. The opt-out system would also take some of the enormous amount of pressure off of the grieving families of potential donors. The death of a relative is always traumatic, and families are not always well placed to make the best decision on behalf of the deceased. The opt-out system takes this responsibility off the grieving family and relies on the decision made by the donor himself. Any opt-out system would have to carefully educate the public that it relates to and make sure that it’s imp licat ions are clearly understood, however, the nature of optout systems is that it is the individual’s responsibility to make their own decision and therefore their responsibility to acquaint themselves with how the law works, as is the true of every other law (28).

proposal would take control away fro m the family back to the indiv idual, thus emphasizing the indiv idual’s interest in taking control over his/her own body even after death. Advocates of the mandated choice system (29) suggest several possible advantages: elimination of the need to obtain family approval; the decision about organ donation is shifted to a more relaxed setting, where judging is likely to be clearer; this method would effectively increase public awareness related to such an important medical and social subject. A total elimination of family involvement in this decision is just not feasible and less likely to happen in a pluralistic society. In the current practice doctors frequently seek consent from family members even in the presence of a signed donor card. The public has a tendency to mistrust med ical institutions and hospitals might be afraid of negative public relations. Doctors should not be perceived as acting against people’s wishes and they might be unwilling to impose more conflict and grief on a reluctant family who is in great pain. Fro m a legal standpoint, in this lit igious age, doctors might be concerned about potential lawsuits and it is the family and not the deceased who might sue them. In addition, possible donors have expressed the fear that in emergency situations carrying an affirmative donor card might make doctors consider their life less important than someone else’s; that they might be more interested in their death than in their survival; that their body parts might be perceived as more valuable than their life; that they would be worth more dead than alive (30). Unfortunately, although

The opt i n system: “ mandated choice”: “ donor card” and “organ registry” Under mandated choice, all competent adults would be demanded to decide and record whether or not they wish to beco me organ donors upon their deaths. This could be accomplished by asking about organ donation on the driver license’ application fo rm, tax returns or any official state identification cards. It was hoped in the beginning that this 105

“mandated choice” is a good way to touch the public sensibility and raise awareness on a tremendously important subject, this strategy does not appear to be a tru ly “mandated” option. It does not involve a legal sanction if it is not accomplished in a certain period of time or even during lifetime. Even if we strongly believe in people’s compassion and altruism, it is less likely that society will unanimously respond and subscribe to this approach, unless there it would be legally binding. Finally, the reality is that the “donor card” is not a very powerful way to stimulate o rgan procurement and had limited beneficial impact for the transplantation community so far. Apparently Japan is the country where the donor card has the most powerful legal enforcement capacity. Similarly to Western societies, the family can oppose donation even when the candidate has signed a donor card. However, if the family supports donation and the prospective donor expressed his/her will orally but did not sign a donor card, no procurement can take place (31). In summary, the mandated choice is a strategy rather “recipient oriented” than donor oriented, a means to increase organ donation by eliminating the need to obtain family approval. It is a method based on the assumption that families do not know the true views on donation of the deceased. Besides, there is no evidence that a lack of knowledge about a patient’s wishes is a primary cause for family refusal or that informat ion retrieved fro m a national database would convince a family that they were carrying out their relative’s true wishes (32). Another problem of this system may be expressed through a

rhetorical question: under mandated choice would in formation on a driver’s license as a non-donor also be honoured? It is hard to imag ine an affirmat ive answer as long as most of the States do not mention the refusal on the driving license and it is also hard to imagine how the actual system of mandated choice could override the family’s wishes. The Organ donor Registry The organ donor registry is an electronic database meant to provide valuable info rmation concerning a deceased’s intentions towards organ donation. Often, personal effects, such as a driver's license, are not immed iately available and families are forced to make a decision without knowing their loved one's wishes about organ donation. With the registry, authorized personnel fro m procurement agencies are able to find out a person's wishes and notify the family, thus easing their decision. Beasley and colleagues (33) performed an interesting study in order to evaluate the effectiveness of the donor registries, using two variables: the number of incremental donors required and the cost per incremental donor. Based on census and public polls the authors estimated that registries have the potential to influence approximately 1 out of 5 possible cases. Unfortunately, there are no data on the cost for registries, and this strategy would be more useful if a true cost effectiveness analysis would be performed. These numbers show that organ registries may not be the most effective use of resources, especially if donation can be increased less inexpensively through alternative methods (public education, transplant 106

coordination enforcement).

programs,

legal

to donation has been in place since then in Spain. However, the presumed consent policy is not strictly applied in practice; relatives are always approached and still have the final veto (35). Since then, rates of deceased donation have progressively increased fro m 14.3 donors pmp at that time to rates of 35.3 donors pmp in the very last years (36,37) (Fig. 1). In parallel, the absolute figures and the rates of kidney transplants performed have also progressively increased. For instance, the number of kidney transplants performed in Spain has doubled, reaching absolute numbers well above 2000 interventions each year (38)(Fig.2). The progressive increase in deceased-donor transplants, along with the reluctance to submit a healthy person to a surgical procedure (38) and the lack of understanding of the need for transplant organs, has limited liv ing-donor kidney transplants to a small number of procedures, performed mainly in specialised hospitals with extensive experience. However, the situation changed since the year 2000, when living-donor kidney transplantations started to increase progressively (Fig 2.). Progress includes improvements not only in terms of graft survival, but also in patient survival. Data fro m the Organ Procurement Transplant Network show that there is a 79.7% kidney graft survival rate at 5 years for liv ing-donor recip ients, compared to 66.5% for deceased-donor recipients, and a 90.1% patient survival rate vs. 81.9% (40).

The Spanish model Spain occupies a privileged position, with deceased donation rates of 33–35 per million population (p mp) and 85 transplants pmp. An evaluation of current challenges, including a decrease in deaths because of traffic accidents and cerebrovascular diseases and a diversity of cultures in Spain, has been follo wed by a co mprehensive strategy to increase organ availability. Actions include an earlier referral of possible donors to the transplant coordination teams, a benchmarking project to identify critical success factors in donation after brain death, new family approach and care methods, and the development of additional training courses aimed at specific groups of professionals, supported by their corresponding societies. Consensus documents to improve knowledge about safety limits for organ donation have been developed to min imize inappropriate discarding of organs. The use of organs fro m expanded criteria donors under an ‘old for o ld’ allocation policy has resulted from adaptation to the progressive decline of optimal organs. Measures implemented in the country were based on an appropriate healthcare, legal, and technical background. The Spanish Transplantation Law was first enacted in 1979 and contained the basic elements of any transplantation law (34). An opting-out system for consent

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Fig 1. Kidney transplant in all co mb inations included (annual rate p.m.p.) in 2011 (36)

Fig 2. Activity of deceased and living-donor kidney transplantation in Spain 19912012 (38) The core princip le of the Spanish Model is a systematic and organizational approach to the process of deceased donation. Donation after brain death (DBD) remains the main source of organs for transplantation

(41). Coord ination of donation activities has been conceived and structured at three different but interlinked levels: national (ONT), regional (17 regional coordinators), and hospital. The first two levels act as 108

an interface between the technical and the political strata and act in support of the process of deceased donation. All national decisions on donation and transplantation activities are agreed upon by the Transplantation Co mmission of the Health Interterritorial Council, wh ich co mprises the ONT as chair and the 17 regional coordinators (42). This network has grown fro m less than 20 hospitals in 1989 to 118 in 1992, a rapid evolution that reflects the significant efforts made by the system and the political support received in its initial years. The network has continued to increase with 170 hospitals involved in 2009. The figure of the transplant coordinator (TC) appointed at each procurement hospital has been considered a key element. The in itiative of designating key donation persons, or TCs, responsible for developing a proactive donor detection program and effectively converting potential into actual donors has progressively been replicated in several other countries. The Quality Assurance Program in the Deceased Donation Process has become an essential tool for the system (43). So far focused on DBD, the program aims to monitor deceased organ donation potential, evaluate performance, and identify key areas for improvement. Already in p lace for over 10 years, the program is based on a continuous clinical chart rev iew of all deaths occurring in crit ical care units (CCU) of procurement hospitals. The adaptation of this organizational approach to other countries and regions in the world has been accomplished with variable results. A successful example is that adaptation experienced by the region of Tuscany, in Northern Italy, which resulted in a sustained

increase in deceased donation activity, reaching levels of over 40 donors pmp (44). More recently, Croatia and Portugal have adopted the “Spanish” model insofar, - with a national transplant agency, a network of regional TC and procurement hospitals with strict protocols covering all aspects of the donation / procurement process (45). As a result, fro m 2006 to 2012 both countries have increased their deceased donation rates by 78% (fro m 12.9 to 23 deceased donors pmp) and 124% (fro m 20.1 to 45.1 deceased donors pmp), respectively. Efforts are underway in Latin A merica to implement the “Spanish model”, in a manner that adapts to local circu mstances through the Iberoamerican Network/Council of Donation and Transplantation. Some elements have been reproduced in Argentina, Brazil, Co lo mbia, and Uruguay, precisely those countries leading the deceased donation activity in South America (37). United Kingdom legislation In the Un ited Kingdom, a country where organ donation works on an “opt in” system, The British Medical Association expressed overwhelming support for the introduction of a system of presu med consent with safeguards. They argue that the majority of people would be willing to donate but only a s mall number are officially registered as future donors or carry a donor card. In England, Wales, and Northern Ireland, the relevant legislation relates to the Human Tissue Act 2007 (47) and the Mental Capacity Act 2005(48). Of interest in this context is the use of the word ‘consent’, wh ich usually imp lies 109

adherence to principles of informed med ical consent related to normal clin ical practice. Ho wever, for the purposes of organ donation, consent in this form is impossible or difficult to achieve in many scenarios due to the loss of capacity and the different levels of consent expressed earlier in life. Valid and legal forms of consent for the purpose of organ donation, with regard to a deceased patient or a patient who lacks capacity, are detailed in the Human Tissue Authority Code of Pract ice. These include: a listing on the organ donor register (ODR), or another applicable advanced directive; consent from a properly appointed nominated representative, who is acting on the patient’s behalf by prior agreement; witnessed statements of the prior views of the potential donor, usually by (but not confined to) an individual in a qualifying relat ionship; consent or refusal fro m indiv idual(s) in a qualifying relat ionship, where the views/wishes of the patient are unknown or cannot be ascertained. The Hu man Tissue Act provides a structure for seeking consent in a sequential manner for organ donation fro m a patient who is deceased or lacks capacity. It is the duty of the healthcare team to seek evidence of the patient’s consent in prior life, and, if this is unknown, to co me to a decision with the family regard ing donation. Up to

10% o f families of potential donors, who are on the ODR, subsequently refuse to assent and at present it is an accepted UK practice to respect such wishes (49), despite the existence of a valid consent, which by law, the family has no right to overturn. Knowledge of a potential donor’s prior consent or their expressed views and wishes is a key issue, so it is important to understand why people do or do not join the ODR or in itiate discussions with their family. Currently, only 31% of the UK adult population are reg istered on the ODR. (50). A lack of awareness, lack of opportunity, an ‘intention–behaviour’ gap, or a specific decision not to join the ODR are all factors, but their respective relative importance is unknown. In the UK, membership of the ODR is the highest in younger age groups (58.8% of ODR members are under 40) and in higher socioeconomic classes (51). Th is contrasts with actual donors who tend to be older and less well off. There is a set of much studied ‘traditional’ variables wh ich help discriminate why people are mo re likely to be on an ODR o r not. These include: a positive attitude to organ donation (52) knowledge about donation, (53) and religious beliefs and altruism (54).

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Fig 3. Percentage of population registered on the NHS Organ Donor Register by 31 March 2013, by Strategic Health Authority (55) Over the past decade there has been a steady rise in the nu mber of people in the UK who have signed up to the donor register, fro m 10.2 million in 2002 to 19.7 million registrants by 2013 [(55). Positive though this is, it is much lo wer than the 90% of the population who claim to support organ donation (56). Those registered on the ODR co me fro m all parts of the UK. Figure 3 shows the percentage of the population registered in each country/ former Strategic Health Authority at 31 March 2013, and the nu mber of registrants. As the total number of deceased donors and transplants continue to increase, the number of patients on the

active transplant list at 31 March 2013 is 304 less than on the same date last year. This drop reflects an increasing number of transplants performed and a reasonably steady number of patients joining the transplant list each year. The increase in donor and transplant numbers (1 April 2003 to 31 March 2013) and the number of patients registered on the transplant lists at 31 March each year is shown in Figure 4. There were 206 mo re deceased donor transplants in 2012-2013 than in the previous year, representing a 7% increase. The corresponding increase in the number of deceased donors was 11%.

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Figure 4. Nu mber of deceased donors and transplants in the UK , 1 April 2003 – 31 March 2013, and patients on the active transplant lists at 31 March (55) Fro m 2012 to 2013 the nu mber of patients who died whilst on the UK transplant list was 466 and a further 766 were removed as their health had deteriorated and they would have died shortly afterwards (55). His torically, the UK has had one of the lowest rates of organ donation in Europe, with only 12.6 people in every million donating organs in 2006, although by 2010 this rate had risen to 27.4 people in every million, close to the European average. Quantitati ve data donors from Romania

on

paradoxical in many respects. First of all, although Ro manians repeatedly man ifested their attachment towards European-shared values, they scored lowest in Eu rope in public surveys regarding openness towards transplantation. In a research done in 2012 (docu menting research done in 2011), which had a few items concerning rate of donation, number of patients on waiting list, significant differences were found between the existing EU and the acceding countries, Ro mania and Bulgaria, with Bulgaria having the lo west approval rates of accepting transplantation (more specifically, transplantation from deceased donors).

li ving-

The organ transplantation system in Ro mania is a peculiar situation in the larger Eu ropean context, and

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Year 2000 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Type of organ Nr.

Cadaveric donors

25

8

10

11

pmp 1.09 0.38 0.48 0.5 TX (included all combinations)

the Nr. 108

Cadaveric transplants

Single TX

Double TX

166

188 182

22

36

1 204

42

70

77

1.71 2.9

2

3.3

3.67 3.42

222

203 212

NHB kidney transplants

227

219

65

177

pmp 4.69 7.9

9

8.66 9.71 10.57 10.8 9.67 10.1 10.43 9.32

Nr.

20

19

39

pmp 0.95 0.76 1

22

16

0.9

1.85 3.33 5.5

70

4.29 5.9

6.86 6.53

Nr.

19

39

89

141

pmp

0.9

1.85 3.33 5.4

4.24 5.85 6.71 6.53

Nr.

0

0

1

70

0

pmp Living transplants

60

Nr.

115

114

1

90

124

123

1

144

3

124

124

0

0.04 0.05 0.05 0.14 86

150

168 163

165

152

112

113

88

75

53

pmp 3.74 7.14 8

7.76 7.86 7.73 5.3

5.38 4.19 3.57 2.79

Nr

0

0

0

0

2 0.1

Waiting list for kidney Tx Nr.

-

1396 1626

4

6

6

0.19 0.29 0.32

1580 1626 2085 2194 2661 3000 3371

ESRD on dialysis

6250 6500

Patients dead while on the WL

5

15

7000 7500 8000 9500 26

24

14

20

22

Tabel 1. Select ion of data for kidney transplantation in Ro man ia 2000-2012 (Data source: Personal interpretation and rearranging of data from www.transplant.ro (57)) If we co mpare Ro mania and Bulgaria with other Eu ropean member states, both are placed well below the European average. The percentage of kidney living and deceased donors for the European countries, in 2012, was 27 p.m.p. (18712 in absolute numbers), while the percentages in Ro man ia and Bulgaria were 10.2 p.m.p and 2.3

p.m.p respectively. It becomes clear that the situation of the two countries is more or less comparable, with differences favouring Ro mania probably related to country size and more nu merous accredited centers for kidney transplant – 3 compared to 1 in Bulgaria.

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Figure 5. Transplant activity from living and deceased donors in Romania. The absolute number increased only fro m 11 deceased donors in 2005 to 77 donors in 2012, with an increase in percentage of 700% (if we refer to 2005). Figure 5 is clearly showing the increasing rate of deceased donors,

while the overall nu mber of transplantations performed remained stable, mean ing that there was a sharp decrease in liv ing donation – from its initial peaks of 80%.

Time

Patient survival Graft survival

1 year

100

99.53

3 years

99.44

97.27

5 years

99.25

95.03

10 years 90.62

76.31

Table 2. Unadjusted one-, three-, five- and ten year graft and recip ient survival rates in adult kidney transplant patients from deceased and living -donors fro m DR. C.I. Parhon, Transplant Center, Iasi, in Romania, 2001-2012 (percentage) In our centre (University Hospital “Dr. C. I. Parhon”), as shown in table 2, the overall graft survival at 1, 5 and 10 years is superior to the average literature -survival (US and Canadian statistics). We could not analyse our data adjusting for donor type because of the small nu mber of deceased donor transplants in our evidence. This high percentage of living-donor transplants could explain the better outcomes in

our unit. We can also mention a better renal graft survival in patients transplanted in our center compared to those transplanted in other centers in Ro mania, part icularly for male ESRD patients who received a living-donor transplant. As the total number of deceased donors and transplants has been relatively stable in the last three years, the number of patients on the active 114

transplant list is greater each year. Figure 6. reflects an increasing nu mber of patients on the wait ing list and a reasonably steady number of

transplants, too small co mpared to the permanent rapid expansion of the dialysis list.

Figure 6. Renal transplant activity fro m deceased donors vs. wait ing list in Ro mania 2000-2012 Discussion The primary ethical dilemmas surrounding organ transplantation arise fro m the shortage of availab le organs (58). Not everyone who needs a kidney gets one and in fact, the scales tip quite heavily in the opposite direction. The United Net work for Organ Sharing (59) maintains a co mprehensive, up-todate website that provides the status of people await ing organ transplants. According to their website (updated daily at www.unos.org) over 120.621 people are currently awaiting transplants in the United States. A policy of "required request" or “required referral” is operating in the United States of America. Required

referral is defined "that it shall be illegal, as well as irresponsible and immo ral to d isconnect a ventilator fro m an individual who is declared dead following brain stem testing without firstly making proper enquiry as to the possibility of that individual's tissues and organs being used for the purposes of transplantation". The policy means that opportunities for donation are less likely to be overlooked. Many individuals may have their right to donate removed if their relatives are not approached. The next of kin a lso has a moral and legal right to know they can donate organs and tissue if they or the family wish so. Many families report that such a 115

donation was helpful rather than harmful (60). Although such a scheme saw an initial increase in the availability of organs, over time the numbers have declined. However, because of public policies, cultural, infrastructural and other factors, changes in transplant policies do not always translate directly into increased effective rates of donation. In terms of effective o rgan donations, in some systems like Australia with 354 donors in 2012 (61), family members are required to give consent or refusal, or may veto a potential recovery even if the donor has consented. Some countries with an opt-out system like Spain (35.3 effective donors per million inhabitants) or Austria (24.4 donors/million) have high donor rates and some countries with opt-in systems like Germany (14.7 donors/million) or Greece (6.9 donors/million) have effective donation lower rates (36). Ho wever, the president of the Spanish National Transplant Organisation has acknowledged that the Spanish legislative approach is likely not the primary reason for the country's success in increasing the donor rates, starting in the 1990s (62). Although more kidney transplantations are being performed, the number of patients on the transplant waiting list has not dropped proportionally (36). There is a delicate balance between the supply and demand of organs for transplantation. Therefore, when there are more donations and transplantations, the criteria fo r including patients on the wait ing list are more flexib le and the demand for transplantations increases. There are ways to increase the number of deceased donations as can

be seen from the results of our Quality Control Programme in Spain. Th is detects the number of potential donors lost in Intensive care units (ICU) due to the patients not being identified, problems preserving the organ, refusal to donate, and, above all, because of medical contraindications (63). Furthermore, the early detection of patients outside the ICU that may progress to brain death can be improved. We must work in close collaboration with the units, departments, and specialities involved in treating the neurocritical patient (63). The number of organ transplants in general and kidney transplants in particular can be increased by creating new non-heart-beating donation programmes and the widespread use of organs from expanded criteria donors (62). The persisting shortfall in the availability of organs for transplants, and the repeated demonstration that kidneys retrieved fro m DCD donors have the same longterm outcome as those from DBD (65,66,67,68), has prompted many countries to re-introduce DCD schemes. Do minguez-Gil study (44) reported in the Council of Europe the 2011 situation of donation after circulatory death (DCD), following a dedicated survey. Of 27 participating countries, only 10 confirmed any DCD act ivity, the highest being described in Belgiu m, the Netherlands and the United Kingdom (main ly controlled) and France and Spain (mainly uncontrolled). DCD is increasingly accepted in Europe but still limited to a few countries. Controlled DCD might negatively impact DBD activ ity. The use of DCD is lower co mpared with DBD. Short-term results of DCD are 116

promising with d ifferences between kidney recipients transplanted fro m controlled versus uncontrolled DCD, an observation to be further analyzed. Nevertheless, in spite of all the above mentioned measures, it is difficult to achieve the estimated necessary number of kidney transplants without complementing it with living-donor kidney transplants. In the context of the fortunate progressive reduction in the number of deaths as a result of traffic accidents throughout the years, if criteria for organ donation had remained unaltered through time (64), the donation and transplantation rate would have dropped dramatically in Spain. To sustain the rate of organ donation and transplantation, the coordination network and surgical teams have progressively increased the number o f organs accepted fro m elderly donors and their subsequent use to try and adapt to this situation and maintain our level of transplantation. Co mpared to many European countries, the Spanish system stands out for the very high number of transplants using organs from elderly donors, through an unofficial, but existent, policy of “old for o ld”. Th is situation makes it easier to carry out transplantations on elderly recipients. The top priority of this policy is the suitability of age between the donor and recipient and not their immunological compatibility (69). In contrast, the large drop in the number o f young donors in Spain means that it is harder to carry out transplants on young recipients with advanced kidney disease and/or on dialysis. This is the population group that would most obviously benefit fro m liv ing-donor kidney transplantation.

The fact that living-donor transplantation is not routinely offered as a therapeutic option was confirmed in a survey carried out on dialysis patients in 2004: 59% patients stated that they had not received any informat ion on this type about transplantation and 83.4% claimed that their med ical team d id not inform them about this therapeutic option (70). The current situation may be entirely different, but the variability described above highlights the need to encourage nephrologists to offer this as another option so that patients and their relatives can make an informed decision. Live kidney donation is an essential element in dealing with the transplantation needs of our population and particularly in a scenario where kidneys appropriate in nephron mass for young recipients are scarce. The evidence of excellent results of live kidney transplantation (11), the knowledge gained about the short-, mid-, and long-term safety of the donor when an appropriate framework of donor care is provided (71,72,73), as well as the incorporation of novel surgical approaches for donor nephrectomy have yielded a progressive change in the conception of live donation in the country, now devised as a need. This change occurred alongside changes in international institutions such as the Council of Europe, which progressed fro m restrict ive princip les (74) to the consideration of new strategies to increase the live donor pool, such as altruistic donation or kidney pair exchange (75). Roo m for improvement exists in liv ing donation activity in many countries. However, living donation activity should always be pro moted as 117

a co mplementary activity to the deceased donation, not in co mpetition, avoiding a negative correlation between the living transplantation activity and the deceased one.

presumed consent. It is possible that in countries with a presumed consent legislation, the population has already strong believes in organ donation. In other words, it may be a country’s attitude toward donation that is causing the presumed consent to be present in the legislation. Simply changing legislation fro m informed consent to presumed consent will not immediately result in a significant increase of donation rate. A country’s pre-existing attitude toward donation is the main factor influencing the donation rate and not the legislation.

Conclusion Organ shortage remains one of the main challenges in organ transplantation. An adequate organization seems to be the clue to increase deceased donation activity in a sustained manner. The public should be prepared for understanding and accepting the

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