According to the WHO, only 10% of transplant needs are covered worldwide. If there is one country that stands out, it is Spain. This model country has doubled its transplant activity in less than a decade.
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For twenty-nine years Spain has been a world champion in organ donation and transplants. The 2020-2021 pandemic and its impact in healthcare systems has certainly slowed down its activity, but the country is still in the lead by far. In 2020, Spain had around 37 organ donors per million inhabitants. This is significantly a higher ratio than in other countries, even pre-pandemic. By comparison, in 2019 Germany had only 11 donors per million inhabitants, Australia 22, Italy 25, and France less than 30.
4,425 organ transplants were carried out in Spain last year.1 1,777 people donated one or more of their organs post-mortem, with the main cause of death being stroke. Road accidents now account for only 4.5% of donations, the lowest rate in the last decade. In addition, 268 people donated a kidney or part of their liver during their lifetime.2
The Strategic Plan of the National Transplant Organization (In Spanish: Organización Nacional de Trasplantes or ONT) is called "50X22". It aims to reach 50 donors per million inhabitants by 2022, and to exceed 5,500 transplants per year. Without the pandemic, these objectives would have been achieved two years ahead of schedule. "The most striking achievement is that the system [set up by the ONT] has made organ procurement a routine activity, regardless of the circumstances of death," said Beatriz Dominguez-Gil, ONT’s Director General. "In Spain, carers looking after patients at the end of life see it as their duty to systematically explore their wishes regarding organ donation after death", she explains.
Spain's success is the result of a specific organisational approach introduced in the 2000s, when the country became aware of the extent of its needs in this aspect. 6% to 8% of patients awaiting transplants (other than kidney transplants) would die each year due to a lack of donors (compared to 4% to 6% by 2016). Also, many patients were taken off waiting lists because they became too ill to be granted a transplant. Spain was therefore the first country to provide each hospital with a transplant coordinator, be it a physician or nurse, and often an intensive care specialist, who was therefore able to identify patients at high risk of brain death or cardiorespiratory arrest. The ONT has already trained more than 18,000 of transplant coordinators in the Spanish hospital system.
The key strength of these coordinators is their ability to inform and encourage the relatives of those deceased to accept the principle of donation. Damiana Gurria, one of these coordinators, explained to AFP in 2017: "If they have a lot of doubts, we ask them what the person was like, if he or she was generous... from there, we get them to consider the donation". This emphasis on communication has borne fruit: organ donation is now a subject that is very familiar to Spaniards. The story of footballer Eric Abidal - saved from liver cancer in 2012 thanks to a transplant - as well as three films3 by Pedro Almodovar that deal with the subject, have also made the general population aware of the issue.
[The following data are from the study “How Spain Reached 40 Deceased Organ Donors per Million Population"4, published in 2017].
A study carried out by the ONT in 2009 showed very heterogeneous results according to regions and hospitals within Spain. The ONT then refined its network by adopting the organisational approaches set up in the ten best performing hospitals. These had proved to be very effective in identifying donors outside their Intensive Care Units (ICUs). From then on, the typical path of a neurocritical patient includes organ donation from the outset, as soon as he or she moves from active treatment to palliative care. The case is passed on to the coordinator and organ donation is discussed with relatives. Relatives also are consulted on the patient’s admission to the ICU for triggering the organ donation process. In its 50X22 plan, the ONT has continued along these lines, with three objectives:
The aim of this approach is to set an early-start of an non-therapeutic ICOD process (intensive care to facilitate organ donation). A national survey undertaken jointly with the Spanish Society of Emergency Medicine (In Spanish: Sociedad Española de Medicina de Urgencias y Emergencias or SEMES) showed, among other things, that out of 2,000 patients admitted to the emergency room, only one was a potential donor.
In the same survey, 69% of these potential donors died outside an ICU, i.e. either in the emergency department itself or in another hospital ward. However, for these patients, the possibility of an organ donation had rarely been considered at the time the team decided to end their treatment. Of the 1,970 potential organ donors, 40% had not been admitted to the ICU, and most of them were not ventilated.
Admitting a maximum number of potential donors to the ICU is a choice that has proved to be beneficial. Firstly, because the stay of future donors is often short: in the Spanish experience, the median time between brain injury and death in the ICU of a patient admitted for donation is one day. Secondly, because it has been estimated that each day of hospitalisation in the ICU for a potential donor translates into a gain of 7.3 corrected years of life. In Spain, one out of every four effective organ donors follows this specific path ("effective" meaning that an organ removal has been carried out).
In the same survey, 43% of potential donors were in their eighties and/or had significant comorbidities. The ONT has therefore introduced extended criteria for donors.
The number of elderly donors, most of whom have died as a result of stroke, is steadily increasing. In Spain, more than half of the deceased donors are over 60 years of age. In 2020, the oldest donor was 90 years old; he allowed three transplants (one liver and two kidney transplants). The ONT has therefore opted for an "elderly to elderly" allocation strategy: for example, elderly kidneys are preferably allocated to elderly recipients without taking into account human leukocyte antigen (HLA) inadequacy.
This strategy has limitations. In the over-60s only 80% of donors are actually removed, and on average only two organs are then transplanted. However, these elderly donors make a major contribution to transplant activities: in 2020, they provided 41% of kidneys (among those taken from deceased donors), 51% of livers and 24% of lungs transplanted.
Another drawback is that the rejection rates of these "elderly" organs are also higher. But the results remain acceptable in view of the survival of the recipients compared to that of the patients who remain on the waiting list. A study carried out in Catalonia showed that the 10-year survival rate of kidney transplants from donors aged 75 and over was 68%. Recipients were half as likely to die as patients on dialysis and on the waiting list.
The ONT has also developed a registry to track recipients transplanted from non-standard risk donors, i.e. with a history of malignancy or active infection. Out of 430 cases, only one transmission of a disease was reported (HCV infection). This recipient, should be noted, was in an absolute emergency situation.
This is the most obvious way of increasing the number of transplants and compensating for the fall in the incidence of brain death (from 65 cases per million inhabitants in 2001 to 50 cases recently in Spain). Indeed, the drop in the number of accidents causing brain damage on the one hand, and improved treatment for patients with neurocritical diseases (particularly neurosurgery) on the other hand, have logically reduced the number of donations after brain death.
In 2020, 35% of Spanish donors (621 individuals) were collected after a death of circulatory origin. This type of donation involves a significant logistical effort and proven cooperation between the different stakeholders. In Spain, eleven specific programmes using the normothermic regional perfusion (NRP) technique have made it possible to carry out a significant number of kidney and liver transplants. The results are close to those obtained, for example, with the livers of brain-dead donors. The results of lung transplants carried out under these conditions are also promising. For heart transplants, the procedure used is based on the use of extracorporeal membrane oxygenation (ECMO). Four heart transplants from asystolic donors could be performed in 2020.
The principle of donation after circulatory arrest had been accepted in Spain as early as the 1990s (this was the case from 2005 onwards in France). A moratorium was then decided in 1996. But the evolution of the strategy of the ONT, and in particular the early orientation of potential donors in ICUs, justified the abandonment of this moratorium.
The COVID-19 crisis caused a decrease in transplant activity in 2020. Transplants fell by 19%, and donations by 23%. But the impact of the pandemic was felt above all between March and May 2020. From June 2020 onwards, transplants returned to rates similar to those of the corresponding months in 2019.
Between 1% and 2% of people who die in hospital are eligible to be donors. In particular this occurs in ICUs. However, during the first COVID-19 wave, these units were saturated; as the priority was to provide care for COVID patients. Another reason for the drop in transplant activity was the concern about possible contamination of the recipients. The ONT has launched a survey to collect data on the impact of COVID infection in transplant patients.
In this context, the ONT was forced to temporarily suspend its 50x22 plan, to recalibrate its objectives and to prioritise transplants for people in absolute emergencies. Above all, the pandemic was an opportunity for the Spanish transplant system to prove itself. Thus, 103 patients awaiting kidney transplants but hyperimmunized - i.e. at risk of acute rejection due to their anti-HLA antibody levels - were able to benefit from the effectiveness of the PATHI “calculator”5 (PATHI is the Spanish acronym for the program named “ Plan Nacional de Acceso al trasplante renal para pacientes hiperinmunizado”, in English: National Access to Kidney Transplantation Plan for Hyperimmunised Patients). Other encouraging results came from paediatric transplants. With 197 children transplanted in 2020, the ONT has not only achieved a record but also realized an initial objective of the 50X22 plan.
As for bone marrow donation, Spain has been barely affected by the pandemic. In 2020, almost 30,000 people were registered in the Spanish Bone Marrow Donor Registry (Spanish acronym: REDMO), which now numbers 440,000. During the first COVID wave, the ONT and REDMO put in place an extraordinary procedure so that expatriate donors could return quickly to Spain whenever they were compatible. By comparison, France has 20 million more inhabitants than Spain, but only 311,000 bone marrow donors.
In the face of the health crisis, the Spanish organ transplant organisation has once again demonstrated its dynamism and flexibility. However, the good results do not explain the entire picture: the drop in the number of Spanish people on the waiting list (4,794 on 31 December 2020, a slightly lower figure than in 2019) is mainly due to the saturation of the health system as a result of the pandemic. It remains to be seen, therefore, whether a rebound could occur in 2021.
In France, at the beginning of 2020, 24,000 people were waiting for transplants. The rate of opposition to organ donation remained stable (around 30% vs. 14% in Spain) and the number of donors is not increasing. Professor Touraine, President of France Transplants, commented in 2019 on the results of a survey carried out by the association. He was alarmed that "between 500 and 800 patients die each year because they have not received an organ" and pointed out the lack of donors but also the lack of dedicated professionals, ranging across the spectrum of needed physicians, surgeons and anaesthetist-animators. Prof. Touraine, also pointed to a "a lack of organisation, with sometimes the impossibility of access to the operating room" for these procedures.
This report pointed out that "more than 8 out of 10 French people volunteer to have their organs removed after their death, in order to treat patients who are in vital need of them (...) Unfortunately, few people write this clearly and when the question is put to the bereaved family, they are disturbed by the questioning and sometimes manifest a refusal which is not the request and wish of the deceased person concerned". In another report6 the French Court of Auditors (in French: Cour des Comptes) also concluded that "the [donation] registry’s chain is fragile".
The pandemic has not improved this situation. In December 2020 the French Biomedicine Agency (in French: Agence de Biomédecine or ABM) noted a 25% drop in transplant activity, for all organs combined, compared to the first eleven months of 2019.
In Italy, there was a sharp but contained slowdown: this is the final balance in the 2020 report of the Italian National Transplant Centre (Italian: Centro Nazionale Trapianti or CNT), which lists the figures for organ, tissue and cell donation and transplantation in the year of the pandemic7. As widely expected, almost 400 fewer transplants (down 10% compared to 2019) have to be added to the coronavirus impact count, but the overall figures show that the transplant network is substantially resilient to the shock wave of the ongoing health emergency.
Inevitably, the saturation of ICUs, which are the trenches in the fight against COVID-19, but also the place where organ and tissue donations necessary for transplants take place, has taken a hit. In 2020, reports of potential donors in intensive care dropped by 11.5% compared to 2019 and this led to a 10.4% decrease in organ retrievals from deceased donors (1,236 compared to 1,379 the previous year). In addition, there was a larger decrease in living donations (294, -19.2%): as this is a programmable surgical activity, this type of transplants suffered a greater slump. The final result is a rate of 20.5 donors per million inhabitants, which takes Italy back five years: since 2016, this indicator has been steadily above 21 (last year 22.8).
In the previous year, the rate of opposition to donations in resuscitation centres also fell, from 31.1% in 2019 to 30.2% in 2020. The drop in donations translated into a mirror-image reduction in transplants. There were 3,441 operations carried out in 2020, 373 fewer than in 2019 (-9.8%). Of these, 3,146 were carried out using the organs of deceased donors (-303, or -8.8% compared to a year ago).
The first Italian uterine transplant, successfully performed in Catania last August, should also be added to this tally. This is one of the many successes that have marked the year 2020 in Italian transplantology, together with the first lung transplant on a COVID-19 patient in Europe (which took place in May at the Policlinico di Milano) and the world's first liver transplants from donors to COVID-19-positive patients, launched thanks to a protocol launched by the CNT in December and already amounting to eight of such procedures.
The health emergency has not stopped the harvesting and transplantation of hematopoietic stem cells. A network of Italian centres immediately put in place COVID-free procedures, and the Italian Bone Marrow Donor Registry (IBMDR) ensured the stable search for compatible donors and the safe transport of biological material. The result was the highest number of bone marrow transplants from non-consanguineous donors ever performed in Italy, 875 (+1.9%), and of donations made, 288 (+1.4%). It is the intake of new donors, on the other hand, that has paid the price for the blockage of social activities that has prevented recruitment events in the public squares across Italy: the number of new members in the IBMDR Registry in 2020 was only 20,960, over a 50% drop compared to the 2019 new registrations.
Fortunately, organ donations have not declined massively in Germany in connection with the restrictions imposed by the Corona pandemic. While donor numbers in January and February were still almost 30 per cent higher than in the same period in 2019, this increase was reduced to 1.7 per cent by the end of September 2020. How this trend performed until the end of 2020 is still to be seen. According to current data from the German Foundation for Organ Transplantation (in German: Deutschen Stiftung Organtransplantation or DSO), a total of 278 hearts had already been donated post-mortem in Germany by November 2020.
"After the negative record year 2017 with only 257 transplanted hearts, an increase to 333 heart transplants could be recorded in 2019. As things stand, it can be assumed that no serious decline is to be expected for 2020, despite the current circumstances," explained Prof. Dr. Jan Gummert, President of the German Society for Thoracic, Cardiac and Vascular Surgery (in German: Deutschen Gesellschaft für Thorax-, Herz- und Gefäßchirurgie e.V. or DGTHG).
Heart-transplant recipients belong to the high-risk group especially against the background of their medication against organ rejection. According to a data collection in all cardiac surgery centres in Germany (as of 26 June 2020), 21 heart transplanted people had been infected with the SARS-CoV2 virus. 38% of those affected required ventilation, and 33% of those died. "Due to the complex heart disease, patients with donor hearts are at great risk and must be especially protected," emphasised Prof. Jan Gummert.