http://www.jhltonline.org

PERSPECTIVE

The unsolved problem of organ allocation in times of organ shortage: The German solution? Alexander M. Bernhardt, MD,a Axel Rahmel, MD,b and Hermann Reichenspurner, MD, PhDa From the aDepartment of Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany; and bEurotransplant International Foundation Leiden, the Netherlands, and the University of Ghent, Belgium.

KEYWORDS: Germany; allocation; heart transplantation; lung transplantation; organ shortage

The concept of the International and Inter-Society Co-ordination Committee (I2C2) has been introduced at the International Society for Heart and Lung Transplantation (ISHLT) annual meeting in Prague. It is a pivotal role of I2C2 to develop formal relationships with other societies involved in the field of thoracic transplantation to attain mutual benefits, share membership, and achieve common goals. This editorial is on behalf of an initiative of the I2C2 committee chairs to report about a specific problem related to thoracic transplantation in 1 European country and the approach chosen by the local national authorities, together with the transplant community, to address this issue. J Heart Lung Transplant 2013;32:1049–1051 r 2013 International Society for Heart and Lung Transplantation. All rights reserved.

Problem Orthotopic heart transplantation continues to be the only curative therapeutic option for patients with terminal heart failure, despite significant progress in the field of medical or resynchronization therapy, the development of surgical circulatory support devices, and promising experimental approaches in the field of regenerative medicine (stem cell research, tissue engineering). As successful as heart transplantation may be, its widespread use has been increasingly limited by the growing gap between the number of patients waiting for a donor heart and the number of available donor hearts. This development is caused by various reasons. On one hand, the incidence of terminal heart failure has increased due to the demographic development. New medical strategies and the introduction of cardiac resynchronization therapy may at first have led to a shorter waiting list. However, after exhausting these options, the need for donor organs rose all the more dramatically. According to the international foundation Eurotransplant data, 381 patients were on the waiting list for hearts in January 2001 in Reprint requests: Alexander M. Bernhardt, MD, University Heart Center Hamburg, Germany, Department of Cardiovascular Surgery, Martinistrasse 52, 20246 Hamburg, Germany. Telephone: þ49-0-4074105-2440. Fax: þ49-0-40-74105-4931. E-mail address: [email protected]

Germany. In January 2011, however, there were already 952 patients on the list, and the number is steadily increasing.1 In contrast, the number of performed heart transplantations decreased from more than 550 in 1995 to 356 in 2011, and further decreased in 2012, with only 327 heart transplants performed. The waiting time and urgency for a patient on the waiting list to be able to receive a transplant has risen accordingly during the past 10 years. In Germany, a patient’s medium waiting time on the waiting list for a heart transplant is steadily rising and has now, at the status of high urgency (HU), reached a median of more than 60 days, with also noticeably longer waiting times of up to 6 to 8 months for individual patients, especially for those with certain blood groups, size, and weight. Whereas most patients were able to electively receive transplants at status T (transplantable) and only about 30% at HU status in 2001, the rate of highurgency patients receiving transplants rose to 88% in 2011 in Germany.1 The German transplant law was amended in 2012 to increase organ donations. The existing “informed consent” law was extended by an element of structural information on organ transplantation to stimulate the individual decisionmaking process regarding organ donation. All German citizens should regularly be given the opportunity to inform themselves on the subject of organ donation and make their

1053-2498/$ - see front matter r 2013 International Society for Heart and Lung Transplantation. All rights reserved. http://dx.doi.org/10.1016/j.healun.2013.08.012

1050

The Journal of Heart and Lung Transplantation, Vol 32, No 11, November 2013

Table 1 Amendments of the General Directives on Organ Transplantation   

Mandatory establishment of interdisciplinary transplant boards Detailed documentation of the results and decisions related to patients registered on the waiting list Random on-site audits of all transplant programs

own decision. Another step was the installation of transplant coordinators in potential organ donor hospitals.

Allocation irregularities in liver transplant centers It was published in the summer of 2012 that individual German university hospitals supposedly either manipulated the laboratory values of patients on the waiting list or hemodialyses data were forged to increase the MELD (model for end-stage liver disease) score. Bilirubin, creatinine, and international normalized ratio levels are used to calculate this score: the higher the score the higher the expected mortality on the waiting list and, thus, the urgency. In the cases that were made public, individual physicians were said to have manipulated scores and procedures when listing the patients at the international organ exchange organization Eurotransplant. In addition, there was accusation of internal non-transparency, as other physicians of the same center claimed to have had no knowledge of the data transmitted to Eurotransplant.2–5 In August 2012, by invitation of the German Health Minister, the Audit and Surveillance Commission (with joint responsibility of the German Hospital Federation, the Central Federation of Statutory Health Insurances, and the German Medical Association) agreed on a new procedure to intensify the monitoring of and within the transplantation centers. All 47 transplantation centers, with their overall 140 organ-specific transplantation programs, are scheduled for an on-site audit at least once during a period of 36 months. Twelve organ-specific monitoring groups will be established for this purpose. Each group will consist of at least 2 members of the Audit and Surveillance Commission and 2 expert and independent physicians of the respective organ transplantation program; in addition, they will be assisted by 2 staff members of the responsible ministries of the federal states. First, all liver transplantation programs are being currently examined. The first visitations in this field of transplantation are to be concluded by the end of 2013. In case irregularities emerge over the course of a visitation necessitating additional audits, these audits will be assigned to a 2-person special inspection force in a second step, which in general, will consist of a physician and a lawyer. The goal of the audits is to objectively clarify irregularities in connection with the management of transplant patient waiting lists and organ allocation. Any irregularities or breaches of regulations that are noticed in the process will be referred to the respective organizations in

close cooperation with the federal state authorities for final objective and legal processing.

Consequences of the irregularities In 2012, the number of organ donations dropped by 12.8% throughout Germany compared with the previous year and has thus reached the lowest level since 2002. Only 1,046 people donated 3,511 organs after their death to help seriously ill patients. In the previous year, there were still 1,200 donors and 3,917 organs that were made available for life-saving transplantations. The decline was most noticeable during the course of the second half of 2012, after the manipulations of the 3 transplantation centers had been made public.1

Changes in the hospital and listings During the summit talk with the German Health Minister on August 27, 2012, a timely implementation of interdisciplinary transplant boards was agreed upon as a key demand to ensure a “multiple-eyes principle” for the registration and care of patients on the waiting list. As a consequence, the German Medical Association amended its guidelines pursuant to Section 16 of the transplant law6 (see Table 1). In the future, a permanent interdisciplinary and organspecific transplant board at each transplantation center will decide on a patient’s admission to the waiting list, waiting list management, and removing of a patient from the list. This takes place within the context of the respective range of treatment and in consideration of the patient’s individual situation. Aside from the directly involved surgical and conservative disciplines, at least 1 other medical discipline, which is not directly involved in the transplantation process and is designated by the hospital’s medical management, has to be included in the weekly meetings of the interdisciplinary transplant board. One representative for each of these 3 disciplines has to be nominated to the allocating authority. The resulting group of 3 experts has the final responsibility for the interdisciplinary transplant board’s organization, including the documentation and transmission of all information and decisions relevant for allocation. It is they, in particular, who sign the decision for a patient being added to the waiting list and transmit the document that is the basis for the registration for the allocating authority. At the same time, the hospital’s medical management is to be informed in writing particular in case of possible deviations (see Table 2). Table 2 Structure of the Interdisciplinary Heart and Lung Transplant Board    

Cardiac/thoracic surgeons Cardiologists/pneumologists/internists Medical delegate of the university hospital chief executive officer Optional: psychiatrist, psychologist, nursing staff, and other involved specialist disciplines

Bernhardt et al.

The Unsolved Problem of Organ Allocation in Times of Organ Shortage

Documentation and application In the future, the audit and surveillance commission will conduct all-encompassing and unannounced on-site audits in all transplantation centers. All steps of the transplantation process, including listing and allocation, have to be documented in a comprehensible manner. With the described measures, the whole process from placement on the waiting list until transplantation will be made completely transparent, not only for the examination commission but, in the last consequence, also to the general public. It is expected that this will help to regain public trust in organ donation and transplantation.

Outlook The classic model of waiting time as the determining factor of allocating hearts was enhanced by the factor urgency in 2000. In Germany, the shortage of donor organs resulted in modifying the allocation criteria to primarily grant HU patients the few available organs. These regulations were tightened again in 2005, so that in the meantime, most patients received a transplant while listed in HU status, as described above. The increasing organ shortage, which entails longer waiting times and the fact that sicker patients receive a transplant, is considered to be an important factor for the declining results of thoracic transplantation in Germany. As a consequence, the expected outcome after transplantation (chances of success) has gained increasing attention in the transplant community and in the general public. Actually, next to the urgency of the transplant, the chances of success are explicitly named as the second important allocation principle in the German transplant law. Currently, allocation based on urgency and outcome is already realized for lung transplantation by the introduction of the lung allocation scores for allocation in 2011. The first experiences with the lung allocation scores have been promising; therefore, a cardiac allocation score (CAS) has been developed. The concept of this CAS was recently presented by Smits et al,7 accompanied by an editorial comment by Lynne Warner Stevenson summarizing different listing strategies and outcomes after heart transplantation in the United States.8 The CAS is based on different risk score models—the Seattle Heart Failure Model (SHFM) and the Index for Mortality Prediction After Cardiac Transplantation (IMPACT) score—to provide accurate risk stratification for urgency for heart transplantation as well as success after heart transplantation. So far, this score seems to work well for regular patients on the waiting list, but for patients being supported by a ventricular assist device, this still remains an unsolved problem. In general, however, an objectively calculated CAS should work better for risk stratification than a high portion

1051

of very sick and hospitalized patients waiting for heart transplantation because this is currently the situation in Germany and in the United States. An important precondition, however, is a regular checking system and audit of submitted data for calculation of the CAS. The results of the cardiac mechanical assist devices have significantly improved with the introduction of the left ventricular assist device with a centrifugal pump. Taking the long waiting time and possibly a marginal donor organ into consideration, an alternative therapy with a left ventricular assist device should be discussed with the patient. Within this context, it should also be considered whether donor hearts should not primarily be reserved for younger patients who have the highest benefit from heart transplant due to, among other factors, a short history of cardiomyopathy and typically limited significant accompanying risk factors. This way, all other patients could primarily receive a left or biventricular cardiac support device. This would particularly concern patients with ischemic cardiomyopathy who have associated risk factors such as diabetes, renal failure, peripheral arterial disease, and pulmonary hypertension. This would, however, make necessary a complete change of the current allocation policy and would probably lead to an extensive discussion before implementation.

Disclosure statement None of the authors has a financial relationship with a commercial entity that has an interest in the subject of the presented manuscript or other conflicts of interest to disclose.

References 1. International Foundation Eurotransplant. Annual report. 2011. http:// www.eurotransplant.org/cms/mediaobject.php?file=ar_2011.pdf. Accessed: July 15, 2013. 2. Transplantations-Skandal an Uni-Klinikum. http://www.sueddeutsche.de/ gesundheit/transplantations-skandal-an-goettinger-uni-klinikum-leberim-angebot-1.1417466. Accessed July 15, 2013. 3. Chirurg fälscht Liste für Organtransplantation. http://www.faz.net/aktuell/ gesellschaft/universitaetsklinik-goettingen-chirurg-faelscht-liste-fuerorgantransplantation-11826324.html. Accessed July 15, 2013. 4. Transplantationen: Uni Leipzig gibt Manipulation bei Organspende zu. http://www.spiegel.de/gesundheit/diagnose/manipulationen-beiorganvergabe-am-transplantationszentrum-leipzig-a-875316.html. Accessed July 15, 2013. 5. Transplantationsskandal an der Universität Göttingen: Erschütterndes Maß an Manipulation. http://www.aerzteblatt.de/archiv/128320/ Transplantationsskandal-an-der-Universitaet-Goettingen-Ersch;uetterndesMass-an-Manipulation?s=skandal. Accessed July 15, 2013. 6. German Medical Association. Organ Transplantation Guidelines. purs. § 16 subp. 1, p. 1, nos. 2 and 5 TPG. Dtsch Arztebl 2012;109:A-2267/ B-1847/C-1811. 7. Smits JM, de Vries E, De Pauw M, et al. Is it time for a cardiac allocation score? First results from the Eurotransplant pilot study on a survival benefit-based heart allocation. J Heart Lung Transplant 2013;32:873-80. 8. Warner-Stevenson L. The urgent priority for transplantation is to trim the waiting list. J Heart Lung Transplant 2013 2013;32:861-7.

The unsolved problem of organ allocation in times of organ shortage: the German solution?

The concept of the International and Inter-Society Co-ordination Committee (I2C2) has been introduced at the International Society for Heart and Lung ...
129KB Sizes 0 Downloads 0 Views