© 2013 John Wiley & Sons A/S.

Clin Transplant 2013: 27 (Suppl. 25): 1–5 DOI: 10.1111/ctr.12157

Factors limiting organ donation in Baden€rttemberg Wu Fischer-Fr€ ohlich C-L. Factors limiting organ donation in BadenW€ urttemberg. Abstract: In the German state of Baden-Wurttemberg, the number of deceased donors from whom organs have been recovered has been decreasing over the past several years. We questioned whether changing donor age and/or cause of death (COD) were contributing to this trend. Methods: All potential donors who reported to our regional BadenW€ urttemberg organ procurement organization were reviewed (2006– 2010, n = 1771). Changes in age distribution and COD were analyzed, factors we thought might have affected the conversion from potential to successful organ donation. Results: Between 2006 and 2010, the annual number of reported cases with subarachnoid hemorrhage (SAH) as the COD decreased from 117 to 65, while the number of deaths from other reasons increased from 264 to 294. Conversion rates were higher in the SAH group (56%) compared with the other reasons group (37%). Discussion: Mortality rates are changing in certain devastating brain injuries. This, and other factors, may contribute adversely to organ donation rates.

A recent trend in fewer organ donations has occurred in the South-West German federal state of Baden-W€ urttemberg (BW). A high refusal rate of organ donation requests contributes to our low donation rates (1). We wondered whether improvements in the therapy of devastating brain injuries had changed the patient demographics of intensive care unit (ICU) admissions. We analyzed the cause of death (COD) and donor age in all potential organ donors reported to the regional organ procurement organization (OPO) – Deutsche Stiftung Organtransplantation (Region Baden-W€ urttemberg; DSO). Our aim was to identify the effect of recent trends in COD and age within BW upon our organ donor conversion rate. Methods

All potential organ donor records were reviewed for the study period (n = 1771, January 2006 to December 2010) from data provided by the OPO in BW – Deutsche Stiftung Organtransplantation (Region Baden-W€ urttemberg; DSO). We examined COD and age and their effect on the organ procurement rate. Potential and successful donors were identified according to the critical pathway for organ dona-

€ hlich Carl-Ludwig Fischer-Fro Deutsche Stiftung Organtransplantation, Stuttgart, Germany

Key words: cause of death – changing donor profile – organ donation Corresponding author: Carl-Ludwig Fischer€hlich, MD, Coordinator (CETC), Deutsche Fro Stiftung Organtransplantation, Kriegerstr. 6, 70192 Stuttgart, Germany. Tel.: +49 69 677 328 5003; Fax: +49 69 677 328 5010; e-mail: [email protected] Conflict of interest: None. Accepted for publication 22 April 2013

tion of the WHO Resolution of Madrid in 2010 (2). Only donation after brain death has been permitted by German law since 1997. Different COD were classified according to the primary reason for the initial treatment of the cerebral complication upon the first admission to an ICU; for example, an ischemic stroke related to vasospasm after subarachnoid hemorrhage (SAH) was re-coded as an SAH. COD were classified into six groups: cerebral hypoxia (HYPOXIA), spontaneous intracerebral bleeding (ICB), atraumatic SAH, traumatic head injury (TRAUMA), ischemic stroke (STROKE), and other reasons (OTHERS). As defined by our national guideline (3), expanded donor criteria (EDC) reflected donor cases at risk of disease transmission because of a recent recovery from sepsis or meningitis, a history of malignancy, hepatitis B or C infection, or a history of drug abuse with a possible recent, that is, pre-seroconversion, window for HIV or HCV infection. The percentage of EDC cases was used as an indicator of insufficient organ donation. A separate anonymous research database was created for secondary data analysis. Some data were extracted from the national real-time donor database (DSOisys).

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Fischer-Fr€ ohlich

Nominal data were presented as numbers and percentages. Metric data were presented as median and interquartile range. Groups were compared using the chi-square test or Wilcoxon test. A significant difference was assumed at p < 0.05. Results

Seven hundred and thirty-two of 1771 (41.3%) reported potential donors underwent successful donation. Medical contraindication (520 [29.4%] cases) and family refusal (519 [29.3%] cases) accounted for the remainder. The reported number of potential donors remained constant between 2006 and 2010, while the number of actual donors decreased (Table 1, p = 0.0538). The median age of potential donors did not change during this period, while the median age of actual donors increased from 51 to 54 yr.

The distribution of COD changed in potential donors (Table 1, p = 0.0072) and actual donors (Table 1, p = 0.0303) during the study period. There was a significant decrease in SAH cases (Table 1, p < 0.0001 and p < 0.0008, respectively) during the study period. For other COD, a drift was observed in potential and actual donors. This observation was more apparent after partitioning the population according to the median age of potential donors (Fig. 1). The median age varied among potential-, realized-, and not-realized-donor COD groupings (Table 2, p < 0.0001). However, within each COD group, no annual change in age was observed (data not shown). The total number of potential donors in each COD group determined the number of actual annual donors (Fig. 1). The conversion rate from potential to actual donor varied between the COD

Table 1. Annual number of potential donors, realized donors and not-realized donors (with reason for breaking off the donation process) as well as median age [IQR] and cause of death

Cases Potential donor Realized donors Not-realized cases Refusal to donation Not brain death Medical contraindication Age Age of potential donor (yr)a Age of realized donors (yr)a Age of not-realized cases (yr)a Cause of cerebral lesion Potential donor Cerebral hypoxia Intracerebral bleeding Subarachnoid hemorrhage Traumatic brain injury Ischemic stroke Other reasons Realized donors Cerebral hypoxia Intracerebral bleeding Subarachnoid hemorrhage Traumatic brain injury Ischemic stroke Other reasons Not-realized cases Cerebral hypoxia Intracerebral bleeding Subarachnoid hemorrhage Traumatic brain injury Ischemic stroke Other reasons a

2006

2007

2008

2009

2010

p

381 169 212 111 27 74

371 163 208 114 30 64

328 138 190 99 33 58

332 127 205 98 32 75

359 135 224 97 48 79

ns 0.0538 ns

54 [42–67] 51 [40–64] 58 [44–71]

57 [44–69] 52 [42–62] 61 [46–72]

55 [42–69] 52 [42–66] 59 [42–71]

57 [42–70] 57 [45–68] 58 [42–73]

56 [44–69] 54 [42–68] 57 [46–71]

ns ns ns

381 66 90 117 71 30 7 169 20 30 64 38 17 0 212 46 60 53 33 13 7

371 64 119 79 70 34 5 163 20 48 53 31 10 1 208 44 71 26 39 24 4

328 65 84 77 68 22 12 138 17 30 44 34 8 5 190 48 54 33 34 14 7

332 64 105 59 60 35 9 127 17 40 31 25 13 1 205 47 65 28 35 22 8

359 77 105 65 64 34 14 135 18 40 30 27 15 5 224 59 65 35 37 19 2

0.0072 nsb nsb 0.0001b nsb nsb nsb 0.0303 nsb nsb 0.0008b nsb nsb nsb ns nsb nsb 0.0109b nsb nsb nsb

Median age [interquartile range]. Change within the subgroup of cause of cerebral lesion. ns, not significant (p > 0.05).

b

2

Factors limiting organ donation in BW Donor age ≤ 55 years: annual change per cause of death (2006-2010) 90 80

potential donors

70

realised donors

cases

60 50 40 30 20 10

Other -

Stroke -

Trauma -

SAH -

ICB -

Hypoxia -

0

Class of cause of death (the point of the line represent the year 2006, 2007, 2008, 2009 and 2010)

Donor age > 55 years: annual change per cause of death (2006-2010) 90 80

potential donors realised donors

70 60 50 40 30 20 10

Other -

Stroke -

Trauma -

SAH -

ICB -

0

Hypoxia -

cases

Fig. 1. Annual change (2006–2010) in cause of death of potential organ donors (black line) and realized donors (gray line) after splitting the population into a group of 0–55 yr of age (upper Figure A) and 56–95 yr (lower Figure B). Abbreviations for cause of death: Hypoxia, cerebral hypoxia; ICB, spontaneous intracranial bleeding; SAH, subarachnoid hemorrhage; Trauma, head trauma; Stroke, ischemic stroke; Other, other reasons. According to the cause of death, the points in the line from the left to the right represent the years 2006, 2007, 2008, 2009 and 2010.

Class of cause of death (the point of the line represent the year 2006, 2007, 2008, 2009 and 2010)

groups and according to the age of the potential donor (Fig. 1A vs. B): In potential donors younger than 55 yr, conversion rates were higher in SAH or TRAUMA cases compared with other COD cases or with older age. Conversion rates were lower in cases with higher age and with COD from HYPOXIA or ICB. EDC accounted for 127 (17.3%) of the 732 actual donors (3). The proportion of cases with EDC increased from 15.0% in 2006 to 20.9% in 2010. The major reasons for the 1039 donor rejections were as follows: (i) donation refusal (n = 519,

50%), (ii) brain death not confirmable (n = 170, 16%), (iii) unacceptable risk of donor-derived disease transmission (n = 87, 8%: infection or malignancies), and (iv) irreversible end organ damage (n = 52, 5%). Discussion

Our analysis disclosed fewer TRAUMA and a steady decrease in SAH cases for organ donation since 2006 (Fig. 1). This may be explained by some unpublished observations: Firstly, neurosurgical centers within BW now perform early decompressive

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Fischer-Fr€ ohlich Table 2. Median donor age [interquartile range] compared with cause of death in potential, realized, and not-realized donors

Cause of death Cerebral hypoxia Intracerebral bleeding Subarachnoid haemorrhage Traumatic brain injury Ischemic stroke Other reasons

Potential donors

Realized donors

Not-realized cases

49 [33–60] yr

45 [32–57] yr

50 [33–61] yr

67 [53–74] yr

63 [52–71] yr

68 [56–76] yr

53 [45–64] yr

52 [44–60] yr

55 [47–69] yr

46 [24–66] yr

42 [22–61] yr

53 [30–71] yr

65 [54–72] yr 40 [14–54] yr p < 0.0001

62 [53–71] yr 26 [5–46] yr p < 0.0001

67 [55–73] yr 47 [20–57] yr p < 0.0001

No significant annual change in age was observed per group of cause of death. Median age [interquartile range].

craniotomy in cases of traumatic brain edema. This is associated with a survival benefit (4). Secondly, coiling of cerebral aneurysms is increasingly used to manage SAH with less frequent clipping of aneurysms. Finally, prophylaxis and treatment of SAH-associated vasospasm have been established as beneficial at many centers. A unique state-wide BW network of stroke units serving 10.2 million people at all major hospitals has been established during the past decade. Changing COD and age determined the number of actual donors in the study population: As the absolute number of potential donors with a certain COD changed, the absolute number of actual donors changed too (Fig. 1). The number of potential donors younger than 55 yr and with a COD from SAH or TRAUMA decreased between 2006 and 2010. The number of actual donors decreased correspondingly. This was not explained by an increased utilization of cases with other COD. The rate of donation with national guideline EDC risk factors (3) might indicate an organ donation limit that had been reached. Unfortunately, we cannot address this directly as many potential donors go unreported to an OPO. According to German law, hospitals must report possible donors, but only once brain death has been certified. This only occurs once an individual with a cerebral lesion is admitted to an ICU and is ventilated and has received proper end of life therapy: At this point, brain death may be certified. One single center study (5) noted that ICU admissions occurred less frequently in cases with devastating cerebral lesions and with advancing age and with additional comorbidity(s) and this meant many potential donors went unreported. Finally, consent was not obtained in approximately one half of our unrealized organ donor

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cases (Table 1). An improved consent rate would increase the number of actual donors notwithstanding changing COD profiles. A recent national study (6) made two points: Firstly, consent rates were positively influenced by trained experienced interviewers able to establish a therapeutic relationship with donor relatives. Secondly, pre-existing organ donation restrictions could not be changed by any means of communication in the ICU. We could not define a benchmark number for annual potential donor cases in BW. Insufficient data prevented systematic evaluation of the number of patients dying from devastating cerebral lesions, with or without admission to ICU, except in those hospitals who voluntarily checked for potential organ donors [e.g., (5)]. Conclusion

We observed a change in BW in the profile of patients at risk for brain death after devastating cerebral complications. In particular, the number of cases with SAH as their COD decreased. New treatments for severe cranial diseases may be changing the profile of ICU cases being diagnosed with brain death. Medical communities must maximize each opportunity for organ donation. Acknowledgement We very much appreciate the support of the coordinators in the region of BW (Stephan Arwinski, Erich Frey, Uwe Hadlich, Agnes Hoßfeld, Barbara J€ akle, Christoph Krenzel, Martina Schimmer, Christian Thurow, Monika Weber) and colleagues at all hospitals in BW. Advice from Professor Dr G€ unter Kirste, Barbara Angerer, and Reiner Endele is gratefully acknowledged.

Author’s contributions

Carl-Ludwig Fischer-Fr€ ohlich designed the study, performed data analysis, and wrote the manuscript. References 1. Deutsche Stiftung Organtransplantation. Jahresbericht Region Baden W€ urttemberg 2010. Frankfurt, Germany: Deutsche Stiftung Organtransplantation, 2011 (in German). Available at: www.dso.de. Accessed 30 December 2011. 2. Council of Europe. Guide to the Safety and Quality Assurance for the Transplantation of Organs, Tissues and Cells, 4th edn. Strasbourg, France: Council of Europe, 2011. 3. German Medical Association (Bundesaerztekammer). Rich€ tlinien zur Organtransplantation nach §16 TPG, Anderung. Dtsch Arztebl 2004: 101: A246 (in German).

Factors limiting organ donation in BW 4. MORGALLA MH, WILL BE, ROSER F, TATAGIBA M. Do longterm results justify decompressive craniotomy after severe traumatic brain injury? J Neurosurg 2008: 109: 685. € € CL, KONIGSRAINER A, LAU5. PETERSEN P, FISCHER-FROHLICH CHART W. Detection of potential organ donors: 2-year analysis of deaths at a German university hospital. Transplant Proc 2009: 41: 2053.

€ CL, KIRSTE G et al. Family 6. SCHAUB F, FISCHER-FROHLICH Approach – Retrospective Analysis of More Than 5000 Donation Requests in Germany. Abstract: 2011 Organ Donation Congress of the International Society of Organ Donation and Procurement and Iberoamerican Society of Transplant Coordinators, Buenos Aires, Argentina, 2011. Abstract.

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Factors limiting organ donation in Baden-Württemberg.

In the German state of Baden-Wurttemberg, the number of deceased donors from whom organs have been recovered has been decreasing over the past several...
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