CONFIDENTIAL - Swisstransplant · (1) An overall objection rate to organ donation of 52.6%. (2) An...

Variation in Organ Donation Rates in Switzerland: Prospective Cohort Study of Potential Donors (SwissPOD)

STUDY REPORT

CONFIDENTIAL

SwissPOD Study Report

Contents

1. Editorial Committee and Authors ............................................................................ 1 1.1. Mandate .................................................................................................................... 1 1.2. Principal Investigator ................................................................................................. 1 1.3. SwissPOD Steering Committee ................................................................................. 1 1.4. Members of the Comité National du Don d’Organes (CNDO) .................................... 1 1.5. Authors ...................................................................................................................... 2 1.6. Executive Summary ................................................................................................... 3

2. Introduction .......................................................................................................... 5 3. Patients and Methods ............................................................................................ 6

3.1. Study Design ............................................................................................................. 6 3.2. Study Period .............................................................................................................. 6 3.3. Participating Hospitals ............................................................................................... 6 3.4. Eligibility Criteria ....................................................................................................... 6 3.5. Exclusion Criteria ....................................................................................................... 6 3.6. Number of Patients ................................................................................................... 6 3.7. Ethical and Regulatory Aspects ................................................................................. 6 3.8. Study Methodology Assessments and Procedures .................................................... 6

3.8.1. The Critical Donation Pathway for Donation after Brain Death (DBD) ............. 7 3.8.2. Data Base ........................................................................................................ 8 3.8.3. Data collection ................................................................................................. 8 3.8.4. Data Analysis ................................................................................................... 8

4. Results .................................................................................................................. 9 4.1. Hospital and Admission Modalities ............................................................................ 9 4.2. Aggregated Data, Donation Outcomes ................................................................... 10 4.3. Possible Donor ......................................................................................................... 11 4.4. Potential Donor ....................................................................................................... 16 4.5. Eligible Donor .......................................................................................................... 16 4.6. Seeking Permission for Donation ............................................................................. 17 4.7. Outcomes for Donation after Circulatory Death (DCD) ............................................ 20 4.8. Comparison of Networks (adult ICU) ....................................................................... 21

4.8.1. Possible Donor ............................................................................................... 22 4.8.2. Outcomes ...................................................................................................... 27 4.8.3. Donation Efficiency........................................................................................ 28 4.8.4. Conversion Rates ........................................................................................... 29 4.8.5. Reasons for Non-Donation ............................................................................ 31 4.8.6. Consent Rate ................................................................................................. 33

4.9. Comparison of University Hospitals / Transplant Centres (adult ICU) ....................... 37 4.9.1. Possible Donor ............................................................................................... 37 4.9.2. Outcomes ...................................................................................................... 41 4.9.3. Donation Efficiency........................................................................................ 42 4.9.4. Conversion Rates ........................................................................................... 43 4.9.5. Reasons for Non-Donation ............................................................................ 44 4.9.6. Consent Rate ................................................................................................. 45

5. Discussion ........................................................................................................... 49 6. References .......................................................................................................... 56 7. Annex ................................................................................................................. 58

7.1. Hospital Characteristics by Network ........................................................................ 58 7.2. Participating hospitals ............................................................................................. 59 7.3. SwissPOD Study Approval ....................................................................................... 60

EDITORIAL COMMITTEE AND AUTHORS

SwissPOD Study Report 1

1. Editorial Committee and Authors

1.1. Mandate

The study “Variation in Organ Donation Rates in Switzerland: Prospective Cohort Study of Potential Donors (SwissPOD)” was mandated by the G15 to

PD Dr. Franz F. Immer and Comité National du Don d’Organes (CNDO) Swisstransplant Laupenstrasse 37 3008 Bern

1.2. Principal Investigator

Comité National du Don d’Organes (CNDO) Swisstransplant Laupenstrasse 37 3008 Bern

1.3. SwissPOD Steering Committee

PD Dr. Markus Béchir, Leitender Arzt, Intensivstation Viszeral-, Thorax- und Transplantations-chirurgie, Universitätsspital Zürich

Prof. Dr. Léo Buhler, Médecin adjoint, Service de chirurgie viscérale et de transplantation, Hôpitaux Universitaires de Genève

Dr. Christian Garzoni, Leitender Arzt Innere Medizin und Infektiologie, Clinica Luganese

PD Dr. Lukas Hunziker, Leitender Oberarzt Medizinische Intensivstation, Universitätsspital Basel

Dr. Roger Lussmann, Leitender Arzt Chirurgische Intensivstation, Kantonsspital St. Gallen

Dr. Bruno Regli, Stv. Chefarzt Universitätsklinik für Intensivmedizin, Inselspital Bern

PD Dr. Jean-Pierre Revelly, Médecin adjoint soin intensifs, Centre Hospitalier Universitaire Vaudois Lausanne

Karin Wäfler, Projektleiterin Bevölkerungsinformation, Sektion Transplantation und Fortpflan-zungsmedizin, Bundesamt für Gesundheit, Bern

1.4. Members of the Comité National du Don d’Organes (CNDO)

PD Dr. Markus Béchir, Leitender Arzt, Intensivstation Viszeral-,Thorax- und Transplantations-chirurgie, Universitätsspital Zürich

Petra Bischoff, Head of Transplant Coordination, Inselspital Bern

Corinne Delalay, Dipl. Pflegefachfrau mit Fachausweis Intensivmedizin, Hôpital de Sion

Dr. Philippe Eckert, Head of ICU, Clinique la Source, Lausanne

PD Dr. Yvan Gasche, Médecin adjoint soin intensifs, Hôpitaux Universitaires de Genève

Eva Ghanfili, Vertretung Intensivpflegepersonal, Ospedale Regionale di Lugano-Civico

Prof. Dr. Christoph Haberthür, Präsident CNDO, Leiter Chirurgische Intensivstation, Kantons-spital Luzern

PD Dr. Lukas Hunziker, Leitender Oberarzt Medizinische Intensivstation, Universitätsspital Basel

PD Dr. Franz Immer, Direktor Swisstransplant, Bern

Dr. Roger Lussmann, Leitender Arzt Chirurgische Intensivstation, Kantonsspital St. Gallen

Dr. Sven Mädler, Leitender Arzt Anästhesie und Intensivmedizin, Kantonsspital Nidwalden

EDITORIAL COMMITTEE AND AUTHORS


Dr. Luca Martinolli, caposervizio pronto soccorso / medicina d'urgenza, Ospedale Regionale di Lugano-Civico

Diane Moretti, coordinatrice générale, Programme Latin de Don d’Organes (PLDO), Hôpitaux Universitaires de Genève

Stefan Regenscheit, Netzwerkkoordinator ZH, Universitätsspital Zürich

Dr. Thomas Riedel, Oberarzt Intensivbehandlung Pädiatrie, Inselspital Bern

Caroline Spaight, data manager, Swisstransplant, Bern

Prof. Dr. Reto Stocker, Institutsleiter Institut für Anästhesiologie und Intensivmedizin, Klinik Hirslanden, Zürich

Dr. Jan Wiegand, Oberarzt Universitätsklinik für Intensivmedizin, Inselspital Bern

1.5. Authors

Caroline Spaight, Julius Weiss, Isabelle Keel, PD Dr. Franz F. Immer

EXECUTIVE SUMMARY


1.6. Executive Summary

SwissPOD, the Swiss Monitoring of Potential Donors, is the first comprehensive, nationwide study to identify the number of patients dying in an intensive care unit (ICU) or accident and emergency department (A&E) who are potential organ donors.

Seventy six (100%) of Swiss hospitals with an intensive care unit recognised by the Swiss Society of Intensive Care Medicine (SSICM) participated to the SwissPOD audit. Data was collected in 139 units; 87 (62.6%) from intensive care units (ICU) and 52 (37.4%) from accident and emergency departments (A&E). Data was collected for all deaths in ICU or A&E, resulting in 4524 audited deaths; 3664 from an adult ICU, 62 from paediatric ICU, and 798 from A&E.

This audit has enabled a general overview of the potential for donation in Switzerland as well as a comparison of the performances in the six donation networks1, and the six university hospitals / transplant centres2.

Main findings

The estimated maximum capacity in Switzerland for organ donation after brain death from ICU and A&E deaths is 290 donors per year, equalling 36.5 per million of population (pmp). It is noteworthy that this capacity does not include patients who died on general hospital wards, intermediate care units and out-of-hospital. There may be an unquantifiable additional potential of donors out of this patient group.

The study shows four major findings:

(1) An overall objection rate to organ donation of 52.6%.

(2) An overall conversion rate of 45.4%.

(3) Structural differences on an organisational level among the networks, resulting in a variation in donation rates.

(4) Varying degrees of awareness for the detection and referral of a possible donor, mainly in smaller hospitals.

(1) Objection to donation

Of the 350 patients considered for donation during the study period, permission was sought in 268 (76.6%) cases. This resulted in 127 consents (47.4%) and 141 objections (52.6%) to organ donation. Objection rates by networks varied between 39.4% and 68.4%. This objection rate is higher than the average European refusal rate of 30% and an increase, compared to a previous Swiss audit which showed a refusal rate of 42% in 2008.

Aggregated study data show that objection to donation was observed during all phases of the donation process, demonstrating that approach to the next of kin in view of seeking consent for donation is occurring at different time points. There was a direct correlation between an early approach for requesting organ donation and the number of objections. Out of 91 approaches at the possible donor level, 71 (78.0%) objected to donation. These early approaches were more frequently documented in the networks of the German-speaking area compared to the Programme Latin de Don d’Organes (PLDO) including the French- and Italian-speaking cantons.

1 The six donation networks and their affiliated cantons are Basel (BS, BL, AG), Bern (BE, SO), Luzern (LU,

OW, NW, UR), Programme Latin de Don d’Organes PLDO (GE, VD, VS, NE, FR, JU, TI), St. Gallen (SG, AR, AI) and Zürich (ZH, SH, TG, ZG, SZ, GL, GR).

2 There are six transplant centres in Switzerland; the university hospitals Basel, Bern, Genève, Lausanne,

Zürich, and St. Gallen cantonal hospital.

EXECUTIVE SUMMARY


(2) Conversion rate

Our Swiss study data showed an overall conversion rate of 45.4%, (calculated as the percentage of potential donors who become an organ donor), which is comparable with UK and US data. Our data shows that Swiss ICUs are generally doing an excellent job in considering the option of donation at end of life care. 350 patients out of the 4524 audited deaths (7.7%), representing 44.0 pmp were considered for organ donation. However, the conversion of these patients to organ donors show variations by networks and by hospital with losses in all steps of the donation process.

(3) Structural differences

This study, in addition to patient information, collected information on hospital infrastructure, hospital policies as well as directives and guidelines for caring for a potential donor. Data revealed that there are considerable variations by network. In some of the networks, there are hospitals without guidelines or institutional directives on brain death. There is also a difference between the networks concerning the number of hospitals that procure organs for transplantation and the availability of an on-site transplant coordinator. Additionally, the PLDO network finances local donor coordinators in each hospital with an ICU. To our knowledge, no canton within a network from the German-speaking area is supporting the local donor coordinators financially. However, article 56(2) of the Transplantation Law (SR 810.21) states that the cantons are in charge of implementing the measures required in the context of organ donation and transplantation. Among others, these include the appointment and training of staff responsible for detecting and referring potential organ donors.

(4) Varying degrees of awareness for the detection and referral of a possible donor

Audited data shows that patients diagnosed brain dead came from three categories of diagnoses: cerebrovascular accident, head trauma and anoxia. All of the 76 hospitals had patients who died from these death selected causes. However, there was a large variation between hospitals and networks for patients dying on an ICU with one of these pathologies and the transfer of these patients from non transplant centres. The study demonstrates that a number of patients with these death selected causes are never admitted to an ICU from A&E or that they were admitted to an ICU but transferred to general ward for end of life care. It would be incorrect to presume that all of these patients could have been brain death diagnosed. However, one can consider that a small proportion of these patients are probably non identified donors due to lack of awareness for organ donation, and therefore the option for donation was not considered.

Conclusion

All 6 networks showed that they were well performing in at least one step of the donation process, such as donor identification, referral, seeking permission for donation, donor management and organ donation. However, all networks equally show that there is room for improvement in one or more steps.

The interpretation of the data is partial, due to a number of small networks and hospitals with limited data samples over the one year period. This has to be considered, to avoid misinterpretation in the understanding of the results.

The high refusal rate in Switzerland is multifactorial and requires detailed further analysis. However, this problem should be addressed both within the hospitals and the public.

The issues concerning the structural differences as well as the varying degrees of awareness in the identification and referral of a possible donor may be overcome by implementing best practices, offering educational programmes for physicians and nurses, and the financing of local donor coordinators in ICUs.

INTRODUCTION


2. Introduction

On the 1st of July 2007, the national Transplantation Law (SR 810.21) was implemented in Switzerland. Alongside the change from centre-oriented organ allocation to patient-oriented national allocation of organs came two new major elements with the aim to increase the Swiss organ donation rate: First, the obligation to detect and refer donors to Swisstransplant (the national organisation for organ donation and transplantation), intended as a quality assurance tool. Secondly, the introduction of “local donor coordinators” in intensive care units of each hospital and financed by the responsible canton.

However, the number of donors in Switzerland has remained stable over the last five years, ranging from 81 deceased donors in 2007 (10.7 per million of population [pmp]) to a maximum number of 103 donors in 2009 (13.2 pmp). The covered study period from 1 September 2011 to 31 August 2012, shows a total of 98 donations after brain death (DBD), representing 2.2% of all audited deaths, and 6 donations after circulatory death (DCD). This equals an actual donation rate of 12.3 pmp (13.1 pmp with DCD included). Despite the actions that have been taken, the donation rate – which is one of the lowest in Europe – has remained static. Yet, considerable variations of the donation rates amid the Swiss regions historically existed and continue to persist.

The Programme Latin de Don d’Organes (PLDO), being one of Switzerland's six “donation networks”, was at the forefront regarding the implementation of the new legal requirements and apposite structures for the purpose of improving the donation process within the hospitals of the PLDO cantons (GE, VD, VS, NE, FR, JU and TI). Pre-eminently, this incorporated enhancements in donor detection within the hospitals, which resulted in improvements in the donation process. In the PLDO network, unlike in the other donation networks, organs are procured not only in the university hospitals (transplant centres) but also in several regional hospitals. In the networks of the German-speaking area of Switzerland, Basel and St. Gallen networks were also able to improve the structures in the donation process, mainly owed to the commitment of their teams. However, the general picture for the German-speaking area shows stable or even slightly decreasing donation rates, resulting in an overall longer waiting list in Switzerland (although this is due also partly to technical reasons), which tends to lead to a higher mortality.

In order to investigate the reasons for the regional differences in organ donation rates, the G15 mandated the Swiss Monitoring of Potential Donors (SwissPOD) study to the Comité National du Don d’Organes (CNDO). SwissPOD is the first comprehensive, nationwide study to try to identify the number of patients dying in a ICU or A&E who could donate their organs after brain death or circulatory death for transplantation. The results presented in this report were obtained by recording detailed information for all deaths from every patient who died in an adult and paediatric ICU, or A&E department. It is important to note that there was a 100% participation rate to the study that included all of the 76 hospitals with an ICU recognised by the Swiss Society of Intensive Care Medicine (SSICM). This audit has enabled a comparison of performance of ICUs between donation networks, university and transplant hospitals as well as hospitals with neurosurgical facilities and those who have no neurosurgical facilities. We have been able to accurately determine the potential donor pool and give reasons why potential donors after brain death did not donate organs for transplantation. However, the data from accident and emergency departments, due to small data samples and a variety of hospital policies, will need further in depth analysis before giving any conclusions.

The G15 (Group of 15) consists of the heads of the university hospitals (Basel, Bern, Genève, Lausanne and Zürich), including the hospital directors, medical directors and the deans of the faculties, as well as the hospital director of St. Gallen cantonal hospital.

PATIENTS AND METHODS


3. Patients and Methods

3.1. Study Design

Prospective cohort study of all deaths in Swiss intensive care units (ICU) and accident and emergency departments (A&E).

3.2. Study Period

1 September 2011 – 31 August 2012

3.3. Participating Hospitals

All 76 hospitals with an ICU recognised by the Swiss Society of Intensive Care Medicine (SSICM) and their associated A&E.

3.4. Eligibility Criteria

All patients who died in a ICU or A&E

3.5. Exclusion Criteria

All deaths under the age of 44 weeks gestation.

All patients, who in life refused to participate to a clinical study.

3.6. Number of Patients

The total number of patients included in this study is 4524.

3664 ICU adult deaths

62 ICU paediatric deaths

798 A&E deaths

3.7. Ethical and Regulatory Aspects

This study was conducted in accordance with ICH-GCP guidelines and Swiss national legislation and regulations as listed below:

Eidgenössische Expertenkommission für das Berufsgeheimnis in der medizinischen Forschung, 17. 8. 2011, 035.0001-59 [copy included in the Annex]

Approval by all Cantonal Ethics Committees, 2011–2012

ICH Topic E6 Guideline for Good Clinical Practice, step 5, consolidated Guideline, 1 May 1996

Verordnung vom 17.10.2001 über klinische Versuche mit Heilmitteln (VKlin; SR 812.214.2)

Bundesgesetz vom 15. Dezember 2000 über Arzneimittel und Medizinprodukte (Heilmittelgesetz; SR 812.21)

3.8. Study Methodology Assessments and Procedures

This cohort study is designed in two parts. One by collecting patient data from medical records for deaths in ICUs and A&E departments, and secondly by collecting information on hospitals and ICUs concerning their structures and policies regarding organ donation.

The collection of patient data was designed on a hierarchical basis with a series of forms using the Critical Donation Pathway for donation after brain death (DBD) as defined by the European Donation Commission in 2010 [1]. The process describes the different steps; possible donor, potential donor, eligible donor, actual donor and utilised donors and the losses at each step of the process with the reasons and causes for possible organ and tissue donors (see next page for details).



The forms include basic demographic information (non patient identifiable). Date, time and cause of admission to hospital and whether the patient was transferred from a regional hospital to a reference centre as well as date, time and cause of death. This is followed by questions on documented signs of brain damage in the absence of an iatrogenic explanation, transient or permanent and whether these signs were observed with the patient under sedation. Detailed information on the causes of brain injury, medical suitability and whether the patient was considered at some point as a possible organ donor are obtained as independent variables. Next, there are questions on brain death with brain death testing and formal diagnosis and if not why. A lot of emphasis is requested on the timing and the process in which the next of kin were approached, the decision of the next of kin and the reasons evoked for their decision. Finally, information on whether organs were retrieved and transplanted. If organs were transplanted, detailed information is asked on the infectious status of the donor. Information on whether organs are offered for transplantation, and if not why, were extracted from the Swiss Organ Allocation System (SOAS).

Hospital and ICU information were collected separately and include selected information from the minimal dataset (MDSi) of the Swiss Society of Intensive Care Medicine (SSICM). Hospital information includes: number of hospital beds, type of hospital, hospital facilities and specialities, hospital catchment area and population, hospital infrastructure enabling to care for a potential donor, hospital policies for the transfer of a potential donor to a reference centre, hospital guidelines and institutional directives on the donation process.

ICU information principally involved: type of ICU, number of beds, total number of admissions by year, total number of deaths by year, mean length of stay, mean occupancy of beds, number of fulltime working physicians and nurses working with and without FMH and ICU speciality.

3.8.1. The Critical Donation Pathway for Donation after Brain Death (DBD)

Organ donation after death is a rare and an infrequent event. It is only authorized in limited circumstances when death occurs in a ICU or A&E after all life saving measures have been taken but have failed and explicit consent for donation has been obtained (signed donor card or consent from the next of kin or person of trust).

Donation after brain death (DBD) is possible when cerebral functions are totally and irreversibly abolished due to a lesion affecting the brain. Death diagnosis in view of organ donation is strictly regulated by the Swiss Academy of Medical Sciences (SAMS) and is governed by the Swiss Transplantation Law.

The dead donor rule applies which is to say that patients may only become donors after death, and the recovery of organs must not cause a donor’s death.

Possible DBD Donor

A person mechanically ventilated, with a devastating brain injury or lesion

Potential DBD Donor

A person mechanically ventilated and whose medical condition is suspected to fulfil brain death criteria1.

1 Brain death criteria as defined by the Swiss Academy of Medical Sciences SAMS must demonstrate that a patient fulfils seven cumulative clinical

signs. The coma must be due to a known origin and the seven clinical signs must be present in the absence of an iatrogenic explanation. The seven clinical signs are:

1) Coma 2) Bilateral fixed mydriasis (absence of pupillary light reaction) 3) Absence of oculocephalic and oculvestibular reflexes 4) Absence of corneal reflex 5) Absence of cerebral reactions to painful stimuli 6) Absence of cough & swallowing reflexes 7) Absence of spontaneous respiration (apnea test)



Eligible DBD Donor

A medically suitable2 person who has been declared dead based on neurologic criteria (brain death) as defined by

the Swiss Academy of Medical Sciences (SAMS)

2 Medically suitable for donation is defined as patients who have no absolute contra-indications for organ donation. Absolute contra-indications include:

coma of an unknown origin unresolved systemic infection or infections from an unknown origin suspicion or risk of prion disease suspicion of rabies degenerative diseases of the nervous system from an unknown origin malignancy or <5 year history of treated malignancy, with the exception of:

– carcinoma in situ – primary central nervous system tumours that rarely metastasise outside the nervous system – low-grade skin tumours with little metastatic capacity such as basocellular carcinoma

Actual DBD Donor

A consented eligible donor:

(A) in whom an operative incision was made with the intent of organ recovery for the purpose of transplantation

or

(B) from whom at least one organ was recovered for the purpose of transplantation

Utilised DBD Donor

An actual donor from whom at least one organ was transplanted.

3.8.2. Data Base

The SwissPOD database was programmed and is operated by EPYX, Lausanne (formerly CAI SA, Lonay).

3.8.3. Data collection

Data are collected and entered to the web-based system database by the local donor coordinator in each hospital (physician or nurse). Each auditor is trained by one of the two data monitors. The system database and documentation are available in the three national languages. Data monitors at Swisstransplant validate and archive each form with any queries being resolved directly with the person who completed the form. Treating clinicians are interviewed if the information in the medical record is not clear. As there is a 100% participation rate, a great effort was made monthly to ensure that the actual number of deaths correspond to the amount of forms entered. There is no missing data from the intensive care units and 9 missing cases were reported for A&E.

3.8.4. Data Analysis

SwissPOD was designed to monitor the potential for organ and tissue donation in a hospital. Limited hospital resources only enabled us to collect data for deaths in ICU and A&E. This report is focused on donation after brain death (DBD) in adult ICUs, and the comparison of performance of these ICUs between donation networks and university hospitals / transplant centres exclusively.

We have chosen not to show detailed data for potential donation after circulatory death and no data for tissue donation as presently only a couple of university hospitals have these policies. Likewise, data from paediatric ICUs and A&E also due to small data samples and a variety of hospital policies, will require further in-depth analysis and will be given posteriorly.

RESULTS Aggregated Study Data


4. Results

4.1. Hospital and Admission Modalities

76 (100%) of Swiss hospitals with an intensive care unit recognised by the Swiss Society of Intensive Care Medicine (SSICM) participated to the Swiss Monitoring of Potential Donors (SwissPOD) audit. Data was collected in 139 units; 87 (62.6%) from intensive care units (ICU) and 52 (37.4%) from accident and emergency departments (A&E). Of the 4524 audited deaths, 3726 (82.4%) came from ICU and 798 (17.6%) came from A&E (Table 1).3

Table 1: Participating hospitals and units

01.09.2011 – 31.08.2012 Number Per million population

Hospitals 76 (100%)

Units

- ICU - A&E

139

87 (62.6%) 52 (37.4%)

Unit deaths

- ICU - A&E

4524

3726 (82.4%) 798 (17.6%)

Brain death diagnosed 142 (3.1%) 17.9

Organ donors 98 (2.2%) 12.3

Table 2: Unit on admission to hospital and unit at death

Unit on admission n % Age (mean) ±1SD

A&E 2808 62.1% 69.0 16.8

of which died on A&E 795 17.6% 70.4 18.9

of which died on ICU 2013 44.5% 68.5 15.9

General ward 979 21.6% 71.0 13.9

of which died on A&E 3 0.1% 62.7 9.5


ICU 684 15.1% 65.9 19.4


Intermediate care unit 53 1.2% 67.5 17.5


All deaths 4524 100.0% 69.0 16.7

Table 2 shows that 62.1% of all audited deaths were admitted to the hospital via the A&E department. 82.4% of these patients died on an ICU and 17.6% in the A&E department. The mean age of all deaths is 69.0 ±16.7 years.

3 Due to rounding, the sum of percentages in the following may not always equal 100 percent.



4.2. Aggregated Data, Donation Outcomes

Figure 1: Aggregated study data: Summary of the DBD donation process



Figure 1 shows a schematic breakdown of the 4524 audited deaths. In summary, 1834 patients (40.5%) had signs of severe brain damage of which 1413 (77.0%) were mechanically ventilated at some point during their stay in ICU or in A&E. (This category of patients is referred to as Possible Donor). 350 (24.8%) of these patients were considered as organ donors. 216 (15.3%) of the patients mechanically ventilated with signs of severe brain damage were suspected to fulfil brain death criteria on clinical grounds (Potential Donors). All 216 cases were documented with clinical signs of brain damage as well as the absence of spontaneous respiration. Of the 216 patients, formal brain death testing was performed in 160 cases (74.1%) which resulted in 142 (88.8%) of these patients being brain death diagnosed (Eligible Donors). 98 patients (69.0%) of those brain death diagnosed actually became organ donors (Utilised Donors) which represents 2.2% of all ICU and A&E deaths.

Table 3: Patient characteristics (gender, age)

Gender n % Age (years [mean]) ±1SD

Female 1783 39.4% 70.3 17.1

Male 2741 60.6% 68.1 16.5

Total 4524 100.0% 69.0 16.7

The patient characteristics of all audited deaths show that 60.6% of deaths were male and 39.4% female. The mean age of the female deaths is 70.3 ±17.1 years compared to 68.1 ±16.5 years for their male counterparts (see Table 3).

4.3. Possible Donor

The identification of a possible donor is the starting point in the donation process. The detection process starts with a patient who has clinical evidence of brain injury. The definition of a possible donor is a person mechanically ventilated, with a devastating brain injury or lesion.

Table 4 (see next page) shows the causes of brain injury for the 1953 patients with a neurological pathology (43.2%) of all 4524 deaths. The 142 patients diagnosed brain dead came principally from three categories of diagnoses (subsequently referred to as “death selected causes”):

(1) Cerebrovascular accident (CVA) all types, intracranial haemorrhage and intracranial ischemia

(2) Head trauma, including open and closed traumatic brain injury (3) Anoxia, all types, including anoxia secondary to cardiac arrest following prolonged

reanimation, asphyxia etc.



Table 4: Causes of brain injury

All patients

(n=4524) Possible donor

1

(n=1413) Potential donor

2

(n=216) Eligible donor

3

(n=142)

Total number of patients with a neurological pathology

1953 (43.17%) 1251 (88.54%) 214 (99.07%) 142 (100.00%)

Patients ventilated with a neurological pathology

1676 (37.05%)

Patients never ventilated with a neurological pathology

277 (6.12%)

Cause of brain injury

intracranial haemorrhage 386 (8.53%) 332 (23.50%) 105 (48.61%) 75 (52.82%)

intracranial ischemia 156 (3.45%) 101 (7.15%) 10 (4.63%) 9 (6.34%)

open traumatic brain injury 27 (0.60%) 26 (1.84%) 9 (4.17%) 6 (4.23%)

closed traumatic brain injury 134 (2.96%) 118 (8.35%) 32 (14.81%) 23 (16.20%)

anoxia/hypoxia (all causes), cardiac arrest 1218 (26.92%) 654 (46.28%) 56 (25.93%) 28 (19.72%)

primary brain cancer 3 (0.07%) 0 (0.00%) 0 (0.00%) 0 (0.00%)

meningitis/encephalitis 15 (0.33%) 13 (0.92%) 3 (1.39%) 1 (0.70%)

intoxication 14 (0.31%) 8 (0.57%) 0 (0.00%) 0 (0.00%)

other diagnoses from non primary cerebral causes

2571 (56.83%) 161 (11.39%) 1 (0.46%) 0 (0.00%)

1A person mechanically ventilated, with a devastating brain injury or lesion. (Patients who have a cardiac arrest with a failed resuscitation are excluded as possible DBD donors but included as a possible DCD donor.)

2A person whose medical condition is suspected to fulfil brain death criteria.

3A medically suitable person who has been declared dead based on neurologic criteria as defined by the Swiss Academy of Medical Sciences (SAMS).

Of the 142 patients who were eligible donors (brain death diagnosed) 141 came from a death selected cause of CVA, head trauma or anoxia, data was analysed to assess the conversion of this patient population to brain death diagnosis.

Figure 2a: Admission diagnosis of patients who died on a ICU or A&E (n=4524)

Figure 2b: Brain death diagnosis by death selected cause (n=141)



Figure 2a shows that 1921 (42.5%) of all ICU and A&E deaths came from a death selected cause; CVA 542 (12.0%), head trauma 161 (3. 6%), or anoxia 1218 (26.9%).

Figure 2b shows that of the 542 patients who died from a CVA, 84 were diagnosed brain dead, which represents 59.6% of the total number of patients diagnosed brain dead. Of the 1218 patients who died from anoxia, 28 were diagnosed brain dead, corresponding to 19.9% of brain deaths, and of the 161 patients who died following traumatic brain injury, 29 were brain death diagnosed, representing 20.6% of brain deaths.

Table 5: Distribution of ICU and A&E deaths by death selected cause

Unit Deaths by selected cause Total number of deaths Mean age [years] ±1SD

ICU* 1378* (71.7%) 3726 (82.4%) 68.7 ±16.2

A&E 543 (28.3%) 798 (17.6%) 70.4 ±18.9

Total 1921 (100.0%) 4524 (100.0%) 69.0 ±16.7 *ICU deaths include adult and paediatric deaths. Of the 1378 patients with a death selected cause, 1339 came from adult ICU from a total of 3664 deaths and 39 out of a total 62 came from a paediatric ICU.

Table 5 shows that out of all 4524 deaths, 1921 (42.5%) died of a death selected cause (CVA, head trauma or anoxia). Out of these deaths, 1378 died on ICU (37.0% of all ICU deaths) and 543 on A&E (68.0% of all A&E deaths).

Table 6: Ventilation

All patients Pat. with signs of brain damage

n % Age (mean) ±1SD n % Age (mean) ±1SD

All deaths 4524 100.0% 69.0 16.7 1834 100.0% 64.9 18.8

Ventilated 2879 63.6% 66.3 17.1 1379 75.2% 62.9 18.8

Ventilation withheld/withdrawn 440 9.7% 69.5 17.4 235 12.8% 68.3 17.7

Never ventilated 1205 26.6% 75.1 13.7 220 12.0% 73.2 16.8

Table 6 displays the distribution of the patients who were mechanically ventilated or never ventilated with clinical signs of brain damage. In summary, 3319 (73.3%) of all deaths were mechanically ventilated at some point during hospital stay. This rises to 88.0% (n=1614) for patients who had a devastating brain injury with clinical signs of brain damage.

As an analysis of the 220 patients with signs of brain damage and who were never ventilated showed, 124 (56.4%) patients died on A&E and 96 (43.6%) died on an ICU (data not shown in table). Of the 124 patients who died on A&E, 34 (27.4%) patients were aged less than 70 years and 90 (72.6%) patients were aged over 70. Of the 90 patients older than 70, 35 patients were aged 70–80 years (28.2%) and 55 patients were older than 80 years (44.4%). Of the 96 patients who died on ICU, 66 (68.8%) were over 70 years old. 31 were aged 70–80 years and 35 were over 80 years old. In general, patients dying on A&E are older (in the order of 80 years) than patients dying on ICU.



Table 7 shows the distribution of patients with documented clinical signs of brain damage for the steps in the donation process.

Table 7: Signs of brain damage

All patients

(n=4524) Possible donor

1

(n=1413) Potential donor

2


3

(n=142)

Total number of patients with clinical signs of brain damage (SBD)

1834 (40.54%) 1413 (100.00%) 216 (100.00%) 142 (100.00%)

Patients with SBD and ventilated 1379 (30.48%) 1192 (84.36%)

Patients with SBD and ventilation withdrawn or withheld

235 (5.19%) 221 (15.64%)

Patients with SBD never ventilated 220 (4.86%)

Clinical signs of brain damage

Total number of patients who showed signs of brain damage who were under sedation

327 (7.23%) 304 (21.51%) 6 (2.78%)

Glasgow Coma Scale GCS <8 1810 (40.01%) 1394 (98.66%) 216 (100.00%) 142 (100.00%)

bilateral fixed mydriasis (absence of pupillary light reaction)

850 (18.79%) 650 (46.00%) 212 (98.15%) 142 (100.00%)

absence of occulocephalic reflex 296 (6.54%) 275 (19.46%) 188 (87.04%) 142 (100.00%)

absence of occulovestibular reflex 269 (5.95%) 251 (17.76%) 181 (83.80%) 142 (100.00%)

absence of corneal reflex 393 (8.69%) 362 (25.62%) 196 (90.74%) 142 (100.00%)

absence of cerebral reactions to painful stimuli

368 (8.13%) 330 (23.35%) 189 (87.50%) 142 (100.00%)

absence of cough reflex 344 (7.60%) 310 (21.94%) 199 (92.13%) 142 (100.00%)

absence of swallowing reflex 317 (7.01%) 286 (20.24%) 194 (89.81%) 142 (100.00%)

absence of spontaneous respiration 237 (5.24%) 231 (16.35%) 216 (100.00%) 142 (100.00%)

1A person mechanically ventilated, with a devastating brain injury or lesion. (Patients who have a cardiac arrest with a failed resuscitation are excluded as possible DBD donors but included as a possible DCD donor.)



Clinical signs are the triggers that show the different degrees of brain damage following a devastating brain lesion and which may lead to a diagnosis of brain death. There are 7 brainstem reflexes that need to be tested as part of brain death determination; all reflexes must be absent in the absence of an iatrogenic explanation.

The seven clinical signs for brain death diagnosis are:

(1) Coma (2) Bilateral fixed mydriasis (absence of pupillary light reaction) (3) Absence of oculocephalic and oculvestibular reflexes (4) Absence of corneal reflex (5) Absence of cerebral reactions to painful stimuli (6) Absence of cough & swallowing reflexes (7) Absence of spontaneous respiration (apnea test)

Note: the table shows only the signs which were documented in medical notes, possibly not all absent reflexes were documented. A patient who has an absence of spontaneous respiration in the absence of sedation or relaxants can be suspected to fulfill brain death criteria.



Table 8 shows the summary of the reasons why the 1271 patients who were possible organ donors were not brain death diagnosed. With 142 patients diagnosed brain dead from 1413 possible donors, this represents a loss of 90.0% of the possible donor pool.

Table 8: Reasons why a patient was eliminated from the potential donor pool

number % of deaths

Total number of patients with clinical signs of brain damage 1834 100%

Patients with clinical signs of brain damage never ventilated 220 12.0%

Total number of possible and potential DBD donors who were not brain death diagnosed

1271 100%

Medical contra-indication to donation 298 23.4%

Not expected to fulfil brain death criteria / did not fulfil brain death criteria

587 46.2%

Objection to donation (patient / next of kin) 105 8.3%

No next of kin/no donor card 12 0.9%

Coroner objection 3 0.2%

Cardiac arrest with failed resuscitation 174 13.7%

End stage therapeutic treatment 58 4.6%

Multi-organ failure 16 1.3%

Considered as an organ donor after circulatory death 18 1.4%

Results show that there are a number of losses in every step of the donation process. From the 1413 possible donors, 1271 (90.0%) patients did not become an eligible donor. Of the 1271 lost cases, 1197 (94.2%) were possible donors who did not become potential donors and 74 (5.8%) were potential donors who did not become an eligible donor.

The principal reasons for not diagnosing brain death were: 587 (46.2%) were not expected to meet brain death criteria, 298 (23.4%) had an absolute or relative contra-indication to donation and 105 (8.3%) objected to donation. 18 (1.4%) patients were considered for donation after circulatory death, Maastricht classification type III. This resulted in 6 patients donating organs after circulatory death.

It is not known and would be incorrect to say that the 587 (46.2%) patients who were not expected to meet brain death criteria were missed donors. However, a proportion of these patients could possibly have become a potential donor after brain death and a number of hospitals did document that a patient was probably a missed donor due to documented imaging findings consistent with brain death. Furthermore some of these patients may have been suitable for donation after circulatory death.



4.4. Potential Donor

The definition of a potential donor is a person who is mechanically ventilated and who is suspected to fulfil brain death criteria.

Table 9: Brain death diagnosis

All patients Patients medically suitable

n % of

all deaths n % of

medically suitable

All deaths 4524 100.0% 3131 100.0%

Signs of brain damage 1834 40.5% 1475 47.1%

Possible donor1 1413 31.2% 1136 36.3%

Suspected to meet brain death criteria2 216 4.8% 204 6.5%

Brain death tests performed 160 3.5% 160 5.1%

Brain death diagnosed 142 3.1% 142 4.5%

1A person mechanically ventilated, with a devastating brain injury or lesion. (Patients who have a cardiac arrest with a failed resuscitation are

excluded as possible DBD donors but included as a possible DCD donor.)


Table 9 shows that out of the 4524 audited deaths, 1393 (30.8%) had an absolute contra-indication to organ donation. Of the 1475 medically suitable patients who were documented to have clinical signs of brain damage, 1136 (77.0%) were mechanically ventilated and could be considered as possible organ donors. 204 (18.0%) of these possible donors were suspected to meet brain death criteria of which 160 (78.4%) underwent formal brain death testing. 142 (69.6%) patients who were suspected to meet brain death criteria were formally brain death diagnosed, representing 3.1% of all audited deaths.

4.5. Eligible Donor

The definition of an eligible donor is a medically suitable person who has been declared dead based on neurologic criteria (brain death) as defined by the Swiss Academy of Medical Sciences (SAMS).

In summary, the study revealed that Switzerland has 142 patients (17.9 per million of population [pmp]) who were brain death diagnosed and who had no contra-indication to donation, representing 3.1% of all ICU and A&E deaths. The percentage of organ donors after brain death from all ICU and A&E deaths is 2.2% (12.3 pmp).

Table 10 shows that 44 (31.0%) of the 142 patients brain death diagnosed did not donate organs. The principal reason why an eligible donor did not become a utilised donor was objection, 75.0% (n=33).

Table 10: Reasons why an eligible donor did not donate organs

number % of deaths

Total number of patients brain death diagnosed who did not become an organ donor 44 100%

Objection to donation 33 75.0%

Consent obtained; no procurement for medical reasons 9 20.5%

Cardiac arrest with failed resuscitation 2 4.5%



4.6. Seeking Permission for Donation

Out of all deaths 350 patients (7.7%) were considered for organ donation. This represents 44.0 pmp. A patient considered for donation is where hospital staffs have brought up the option of donation at end stage therapeutic treatment. This does not necessarily mean that a patient was suspected to fulfil brain death criteria or that the next of kin were approached in view of seeking permission for donation.

16 (4.6%) patients of those considered for donation had no next of kin or the next of kin was not attainable and the patient was not known to have a donor card. The option for donation was abandoned for these cases as the Transplantation Law requires an explicit consent for donation.

Table 11 shows detailed information on patients considered for organ donation and seeking permission.

Table 11: Seeking permission for donation

Considered as a DBD or DBD/DCD donor

1 (n=350)

Potential donor2


3

(n=142)

Seeking Permission for donation

next of kin approached in view of seeking permission for organ donation

247 (70.57%) 183 (84.72%) 141 (99.30%)

no next of kin/next of kin not available/patient was not known to have a donor card

16 (4.57%) 6 (2.78%) 0 (0.00%)

no approach the next of kin spontaneously object to donation before formal request

10 (2.86%) 2 (0.93%) 1 (0.70%)

no approach: medical reasons 41 (11.71%) 4 (1.85%) 0 (0.00%)

no approach: coroner objection 2 (0.57%) 2 (0.93%) 0 (0.00%)

no approach: absolute contra indication to organ donation

23 (6.57%) 12 (5.56%) 0 (0.00%)

no approach: patient objected to organ donation (donor card)

8 (2.29%) 2 (0.93%) 0 (0.00%)

no approach: patient not considered for organ donation

0 (0.00%) 5 (2.31%) 0 (0.00%)

considered as a DBD organ donor, but next of kin only approached for tissue donation

3 (0.86%) 0 (0.00%) 0 (0.00%)

1All patients who at any time were considered or discussed on ICU or A&E, or with any local, regional or national authority as a possible DBD or DBD/DCD organ donor.





Table 12 shows that permission for donation was sought for 268 patients. This includes either patient (donor card) or the next of kin who was approached for organ donation and who consented or objected. The next of kin who spontaneously brought up the subject of donation and objected to organ donation as well as coroner objections were included as seeking permission. Cases where the next of kin were approached but who did not take a decision were counted as a refusal.

Of the 268 cases where permission for organ donation was sought, 127 (47.4%) consented to organ donation and 141 (52.6%) objected.

Table 12: Seeking permission for donation, consents vs. objections

Seeking permission (n=268)

Potential donor2 where

permission was sought (n=190)

Eligible donor3

(n=142)

TOTAL CONSENTS to organ donation* 127 (47.39%) 120 (63.16%) 109 (76.76%)

Consent Summary

next of kin consented to any donation following approach

112 (41.79%) 106 (55.79%) 96 (67.61%)

next of kin consented to organ donation only following approach

15 (5.60%) 14 (7.37%) 13 (9.15%)

patient consented to any donation (donor card)

17 (6.34%) 14 (7.37%) 13 (9.15%)

patient consented to organ donation only (donor card)

4 (1.49%) 3 (1.58%) 2 (1.41%)

TOTAL OBJECTIONS to donation 141 (52.61%) 70 (36.84%) 33 (23.24%)

Objection Summary

next of kin spontaneously objected to donation before formal request

10 (3.73%) 2 (1.05%) 1 (0.70%)

next of kin objected to any donation following approach

116 (43.28%) 62 (32.63%) 32 (22.54%)

next of kin objected to organ donation only following approach

1 (0.37%) 0 (0.00%) 0 (0.00%)

next of kin did not take a decision following approach

3 (1.12%) 1 (0.53%) 0 (0.00%)

coroner objection 3 (1.12%) 3 (1.58%) 0 (0.00%)

patient objected to any donation (donor card)

8 (2.99%) 2 (1.05%) 0 (0.00%)

1All patients who at any time were considered or discussed on ICU or A&E, or with any local, regional or national authority as a possible DBD or DBD/DCD organ donor and where consent was sought in view of donation.

2A person whose medical condition is suspected to fulfil brain death criteria. 3A medically suitable person who has been declared dead based on neurologic criteria as defined by the Swiss Academy of Medical Sciences (SAMS).

*Total consents to organ donation correspond to a consent by patient. The sub types of consent show absolute numbers for a specified type of consent. The sub types added together can be superior to the sum of total consents (for example a patient can have a donor card with consent for donation and the next of kin can be approached for organ donation and consent. This will be counted as one consent in the total consent field).



Objection to donation is documented in all steps of the donation process. Of the 141 objections to donation, 71 objections (50.4%) were documented at the possible donor level (patients mechanically ventilated with clinical signs of brain damage). 37 objections (26.2%) were recorded at the potential donor level (patients who were suspected to fulfil brain death criteria) and 33 objections (23.4%) occurred at the eligible donor level (after brain death had been formally diagnosed). Of the total 141 objections to donation, 108 (76.6%) were documented as occurring before brain death diagnosis.

Figure 3 shows the percentage of objections vs. consents at each level of the donation process. Out of 91 approaches at the possible donor level, 71 (78.0%) objected to donation. There were 118 approaches at the potential donor level, resulting in 37 (31.4%) objections. Out of 59 approaches at the eligible donor level, 33 (55.9%) objected to donation.

Figure 3: Objection vs. consent during the donation process

Table 13: Donor card

Considered as a DBD or DBD/DCD donor

1 (n=350)

Potential donor2


3

(n=142)

Donor card not known to exist 294 (84.00%) 173 (80.09%) 106 (74.65%)

Patient had a donor card 56 (16.00%) 43 (19.91%) 36 (25.35%)

consent for any donation 17 (4.86%) 14 (6.48%) 13 (9.15%)

consent for organ donation only 4 (1.14%) 3 (1.39%) 2 (1.41%)

consent for tissue donation only 0 (0.00%) 0 (0.00%) 0 (0.00%)

decision taken by person of trust 27 (7.71%) 24 (11.11%) 21 (14.79%)

objection to any donation 8 (2.29%) 2 (0.93%) 0 (0.00%)

1All patients who at any time were considered or discussed on ICU or A&E, or with any local, regional or national authority as a possible DBD or

DBD/DCD organ donor.



Table 13 shows that 56 patients (16.0%) who were considered for donation carried a donor card. This is not representative of all deaths as hospital staff would have no reason to look for the presence of a donor card if the patient was not considered for donation. From the 56 patients who had a donor card, 27 (48.2%), chose to leave the decision on organ donation to a person of trust. This resulted in 22 (81.5%) of the next of kin (person of trust) consenting to organ donation.



4.7. Outcomes for Donation after Circulatory Death (DCD)

Donation after circulatory death (DCD) is authorized following death diagnosis of a permanent cardio-circulatory arrest in medical establishment as defined by the SAMS and is governed by the Swiss Transplantation Law.

Figure 4: Aggregated study data, summary of the DCD donation process for university hospitals / transplant centres

Donation after circulatory death is limited to university hospitals / transplant centers. Figure 4 shows that from the 1813 ICU and A&E deaths from these hospitals, 86 (4.7%) patients were roughly estimated as a possible/potential donor pool for DCD donation. These were split into two categories; Maastricht category type III, for which we selected patients who had at least 5 of the 7 clinical signs of brain death, who did not die from polytrauma and who were aged between 16 to 65 years old which resulted in 67 patients (3.7%) if death was to occur in a time frame that would enable organ donation. The second group was evaluated for Maastricht category type II, for patients who died following a cardiac arrest with failed resuscitation, excluding polytrauma patients and who were aged between 16 and 55 years old, resulting in 19 patients (1.0%).

From these 1813 patients, 35 (1.9%) were considered for DCD donation. 18 (51.4%) patients for DCD Maastricht Category type III and 17 (48.6%) for Maastricht Category type II.

During the study period, only Zürich university hospital had a DCD policy for Maastricht category type III on ICU, and Genève university hospital with a DCD Maastricht Category type II in A&E which started in January 2012. St. Gallen cantonal hospital wishes to start with a DCD Maastricht Category type III policy and did consider a couple of patients for DCD donation, although no procedure was started for medical reasons and age.

The main reasons why 27 procedures were not started were age, objection to donation and absence of the next of kin. 13 patients (48.1%) were over age limits, 5 (18.5%) objected to donation and of 4 patients (14.8%) the next of kin were not available.

From the 8 procedures that were started, 6 (75.0%) were completed and resulted in organs being donated for transplantation. All these patients came from Zürich university hospital.

RESULTS Comparison of Networks


4.8. Comparison of Networks (adult ICU)

There are six donation networks in Switzerland: Basel, Bern, Luzern, PLDO, St. Gallen and Zürich. Figure 5 shows the cantons which are affiliated to these networks and their population. Results should be interpreted with caution due to the fact that two of the networks, Luzern and St. Gallen have small data samples.

Results for the comparison of networks are shown exclusively for ICU adult deaths (n=3664). Paediatric (n=62) and A&E (n=798) deaths have been excluded due to small data samples and a variety of hospital procedures.

Figure 5: Overview of the donation networks

Network Affiliated cantons Number of procurement centres*

Population [2]

Percentage

Basel BS, BL, AG (Aarau and Baden cantonal hospitals) 2 1'079'913 13.6%

Bern BE, SO 1 1'242'036 15.6%

Luzern LU, OW, NW, UR 1 494'544 6.2%

PLDO GE, VD, VS, NE, FR, JU, TI 7 2'368'836 29.8%

St. Gallen SG, AR, AI 1 552'212 6.9%

Zürich ZH, SH, TG, ZG, SZ, GL, GR, AG (Hirslanden Klinik Aarau; the population of AG is counted in Basel network only)

2 2'217'121 27.9%

*A procurement centre is a hospital that has the authorisation from the FOPH and necessary infrastructure for the retrieval of organs for transplantation.

A table showing the hospital characteristics by network can be found in the annex.



4.8.1. Possible Donor

Data shows that the patients diagnosed brain dead came from three categories of diagnoses: cerebrovascular accident (CVA), head trauma (HT) and anoxia (ANOX). These death selected causes are examined individually by network and show the percentage of these deaths that were brain death diagnosed.

Figure 6: Death selected causes as percentage of total ICU deaths

Figure 6 shows that of the 3664 ICU adult deaths, 1339 died from a death selected cause. There are important variations by network.

The Swiss average of all ICU deaths with these neurological pathologies was 36.5%. Basel, Luzern and Zürich networks had fewer deaths on their ICUs from these death selected causes than Bern, the PLDO and St. Gallen who were above the national average.

With the exception of 1 patient, all patients diagnosed brain dead came from a death selected cause of CVA, head trauma or anoxia, data was analysed to assess the conversion of this patient population to brain death diagnosis by network.



Figures 7a/b to 12a/b show (a) the percentage of death selected causes out of ICU adult deaths, (b) the percentage of patients brain death diagnosed by death selected cause.

Figure 7a: Basel network

Admission diagnosis of patients who died on an adult ICU

Figure 7b: Basel network

Brain death diagnosis by death selected cause

Figure 7a shows that 152 (30.4%) of the 500 audited ICU deaths, came from a death selected cause; CVA 62 (12.4%), head trauma 12 (2.4%) or anoxia 78 (15.6%. Figure 7b shows that the 20 patients who were diagnosed brain dead all came from one of these death selected causes. 14 (70.0%) of brain deaths came from the CVA group, 4 (20.0%) from head trauma, and 2 (10.0%) from anoxia.

Figure 8a: Bern network


Figure 8b: Bern network


Figure 8a shows that 241 (41.2%) of the 585 audited ICU deaths came from a death selected cause; CVA 96 (16.4%), head trauma 30 (5.1%) or anoxia 115 (19.7%). from Figure 8b shows that the 31 patients who were diagnosed brain dead all came from one of these death selected causes. 20 (64.5%) of brain deaths came from the CVA group, 7 (22.6%) from head trauma, and 4 (12.9%) from anoxia.



Figure 9a: Luzern network


Figure 9b: Luzern network


Figure 9a shows that 71 (32.4%) of the 219 audited ICU deaths came from a death selected cause; CVA 24 (10.9%), head trauma 7 (3.2%) or anoxia 40 (18.3%). Figure 9b shows that the 6 patients who were diagnosed brain dead all came from one of these death selected causes. 3 (50.0%) of brain deaths came from the CVA group, 2 (33.3%) from head trauma, and 1 (16.7%) from anoxia.

Figure 10a: PLDO Network


Figure 10b: PLDO Network


Figure 10a shows that 456 (42.5%) of the 1072 audited ICU deaths came from a death selected cause; CVA 139 (12.9%), head trauma 29 (2.7%) or anoxia 288 (26.9%). Figure 10b shows that the 55 patients who were diagnosed brain dead came from one of these death selected causes (the total of brain death diagnosed patients is 56, but 1 patient who died of meningitis is excluded). 32 (58.2%) of brain deaths came from the CVA group, 8 (14.5%) from head trauma, and 15 (27.3%) from anoxia.



Figure 11a: St. Gallen Network


Figure 11b: St. Gallen Network


Figure 11a shows that 73 (38.6%) of the 189 audited ICU deaths came from a death selected cause; CVA 34 (18.0%), head trauma 5 (2.6%) or anoxia 34 (18.0%). Figure 11b shows that the 12 patients who were diagnosed brain dead all came from one of these deaths selected causes. 10 (83.3%) of brain deaths came from the CVA group, none from head trauma, and 2 (16.7%) from anoxia.

Figure 12a: Zürich Network


Figure 12b: Zürich Network


Figure 12a shows that 346 (31.5%) of the 1099 audited ICU deaths came from a death selected cause; CVA 110 (10.0%), head trauma 35 (3.2%) or anoxia 201 (18.3%).. Figure 12b shows that the 8 patients who were diagnosed brain dead all came from one of these deaths selected causes. 3 (37.5%) of brain deaths came from the CVA group, 4 (50.0%) from head trauma, and 1 (12.5%) from anoxia



In summary, total CVA deaths on ICUs by network varied between 10.0% for Zürich network and 18.0% for St. Gallen with Luzern 10.9%, Basel 12.4%, the PLDO 12.9% and Bern 16.4% in-between. Resulting that 37.5% of these patients in Zürich network were brain death diagnosed, 50.0% for Luzern network, 58.2% for the PLDO network, 64.5% for Bern network, 70.0% for Basel network and 83.3% for St. Gallen network.

Head trauma deaths varied between 2.4% for Basel and 5.1% in Bern networks, with St. Gallen 2.6%, the PLDO 2.7%, Zürich and Luzern both with 3.2%, in-between. Resulting that 0% of these patients were diagnosed brain dead for St. Gallen network, 14.5% for the PLDO network, 20.0% for Basel network, 22.6% for Bern network, 33.3% for Luzern, and 50.0% for Zürich.

Anoxia deaths varied between 15.6% for Basel network and 26.9% for the PLDO, with St. Gallen 18.0%, Luzern and Zürich both with 18.3% and Bern 19.7% in-between. Resulting that 10.0% of these patients were diagnosed brain dead for Basel network, 12.5% for Zürich network, 12.9% for Bern network, 16.7% for Luzern network, 16.7% for St. Gallen network and 27.3% for the PLDO network.

Note: The percentages need to be taken with caution and should not lead to misinterpretation due to the small data samples in all networks (see Discussion section).



4.8.2. Outcomes

Potential Donor

Figure 13a shows the outcomes for possible, potential, eligible and utilised donor as a percentage of all deaths. It visualises the results displayed in table 14.

Figure 13a: Outcomes from all deaths

Figure 13b shows the outcomes for possible, potential, eligible and utilised donor as a percentage of deaths from a selected cause (CVA, head trauma, anoxia).

Figure 13b: Outcomes from death selected causes



Ad figure 13a: Of the total 3664 patients, 198 (5.4%) were potential donors, i.e., suspected to fulfil brain death criteria. St. Gallen network with 19 potential donors, representing 10.1% of all 189 deaths had the highest conversion rate followed by the PLDO with 78 potential donors, representing 7.3% of all 1072 deaths; Bern network with 43 potential donors, representing 7.4% of all 585 deaths; Basel network with 25 potential donors, representing 5.0% of all 500 deaths; Luzern with 7 potential donors, representing 3.2% of all 219 deaths; and Zürich network with 26 potential donors, representing 2.4% of all 1099 deaths.

Ad figure 13b: Of the total 1339 patients who died from a death selected cause, 194 (14.5%) were potential donors, i.e., suspected to fulfil brain death criteria. St. Gallen network with 19 potential donors, representing 26.0% of all 73 deaths from a selected cause had the highest conversion rate, followed by Bern with 42 potential donors, representing 17.4% of all 241 deaths from a selected cause; the PLDO with 76 potential donors, representing 16.7% of all 456 deaths from a selected cause; Basel network with 24 potential donors, representing 15.8% of all 152 deaths from a selected cause; Luzern with 7 potential donors, representing 9.9% of all 71 deaths from a selected cause; and Zürich network with 26 potential donors, representing 7.5% of all 346 deaths from a selected cause.

4.8.3. Donation Efficiency

Donation efficiency shows how a hospital or network converts their potential for donation. It is calculated from the patients who donated their organs for transplantation where at least one solid organ was retrieved and transplanted plus the patients where an operative incision was made with the intent of organ retrieval, divided by the number of patients who died of a death selected cause (CVA, head trauma or anoxia).

Figure 14: Donation efficiency

Figure 14 shows the percentage of patients who became an organ donor from death selected causes (CVA, head trauma, anoxia; CH: n=1339 [36.5% of all ICU adult deaths]).

Data shows that St. Gallen network with a donation efficiency index of 13.7%, Basel network with 11.8% and Luzern network with 8.5% are better performing in the conversion of their pool of potential donors than Bern and the PLDO networks with both 7.9%, and Zürich network with 2.0%. Data shows that there is no direct correlation with the conversion of patients who died from a death selected cause to a patient who donated organs for transplantation; this is demonstrated with Basel network that had the lowest percentage of deaths from death selected causes but one of the highest donation efficiency rates, thus making the most of their potential (see Discussion section).



4.8.4. Conversion Rates

Conversion rates of ICU adult deaths by network are shown by step of the donation process and are calculated as a percentage of all deaths.

Table 14: Conversion rates

Basel Bern Luzern PLDO St. Gallen Zürich CH

ICU adult deaths (number equalling 100% in each column)

500 585 219 1072 189 1099 3664

Possible donor (patients with signs of brain damage)

151 (30.2%)

232 (39.7%)

56 (25.6%)

400 (37.3%)

89 (47.1%)

276 (25.1%)

1204 (32.9%)

Potential donor (patients suspected to fulfil brain death criteria)

25 (5.0%)

43 (7.4%)

7 (3.2%)

78 (7.3%)

19 (10.1%)

26 (2.4%)

198 (5.4%)

Eligible donor (patients who had brain death diagnosed)

20 (4.0%)

31 (5.3%)

6 (2.7%)

56 (5.2%)

12 (6.3%)

8 (0.7%)

133 (3.6%)

Utilised donor (organs procured for transplantation)

18 (3.6%)

18 (3.1%)

6 (2.7%)

36 (3.4%)

10 (5.3%)

6 (0.6%)

94 (2.6%)

Table 14 shows the conversion rates of ICU adult deaths by network. There are important variations in all steps of the donation process which demonstrate that each network is losing potential at different levels.

The percentage of potential donors who became utilised donors is 47.5% on average for adult ICU deaths. Luzern network has the highest conversion rate with 85.7% followed by Basel with 72.0%, St. Gallen with 52.6%, the PLDO with 46.2%, Bern with 41.9%, and Zürich with 23.1%.

Conversion rates were equally analysed by hospital type, for hospitals with neurosurgical facilities and for those without neurological facilities by network. One would presume that patients with a neurological pathology would be treated in a reference centre with neurosurgical facilities (table 15).

Eligible Donor

Bern network had 31 patients diagnosed brain dead, representing 5.3% (25.0 pmp) of all deaths; the PLDO had 56 patients diagnosed brain dead, representing 5.2% (23.6 pmp) of all deaths; St. Gallen had 12 patients diagnosed brain dead, representing 6.3% (21.7 pmp) of all deaths; Basel network had 20 patients diagnosed brain dead, representing 4.0% (18.5 pmp) of all deaths; Luzern network had 6 patients diagnosed brain dead, representing 2.7% (12.1 pmp) of all deaths and Zürich network had 8 patients diagnosed brain dead, representing 0.7% (3.6 pmp) of all deaths (table 14).

Utilised Donor

There were 94 patients out of all ICU adult deaths who donated organs for transplantation, representing 2.6% (11.8 pmp) of all ICU deaths. St. Gallen network had 10 utilised donors representing 5.3% (18.1 pmp) of all deaths; Basel network had 18 donors corresponding to 3.6% (16. 7 pmp) of all ICU deaths; the PLDO had 36 donors equivalent to 3.4% (15.2 pmp) of all deaths; Bern network had 18 donors representing 3.1% (14.5 pmp); Luzern network with 6 donors corresponding to 2.7% (12.1 pmp) of all deaths and Zürich with 6 donors representing 0.6% (2.7 pmp) of all deaths (table 14).



Table 15: Comparison of hospitals with neurosurgical facilities vs. hospitals with no neurosurgical facilities by network

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Adult ICU deaths with a

neurological pathology 232 128 104 245 185 60 72 54 18 467 355 112 76 75 1 354 215 139 1446 1012 434

% 100.0% 55.2% 44.8% 100.0% 75.5% 24.5% 100.0% 75.0% 25.0% 100.0% 76.0% 24.0% 100.0% 98.7% 1.3% 100.0% 60.7% 39.3% 100.0% 70.0% 30.0%

pmp 118.5 96.3 148.9 48.3 109.2 36.4 149.9 47.3 135.8 1.8 97.0 62.7 127.2 54.6

Possible DBD donor with a

neurological pathology* 122 104 18 210 176 34 47 38 9 371 286 85 67 66 1 241 163 78 1058 833 225

% 52.6% 44.8% 7.8% 85.7% 71.8% 13.9% 65.3% 52.8% 12.5% 79.4% 61.2% 18.2% 88.2% 86.8% 1.3% 68.1% 46.0% 22.0% 73.2% 57.6% 15.6%

pmp 96.3 16.7 141.7 27.4 76.8 18.2 120.7 35.9 119.5 1.8 73.5 35.2 104.7 28.3

Potential DBD donor 25 25 0 42 40 2 7 7 0 78 72 6 19 19 0 26 17 9 198 180 17

% 10.8% 10.8% 0.0% 17.1% 16.3% 0.8% 9.7% 9.7% 0.0% 16.7% 15.4% 1.3% 25.0% 25.0% 0.0% 7.3% 4.8% 2.5% 13.7% 12.4% 1.2%

pmp 23.2 0.0 32.2 1.6 14.2 0.0 30.4 2.5 34.4 0.0 7.7 4.1 22.6 2.1

Eligible DBD donor 20 20 0 31 29 2 6 6 0 56 53 3 12 12 0 8 8 0 133 128 5

% 8.6% 8.6% 0.0% 12.7% 11.8% 0.8% 8.3% 8.3% 0.0% 12.0% 11.3% 0.6% 15.8% 15.8% 0.0% 2.3% 2.3% 0.0% 9.2% 8.9% 0.3%

pmp 19 0 23 2 12 0 22 1 22 0 4 0 16 1

Utilised DBD donor 18 18 0 18 17 1 6 6 0 36 35 1 10 10 0 6 6 0 94 92 2

% 7.8% 7.8% 0.0% 7.3% 6.9% 0.4% 8.3% 8.3% 0.0% 7.7% 7.5% 0.2% 13.2% 13.2% 0.0% 1.7% 1.7% 0.0% 6.5% 6.4% 0.1%pmp 16.7 0.0 13.7 0.8 12.1 0.0 14.8 0.4 18.1 0.0 2.7 0.0 11.6 0.3

Basel network Bern network Luzern network PLDO network St. Gallen network Zürich network Total

Table 15 shows that on average 70.0% of all adult ICU deaths died in a reference centre (hospital with neurosurgical facilities). Data shows there are variations by network ranging from 55.2% in Basel to 98.7% in St. Gallen. The high percentage in St. Gallen could be explained by the fact that there are only a couple of hospitals in this network and that patients are systematically referred to a reference centre.

The percentage of possible donors dying in a non reference centre equally vary by network with only 1.3% of possible donors in St. Gallen dying in a non reference centre compared with Zürich network who has 22.0% of their patients dying in a non reference centre. The interpretation of this data should be treated with caution. However, it may suggest that there could be a lack of awareness in the detection of a possible donor in networks and that the option for donation was not considered and that these patients are not referred to a reference centre.



Table 16: Variations in transfer policies

Network Number of reference centres (hospitals with neurosurgical facilities)

ICU adult deaths

Number of adult ICU deaths with a neurological pathology (death selected causes; CVA, head trauma, anoxia) transferred from a hospital with no neurosurgical facilities to a reference centre

Percentage of patients with death selected causes transferred from a hospital with no neurosurgical facilities to a reference centre

Basel 2 194 / 140 6 / 20 3.1% / 14.3%

Bern 1 282 55 19.5%

Luzern 1 194 6 3.1%

PLDO 4 108 / 62 / 229 / 238

5 / 9 / 14 / 27 4.6% / 14.5% / 6.1% / 11.3%

St. Gallen 1 63 2 3.2%

Zürich 2 63 / 295 2 / 26 3.2% / 8.8%

Table 16 shows the variations in transfer policies among the networks. It shows the percentage of patients, who died from a death selected cause (CVA, head trauma or anoxia), transferred from a hospital with no neurosurgical facilities to one with neurosurgical facilities (reference centre). Data shows that networks have different transfer policies for patients with neurological pathologies. Additionally there is to mention, that transfers to reference centres do not necessarily only occur within the network a hospital is affiliated to (e.g., a hospital affiliated to the PLDO network may transfer patients to Bern or Basel university hospital). 4.8.5. Reasons for Non-Donation

Of the 3664 audited deaths, 1204 (32.9%) were possible donors. Out of these, 1071 (89.0%) did not become an eligible donor. There are various reasons for losses in the donation process.

Table 17: Reasons for non-donation

Basel Bern Luzern PLDO St. Gallen Zürich CH

Total number of possible and potential donors who did not become an eligible donor (number equalling 100% in each column)

131 201 50 344 77 268 1071

Contra-indication to organ donation 42

(32.1%)

42

(20.9%)

13

(26.0%)

76

(22.1%)

22

(28.6%)

69

(25.7%)

264

(24.6%)

Not expected to fulfil brain death criteria

62

(47.3%)

117

(58.2%)

22

(44.0%)

198

(57.6%)

26

(33.8%)

117

(43.7%)

542

(50.6%)

Objection to donation 12

(9.2%)

23

(11.4%)

5

(10.0%)

15

(4.4%)

17

(22.1%)

25

(9.3%)

97

(9.1%)

Coroner objection to donation - - - 2

(0.6%)

- - 2

(0.2%)

No next of kin/no donor card 1

(0.8%)

2

(1.0%)

1

(2.0%)

2

(0.6%)

- 3

(1.1%)

9

(0.8%)

Cardiac arrest with failed resuscitation 11

(8.4%)

17

(8.5%)

7

(14.0%)

27

(7.8%)

5

(6.5%)

27

(10.1%)

94

(8.8%)

Multi-organ failure 2

(4.0%)

6

(1.7%)

3

(3.9%)

3

(1.1%)

14

(1.3%)

End stage therapeutic treatment 3

(2.3%)

- - 19

(5.5%)

- 9

(3.4%)

31

(2.9%)

Considered as a DCD Maastricht category type III donor

- - - - 4

(5.2%)

14

(5.2%)

18

(1.7%)



As shown in Table 17, the principal reasons for not diagnosing brain death were: not expected to meet brain death criteria, absolute or relative contra-indication to donation and objection.

For patients who were not expected to meet brain death criteria, important variations between networks can be observed. Bern network had the highest rate with 117 patients (58.2%) of their 201 drop-offs, against St. Gallen who had 26 patients (33.8%) of their 77 drop-offs.

Equally, variations are shown for patients with a contra-indication for organ donation with Basel network who documented 42 patients (32.1%) against Bern network with 42 representing (20.9%) of audited deaths.

Lastly, data revealed that objection to donation before brain death diagnosis was an important loss with large variations by network. A possible explanation for this could be that the request for organ donation is occurring at different time points. St. Gallen had the highest rate with 17 (22.1%) of their 77 drop-offs compared to the PLDO with only 15 (4.4%) of their 344 drop-offs.



4.8.6. Consent Rate

Figure 15 displays the percentage of consent vs. objection in seeking permission for donation by network for ICU adult deaths. 320 patients out of 3664 audited deaths (8.7%), representing 40.2 pmp, were considered for organ donation. Of the 320 considered for donation, permission was sought in 249 (77.8%) cases and resulted in 121 (48.6%) consents for donation and 128 (51.4%) objections.

Figure 15: Consent rate

60.6%

39.3%54.5% 60.0%

41.9%31.6%

39.4%

60.7%45.5% 40.0%

58.1%68.4%

0%

20%

40%

60%

80%

100%

Basel Bern Luzern PLDO St. Gallen Zürich

Consent (ICU adults CH average: 48.6%) Objection

With the average consent rate of 48.6% (ICU adult deaths), objection to donation is one of the main reasons for non-donation in Switzerland. Three networks have a consent rate over 50%, Basel and the PLDO with 60.6% and 60.0% respectively, and Luzern with 54.5%.

Basel network considered 39 patients (7.8%) 0f all deaths for organ donation. There were 33 documented cases where permission for donation was sought, resulting in 20 (60.6%) consents for donation and 13 (39.4%) objections.

Bern network considered 71 patients (12.1%) 0f all deaths for organ donation. There were 56 cases where permission for donation was sought, resulting in 22 (39.3%) consents for donation and 34 (60.7%) objections.

Luzern network considered 15 patients (6.8%) 0f all deaths for organ donation. There were 11 cases where permission for donation was sought, resulting in 6 (54.5%) consents for donation and 5 (45.5%) objections.

The PLDO network considered 96 patients (9.0%) 0f all deaths for organ donation. There were 80 cases where permission for donation was sought, resulting in 48 (60.0%) consents for donation and 32 (40.0%) objections.

St. Gallen network considered 40 patients (21.2%) 0f all deaths for organ donation. There were 31 cases where permission for donation was sought, resulting in 13 (41.9%) consents for donation and 18 (58.1%) objections.

Zürich network considered 59 patients (5.4%) 0f all deaths for organ donation. There were 38 cases where permission for donation was sought, resulting in 12 (31.6%) consents for donation and 26 (68.4%) objections.



Figure 16a: Consent and objection by level vs. total approaches

Figure 16b: Consent and objection by level vs. total consents and total objections

ICU adult data shows that objection to donation was observed during all phases of the donation process. Figures 16a/b show the percentage of objections and consents for the levels possible, potential and eligible donor by network. This demonstrates that approach to the next of kin is occurring at different time points and can be an explanation for the differences in conversion rates.



Possible Donor: The distribution of objections and consents at the possible donor level in the networks are:

Basel sought permission for donation in 33 cases; from these 33 cases, 11 (33.3%) were sought at this level, resulting in 10 (30.3%) objections and 1 (3.0%) consents (figure 16a). Objections at this level represent 76.9% of the 13 total objections and consents at this level represent 5.0% of the 20 total consents (figure 16b).

Bern sought permission for donation in 56 cases; from these 56 cases, 16 (28.6%) were sought at this level, resulting in 16 (28.6%) objections and no consents (figure 16a). Objections at this level represent 47.1% of the 34 total objections (figure 16b).

Luzern sought permission for donation in 11 cases; from these 11 cases, 8 (72.8%) were sought at this level, resulting in 4 (36.4%) objections and 4 (36.4%) consents (figure 16a). Objections at this level represent 80.0% of the 5 total objections and consents at this level represent 66.7% of the 6 total consents (figure 16b).

The PLDO sought permission for donation in 80 cases; from these 80 cases, 10 (12.5%) were sought at this level, resulting in 8 (10.0%) objections and 2 (2.5%) consents (figure 16a). Objections at this level represent 25.0% of the 32 total objections and consents at this level represent 4.2% of the 48 total consents (figure 16b).

St. Gallen sought permission for donation in 31 cases; from these 31 cases, 15 (48.4%) were sought at this level, resulting in 12 (38.7%) objections and 3 (9.7%) consents (figure 16a). Objections at this level represent 66.7% of the 18 total objections and consents at this level represent 23.1% of the 13 total consents (figure 16b).

Zürich sought permission for donation in 38 cases; from these 38 cases, 19 (50.0%) were sought at this level, resulting in 16 (42.1%) objections and 3 (7.9%) consents (figure 16a). Objections at this level represent 61.5% of the 26 total objections and consents at this level represent 25.0% of the 12 total consents (figure 16b).

Potential Donor: The distribution of objections and consents at the potential donor level in the networks are:

Basel sought permission for donation in 33 cases; from these 33 cases 20 (60.6%) were sought at this level, resulting in 2 (6.1%) objections and 18 (54.5%) consents (figure 16a). Objections at this level represent 15.4% of the 13 total objections and consents at this level represent 90.0% of the 20 total consents (figure 16b).

Bern sought permission for donation in 56 cases; from these 56 cases, 23 (41.1%) were sought at this level, resulting in 8 (14.3%) objections and 15 (26.8%) consents (figure 16a). Objections at this level represent 23.5% of the 34 total objections and consents at this level represent 68.2% of the 22 total consents (figure 16b).

Luzern sought permission for donation in 11 cases; from these 11 cases, 3 (27.3%) were sought at this level, resulting in 1 (9.1%) objections and 2 (18.2%) consents (figure 16a). Objections at this level represent 20.0% of the 5 total objections and consents at this level represent 33.3% of the 6 total consents (figure 16b).

The PLDO sought permission for donation in 80 cases; from these 80 cases, 39 (48.8%) were sought at this level, resulting in 8 (10.0%) objections and 31 (38.8%) consents (figure 16a). Objections at this level represent 25.0% of the 32 total objections and consents at this level represent 64.6% of the 48 total consents (figure 16b).




Zürich sought permission for donation in 38 cases; from these 38 cases, 18 (47.4%) were sought at this level, resulting in 9 (23.7%) objections and 9 (23.7%) consents (figure 16a). Objections at this level represent 34.6% of the 26 total objections and consents at this level represent 75.0% of the 12 total consents (figure 16b).

Eligible Donor: The distribution of objections and consents at the eligible donor level in the networks are:


Bern sought permission for donation in 56 cases; from these 56 cases, 17 (30.4%) were sought at this level, resulting in 10 (17.9%) objections, and 7 (12.5%) consents (figure 16a). Objections at this level represent 29.4% of the 34 total objections and consents at this level represent 31.8% of the 22 total consents (figure 16b).

Luzern sought permission for donation in 11 cases; from these 11 cases, none were sought at this level.

The PLDO sought permission for donation in 80 cases; from these 80 cases, 31 (38.8%) were sought at this level, resulting in 16 (20.0%) objections and 15 (18.8%) consents (figure 16a). Objections at this level represent 50% of the 32 total objections and consents at this level represent 31.3% of the 48 total consents (figure 16b).

St. Gallen sought permission for donation in 31 cases; from these 31 cases, 1 (3.2%) were sought at this level, resulting in 1 (3.2%) objections and no consents (figure 16a). Objections at this level represent 5.6% of the 18 total objections (figure 16b).

Zürich sought permission for donation in 38 cases; from these 38 cases, 1 (2.6%) were sought at this level, resulting in 1 (2.6%) objections and no consents (figure 16a). Objections at this level represent 3.8% of the 26 total objections (figure 16b).

In summary, of the total 128 objections, 66 (51.6%) were reported for a possible donor; 33 (25.8%) were documented for a potential donor and 29 (22.7%) for an eligible donor after brain death diagnosis.

At the possible donor level the 66 (51.6%) of total objections were divided as follows: Luzern 4 (80%) out of 5 objections, Basel 10 (76.9%) out of 13 objections, St. Gallen 12 (66.7%) out of 18 objections, Zürich 16 (61.5%) out of 26 objections, Bern 16 (47.1%) out of 34 objections, and the PLDO 8 (25.0%) out of 32 objections.

At the potential donor level the 33 (25.8%) of total objections were divided as follows: Zürich 9 (34.6%) out of 26 objections, St. Gallen 5 (27.8%) out of 18 objections, the PLDO 8 (25.0%) (of which 2 were coroner objections) out of 32 objections, Bern 8 (23.5%) out of 34 objections; Luzern 1 (20.0%) out of 5 objections, and Basel 2 (15.4%) out of 13 objections.

At the eligible donor level the 29 (22.7%) of total objections were divided as follows: the PLDO 16 (50.0%) out of 32 objections, Bern 10 (29.4%) out of 34 objections, Basel 1 (7.7%) out of 13 objections, St. Gallen 1 (5.6%) out of 18 objections, Zürich 1 (3.8%) out of 26 objections, and Luzern with no reported objections at this step.

RESULTS Comparison of University Hospitals / Transplant Centres


4.9. Comparison of University Hospitals / Transplant Centres (adult ICU)

There are five university hospitals in Switzerland; Basel (Universitätsspital Basel), Bern (Universitätsspital Bern), Genève (Hôpitaux Universitaires de Genève), Lausanne (Centre Hospitalier Universitaire Vaudois) and Zürich (Universitätsspital Zürich). St. Gallen (Kantonsspital St. Gallen) is a transplant centre. These six hospitals are the principal reference centres in Switzerland.

Results for the comparison of university hospitals / transplant centres are shown exclusively for the 1412 ICU adult deaths. Paediatric and A&E deaths have been excluded due to small data samples and a variety of hospital procedures.

4.9.1. Possible Donor

Data shows that the patients diagnosed brain dead come from three categories of diagnoses: cerebrovascular accident (CVA), head trauma (HT), anoxia (ANOX). These death selected causes are examined individually by university hospital / transplant centre and show the percentage of these patients diagnosed brain dead.

Figure 17: Percentage of total deaths by death selected cause by university hospital / transplant centre

Figure 17 shows that these reference centres have important differences in the number of deaths by death selected causes. Bern had largest population with 175 patients (62.1%) of ICU deaths with a death selected cause of CVA, head trauma or anoxia; Lausanne had 121 (50.8%) of deaths; Genève had 103 (45.0%) of deaths; St. Gallen had 72(41.4%) of deaths; Zürich had 121 (41.0%) of deaths and Basel had 70 (36.1%) of ICU deaths.

With the exception of 1 patient, all patients diagnosed brain dead came from a death selected of CVA, head trauma or anoxia, data was analysed to assess the conversion of this patient population to brain death diagnosis by university hospital / transplant centre.



Figures 18a/b to 23a/b show (a) the percentage of death selected causes out of ICU adult deaths, (b) the percentage of patients brain death diagnosed by death selected cause.

Figure 18a: Basel university hospital


Figure 18b: Basel university hospital


Figure 18a shows that 70 (36.1%) of the 194 audited ICU deaths came from a death selected cause; CVA 31 (16.0%), head trauma 5 (2.6%) or anoxia 34 (17.5%). Figure 18b shows that the 11 patients who were diagnosed brain dead all came from one of these deaths selected causes. 7 (63.6%) of brain deaths came from the CVA group, 2 (18.2%) from head trauma, and 2 (18.2%) from anoxia.

Figure 19a: Bern university hospital


Figure 19b: Bern university hospital


Figure 19a shows that 175 (62.1%) of the 282 audited ICU deaths, came from a death selected cause; CVA 85 (30.2%), head trauma 30 (10.6%) or anoxia 60 (21.3%). Figure 19b shows that the 29 patients who were diagnosed brain dead all came from one of these deaths selected causes. 20 (68.9%) of brain deaths came from the CVA group, 7 (24.2%) from head trauma, and 2 (6.9%) from anoxia.



Figure 20a: Genève university hospital


Figure 20b: Genève university hospital



Figure 21a: Lausanne university hospital


Figure 21b: Lausanne university hospital


Figure 21a shows that 121 (50.8%) of the audited 238 ICU deaths came from a death selected cause; CVA 46 (19.3%), head trauma 7 (2.9%) or anoxia 68 (28.6%). Figure 21b shows that the 19 patients who were diagnosed brain dead came from one of these deaths selected causes (the total of brain death diagnosed patients is 20, but 1 patient who died of meningitis is excluded). 12 (63.2%) of brain deaths came from the CVA group, 3 (15.8%) from head trauma, and 4 (21.1%) from anoxia.



Figure 22a: St. Gallen cantonal hospital


Figure 22b: St. Gallen cantonal hospital


Figure 22a shows that 72 (41.4%) of the 174 audited ICU deaths came from a death selected cause; CVA 34 (19.5%), head trauma 5 (2.9%) or anoxia 33 (19.0%). Figure 22b shows that the 12 patients who were diagnosed brain dead all came from one of these deaths selected causes. 10 (83.3%) of brain deaths came from the CVA group, 0 from head trauma, and 2 (16.7%) from anoxia.

Figure 23a: Zürich university hospital


Figure 23b: Zürich university hospital





4.9.2. Outcomes

Potential Donor

Figure 24a shows the outcomes for possible, potential, eligible and utilised donor as a percentage of all deaths. It visualises the results displayed in table 18.

Figure 24a: Outcomes from all deaths

Figure 24b shows the outcomes for possible, potential, eligible and utilised donor as a percentage of deaths from a selected cause (CVA, head trauma, anoxia).

Figure 24b: Outcomes from death selected causes



Ad figure 24a: Of the total 1412 patients, 130 (9.2%) were potential donors, i.e., suspected to fulfil brain death criteria. Bern had the highest conversion rate with 41 potential donors, representing 14.5% of all 282 deaths; followed by St. Gallen with 19 potential donors, representing 10.9% of all 174 deaths; Genève with 25 potential donors, representing 10.9% of all 229 deaths; Lausanne with 24 potential donors, representing 10.1% of all 238 deaths; Basel with 12 potential donors, representing 6.2% of all 194 deaths; and Zürich with 9 potential donors, representing 3.1% of all 295 deaths.

Ad figure 24b: Of the total 662 patients who died from a death selected cause, 126 (19.0%) were potential donors, i.e., suspected to fulfil brain death criteria. St. Gallen cantonal hospital with 19 potential donors, representing 26.4% of all 72 deaths from a selected cause had the highest conversion rate, followed by Genève university hospital with 24 potential donors, representing 23.3% of all 103 deaths from a selected cause; Bern with 40 potential donors, representing 22.9% of all 175 deaths from a selected cause; Lausanne with 23 potential donors, representing 19.0% of all 121 deaths from a selected cause; Basel with 11 potential donors, representing 15.7% of all 70 deaths from a selected cause; and Zürich university hospital with 9 potential donors, representing 7.4% of all 121 deaths from a selected cause.

4.9.3. Donation Efficiency

Donation efficiency shows how a hospital converts their potential for donation. It is calculated from the patients who donated their organs for transplantation where at least one solid organ was retrieved and transplanted plus the patients where an operative incision was made with the intent of organ retrieval, divided by the number of patients who died of a death selected cause (CVA, head trauma or anoxia).

Figure 25: Donation efficiency

Figure 25 shows the percentage of the patients who were organ donors from death selected causes (CVA, head trauma, anoxia). In the university hospitals / transplant centres, patients with death selected causes (n=662) account for 46.9% of all ICU adult deaths.

Data shows that Basel university hospital with a donation efficiency index of 14.3%; St. Gallen with 13.9%; Lausanne with 10.7% and Bern with 10.3% ,are better performing in the conversion of their pool of potential donors than Genève with 9.7% and Zürich with 3.3% who are under the average index of 9.8% for university hospitals. Data shows that there is no direct correlation with the conversion of patients who died from a death selected cause to a patient who donated organs for transplantation; this is demonstrated with Basel university hospital that had the



lowest percentage of deaths from death selected causes but one of the highest donation efficiency rates, thus making the most of their potential (see Discussion section).

4.9.4. Conversion Rates

Conversion rates of ICU adult deaths by university hospital / transplant centre are shown by step of the donation process and are calculated as a percentage of all deaths.

Table 18: Conversion rates

Basel Bern Genève Lausanne St. Gallen Zürich Average

ICU adult deaths (number equalling 100% in each column)

194 282 229 238 174 295 1412 (total)

Possible donor (patients with signs of brain damage)

74 (38.1%)

184 (65.2%)

96 (41.9%)

111 (46.6%)

88 (50.6%)

104 (35.3%)

657 (46.5%)

Potential donor (patients suspected to fulfil brain death criteria)

12 (6.2%)

41 (14.5%)

25 (10.9%)

24 (10.1%)

19 (10.9%)

9 (3.1%)

130 (9.2%)

Eligible donor (patients who had brain death diagnosed)

11 (5.7%)

29 (10.3%)

18 (7.9%)

20 (8.4%)

12 (6.9%)

4 (1.4%)

94 (6.7%)

Utilised donor (organs procured for transplantation)

10 (5.2%)

17 (6.0%)

10 (4.4%)

13 (5.5%)

10 (5.7%)

3 (1.0%)

63 (4.5%)

Table 18 shows the conversion rates of ICU adult deaths by university hospital / transplant centre. There are important variations in all steps of the donation process which demonstrate that each hospital is losing potential at different levels.

The percentage of potential donors who became utilised donors is 48.5% on average for adult ICU deaths in university hospitals / transplant centres. Basel has the highest conversion rate with 83.3% followed by Lausanne with 54.2%, St. Gallen with 52.6%, Bern with 41.5%, Genève with 40.0% and Zürich with 33.3%.

Eligible Donor

Bern had 29 patients brain death diagnosed, representing 10.3% of all deaths; Lausanne had 20 patients brain death diagnosed (including 1 patient who died of meningitis), representing 8.4% of all deaths; Genève had 18 patients brain death diagnosed, representing 7.9% of all deaths; St. Gallen had 12 patients brain death diagnosed, representing 6.9% of all deaths; Basel had 11 patients brain death diagnosed, representing 5.7% of all deaths and Zürich had 4 patients brain death diagnosed, representing 1.4% of all deaths (table 18).

Utilised Donor

There were 63 patients who donated organs for transplantation, representing 4.5% of all ICU deaths in university hospitals. Bern university hospital had 17 utilised donors corresponding to 6.0% of all ICU deaths; St. Gallen had 10 donors representing 5.7% of all ICU deaths; Lausanne had 13 donors representing 5.5% of all ICU deaths; Basel had 10 donors representing 5.2% of all ICU deaths; Genève had 10 donors representing 4.4% of all ICU deaths and Zürich had 3 donors, representing 1.0% of all ICU deaths (table 18).



4.9.5. Reasons for Non-Donation

Of the 1412 audited deaths, 657 (46.5%) were possible donors. Out of these, 563 (85.7%) did not become an eligible donor. There are various reasons for losses in the donation process.

Table 19: Reasons for non-donation

Basel Bern Genève Lausanne St. Gallen Zürich Average

Total number of possible and potential donors who did not become an eligible donor (number equalling 100% in each column)

63 155 78 91 76 100 563 (total)

Contra-indication to organ donation 26 (41.3%)

27 (17.4%)

13 (16.7%)

29 (31.9%)

22 (28.9%)

24 (24.0%)

141 (25.0%)

Not expected to fulfil brain death criteria 20 (31.7%)

93 (60.0%)

52 (66.7%)

48 (52.7%)

25 (32.9%)

37 (37.0%)

275 (48.8%)

Objection to donation 10 (15.9%)

22 (14.2%)

3 (3.8%)

4 (4.4%)

17 (22.4%)

19 (19.0%)

75 (13.3%)

No next of kin/no donor card 1 (1.6%)

1 (0.6%)

- 1 (1.1%)

1 (1.0%)

4 (0.7%)

Coroner objection to donation - - 2 (2.6%)

- - - 2 (0.4%)

Cardiac arrest with failed resuscitation 6 (9.5%)

12 (7.7%)

3 (3.8%)

5 (5.5%)

5 (6.6%)

5 (5.0%)

36 (6.4%)

End stage therapeutic treatment - - 5 (6.4%)

4 (4.4%)

3 (3.9%)

2 (2.0%)

14 (2.5%)

Considered as a DCD Maastricht category type III donor

- - - - 4 (5.3%)

12 (12.0%)

16 (2.8%)

As shown in Table 19, the principal reasons for not diagnosing brain death were: not expected to meet brain death criteria, absolute or relative contra-indication to donation and objection.

For patients who were not expected to meet brain death criteria, important variations between university hospitals / transplant centres can be observed. Genève had the highest rate with 52 patients, (66.7%) of their 78 drop-offs, against Basel who had 20 patients (31.7%) of their 63 drop-offs.

Equally, variations are shown for patients with a contra-indication for organ donation with Basel university hospital who documented 26 patients (41.3%) of their 63 drop-offs, against Bern with 27, representing (17.4%) of drop-offs.

Lastly, data revealed that objection to donation before brain death diagnosis was an important loss with large variations by university hospital / transplant centres. A possible explanation for this could be that the request for organ donation is occurring at different time points. St. Gallen had the highest rate with 17 (22.4%) of their 76 drop-offs compared to Genève with only 3 (3.8%) of their 78 drop-offs.



4.9.6. Consent Rate

Figure 26 displays the percentage of consent vs. objection in seeking permission for donation by university hospital / transplant centre for ICU adult deaths. 212 patients out of 1412 audited deaths (15.0%) were considered for organ donation. Of the 212 considered for donation, permission was sought in 179 (84.4%) cases and resulted in 80 (44.7%) consents for donation and 99 (55.3%) objections.

Figure 26: Consent rate

Objection to donation is the principal reason for non-donation in Switzerland. The university hospitals / transplant centres show a similar pattern to their respective networks, indicating that the majority of approaches to the next of kin are made in these reference centres. The average consent rate in the university hospitals / transplant centres is 44.7%.

Basel considered 25 patients (12.9%) 0f all deaths for organ donation. There were 22 documented cases where permission for donation was sought, resulting in 12 (54.5%) consents for donation and 10 (45.5%) objections.

Bern considered 57 patients (20.2%) 0f all deaths for organ donation. There were 52 cases where permission for donation was sought, resulting in 21 (40.4%) consents for donation and 31 (59.6%) objections.

Genève considered 29 patients (12.7%) 0f all deaths for organ donation. There were 27 cases where permission for donation was sought, resulting in 16 (59.2%) consents for donation and 11 (40.8%) objections.

Lausanne considered 26 patients (10.9%) 0f all deaths for organ donation. There were 24 cases where permission for donation was sought, resulting in 14 (58.3%) consents for donation and 10 (41.7%) objections.

St. Gallen considered 40 patients (23.0%) 0f all deaths for organ donation. There were 31 cases where permission for donation was sought, resulting in 13 (41.9%) consents for donation and 18 (58.1%) objections.

Zürich considered 35 patients (11.9%) 0f all deaths for organ donation. There were 23 cases where permission for donation was sought, resulting in 4 (17.4%) consents for donation and 19 (82.6%) objections.



Figure 27a: Consent and objection by level vs. total approaches

Figure 27b: Consent and objection by level vs. total consents and total objections

Study data shows that objection to donation is observed during all steps of the donation process. Figures 27a/b show the variations of objection by step for a possible, potential and eligible donor by university hospital / transplant centre. It demonstrates that approach to the next of kin is occurring at different time points. This is one of the principal explanations for the differences in conversion rates.



Possible Donor: The distribution of objections and consents at the possible donor level in the university hospitals / transplant centres are:


Bern sought permission for donation in 52 cases; from these 52 cases, 14 (26.9%) were sought at this level, resulting in 14 (26.9%) objections and no consents (figure 27a). Objections at this level represent 45.2% of the 31 total objections (figure 27b).

Genève sought permission for donation in 27 cases; from these 27 cases, 3 (11.1%) were sought at this level, resulting in 2 (7.4%) objections and 1 (3.7%) consents (figure 27a). Objections at this level represent 18.2% of the 11 total objections and consents at this level represent 6.3% of the 16 total consents (figure 27b).

Lausanne sought permission for donation in 24 cases; from these 24 cases, 2 (8.3%) were sought at this level, resulting in 2 (8.3%) objections and no consents (figure 27a). Objections at this level represent 20.0% of the 10 total objections (figure 27b).


Zürich sought permission for donation in 23 cases; from these 23 cases, 14 (60.9%) were sought at this level, resulting in 14 (60.9%) objections and no consents (figure 27a). Objections at this level represent 73.7% of the 19 total objections (figure 27b).

Potential Donor: The distribution of objections and consents at the potential donor level in the university hospitals / transplant centres are:

Basel sought permission for donation in 22 cases; from these 22 cases, 6 (27.3%) were sought at this level, resulting in no objections and 6 (27.3%) consents (figure 27a). Consents at this level represent 50.0% of the 12 total consents (figure 27b).



Lausanne sought permission for donation in 24 cases; from these 24 cases, 10 (41.6%) were sought at this level, resulting in 2 (8.3%) objections and 8 (33.3%) consents (figure 27a). Objections at this level represent 20.0% of the 10 total objections and consents at this level represent 57.1% of the 14 total consents (figure 27b).


Zürich sought permission for donation in 23 cases; from these 23 cases, 9 (39.1%) were sought at this level, resulting in 5 (21.7%) objections and 4 (17.4%) consents (figure 27a). Objections at this



level represent 26.3% of the 19 total objections and consents at this level represent 100.0% of the 4 total consents (figure 27b).

Eligible Donor: The distribution of objections and consents at the eligible donor level in the university hospitals / transplant centres are:

Basel sought permission for donation in 22 cases; from these 22 cases, none were sought at this level.



Lausanne sought permission for donation in 24 cases; from these 24 cases, 12 (50%) were sought at this level, resulting in 6 (25.0%) objections and 6 (25.0%) consents (figure 27a). Objections at this level represent 60% of the 10 total objections and consents at this level represent 42.9% of the 14 total consents (figure 27b).

St. Gallen sought permission for donation in 31 cases; from these 31 cases, 1 (3.2%) were sought at this level, resulting in 1 (3.2%) objections and no consents (figure 27a). Objections at this level represent 5.6% of the 18 total objections (figure 27b).

Zürich sought permission for donation in 23 cases; from these 23 cases, none were sought at this level.

In summary, of the total 99 objections, 54 (54.5%) were reported for a possible donor; 23 (23.2%) were documented for a potential donor and 22 (22.2%) for an eligible donor after brain death diagnosis.

At the possible donor level the 54 (54.5%) of total objections were divided as follows: Basel 10 (100.0%) out of 10 objections, Zürich 14 (73.7%) out of 19 objections, St. Gallen 12 (66.7%) out of 18 objections, Bern 14 (45.2%) out of 31 objections, Lausanne 2 (20.0%) out of 10 objections, and Genève 2 (18.2%) out of 11 objections.

At the potential donor level the 23 (23.2%) of total objections were divided as follows: St. Gallen 5 (27.8%) out of 18 objections, Zürich 5 (26.3%) out of 19 objections, Genève 3 (27.3%) (of which 2 were coroner objections) out of 11 objections, Bern 8 (25.8%) out of 31 objections, and Lausanne 2 (20.0%) out of 10 objections.

At the eligible donor level the 22 (22.2%) of total objections were divided as follows: Lausanne 6 (60.0%) out of 10 objections, Genève with 6 (54.5%) out of 11 objections, Bern 9 (29.0%) out of 31 objections, St. Gallen 1 (5.6%) out of 18 objections, and Zürich and Basel had no objections at this level.

DISCUSSION


5. Discussion

The basic intention of the Swiss Transplantation Law with regard to organ donation, is to provide authoritative directives (adapted from the Spanish Model [3,4]) for the structures of the donation process, with the objective to increase organ donation activity. Yet, despite these measures taken, the number of deceased organ donors in Switzerland has remained largely constant. Since the low donation rate in Switzerland (one of the lowest in Europe, see figure 28 below) has an immediate impact on the number of patients on the waiting list, it comes as no surprise that it has risen by 23% from 870 patients by the end of 2007 to 1074 patients in 2011 [5], meaning that waiting list mortality remains a major concern. The SwissPOD study was initiated to expose the causes of the overall low donation rate in Switzerland, and explain the differences between networks. In view of the fact that the detection and referral of potential donors is required by law, there was a 100% participation rate from the 87 intensive care units (ICU) accredited by the Swiss Society of Intensive Care Medicine SSICM; furthermore, 52 accident and emergency departments (A&E) also participated. This shows the hospitals authorities’ commitment to the improvement of the situation by providing an insight to their data and processes. In the future, the SwissPOD database, developed for this study, will continue to be used as a quality assurance tool. SwissPOD is the first comprehensive, nationwide study which gives an overview of the donation process and its outcomes for patients dying in an ICU or A&E. The present report only provides a summary of the results. The reasons for non-donation are multiple and are documented in all levels of the donation process. Our findings concerning the variations in donation rates between networks and hospitals are multifactorial, and therefore need to be analysed in-depth posteriorly.

In summary, the SwissPOD study shows four major findings, discussed in detail below:

(1) An overall objection rate to organ donation of 52.6%.

(2) An overall conversion rate of 45.4%.

(3) Structural differences on an organisational level among the networks, resulting in a variation in donation rates.

(4) Varying degrees of awareness for the detection and referral of a possible donor, mainly in smaller hospitals.

Potential for organ donation and donation rate

Study data analysis showed that the estimated maximum capacity in Switzerland for organ donation after brain death from patients deceased in ICU and A&E is 290 donors per year, equalling 36.5 per million of population (pmp). The actual capacity for organ donation is dependent on the number of patients diagnosed brain dead in a hospital. The estimated capacity for donation is measured by the number of patients who are suspected to fulfil brain death criteria and include a limited number of drop-offs such as patients documented as not being identified as a potential donor and a number of patients or next of kin who objected to donation. It is noteworthy that this capacity does not include patients who died on general hospital wards, intermediate care units and out-of-hospital. There may be an unquantifiable additional potential of donors out of this patient group. During the study period, there were 98 donations after brain death (DBD), representing 2.2% of all audited deaths, and 6 donations after circulatory death (DCD). This equals an actual donation rate of 12.3 pmp (13.1 pmp with DCD included). Remarkably, a study by Wesslau et al who evaluated the donor potential in the north-east donor region of Germany (7.69 million inhabitants which is almost identical to Switzerland's with 7.95 million, and a similar donation rate) estimated their pool of potential donors to be 40.7 pmp [6].

DISCUSSION


Over the last 10 years, the Swiss organ donation rate has remained relatively static, ranging from 75 deceased donors in 2002 (10.3 pmp) to 103 donors in 2009 (13.2 pmp) [5]. Contrariwise, other European countries, that one or two decades ago showed similar donation rates to Switzerland’s, increased the numbers of donors substantially [3,7]. We are aware that variations in donor rates may occur in shorter time periods, as shown in Croatia recently. Therefore, Swisstransplant analysed the donor rates in the decade before the Transplantation Law came into force (1.7.1997–30.6.2002 [period A] and 1.7.2002–30.6.2007 [period B]) and compared it with the 5 years after (1.7.2007 to 30.6.2012 [period C]). This evaluation revealed that the average donor rate was 85.6 donors per year in period A; 83.4 donors per year in period B; and 95.6 donors per year in period C. Looking at the evolution among the networks, the increase in period C, compared to periods A and B was mainly due to the PLDO (+29 donors [+18.7%]), Basel (+25 donors [+61.0%]), and St. Gallen (+5 donors [+12.8%]) networks. The other networks remained at an unchanged or even decreasing donor rate. The increase shown in the PLDO network can be explained with the creation of a structure and the implementation of processes in accordance to the legal requirements. Consequently, the assumption that by implementing structures and processes for donor awareness in non procurement hospitals in the German-speaking networks of Switzerland will have an impact on the donation rate, appear reasonable. These structural and awareness issues (findings 3 and 4) are discussed in more detail below. Our study findings show that the actual capacity for donation (patients brain death diagnosed vs. all deaths) per million of population by network varies between 3.6 pmp and 25.0 pmp. Bern has the highest rates with 25.0 pmp, followed by the PLDO with 23.6 pmp, St. Gallen with 21.7 pmp, Basel with 18.5 pmp, Luzern with 12.1 pmp and Zürich with 3.6 pmp. However, findings show that the actual donation rate (utilised donors vs. all deaths) by network per million of population is 18.1 pmp for St. Gallen, 16.7 pmp for Basel, 15,2 pmp for the PLDO, 14.5 pmp for Bern, 12.1 pmp for Luzern and 2.7 pmp for Zürich. This confirms the increase in donation rates shown over the past few years for Basel university hospital, Aarau cantonal hospital and St. Gallen cantonal hospital due to local initiatives. Audited data shows that patients diagnosed brain dead during the study period came from three categories of diagnoses: cerebrovascular accident (CVA), head trauma and anoxia. All of the 76 hospitals had patients who died from these death selected causes (figure 2a/b). However, there was a large variation between networks (figures 7a/b–12a/b) and university hospitals / transplant centres (figures 18a/b–23a/b) for patients dying on an adult ICU with one of these pathologies and the transfer of these patients from non transplant centres. Basel, Luzern and Zürich networks showed that roughly 30% of all ICU deaths came from one of these death selected causes, compared to the PLDO, Bern and St. Gallen networks with approximately 40%.

There may be a correlation between the differences in percentage of patients who died of a death selected cause in university hospitals / transplant centres and the number of transfers to one of these hospitals from a hospital with no neurosurgical facilities.

As shown in table 16, the highest number of transfers was to Bern university hospital (19.5%). They also have the highest percentage of patients dying of a death selected cause with 62.1% (figure 17). Zürich university hospital with 8.8% of patients transferred to their hospital also had a much lower number of patients dying of a death selected cause (41.0%). This can be due to different transfer policies.

However, this can not be said generally as transfer policies may show an impact in large networks with a high number of hospitals with no neurosurgical facilities, but not necessarily in small networks. It is to assume that patients with a death selected cause in small networks are usually directly admitted to the reference centre, which would result in a smaller number of transfers.

Our observations concerning the referral of patients from hospitals without neurosurgical facilities to reference centres are in line with a Dutch study showing that hospitals with a neurosurgery department had an increased number of donors as compared to those without neurosurgical facilities [8].

DISCUSSION


Taking into account the important variations of death selected causes by networks and looking at the statistics for the identification and referral of a possible organ donor, one may conclude that hospitals within the PLDO, Bern and St. Gallen networks have put into place good practices which enable this awareness for donation. Basel network has the lowest death rate by selected cause, which could be explained that patients dying from these diagnoses are not admitted to ICU or not transferred from hospitals with no neurosurgical facilities. Interestingly, a Dutch study showed that 17 out of 100 dead from accidents or suicides became donors, whereas only 4.9 out of 100 dead from a CVA became a donor [8]. Similar results are found in a recent US study, where CVA accounted for 5.5% of donors [9]. Our findings showed that we were above these results with 11.2% of our CVA deaths resulting in the donation of organs.

However, our limited data collection (restricted to ICU and A&E deaths) excludes the possibility to quantify how many patients are dying outside of an ICU or A&E with one of these pathologies in Switzerland. Study data strongly suggests that a number of patients with these death selected causes are never admitted to an ICU from A&E or that they were admitted to an ICU but transferred to a general ward for end of life care. In parallel to study data, we examined all Swiss inhabitant deaths by networks from these death selected causes. Data from the Swiss Federal Statistical Office showed that all types of death were distributed similarly in all networks, which confirms as a benchmark that there are not more or less deaths from selected types of causes for different regions in Switzerland. Thus, the fact that there are differences in the types of death that can lead to brain death diagnosis in ICUs suggests that these deaths are occurring elsewhere. There can be a number of explanations for this, such as lack of awareness for organ donation and the option for donation was not considered; no available bed on an ICU or the need for a bed. Another reason could be that older patients with (severe) cerebral lesions but spontaneously breathing were not intubated and, thus, were transferred to a general ward instead of the ICU. It could also be that a patient had expressed his wish in life for no active treatment in the event of a life threatening pathology. This could result that the patient would not be admitted to an intensive care unit. This can also be the reason for a non transfer of a patient from a non reference centre to a reference centre for treatment where one would expect this type of pathology to be treated. Furthermore, it would be incorrect to presume that all these patients could have been brain death diagnosed. Yet, as past and present audits from the PLDO network indicate, one can consider that a small proportion of these patients are probably non identified donors due to lack of awareness for organ donation, and that the option for donation was not considered. Since 2008, and the development of the PLDO network, approximately one third of organ donors have been detected by their non transplant centres against a minority of certain networks in the German-speaking area.

(1) Objection rate

Our study showed that objection to donation was one of the main reasons for non-donation in Switzerland. Of the 350 patients considered for donation in total, permission was sought in 268 (76.6%) cases. This resulted in 127 consents (47.4%) and 141 objections (52.6%) to organ donation (tables 11, 12). When looking at the subgroup of 320 ICU adult deaths considered for donation, permission was sought in 249 (77.8%) cases, and resulted in 121 (48.6%) consents for donation and 128 (51.4%) objections (figure 15).

Due to a lack of published data from major European countries (e.g., Austria, France, Germany), it is difficult to compare objection rates within Europe. However, data from Italy, Spain and the United Kingdom show considerable variation. The refusal rate, calculated as a percentage of the number of next of kin approached for seeking permission for donation, is 19% in Spain, 31.5% in Italy and 43% in the UK [10]. The study from the north-east region of Germany and studies from the UK and the US showed objection rates of 73%, 41% and 46%, respectively [6,11,12]. In a recent Dutch study, the objection rate was estimated to amount to approximately 60% [13], Danish data showed 49% next of kin refusals [14].

DISCUSSION


Remarkably, there is considerable discrepancy between actual donation rates and people’s attitudes toward organ donation. In figure 28, bars show the number of deceased organ donors (including non heart beating donors) per million of population in selected European countries [10]. The line above displays survey data, showing the percentage of people who answered “yes” to the question “If you were asked in a hospital to donate an organ from a deceased close family member, would you agree?” [15] or “I would (rather) agree to donate my organs after death”[16], respectively.

Figure 28: Donation rates vs. attitude towards donation in selected European countries

Several studies emphasise on the time point of the next of kin approach having a crucial impact on consent by next of kin [17–21]. The fact that in our study, objection to donation was observed during all phases of the donation process (as shown in figures 16a/b for networks and 27a/b for university hospitals / transplant centres), demonstrates that approach to the next of kin in view of seeking permission for donation is occurring at different time points. Actually, there was a co-variation of an early approach for requesting organ donation and objection. Out of 91 approaches at the possible donor level, 71 (78.0%) objected to donation. There were 118 approaches at the potential donor level, resulting in 37 (31.4%) objections. Out of 59 approaches at the eligible donor level, 33 (55.9%) objected to donation. Our data shows that early approaches were more frequently documented in the networks of the German-speaking area compared to the PLDO network. A possible explanation for this finding may lay in an ethical issue, as at end-of-life-care, when all life saving measures have been taken but failed, the discussion with the next of kin is based on “how to die with dignity”. This discussion is essential and gives the line for patient management for possible organ donors, leading either to end stage therapeutic treatment or to organ donation with its preliminary measures in view of maintaining organ viability.

(2) Conversion rates and donation efficiency

As pointed out by Barber et al, who evaluated the potential for organ donation in the United Kingdom, the donor rate per million of population may not be an entirely appropriate measure for comparing different countries. They emphasised that several factors may influence the number of potential donors that are available. These include the provision of intensive care beds, neurosurgical practice and the death rates from intra-cerebral bleeding and road traffic accidents. Therefore, they suggest considering the donor rate in terms of a “percentage of the potential” or the “conversion rate” [11].

DISCUSSION


Our Swiss study data showed an overall conversion rate of 45.4%, (calculated as the percentage of potential donors who become an organ donor). The conversion rate in the study by Wesslau et al was 47% [6]. These are similar results to those found by Barber et al for the UK (45%) and the 46% in a large US study by Sheehy et al [11,12]. Our data equally shows that Swiss ICUs are generally doing an excellent job in considering the option of donation at end of life care. 350 patients out of the 4524 audited deaths (7.7%) representing 44.0 pmp were considered for organ donation. However, the conversion of these patients to organ donors show variations by networks (table 14) and by university hospital / transplant centre (table 18) with losses in all steps of the donation process.

The donation efficiency index (figure 14 for networks, 25 for university hospitals / transplant centres), calculated as a percentage of patients who donated organs from the number of deaths from death selected causes (CVA, head trauma and anoxia). This indicator shows large differences with Basel network that has the lowest percentage of deaths from death selected causes but the highest donation efficiency with 11.8%, thus making the most of their potential. The differences documented show the lower efficiency indexes for Bern, Luzern and Zürich networks due to their high objection rates.

(3) Structural differences

Article 56(2) of the Transplantation Law (SR 810.21) states that the cantons are in charge of implementing appropriate structures in relation to transplantation. Among others, these include the appointment of staff responsible for local coordination and training programmes. This study, in addition to patient information, collected information on hospital infrastructure, hospital policies as well as directives and guidelines for caring for a potential donor. Data revealed that there are considerable variations by network. In some of the networks, there are hospitals without guidelines or institutional directives on brain death. Less than 50% of hospitals in Bern and Zürich networks declared having guidelines or institutional directives on brain death compared to 100% of the PLDO network public hospitals (see hospital characteristics in the annex). There is also a difference between the networks concerning the number of hospitals that procure organs for transplantation and the availability of an on-site transplant coordinator. The PLDO network has 7 procurement hospitals with an on-call transplant coordinator who can be dispatched to any requesting establishment. Basel and Zürich networks have 2 procurement hospitals with an on-call transplant coordinator to these institutions, whilst Bern, Luzern and St. Gallen networks only have one procurement hospital with no transplant coordinator working outside of the university or cantonal hospitals. Additionally, the PLDO network finances local donor coordinators in each hospital with an ICU. To our knowledge, in the German-speaking area the networks and their affiliated cantons have not yet fully implemented these structures. However, individual teams such as in Basel university hospital and Aarau cantonal hospital, and in St. Gallen cantonal hospital have increased their donation rates over the last five years due to local initiatives. They did so by implementing processes, based on guidelines developed by the heads of ICUs from these hospitals.

When considering the necessary structural improvements required for an increasing donation rate, it is noticeable that only the cantons associated to the PLDO network have complied and implemented the standards required by law. They did so by financing local donor coordinators, nurses and physicians from the intensive care unit in each hospital. Conversely, in the networks of the German-speaking area, due to lack of financial resources, the local donor coordinators often – if not always – are the heads of ICUs. This could mean that implementing structures and processes with the resources available may be difficult. Apart from a few local initiatives, there was little organisational improvement in the cantons of the German-speaking area within the last five years. As a consequence, the differences in donation rates between the regions that had existed before the coming into force of the national

DISCUSSION


Transplantation Law prevail, even though there was hope that the law would ameliorate the overall situation.

(4) Varying degrees of awareness for the detection and referral of a possible donor

Out of the total 4524 audited deaths, 350 patients (7.7%, representing 44.0 pmp) were considered for organ donation (i.e., the option for donation was discussed at end of life care). This shows that there is awareness for donation in the ICUs, although this awareness is more prominent in the reference centres or university hospitals / transplant centres than in smaller hospitals. This is demonstrated with the observed increase in donation rates for Basel, the PLDO and St. Gallen networks in the last five years, with a rise in the referral of patients from non procurement centres to reference centres. This was less predominant in Bern and Zürich network, as revealed in the Swiss Organ Allocation System (SOAS). As a side effect of the SwissPOD study, there has been a marked increase in awareness towards the end of the study period. Enhancing awareness seems to be a very effective measure in order to improve donation rates. This is also confirmed by several studies that evaluated the impact of a best practice system in the United States (the US Organ Donation Breakthrough Collaborative) and showed its positive effect on awareness of organ donation and, ultimately, consent and conversion rates [22–25].

Conclusions

Limitations of the study: We are well aware of the fact that a comparison of the results from the networks and hospitals must be carried out with maximal scrutiny, because the variations result from a large number of factors that need to be taken into account. Furthermore, the interpretation of the results needs to be handled with caution due to a number of small networks and hospitals with limited data samples over the one year period. A&E data has not been detailed in this report as data showed no common standardised structures, polices or procedures. Another limitation of the study lies in the fact that it does not include patients who died on general hospital wards, intermediate care units and out-of-hospital.

In conclusion, we were able to show that the high refusal rate (and thus the low donation rate) in Switzerland results from various factors or causes that require detailed further analysis. The reasons for non-donation are multiple and are documented in all steps of the donation process. However, all networks and hospitals equally show that there is room for improvement in one or more steps. This report only provides a summary of the results and an in-depth analysis of the data will be carried out posteriorly. We strongly advise that the issues identified in our study should be addressed within the networks and hospitals as well as in the public.

In-hospital actions have been anticipated by the Comité National du Don d’Organes (CNDO), which started an educational program in 2011 with the aim to improve the communication to the next of kin when seeking permission for donation. Furthermore, expert groups created documents with recommendations to every step of the donation process (Swiss Donation Pathway). These recommendations will be available for hospital staff. As from summer 2013, specialised teams for requesting organ donation will be available on call. These teams, who have the aim to provide competent and transparent information to the family, will act as a support to local hospitals assisting in the communication to the next of kin in the context of organ donation.

It is essential for the cantons in the German-speaking area to finance the required personnel (local donor coordinator) in each hospital with an ICU and the structures required so as to fulfil the tasks described by the Transplantation Law. Funding of training and education of local coordinators must be guaranteed in order to establish a national standard for the networks under the hat of the CNDO. Quality control is required by the law for all hospitals, and should lead to a continuous improvement of donor detection and referral at each level of the donation process.

DISCUSSION


Acknowledgments

We are very grateful to all those who have contributed to this study, particularly to the local donor coordinators who have collected and entered the data. To all the heads of intensive care and accident & emergency who have accepted to participate to the study. To the Swiss Society of Intensive Care Medicine (SSICM), the Schweizerische Gesellschaft für Notfall- und Rettungsmedizin (SGNOR), Head of networks & their general donor coordinators for their support.

Contributors:

Code book and audit form: Caroline Spaight, Isabelle Keel, David Egger Implementation of the study and management of data collection: Caroline Spaight, Isabelle Keel Referral person for data collection in Ticino: Eva Ghanfili Documentation: Caroline Spaight Database: Yvan Schmutz, Thierry Berset Translation of documents/database: Caroline Spaight; Marie-Pierre Chambet (French); Isabelle Keel (German); Luca Imperatori, E.Ghanfili, Tatjana Crivelli, Andreina Bocchi, Diane Moretti (Italian) Extraction/analysis of data: Caroline Spaight, Isabelle Keel

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6. References

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http://ec.europa.eu/health/ph_threats/%0bhuman_substance/oc_organs/docs/fact_figures.pdf

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ANNEX


7. Annex

7.1. Hospital Characteristics by Network

Basel Bern Luzern PLDO St. Gallen Zürich

Number of hospitals 6 12 6 19 2 23

Type of hospital

university hospital / transplant centre 1 1 - 2 1 1

hospital with neurosurgery 1 3 2 2 - 7

hospital without neurosurgery 4 8 4 15 1 15

Number of hospital beds 2574 2802 2802 6168 935 5997

Hospital infrastructure enabling to care for a potential donor/retrieve organs

care for a potential donor (yes/no) 6/0 11/1 6/0 18/1 2/0 21/2

retrieve organs (yes/no) 2/4 1/11 2/4 9/10 1/1 2/21

Hospital policy to transfer a potential donor to another establishment (yes/no)

5/1 11/1 5/1 14/5 1/1 22/1

Number of hospitals with guidelines/institutional directives for

possible donors after brain death (DBD) 4 5 5 17 2 13

possible donors after circulatory death (DCD) 1 - - 2 1 1

tissue donation - 2 2 3 - 3

Type of consent policy for donation

written and signed consent 2 1 1 8 1 2

oral consent 3 10 5 8 1 15

n.a. 1 1 - 3 - 6

Hospital facilities & specialties

0perating theatres (no. of hospitals) 6 12 6 19 2 23

Radiology (no. of hospitals) 6 12 6 19 2 23

Neurology (no. of hospitals)

neurologist available 24/7 2 2 2 5 1 6

neurologist in-house limited availability 2 2 - 5 1 4

neurologist not in-house but available on call 1 5 4 7 - 8

no neurological facilities / n.a. 1 3 - 1/1 - 4/1

Neurosurgery (no. of hospitals)

neurosurgeon available 24/7 2 2 2 3 1 6

neurosurgeon in-house limited availability - 1 - - - 1

neurosurgeon not in-house but available on call - 1 1 5 - 2

no neurosurgical facilities 4 8 3 11 1 14

Availability of a transplant coordinator (TC)

in-house TC 1 1 - 2 1 1

TC available (on call) on site if requested 1 - 1 9 - 1

no TC 4 11 5 8 1 21

ANNEX


7.2. Participating hospitals

Basel Network Kantonsspital Baden St. Claraspital, Basel Universitätsspital Basel Universitäts-Kinderspital Basel UKBB Kantonsspital Bruderholz, Basel Kantonsspital Liestal Kantonsspital Aarau Bern Network SRO Langenthal Inselspital - Universitätsspital Bern Regionalspital Emmental AG, Burgdorf Regionalspital Interlaken - Spitalverbund fmi Spitalzentrum Biel Hirslanden Klinik Beau-Site, Bern Lindenhofspital Bern Klinik Sonnenhof, Bern Spital STS AG Simmental-Thun-Saanenland, Spital Thun Bürgerspital Solothurn Kantonsspital Olten Spital Bern-Tiefenau Luzern Network LUKS Kinderspital Luzern LUKS Luzern LUKS Sursee Hirslanden Klinik St. Anna, Luzern Kantonsspital Uri, Altdorf LUKS Wolhusen Paraplegikerzentrum Nottwil Kantonsspital Nidwalden PLDO Network Centre Hospitalier Universitaire Vaudois Hôpitaux Universitaires de Genève Hôpitaux Fribourgeois - Hôpital Cantonal Fribourg Hôpital Neuchâtelois-Pourtalès Hôpital Neuchâtelois - La Chaux-de-Fonds Hôpital du Chablais - Hôpital de Monthey Centre Hospitalier du Centre du Valais - Hôpital de Sion Centre Hospitalier du Centre du Valais - Hôpital de Martigny Centre Hospitalier du Centre du Valais - Hôpital de Sierre Hôpital de la Riviera - Vevey, Le Samaritan

Etablissements Hospitaliers du Nord Vaudois - Hôpital d'Yverdon Ensemble Hospitalier de la Côte - Hôpital de Morges Groupement Hospitalier de l'Ouest Lémanique - Hôpital de Nyon Hôpital Intercantonal de la Broye - Hôpital de Payerne Hôpital du Jura - Hôpital de Delémont Ospedale Regionale di Bellinzona e Valli Ospedale Regionale di Mendrisio Ospedale Regionale di Lugano Ospedale Regionale di Locarno Cardiocentro Ticino, Lugano Hirslanden Clinique Cécil, Lausanne Hôpital de la Tour, Genève St. Gallen Network Ostschweizer Kinderspital St. Gallen Kantonsspital St.Gallen Kantonsspital Herisau Zürich Network Spital Schwyz Spital Lachen Kantonsspital Thurgau AG, Münsterlingen Kantonsspital Thurgau AG, Frauenfeld Kantonsspital Schaffhausen Spital Bülach GZO Wetzikon Stadtspital Triemli, Zürich Spital Männedorf Stadtspital Waid, Zürich Klinik Hirslanden, Zürich Spital Limmattal, Schlieren Spital Uster Spital Zollikerberg See Spital, Horgen Kantonsspital Winterthur Universitäts Spital Zürich Universitätskinderklinik, Zürich Hirslanden Klinik im Park, Zürich Kantonsspital Zug Hirslanden Klinik Aarau Kantonsspital Glarus Kantonsspital Graubünden, Chur Spital Oberengadin, Samedan

ANNEX


7.3. SwissPOD Study Approval

ANNEX


CONFIDENTIAL - Swisstransplant · (1) An overall objection rate to organ donation of 52.6%. (2) An...

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