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Scientific Statement on Organ Donation After Out-of-Hospital Cardiac Arrest: Scope of Work Proposal for Public Comments by Health Care Providers (ALS): Scoping Review

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For Health Care Providers

The International Liaison Committee on Resuscitation Scientific Statement on Organ Donation After Out-of-Hospital Cardiac Arrest: Scope of Work Proposal for Public Comments

The International Liaison Committee on Resuscitation (ILCOR) has commissioned a scientific statement pertaining to organ donation after out-of-hospital cardiac arrest. The purpose of this post on ILCOR.org is to reach out to the broader community for comments on the scope of the review. Some of the sections below are very technical. We have provided a plain English version at the end of this document, but resuscitation or transplant specialists in your country can explain them as well if you need help.

Lay Summary

It is unclear how many victims who die after initial resuscitation from out-of-hospital cardiac arrest have wishes consistent with, and are eligible to provide organs or tissues for donation. This is important because potentially 8 individuals waiting for transplantation can be helped by a single donor. If we can optimize the organ donation process for our communities we may see a dramatic improvement in survival and quality of life or wellness index within our communities. There are lots of barriers to helping physicians and families make decisions about organ donation after out-of-hospital cardiac arrest and this summary could contribute to helping to break down these barriers. There are countries (e.g. Spain and the Netherlands) that are achieving high rates of organ donation that may be using strategies that others can learn from. There are countries such as South Africa where organ donation after cardiac death has not been implemented and where the potential for transplant is lost.

Scope of work of the proposed scientific statement for clinicians and scientists

Definitions:

Two main categories of organ donation pathways Circulatory death (DCD) and Donor after Neurological Determination of Death (DNDD). The DCD category includes the modified Maastricht Classification of DCD sub-categories IA, IIA, III, IV

Category I- Uncontrolled IA out of hospital CA- Found Dead
Category II - Uncontrolled IIA out of hospital CA - Witnessed Cardiac arrest
Category III - Controlled - Withdrawal of Life Sustaining Therapy
Category IV - Uncontrolled controlled - sudden Cardiac arrest during or after the process of brain death determination and prior to organ procurement

1.0 Introduction

Look at how OHCA patients who do not survive can become organ donors after circulatory death (DCD) or after Neurological Determination of Death (DNDD).

Donation after circulatory death (DCD) can occur in a number of situations

Category I- Uncontrolled IA out of hospital CA- Found Dead
Category II - Uncontrolled IIA out of hospital CA - Witnessed Cardiac arrest
Category III - Controlled - Withdrawal of Life Sustaining Therapy
Category IV - Uncontrolled controlled - sudden Cardiac arrest during or after the process of brain death determination and prior to organ procurement

2.0 Background

2.1 The incidence and outcomes (e.g. number of organs transplanted, graft survival, recipient outcomes) of organ donation after out-of-hospital cardiac arrest in the world literature. Report as per both categories DCD (uDCD=uncontrolled as a subcategory) and DNDD

2.2 The estimation of potential donors after OHCA for DCD (uDCD=uncontrolled as a subcategory) and DNDD based on published registry data.

3.0 Strategies to close the gap between incidence of donation and potential donation

3.1 Strategies published in the literatures that are associated with increased rates of organ donation among patients after OHCA

3.2 Strategies published in the literature associated with improved organ viability and organ transplantation success rates after OHCA (e.g. organ preservation and optimization after OHCA)

3.3 Special Case Extracorporeal CPR (ECPR)

3.3.1 Published decision rules to guide end-of-life care in patients treated with ECPR after OHCA so that potential organ donors can be identified in this
3.3.2 Published guidelines for when to terminate ECPR and consider organ donation
3.3.3 Identify the knowledge gap and the need for a decision rule to guide when ECPR should be ceased and organ donation considered

3.4 Criteria (When) for transitioning from active resuscitation to organ preservation in patients with OHCA - Look for guidelines and decision rules that address this

3.5 Process (How) for transitioning from active resuscitation to organ preservation in patients with OHCA - look for implementation strategies

4.0 Ethical considerations around uDCD after out-of-hospital cardiac arrest

4.1 Describe the ethical issues that arise at the transition between the resuscitation clinical teams and organ procurement teams and address or identify the international variability

4.2 Describe the patient and family perspective, including issues of consent, when transitioning from active resuscitation to organ preservation in patients with unsuccessful resuscitation of out of hospital cardiac arrest

4.3 Do you think there is a problem deciding when to change from trying to resuscitate a person to preserving their organs for transplantation?

5.0 Cost effectiveness of donation after out-of-hospital cardiac arrest

5.1 DCD and DNDD post ROSC (no eCPR)

5.2 DCD and DNDD with ongoing eCPR

5.3 uDCD with ongoing CPR/eCPR without ROSC

Deliverable:

A narrative review and consensus across international experts from multiple disciplines, that will summarize key published data on important issues related to organ donation after OHCA. The review will provide guidance and support the development of treatment recommendations and identify strategies to optimize rates of ethical organ procurement and successful organ transplantation after out-of-hospital cardiac arrest. We will identify knowledge gaps and priorities for research.

To ensure the review includes the patient, family and community perspective we will use www.ilcor.org to iteratively engage relevant sectors of the global public to provide input and shape the final product. We thank you for taking the time to review and comment on this scope of work proposal.

The Authors:

The approved writing group consists of scientists representing allied health professionals and physicians from across the world. The authors have been reviewed and approved based on the conflict of interest policy.

Advanced Life Support

Miscellaneous

Discussion

ILCOR staff

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ILCOR staff

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ILCOR staff

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Excellent approach that were really necessary: A comprehensive approach to refractory OHCA according with best evidence on both Resuscitation and Deceased Organ Donation. Already conducted SR on uDCD and ECPR suggest that both strategies are compatible when priorities are clear (life-saving ECMO for recovery with QOL first and then Organ Preserving ECMO). And not only compatible but also more efficient that current practice (saving more lives one way or another). Finally, when process is based on a truthful and honest approach to relatives or proxies in such a critical events, confidence on organ donation system is reinforced. Knowledge gap already exists regarding on predictive model to dilucidarse to whom offer ECPR/uDCD when at the scenario of refractory both IHCA and OHCA. We will continue working on it!

ILCOR staff

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Just a little but important nuance regarding on Categories on Deceased Donation. Hope will be of interest and clarifying for the workgroup. Although the classification presented above on "Scope of work of the proposed scientific statement for clinicians and scientists; Definitions" was originally this presented by the work group (Maastricht Classification from Prof Koostra, 1996) it was modified at Paris International DCD conference (2012) to better accommodate to real practice regarding on uDCD. Particularly, because IA Category (Found dead) never has been reported (not a single case worldwide for organ recovery and only few ones for tissues). However, Category II needed changes. First, the uDCD case is "After Unsuccessful Resuscitation" , as is not certain that is always "witnessed"; e.g. Spain protocols accept no-flow time ranging from 0 to 30 min. Second, practices were very heterogeneous worldwide depending on IHCA vs OHCA event origin. In fact, logistics, I/E criteria to select potential donors, no-flow and low-flow times, consent request and timing, family presence and approach to them, organ preservation techniques as also final outcomes and quality/quantity of organs recovered were very different in the two situations, as easy to understand. That was why in Paris 2012 was suggested, and lately accepted and integrated by both clinicians and Academia, to modify the original Maastricht Category (1996) to Paris (2012) one. Today, Category I ( Found dead) is only testimonial (for tissues recovery due to WIT starting point is "too much uncontrolled"/unknown), Category II (after unsuccessful CPR instead of "witnessed cardiac arrest" said) includes A type: after unsuccessful IHCA resuscitation and B type: after unsuccessful OHCA resuscitation. This is the classification accepted in reported cases, series,SRs and interbational recommendations/guidelines according with benchmark. I hope to have been useful.

ILCOR staff

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Please ensure there are front line paramedics and EMS medical directors representing on this work as there are significant ethical and operational implications to adjusting practice to include consideration of organ donation and organ harvesting from OHCA (especially patients that previously would have had resuscitation discontinued in the field). There are already many complexities around out of hospital cardiac arrest (withholding or ceasing resuscitation, alignment with patient wishes/goals for resuscitation or not (goals of care and/or do not resuscitate orders), having difficult conversations with little historical information under time pressure to initiate resuscitation, etc.) and the general public's understanding of the outcome of out of hospital cardiac arrest (assumption that good outcome is the norm) that place paramedics in very difficult ethical decision making situations on a daily basis. The general public does not talk about their wishes for care and/or document these in a coordinated fashion currently (most patients have wills, but few have easily accessible documentation about their health care wishes in their homes (most paramedics do not have access to any other health system records), these conversations are not consistently happening with patients and their primary care teams and health systems across North America are in varying stages of implementing consistent documentation re: resuscitation wishes in hospitals, let alone across community). The addition of continued resuscitation for the purpose of organ harvesting (rather than perceived outcome of ROSC) is going to add another layer of ethical complexity for paramedics and families when patients suffer OHCA. In the field, there will not be a different team of experts to transition the patient to when the discussion changes from resuscitation for ROSC vs continued resuscitation for transport for organ harvesting (this will be the same paramedic crew that will be required to shift gears and own the discussion, with no other support, like teams in hospital that specialize in organ donation conversations with families). I 100% support this discussion and see opportunity for the potential for increased organ donation related to patients that suffer cardiac arrest out of hospital, however paramedics would need to be better prepared to have difficult discussions with families at the time of the event (which is already extremely difficult and stressful). A greater emphasis on public discourse around goals of care, advance care planning and how that information is shared with paramedics at the time of OHCA is required to support a shift in this direction as well. There are already circumstances where resuscitation is performed against family/patient wishes and/or not an appropriate intervention based on the patient's medical history and prognosis (based on an assumption that everyone would want CPR and resuscitation). There will need to be a greater commitment from the whole healthcare system to prioritize those difficult conversations about advance care planning, wishes/goals and end of life with all patients as a standard practice across their whole lives (not just when nearing end of life or at diagnosis of a life limiting condition or illness). Additionally, current paramedic education (length of educational programs and focus on technical skills) is limiting this type of expansion of care, which requires a strong foundation in ethical decision making, critical thinking, communication skills and comfort with having difficult conversations. Paramedics (US and Canada) are not currently appropriately prepared in their education for these types of ethical discussions and that support will be needed to implement alternative pathways for OHCA that consider continuance of resuscitation for the purpose of organ harvesting at hospital. There are learnings in Canada (Alberta, Nova Scotia and PEI) that would aid in this discussion based on work that has been done around advance care planning, goals of care and paramedics supporting palliative/end of life care patients in community (knowledge gap for paramedics around grief/bereavement, need for documentation of patient wishes easily accessible to paramedics in community, skill deficit for having difficult conversations with family members, identity shift from resuscitation (fix, fix, fix) to supportive care/symptom management for actively dying who do not want (and it's not appropriate) resuscitation) . Learnings and experience in this area would translate directly to some of the anticipated ethical challenges and skills needed for paramedics to be able to support organ donation pathways from OHCA. I also encourage that there be patient and family advisers (with personal experience with OHCA in their home) directly involved in this work to help inform what needs to be considered from the family's perspective (there are far more supports for families in hospital than out - again, paramedics would be alone in what they can provide at the time of this difficult decision or shift in care). I also advocate for the involvement of palliative care and experts in grief and bereavement (we know that how a loved one dies has high impact on the survivor's grief and bereavement and care misaligned with pre-identified preference often leads to complicated grief for families). Happy to share learnings or connect the group to others from Canada who can speak to what we have learned around ethical challenges re: resuscitation, palliative care, advance care planning, in relation to EMS (paramedics) - cheryl.l.cameron@gov.ab.ca

ILCOR staff

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ILCOR staff

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In Spain for many years a type of donation that has suffered a considerable increase is the Donation in Uncontrolled Asystolia or UDCD. This type of donation involves the emergency services as detectors of the possible donor. These patients are victims of PCR that have not been recovered from it. It is important as a first point to note that spontaneous pulse recovery attempts have to be carried out to their full extent. That is, all the mechanisms that the emergency team can use should be used. Even therapies even in research like ECMO or similar. Once the emergency team has decided that resuscitation can not be continued for spontaneous pulse recovery because of its futility, this resuscitation becomes maintenance of the possible donor, This point is essential because this change of therapeutic objective must be informed to the family, the change of my objective as recovery of pulse to maintenance of a possible donor. But with the information to the family we found a first barrier and is that the family at those times is not able to receive much information. In Spain according to the Consensus Document of the National Transplant Organization 2012 on the Promotion of the donation in asystole, four situations of information to the family are established. These four situations are actually summarized in a message:

ILCOR staff

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Another important point that is exposed in the development is the part of the effectiveness of the UDCD. In kidney transplantation the evolution of renal grafts is superimposable to renal grafts of encephalitic death or controlled donation. The main difference is the delay in kidney function that usually doubles the kidneys of another type, although creatinine at 6 months and 12 years is normal in most cases. With respect to lung transplants, in the cases in which the transplant is performed, the evolution is equally satisfactory, although it is true that these lungs undergo a very important validation ex vivo with a perfusion ventilation machine. The organ that has not shown a fully satisfactory evolution is the liver. And do not forget the important source of tissues that correspond to these donors. In brief I will insert bibliography in this regard that we are compiling.

ILCOR staff

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1) Suggest that the document uses consistent and precise terminology: e.g. ‘Donation after circulatory determination of death’ and ‘Donation after neurological determination of death’. 2) Suggest that there is a recommendation that death be determined according to clear, reliable and robust criteria with donation procurement only beginning after this. This is relevant to both the sections dealing with criteria used when transitioning from active resuscitation to organ donation procedures and also for the ethical section. This is vital for adherence to the dead donor rule (organ procurement can only begin after the person has been determined to be deceased) and community trust and willingness to participate in deceased donation. It is also important that these processes are consistent with broad internationally accepted death determination criteria and practices. This is a contentious area of practice in uncontrolled DCD, including ECPR. Note that international consensus is lacking in this area and practice varies regionally and may be influenced by local laws if they and medical codes of practice. Australia, for example, has in law that death occurs when there is “irreversible cessation of circulation of blood in the body of the person”. This prohibits any reanimation of the circulation after death determination for the purposes of donation. Other countries, such as the UK, do not have a statutory legal definition of death and instead have a medical standard being ‘irreversible loss of the capacity for consciousness, combined with irreversible loss of the capacity to breathe’. An international group of experts through consensus recommended that death be defined as ‘The permanent loss of capacity for consciousness and all brainstem functions, as a consequence of permanent cessation of circulation or catastrophic brain injury’ (Shemie SD, Hornby L, Baker A et al. International guideline development for the determination of death. Intensive Care Med. 2014; 40(6): 788-97.) Having clear criteria for death determination is important as this directs what are permissible practices prior to and after death. Only certain practices may be permissible for the purpose of organ donation prior to death (ante-mortem interventions). An important element is the duration of absence of circulation required before death can be determined (to provide certainty that there is ‘permanent’ or ‘irreversible’ cessation of the circulation). Once death is determined, then procedures that would contravene the basis on which death was determined should not be allowed (e.g. those that would re-establish blood flow to the brain and therefore potentially consciousness and brain function).

ILCOR staff

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This systematic review is most welcome. There is a plethora of information about the subject, with a multitude of definitions, legislations, opinions and interpretations. 1. Related to “The Purpose” “One donor can save eight lives”. Obstacles for achieving this goal are situated at a structural level in the community (law/organisation) but also at the levels of attitude of the community, and at the level of the real-life practices by the end-of-life healthcare professionals. The goal is to achieve more preparedness to consider/accept/allow organ donation and also more organ harvesting and transplantations after death of potential donors. The purpose of his review is, therefore, to provide adequate information that can help to modify the attitude of the actors in the prehospital phase (community, prehospital rescuers), and also to change the real-life practices of the professional decision-makers (such as emergency physicians (or equivalent), intensivists) in end-of-life situations. This distinction prehospital/inhospital could be emphasised in the purpose of the project. 2.Related to” The Summary” There are some additional inaccuracies in the introduction - Line 2-3 should better read: "Potentially 8 individuals waiting for transplantation of a vital organ can be helped by a single donor and many more by transplantation of tissues" - Line 7 is not correct. According to recent data from Eurotransplant, European Commission, IRODaT registry and other sources, the rates of Deceased Organ Donation and Transplantation are high for Spain with 47/million/year, Portugal 34, Croatia 33, USA 32, Belgium 30, France 30; but Netherlands only 15, Germany 10, Greece 6. Therefore, my recommendation is to delete the examples (Spain and the Netherlands). - Line 9: The sentence about South Africa is unclear. How is ‘cardiac death’ defined? The rate of kidney transplant is low (4/million/year) due to very low registration as potential organ donor. - It could also be recognised that organ donation and transplantation are usually performed after in-hospital Brain Death Diagnosis. The contribution of initially resuscitated OHCA is substantial. However, in many cases of Brain Death Diagnosis organ donation/transplantation is not considered. Here is room for substantial progress. Therefore, it could be recommended to review also data on the rate of potential organ donors (brain death diagnosis) that do not result in organ transplantation. 3. Related to “The Strategies and Ethical considerations” It could be considered to address also the following aspects in the review: - definitions of death in several countries, and changing definitions in the hypothermia and ECPR era - overview of the legal rules related to organ donation/procurement in the community and in the hospital - overview of the rules of religions related to organ procurement

ILCOR staff

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1) The tittle " Organ Donation After Out-of-Hospital Cardiac Arrest" would cover different procesess of organ donation. If the patient recovered spontaneus pulse after CPR and is admitted in the ICU they may evolve to brain dead and be a potential DBD donor or to postanoxic encephalopathy and eventually become a cDCD donor. If you like to focus on uDCD, it should be specify in the tittle : i.e. Organ Donation After Out-of-Hospital Cardiac Arrest after unsuccessful CPR. 2) Lay Summary: Not only physicians but health care proffesionals Data regarding rates on organ donation ( number of actual donor pmp) does not reflect the current published data. Regarding the number of global actual donors pmp ( cDCD+u DCD) in 2017 Spain is the leader 12,4 , Belgium 9,0 pmpo, UK 9,0 pmp, Netherland 8,6 pmp , USA 5,8 pmp . Thus the Netherland is not a leader but the fouth country in the word. If you are mentioning the countries with uDCD the leaders are Spain and France. http://www.ont.es/publicaciones/Documents/NewsleTTER%202018%20final%20CE.pdf

ILCOR staff

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uDCD remains an unusual activity in Europe and elsewhere despite some international organizations have called to considering this type of donation activity. For example, the 2015 European Resuscitation Council’s guidelines recommend that “After stopping cardiopulmonary resuscitation, the possibility of ongoing support of the circulation and transport to a dedicated center in perspective of organ donation should be considered”. The largest uDCD programs have been developed in Spain and France. The most important obstacles to the expansion of this type of donation is the absence of a legal framework supporting these programs, some ethical concerns well addressed in the outline provided, lack of organizational capability and technical expertise, and doubts about the quality of organs retrieved from uDCD donors. In fact, countries that have successfully implemented DCD programs have done so primarily by establishing a national ethical, professional and legal framework to address both public and professional concerns with all aspects of the DCD pathway. Therefore, identifying and addressing the aspects of the uDCD pathway that raise such professional and public concerns in the current project is pertinent and highly relevant. We take the opportunity of stressing how some of these aspects have been addressed in the Spanish regulatory framework and national guidelines that apply to uDCD: • The decisions to abandon CPR is always disconnected from any consideration of organ donation. The roles of each healthcare professional (HCP) involved in uDCD have been well defined. Thus each decision over the uDCD process is undertaken by a different HCP, to minimize any potential conflict of interests. o CPR is performed by the emergency medical service in according with the Guidelines of the Spanish Resuscitation Council, which are aligned with international standards on CPR. CPR is deemed unsuccessful and abandoned when resuscitation efforts have been exhausted according to existing protocols and best clinical expertise. Considering the option of donation whenever possible―based on the circumstances of the cardiac arrest and the inclusion criteria of the uDCD protocol―is considered a responsibility of any HPC. Once CPR is deemed unsuccessful by the attending team, if organ donation is possible, the candidate is referred to the Donor Coordinator (DC) who will evaluate the case and authorize the transfer to a hospital with an uDCD program. o During the transfer of the potential donor, cardiac compression and mechanical ventilation are maintained with the purpose of preserving potentially transplantable organs. Once in the emergency room of the receiving hospital, a physician independent of the out of hospital emergency team and the DC, must confirm that no further therapeutic efforts are indicated and declare the death of the individual after observing a period of 5 minutes of absence of spontaneous breathing and circulation. • The deceased person’s wishes regarding organ donation are ascertained by several methods, including donor registries, advanced directives, and after discussion with surrogates. The timing of the surrogate discussion varies according to pre-defined scenarios. Transparency is paramount during interactions with families, but disclosure of the critical information requires compassion and privacy, and consideration about their emotional capability to cope with the stressing news must drive the communication process.

ILCOR staff

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And a noteworthy part, not explained, of the protocol is crucial; after declaring death, a balloon is inserted in the aorta and inflated (Fogarty catheter) to avoid reperfusion of both heart and brain that would restore flow after death declaration and theoretically (not only tough, as it has already happened) restore life to the individual. In addition, should be said that in the running protocols at Spain is said to prehospital EMS professionals to convey the individual ASAP to the center in which uDCD protocol is implemented, without giving any information about the target of this specific destination to the proxies unless they specifically ask for this sensible info. Where truthfulness and transparency in the clinical relationship remain at this point? How many pillars of both legal frame and ethical principles are underminned while doing this? It is understandable that uDCD outcomes have been decreased 36% in last two years at Madrid region, which was the more powerful international uDCD program for many decades... Health care providers and society begin to be uncomfortable with such a way to proceed. At the same time, starting ECPR programs for refractory OHCA show us that eligibility criteria to be enrolled as patient or as potential deceased donor are too much similar... Therefore, conflicts of interest are clear and EMS professionals' loyalty to life saving purposes is evident, so uDCD future is in really danger. While policy-makers on Deceased Donation will continue to maintain such an ambiguity and lack of transparency on their uDCD programs, the whole so-called Spanish Organ Donation model will be put in danger too. It's a pity, though.

ILCOR staff

(modified: )

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Scientific Statement on Organ Donation After Out-of-Hospital Cardiac Arrest: Scope of Work Proposal for Public Comments by Health Care Providers (ALS): Scoping Review

ILCOR staff

The International Liaison Committee on Resuscitation Scientific Statement on Organ Donation After Out-of-Hospital Cardiac Arrest: Scope of Work Proposal for Public Comments

Lay Summary

Scope of work of the proposed scientific statement for clinicians and scientists

Definitions:

1.0 Introduction

2.0 Background

3.0 Strategies to close the gap between incidence of donation and potential donation

4.0 Ethical considerations around uDCD after out-of-hospital cardiac arrest

5.0 Cost effectiveness of donation after out-of-hospital cardiac arrest

Deliverable:

The Authors:

Discussion

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