Consensus on Science and Treatment Recommendations (CoSTR)
To be fair, "the continuous evidence evaluation process for the production of the Consensus on Science with Treatment Recommendations (CoSTR)" actually did not started with a systematic review of ECPR (Holmberg 2018 91 – PROSPERO Registration CRD42018085404) as stated in this provided link, but with another one (2016 Ortega-Deballon I et al. Resuscitation. 2016;101:12-20. PROSPERO, CRD 42014015259). http://dx.doi.org/10.1016/j.resuscitation.2016.01.018.
This PREVIOUS, and to our knowledge the first systematic review performed on ECPR topic until that moment, followed PICOTS question format, PRISMA format, explored both level of evidence (following the LOE scale tool proposed by ILCOR) and quality of guidelines (following AGREE II) from ECPR for refractory OHCA of cardiac origin in adults. In short, did pretty the same that Holmberg et al have been published.
We do not understand, at first, why previous work is not referenced at any moment, why the research question, methodology and search strategy is close to duplicate and already did research and why if findings are pretty a duplication of our previous systematic review, the efforts were not focused on reducing knowledge gap while recognizing previous research work from colleagues instead.
In any case, although, again, findings and results from the latter (2018 Holmberg et al) are practically identical to the former that we authorized (and conducted less than 2 years later) we are sure that running RCTs will help to really increase LOE and reduce knowledge gap in order to inform future research. At the same time, many other questions will remain despite of RCT publication, as such a methodology have also limitations when referred to Resuscitation Research environment.
Finally, from a comprehensive approach to sudden cardiac arrest in the prehospital environment, we suggest that the option of Deceased Organ Donation (both after neurologic determination of death -NDD- and after circulatory determination of death -DCD-) should be explored between non eligible for/non survivors from "ECPR strategy", as also between patients with a very poor neurologic prognosis (CPC>3) despite of ROSC after ECPR strategy.
This approach, has been already encouraged by ILCOR in 2015 Guidelines and should not be disregarded from a more effective, efficient and ethically sound point of view. Rowing together, both Resuscitationists/ECMOlogists community and Organ Donation & Transplant community, we really will do our best for both patients, their proxies, health providers confidence and thrutfulness of whole system from society according with best scientific evidence and ethical principles, taking into account the specific legal frame and cultural believes at each country.
We really stress that this opportunity should not be lost again. We will continue working on it. The final goal, to increase survival from OHCA with QOL first and organ donation pool to reduce organ shortage for transplant when not possible, deserve to do so.
There are many variables in assessing dispatcher assisted CPR.
This review does not take into account the nature of the advice vs the outcome i.e. ROSC, short term survival and survival to discharge i.e. compressions only (in the case of predominately cohorts of adult subjects or traditional compressions and ventilation CPR. Various studies have shown that compression-only CPR (as the primary scenario usually involves adults and is a SCA [>80%]) is as (or more) effective in producing favourable outcomes. Research in Sweden indicated compression-only instruction by Emergency Dispatchers/Calltakers resulted in a 75% increase in bystander willingness to commence resuscitation prior to ambulance arrival a factor not addressed in the review. In Australia (and no doubt other countries) ventilations are still part of dispatcher assisted CPR advice, despite no evidence that bystanders in an emergency (with or without training) can master both airway management and control of tidal volume to prevent aspiration.
The is also significant barriers identified in research to the ability of non-clinical emergency calltakers to determine cardiac arrest i.e. an inability to correctly identify and recognise agonal respirations (in the absence of a response to pain) as indicative of SCA. This would further influence the accuracy of the outcomes reported. Although the presence or absence of “breathing” by a novice is extremely unlikely to be accurate nor to consider or recognise if the patient is “breathing normally”; the incorrect question (i.e. presence or absence of breathing) is still used by some emergency services (including Australia where there is a legacy and undying commitment to bystander ventilations despite evidence to the contrary in regard to efficacy). There is therefore doubt as to determining circumstances of an arrest as determined in reviewing the evidence and making assumptions.
It is also a mistake in assuming bystanders are capable of effective ventilation and airway management and that will not result in gastric distension and aspiration (a significant cause of failure to survive to discharge due to aspiration pneumonia). This also applies to those trained in BLS, who must only be considered novices for the purposes of airway management and ventilation and not “trained individuals” as determined in other ILCOR documentation.
Lastly it would be helpful to understand what formal consideration of public feedback is undertaken by the relevant ILCOR committees, prior to the release of treatment recommendations i.e. as to whether this input is just consultative or collaborative as in the past the drafts and final documents seem unchanged despite legitimate concerns about the utility and efficacy of the recommendations.
I strongly recommend that "in any setting" needs to be altered to "in a setting where the patient is normothermic" or "where the cause of cardiac arrest is not accidental hypothermia". The survival outcomes for Hypothermic Cardiac arrest is totally different from normothrmic cardiac arrest as is eloquently described in the article "Normothermic and hypothermic cardiac arrest—Beware of Jekyll and Hyde"
Article in Resuscitation 129 · April 2018
The survival data particularly form Dr Tomasz Darocha and his team in Krakow are not approaching 70% with neurological intact outcome. The overall European survival of hypothermic cardiac arrest treated with mechanical CPR and ECLS with intact neurological status is about 50% , thus way better than in normothermic cardiac arrest
*This is not a comment to add*
One of my comments has been published duplicated. Is this one:
2018.11.02 13:37:17 (modified: 2018.11.02 20:06:52)
Thanks for removing THIS specifically.
In the field first responders do not have the tools to determine if resuscitation is possible, but if during training the option of organ donation is discussed, it provides another reason to continue CPR - for the best outcome for whoever. Maintaining organ tissue allows the family more options.
I am a consumer/patient and I am interested in issues pertaining to end of life care and organ donation. I personally think that if I had a cardiac arrest and my heart could be of any use to help someone, in principal I do not have any problems with it being harvested. I have asked other consumers and some had the same opinion as me, but many people said that they would have to consult their priest or spiritual leader. I believe that would cause some delays in obtaining consent and therefore cause delays in harvesting the organ and transporting it to nearest hospital. I spoke with people of three different religious faiths, and they were adamant that they would consent only upon their religious leader approval.
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.
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
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
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).