Chapter 9 – Shared Decision-Making during Extracorporeal Membrane Oxygenation

Abstract

The use of extracorporeal membrane oxygenation (ECMO) supports a patient’s respiratory or cardiovascular systems via an oxygenator and pump to enhance native function. Venoarterial support takes blood from a major vein and returns it to the arterial system when a patient has predominant cardiac failure. Venovenous support drains desaturated venous blood and returns it oxygenated to a major vein in cases of isolated respiratory failure. In recent years, ECMO has advanced from being simply a rescue therapy used when standard treatment modalities fail; more trained clinicians are approving it for novel indications.1–3 Although the skills to initiate ECMO quickly have been established with structured training programs,4 and there have been improvements to the technology to maintain extracorporeal circuits for prolonged periods to enable organ recovery or act as a bridge to further decisions on medical management, this innovative technology has presented a complex set of ethical challenges (Figure 9.1).

Chapter 9 Shared Decision-Making during Extracorporeal Membrane Oxygenation

Barnaby Lewin and Kollengode Ramanathan

The use of extracorporeal membrane oxygenation (ECMO) supports a patient’s respiratory or cardiovascular systems via an oxygenator and pump to enhance native function. Venoarterial support takes blood from a major vein and returns it to the arterial system when a patient has predominant cardiac failure. Venovenous support drains desaturated venous blood and returns it oxygenated to a major vein in cases of isolated respiratory failure. In recent years, ECMO has advanced from being simply a rescue therapy used when standard treatment modalities fail; more trained clinicians are approving it for novel indications.¹^–³ Although the skills to initiate ECMO quickly have been established with structured training programs,⁴ and there have been improvements to the technology to maintain extracorporeal circuits for prolonged periods to enable organ recovery or act as a bridge to further decisions on medical management, this innovative technology has presented a complex set of ethical challenges (Figure 9.1).

Figure 9.1 Ethical and technical aspects of patient management during ECMO that can be facilitated by shared decision-making.

Although full-fledged evidence for the use of ECMO as a standard of care is still lacking, the conclusions from observational studies and randomized controlled trials do not necessarily replicate patient individuality (factors like comorbidities, insurance coverage, financial liabilities, affordability, and situations in which the individual has lost capacity to decide) during decisions surrounding the initiation, maintenance, or termination of ECMO. Clinicians and patients need to share the best available medical evidence when making decisions, thereby evoking a process of shared decision-making.⁵^, ⁶ A mutually respected scenario would be ideal, where the doctor is involved in the diagnosis and establishing the prognosis, leading to recommendations on treatment while the patient or their proxies can accept or refuse the recommendation (Figure 9.1). A default shared decision-making process should include three major components: information exchange, discussion and deliberation, and eventually decision-making.⁷ This chapter highlights some important aspects of shared decision-making for the management of the clinical, ethical, and patient-centered problems during ECMO initiation, maintenance, and termination.

9.1 Shared Decision-Making during ECMO Initiation

Case 1

A 59-year-old woman presents with a 4-week history of dry cough, with 3 days of increasing breathlessness. She has a past medical history of breast cancer 5 years back, for which she had a mastectomy and is currently undergoing hormonal therapy with tamoxifen. She presented to the emergency department with a fever and respiratory distress. Over 24 hours, she requires intubation. Her FiO₂ of 0.8 yields a PaO₂ of 55 mmHg. Noradrenaline has escalated to 0.5 μg/kg/min. Urine output is less than 0.3 mL/kg/h. Bronchoscopy demonstrates diffuse bloody secretions. Cultures and autoantibodies have been sent. Antibiotics have been started; clotting tests are normal.

Physicians often face highly ambiguous situations such as this case when making decisions surrounding initiating ECMO. At first, we often have insufficient information to make a firm diagnosis and benefit from the viewpoint of clinical specialists as well as the results of timely investigations. In this case, the dilemma is a deteriorating patient with the need for a rapid decision for whether or not to initiate ECMO, but with the potential of underlying illness that may not be reversible.⁸ In general, candidates for the initiation of ECMO include those with reversibility of illness and an improved quality of life after critical illness, as well as an absence of contraindications. These clinical decisions benefit from the input of primary team doctors who are familiar with the clinical course of the suspected illness, the ECMO insertion team, and teams that specialize in critical illness.⁹

Shared decision-making in such scenarios of ECMO initiation has its own set of challenges. Optimally, there should be rapid intervention to sustain life until there is sufficient information for more accurate diagnostics. However, this practice could lead physicians into more difficult situations where the patient is found to have an extremely poor prognosis but is stable on ECMO in the short term, and a decision to withdraw ECMO therapy would be very difficult, psychologically, for the family.⁵ It should be acknowledged that this patient has a history of malignancy in the past from which she is recovering and she could be in a relative immunosuppressed state, where ECMO outcomes are poor.¹⁰ However, the fact that she has not had a relapse after her primary surgery and that she has been tolerating her hormonal treatment would make her an eligible candidate for ECMO. There is great variability between physicians, hospitals, and health-care systems in terms of the decisions made in cases like these. A frank discussion with the patient’s next of kin on the prognosis in relation to the history of malignancy would be paramount, not only in decision-making during initiation, but also during further management. A conversation with her oncology team highlighting the realistic expectations may add value to the decision-making process in this case. It is important to front-load escalation of care with family discussions, ensuring that a realistic picture has been painted; although support is being escalated, if it does not benefit the patient then it should be withdrawn to minimize suffering. It is worth noting the emotional cost families experience with an extended dying period, and the difficulty this may present to health-care staff who will be heavily invested in this patient, yet unable to achieve their aims of caring and healing.

Where a patient can express, or has previously expressed, an opinion of sound mind that they do not wish for invasive interventions during their natural illness, then a decision not to initiate therapy may be seamless.⁸ The more difficult decisions surround the provision of a service in situations when a patient is no longer able to express their wishes, and the intervention may prolong life but ultimately fail, or the quality of life that is salvaged is less than would be desired. Consultation and collaboration with families to have a plan of action is critical to inform the best decision. It must be acknowledged that families consenting to ECMO initiation do so at times of high stress.⁵ Families may base their decisions for expensive, resource-intensive therapies on input from friends and relatives who support the patient, insurance plans, doctors who provide treatment, or second opinions, and so on. This situation is all the more daunting in the context of ECMO initiation with ongoing cardiopulmonary resuscitation when doctors and families have limited time and opportunity to discuss and deliberate the possible pros and cons. One has to assume that truly informed consent requires time and repetition and that in this context patient proxies should be aware that no recovery of cardiopulmonary function would necessitate stopping ECMO.⁵^, ¹¹

Similarly, issues of affordability and cost must be sensitively raised with the family as part of these discussions, depending on the health-care system. This point highlights one of the difficulties with shared decision-making around ECMO, given the expenses of equipment, available service, and staffing. The emphasis is more related to the ethical principle of fairness. It has been established that careful patient selection can result in improved quality adjusted life years (as found in the CESAR trial)¹²; however, this is likely to be lesser in more complex patients. It must be accepted that sophisticated treatment modalities like ECMO or cancer chemotherapy are expensive and often not 100% effective; in situations where judgements of affordability based on economic evaluation exercises would likely be challenging for families during the consenting process. In many (principlist) health-care systems the ethical tenet of justice will distribute the cost to the health-care system as a whole, whereas in semiprivatized systems, it may have economic impacts that affect families for a lifetime. Although it would be daunting not to offer ECMO to eligible patients based on financial grounds, it is necessary that health-care institutions offering ECMO have policies on initiation to deal with such ethically conflicting situations.

Collaborative care decision during extracorporeal cardiopulmonary resuscitation is also fraught with practical difficulties. The evidence for ECMO in such settings is variable between single-center, regional, and extracorporeal life support organization registries.¹³^, ¹⁴ Discussions with families on short-term outcomes, complications, and other uncertainties, including poor neurological outcomes, can be challenging in these emergent situations. Center-specific criteria for ECMO initiation and informed consent permit appropriate patient selection, while allowing families to cope with the shock of the present situation and make an informed decision regarding the clinical teams’ decision to initiate ECMO. The clinical team must revisit the need to continue or terminate ECMO at regular intervals and families need regular updating in such scenarios.¹¹