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Should you go on ECMO if you have no end in sight? – When is ‘enough’ Enough? Moderator Dr. Aruna T. Nathan, MBBS Assistant Professor, Anesthesiology and Critical Care Medicine, Division of Cardiothoracic Anesthesiology, The Children’s Hospital of Philadelphia, Philadelphia, PA Goals 1. Understand the ethical and medical dilemmas involved in offering extra-­‐ordinary care to children and infants with severe irreversible cardio-­‐pulmonary disease 2. Understand the dilemmas and options when, after emergent ECMO, it is understood that the primary condition is untreatable or impossible to palliate 3. Understand the criteria, process and constraints for discontinuing ECMO in such a situation 4. Understand the difficulties and challenges in defining futile therapy 5. Understand the challenges and options to resolve and manage conflict between the care providers and family Case history A 10 year old boy with a history of severe pulmonary arterial hypertension by echocardiogram presents for further evaluation and treatment in the setting of 2 syncopal episodes. Questions What is idiopathic pulmonary hypertension? What are the concerns with pulmonary hypertension? What is the natural progress of idiopathic PHTN? What is the usual cause of death? What are the anesthetic implications of PHTN? Case history and physical examination (continued) After admission to the cardiac intensive care unit, dopamine therapy was initiated at 5mcg/kg/min and inhaled nitric oxide iNO was commenced at 40 ppm in 3 LPM nasal cannula oxygen. His medications include lasix 20 mg BID, treprostinil 140 ng/kg/min infusion via a broviac line, and oxygen at 1LPM. He weighs 25 kg. Physical examination revealed a thin male sitting in bed with no signs of distress. Vital signs were: SpO2 95%, RR 24 bpm, and a BP of 100/54. Lungs are clear to auscultation. A 3/6 harsh systolic murmur is heard over the apex, and the liver is enlarged to 5cm below the costal margin. His extremities are cool to touch. His initial presentation at 9 years of age was with a history of recurrent fevers, generalized malaise and lack of appetite. An echocardiogram at that time was significant for severe RV hypertension, dilatation, and hypertrophy with severely diminished RV function. Three weeks later, after ECHO demonstration of normalized RV function on inotropic support, a limited right heart catheterization with conscious sedation revealed a pulmonary vascular resistance (PVR of 24 wood units). He was started on treprostinil therapy. Questions What is the typical management strategy for patients with PHTN? He is scheduled for an urgent cardiac catheterization and drug study, and possible transplant evaluation. Preoperative studies: An EKG shows normal sinus rhythm, RVH, RAD, diffuse ST-­‐T wave changes (unchanged from before) and a QTc of 499 ms. An echocardiogram (ECHO) shows severe right ventricular (RV) hypertension, and severe dilatation of the RV and dysfunction. The ventricular septum is flattened in relation to the LV. Labs are remarkable for a B-­‐natriuretic peptide level of 3567.5mcg/dl. Questions What is the natural progression of PHTN? How would you assess severity? How does cardiac dysfunction manifest in a child with PHTN? What risks and possible complication should be disclosed to the patient (and his parents)? Would you mention death as a possible complication? How do you present these complications? Case progression His intensivist, cardiologist and pulmonary hypertension physician were consulted to discuss the procedure and the patient and his family were subsequently counseled regarding the high risks involved. Specific considerations were employed in terms of candidacy for extra-­‐
corporeal support. Questions Anesthetic #1 So what is your anesthetic plan? Cardiac catheterization was significant for a PVR of 33 wood units, unresponsive to oxygen or iNO. He was listed status 1a for lung transplantation. An endothelin receptor antagonist (Bosentan) and phospho diesterase 3 inhibitor (Sildenafil) was initiated and treprostinil up titrated to 185ng/kg/min. Within half an hour following the anesthetic the patient progresses to respiratory failure and profound bradycardia with severe hypotension with near cardiac arrest. Resuscitation is commenced and is successful. Do you discuss the problems with the patient and his family? Do you call risk management? Do you have any other concerns (ethical)? What other thoughts might you have at this point in the patient’s treatment? Do you call a family meeting? Anesthetic #2 The patient presents with increasing instability of severe right ventricular hypertension and poor cardiac output for urgent ECMO cannulation while awaiting organs. Multiple discussions have taken place in the cardiac center between the surgeons, the intensivists, the pulmonary hypertension specialists and other cardiologists regarding his condition. This plan is thoroughly discussed with his parents detailing all risks, benefits and all complications of the surgery throughout various family meetings. They wish to proceed with the operation. His ECHO reveals severely diminished biventricular function in the setting of supra-­‐systemic RV pressures. So what is your anesthetic plan? Do we have alternative ways of taking care of this patient? Do you have any other concerns i.e ethical? Anesthetic # 3 His ECMO course has been complicated by recurrent pulmonary hemorrhage. Suitable donor lungs have not become available. Because of the unlikelihood of successful bridging to lung transplant on ECMO support given the number of complications that he has had, creation of a palliative Potts shunt to decrease the PA pressure and improve RV function is planned. So what is your anesthetic plan? Do you have any other concerns i.e ethical? During the course of this surgery, he develops hemorrhagic lungs, poor oxygenation and diffuse coagulopathy with hemodynamic compromise. Pericardiocentesis, and mediastinal reexploration are performed, and patient is urgently moved to the CICU. After a prolonged resuscitation, he dies. Ethical and Humanitarian Questions WHEN IS ENOUGH ENOUGH? When does care become extra-­‐ordinary care? When does it become “futile”? What other resources might be available or used to facilitate or withdraw further care? What do you do if there is conflict between the care givers and health care professionals? Or, even amongst the various health care providers? Are there institutional guidelines that could help resolve conflict in such situations? Are there any legal guidelines for management of extraordinary care? Discussion Pulmonary Hypertension is a vascular disease involving the pulmonary vasculature that gradually results in increasing afterload to the right ventricle and ultimately right ventricular failure. PHTN can either be idiopathic (primary PHTN) or secondary to a host of cardiac, respiratory and connective tissue disorders. Patients might present with exercise intolerance, mild dyspnoea, fatigability or more severe symptoms such as dizziness, chest pain, presyncope and syncope. Multiple clinical studies in adults and children with PHTN have associated the presence of PHTN with an increase in perioperative/ peri-­‐anesthetic morbidity and mortality. There is no safe anesthetic agent or technique in these patients. Induction of anesthesia, endo tracheal intubation and emergence are all fraught with risk of increased pulmonary vasoreactivity and PHTN crises with RV failure in the prolonged post operative recovery period. In two recent studies, presence of PAH was shown to be a significant predictor of major peri-­‐
operative cardiovascular complications including pulmonary hypertensive crises, cardiac arrest and death in pediatric patients undergoing cardiac catheterization or non cardiac surgery under anesthesia. The severity of baseline PHTN, especially supra systemic PHTN, prolonged duration of the procedure (greater than 3 hours) and significant intra-­‐operative decreases of oxygen saturation was related to adverse events. The major factors associated with adverse outcomes were the diagnosis of primary (idiopathic) PHTN and presence of major symptoms such as syncope, dizziness, chest pain and a TR jet >4 m/sec. In a study involving children undergoing cardiac surgery on cardiopulmonary bypass over a 15 year period, the presence of PHTN was associated with an increased incidence of adverse outcomes including death. In summary, severe irreversible PHTN is a progressive, lethal disease with an increased risk for adverse events in the peri-­‐operative period. Although, the prognosis has classically been bleak, there have been strides in improving quality of life and life expectancy of these patients, thus making it ever more likely that they will come to our operating rooms. Often, when confronted with clinical scenarios of “futile” care, these situations cause profound distress, confusion and therapeutic dilemmas both for care providers and care givers. The Ethical and Humanitarian Aspects of Care – When Enough is Enough! And Doing the Right Thing takes Precedence How can we define futility of care? Futility is difficult to define in Medicine. If, in the past 100 similar cases, the expected goal has not been achieved, 1.2 <1% success rate with the considered therapy the physician might claim legitimately, that the therapy should not be provided in the setting of physiologic futility. To some degree, the concepts of quantitative and qualitative futility involve value judgments, which are highly subjective and not something that physicians can easily use to make unilateral judgments. Weighing into this decision is the probable prolongation of suffering.
Can we resolve futility disputes? Medical futility disputes are best avoided. Can this objective be achieved with improved communication between physicians and parents? Frequent conversations? Truly listening to the emotional needs of the family and understanding the problem from the family’s perspective? How can such differences in opinion and values be moderated? Allowing continuous access to the sick child? Allowing them to participate in daily care? Assuring them that their emotions are valid and their decisions are worthy? Some of these objectives could be met with continuity of care, clear and concise updates, promoting realistic expectations, being compassionate and flexible, and being transparent. Could we use shared decision making? There could be institutional policies or guidelines and legal statutes that help guide the decision making process. One such is the hospital futility policy. Does your hospital have a futility policy? The best policies are bilateral. Clear documentation of efforts to achieve a resolution is necessary. If, the efforts fail, the case will be referred to the Hospital Ethics Committee; the committee then meets with the care team and patient/family alone and then by themselves. The outcomes could be-­‐ further negotiation between the health care team and family, transfer of care, judicial resolution or the committee might sanction unilateral forgoing of life sustaining treatment. Some states and countries mandate the formation of Hospital Ethics Committees. These are seconded by the accreditation standards of the Joint Commission in the U.S. These are multidisciplinary committees usually formed by diverse members of society, who have demonstrated a commitment of patient rights. These committees might have policies related to bioethical issues and advance directives, or patient specific bioethical issues. Some statutes require informed deliberation and transparency of case consultation. Most committees remain optional, allowing joint treatment decisions between the health care team and parent, however some ethics committees retain decision making authority, and can mediate. These can be consulted in challenging situations for decision making without surrogates, adjudicating futility disputes, and gate keeping. Are there state laws or directives to guide practice? Another such directive is the Texas Advance Directives Act. When there is a Family Vs Provider disagreement about futility, the family is given written notice that the process is beginning, and an Ethics or Medical Review Board is consulted. If there is concurrence that care is futile, the family is given 10 days to arrange transfer of care, or legal action. Thereafter, life-­‐sustaining measures can be discontinued without fear of legal prosecution of the physicians. In one small case series, for 4 out of 5 patients where this act was revoked in a pediatric intensive care unit, the medical team felt that the families were given time and opportunity to be heard, come to the right decision, and were appreciative of all that was done for their child. For the 5th child, the family obtained a transfer of care. The Ontario Consent and Capacity Board is another such model. The CCB is an independent quasi judicial tribunal whose decision can be reversed by an appeal. The CCB’s authority is limited to replacing surrogates that fail to act in a patient’s best interests. However, there are legal and statutory challenges when it comes to situations where the diagnosis of brain death based on neurologic criteria is in contradiction to the family or individual’s religious beliefs or moral convictions, especially when these have been communicated to the licensed physician. The New Jersey Statute clearly states that in this situation, death cannot be declared. Where then does this leave the health care team providing futile care in the face of ongoing suffering and no chance of recovery? What about improved Communication and Negotiation? There is much value in building an alliance between the family and the health care team, where it is important to emphasize the suffering of the child, and maximize comfort, provide ongoing superlative care. The entire team should work towards incorporating the parents into the care giving model with time, patience and visible continuity of care– this would improve trust when conflicts arise. One approach is to use the ‘principled negotiation approach’. Four essential conditions should be met – separate the people from the problem, focus on interests rather than positions, generate a variety of options before settling on an agreement, insist that this agreement is based on objective criteria. This is often achieved with multiple multi-­‐disciplinary family meetings involving primary physicians, social workers, spiritual advisors, psychologists, palliative care specialists and the immediate care providers and hospital ethics committees. If none of these meetings help improve the position, it might become necessary to seek external opinions, or obtain mediation. In all instances, legal consults and courts should be the last resort. If ongoing futile care is provided, do so with support to both family and professionals. Professionals involved in making these decisions would benefit from team meetings with debriefings and psychological support. Families will need to live with these decisions – it is important not to coerce them into making decisions that are against their beliefs and to provide them with adequate psychological and spiritual support through and beyond the process. References 1. Rich S, Dantzker DR, Ayres SM, et al; Primary pulmonary hypertension: a national prospective study. Ann Intern Med 1987; 107: 216-­‐23 2. Cormosino MJ, Friesen RH, Doran A, Ivy DD: Perioperative Complications in Children with Pulmonary Hypertension Undergoing Noncardiac Surgery or Cardiac Catheterization. Anesth Analg. 2007; 104 (3):521-­‐527 3. Taylor CJ, Derrick G, McEwan A, Haworth SG, Sury MRJ: Risk of Cardiac Catheterization under Anaesthesia in Children with Pulmonary Hypertension. Br J Anaesth.2007; 98(5):657-­‐61 4. Bando K, Turrentine MW, Sharp TG et al. Pulmonary hypertension after operations for congenital heart disease: analysis of risk factors and management. J Thorac Cardiovasc Surg 1996; 112: 1600-­‐1609 5. Clabby ML, Canter CE, Moller JM, Bridges ND. Hemodynamic data and survival in children with pulmonary arterial hypertension. J Am Coll Cardiol. 1997; 30:554-­‐60. 6. Bernat JL. Medical Futility: Definition, Determination, and Disputes in Critical Care. Neurocrit. Care 2005;2:198-­‐205 7. Burns JP, Truog RD: Futility: A concept in evolution. Chest 2007; 132:1987–1993 8. Okhuysen-­‐Cawley R, McPherson ML, Jefferson LS. Use of institutional policies in accordance with the Texas Advance Directives Act may assist in the care of terminally ill children and their families. Pediatr Crit Care Med 2007; 8:225-­‐230 9. Pope TM. Legal Briefing: Futile or Non-­‐Beneficial Treatment. The J Clin Ethics. 2011; 22(3): 277-­‐96. 10. Pope TM. Legal Briefing: Healthcare Ethics Committees. The J Clin Ethics. 2011; 22(1): 74-­‐93. 11. Davidson JE, Powers K, Hedayat KM, et al: Clinical practice guidelines for support of the family in the patient-­‐centered intensive care unit: American College of Critical Care Task Force 2004–2005. Crit Care Med 2007; 35:605–622 12. McNutt RA: Shared medical decision making: Problems, process, progress. JAMA 2004; 292:2516–2518 13. Tulsky JA: Beyond advance directives: Importance of communication skills at the end of life. JAMA 2005; 294:359–365 14. Feudtner C: The breadth of hopes. N Engl J Med 2009; 361:2306–2307