Ethical Dilemmas with the Use of Mechanical Circulatory Devices

2014 - 4 August - Ethics in Critical Care
Maribeth Guletz, DO; Thomas Papadimos, MD, MPH, FCCM; Christine C. Toevs, MD, FCCM
This ethics case study deals with the manifestation of moral distress as medical personnel struggle with patient and family desires that conflict with the recommended treatment course.

Exploring Ethics

Readers are invited to submit cases that have led to ethical questions or conflicts, or those that caused moral distress. The Society of Critical Care Medicine Ethics Committee will solicit analyses authored by qualified ethics consultants with expertise in critical care environments. Through this process, we hope that readers will gain a better appreciation of ethical issues facing critical care clinicians, intensive care unit patients, and families of critically ill and injured patients. We believe that readers will also develop a richer understanding of the role of healthcare ethics consultants and become more comfortable in using local resources.

 

CASE STUDY

A 65-year-old man was admitted to the intensive care unit (ICU) in cardiogenic shock. His past history included advanced stage D, class IV ischemic cardiomyopathy, chronic obstructive pulmonary disease (COPD), tobacco use, coronary artery disease, coronary artery bypass grafting, and multiple percutaneous interventions and stent placements. He required a dobutamine drip on admission and underwent a right heart catheterization that revealed a severely diminished cardiac index (1.15 L/kg/m2), an estimated ejection fraction of 15% and a mixed venous saturation of 15%.  He also had pulmonary function testing that demonstrated a restrictive lung pattern. His providers determined that he required a left ventricular assist device (LVAD).

The patient's eligibility was determined by the Centers for Medicare & Medicaid Services. Contraindications were excluded and his risks were explained. The patient's social, family, religious, and personal issues were assessed by a device coordinator, a social worker and a palliative medicine team to determine his psychosocial stability. Goals of care were correspondingly established. His dossier went to the device/transplant committee, and he was determined to be an acceptable candidate for LVAD placement.
 
He received informed consent and was instructed that his recovery process would be lengthy and that the first six to 12 weeks could be particularly difficult. He understood that his COPD could make his liberation from mechanical ventilation difficult. The patient underwent LVAD insertion. Postoperatively, he had a significant coagulopathy and required reexploration on postoperative day one and ongoing inotropic support. He also developed postoperative hypercarbic respiratory failure. Once extubated, inhalers and noninvasive mechanical ventilation were initiated for wheezing and persistent hypercarbia. (To rule out vocal cord dysfunction, the patient underwent a nasopharyngolaryngoscopy, which revealed normal vocal cord motion.)  He required reintubation but was successfully weaned and extubated a second time. He intermittently needed noninvasive bilevel ventilation (BiPAP) for six to 12 hours per day. 

The care teams explained to him it would be in his best interest to receive a tracheostomy. The patient had never explicitly said that he did not want a tracheostomy or dialysis preoperatively. It was explained to him and his wife that a tracheostomy was a temporary measure and that the medical staff was confident he would not need it in the long term. At this juncture, the patient decided that he would not accept noninvasive ventilation, reintubation or tracheostomy. This conversation was followed by several reasonably good clinical days for the patient.  However, his carbon dioxide levels began to rise again and he became predictably less responsive. The care teams asked his wife to allow them to administer BiPAP one more time to make him more alert in order to ascertain whether he still felt the same regarding tracheostomy in light of his recent acceptable clinical course. She refused. The staff was distressed by this decision because his LVAD was working well and he was hemodynamically stable. The patient expired 24 hours later.

ANALYSIS

This complicated case highlights several important ethical issues. The first issue is informed consent, which has multiple components.(1) The nature of the decision/procedure/diagnosis must be explained in terms the patient understands, including the reasonable alternatives, relative risks, benefits, and uncertainties. An assessment of patient understanding, decision-making capacity and acceptance or rejection of the proposed treatment is needed. In this case, a very extensive process occurred for the evaluation of the LVAD placement. The patient and his family interacted with a complex multidisciplinary team, including physicians, a social worker, a device coordinator, and the palliative medicine team. This process took a great deal of time, allowing the patient and his family to ask many questions and decide goals of care. At any point, the patient could have withdrawn from consideration for a LVAD. He was informed the postoperative course would be rocky for the first several months but was expected to stabilize. By all standards of informed consent, he was given adequate information, time and opportunity for participation in the process. He was also given multiple assessments of his physical, spiritual and emotional level. He and his family demonstrated understanding and requested the procedure.
 
The second issue is one of surgical “buy-in.” This term, coined by Schwarze and colleagues, explains the expectation of the medical team that the patient consents not only to the procedure but also to the often rocky postoperative course in these complex medical/surgical treatments.(2) The patient, the family and the medical team recognize that the procedure itself is not the entire treatment; the postoperative period required to stabilize the patient and deal with complications and any unanticipated events is an equally important component of the procedure on par with the surgical act of implanting the device. Surgeons especially are committed to the postoperative period as part of the consent for the procedure itself. The surgeon and the medical team expect the patient and the family to understand that consent includes treatment necessary to survive the postoperative period. In this case, the postoperative period was clearly defined as several months, after which time the patient would stabilize with his LVAD. The team expected the patient and the family to understand that consent to the procedure meant consent to the return to the operating room for bleeding, the temporary tracheostomy and the prolonged ICU course. The patient had multiple opportunities to express goals and desires for that period. Schwarze and colleagues have stated that however obvious this buy-in is to us as medical professionals, we often do not do a very good job explaining this period to the patient. (2) In this case, it is very likely the medical team feels either betrayed or distressed by the patient and family denying further treatment.
 
The third issue is one of autonomy. Autonomy tends to be seen as a positive right; the patient and family “want everything done.” In reality, autonomy is a negative right -- the right to protect our bodies from unwanted medical interventions. We get to decide at any point what therapies and interventions we do not want. In this case, the patient and family decided they did not want any more respiratory interventions -- including BiPAP and a tracheostomy -- recognizing that refusal of these interventions would lead to death. Under the principle of autonomy, they are allowed to refuse additional medical therapy, even if the medical team would not agree with their choice.

The last ethical principle highlighted in this case is one of distributive justice. Many resources were expended in the care of this patient. The number of LVADs is limited and the cost is prohibitive, requiring preauthorization by payers. The subsequent prolonged ICU stay uses many resources in terms of staffing, the medical team and limited ICU beds. There are a finite number of surgeons with training to implant the devices and a finite number of physicians with the expertise to manage these devices. In this case, extensive resources were used with the expectation that the patient would survive the procedure and the postoperative period and live the remainder of his life outside of the hospital with a LVAD. When the patient and the family no longer want to continue with the treatment after very limited resources have been expended with the expectation of a life saved, the situation becomes very difficult for the medical team. The team often feels that because these resources were used, the patient doesn’t have a choice or should not withdraw consent during the recovery period. Some might feel that if the patient and family knew they wouldn’t want “all” of the treatment, they should have declined before the surgical procedure so that the resources could be given to another patient.

This case highlights many of the difficult ethical issues that arise in a resource-constrained environment. The days of perceived unlimited medical resources no longer exist,(3) and these ethical issues are becoming more common as we provide medical care in a time of extensive technology and great cost. Although the informed consent process can help prevent situations such as the case described, the process can still fail and a patient who was expected to survive might not. In this case, although it appears the medical team did all they could to prepare the patient and the family for the process of LVAD placement, the patient’s death still feels like a failure on many levels. Ethics consults and principles cannot prevent these situations from occurring but can give the family and the medical team a way to process the events and deal with the moral distress that occurs. 

References:

1. Abaunza H, Romero K. Elements for adequate informed consent in the surgical context. World J Surg. 2014;38(7):1594-1604.
2. Schwarze ML, Redmann AJ, Alexander GC, Brasel KJ. Surgeons expect patients to buy-in to postoperative life support preoperatively: results of a national survey. Crit Care Med. 2013;41(1):1-8.
3. Scheunemann LP, White DB. The ethics and reality of rationing in medicine. Chest. 2011;140(6):1625-1632.