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Medical Ethics |

Challenges in Deactivating a Total Artificial Heart for a Patient With CapacityDeactivating a Total Artificial Heart FREE TO VIEW

Courtenay R. Bruce, JD; Nathan G. Allen, MD; Bridget N. Fahy, MD; Harvey L. Gordon, MD; Erik E. Suarez, MD; Brian A. Bruckner, MD
Author and Funding Information

From the Center for Medical Ethics & Health Policy (Prof Bruce and Drs Allen, Fahy, and Gordon), and Section of Emergency Medicine (Dr Allen), Department of Medicine, Baylor College of Medicine; The Methodist Hospital System (Prof Bruce and Drs Allen, Fahy, and Gordon), The Methodist Hospital System Ethics Program; Department of Surgery (Dr Fahy), Weill Cornell Medical College, Methodist Hospital; Division of Palliative Medicine (Dr Fahy), The Methodist Hospital; Methodist DeBakey Heart and Vascular Center and JC Walter Jr Transplant Center (Drs Suarez and Bruckner); and Texas Heart Institute (Dr Bruckner), St. Luke’s Episcopal Hospital, Houston, TX.

Correspondence to: Courtenay R. Bruce, JD, Center for Medical Ethics & Health Policy, Baylor College of Medicine, One Baylor Plaza, MS: BCM 420, Houston, TX 77030; e-mail: crbruce@bcm.edu


An abstract of this study was presented at the International Society of Heart and Lung Transplantation Annual Meeting and Scientific Sessions, Montreal, Quebec, Canada, April 2013 and published in abstract form (Suarez E, Bruce C, Gordon HL, Loebe M, Bunge RR, Bruckner BA. J Heart Lung Transpl. 2013;32(4):S286).

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2014;145(3):625-631. doi:10.1378/chest.13-1103
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The use of mechanical circulatory support (MCS) devices has increased sixfold since 2006. Although there is an established legal and ethical consensus that patients have the right to withdraw and withhold life-sustaining interventions when burdens exceed benefits, this consensus arose prior to the widespread use of MCS technology and is not uniformly accepted in these cases. There are unique ethical and clinical considerations regarding MCS deactivation. Our center recently encountered the challenge of an awake and functionally improving patient with a total artificial heart (TAH) who requested its deactivation. We present a narrative description of this case with discussion of the following questions: (1) Is it ethically permissible to deactivate this particular device, the TAH? (2) Are there any particular factors in this case that are ethical contraindications to proceeding with deactivation? (3) What are the specific processes necessary to ensure a compassionate and respectful deactivation? (4) What proactive practices could have been implemented to lessen the intensity of this case’s challenges? We close with a list of recommendations for managing similar cases.

The use of mechanical circulatory support (MCS) devices has increased sixfold since 2006.15 Ethical challenges and value conflicts are becoming more common with the growing number of patients receiving device placement.3 Although improving functionality and increasing long-term survival might be expected to resolve these challenges, in many cases, the effect has been to add to the complexity.

There is an established legal and ethical consensus that patients have the right to withdraw or withhold life-sustaining interventions when burdens exceed benefits.68 However, this consensus arose prior to the widespread usage of MCS technology, and it is not uniformly accepted in MCS cases.9,10 There are aspects to deactivating or withdrawing life-sustaining treatment in MCS cases that deserve unique ethical and clinical consideration. As an illustrative example, our center recently encountered the ethical challenge of an awake and functionally improving patient with a total artificial heart (TAH) who requested its deactivation: the case of Mr N.

In responding to this request, our team was confronted with addressing and weighing the following four clinical and ethical concerns: (1) Is it ethically permissible to deactivate this particular device, the TAH? (2) Are there any particular factors in this case that are ethical contraindications to proceeding with deactivation of the device? (3) What are the specific processes necessary to ensure a compassionate and respectful deactivation? (4) What proactive practices could have been implemented to lessen the intensity of the challenges in this case?

In what follows, we provide a narrative description of what occurred in the process of addressing the four challenges of Mr N’s case from the perspective of 16 health-care professionals involved in his care.11 The quotations used are from a larger, internally funded, institutional review board-approved qualitative study. The interviews were audio recorded, transcribed, double coded, and analyzed using content thematic analysis. Quotations are interspersed with our analysis of the ethical challenges of this case and descriptions of the decisions that were made. We close with a list of recommendations for managing similar cases.

Twelve years prior, Mr N acquired viral myocarditis resulting in heart failure. He underwent a prolonged hospitalization for over a year before he was implanted with a HeartMate II left ventricular assist device (VAD) (Thoratec Corp) prior to bridging to successful heart transplantation. Almost a decade later, he began to develop posttransplant vasculopathy and was relisted for a second heart transplant. Subsequently, he began to suffer from worsening renal and cardiac dysfunction, and he underwent SynCardia (SynCardia Systems Inc) TAH placement as a bridge to transplant.

His postoperative course was complicated by renal failure requiring dialysis and hemorrhagic pancreatitis requiring no oral intake and total parenteral nutrition dependency. Liver dysfunction led to jaundice and GI bleeding, requiring multiple blood transfusions. He also received a tracheostomy for postoperative respiratory failure. Due to comorbidities and high antibody titers, he was removed from the transplant list pending further recovery. Five months postimplantation, Mr N requested discontinuation of his TAH and was aware that doing so would result in his immediate death.

VAD coordinator:Do we just turn the switch? And the flip of a switch is equivalent to death? [The TAH is different than VADs] where they still have the heart, so it may function for multiple days or weeks or months [after stopping it].

Palliative care specialist: “The [cardiologists and cardiothoracic surgeons] were very hung up on this ‘we’re killing him, we’re killing him’ thing. They will [withdraw] ventilators all day long, but the heart was different for them.”

Cardiologist:I see the ventilator as different. There’s a hope of weaning it, and you can make an effort to do that. Mechanical circulatory support is not a tube that you can [wean or] take out. It’s in your body. So you turn it off.”

When assessing deactivation of MCS devices in general, with a few notable exceptions,9,10 most authors argue that it is permissible to deactivate a MCS device in many circumstances.1223 The grounds for permissibility are based primarily on the ethical precept allowing informed refusal of life-sustaining therapies and the fact that, upon deactivation, the patient will die of underlying heart disease.1216 This is considered similar to a patient who dies of underlying lung dysfunction upon extubation.

The TAH can be seen as unusually complex for reasons highlighted by the cardiologist and VAD coordinator, and the ethics of deactivating it could be viewed differently. First, the heart is removed with the TAH. The TAH is not sustaining the heart (as would be the case for a VAD); rather, it is functioning as the heart. One could argue that the patient with a TAH cannot have a natural death from failure of endogenous organs because that option was eliminated when the failing heart was removed. Second, death is more immediate following a TAH deactivation. Health-care providers may view themselves as the proximate cause of the patient’s death more so than with other types of life-sustaining treatment. This illustrates a possible dissonance between what is academically considered ethically permissible in MCS deactivation and the psychologic burdens to health-care professionals in TAH deactivation cases.

Looking specifically within the scarce ethics literature specific to TAHs,13,1824 most authors argue that deactivating a TAH is acceptable, although they differ in their analyses.19,23 The argument usually proceeds as follows: The immediacy of the death, while psychologically relevant, is not specifically morally problematic.12,13,18,20 While the heart is almost entirely removed with the TAH, its absence is not per se an ethical contraindication. The absence of the heart means the disease process of the heart has become all consuming.19 When the device is deactivated, the patient dies naturally from an all-consuming cardiac dysfunction. Other ethicists add that the TAH is not a true replacement for the heart because it is not physiologically integrated into the body and cannot function independent of a battery source or expert for control.12,13 It is, therefore, artificial in the same way that other life-sustaining interventions are artificial. We feel that the balance of the literature and our own assessment favor the opinion that deactivation of a TAH is ethically permissible.

Surgical Buy-in

Cardiologist: [In a similar case], the family was literally fighting us, [saying] that we were preventing [the patient] from dying…So I kind of raised my voice and told them there is an obligation [the patient] owes us.”

Had there been no operation, Mr N would have died independent of the surgeons’ and MCS teams’ efforts. But, because there was an operation, Mr N was requesting to be free from the device that was placed and faced a different kind of death than if the device were not placed. Several authors have argued that surgeons feel personally responsible for poor operative outcomes because of the significant personal investment in time and technical skill they put into their surgical cases.2528 This sense of personal responsibility could conceivably be greatest in situations where the patient requests to be free from a device the surgeon placed. Surgeon: “To sit down a very aggressive, optimistic surgeon, to say that you want to turn off the machine that they put in, it’s hard for us to accept, simply put.”

Previous researchers have described a phenomenon referred to as surgical buy-in.26,27 Here, surgeons are reluctant to withdraw postoperative life-sustaining interventions by citing an implicit contract formed between the surgeon and patient preoperatively. The research that has been done on surgical buy-in is limited, and the details of this implicit contract are not fully understood. In work done by a surgeon-ethicist Schwarze and colleagues,26,27 none of the surgeon-interviewees noted formal documentation of the implicit contract, and it was unclear what the surgeon and patient owed each other. However, it was clear that, in the minds of their surgeon-interviewees, surgeons had a defined number of days they believed were necessary for patients to continue postoperative interventions. This defined period varied between interviewees and was largely dependent on the clinical situation and the likelihood of achieving surgical cure.26

From our interviews, we theorize that the concept of an implicit contract between a patient and surgeon may not be surgeon-specific but, rather, refer to a belief shared by all MCS team members that certain obligations are created and owed by the patient on MCS and team. The contours of these team buy-in obligations remain speculative. It is unclear when the obligations are formed, how they are formed, or what is necessary to discharge these obligations. Our interviewees believed that the team is obligated to “continue the fight” until an unspecified goal could be achieved. Psychiatry:We have an extra, extra duty for [patients on MCS]. When we put VADs in people, we somehow are making them a promise that their life is going to be better…or maybe they’ll get that big reward, the transplant. We all try really hard to keep that promise.” The patient, in turn, was obligated to likewise “continue the fight” and commit to endure potentially burdensome postoperative care.

When addressing this desire to “continue the fight,” we found it difficult to ethically justify an implied contract. The word “contract” suggests equal bargaining power.29 Mr N was not on equal footing with our team because he was dependent on our team for the device, a transplant, and deactivation of the device. To Mr N, the burden was the TAH itself rather than other forms of standard or expected postoperative care. The surgical buy-in or team buy-in contract should be distinguished from an ethically justified time-limited trial (described later in this article), which shifts focus away from the abstract concept of “needing more time” to identifying and addressing specific patient-centered goals and concerns.30 A time-limited trial construct may be the optimal way to address an MCS team’s concerns while simultaneously respecting patient wishes.

Uncertainty

Surgeon:Well, we felt like he was making some progress…If we felt like there was no way he was ever going to get a [transplant], [we] would understand, but there was that possibility…that he could get a [transplant] someday.”

Implicit in the argument raised in the previous section is the question: When is it not too premature to request MCS deactivation? Is it when the patient is no longer a transplant candidate? Is it when the patient irreversibly loses the ability to interact with the environment secondary to brain injury? In Mr N’s case, the MCS team and the patient disagreed whether the benefits would, at some point, outweigh the burdens in such a way that Mr N would find the outcome, however defined, acceptable. Defining this point and this outcome were distinct challenges in this case.

The experiences and outcomes of patients on MCS devices may be contingent on their candidacy for transplantation. Candidacy for transplantation may evolve over time with the development or amelioration of contraindications to transplantation, often resulting in a rollercoaster of patient experiences and emotions. The variable outcomes and clinical uncertainty of transplant candidacy at any point in time may greatly impact the patient’s willingness to continue aggressive therapies and the clinicians’ perceptions of whether it is ethically appropriate to withdraw them.31 In the case of Mr N, team members disagreed about transplant candidacy, outcomes, and perceptions of quality of life:

Social worker:He was not a transplant candidate. It was a matter of dying now or dying later…There comes a point with any kind of terminal illness where some patients hit the wall and go, ‘That’s enough. I’ve suffered enough.’”

Mr N:I have been in the [ICU] on and off through out my life. I don’t want to die, but I don’t want to live like this, on this, and there’s no end in sight” [paraphrased; not audio recorded]. Ethicist: “Would you feel differently if we had a heart and kidney available for you today?” Mr. N: “No.”

There is always the possibility that Mr N would regret his decision to have the device deactivated if transplant became a viable option. But the alternative, to insist on indefinite, unwanted use of an intervention, would contravene his autonomy and become, as one surgeon described, “a practical disaster.”

The ethical permissibility of requiring a waiting period before allowing MCS deactivation hinges on its intended purpose and the duration of time required to accomplish that purpose balanced against the patient’s preferences. The ethical justifications and goals of a time-limited trial are fivefold: (1) to preserve patient autonomy while preventing impetuous deactivation decisions; (2) to facilitate fully informed patient decision making by allowing adaption to a “new normal”; (3) to palliate symptoms, distress, or other unmet needs that may be impacting informed decision making; (4) to set goals, evaluate trends, and monitor progress; and (5) to enhance the clinician-patient therapeutic alliance by committing to follow through with the patient’s informed decision.30,32,33

To this end, a well-defined, time-limited trial of continued interventions may be appropriate when the patient has unmet needs, inconsistency in stated preferences, fluctuating clinical status, or fluctuating capacity. Potentially reversible aspects of the patient’s suffering, including physical, emotional, and spiritual disturbances, should be the point of multidisciplinary team focus.29,32 The time frame for the trial should be driven by evidence-based assessments of the usual clinical time frame needed to achieve the patient’s goal.33 For instance, evidence suggests it may take 1 to 3 months to adapt to dialysis and regain functional status.33

The ethical supportability of a time-limited trial, then, depends on whether the patient’s values and goals can be fully elucidated, whether there is clinical knowledge about an intervention’s efficacy, and whether its efficacy for the patient can be determined within a specified time frame.33 The purpose of the time-limited trial, the goal to be achieved, and the specific length of time should be communicated to and agreed upon by the patient.33

Where and Who Questions

Cardiologist:We were not going to [perform the TAH deactivation]. And there were also discussions [that some team members] wanted to just send him home to do what he wanted to do at home. I think we are not obligated to end somebody’s life.”

Sending a patient home to withdraw his own interventions is not ideal. Even where it is physically possible, it demonstrates a lack of compassion and respect for the patient, family, and their needs. The MCS team is professionally and ethically obligated to try to maximize the patient’s comfort and not abandon the patient. These obligations cannot satisfactorily be met by sending the patient home without adequate assistance.3436 Services including ethics, psychiatry, palliative medicine, and chaplaincy can collaborate to meet the patient’s, family’s, and team’s needs for compassionate support during the deactivation process.

For some team members, the moral distress of being involved in the deactivation process may be too high for them to participate. If possible, individuals who conscientiously object to deactivation of the device should not be asked to be involved. A conscience-based refusal is one where the health-care professional has a core set of ethical or religious beliefs that are violated when complying or participating in a deactivation request.3740 The ethical justification for respecting conscience-based refusals is to protect and promote health-care professionals’ mortal integrity.3739 Countervailing ethical considerations including respecting patient dignity and autonomy, refraining from discrimination, and promoting patient well-being can limit conscience-based refusals.3740 Patient preferences should take precedence over health-care professionals’ conscientious objections when an appropriate voluntary team cannot be found.40 For Mr N, a voluntary team consisting of a perfusionist, respiratory therapist, and a palliative medicine physician performed the deactivation. Only one health-care professional, a bedside nurse, refused to participate.

The How Question

Palliative care specialist: “[The cardiologists and surgeons] were very insistent that everything be deactivated simultaneously…They had a lot of angst about the thought that it was deactivation of ‘their device.’ They kind of wanted everything removed so we would just say that everything was shutting down.”

All parties who will be present prior to and during the deactivation should participate in a predeactivation planning meeting, including nursing, perfusion, palliative care, the ICU members, respiratory care, and other clinical team members. A planning meeting of this nature may help mitigate some of the distress felt by team members. Involvement of palliative care physicians or those with expertise in pain and symptom management to determine the order in which the interventions are withdrawn is advised and should be based on the patient’s comfort.41

Once the technical and clinical aspects have been clarified, the next step is informing the patient and family of what to expect, with an emphasis on measures taken to manage potential discomfort. Patients and families should be encouraged to direct the timing of the process as much as possible to reinforce that deactivation is a demonstration of respect for the patient rather than a technical exercise driven by the care team. It should be a time when enough clinicians and ancillary staff are available to meet the needs of the patient and family. The irrevocable nature of the decision and process require that the decision be made in the absence of any coercion or external pressure.

Family participation in patient care may provide them a sense of intimacy and should be encouraged (if desired by the family).41 From our experience, most family members want to participate by touching the patient, presenting or posting photographs, speaking to the patient, and playing music. An offer of chaplaincy support should be made. The patient should be asked about any specific death rituals required by their faith tradition and efforts should be made to accommodate these requests. Private family time with the patient should be afforded, where possible, but clinicians should remain in visual or hearing distance in case the family needs assistance.41

Case Resolution and Proactive Ethics Recommendations

In every conversation, Mr N had decision-making capacity, was consistent in his preferences, and was not clinically depressed. His family supported his decision. A decision to withdraw his TAH support was reached after 2 weeks of multidisciplinary meetings, discussion, and evaluation. The palliative care specialist had a number of premedication orders that the nurse started so that Mr N would be very well sedated. The ventilator and the TAH were withdrawn simultaneously. Because death follows TAH deactivation, the device did not need to be explanted to complete the withdrawal process, and this was not requested by the patient or family.

Our experiences and recommendations may not be applicable to all centers. However, given the paucity of literature on complex cases of this nature, we offer the following recommendations when considering deactivation of a TAH or an MCS in general. We hope this promotes further discussion about best practices for managing challenging MCS deactivation cases.

  • 1. Revisit complex cases involving prolonged and/or repeated hospitalizations for patients on MCS in the multidisciplinary transplant/device selection committee meetings to reassess the patient’s candidacy for transplantation and to develop team/patient goals. This can help to identify ethically challenging cases in advance.

  • 2. When a patient expresses desire to deactivate a MCS device, it is appropriate to consult psychiatry, ethics, palliative care, social work, and chaplaincy (if they are not involved already). Psychiatry can address decision-making capacity and depression concerns. Palliative care, chaplaincy, and social work can examine and address unmet psychosocial, spiritual, or physical needs of the patient or family. Ethics can gather facts and determine whether there are any ethical contraindications to proceeding, as well as facilitate debriefing sessions, conduct ethics education on the ethical permissibility of deactivating MCS devices, and facilitate dispute resolution.42,43 In the case of Mr N, the ethicist involved convened ethics committee members to review the case because of the number of ethical and practical challenges and the varying strong emotions and opinions of the MCS team.

  • 3. It is ethically preferable to elicit preferences from an awake and capacitated patient, as it is the best way to learn a patient’s wishes. However, this wakefulness may be a source of psychologic distress for the health-care professionals involved. Withdrawing MCS support from an awake patient may feel uncomfortable for providers. Proactive ethics education and debriefing during and following a case may diminish this.

  • 4. A well-defined, time-limited trial of continued interventions can be appropriate when the patient has unmet needs, inconsistency in stated preferences, fluctuating clinical status regarding transplant candidacy, or fluctuating capacity, but a time-limited trial is not appropriate to “buy time” or “get the patient to change his or her mind.”44

  • 5. There should be a predeactivation planning meeting with the team and patient and family. All team members who took part in the patient’s care should be encouraged to talk with the patient and say their goodbyes. This can be an important opportunity for closure. This would also be the ideal time to determine who is willing and able to participate in the deactivation process.

  • 6. Interviewees described finding routine, regularly scheduled, unit-based debriefing sessions therapeutic. Not only do debriefing sessions provide an opportunity for “venting,” they also provide an opportunity to perform root-cause analyses for problems that occurred in the case and to develop action plans to minimize the chances of future problems. Ethicists should be well positioned to lead debriefing sessions on complex MCS cases and to assess the degree of health-care professionals’ moral distress.42,43

As new devices are introduced and new ethical issues are raised, it is important to include all health-care professionals involved in the care of these patients in team and family meetings and, ideally, in the informed consent dialogue with patients. This is because, with the introduction of any new medical technology, the diffusion of the technology and its proliferation often outpaces health-care providers’ comfort levels. There is an adjustment period between the introduction of the technology and health-care professionals’ familiarity with it.45

An observation from these interviews is that bedside nurses tended to be more negative than other clinicians about the technology itself, often referring to the life on a TAH or extracorporeal membrane oxygenation as “experimentation,” “warm autopsies,” and “dead bodies on machines.” By allowing the providers who do hands-on care for the patients to be included in the discussions concerning device placement, some of this distress might be mitigated.

It is important to validate the emotional toll that such cases can take on MCS team members and the resulting inclination to detach for self protection. Every one of our interviewees mentioned that emotionally and ethically challenging cases result in detachment from the patient. Increasing awareness of this moral distress may help to mitigate the impulse to detach at the time the patient needs the health-care professionals the most.

Financial/nonfinancial disclosures: The authors have reported to CHEST the following conflicts of interest: Dr Bruckner is a consultant with Baxter Healthcare and Medafor, Inc. Prof Bruce and Drs Allen, Fahy, Gordon, and Suarez have reported that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

Other contributions: The authors would like to thank the interviewee-clinicians who graciously provided their time and candor for this project. The authors and Mr N’s family would also like to thank these clinicians and all other health-care professionals involved in Mr N’s care for the time, skill, commitment, and support they invested in Mr N’s case.

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Prendergast TJ, Puntillo KA. Withdrawal of life support: intensive caring at the end of life. JAMA. 2002;288(21):2732-2740. [CrossRef] [PubMed]
 
American Society for Bioethics and Humanities (ASBH). Core Competencies for Healthcare Ethics Consultation.2nd ed. Glenview, IL: American Society for Bioethics and Humanities; 2011.
 
Epstein EG, Hamric AB. Moral distress, moral residue, and the crescendo effect. J Clin Ethics. 2009;20(4):330-342. [PubMed]
 
Bruce CR, Brody B, Majumder MA. Ethical dilemmas surrounding the use of ventricular assist devices in supporting patients with end-stage organ dysfunction. Methodist Debakey Cardiovasc J. 2013;9(1):11-14. [PubMed]
 
Eaton ML, Kennedy DL. Questions, Issues, and Recommendations Going Forward. Innovation in Medical Technology: Ethical Issues and Challenges. Baltimore, MD: Johns Hopkins University Press; 2007:94-114.
 

Figures

Tables

References

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Magelssen M. When should conscientious objection be accepted? J Med Ethics. 2012;38(1):18-21. [CrossRef] [PubMed]
 
Prendergast TJ, Puntillo KA. Withdrawal of life support: intensive caring at the end of life. JAMA. 2002;288(21):2732-2740. [CrossRef] [PubMed]
 
American Society for Bioethics and Humanities (ASBH). Core Competencies for Healthcare Ethics Consultation.2nd ed. Glenview, IL: American Society for Bioethics and Humanities; 2011.
 
Epstein EG, Hamric AB. Moral distress, moral residue, and the crescendo effect. J Clin Ethics. 2009;20(4):330-342. [PubMed]
 
Bruce CR, Brody B, Majumder MA. Ethical dilemmas surrounding the use of ventricular assist devices in supporting patients with end-stage organ dysfunction. Methodist Debakey Cardiovasc J. 2013;9(1):11-14. [PubMed]
 
Eaton ML, Kennedy DL. Questions, Issues, and Recommendations Going Forward. Innovation in Medical Technology: Ethical Issues and Challenges. Baltimore, MD: Johns Hopkins University Press; 2007:94-114.
 
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