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Along with the growing utilization of the total artificial heart (TAH) comes a new set of ethical issues that have, surprisingly, received little attention in the literature: (1) How does one apply the criteria of irreversible cessation of circulatory function (a core concept in the Uniformed Determination of Death Act) given that a TAH rarely stops functioning on its own? (2) Can one appeal to the doctrine of double effect as an ethical rationale for turning off a TAH given that this action directly results in death? And, (3) On what ethical grounds can a physician turn off a TAH in view of the fact that either the intent of such an action or the outcome is always, and necessarily, death? The aim of this article is not to answer these questions but to highlight why these questions must be explored in some depth given the growing use of TAH technology.

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OBJECTIVES: To describe the characteristics of patients who undergo withdrawal of total artificial heart support and to explore the ethical aspects of withdrawing this life-sustaining treatment. PATIENTS AND METHODS: We retrospectively reviewed the medical records of all adult recipients of a total artificial heart at Mayo Clinic from the program's inception in 2007 through June 30, 2015. Management of other life-sustaining therapies, approach to end-of-life decision making, engagement of ethics and palliative care consultation, and causes of death were analyzed. RESULTS: Of 47 total artificial heart recipients, 14 patients or their surrogates (30%) requested withdrawal of total artificial heart support. No request was denied by treatment teams. All 14 patients were supported with at least 1 other life-sustaining therapy. Only 1 patient was able to participate in decision making. CONCLUSION: It is widely held to be ethically permissible to withdraw a life-sustaining treatment when the treatment no longer meets the patient's health care-related goals (ie, the burdens outweigh the benefits). These data suggest that some patients, surrogates, physicians, and other care providers believe that this principle extends to the withdrawal of total artificial heart support.

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One day soon it may be possible to replace a failing heart, liver, or kidney with a long-lasting mechanical replacement or perhaps even with a 3-D printed version based on the patient's own tissue. Such artificial organs could make transplant waiting lists and immunosuppression a thing of the past. Supposing that this happens, what will the ongoing care of people with these implants involve? In particular, how will the need to maintain the functioning of artificial organs over an extended period affect patients and their doctors and the responsibilities of those who manufacture such devices? Drawing on lessons from the history of the cardiac pacemaker, this article offers an initial survey of the ethical issues posed by the need to maintain and service artificial organs. We briefly outline the nature and history of cardiac pacemakers, with a particular focus on the need for technical support, maintenance, and replacement of these devices. Drawing on the existing medical literature and on our conversations and correspondence with cardiologists, regulators, and manufacturers, we describe five sources of ethical issues associated with pacemaker maintenance: the location of the devices inside the human body, such that maintenance generates surgical risks; the complexity of the devices, which increases the risk of harms to patients as well as introducing potential injustices in access to treatment; the role of software-particularly software that can be remotely accessed-in the functioning of the devices, which generates privacy and security issues; the impact of continual development and improvement of the device; and the influence of commercial interests in the context of a medical device market in which there are several competing products. Finally, we offer some initial suggestions as to how these questions should be answered.

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BACKGROUND: To date the CardioWest™ total artificial heart is the only clinically available implantable biventricular mechanical replacement for irreversible cardiac failure. OBJECTIVES: This article presents the indications, contraindications, implantation procedere and postoperative treatment. MATERIAL AND METHODS: In addition to a overview of the applications of the total artificial heart this article gives a brief presentation of the two patients treated in our department with the CardioWest™. RESULTS: The clinical course, postoperative rehabilitation, device-related complications and control mechanisms are presented. CONCLUSION: The total artificial heart is a reliable implant for treating critically ill patients with irreversible cardiogenic shock. A bridge to transplantation is feasible with excellent results.

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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.

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Many bioethical arguments rely implicitly on the assumption that the concept of "human part" is one on which everyone must agree, because it is unambiguous. But various parties interpret this "unambiguous" term in incompatible ways, leading to contention. This article is an informal presentation of a topomereological system on whose preferred interpretation several distinct but related meanings of "human part" can be isolated: part of a human body, part of the completion of a human body, and part of a human being. A case is analyzed (the first total artificial heart (TAH) implantation), demonstrating in the process much of the apparatus of the system. By means of a casuistic methodology, the analysis is translated into recommendations for the ethical conduct of future TAH research. The more general conclusion, however, is that formal methods may provide useful tools for clarifying thought processes and organizing arguments in debates over bioethical issues.

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Some commentators believe that persons facing imminent death are incapable of making autonomous, informed decisions about whether to enter high-risk, end-of-life research trials. Using the AbioCor artificial heart trial as an example, this essay argues to the contrary. Although some people are incapacitated, many are capable of making such decisions. To forbid dying people to make a decision about whether to enter a clinical trial may insult deeply held personal values at a time when honoring those values may be most important. Moreover, to deny dying persons entry into high-risk clinical trials leaves ethically worse alternatives: using healthier people, requiring surrogates to decide even when the patient is competent, or simply forgoing all research featuring high-risk, potentially life-saving interventions. Once we agree that it is at least sometimes acceptable to permit dying persons to choose high-risk research, a number of practical safeguards can be implemented to ameliorate the challenges that can hinder decision making in this difficult area.

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Total artificial heart technology as a potential clinical therapy raises the issue of elective device inactivation in both futile and non-futile situations. This article explores elective device inactivation in non-futile situations. In reply to such requests for inactivation, the medical team should reflect on the individual's decision-making capacity, the clinical appropriateness of the therapy, and the setting of the request (clinical research vs. clinical practice). A decision-making flowchart is presented as a guide for managing inactivation requests. In the research setting, current U.S. federal regulations are murky as to the matter of study withdrawal made by participants who lack decision-making capacity. This compared with clear legal and ethical approaches in the non-research setting (clinical practice).

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Though currently an experimental technology, there is the potential for implantation of 100,000 total artificial replacement hearts each year in the United States once regulatory approvals are obtained. Although these devices are intended to lengthen life and improve its quality, clinical scenarios can emerge in which the device is no longer serving these goals and termination of life support, including inactivation of the implant, must be contemplated. Although the literature is replete with guidance on the withdrawal of non-implantable therapies, such as dialysis and artificial ventilation, there has been minimal discussion involving the deactivation of implanted therapies. Here, guidance is offered regarding the withdrawal of total artificial heart therapy.

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It seems generally correct that patients (or their valid surrogates) should be able to withdraw consent for the use of the total artificial heart (TAH) just as they presently may withdraw consent for other life-prolonging technologies such as the ventilator, but lingering moral problems remain with such decisions. First, should patients be permitted to demand actual removal of the TAH rather than mere deactivation? Second, foregoing other life-prolonging technologies is normally considered "indirect" killing and is therefore judged legal (as well as moral to those who accept only indirect killing). As long as the society includes irreversible stoppage of the heart as one of the criteria for death, however, stopping a TAH will be considered direct killing, i.e., murder. To circumvent this inconsistency, society must change its conclusion that stopping other life-prolonging technologies is merely indirect killing, explicitly legalize direct killing by means of stopping a TAH, or revisit the definition of death to eliminate the cardiac standard for death from the definition of death. Assuming that the stopping of the TAH with patient or surrogate consent is acceptable, we must then face the question of whether physicians who believe the TAH is serving no purpose can unilaterally stop the device against the wishes of a patient or surrogate who believes it is still serving a worthwhile purpose. Clinicians should be presumed authoritative in determining the predicted effect of the TAH, but, if the TAH can temporarily prolong life for a patient in a way that is desired by the patient or surrogate, case law, professional society recommendation, and moral analysis all support the conclusion that the TAH must be continued even against the conscientious objection of the physician

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Moral problems arise when contemplating the inactivation of total artificial heart technology: however, an ethical obligation to explant the device as part of therapy withdrawal is not one of them. Further, arguments will be presented justifying that inactivation of the device is not morally equivalent to active killing of the patient. When device inactivation is clinically and ethically warranted, this decision should not be unilaterally made by the physician but through thorough discussion with the patient (if possible), the patient's surrogate, and the medical team. Consultation with legal counsel and the hospital ethics committee may also be appropriate

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This paper is a general survey of ethical issues related to the artificial heart. It begins by looking at the history of funding of the artificial heart program through the National Institute of Health in 1965. Attention is paid to the problem of the lack of planning related to social, ethical, economic, and legal implications. The paper then deals with three areas of ethical concerns. They are those issues relating to the experimental versus therapeutic benefits, the cost, and public involvement with a private interest.

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