Ethics and the Cardiac Pacemaker: More Than Just End-of-life Issues

Katrina Hutchison; Robert Sparrow

Disclosures

Europace. 2018;20(5):739-746. 

In This Article

Abstract and Introduction

Abstract

For many years, ethical debate about pacemakers has focused on whether and under what circumstances they may be turned off in end of life care. Several other important ethical issues have been neglected, perhaps because the dilemmas they pose for cardiologists are not so immediate. These include: potential conflicts of interest, particularly those arising from the role of industry employed allied professionals (IEAPs) in pacemaker care; unanticipated impacts of commercial competition and the device improvement cycle; risks associated with remotely accessible software; equity in access to healthcare; and questions about reuse of explanted pacemakers in low and middle income countries. This paper analyses these issues in order to facilitate a more comprehensive approach to ethics and the cardiac pacemaker. Cardiologists should be aware of all of these issues and contribute to ongoing discussions about how they are resolved.

Introduction

Although the pacemaker is a safe, effective and long-established treatment for a range of cardiovascular rhythm disorders, implantation gives rise to a number of ethical issues. For many years, the ethical debate about pacemakers has focused on end of life care—whether or not a patient has the right to have their pacemaker disabled, as well as who can disable it and when. While these are important questions, the attention paid to them risks obscuring the existence of other issues. In this paper, we review the ethical issues posed by pacemakers, and advocate for clinicians to be attentive to all these issues in their practice. In addition to the ethical challenges associated with pacemaker deactivation in end of life care, we analyse five other issues that have been relatively neglected in the literature: potential conflicts of interest, especially those associated with industry employed allied professionals (IEAPs); unanticipated impacts of commercial competition and the continuing cycle of device improvement; risks associated with remotely accessible software; equity in access to healthcare; and questions about reuse of explanted pacemakers in low and middle income countries. Some of these are most urgent for regulators and manufacturers of pacemakers. However, clinicians should be aware of these issues, and can offer a unique perspective on how to address them. To facilitate better engagement with these issues by cardiologists and other members of the medical profession, we provide tables listing key questions associated with each issue. Our focus is limited to pacemakers, although aspects of the analysis might also be usefully applied to closely related cardiac devices such as implantable cardioverter defibrillators (ICDs), which pose some of the same ethical concerns. Similarities between devices, however, should not be overstated.

Deactivation and End of Life Care

Recent discussion of ethical issues relating to pacemakers has focused on end of life care and withdrawal of treatment.[1–8] Pacemakers are a difficult case in this context. Implanted devices are more likely to be perceived by both patients and health professionals as part of patients' bodies, and thus may not be straightforwardly regarded as the sort of 'treatment' that can be withdrawn.[6,9] This is further complicated when patients are pacemaker dependent. In these patients, deactivation leads quickly to increased suffering and likely death. Studies with health professionals responsible for device deactivation in end-of-life settings suggest that they are much more reluctant to deactivate a pacemaker in a pacemaker-dependent patient than a device such as an implanted cardioverter defibrillator (ICD) that only intervenes intermittently and might increase suffering by giving shocks to a dying patient.[9]

There is also controversy about who should carry out the deactivation. In some jurisdictions, IEAPs are expected to deactivate cardiac devices, and are sometimes inappropriately charged with discussing this with families. This is inconsistent with guidelines about the role of IEAPs, as well as expectations that appropriate counselling be provided by a trained person.[10–12] In a North American survey, for example, half of the respondents said that pacemakers were usually deactivated by IEAPs.[13]

Despite local variations, the principle that under certain conditions an informed and autonomous patient has the right to request the withdrawal of treatment applies to pacemakers in most jurisdictions.[1,3] The distinctions that clinicians and patients make between pacemakers and ICDs are less often regarded as salient by legal scholars.[9,14] Clinicians need to be responsive to local regulations as well as their own ethical deliberations when patients request deactivation of a pacemaker. It may also be appropriate to discuss deactivation options before the pacemaker is implanted or replaced, so that patients and their families are not confronting this issue for the first time in the end-of-life setting.[15–17] The key questions that clinicians should consider in relation to the deactivation of pacemakers in end of life care are summarized in Table 1.

The ethics of the deactivation of pacemakers in the context of end-of-life care is an important issue and discussion and debate about it will undoubtedly continue. Indeed, we believe that device deactivation in end-of-life care is only likely to become more controversial as a wider range of life-sustaining implantable medical devices is developed.[18] As such, it is appropriate that this issue receives significant attention, and that tools are developed for addressing it in clinical contexts (e.g. the decision aid recently developed by an Australian team).[17] Nevertheless, it would be a profound mistake to let a focus on this issue obscure the existence of a number of other ethical issues that are also raised by the pacemaker. It is to these issues, which have been comparatively neglected, that we now turn.

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