[Implantable cardiac device deactivation at the end of life]. / La disattivazione dei dispositivi cardiaci impiantabili alla fine della vita.

Treatment of patients with heart failure is based on drugs, cardiac surgery and implantable cardiac devices to prevent sudden cardiac death (implantable cardioverter-defibrillator [ICD]), to reverse left ventricular dysfunction associated with left bundle branch block (cardiac resynchronization therapy) or mechanical circulatory support in more advanced phases of heart failure (left ventricular assist devices [LVAD]).During the follow-up, patients may die from progression of their underlying heart disease or from non-arrhythmic causes, such as malignancies, multi-organ failure, stroke, etc., without benefits by implanted devices. Patients implanted with ICD could die from non-arrhythmic causes, without appropriate shocks until the last few days or weeks of their life. These events occur roughly in 30% of patients, mainly in the last 24 h before death. LVAD therapy may induce significant complications, such as infections, hemorrhagic stroke, thromboembolism, right ventricular failure. In these cases, inappropriate and even appropriate shock deliveries by ICD can no longer prolong life and may simply lead to pain and reduced quality of life, as well as LVAD may prolong life with painful distress due to complications. Therefore, it appears important to discuss early with the patients and their relatives about deactivation of ICD or LVAD at the end of life. The goal of this paper is to provide an overview of the ethical, clinical and communication issues of cardiac implanted device deactivation, with a special focus on issues associated with advance care planning, which require shared decision-making, including those related to end of life decisions (advance directives). Palliative care should be early implemented, particularly in patients with LVAD.

Treating or Killing? The Divergent Moral Implications of Cardiac Device Deactivation.

In this article, I argue that there is a moral difference between deactivating an implantable cardioverter defibrillator (ICD) and turning off a cardiac pacemaker (CP). It is, at least in most cases, morally permissible to deactivate an ICD. It is not, at least in most cases, morally permissible to turn off a pacemaker in a fully or significantly pacemaker-dependent patient. After describing the relevant medical technologies-pacemakers and ICDs-I continue with contrasting perspectives on the issue of deactivation from practitioners involved with these devices: physicians, nurses, and allied professionals. Next, I offer a few possible analyses of the situation, relying on recent work in medical ethics. Considerations of intention, responsibility, and replacement support my distinguishing between ICDs and CPs. I conclude by recommending a change in policy of one of the leading cardiac societies.

Allowing Adolescents to Weigh Benefits and Burdens of High-stakes Therapies.

We present the case of a girl aged 17 years and 10 months who has a strong family history of long QT syndrome and genetic testing confirming the diagnosis of long QT syndrome in the patient also. She was initially medically treated with ß-blocker therapy; however, after suffering 1 episode of syncope during exertion, she underwent placement of an implantable cardioverter defibrillator. Since then, she has never had syncope. However, during the few months before this presentation, she experienced shocks on multiple occasions without any underlying arrhythmias. These shocks are disconcerting for her, and she is having significant anxiety about them. She requests the defibrillator to be inactivated. However, her mother, who also shares the diagnosis of long QT syndrome, disagrees and wants the defibrillator to remain active. The ethics team is consulted in this setting of disagreement between an adolescent, who is 2 months shy of the age of maturity and medical decision-making, and her mother, who is currently responsible for her medical decisions. The question for the consultation is whether it would be ethically permissible for the doctors to comply with the patient's request to turn off the defibrillator or whether the doctors should follow the mother's wishes until the patient is 18 years of age.

Moral Distress at the End of a Life: When Family and Clinicians Do Not Agree on Implantable Cardioverter-Defibrillator Deactivation.

A 63-year-old man with end-stage ischemic cardiomyopathy presented with incessant ventricular tachycardia. He had been hospitalized multiple times in the past year for severe heart failure. As he approached end of life and was regularly receiving defibrillator shocks, his care team recommended deactivation of his implantable cardioverter-defibrillator. However, his family did not wish to allow deactivation, reporting a religious obligation to prolong his life, regardless of the risk of suffering. The patient was unable to adequately participate in the decision-making process. An implantable cardioverter-defibrillator can serve to avoid sudden death but may lead to a prolonged death from heart failure. This possibility forces the examination of values regarding prolongation of life, sometimes producing disagreement among stakeholders. Although ethical consensus holds that defibrillator deactivation is legal and ethical, disagreements about life prolongation may complicate decision making. The ethical, technical, and medical complexity involved in this case speaks to the need for clear, prospective communication involving the patient, the patient's family, and members of the care team.

[Implantable cardioverter-defibrillator deactivation at the end of life: ethical, clinical and communication issues]. / La disattivazione del defibrillatore impiantabile alla fine della vita: etica, clinica, comunicazione.

The number of cardioverter-defibrillator implants is increasing worldwide, with the main indication being primary prevention of sudden cardiac death. During the follow-up, patients may die from progression of their underlying heart disease or from nonarrhythmic causes, such as malignancies, dementia and lung disease, without receiving appropriate shocks until the last few days or weeks of their life. These events occur roughly in 30% of patients, mainly in the last 24 hours before death. In this case, inappropriate and even appropriate shock deliveries can no longer prolong life and may simply lead to pain and reduced quality of life. Therefore, it appears important to discuss early with the patients and their relatives about deactivation of the implantable cardioverter-defibrillator (ICD) at the end of life.The goal of this review is to provide an overview of the ethical, clinical and communication issues of ICD deactivation, with a special focus on patients' wishes. It is outlined that patients are not adequately informed about risks and benefits of ICD and the option of ICD deactivation; the doctors are not used to discuss with the patients the topics of end-of-life decisions. Complete information must be part of current informed consent before ICD implantation and should be updated during the follow-up, with special attention to patients with heart failure in relation to their prognosis and advance directives, as suggested by international guidelines.

[ICD in elderly patients]. / ICD im Alter.

Treatment with an implantable cardioverter-defibrillator (ICD) represents a prognostic but not symptomatic therapy. It should therefore be restricted to patients where an improvement of prognosis is possible and reasonable. ICD implantation should only be performed in patients with a life expectancy of at least 1 year at reasonable quality of life. The decision in which patient improvement of prognosis is no longer a desirable target is problematic, both medically and ethically. It is not entirely clear in which elderly patient an ICD therapy can convey prognostic benefit despite comorbidity and competitive life-threatening diseases, as it is unclear how old age should be defined. In primary prophylaxis of sudden cardiac death, data on a prognostic benefit of the ICD in elderly patients are less clear than in secondary prophylaxis since short-term mortality due to other causes is higher in the elderly. However, elderly ICD patients have a similar rate of appropriate ICD therapy as younger patients. Complications at ICD implantation or long-term lead failure do not occur more frequently in elderly patients and therefore do not represent a reason to withhold ICD implantation in elderly patients or to set an age limit above which ICD implantation should no longer be performed. The ICD indication in elderly patients should be individualized depending on remaining life expectancy, comorbidity, "biological age" and patient preferences which play a particularly important role in elderly patients. Aspects of a potential improvement in quality of life by the ICD which may also serve as a system for antibradycardiac or resynchronization treatment should be included into considerations. Deactivation of at least shock therapy should be discussed in elderly patients fitted with an ICD if the subject is brought up by the patient or if clinical deterioration suggests the need to talk about a "do not resuscitate" order. This talk should be performed before death is imminent and before an electrical storm in terminal illness leads to multiple shocks by the active device.

Sports and Driving With an Implantable Cardioverter-Defibrillator.

Many patients with implantable cardioverter-defibrillators (ICD) want to participate in sports and many need or wish to operate a personal motor vehicle. Healthcare providers need to advise patients regarding restrictions related to these activities in the context of the clinical indication for the ICD. Ethical considerations need to be considered when advising ICD patients of restrictions to reduce risk of injury to themselves and to others when participating in either sports or driving. Shared decision-making is necessary to have ICD patients understand and comply with recommended restrictions. Guidelines have been developed based on available studies; however, studies assessing the need for ICD patients to restrict these activities are observational and often out of date. More recent studies challenge driving and sports restrictions that are recommended by the guidelines. Recommendations to ICD patients must be individualized yet be compliant with the guidelines, and need to adapt to changes in a patients' condition.

[Ethics in intensive care and euthanasia : With respect to inactivating defibrillators at the end of life in terminally ill patients]. / Ethik in Intensivmedizin und Sterbehilfe : Zur Frage der Inaktivierung von Defibrillatoren vor dem Lebensende bei Schwerstkranken.

BACKGROUND: In critically ill patients, intensive care medical procedures allow diseases to be cured or controlled that were considered incurable many years ago. For patients with terminal heart failure or heart disease with other severe comorbidities (cancer, stroke), the questions whether the deactivation of defibrillators is appropriate or must be regarded as active euthanasia may arise. MATERIALS AND METHODS: Notable cases from the author's hospital are analyzed. The literature on the topic euthanasia and basic literature regarding defibrillator therapy are discussed. DISCUSSION AND CONCLUSION: It is undisputed that patients as part of their self-determination have the right to renounce treatment. Active euthanasia and the thereby deliberate induction of death is prohibited by law in Germany and will be prosecuted. Passive euthanasia is the omission or reduction of possibly life-prolonging treatment measures. Passive euthanasia requires the patient's consent and is legally and ethically permissible. Indirect euthanasia takes into account acceleration of death as a side effect of a medication. Unpunishable assisted suicide ("assisted suicide") is the mere assistance of self-controlled and self-determined death. Assisted suicide is fundamentally not a criminal offense in Germany. Deactivation of a defibrillator is a treatment discontinuation, which is only permitted in accordance with the wishes of the patient. It is not a question of passive or active euthanasia. Involvement of a local ethics committee and/or legal consultation is certainly useful and sometimes also allows previously unrecognized questions to be answered.

The ethics of unilateral implantable cardioverter defibrillators and cardiac resynchronization therapy with defibrillator deactivation: patient perspectives.

AIMS: Decisions about deactivation of implantable cardioverter defibrillators (ICDs) are complicated. Unilateral do-not-resuscitate (DNR) orders (against patient/family wishes) have been ethically justified in cases of medical futility. Unilateral deactivation of ICDs may be seen as a logical extension of a unilateral DNR order. However, the ethical implications of unilateral ICD deactivation have not been explored. METHODS AND RESULTS: Sixty patients who had an ICD or cardiac resynchronization therapy with defibrillator (CRT-D) were interviewed at a quaternary medical centre outpatient electrophysiology practice. Survey questions addressed whether deactivation of defibrillator function was included in advanced directives, whether deactivation constitutes physician-assisted suicide, and whether unilateral deactivation can be ethically justified. Responses were elicited to scenarios in which defibrillation function was deactivated in different contexts (including patient request to deactivate, existing DNR, and unilateral deactivation). Only 15% of respondents had thought about device deactivation if they were to develop a serious illness from which they were not expected to recover. A majority (53%) had advance directives, but only one mentioned what to do with the device. However, a majority (78%) did not consider deactivation of an ICD shocking function against patients' wishes to be ethical or moral. CONCLUSION: Management of ICDs and CRT-Ds as patients near the end of their lives creates ethical dilemmas. Few patients consider device deactivation at end-of-life, although a large majority believes that unilateral deactivation is not ethical/moral, even in the setting of medical futility. Advance care planning for these patients should address device deactivation.

Cardiovascular implanted electronic devices in people towards the end of life, during cardiopulmonary resuscitation and after death: guidance from the Resuscitation Council (UK), British Cardiovascular Society and National Council for Palliative Care.

The Resuscitation Council (UK), the British Cardiovascular Society (including the British Heart Rhythm Society and the British Society for Heart Failure) and the National Council for Palliative Care recognise the importance of providing clear and consistent guidance on management of cardiovascular implanted electronic devices (CIEDs) towards the end of life, during cardiorespiratory arrest and after death. This document has been developed to provide guidance for the full range of healthcare professionals who may encounter people with CIEDs in the situations described and for healthcare managers and commissioners. The authors recognise that some patients and people close to patients may also wish to refer to this document. It is intended as an initial step to help to ensure that people who have CIEDs, or are considering implantation of one, receive explanation of and understand the practical implications and decisions that this entails; to promote a good standard of care and service provision for people in the UK with CIEDs in the circumstances described; to offer relevant ethical and legal guidance on this topic; to offer guidance on the delivery of services in relation to deactivation of CIEDs where appropriate; to offer guidance on whether any special measures are needed when a person with a CIED receives cardiopulmonary resuscitation; and to offer guidance on the actions needed when a person with a CIED dies.

Normativity under change: Older persons with implantable cardioverter defibrillator.

BACKGROUND: In modern society, death has become 'forbidden' fed by the medical technology to conquer death. The technological paradigm is challenged by a social-liberal political ideology in postmodern Western societies. The question raised in this study was as follows: Which arguments, attitudes, values and paradoxes between modern and postmodern tendencies concerning treatment and care of older persons with an implantable cardioverter defibrillator appear in the literature? AIMS: The aim of this study was to describe and interpret how the field of tension concerning older persons with an implantable cardioverter defibrillator - especially end-of-life issues - has been expressed in the literature throughout the last decade. METHODS: Paul Ricoeur's reflexive interpretive approach was used to extract the meaningful content of the literature involving qualitative, quantitative and normative literature. Analysis and interpretation involved naive reading, structural analysis and critical interpretation. ETHICAL CONSIDERATIONS: The investigation complied with the principles outlined in the Declaration of Helsinki. FINDINGS AND DISCUSSIONS: The unifying theme was 'Normativity under change'. The sub-themes were 'Death has become legitimate', 'The technological imperative is challenged' and 'Patients and healthcare professionals need to talk about end-of-life issues'. There seems to be a considerable distance between the normative approach of how practice ought to be and findings in empirical studies. CONCLUSION: Modern as well as postmodern attitudes and perceptions illustrate contradictory tendencies regarding deactivation of the implantable cardioverter defibrillator and replacement of the implantable cardioverter defibrillator in older persons nearing the end of life. The tendencies challenge each other in a struggle to gain position. On the other hand, they can also complement each other because professionalism and health professional expertise cannot stand alone when the patient's life is at stake but must be unfolded in an alliance with the patient who needs to be understood and accepted in his vulnerability.

Ethical considerations for turning off pacemakers and defibrillators.

The 2010 guidelines regarding management of cardiovascular implantable electronic devices (CIEDs) conclude that patient requests to deactivate these devices at the end of life should be honored. Nevertheless, many clinicians and patients report feeling uncomfortable discontinuing such therapies, particularly pacemakers. If the principles of clinical ethics are followed, turning off CIEDs at the end of life is morally permissible. Clinicians managing CIEDs should discuss the option of deactivation with the patient at the time of implantation and be prepared to reopen the question as warranted by the patient's clinical course and respect for the patient's authentic values.

Primary prevention implantable cardioverter-defibrillator implantation in elderly patients: is it justified to withhold treatment?

Implementation of primary prevention implantable cardioverter-defibrillator (ICD) treatment in the current clinical guidelines led to a significant increase in patients that may benefit from implantation of an ICD. Currently non-guideline-guided patient selection takes place by physicians whereby patients at higher age are more frequently excluded for ICD implantation. This editorial focuses on ICD treatment in the elderly and aims to clarify whether it is justified to withhold ICD treatment in these patients.

Ethical challenges of deactivation of cardiac devices in advanced heart failure.

More than 23 million adults worldwide have heart failure (HF). Although survival after heart failure diagnosis has improved over time, mortality from heart failure remains high. At the end of life, the chronic HF patient often becomes increasingly symptomatic, and may have other life-limiting comorbidities as well. Multiple trials have shown a clear mortality benefit with the use of implantable cardioverter defibrillators (ICDs) in patients with cardiomyopathy and ventricular arrhythmia. However, patients who have an ICD may be denied the chance of a sudden cardiac death, and instead are committed to a slower terminal decline, with frequent DC shocks that can be painful and decrease the quality of life, greatly contributing to their distress and that of their families during this period. While patients with ICDs are routinely counseled with regard to the benefits of ICDs, they have a poor understanding of the options for device deactivation and related ethical and legal implications. Deactivating an ICD or not performing a generator change is both legal and ethical, and is supported by guidelines from both sides of the Atlantic. Patient autonomy is paramount, and no patient is committed to any therapy that they no longer wish to receive. Left ventricular assist devices (LVADs) were initially used as bridge in patients awaiting heart transplantation, but they are currently implanted as destination therapy (DT) in patients with end-stage heart failure who have failed to respond to optimal medical therapy and who are ineligible for cardiac transplantation. The decision-making process for initiation and deactivation of LVAD is becoming more and more ethically and clinically challenging, particularly for elderly patients.

ICD recipients' understanding of ethical issues, ICD function, and practical consequences of withdrawing the ICD in the end-of-life.

BACKGROUND: The current international expert consensus statements recommend that clinicians should discuss elective implantable cardioverter defibrillator (ICD) deactivation before implantation of the device, and then consistently during the illness trajectory. However, no previous studies have investigated predictors of ICD patients' knowledge about end-of-life issues or whether knowledge influences patients' attitudes about deactivation. METHODS: This nationwide survey study (n = 3,067) had a cross-sectional correlational design of self-reported data. Participants were recruited from the Swedish ICD and Pacemaker Registry and asked to complete a questionnaire about knowledge in relation to the ICD and end-of-life. RESULTS: Only 79 respondents (3%) scored correctly on all 11 questions. The mean sample score was 6.6 ± 2.7 out of a maximum score of 11. A total of 835 participants (29%) had an insufficient knowledge when using the 25th percentile as a cutoff. Younger ICD recipients, those cohabiting, male participants, and those who had received shocks, had a generator replacement, or who had discussed illness trajectory with their physician were more likely to have sufficient knowledge on the end-of-life issues. Insufficient knowledge was associated with indecisiveness to make decisions about ICD deactivation in the end-of-life situations, and with favorable attitudes about replacing the ICD even if seriously ill or have reached an advanced age, and keeping the shock therapy of the ICD even in a terminal phase of life when dying from cancer or other serious chronic illnesses. CONCLUSION: Insufficient knowledge is common among ICD recipients and is associated with attitudes and decisions that may result in a stressful and potentially painful end-of-life situation.

[Remarks on the guideline recommendations for cardioverter-defibrillator implantation for primary prevention of sudden cardiac Death in patients with severe ventricular dysfunction. Consensus Document of the Italian Association of Hospital Cardiologists (ANMCO)/Italian Society of Cardiology (SIC)/Italian Association of Arrhythmology and Cardiac Pacing (AIAC)]. / Considerazioni sulle raccomandazioni delle linee guida all'impianto del cardioverter-defibrillatore per la prevenzione primaria della morte cardiaca improvvisa nei pazienti con grave disfunzione ventricolare. Documento di Consenso dell'Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO)/Società Italiana di Cardiologia (SIC)/Associazione Italiana di Aritmologia e Cardiostimolazione (AIAC).

The indications for implantable cardioverter-defibrillator (ICD) therapy for the prevention of sudden cardiac death in patients with severe left ventricular dysfunction have rapidly expanded over the last 10 years on the basis of the very satisfying results of the numerous randomized clinical trials that have provided the framework for guidelines. However, the analysis of clinical practice in the real world has highlighted some important criticisms in the complex process of selection-management of those patients candidates for ICD therapy: 1) approximately one fourth of all ICD implantations is not justified by clinical evidence, 2) approximately one half of patients with an indication for ICD therapy do not undergo implantation, 3) the benefits from ICD therapy do not apply uniformly to all patients, 4) the relationship between the lifesaving benefit and the potential for harm of ICD therapy is still scarcely known. The main reason for this clinical scenario can be ascribed to the guideline recommendations that are based only on few standard cut-off criteria and therefore too generic and insufficiently detailed. This does not help cardiologists in their decision-making process, and results in fear, uncertainty, and sometimes emotional choices. The aim of this consensus document is to discuss current guideline recommendations and to provide the Italian cardiologists with the most updated information to optimize the selection of patients with severe left ventricular dysfunction who should receive ICD therapy.