Background: Implantable cardioverter-defibrillators (ICDs) cannot prevent death from progressive heart failure or non-cardiac disease. Patients with ICDs may receive defibrillation therapy from their devices in the last days of their lives, when such therapy does not accord with the goal of palliative treatment, but rather lowers these patients’ quality of life and compromises their dignity.
Methods: We present a case report and a selective review of pertinent literature retrieved by a PubMed search, including two up-to-date consensus documents.
Results: One-third to two-thirds of all ICD patients receive defibrillation therapy in the final days of their lives. Patients and their physicians rarely discuss deactivating the ICD. The ethical aspects of such decisions need to be considered. As a practical matter, it is possible to deactivate certain types of electrotherapy selectively, while leaving others active. There are logistical considerations as well.
Conclusion: Automatic defibrillation therapy in a terminally ill patient with an ICD is painful and distressing, serves no medical purpose, and should be avoided. This issue should be discussed with ICD patients and their families. Institutions caring for terminally ill patients, as well as cardiology units where ICD patients are treated, should develop ethically and legally well-founded protocols for dealing with the question of ICD deactivation.
Prophylactic treatment using an implantable cardioverter-defibrillator (ICD) is indicated for patients with an increased risk of sudden cardiac death but an otherwise good prognosis (1, 2, e1). Germany leads Europe in this area, with more than 300 ICDs fitted per million inhabitants per year (3). Approximately one-third of patients newly fitted with ICDs in Western countries are 70 or more years old (4). While an implantable cardioverter-defibrillator (ICD) does effectively reduce the risk of sudden cardiac death, it cannot prevent death from heart failure or noncardiac diseases.
When a patient with an implantable defibrillator approaches the end of his/her life, whether as a result of treatment-refractory heart failure or due to a noncardiac disease, discussion of the end of ICD treatment may be indicated. Shock therapy at the end of life has no medical benefit and may cause significant stress for the patient, his/her relatives, and nursing staff. Side effects associated with shocks, sometimes occurring simultaneously (including transient loss of consciousness, uncontrolled defecation, enuresis, nausea, and vomiting) can have an adverse effect on the patient’s dignity (5, e2).
This article begins with a case study and describes these issues on the basis of the results of a search of the literature. In 2010 two consensus documents, one European (6) and one from the USA (7), were published on the subject of pacemaker and defibrillator deactivation. The medical and ethical problems discussed are not confined to ICD treatment; rather, medical and technical developments have also resulted in similar conflicts in other areas of medicine, such as treatment with implantable left ventricular assist devices (e3).
This article follows international guidelines (6, 7) and is based on a selective search of the literature using the database PubMed (www.ncbi.nlm.nih.gov), which found 75 articles using the keywords “ICD deactivation” and “defibrillator deactivation.” A case study should serve as an introduction for readers who are not cardiac specialists. Legal aspects are also included in this review article.
In June 2009 a 67-year-old man was fitted with a defibrillator when a biventricular pacemaker was implanted (cardiac resynchronization therapy, or CRT–D) (see Glossary). He was suffering from NYHA Class II–III heart failure caused by nonischemic cardiomyopathy. His left ventricular function was considerably compromised, with an ejection fraction of 25% to 30%, and he had a complete left bundle branch block. Despite anticongestive drug treatment and technically functional biventricular stimulation, his heart failure continued to worsen. Six months after implantation it was recognized that the patient belonged to the small group of nonresponders, i.e. patients who are not helped by CRT (8, 9). The next treatment option selected was palliative treatment involving care at home in communication with the hospital. Despite good home care, during the winter of 2009/2010 the patient had to be admitted to the hospital several times. Each time he was cared for in a palliative care unit, where he was treated for anxiety attacks (caused by paroxysmal dyspnea) in particular. At this time his heart failure was described as NYHA Class III–IV. In early February he was readmitted to the palliative care unit and a decision was made to end drug-based treatment for his heart failure. He now received only palliative treatment. At the same time, morphine treatment was begun. In October 2009 his treating physician had already recorded in his electronic medical records that the patient should not be resuscitated in the event of cardiac arrest. In conversation with the palliative care physician, the patient himself now reported a feeling of security, which in his opinion was connected with the ICD. The physician observed at this time that the existence of the defibrillator represented an “ethical dilemma.” On the day before the patient’s death in February 2010 the cardiology hospital was consulted, with the request to deactivate the ICD, because the patient had received shock therapy induced by the device several times in a short period. In the opinion of both the patient’s wife and the nursing staff who were present, the shocks were considerably stressful. At this point the patient was somnolent and moribund. The staff recorded in the patient’s electronic medical records that ICD treatment had been “unethical” and had disrupted the patient’s dignified, peaceful death. The patient died the day after his ICD had been deactivated.
One medical aspect of this case which may seem trivial but is worth mentioning from the outset is that all patients, including those with an ICD will die eventually. The annual mortality rate of patients with ICDs varies depending on the underlying disease. In one US registry study, it was between 11.3% and 16.8% (8). Most ICD patients die of heart failure. Noncardiac causes of death such as cancer do, however, occur. A patient with an ICD may die just a few months after the defibrillator is implanted, but may live for more than 20 years, with several changes of device. Relevant medical guidelines state that ICD implantation is only indicated if the patient has a good prognosis when the ICD is fitted, apart from the risk of sudden cardiac death, and that his/her statistical life expectancy is at least one year (2). As the case study illustrates, it is impossible to determine a patient’s prognosis reliably, partly because of the epistemological status of prognosis (10). Uncertainty of prognosis is a particular problem when a patient with severe or very severe heart failure (NYHA Class III–IV) is fitted with a combined pacemaker for biventricular stimulation and defibrillation (a CRT defibrillator) and continues to deteriorate, i.e. is a nonresponder (9), developing terminal, treatment-refractory pump weakness.
By no means do all ICD patients receive shock therapy despite active treatment functions while moribund, because ventricular arrhythmia does not necessarily occur while patients are moribund. In a summary of deceased ICD patients, it was found that 15 of 55 (27%) had received appropriate shock therapy in the last phase of their lives, one further patient (2%) had received inappropriate shocks, and for the remaining 39 of the 55 patients (71%) neither ventricular arrhythmia nor shock therapy was recorded (Goldenberg I, Moss AJ, McNitt S, Zareba W, Andrews ML: Defibrillator discharge at the time of terminal events in Madit-II. HRS annual meeting 2007, abstract AB 14–6, www.abstracts2view.com/ hrs/view.php?nu=HRS7L_20075088). If an ICD also acts in the event of non-life-threatening tachycardia, e.g. with high ventricular rate as a result of atrial fibrillation, treatment is described as inadequate. If appropriate shocks are given as a result of ventricular tachycardia or ventricular fibrillation, the ICD has provided appropriate treatment. A further study from US hospices reports that 64% of ICD patients received shock therapy during the last phase of their lives, or even after death (5).
It might initially be assumed that an ICD or pacemaker is no different from other hi-tech medical treatments or aids in terms of the ethical discussion surrounding their deactivation. Respect for patients’ self-determination, which is becoming more and more strongly enshrined in law (e.g. in Germany with the 2009 act that introduced the third change to the law on care), includes a patient’s right to refuse treatment (Box). If a patient dies after the end of a treatment that is no longer indicated, death is considered to be the result of the underlying disease and not of treatment provided by the physician. The increasingly common argument that deactivating a hi-tech medical aid is “passive assistance in dying,” or even that switching off a device is “active assistance in dying” because of the nature of treatment, is ethically incorrect in the precisely defined situation described above. Physicians’ and patients’ assessments of active and passive treatments are often dominated by great uncertainty. This can lead to disputes in determining the aim of treatment, though ethically such controversy is often unfounded (11–15, e4–e8). In daily clinical practice, for example, the end of mechanical ventilation or dialysis treatment is a subject of ethical discussion. Numerous studies show that it is not unusual for physicians and lawyers to differ from each other in where they define the boundary between ending life-sustaining treatment, which is permitted, and euthanasia or even assisted suicide, which are not permitted (11–15, e9–e14). Implanted defibrillators and pacemakers are different from other hi-tech medical aids such as ventilation or dialysis machines because they are implanted into the patient’s body. The term “integral device” (11) was introduced to describe these devices, though naturally this did not lead to any automatic improvement in the clarity of ethical discussions. Thus, in medical ethics literature it is often asked what distinguishes an external ventilation machine, implanted pacemaker, or ICD from a transplanted heart. The terms “replacement therapy” and “substitutive therapy” were introduced into the literature in order to provide more precise definitions (12). If an item functions as part of the body and completely replaces a physiological function, it can be described as “replacement therapy.” This means that a transplanted heart or a transplanted kidney is replacement therapy, whereas the use of a ventilation machine must be classified as “substitutive therapy.” Different rules apply to ending these two types of therapy. Nobody would describe the “deactivation” of a transplanted heart via intravenous administration of a fatal dose of potassium as anything other than active killing, whereas switching off a ventilation machine or ending dialysis treatment must be regarded as medically and ethically justifiable in certain cases. An item classified as substitutive therapy has not become part of the patient’s body; this excludes integrated devices like pacemakers or ICDs. Discussion is still ongoing as to how pacemakers and defibrillators should be classified: as replacement therapy or substitutive therapy (11, 12). However, there does seem to be extensive agreement that the deactivation of a pacemaker in a pacemaker-dependent patient is fundamentally different from the deactivation of the antitachycardia functions of an ICD (6, 7, 13–15). In the former case, the intervention leads to the patient’s death within a short time, while in the latter only a risk-reducing treatment is deactivated (14). The differences between the two interventions described above, from the point of view of medical ethics, are questioned by some authors, who state that only the patient’s wishes should be the basis for this kind of ethical judgment, not an artificial difference between forms of treatment (14). However, this point of view overlooks the objections to an idealized concept of patient autonomy that have recently been discussed at length. These objections concern the fact that the concept of autonomous patient wishes is based on an ideal of rational decision-making that has never occurred in real life and is advocated from an individualistic point of view (in other words without sufficiently taking into account other persons who may be significant) and also disregards the fact that the person making the decision is dependent, when making decisions, on his/her body in a specific way (embodiment). Because a patient can come to feel that an ICD is a part of his/her body and so becomes part of his/her sense of self, the last point of this criticism is particularly relevant and should not be passed over. It is therefore also unsurprising if these authors consider the cause of the patient’s death to be the underlying disease, e.g. third-degree AV block with no escape rhythm, rather than the deactivation of the pacemaker, for pacemaker-dependent patients. Deactivation of an “integral device” is not legally considered to be the cause of death (14).
There is usually more than one possible answer to these questions, which have been discussed only briefly here. Generally there are several possible answers, depending, in particular, on the socially and culturally contingent values of patients, doctors, and others involved in health care, and also on norms that have become law in various countries. The published guidelines therefore also stress that detailed, individual discussion with the patient must always take place and must be recorded before an ICD can be deactivated. The physician’s freedom of conscience is also discussed: physicians may not want to deactivate an ICD, e.g. for religious reasons, but should refer a patient who wants his/her ICD to be deactivated to another physician (6, 7). A consensus document of this type, in Europe multinational (6) and in the USA covering several states (7), must be adapted to national and state behaviors and legal systems. However, regardless of national law, the deactivation of an ICD against the patient’s will or against the will of the patient’s representative or carer, or even unilateral (paternalistic) deactivation, may be ruled out (6, 7). In this context the boundary between a DNR (do not resuscitate) order in cases with no hope of recovery and the switching off of an ICD as a device integrated into the patient’s body must be discussed (6, 7): The decisive factor is that the patient is not entitled to demand an intervention that can have no medical benefit but is—according to prevailing opinion (6, 7)—entitled to refuse to allow his/her ICD to be deactivated.
Empirical ethical research shows that patients’ and physicians’ judgments do not always accord with the considerations of professional ethics (16–22, e15–e16). Patients also tend to overestimate the potential of an ICD in preventing death, so it is not uncommon for them to view consent for ICD deactivation as an act of suicide (20, e9). Most patients are hesitant to accept ICD deactivation, even when death from another cause is not far away (17). Physicians are equally disinclined to discuss this subject with their patients (18, e17).
An ICD can provide both multiple kinds of antitachycardia treatment and antibradycardia stimulation (see Box, Glossary). Antitachycardia treatments that are automatically included are defibrillation (shock therapy) (see Figure) and antitachycardia pacing (ATP).
Conflict of interest statement
Prof. Pfeiffer formerly worked as a consultant for Boston Scientific. He has received reimbursement of conference fees/continuing education costs and travel expenses from St. Jude Medical, ELA Medical, and Boston Scientific. He has received monies paid into a third-party account from St. Jude Medical, ELA Medical, Boston Scientific, and Biotronic.
The other authors declare that no conflict of interest exists.
Manuscript received on 11 July 2011, revised version accepted on
24 January 2012.
Translated from the original German by Caroline Devitt, MA.
Prof. Dr. med. Jörg Carlsson
Department of Internal Medicine
Section of Cardiology
Kalmar County Hospital
S-391 85 Kalmar, Sweden
@For eReferences please refer to:
|1.||Myerburg RJ, Reddy V, Castellanos A: Indications for implantable cardioverter-defibrillators based on evidence and judgement. J Am Coll Cardiol 2009; 54: 747–63. CrossRef MEDLINE|
|2.||Epstein AE, DiMarco JP, Ellenbogen KA, Estes NA 3rd, Freedman RA, Gettes LS, et al.: ACC/AHA/HRS 2008 guidelines for device-based therapy of cardiac rhythm abnormalities. J Am Coll Cardiol 2008; 51: e1–e62. CrossRef MEDLINE|
|3.||Camm AJ, Nisam S: European utilization of the implantable defibrillator: has 10 years changed the „enigma“? Europace 2010; 12: 1063–9. MEDLINE|
|4.||Gadler F: Svenska ICD- och Pacemakerregistret. www.pacemakerregistret.se|
|5.||Fromme EK, Lugliani Stewart T, Jeppesen M, Tolle SW: Adverse experiences with implantable defibrillators in Oregon Hospices. Am Hosp Hosp Palliat Care 2011; 28: 304–9. CrossRef MEDLINE|
|6.||Padeletti L, Arnar DO, Boncinelli L, et al.: European Heart Rhythm Association expert consensus statement on the management of cardiovascular electronic devices in patients nearing end of life or requesting withdrawal of therapy. Europace 2010; 12: 1480–9. CrossRef MEDLINE|
|7.||Lampert R, Hayes DL, Annas GJ, et al.: Heart Rhythm Society expert consensus statement on the management of cardiovascular electronic devices (CIEDs) in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm 2010; 7: 1008–26. CrossRef MEDLINE|
|8.||Thibodeau JB, Pillarisetti J, Khumri TM, Jones PG, Main ML: Mortality rates and clinical predictors of reduced survival after cardioverter defibrillator implantation. Am J Cardiol 2008; 101: 861–4. CrossRef MEDLINE|
|9.||Vidal B, Delgado V, Mont L, et al.: Decreased likelihood of response to cardiac resynchronization in patients with severe heart failure. Eur J Heart Fail 2010; 12: 283–7. CrossRef MEDLINE|
|10.||Paul NW: Diagnose und Prognose. In: Schulz S, Steigleder K, Fangerau H, Paul NW (eds.): Geschichte, Theorie und Ethik der Medizin: Eine Einführung. Frankfurt/M: Suhrkamp 2006; 143–52.|
|11.||England R, England T, Coggon J: The ethical and legal implications of deactivating an implantable cardioverter-defibrillator in a patient with terminal cancer. J Med Ethics 2007; 33: 538–40. CrossRef MEDLINE PubMed Central|
|12.||Sulmasy DP: Within you/without you: biotechnology, ontology, and ethics. J Gen Intern Med 2007; 23(Suppl 1): 69–72. CrossRef MEDLINE PubMed Central|
|13.||Zellner RA, Aulisio MP, Lewis WR: Should implantable cardioverter-defibrillators and permanent pacemakers in patients with terminal illness be deactivated? Deactivating permanent pacemaker in patients with terminal illness. Patient autonomy is paramount. Circ Arrhythmia Electrophysiol 2009; 2: 340–4. CrossRef MEDLINE|
|14.||Kay GN, Bittner GT: Should implantable cardioverter-defibrillators and permanent pacemakers in patients with terminal illness be deactivated? Deactivating implantable cardioverter-defibrillators and permanent pacemakers in patients with terminal illness. An ethical distinction. Circ Arrhythmia Electrophysiol 2009; 2: 336–9. CrossRef MEDLINE|
|15.||Wu EB: The ethics of implantable devices. J Med Ethics 2007; 33: 532–3. CrossRef MEDLINE PubMed Central|
|16.||Facciorusso A, Stanislao M, Fanelli M, Valori VM, Valle G: Ethical issues on defibrillator deactivation in end-of-life patients. J Cardiovasc Med 2011; 12: 498–500. CrossRef MEDLINE|
|17.||Goldstein NE, Mehta D, Siddiqui S, et al.: „That’s like an act of suicide“: patients attitudes towards deactivation of implantable defibrillators. J Gen Intern Med 2008; 23(Suppl 1): 7–12. CrossRef MEDLINE PubMed Central|
|18.||Goldstein NE, Mehta D, Teitelbaum E, Bradley EH, Morrison RS: „It’s like crossing a bridge“ Complexities preventing physicians from discussing deactivation of implantable defibrillator at the end of life. J Gen Intern Med 2007; 23(Suppl 1): 2–6. CrossRef MEDLINE PubMed Central|
|19.||Goldstein NE, Bradley E, Zeidman J, Mehta D, Morrison RS: Barriers to conversations about deactivation of implantable defibrillators in seriously ill patients. J Am Coll Cardiol 2009; 54: 371–3. CrossRef MEDLINE PubMed Central|
|20.||Stewart GC, Weintraub JR, Semigran MJ, et al.: Patient expectations from implantable defibrillators to prevent death in heart failure. J Card Fail 2010; 16: 106–13. CrossRef MEDLINE|
|21.||Kelley AS, Reid MC, Miller DH, Fins JJ, Lachs MS: Implantable cardioverter-defibrillator deactivation at the end of life: a physician survey. Am Heart J 2009; 157: 702–8. CrossRef MEDLINE|
|22.||Sherazi S, Daubert JP, Block RC, et al.: Physician’s preferences and attitudes about end-of-life care in patients with an implantable cardioverter-defibrillator. Mayo Clin Proc 2008; 83: 1139–41. CrossRef MEDLINE|
|23.||Paul NW: Klinische Ethikberatung: Therapieziele, Patientenwille und Entscheidungsprobleme in der modernen Medizin. In: Junginger T, Perneczky A, VAHL CF, Werner C (eds.): Grenzsituationen der Intensivmedizin: Entscheidungsgrundlagen. Heidelberg: Springer 2008; 207–17.|
|24.||Paul NW: Clinical Ethics Counseling: Therapeutic Goals, the Patient´s Will and Decision-making Problems in Modern Medicine. Formosan Journal of Medical Humanities 2010; 11: 19–36.|
|25.||Beets MT, Forringer E: Urgent implantable cardioverter defibrillator deactivation by unconventional means. J Pain Symptom Manage 2011; 42: 941–5. CrossRef MEDLINE|
|e1.||Trappe HJ, Gummert J: Current pacemaker and defibrillator therapy. Dtsch Arztebl Int 2011; 108(21): 372–80. VOLLTEXT|
|e2.||Nambisan V, Chao D: Dying and defibrillation: a shocking experience. Palliat Med 2004; 18: 482–3. MEDLINE|
|e3.||Rizzieri AG, Verheijde JL, Rady MY, McGregor JL: Ethical challenges with the left ventricular assist device as a destination therapy. Philos Ethics Humanit Med 2008; 3: 20. CrossRef MEDLINE PubMed Central|
|e4.||Lindblad A, Juth N, Fürst CJ, Lynöe N: When enough is enough; terminating life-sustaining treatment at the patient´s request: a survey of attitudes among Swedish physicians and the general public. J Med Ethics 2010; 36: 284–9. CrossRef MEDLINE|
|e5.||Kramer DB, Kesselheim AS, Salberg L, Brock DW, Maisel WH: Ethical and legal views regarding deactivation of cardiac implantable electrical devices in patients with hypertrophic cardiomyopathy. Am J Cardiol 2011; 107: 1071–5. CrossRef MEDLINE|
|e6.||Morrison LJ, Calvin AO, Nora H, Porter Storey C Jr.: Managing cardiac devices near the end of life: a survey of hospice and palliative care providers. Am J Hosp Palliat Care 2010; 27: 545–51. MEDLINE|
|e7.||Kramer DB, Kesselheim AS, Brock DW, Maisel WH: Ethical and legal views of physicians regarding deactivation of cardiac implantable electrical devices: a quantitative assessment. Heart Rhythm 2010; 7: 1537–42. CrossRef MEDLINE PubMed Central|
|e8.||Marinskis G, van Erven L, EHRA Scientific Initiatives Committee: Deactivation of implanted cardioverter-defibrillators at the end of life: results of the EHRA survey. Europace 2010; 12: 1176–7. MEDLINE|
|e9.||Rady MY, Verheijde JL: End-of-life discontinuation of destination therapy with cardiac and ventilatory support medical devices: physician-assisted death or allowing the patient to die? BMC Medical Ethics 2010; 11: 15. CrossRef MEDLINE PubMed Central|
|e10.||Dev S, Galanos AN: Complexities of defibrillator deactivation. Ann Intern Med 2010; 153: 133–4. MEDLINE|
|e11.||Mueller PS, Swetz KM, Freeman MR, Carter KA, Crowley ME, Severson CJ, Park SJ, Sulmasy DP: Ethical analysis of withdrawing ventricular assist device support. Mayo Clin Proc 2010; 85: 791–7. MEDLINE PubMed Central|
|e12.||Goldstein NE, Lampert R, Bradley E, Lynn J, Krumholz HM: Management of implantable cardioverter defibrillators in end-of-life care. Ann Intern Med 2004; 141: 835–8. MEDLINE|
|e13.||Berger JT: The ethics of deactivating implanted cardioverter defibrillators. Ann Intern Med 2005; 142: 631–4. MEDLINE|
|e14.||Oorschot B, Simon A: Aktive, passive oder indirekte Sterbehilfe? Über subjektive Definitionen und Klassifikationen von Ärzten und Richtern in Entscheidungssituationen am Lebensende. Psychologie & Gesellschaftskritik 2008; 32: 39–53.|
|e15.||Kapa S, Mueller PS, Hayes DL, Asirvatham SJ: Perspectives on withdrawing pacemaker and implantable cardioverter-defibrillator therapies at the end of life: results of a survey of medical and legal professionals and patients. Mayo Clin Proc 2010; 85: 981–90. CrossRef MEDLINE PubMed Central|
|e16.||Mueller PS, Hook C, Hayes DL: Ethical analysis of withdrawal of pacemaker or implantable cardioverter-defibrillator support and the end of life. Mayo Clin Proc 2003; 78: 959–63. MEDLINE|
|e17.||Raphael C, Kanagaratnam P, Francis DP: Further barriers to conversations about deactivation of implantable cardioverter-defibrillators. J Am Coll Cardiol 2010; 55: 701–2. CrossRef MEDLINE|