Methods: Using relevant search terms, a literature search for articles on the topics of interest was performed in multiple databases. The search was limited to articles published in English in peer-reviewed journals between January 1, 1999, and October 31, 2010. Reference lists of applicable articles were also examined for any additional relevant studies. After applying inclusion and exclusion criteria, 14 studies investigating the topics of interest were identified and are included in this review.

Findings: Providers' knowledge deficits about ICD functions and attitudes about ICD deactivation in terminally ill patients can adversely affect the timing of deactivation discussions. Providers' reluctance to discuss deactivation may stem in part from personal discomfort and lack of experience with this option. ICDs may be viewed differently from other life-sustaining measures. Providers may also feel ill prepared to initiate a discussion about deactivation with patients; some might prefer expert guidance or that others initiate such discussion. There's evidence that ICD deactivation is most often performed by an industry representative, and that continuity of care is lost. Although there's been scant research on patient attitudes about ICD deactivation, it appears that patients lack sufficient knowledge of ICD function to make informed decisions about deactivation. A complex psychological relationship may exist between patients and their ICDs. Deactivation discussions occur more frequently when a formal institutional policy exists. ICD deactivation in terminally ill patients is more likely when deactivation is discussed as part of an interdisciplinary approach to care.

Conclusions: Both patients and providers need better knowledge of ICD functions and options at the end of life in order to foster more timely discussion of device deactivation. More research is needed, in particular regarding patient attitudes toward ICD deactivation. Formal ICD deactivation policies should be developed to guide providers. A comprehensive and interdisciplinary approach to deactivation discussions should be considered.

A few years ago, in a letter to the editor of another journal, an NP described how one of her patients, a man on home hospice care, had suffered 33 shocks as he lay dying in his wife's arms.1 The source of those shocks, his implantable cardioverter-defibrillator (ICD), reportedly "got so hot that it burned through his skin." The device that had been implanted to save his life caused this man and his wife great distress in his final hours. Device deactivation at the end of life is an option; but in this case, apparently, it had never been discussed. It was, in part, anecdotes like this one that prompted the investigation described here.

ICDs were first introduced in 1980 as a means of treating life-threatening cardiac arrhythmias and preventing sudden cardiac arrest,2 an event that kills some 250,000 to 300,000 Americans annually.3 The device works by constantly monitoring the heart for such arrhythmias and, when it senses them, delivering high-energy electric shocks to restore normal rhythm. Major studies of the device have included the Multicenter Automatic Defibrillator Implantation Trial (MADIT),4 the Antiarrhythmics Versus Implantable Defibrillators (AVID) trial,5 the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II),6 the Multicenter Unsustained Tachycardia Trial (MUSTT),7 and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT).8 Data from these studies have led to a consensus among providers that ICDs are an essential part of treatment in those at risk for life-threatening arrhythmias.9 In the United States, over 140,000 ICDs were implanted in 2009 alone, according to the National ICD Registry.10

But people with ICDs who are terminally ill (either with heart disease or another illness) are apt to change their treatment preferences from care aimed at prolonging life to palliative care. Thus, in a terminally ill patient who's actively dying, the device can cause needless pain. In such cases, an ICD can be deactivated so the patient can experience a more peaceful death. But many providers and patients aren't discussing the possibility of ICD deactivation.11-14 To better understand such situations, I conducted a systematic review of the relevant literature. This article first offers a brief overview of ICDs and deactivation issues, then describes and discusses the findings of my review.

THE NATURE AND FUNCTION OF ICDs

ICDs are primarily used to treat ventricular tachyarrhythmias and ventricular fibrillation. When the device detects tachyarrhythmias or fibrillation, it delivers one or more strong electrical shocks (often called shock therapy). It's programmed to do so in response to specific ventricular rates over a specific interval of time. These parameters are determined and programmed by clinicians based on a patient's history or risk of arrhythmia.15 ICDs can also treat tachyarrhythmias with a relatively painless alternative, antitachycardia pacing, which involves a short series of low-energy electrical pulses.16 Yet despite these various programming options, many providers and patients view ICD therapy as an all-or-nothing phenomenon.11, 12

In studies investigating physician and patient attitudes about ICD deactivation, Goldstein and colleagues found that both groups viewed ICDs as intrinsically different from other lifesaving therapies.11, 12 First, ICDs are "typically implanted well before [patients perceive] themselves to be seriously and terminally ill."11 Because an ICD can seem like a sentinel against death, a patient can develop "a complex psychological relationship" with her or his device.11 There's evidence that most patients overestimate the lifesaving capabilities of their ICDs,17 perhaps because of this relationship. Physicians noted that the interval between ICD deactivation and death can be much longer than would follow cessation of other lifesaving therapies (such as mechanical ventilation or dialysis).12 And because an ICD is small and, once implanted, unseen, both patients and physicians tend to regard it as an intrinsic part of the patient and to overlook it when advance directives are discussed.11, 12, 18 Moreover, patients with ICDs don't have full autonomous control of their devices. It's possible to temporarily deactivate an ICD by placing a strong magnet over it (unless this feature is specifically programmed off).19 But such control is limited. For permanent deactivation or disabling of shock therapy, a knowledgeable provider must reprogram the device.

HOW ICDs CAN AFFECT THE DYING PROCESS

An actively dying patient can develop tachyarrhythmias triggered by events such as hypoxia and electrolyte imbalances. Unless the ICD has been deactivated or reprogrammed to disable shock therapy, the device will continue to try to restore a normal heart rhythm by delivering painful shocks. Several case reports have described terminally ill patients receiving multiple shocks during their final minutes or hours.1, 20-22 (Mainstream media have also reported this phenomenon.23, 24) These anecdotal reports also detail the frustration and distress felt by family members and providers who witnessed the patient's suffering. In some cases, ICD deactivation was further delayed because it hadn't previously been discussed with the patient and family or because appropriately trained personnel or proper deactivation equipment weren't available.

Management of terminally ill patients with ICDs can present great challenges for providers. No standard protocol regarding deactivation exists, and several case reports illustrate the dilemmas that providers face.25-29 It can be hard for providers to know when to initiate discussion of possible ICD deactivation and when to deactivate an ICD.30 In some cases, as in patients with end-stage congestive heart failure, it can be extremely difficult to estimate the patient's life expectancy. A clearly defined terminal phase may not exist.31-33

DEACTIVATION

Legal and ethical considerations. As yet, no legal case precedent specific to ICD deactivation exists. Many authors have examined the ethical aspects or questioned the legality, or both, of such deactivation at the end of life.20, 22, 28, 32, 34-36 In one analysis of cases in which patients or their surrogates had requested "withdrawal of pacemaker or ICD support" near the end of life, the authors concluded that granting such requests is both legal and ethical.37 And decisions to honor the request of a competent patient to have other types of life-prolonging measures withdrawn or withheld have been well documented. A consensus exists that such decisions can be both legally and ethically justifiable.38-41 The individual's right to refuse treatment, including her or his right to withdrawal or withholding of treatment, is considered a constitutional right based on the right to self-determination; as Kay notes, it's a right "well settled in common law."39

But in practice, patient and family education about ICDs is lacking. During the consent process before implantation, patients aren't often made sufficiently aware of the ramifications of living with an ICD or how the device might affect them during active dying.29, 42 Wu raises the concern that "consent is [generally] more about trust than about balancing risks and benefits."43 And as Withell states, "The duration of consent to treatment is another dimension that is often overlooked."29 Salber suggests that during the consent process, it's unethical for providers not to adequately prepare patients for the possible effects of an ICD on quality of life; for example, some patients find the shocks more painful and unpredictable than expected and develop chronic anxiety or depression.36 Could it be considered similarly unethical for providers not to prepare patients for the possible effects of an ICD on the quality of death?

Current guidelines on ICD deactivation. There are currently no formal practice protocols that address ICD deactivation. That said, the American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Rhythm Society (HRS) all recommend that patient education at the time of device implantation should include comprehensive information regarding end-of-life issues and that guidelines for device management in patients with a terminal illness should be developed.44 Moreover, guidelines for device-based therapy of cardiac rhythm abnormalities, jointly issued by the ACC, AHA, and HRS, indicate that approaches to deactivation should include the following45:

The following are results grouped by the three areas of focus. For a summary of each study's sample, methods, and findings, as well as brief comments, see Table 1 (to see the entire table with all 14 studies, go to http://links.lww.com/AJN/A29).11-14, 17, 46-54 (It may be worth noting that, of the 14 studies, five were conducted by Goldstein and colleagues.)

Table 1. SELECTED RESEARCH STUDIES PERTAINING TO ICD DEACTIVATION IN END-OF-LIFE CARE (N=14)

Clinical practice and management of ICD deactivation in end-of-life care was examined in six studies,13, 14, 47, 48, 52, 53 mainly among physicians. Only one study specifically included nurses and device company representatives.53 All six studies found that deactivation discussions were not commonplace. Goldstein and colleagues surveyed the next of kin of patients who had died with an ICD in place, and found that deactivation had been discussed in 27 of 100 cases.48 Even among patients with DNR orders, deactivation had been discussed with fewer than 45%. A survey by Hauptman and colleagues of 734 cardiologists, internists and family practitioners, and geriatricians also showed that, overall, discussions of ICD deactivation with patients or family members were uncommon.13 Just 25% of internists and family practitioners and 40% of geriatricians reported having such discussions. And in a survey by Marinskis and van Erven of European electrophysiologists and cardiologists, 85% of respondents reported discussing deactivation only "in specific cases during the follow-up."14 Only 4% of all respondents routinely discussed deactivation options at the time of implantation.

Notably, Hauptman and colleagues found that 75% of cardiologists did discuss device deactivation at least once.13 Similarly, Marinskis and van Erven found that 78% of respondents had been involved in a "few cases" of device deactivation; another 11% had been involved "often."14 Another survey by Mueller and colleagues of 787 heart rhythm specialists found that 87% had been involved in the care of a terminally ill patient who requested deactivation of a pacemaker or an ICD, and 95% had cared for a patient in whom such deactivation was ordered.53 Yet despite this involvement, continuity of care was often lost. Most respondents didn't feel it was necessary for a physician to be present during deactivation. Respondents also reported that, in their experience, ICD deactivation was most often carried out by an industry representative.

Study findings also indicated that deactivation discussions were less likely when formal policies or guidelines for such discussions were absent. Goldstein and colleagues found that deactivation discussions weren't typically approached proactively; most weren't conducted until the last days or hours of a patient's life.48 Another study found that patients in hospices with a formal ICD deactivation policy were far more likely to have had their device deactivated than were patients in hospices without such a policy.47 And Lewis and colleagues studied the use of a comprehensive interdisciplinary approach that incorporated deactivation discussions into routine ICD follow-up care.52 During follow-up, about one-third of the patients were found to have a clearly identified terminal illness, and all of these patients eventually elected to deactivate their ICDs. The researchers concluded that the interdisciplinary approach had prevented "inappropriate shocks" at the end of life for a significant number of patients.

Provider attitudes regarding ICD deactivation for patients at the end of life was explored in seven studies.12, 13, 46, 49, 50, 53, 54 Most focused on physicians; only one included nurses and other providers who weren't physicians.53

One finding common to several studies was that most providers are reticent when it comes to discussing ICD deactivation with patients. A study by Goldstein and colleagues found that although many physicians said they believed device deactivation discussions should be included in advance care planning, they also admitted they rarely did so.12 Kelley and colleagues found that, overall, 77% of physicians believed that information about deactivation should be included when obtaining informed consent prior to implantation.50 But the physicians also reported being less likely to discuss ICD deactivation than to discuss advance directives with terminally ill patients.50 Furthermore, few physicians would accept primary responsibility for initiating deactivation discussions.49

The studies revealed several factors that might cause providers to delay discussing deactivation with terminally ill patients. One such factor was personal discomfort. In a survey of 67 physicians, Sherazi and colleagues found that 22% would feel uncomfortable deactivating an ICD for a terminally ill patient, even though 59% of those surveyed knew an ICD shock would be painful.54 Another study, conducted with heart rhythm specialists and device company representatives, found that only 57% would feel comfortable deactivating an ICD following a patient request.53 One study by Goldstein and colleagues did find that, more generally, 88% to 100% of the surveyed physicians felt comfortable communicating with patients about treatment options at the end of life.46 But in another study by Goldstein and colleagues, physicians felt there was "something intrinsic to the nature" of ICDs that made addressing deactivation with patients more difficult.12 One cardiologist said she feared that talking about deactivation with patients would be like "shutting off the hope."

Also underlying providers' tendency to delay deactivation discussions were a lack of experience and a need for guidance. Kelley and colleagues found that a majority of physicians wanted more expert guidance in managing ICDs at the end of life.50 They also found that the strongest predictor of willingness to discuss ICD deactivation was prior experience with such discussions. Similarly, Hauptman and colleagues determined that conversations regarding deactivation were more likely to occur when physicians were cardiology specialists or "had formal training in palliative care," or when they used relevant clinical guidelines for decision making.13 And Sherazi and colleagues discovered that nearly half of the 87 physicians surveyed were either misinformed or confused about the legality of deactivation.54

Other factors included inadequate knowledge and time constraints. Kelley and colleagues found that 10% of physicians thought ICD shocks weren't distressing to terminally ill patients and their families, and 14% were "uncertain."50 In another study by Kelley and colleagues, 9% of physicians reported having insufficient knowledge of ICD functions and deactivation options; and 6% said they'd never thought about discussing ICD deactivation with terminally ill patients.49 Goldstein and colleagues found that many physicians felt time constraints prevented them from developing the provider-patient rapport necessary to approach the topic of deactivation.12

A lack of confidence in one's ability to accurately predict time of death can also delay deactivation discussions. Hauptman and colleagues found that, overall, only 16% of specialists surveyed felt they could accurately predict time of death for their patients with heart failure.13 The researchers concluded that such lack of confidence affects physicians' decision making regarding ICD deactivation.

Finally, there are indications that even when a terminally ill patient requests ICD deactivation, some physicians might inadvertently create barriers to a timely honoring of the request. In one study by Kelley and colleagues, when physicians were given hypothetical scenarios involving terminal patients with ICDs, most said they'd discuss ICD deactivation with the patients.50 But in a related study by Kelley and colleagues, 21% of the surveyed physicians said they'd advocate further life-prolonging therapies before discussing deactivation, 12% said they preferred to postpone such discussion, and 7% wanted the patient or a family member to initiate the discussion.49 Similarly, Mueller and colleagues showed that many respondents believed that, before a patient's request for deactivation is honored, the patient should undergo a psychiatric evaluation (37%) and have an ethics consultation (28%).53

Patient attitudes regarding ICD deactivation. There is scant research in this area; my search turned up no large studies that examined patient preferences or attitudes regarding ICD deactivation. Three small studies have been conducted relative to this topic.11, 17, 51 Goldstein and colleagues conducted focus groups with 15 patients with ICDs and found that, despite expressing "a great deal of anxiety" about receiving shocks, none was willing to discuss the possibility of device deactivation at the end of life.11 Kobza and Erne reviewed the cases of eight patients with ICDs who had malignant tumors and subsequently died.51 They found that although six of the eight had discussed ICD deactivation "extensively" prior to death, none had elected deactivation. Stewart and colleagues surveyed symptomatic heart failure patients from two specialty centers in Boston and found that those with ICDs feared turning off their devices.17 The 67 ICD recipients were asked to consider several situations. Given a description of "possible terminal disease, during which death could occur suddenly or slowly," 39% indicated that they'd never turn off their ICD. Almost 55% said they'd keep it turned on even "if receiving daily shocks"; and 70% said they'd keep it on even "if they were dying of cancer or knew they would be dead within a month from another noncardiac cause." These findings seem to contradict the findings of Lewis and colleagues described earlier, in which deactivation discussion was part of a comprehensive interdisciplinary approach to care; in that study, all 20 patients with an ICD and an identified terminal illness chose deactivation.52

Stewart and colleagues also found that 70% of the ICD recipients identified their physician as the main source of information about their devices.17 The researchers determined that most of these patients understood the ease of reprogramming. They also concluded that symptomatic heart failure patients-whether they have an ICD or not-tend to have unrealistic expectations of the device's lifesaving ability and to overestimate the survival benefits. Goldstein and colleagues found that patients lacked sufficient knowledge about ICD functions and the role the devices had in their health.11 They postulated that patients might develop unique, complex psychological relationships with their ICDs. For example, they noted that patients perceive the devices as providing a sense of security and think of them as a "trusted friend."

DISCUSSION

Findings on clinical practices. Deactivation discussions are uncommon in clinical practice.13, 14, 48 Despite ACC, AHA, and HRS recommendations that future deactivation be included in preimplantation discussions, the evidence suggests that physicians rarely do so. Although Kelley and colleagues found that most physicians believe that ICD deactivation must be addressed when obtaining a patient's informed consent for implantation, the study didn't investigate actual practice.50 Marinskis and van Erven found that most electrophysiologists and cardiologists said they would consider deactivation of ICDs in terminally ill patients, but that "real-time practices" often varied; the researchers concluded that ICD deactivation wasn't routinely discussed.14 As indicated earlier, Goldstein and colleagues found that when deactivation discussions did occur, most took place in the last days of a patient's life.48 Therefore it seems unlikely that patients receive adequate information about their options at the time of implantation. And with most deactivation discussions occurring when time is of the essence, it may well be a provider unfamiliar to the patient who is broaching the subject.

Moreover, it appears that it's often someone other than the patient's primary care provider who deactivates the device.53 In such instances, continuity of care is lost, and the psychological and emotional impact this has on patients and their families is unknown. But when guidelines or policies addressing deactivation are present, or when a comprehensive interdisciplinary approach is used to foster deactivation discussion, deactivation at the end of life is more likely.47, 52 Such models of care may also promote timelier discussions, lead to more timely deactivations, and prevent more patients from experiencing painful shocks as they're dying. Further research into these models of care is needed so that universal practice guidelines for the management of ICDs in terminally ill patients can be developed.

Findings on provider attitudes. Provider attitudes about ICD deactivation at the end of life can adversely affect the timing of deactivation discussions. This review indicates that most physicians are reticent when it comes to such discussions, which may explain their infrequency. Factors that can cause deactivation discussions to be delayed include providers' personal discomfort with deactivation as part of end-of-life care,12, 13, 50, 53, 54 inadequate knowledge of device functions,49, 50 physicians' lack of confidence in their ability to predict time of death,13 and time constraints that prevent strong physician-patient rapport.12 Physicians might omit ICDs from end-of-life discussions because they view ICDs as intrinsically different from other life-sustaining therapies.12 Many physicians appear to lack appreciation for the complexity of ICDs.49 Indeed, physicians seem to view ICD treatment as an all-or-nothing phenomenon; none brought up the possibility of reprogramming the device12-such as lengthening the detection interval, limiting the number of shocks, or deactivating the shock function while retaining antitachycardia pacing-which may be a possible option.44 Some physicians don't believe that ICD shocks can negatively affect the quality of a patient's death.50 Confusion about the legality of ICD deactivation49, 54 might also hinder timely discussion.

Although patients don't often understand how their ICDs work and what their options are,11 physicians seem to believe that patients are knowledgeable about their ICDs.46 This misunderstanding may be another factor in delaying deactivation discussions, especially since many physicians say they'd prefer the patient or a family member to initiate the discussion.49 Yet, without physician prompting, a patient or family member might not do so until the patient is near death and perhaps already receiving shocks. Physicians and other providers may also inadvertently impede timely deactivation by requesting unnecessary ethics consultations or psychiatric evaluations.53

Overall, the evidence suggests that providers consider discussing ICD deactivation only when a patient is terminally ill or actively dying, rather than well in advance of these states.14, 49, 50 Study findings indicate that providers would welcome some form of guidance for holding deactivation discussions.14, 50 However, these findings may indicate a response bias, as participation in the studies was voluntary and participants may have had an interest in the topic. Another limitation is that some studies asked questions that were based on hypothetical scenarios rather than actual practice. Further research into providers' decision-making processes regarding both ICD deactivation and deactivation discussions is warranted.

Findings on patient preferences. A significant finding of this review is the dearth of research on patient attitudes about ICD deactivation. The three studies that have been conducted indicate that patients want their ICDs to remain activated even at the end of life. But all studies were relatively small and poorly stratified. Kobza and Erne's findings were drawn from only six patients.51 Stewart and colleagues' study, although conducted in patients with heart failure, presented patients with hypothetical scenarios.17 The study by Goldstein and colleagues was conducted in participants with no significant comorbidities.11 People who have known terminal illness may view this issue differently.

Moreover, Goldstein and colleagues thought the study participants didn't really understand how an ICD functions and thus lacked the knowledge "necessary to adequately weigh the option of deactivating the device"; they also seemed unaware that a range of reprogramming options might exist.11 As Carroll points out, such lack of knowledge highlights the need for better patient education, including discussion of potential deactivation.55 That need is also supported by Stewart and colleagues' finding that most patients said they wouldn't want their ICD turned off even if near death and suffering with symptoms such as constant dyspnea.17 The researchers added that "the inherent difficulties physicians have communicating risk and prognosis in heart failure" may also contribute to "patient misunderstandings" of what lies ahead. Currently there are no standards for including a discussion of advanced planning when obtaining informed consent for ICD implantation. Without adequate knowledge, patients cannot make informed decisions about deactivation.

RECOMMENDATIONS AND CONCLUSIONS

By acting as patient advocates and calling attention to the need to address potential device deactivation with terminally ill patients, nurses can help to ensure better patient-centered care. Regardless of a provider's comfort level with the subject, patients have the right to be informed of all treatment options, including ICD deactivation.32 Nurses must support this right. Such advocacy can occur both at the individual level, through conversations with patients, their families, and their physicians; and at the institutional level, through involvement in creating programs and policies. Individual actions might make the most dramatic difference, since nurses are often the first to recognize when a patient's condition changes and can intervene quickly. But creating policies and procedures is essential as well.

The fact that physicians report a reluctance to initiate deactivation discussions and a preference for guidance speaks to a need for stronger alliances between primary care providers and cardiology and palliative care experts. Nurses can be instrumental in helping to create interdisciplinary committees to examine the issues surrounding ICD deactivation at the end of life. These alliances might help to ease providers' discomfort in discussing deactivation with patients. The committee could review existing institutional practices and create device deactivation protocols or policy. For example, nurses might advocate that ICD deactivation be discussed whenever a DNR order is written or a terminally ill patient requires hospice care. An excellent example of a deactivation policy, drafted by Goldstein and colleagues, is available online (http://1.usa.gov/ilwqs6).47 A synthesis of policies used in some hospices, it explains the rationale for deactivation, describes a screening process for device identification, outlines points for discussing deactivation and obtaining informed consent, and explains device reprogramming. It's a useful tool that can guide other institutions in creating policies of their own.

At the individual level, nurses can help by incorporating device deactivation discussions into the plan of care. Nurses can explore a patient's understanding and preferences regarding device deactivation during preimplantation teaching and routine follow-up. An expert consensus statement developed by the HRS and others on the management of cardiovascular implantable electronic devices in terminally ill patients, offers examples of questions for starting such conversations, including44:

Lipman has written about why it's essential for physicians to use neutral language and "universally understood definitions" when discussing ICD functions and deactivation.56 As she observes, being clear and nonjudgmental helps to promote conversation and avoid conflict; it's a recommendation that makes sense for nurses as well.

Nurses in administrative roles should advocate that deactivation be addressed as part of the process of obtaining informed consent for implantation.18, 33, 44 Nurse administrators are encouraged to participate in creating educational programs for staff to keep them abreast of options in device management. Such programs can also help build strong alliances across specialties. Lastly, nurses can lead further research, which is especially needed in the areas of patient perceptions and preferences regarding ICD deactivation.

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For 39 additional continuing nursing education articles on cardiovascular topics, go to http://www.nursingcenter.com/ce.