Implantable cardioverter defibrillators (ICDs) reduce mortality in selected patients at risk for life-threatening heart arrhythmias, and their use is increasingly common. However, these devices also confer risk for delivery of unexpected painful shocks during the dying process, thus reducing the quality of palliative care at the end of life. This scenario can be avoided by ICD deactivation in appropriate circumstances but patients will remain unaware of this option if not informed about it. It is not known how often end-of-life implications are discussed with patients prior to ICD implantation, when focus is primarily on the short-term potential complications of the device placement procedure itself. We conducted a retrospective chart review to determine how often end-of-life implications were discussed with patients as part of the informed consent process. We evaluated consent forms and related other chart documentation for 91 patients (ranging from age 60 to 89 years) undergoing first-time ICD placement at a mid-western academic medical center from 2006-2008. Only one chart documented any discussion of end-of-life implications, in a case where the issue was raised by a patient who noted that quality of life was their main focus. Consent was provided by a health care surrogate in only four of the 91 cases. In conclusion, patients giving consent for ICD implantation may be uninformed about the device's potential future impact on end-of-life care, the dying process, and the option for device deactivation. Truly informed consent requires that both short- and long-term potential implications be reviewed with patients.
- Informed Consent
- Care of the Dying Patient
- Technology/Risk Assessment
- Clinical Ethics
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Implantable cardioverter defibrillators (ICDs) are placed for prevention of fatal abnormal heart rhythms or cardiac arrest. In selected patients at risk for these life threatening events, multiple randomised clinical trials have shown that ICDs reduce mortality.1 Indications for ICD placement have been disseminated by the American College of Cardiology and American Heart Association Task Force on Practice Guidelines.2 A striking increase in the number of ICD placements has been observed in response to these new guidelines.2
Like any other procedure, placement of an ICD requires informed consent. Informed consent requires understanding of risks and benefits of the procedure. Along with short-term complications of the ICD placement procedure, there are also longer-term or therapy-related complications including frequent and/or painful shocks (appropriate or inappropriate) and psychological reactions. Another potential long-term complication of the device includes prolongation of an uncomfortable dying process. Patients or their surrogate decision makers have the option of deactivating the ICD in this situation.3 Deactivation can lead to an uncorrected fatal abnormal heart rhythm, allowing death to occur naturally without the possibility of unwanted electrical shocks.
Unfortunately, clinicians discuss deactivation of the ICD with few patients.4 When the discussion does take place, it happens more often in the last few days of life.4 Deactivating the ICD is an ethically-challenging decision for the patient, the family and the clinician. Although some feel that deactivation will assist death and is therefore unethical, competent patients have the right to refuse or discontinue any treatment for any reason.5
Since some patients with ICDs will eventually reach a clinical situation in which high quality end-of-life treatment and palliative symptom management are their preferred goals of care, it is important for them to understand that the option exists to deactivate or reprogramme the ICD, if they wish, so that its function does not interfere with the natural dying process. However, many patients are unaware of this option.4 We hypothesised that patients eligible for ICD placement are not fully informed during the consent process of its potential future impact on end-of-life care.
Our primary goal was to review ICD consent forms and related hospital charting to determine whether end-of-life implications appear to have been discussed and documented during the consent process. Our focus was on persons aged 60 years and older, in part because the vast majority of ICD placements occur in this age group.6 In addition, older adults are more likely to have multi-morbidity, and thus a greater risk of competing mortality from other conditions, compared with most young persons who receive an ICD. At advanced age, patient preferences may be influenced in part by perceived proximity to death, burden of disease, functional impairment, quality of life and other considerations. A secondary goal was to determine how often proxy consents were obtained, rather than direct patient consent, for older persons receiving ICDs, and why the proxy consent was obtained.
Our findings are fodder for ethics consideration on moral responsibility in the ICD informed consent process. Provider responsibility is shirked if that process does not include overt discussion of deactivation options. Physician providers in particular have a moral duty to ensure this by various means.
We conducted a retrospective chart review for patients who underwent ICD placement at a mid-western academic medical centre from 2006–2008. Inclusion criteria were age 60 years or older and a first time ICD placement procedure. We excluded procedures that represented upgrades from previously placed ICD or pacemakers. We also excluded subjects for whom the consent form or relevant parts of the medical record were missing.
We reviewed inpatient charts from each ICD placement admission to abstract data including sex, age, cardiovascular diagnoses, other serious life-limiting diagnoses, any evidence of cognitive impairment and all elements related to the ICD consent process. Specifically, we reviewed the history and physical examination, consent forms for ICD placement, electrophysiology consult contents and discharge summary contents. We also gathered information from progress notes that were relevant to the ICD consent discussion and considered any comments about ICD consent, risks and/or benefits to be part of the consent discussion, if they were mentioned anywhere in the charting.
We determined whether the consent form was a generic consent form (ie, with blank lines that can be filled in to describe risks for any medical procedure) or a pre-printed consent form specifically design for ICD placement. We categorised what type of health professional explained the risks and benefits and obtained the consent. We abstracted all risks that were documented to be associated with the procedure, whether any option for device deactivation in future was mentioned, whether any mention was made of the possibility that the device might impact future end-of-life care. We determined whether or not a proxy had signed the consent form, the relationship of the proxy consenter to the patient, and whether or not a reason was documented for the use of a proxy. We specifically looked for mention of dementia, delirium, agitation, or care processes that would preclude communication with the patient, such as mechanical ventilation.
Descriptive statistics were calculated for all demographic and clinical variables. The University of Kansas Medical Center Human Subjects Committee approved the chart review study protocol.
Ninety-one patients met the inclusion/exclusion criteria. The median age was 72 years, with an age range of 60–89 years, and 62% (n=56) were men. Physicians (electrophysiologists) obtained the consent in all cases. All consent forms used were generic, with only the risks of bleeding and infection pre-printed in the procedure consent form. Although additional space is provided in the consent form to add additional procedure-specific risks, only one patient signed a consent form to which ICD-specific risks had been added.
When taking into account other elements that mentioned procedure risks and consent, we found 16 subjects (17.5%) for whom additional risks were documented to have been discussed. These additions were usually found in the admitting history and physical examination or the electrophysiology consultation notes. Among these 16 patients, the following individual complications were documented as possible procedure-related risks: infection 100% (n=16), bleeding (100% (n=16), pneumothorax 75% (n=12), cardiac perforation (69% (n=11), stroke 56% (n=9), death 50% (n=8), myocardial infarction 44% (n=7), hemothorax 19% (n=3), swelling 19% (n=3), device malfunction 6% (n=1) and end-of-life implications 6% (n=1).
Only one study subject had documentation of a discussion regarding device impact on future end of life care. The discussion was initiated by the patient in whom quality of life was the main concern. Documentation showed that the physician indicated that the defibrillator could be turned off if she later became dissatisfied with the quality of life or became disinterested in ICD therapy. She then received the ICD. No other patients had a documented discussion of the possibility of future device deactivation.
Of all consents obtained, only four were proxy consents. The age of these patients ranged from 76 to 88 years. Two of the proxies were a spouse, one was the oldest child, and one was of unknown relation. All proxies were health care surrogate decision makers. The reasons for proxy consent were the following: two were sedated and mechanically ventilated, and two were legally blind requiring a spousal signature for consent. Neither dementia nor delirium was documented in the charts of any of the entire group of 91 patients.
Although the informed consent process offers a key opportunity to discuss eventual end-of-life implications, our results suggest that consent discussions rarely touch upon this topic.
Historically, opinions regarding timing of disclosure of long-term potential complications of ICDs have varied. This issue reached the lay public's attention in 2002 through a New York Times article regarding defibrillators and their potential to prolong misery at the end-of-life. Some cardiologists were not inclined to discuss this issue until an end-of-life situation had arisen, while other cardiologists felt it was appropriate to discuss this issue with the patient while they are healthy before the implantation.7 Ironically, many patients are not healthy at the time of implant, as some already have symptomatic heart failure at the time of implantation.8
Other studies published in 2008 and 2009 describe a variety of conflicting views about the appropriate timing of the conversation about end-of-life implications of having an ICD implanted. Some specialists and primary care providers agree that the possibility of future ICD deactivation should be addressed as part of advance care planning.9 The majority of general internists (95%) and geriatricians (95%) believed that information about deactivation should be given during the time of the consent process.10 In striking contrast, only 56% of electrophysiologists agreed that deactivation information should be provided during procedure consent.10 Another qualitative study published 2008 showed that the majority of surveyed physicians, including electrophysiologists, feel it is not their responsibility to have this discussion.11
A more recent systematic review of attitudes about ICD deactivation published in 2011 shows that many providers are reluctant to discuss the option of deactivation, even at the end of life.12 Varying patient attitudes and level of understanding also contribute. Russo points out that, ‘…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’.12
Thus it should be no surprise that discussion of these issues prior to device implantation—often years or even decades before deactivation might be clinically relevant—is even less common. However, relevant professional organisations agree that pre-implantation patient education should include end-of-life implications.12 Consensus statements from both Heart Rhythm Society and European Heart Rhythm Association in 2010 recommend that communications about ICD deactivation begin prior to implantation and continue over time as a patient's health status changes.13 ,14
Some postulated reasons why future deactivation is generally not discussed during the consent process may include a lack of time, a feeling of an inadequate patient-physician relationship to discuss deactivation, discomfort with the conversation, and fear of taking away hope.9
Informed consent discussion of other longer-term, future complications might also be avoided too often by physicians. These other long-term complications include decreased quality of life due to psychological consequences, especially in patients who have received shocks.8 In a time-pressured, procedural environment in which the electrophysiologist does not know the patient as well as their primary care provider, it may seem preferable to those obtaining consent to focus on the immediate procedure-related complications at the time of consent, and leave the long-term complications for a later discussion.
Some data suggest that patients prefer not to discuss device deactivation and would prefer their physician to make that decision.15 Similarly, patients interviewed in Agards study, who were asked about their experience of the disclosure of information and their role in the decision to start ICD treatment, felt that the decision was too complex for them to have an opinion, and therefore relied on the doctors judgment. These patients were all had chronic moderate to severe heart failure. The patients only understood that they needed an ICD to prevent future occurrences of a serious event, and did not feel that more information was necessary.16 This may reflect patients’ desire for greater physician responsibility and not necessarily a hankering for bygone days of medical paternalism. It is true that some patients are offered an ICD during the time of an acute illness and hospitalisation, and may not have the mental capacity to support full disclosure of risks of an ICD.
In the emergent cases in which patients do not have the mental capacity for full disclosure of ICD long-term complications, other opportunities do arise when the patient is in more stable condition for further education and disclosure. The goal is to prepare the patient for further discussion when the need does arrive to consider deactivation of the ICD.
In our study, proxies for ICD consent accounted for few cases (4 of 91). All four patients with proxy consent were over age 75 years, and the stated reasons did not include chronically or acutely-impaired cognition. Proxies likely are more involved at later stages of care and decision making. Inclusion of future proxies in the informed consent discussion is still warranted then, and in particular, that part pertaining to end-of-life considerations such as deactivation of ICDs.
Despite a preponderance of medical and ethical opinion that doing so could be morally permissible, deactivation as an end-of-life option remains controversial. Wu has argued that patients have an autonomy right to terminate an ICD device, but that this right is not absolute. ‘By consenting to having an implantable device placed, the patient is indirectly giving up the right to autonomous control of the device’.17 Sulmasy acknowledges an emotional distinction between external devices and those implanted, but makes a case on Catholic moral grounds that ‘the deactivation of an ICD is best classified…as the forgoing of an extraordinary means of care’.18 He claims that ICD deactivation therefore could be morally permissible even for those who oppose acts of euthanasia or assisted suicide.18 Goldstein et al describe a focus group of 15 ICD patients, none of whom had discussed deactivation with physicians amidst assumption that deactivation would be ‘like an act of suicide’.15 Citing Sulmasy's distinction between ‘substitutive’ and ‘replacement’ therapies,18 Kay and Bittner are ethically agreeable to ICD deactivation, while not so for pacemakers, the termination of which they believe constitutes ‘killing the patient’ and ‘euthanasia’.19 Ethics controversy merely confirms the notion that ICD placement requires more attention upfront to the difficult decisions that patients, proxies, and providers all might encounter down the road.
What all agree upon surely is that the sort of situation described by a VA hospice nurse practitioner is ethically unacceptable. In response to Ballentine's article on the ethics of ICD deactivation,5 Deborah Grassman writes:
We had a patient who went home with home hospice. The defibrillator was never turned off. As a result, the wife reported that the patient died in her arms while the defibrillator jolted him 33 times before the battery ran down. She stated that the defibrillator got so hot that it burned through his skin. Needless to say, this greatly distressed his wife. She's had difficulty getting this memory of her last moments with her husband out of her mind.20
The caregiver asks retrospectively about obligation and responsibility: ‘Doesn't the manufacturer have an ethical and legal obligation to address this issue in its printed materials?…Should surgeons and manufacturers be forced to watch a person get shocked 33 times as they die so they might then accept responsibility for providing informed consent?’20
Our data and ethical reflection lead us, also, to ask questions of obligation and responsibility. Universally accepted medical principles of beneficence and non-maleficence speak to the clear obligations of treating physicians to do what is necessary for their patients’ benefit, and so as to avoid horrific death scenes as described by Grassman. Therefore physicians surely bear moral obligation to inform patients as fully as possible, in advance, about end-of-life deactivation.
Moral responsibility is understood as response-ability, weighing most heavily in any given situation on those situated so as to be best able to respond. With variance a possibility, it would seem that an ICD patients’ cardiologist or electrophysiologist typically might be in optimal position to initiate discussion of future deactivation decisions. If so, this constitutes heavy moral responsibility, one that data suggests remains largely unfulfilled.
One potential solution to this problem is to use pre-printed, procedure-specific consent forms that contain more detail, including checklists of short-term risks and their estimated rates, longer-term risks, and end-of-life implications that the patient may or may not want to then discuss further prior to ICD implant. More time may need to be allotted by cardiologists to the consent process, with greater intentionality around end-of-life considerations. If this is an uncomfortable topic, moral courage is required as well. An ethics consultant, social worker, or some other colleague with ethics competence might become a routine co-informer and discussant so as to enable and ensure a better consent conversation.
Additionally, if education about the option to deactivate cannot or does not occur at the time of consent for ICD implantation, there is ample opportunity for most patients to have this education afterwards. Regular follow-up appointments with cardiologists, during which these devices are routinely checked, provide another venue in which specific patient education about ICDs, and the option to deactivate during end of life care, can be reinforced.
A widely accepted principle of medical ethics is respect for patients’ autonomy, upon which all informed consent is premised. In the case of ICD placement, and potential future deactivation, it is the height of respect to offer crucial information that seems to have been missed in the consent discussions reviewed in our data. Rectifying this omission is ethically and practically requisite if patients and/or proxies are to make good decisions at the end of life.
There are several important limitations to the conclusions that can be drawn from these results. First, as in any chart review, we can only identify what was discussed from what was documented in the hospital chart. Many of the study charts contained the statement ‘risks discussed in detail,’ and it is possible that end of life implications were discussed with patients and families, but that busy practitioners chose only to document the short-term procedural risks associated with ICD placement. Direct field observation of the consent process would be necessary to establish such a discrepancy. Another possibility is that some risks may have been discussed by a patients’ primary care physician prior to referral to the cardiologist, or by the cardiologist prior to admission for the procedure. Finally, these results are derived from a single academic medical centre in the Midwest and may not generalise well to other patient populations or other medical centres including community-based hospitals. It is possible also that some providers have rectified ICD informed consent deficiencies since 2008, the last year from which our data is drawn. However, Russo's thorough literature review published October 2011 confirms our sense that not much yet has changed.12
Contributors AN, JB and SR were involved in the conception and design of the study. AN was involved in the acquisition of data and along with SR analysed the data. AN, JB, TR and SR contributed to the interpretation of data. AN contributed to the drafting of the manuscript and the statistical analysis. JB, TR and SR were involved in the critical revision of the manuscript for important intellectual content. SR provided administrative and material support and supervision.
Competing interests None.
Ethics approval University of Kansas Medical Center Human Subjects Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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