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Ethical and legal perspective of implantable cardioverter defibrillator deactivation or implantable cardioverter defibrillator generator replacement in the elderly

Wright, Gary A.; Klein, George J.; Gula, Lorne J.

Current Opinion in Cardiology: January 2013 - Volume 28 - Issue 1 - p 43–49
doi: 10.1097/HCO.0b013e32835b0b3b
ARRHYTHMIAS: Edited by Anthony Tang

Purpose of review Implantable cardioverter defibrillator (ICD) implantation has become a common and standard treatment for primary and secondary prevention of sudden cardiac death in patients with poor left ventricular ejection fraction across the world. Circumstances, of course, change after the initial implant as patients age. This raises legal and ethical questions about deactivating or not replacing ICD generators when the likelihood of meaningful benefit has diminished.

Recent findings Health professionals are reluctant to discuss the end-of-life planning with patients who have ICDs. Older patients are more likely to have multiple comorbidities that worsen or accumulate further after initial implantation and attenuate the survival benefit of ICDs. Joint guidelines suggest physicians educate patients during the initial consent process about the possibility of deactivating ICDs after implantation if their individual situation changes to the point of futility.

Summary ICD deactivation and nonreplacement are unavoidable issues that require clarity for meaningful and ethical implementation. This is an ongoing process.

Division of Cardiology, University of Western Ontario, London, Ontario, Canada

Correspondence to Dr Lorne J. Gula, MD, 339 Windermere Road, C6-110, London, ON, Canada N6A 5A5. Tel: +1 519 663 3746; fax: +1 519 663 3782; e-mail: lgula@uwo.ca

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INTRODUCTION

Despite the introduction of new technologies, all patients will ultimately reach the end of their lives. The time course of this is related to the underlying cardiac condition, development of another terminal illness, or worsening of concomitant chronic diseases. Twenty percent of implantable cardioverter defibrillator (ICD) patients receive shocks in the last weeks of their lives. These are painful and decrease the quality of life, greatly contributing to the distress of patients and their families in this period [1–3]. The United States National ICD registry reveals that, over a 3-year period from 2006 to 2008, there were 339 076 ICDs implanted, with increasing device implants year on year [4]. There is growing prescription of ICDs in the elderly, with 42% of these patients being above the age of 70 years and 12.4% older than 80 years. Of these age groups, 82 and 79% were for primary prevention, respectively. The number of ICDs implanted internationally is variable, with Europe having approximately one quarter of that in the USA [5,6].

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IMPLANTABLE CARDIOVERTER DEFIBRILLATORS IN THE ELDERLY

Elderly patients (≥75 years) with a history of life-threatening ventricular arrhythmias have a high incidence of nonarrhythmic death [7]. Although none of the large ICD trials excluded elderly patients, this group was poorly represented in these trials, with a mean age of participants of less than 70 years. A meta-analysis of three secondary prevention trials comparing ICD implantation with antiarrhythmic medication showed that patients older than 75 years were more likely to die of either nonarrhythmic death (13.46% per year vs. 5.47% per year, P = 0.001) or arrhythmic death (6.73% per year vs. 3.84% per year, P = 0.03) over a mean follow-up of 2.3 years. The ICD significantly reduced all-cause and arrhythmic death in patients less than 75 years old but not in patients of at least 75 years old [7]. Trial data on the elderly population exist but are underpowered and inconclusive. Those pertaining to patients with serious comorbidities are nonexistent as patients with renal disease, liver disease, valvular disease, psychiatric history, and numerous other comorbidities were excluded from the trials.

Box 1

Box 1

Quantifying the probable benefit of ICD insertion for a patient on the basis of data from existing trials is challenging, because the data on risk reduction are derived from trials with broad enrollment criteria. Although relative reductions in mortality risk with ICD insertion in this group range from 23 to 59%, the absolute risk reductions are much smaller (7–19%) [8,9].

Among 204 elderly patients (≥75 years) with a prior myocardial infarction and left ventricular ejection fraction (LVEF) less than 30% enrolled in Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II, a primary prevention ICD trial, mortality with ICD therapy was similar to that for younger patients [10]. Subgroup analyses by age (≤65 vs. > 65 years) from Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure and Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) showed some attenuated benefit among the older group, but lack of significant interaction between age and outcome in subsequent analysis lends uncertainty to the impact of age on treatment effects [11].

In a study of 107 consecutive patients greater than 80 years of age (82% with ischemic cardiomyopathy) and 241 consecutive patients 60–70 years of age (80% with ischemic cardiomyopathy), life-expectancy after ICD implantation among those greater than 80 years was 4.2 years compared with 7 years among those 60–70 years old (P = 0.004) [12]. Poor renal function was the most powerful prognosticator for poor outcome in both groups.

In addition to age, the nature and number of noncardiac comorbidities greatly influence ultimate survival benefit from the ICD. In one registry of 2467 patients who received ICD therapy, although age greater than 75 years and heart failure were important predictors of death at 1 and 2 years of follow-up, the presence of three or more noncardiac comorbidities was associated with a three-fold increase in the hazard for mortality in a multivariate model adjusted for age, sex, and prior heart failure. Impaired renal function again conferred a particularly poor prognosis [13▪].

Although potentially life-saving, ICD implantation remains an invasive procedure with potential for mortality and serious morbidity. Acute complications occurred in 5% of patients randomized to receive ICD therapy in the SCD-HeFT trial [9] and about 2.5% of patients randomized to receive ICD implantation in MADIT-II [14]. These risks would not be expected to diminish in the elderly with significant comorbidities.

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IMPLANTABLE CARDIOVERTER DEFIBRILLATOR GENERATOR REPLACEMENT: A TIME OF CHANGE IN THE RISK/BENEFIT PROPOSITION?

The question of age and comorbidity in the initial decision to implant is complicated, but many elderly patients receive and benefit from ICDs. This must remain a thoughtful decision based on guidelines and individual considerations. A related issue is whether to replace a generator that is approaching end of life at a time when there can be little expected improvement in quality and lifespan to balance against the cost and complications of replacement. A contemporary prospective, multicenter, population-based registry study in Ontario, Canada, examined 45-day complication and mortality rates in all patients undergoing ICD generator replacement. Over a 30-month period, 1081 generator replacements were performed in 18 centers across Ontario. The mean age was 64.3 years. A total of 4.3% of patients undergoing ICD generator change experienced a complication in the 45 days after procedure [15▪].

An earlier retrospective report from 17 Canadian centers described a major complication rate of 5.8% in 533 patients at 3 months and a 5.9% rate in 451 patients at 12 months for patients undergoing an ICD generator replacement because of an advisory indication [16]. Similar results were seen in a recent large, prospective, American study. The REPLACE registry assessed complication rates with generator replacement over a 6-month follow-up. A total of 1031 patients at 72 academic US centers were included with a mean age 70.6 ± 14.1 years [17▪▪]. The major complication rate was 4.0% and minor complication rate 7.4%. Risk of complications with ICD generator change was higher than pacemaker generator change (odds ratio 2.38; 95% confidence interval 1.30–4.38). As well as complications from device implant and generator change, some studies report that 25–35% of patients receive inappropriate shocks from ICDs, which can be distressing for the patient and family [18,19].

There are obvious financial considerations relating to ICD replacement. Sanders et al. [20] performed an extensive analysis of the cost-effectiveness of ICDs for the major randomized ICD trials, which ranged from $25 000 to $50 000 per life-year saved. The populations showing greatest cost-effectiveness of the ICD, consistent with the lower numbers needed to treat, were those in MADIT and Multicenter Unsustained Tachycardia Trial, with approximately $25 000 per life-year added. The ICD was less cost-effective in the MADIT-II and SCD-HeFT populations, with $39 000 to $50 000 per life-year added, respectively.

Finally, the very elderly patient may come to ICD end-of-life after 5–7 years without a history of tachycardia detection over the past 5–8 years. They arguably represent a relatively low risk for arrhythmic death and any potential ‘returns’ in meaningful life prolongation from the ICD have diminished. In these patients in particular, the risk of a complication may well outweigh foreseeable benefit.

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IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEACTIVATION: AN EMERGING ISSUE

This issue is related to the decision to replace a generator at the end of life in that a patient and the supporting health team decide that the device is no longer performing a meaningful purpose for them. It is unique in that it actively involves a programming change that removes potentially life-saving therapies but does not involve any intrinsic risk or cost. Nonetheless, many of the ethical considerations and guidelines seem appropriate for both these related issues. Among physicians caring for patients with heart failure, few regularly discuss device deactivation with their patients [21]. Expert consensus statements published in 2008 and 2010 by the Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA) argue that patients near the end of life are very likely to develop frequent arrhythmias owing to hypoxia, sepsis, heart failure, and electrolyte imbalance [22–24]. The resultant ICD discharges are sometimes so frequent and uncomfortable that the harm derived from an ICD outweighs the benefits. Deactivation removes the direct therapeutic benefit of the ICD and neutralizes the harm from the device. Hence, in a patient near the end of life, reprogramming or deactivating the ICD could be appropriate. Both European and North American guidelines state that an ICD is appropriate in patients who fit the criteria and have a good quality of life, and have a life-expectancy of more than 1 year [22,25].

The HRS/EHRA Consensus on the monitoring of cardiovascular implantable electronic devices (CIEDs) stated that ‘The primary aim behind the rationale for deactivation must always be to respect the patient's right to live, or at least to die with dignity, while limiting any therapeutic action that increases the patient's level of stress, pain, or anxiety’ [23,24]. Many healthcare professionals and society in general remain uncomfortable with making any formal arrangement related to dying and are reluctant to engage with patients in any way that might lead to premature death, as technical developments may greatly extend life.

Unfortunately, few clinical trials of device-based therapy have enrolled enough elderly patients (age greater than 75 years) to reliably estimate the benefits of device-based therapy in this group. Indeed, patients in device trials have generally had an average age less than 65 years and little comorbidity. In contrast, the average patient hospitalized with heart failure and low LVEF is 75 years old with two comorbidities. The 1-year mortality rate for this population is in the range of 30–50%, with a two-fold higher risk of death in patients with estimated creatinine clearance less than 60 ml/min [26]. The presence of dementia and chronic pulmonary disease increases the risk for death further. Fewer than 10% of deaths in this population could be attributed to presumed sudden cardiac death in patients living independently [27,28▪▪].

In accord with the first dictum of the Hippocratic oath ‘first do no harm’, the treating and implanting physician bears responsibility for providing guidance to their patients facing decisions related to not performing generator change or ICD deactivation. Performing generator change has become automatic in the vast majority of practices. Given the conflicting evidence regarding the benefit of ICDs in the elderly population, especially those with concomitant comorbidities and the potential for harm, either by the device or during generator change, it is imperative that clinicians fully discuss the risks and benefits. This may mean a discussion about not performing a generator change at battery depletion or even of deactivating the ICD therapies entirely.

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WHO DECIDES TO DEACTIVATE AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR OR NOT PERFORM GENERATOR REPLACEMENT?

Informed consent is the most important aspect in the doctor–patient relationship. Doctors are ethically and legally obligated to ensure that patients are informed and allowed to participate in decision-making regarding their diagnoses and treatment options [29]. In addition to informed consent to a procedure, a patient also has the right to refuse any treatment and, importantly, to withdraw consent to a previously consented treatment if it no longer meets the patient's healthcare goals or if the perceived burden of the ongoing treatment outweighs the perceived benefits of the treatment [30–33]. If a clinician initiates or continues a treatment that a patient or surrogate decision maker has refused, then ethically and legally the clinician is in the wrong, regardless of the clinician's intent.

Importantly, these rights of refusal to treatment or previously agreed treatment extend to patients who lack decision-making capacity through previously expressed statements such as an advance directive and surrogate decision-makers [31–34].

There are a number of important legal and ethical principles to consider before deactivating an ICD or not performing a generator change in a patient with a functioning ICD. These principles are sanctioned by both the Heart Rhythm Society in North America and the EHRA in Europe and include the following concepts [23,24,35]:

  1. A patient or surrogate decision-maker has the legal right to refuse or request the withdrawal of ICD therapy.
  2. If a patient has the ability to understand the nature and consequences of their decisions, then legally they are competent to make those decisions.
  3. There are no ethical or legal differences between refusing ICD insertion and requesting withdrawal of ICD therapy in the form of deactivating the device or refusing or not performing generator change.
  4. Legally and ethically, carrying out a request to withdraw ICD therapy is neither physician-assisted suicide nor euthanasia.
  5. A clinician is not obligated to carry out ICD deactivation if it is in conflict with their individual values. In these circumstances, the clinician should involve a colleague who is willing to carry out the procedure [35].

A patient has the right to request the withdrawal of ICD therapies regardless of the reason and regardless of whether the ICD prolongs life. This is not the same as assisted suicide and there are two important factors, which are in accordance with fundamental legal principles of causation and intent, that differentiate the two. The first is the intent of the caregiver or doctor and the second is the cause of death. Firstly, by withdrawing an unwanted therapy, the doctor's intent is not to hasten the patient's demise but to remove a treatment perceived by the patient to be of no benefit and burdensome. Secondly, in assisted suicide the cause of death is the intervention itself as opposed to the underlying cause of the patient's medical condition; for example, a patient dying of ventricular tachycardia after deactivating an ICD or not performing a generator change would not be classed as assisted suicide or euthanasia, as this was the express wish of the patient, who died as a consequence of their underlying medical condition and not as a direct result of a medical intervention.

Each patient is unique and weighs the potential benefit and burden of ICD therapy in relation to their own values, preferences, and healthcare-related goals differently. Particular consideration needs to be given to older patients, as these values and goals may change over a short period of time compared with younger patients and need to be continuously reassessed by healthcare professionals. And, as mentioned above, older patients may cease to benefit from a previously implanted ICD because of progression of their underlying condition or development of concomitant comorbidities that reduce survival or quality of life. It is the job of the healthcare professionals, including the patient's family doctor, heart failure doctor, heart failure nurse, terminal care doctor, and implanting physician, to reassess their beliefs and values with regard to ICD deactivation. This is a continual process and part of the informed consent process. It may be that the best person to discuss this with the patient is a member of the heart failure team who sees the patient regularly and has formed a closer bond. They may be in a better position to evaluate the patient's decline in health and initiate a discussion about ICD deactivation or not proceeding with generator change well in advance of terminal illness.

Patients might request removal of the ICD generator rather than reprogramming. As the same effect can be obtained by reprogramming, surgical intervention is not recommended, especially as surgical intervention carries with it risk. Legally, patients have a right to refuse any treatment, but do not have the right to demand mistreatment. A physician may judge the removal reasonable under certain circumstances and after considered discussion and informed consent.

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WHO SHOULD DEACTIVATE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR?

Ethical and legal consultation is not required prior to device deactivation, but may be helpful in situations that are difficult to resolve, such as conflict between members of a family or disagreement between members of the healthcare team caring for a patient. The Joint European and North American guidelines require that healthcare institutions have a process for addressing ethical concerns.

Patients with ICDs rarely discuss device deactivation with their doctors or know that it is an option [1,2,36,37]. Doctors generally believe they should engage in these types of conversations with patients but rarely do [2,37–40]. Patients want to engage in discussions with health professionals about their health, and these conversations should include a discussion of quality of life, functional status, and what elements are important to the patient regarding control and dignity. We must determine what the patient and their family knows about the role the device plays in their health both currently and in the future [41]. This is particularly important, because data shows that some patients with ICDs do not understand the role the device plays in their health, particularly at the end of life [36].

Clinicians differ in their levels of expertise and comfort with these discussions and, as such, consultation with doctors from other specialties may be helpful. A multidisciplinary approach that includes doctors and nurses is essential to support and guide the patient and family through this decision [40]. There is general agreement in North America and Europe with regard to ICD deactivation in patients who request it.

Clinicians and allied health professionals, including industry, should not be compelled to carry out device deactivations if they view the procedure as morally objectionable. Both parties should work to achieve a mutually agreeable care plan. If such a plan cannot be achieved, then the primary physician should involve a second physician who is willing to co-manage the patient and provide care such as ICD deactivation, if this is the wish of the patient.

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LOGISTICS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DEACTIVATION

After discussing the issue of ICD deactivation with the patient and deeming the patient or surrogate to have capacity, the doctor must document this discussion and the patient's informed wishes. Deactivation of an ICD requires a written order from the responsible physician. According to the Joint Consensus guidelines, individuals with electrophysiology expertise should perform deactivation where possible [23,24]. This includes device physicians, nurses, or technologists. Deactivation of antitachycardia functions, with ongoing pacing for bradycardia as necessary, can be accomplished by device programming, or, if this is not available and in an emergent situation, then by application of a magnet directly over the device. Industry-employed allied professionals are permitted to provide technical assistance to medical personnel, who should then perform the actual deactivation. For patients in a medical facility without electrophysiology expertise, the healthcare provider must contact the principal responsible physician, who must then contact the device physician responsible for the patient's ICD to determine what therapies to deactivate. For patients who are unable to travel, the responsible physician should arrange for a programmer to be brought to the patient, whether that be in a medical facility or the patient's home.

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CONCLUSION

ICD implantation in North America and Europe is increasing year after year, with most patients being over 65 years old and more than 10% over 80 years old. ICD implantation in this latter group, especially, should be highly individualized as they are more likely to have multiple comorbidities that attenuate survival benefit. Joint guidelines suggest physicians meaningfully discuss during the consent process the possibility of deactivating ICDs after implantation if the individual situation changes such that potential harm outweighs benefit. This requires a continuing assessment and involves all involved healthcare professionals. The ultimate person to decide whether the ICD is burdensome is the patient or, if the patient lacks decision-making capacity, then the surrogate decision-maker or living will of the patient. Deactivation of an ICD or not performing a generator change is both legal and ethical, and supported by the guidelines from both sides of the Atlantic.

The replacement of the ICD generator in a patient whose situation has changed sufficiently to question the benefit and utility of the device is similar to the deactivation decision. There are no robust trial data to specifically guide us. As for deactivation, the decisions need to be individualized and made in concert with an informed patient, but ‘automatic’ replacement is inappropriate and there needs to be a thoughtful discussion with patients and their families about any potential continued benefit.

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Acknowledgements

None.

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Conflicts of interest

George Klein is a consultant for Medtronic. Lorne Gula has received speaker's fees and research funding from Medtronic. For Gary A. Wright, none were declared.

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REFERENCES AND RECOMMENDED READING

Papers of particular interest, published within the annual period of review, have been highlighted as:

  • ▪ of special interest
  • ▪▪ of outstanding interest

Additional references related to this topic can also be found in the Current World Literature section in this issue (p. 82).

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REFERENCES

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This study illustrates that patients with multiple comorbidities and, in particular, renal failure and diabetes with microvascular complications have a high mortality and may not benefit from ICD implantation.

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This study illustrates the high complication rates from ICD generator replacement and illustrates that it is not a benign procedure and can result in mortality.

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This large study again illustrates that ICD generator replacement has a significant complication rate.

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An analysis of MADIT-II showing that patients with significant comorbidities do not benefit from ICD therapy or have attenuated efficacy.

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Keywords:

elderly; ethics; ICD deactivation; legal

© 2013 Lippincott Williams & Wilkins, Inc.