Ethical challenges in advanced heart failure : Current Opinion in Supportive and Palliative Care

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Ethical challenges in advanced heart failure

Kini, Vinay; Kirkpatrick, James N.

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Current Opinion in Supportive and Palliative Care 7(1):p 21-28, March 2013. | DOI: 10.1097/SPC.0b013e32835c4915
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More than 23 million adults worldwide have heart failure [1]. Although survival after heart failure diagnosis has improved over time, mortality from heart failure remains high. Approximately 50% of people diagnosed with heart failure will die within 5 years [2]. Many of these patients will progress to advanced heart failure (AHF, known as ‘stage D’), which is characterized by symptoms at rest despite maximal medical therapy [3]. These patients are considered refractory, and upon reaching this stage both patient and physician are faced with difficult ethical decisions. Consideration of advanced therapies such as left ventricular assist devices (LVADs) or transplant, involvement of palliative care, transition to hospice care, and end-of-life issues such as advance directives and implantable cardioverter-defibrillator (ICD) deactivation need to be addressed.

Many advanced therapies such as LVADs and cardiac resynchronization therapy (CRT) are becoming more readily available to older and more refractory patients. Expanding indications for device therapy in AHF are based on clinical trials and expert opinion regarding their beneficial effects. However, careful consideration must be given to the possibility of doing harm, the potential to reduce quality of life, the cost to the general public, and disparities in the care of AHF patients. In this article, we will review the ethical considerations that patients and physicians face in the treatment of AHF, and present recommendations for new avenues of ethics research and training initiatives.


The traditional model for palliative care was developed in the 1960s to provide symptom control and psychosocial support during the terminal phase of a serious illness (primarily cancer) [4]. In contrast, the new palliative care model has a focus on maintaining and improving quality of life during any stage of illness, and involves life-prolonging therapy, symptom control, or both [5]. This new model is ideal for patients with AHF given difficulties in prognostication, the fact that most therapies in AHF are both life-prolonging and quality-of-life improving, and the ethical challenges that arise when discussing the various options for care of these patients.

Box 1:
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Prognosticating disease trajectory for patients with AHF is fraught with difficulty. Although many models have been developed for patients with heart failure, perhaps the most validated and widely used is the Seattle Heart Failure model. This model employs clinical characteristics to predict, with fairly good accuracy, an ambulatory heart failure patient's mortality at 1, 2, and 5 years [6]. However, a recent study showed that among a cohort of AHF patients being considered for LVAD or transplant, the model provided only modest discrimination of risk for mortality [7]. Another study tried to apply both the Seattle Heart Failure Model and Gold Standards Framework Prognostic Indicator Guide (simple criteria that identify patients who are near the end of life) [8] to ambulatory patients with severe heart failure [9▪▪]. Neither model accurately predicted which patients were in the last year of life. This difficulty in prognostication creates a challenge for clinicians to determine the appropriate time for the initiation of hospice care, or referral for advanced therapies such as LVAD.

Another challenge arises when considering advanced therapies for heart failure. In contrast to other terminal diseases such as cancer, many of the therapeutic options available for AHF are also palliative, that is, both life-prolonging and quality-of-life improving. Studies have shown that symptom burden and depression rates are similar among patients with heart failure and cancer [10]. Over 50% of patients with heart failure experience pain, with a majority of patients rating pain in the moderate-to-severe category [11]. Symptoms are often underrecognized by physicians and underreported by patients. In the Randomized Evaluation of Medical Assistance for Treatment of Congestive Heart Failure (REMATCH) study of destination LVAD therapy, patients randomized to LVAD not only lived longer than those randomized to medical therapy but also reported significant improvements in their quality of life [12]. However, complication rates were not negligible. A more recent study with second-generation LVADs showed slightly improved but still significant rates of infection, bleeding, and stroke [13▪]. The fact that patients who receive LVADs have improved quality of life despite increased rates of stroke and infection are likely more indicative of the severe symptoms experienced by heart failure patients than the ability of devices to deliver a good quality of life.

Several older studies highlighted that advance directives are underutilized in patients with heart failure [14,15], and recent studies show that this trend has continued. A study of Dutch outpatients with heart failure demonstrated that although most patients have preferences regarding their end-of-life care, only 3.9% of patients had discussed this with their clinician [16▪▪]. Another study in Canadian patients with heart failure showed that only 24% of patients knew what advance directives were. Once the concept of an advance directive was explained, a vast majority of patients (80%) wanted to discuss it with their clinicians [17▪]. These studies highlight the need and feasibility for advance care planning in patients with heart failure, and the need for palliative care staff to be involved in the decision-making process.

It has been suggested that the traditional hospice model, which includes the 6-month prognosis criterion from the Medicare Hospice Benefit, is unsuitable for AHF. A study from 2009 found that patients with AHF were significantly more likely than cancer patients to receive hospice care for greater than 6 months, and more likely to be discharged from hospice alive [18]. In addition, multiple recent studies have highlighted the significant gaps in the transition of care to hospice that heart failure patients experience. One study surveyed staff at over 100 hospice care facilities and found that significant amounts of clinically valid data were missing from patients with heart failure [19▪▪]. Adequate information regarding pacemakers was present only 70% of the time and ejection fraction only 50% of the time. In another study, 58% of hospice facilities reported that at least one patient had been shocked over the last year, but only 25% of facilities had a magnet available to deactivate an ICD [20].


Certain therapies for AHF pose very specific ethical challenges. In this section, ethical dilemmas related to ICDs and CRT devices, LVADs, intravenous inotropic therapy, and implantable monitoring devices will be discussed.

Implantable cardioverter defibrillators and cardiac resynchronization therapy

Primary prevention of sudden cardiac death in patients with systolic heart failure has rapidly become the most common indication for ICD implantation. Multiple trials have shown a clear mortality benefit in patients with cardiomyopathy and ventricular arrhythmia [21,22]. The mortality benefit may come at a price; although an older study showed that ICDs do not seem to affect patients’ quality of life [23], newer studies have challenged this notion. One recent study reported more than 10-fold higher levels of phobic anxiety among patients with ICDs, especially among those who had received shocks [24▪]. A large meta-analysis of over 5000 ICD patients reported an 11–28% incidence of depressive disorders and 11–26% incidence of anxiety disorder [25].

The concept of ‘quality of death’ in patients with ICDs is a challenging issue when patients approach end of life from progressive pump failure. Because ICDs perform the same function as external defibrillation, a decision to forego resuscitation should logically lead to deactivation of the ICD. Indeed, there have been media reports of patients receiving multiple shocks, while families watch helplessly [26]. In a telephone survey of next of kin of patients with ICDs who died of any cause, 8% reported that their family member received a shock from their ICD in the minutes before death. Fewer than one-third of these next of kin reported a discussion about end-of-life management of defibrillators [27]. Another study showed that of 420 patients who received an ICD, only 30% had an advance directive. Of these, only 2% had an advance directive that specifically mentioned the ICD or its deactivation at the end of life [28▪▪]. In another study of 278 patients with an ICD, more than half had completed an advance directive, but only 3 had included a plan for their ICD. Although a sizeable minority of patients did not believe that ICDs should be automatically deactivated in the setting of hospice or a DNR order, nearly all agreed that they should have the opportunity to complete an advance directive that specifically addressed their ICD [29▪]. Another recent study showed that most patients who have ICDs are unaware that their ICD can be deactivated, but the vast majority of these patients (84%) wanted to be involved in a discussion on ICD deactivation, and many felt that this should have been done prior to ICD implantation [30▪▪].

Furthermore, some recent data has shown that ICDs are not effective in preventing sudden death in older patients with heart failure. In a cohort of 99 heart failure patients older than 80 who received ICDs for primary prevention compared to a similar cohort who did not receive an ICD, only age and renal disease were the main determinants of survival. ICDs did not confer a survival benefit in patients older than 84 and with glomerular filtration rate less than 39 ml/min [31▪]. These may therefore be reasonable quantitative parameters that physicians and patients can use to discuss the timing of ICD deactivation.

CRT (biventricular pacing) has been proven in multiple trials to not only prolong life, but also to significantly improve symptoms such as exercise tolerance and dyspnea [32,33]. As the indications for CRT have increased, the number of biventricular pacemaker/ICDs (or CRT-D, ‘cardiac resynchronization therapy-defibrillators’) being placed has also increased. However, up to a third of patients who have biventricular pacemakers implanted do not derive benefit from their devices. These patients are unnecessarily put at risk of immediate complications of device placement, such as pneumothorax and tamponade, and longer term consequences such as device infection and lead malfunction which can cause significant morbidity and mortality. Patients who have CRT-D devices should have the same opportunity to have an advance directive discussion about ICDs at the end of life as described above. As CRT alone both prolongs life and improves symptoms, there should be no need to deactivate it.

Ventricular assist devices

The anticipated explosion of destination LVAD use is already being seen from recent registry data [34] and has created ethical questions as patients are now living on long-term mechanical support. First, with an increase in the number of implanting centers, competency to implant becomes an issue. Long-term success rates of implantation may decrease and rates of complications may increase. Second, as LVAD technology improves, elderly people and those with more comorbidities are likely to get destination therapy. Many of these patients will live long enough to die from other diseases. Device failure may also become more of an issue as patients who have less severe heart failure may get destination therapy and live much longer on LVAD support. These issues raise the following questions: Should patients who are candidates for LVADs be required to complete advance directives? Should palliative care become involved prior to an LVAD being implanted? How should LVAD withdrawal take place?

Several recent studies have begun to examine these questions. One described a ‘preparedness planning’ protocol with 13 patients who were undergoing destination LVAD therapy. The protocol included psychosocial and financial considerations, caregiving concerns, quality of life indicators, and discussion of catastrophic complications such as device failure. The authors importantly also addressed possible scenarios that would lead to significantly decreased quality of life such as nonfatal stroke and permanent renal failure [35▪▪]. Another recent study outlines a comprehensive 10-point model addressing the ethical and psychosocial issues, including completion of a device advance directive, that should be discussed with patients prior to undergoing LVAD implantation [36▪▪]. Two other small retrospective studies analyzed the experiences with patients or surrogates who requested LVAD withdrawal. They found that request for withdrawal was not uncommon in terminal situations such as cancer, or situations with low quality of life such as irreversible ventilator-dependent respiratory failure. However, none of the patients had device advance directives [37,38].

The interaction of LVADs and heart transplant raises another host of ethical questions. With the expected increase in the durability of LVADs, patients with AHF may become less dependent on cardiac transplant for definitive therapy. Could LVAD free up donor hearts for other patients? Should patients have to be on an LVAD for a certain amount of time in order to get a transplant? If a patient is nearing the age cutoff for transplant, would it be better not to get an LVAD but instead remain sick enough to be high on the transplant list to improve the chance of getting a suitable donor organ? This last issue was raised over 10 years ago [39], but remains a dilemma today.

Intravenous inotropes

Continuous intravenous inotropic therapy can treat refractory symptoms of AHF. While this therapy has traditionally been used as a bridge to transplant or LVAD, it may also be considered as part of palliative or hospice care [40,41]. However, intravenous infusions at home can present a major burden to the family and health services, and may ultimately increase the risk of death from arrhythmia. The primary ethical tension is between improved quality of life and shortening of life. If continuous inotropic therapy is being considered for a patient who is not a transplant or LVAD candidate, informed consent should be part of the process, and palliative care teams should probably be involved. If a patient has an ICD in place, it should be turned off to prevent recurrent shocks.

Implanted monitoring devices

Implantable monitoring devices are a newer technology that has gained some support. These devices can provide minute-by-minute information about a patient's hemodynamic status. Physicians receiving reports can adjust therapy in order to reduce hospitalizations and stave off symptoms, thereby improving quality of life. In one major trial, patients were randomized to daily hemodynamic measurements via implantation of a wireless pulmonary artery monitoring device, versus standard of care (regular visits with clinicians and symptom-based therapy) [42]. This trial demonstrates an inherent tension between beneficence and nonmaleficence that is common to invasive diagnostic techniques and therapies. The treatment group did have a 37% reduction in heart-failure-related-hospitalization compared to the control group, but there were 15 serious adverse events reported during 575 implant attempts. Quality of life of the patients was not reported by the authors. The role of implantable monitoring devices in AHF is still not well defined, and requires further study and ethical analysis.


The ethical challenges of the treatment of AHF are not limited solely to the patient. In this section, the societal impact of treating AHF will be discussed.

Costs and cost–effectiveness of device therapy in advanced heart failure

It is estimated that the total direct and indirect costs of caring for patients with heart failure in 2010 was US$34.4 billion [43]. With the recent increased emphasis on containing the costs of healthcare, it is important to understand the economic burden of AHF and how device therapies can affect the costs of caring for these patients.

In a recent analysis, the incremental cost–effectiveness ratio (ICER) of a continuous flow LVAD was US$198 194 per quality-adjusted life year (QALY) [44▪], which does not meet the currently accepted standard principle of resource allocation in the USA. Multiple cost–effectiveness analyses in both the USA and Europe have concluded that ICDs, CRT, and CRT-D, are costeffective [45▪,46–48]. However, it should be kept in mind that ICDs are not effective in patients who are dying from progressive pump failure, and should only be considered in patients who are receiving optimal medical therapy and have a reasonable expectation of survival with good functional status for greater than 1 year [49].

Furthermore, general cost–effectiveness data does not take into account the burden that widespread use of devices will bring. Although a single device may be costeffective, implanting many devices into an aging population can lead to significant increases in healthcare expenditures. Elderly people who live longer because of device implantation may develop other morbid illnesses and thereby may increase healthcare spending as well as have a lower quality of life. The considerable cost to society should not be disregarded, especially as device usage is expected to increase significantly.

Caregiver stress

Caring for the patient with AHF can have significant impact on the caregiver. There have been several recent studies exploring this issue. One study surveyed 14 partners of individuals diagnosed with severe heart failure and found that caregivers had difficulty planning for the future because of a poor understanding of the patient's prognosis [50▪]. Another study found that caregivers who had less social support perceived their caregiving as more burdensome and less rewarding [51]. Yet another study found that high caregiver burden correlated strongly with symptoms of depression [52▪]. All of the studies found that caregiving results in social isolation. Clinicians are likely to underappreciate the fact that illness affects more than just their patient. The stress of caregiving may impact the caregiver to the point that they are not capable of taking care of their loved one.

Disparities and distributive justice

It is clear that disparities in the provision of care exist based on race, ethnicity, sex, and socioeconomic status. A recent meta-analysis of 28 studies from across the world showed that patients of low socioeconomic status (including factors such as education, occupation, employment relations, social class, income, and housing characteristics) not only have a significantly increased incidence of heart failure, but also have higher readmission rates and higher mortality from heart failure [53▪]. In the USA, it has been recognized that underrepresented minorities with heart failure are hospitalized more frequently than whites, possibly because of decreased health literacy, absence of medical homes in minority neighborhoods, and the cost of seeking longitudinal medical care [54▪]. It has also long been recognized that women with acute cardiovascular disease have a higher mortality than men and are also less likely to receive adequate cardiovascular preventative care than men [55,56].

Distributive justice incorporates issues of rationing and fairness. Expensive and resource-limited therapies such as LVADs and transplant are usually offered only to the patients with the best chance to have a successful outcome based on age, comorbidities, and psychosocial factors. In Europe, therapies are rationed based on age and comorbidity. In the USA, certain therapies are rationed based on insurance status. Across the world, rationing may become increasingly necessary as government budgets are stretched, the population ages, and more people develop AHF. Decisions to offer LVADs and transplantation usually occur after committee debate or at least an informal discussion with several different physicians. The subjective nature of this process has both advantages and disadvantages over strict adherence to universal criteria. Local factors and patient characteristics can be taken into consideration. However, the possibility for social bias to influence deliberations (even if unconsciously) harkens to the use of social worth criteria by the so-called ‘Seattle God Committee’ in the USA to determinate candidates for the first renal dialysis machines.


It is clear that the ethical challenges abound in the treatment of patients with AHF. In this section, future directions and models to improve the care of patients with AHF will be discussed.

Cross training in cardiovascular disease and palliative care

It is estimated that by the year 2030, an additional 3 million people in the USA will have heart failure, a 25% increase in prevalence from 2010 [2]. Although comparative international epidemiological data are lacking, it is very likely that the prevalence of heart failure is on the rise because of the aging of the global population [57]. Currently, heart failure patients are much less likely than cancer patients to utilize hospice services [58]. It is almost certain that there will be a growing demand for tailored end-of-life care, and providers who are cross-trained in cardiovascular medicine and palliative care will play an important role. Cardiovascular training programs should incorporate training in palliative care skills, and palliative care providers should gain more experience with heart failure patients and heart failure therapies.

New models for advance directives tailored to advanced heart failure

Advance directives that specifically address what to do with heart failure devices at the end of patients’ lives should be the standard of care and filled out by patients prior to implantation or at the first follow-up visit. For patients with devices that impact quality of life such as LVAD and CRT, it may be advisable to readdress advance directives after patients have had a chance to ‘get used to’ the device. These device advance directives need not be overly detailed but should follow the general principle of the ‘preparedness plan’ proposed by Swetz et al. in listing certain known potential clinical states which might lead to reconsideration of device therapy. Patients’ values and goals should be elicited by clinicians in order to inform recommendations about the initial implantation and discontinuation of device therapies [59].

The timing of advance directives discussions should be ‘early and often’. Professional societies have published scientific statements advocating the early introduction of the concept that heart failure is a progressive and terminal condition. These statements provide sample language to use in addressing the care of heart failure devices at different stages in the disease course [60–62]. Advance directives should also be revisited at opportune times, such as deterioration in the clinical status, development of significant comorbidities, and need for device upgrade [63].

Ethical discussion of resource utilization

Systematic differences in the treatment of patients of different race, sex, and socioeconomic status with heart failure deserve further study. Efforts must be made to reduce the gap in provision of care for these groups. A better understanding of cultural differences in end-of-life care is needed to improve palliative care and hospice utilization among underrepresented groups. Further work is needed to explore the ethical and moral values underlying rationing schemes for heart failure devices and heart transplantation, particularly the impact on the clinician–patient relationship if rationing decisions are made at the bedside, the influence of unconscious bias and strong personalities on committee level decisions, and inflexibility and lack of social consensus pertaining to universal criteria.


Clinicians caring for patients with AHF must navigate ethical challenges. Difficulties in prognostication, complexities of cardiovascular device therapy, potential harm of these devices to patient and society, and specific palliative care needs are issues that must be explored. More research needs to be done to better understand these ethical dilemmas in order to provide better and more appropriate care for patients.



Conflicts of Interest

Dr Kirkpatrick reports receiving a grant from the Greenwall Foundation to study caregiver stress in LVAD patients. Dr Kini reports no conflicts of interest.


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 (pp. 117–118).


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50▪. Imes CC, Dougherty CM, Pyper G, et al. Descriptive study of partners’ experiences of living with severe heart failure. Heart Lung 2011; 40:208–216.

The authors of this study conducted interviews with caregivers of patients with heart failure, and found that caregiving results in social isolation and difficulties in planning for the future.

51. Hwang B, Fleischmann KE, Howie-Esquivel J, et al. Caregiving for patients with heart failure: impact on patients’ families. Am J Crit Care 2011; 20:431–442.
52▪. Trivedi RB, Piette J, Fihn SD, et al. Examining the interrelatedness of patient and spousal stress in heart failure: conceptual model and pilot data. J Cardiovasc Nurs 2012; 27:24–32.

The authors of this study conducted interviews with patients with heart failure and their spouses, and found high levels of depression and caregiver burden.

53▪. Hawkins NM, Jhund PS, McMurray JJ, et al. Heart failure and socioeconomic status: accumulating evidence of inequality. Eur J Heart Fail 2012; 14:138–146.

The authors of this study conducted an international meta-analysis of 28 studies that examined the impact of socioeconomic status on heart failure, and found that patients with lower socioeconomic status have an increased prevalence of heart failure and higher mortality from heart failure.

54▪. Chaudhry SI, Herrin J, Phillips C, et al. Racial disparities in health literacy and access to care among patients with heart failure. J Card Fail 2011; 17:122–127.

The authors of this study showed that among patients with heart failure, black race was strongly associated with worse health literacy and all measures of poor access to care.

55. Vaccarino V, Parsons L, Peterson ED, et al. Sex differences in mortality after acute myocardial infarction: changes from. Arch Intern Med 2009; 169:1767–1774.
56. Mosca L, Linfante AH, Benjamin EJ, et al. National study of physician awareness and adherence to cardiovascular disease prevention guidelines. Circulation 2005; 111:499–510.
57. Tendera M. Epidemiology, treatment, and guidelines for the treatment of heart failure in Europe. Eur Heart J Suppl 2005; 7:J5–J9.
58. Setoguchi S, Glynn RJ, Stedman M, et al. Hospice, opiates, and acute care service use among the elderly before death from heart failure or cancer. Am Heart J 2010; 160:139–144.
59. Allen LA, Stevenson LW, Grady KL, et al. Decision making in advanced heart failure: a scientific statement from the American Heart Association. Circulation 2012; 125:1928–1952.
60. Lampert R, Hayes DL, Annas GJ, et al. HRS expert consensus statement on the management of cardiovascular implantable electronic devices in patients nearing end of life or requesting withdrawal of therapy. Heart Rhythm 2010; 7:1008–1026.
61. McKelvie RS, Moe GW, Cheung A, et al. The 2011 Canadian Cardiovascular Society heart failure guidelines update: focus on sleep apnea, renal dysfunction, mechanical circulatory support, and palliative care. Can J Cardiol 2011; 27:319–338.
62. Wilkoff BL, Auricchio A, Brugada J, et al. HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): description of techniques, indications, personnel, frequency and ethical considerations. Europace 2008; 10:707–725.
63. Goodlin SJ, Hauptman PJ, Arnold R, et al. Consensus statement: palliative and supportive care in heart failure. J Card Fail 2004; 10:200–209.

advance directives; advanced heart failure; ethics; implantable cardioverter defibrillators; ventricular assist devices

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