Psychosocial and Quality of Life Issues in Mechanical Circulatory Support

Disparities in Access to Mechanical Circulatory Support

Disparities in access to health care, including organ transplantation, have been well documented; there are enduring worldwide disparities based on race/ethnicity, sex, geographic region, and socioeconomic status. Evidence suggests that similar psychosocial disparities exist for access to care for advanced heart disease, including MCS. Some disparities specific to MCS may have reflected technological limitations. For example, the larger fully implantable pulsatile devices that predominated in the 1990s and early 2000s were not compatible with female patients’ typically smaller body habitus. However, despite the smaller size of current MCS devices, the proportion of MCS recipients who are women continues to underrepresent the proportion of women with advanced heart disease who could benefit from this therapy.

Joyce and colleagues provided the most comprehensive analysis to date of not only sex-related but also other psychosocial disparities in access to MCS. They examined a large national database on interventions used for patients aged 18 to 85 years hospitalized from 2002 to 2003 for congestive heart failure or cardiogenic shock. Patients with diagnoses that represented clear contraindications to MCS implantation were excluded. Results indicated that, even after controlling for severity of medical comorbidities, patients who were older than 65 years, female, and/or African American were less likely to receive MCS. There were also marked geographic variations, with patients from the western United States showing the highest likelihood of receiving MCS relative to all other regions. Geographic disparities have been similarly noted in other countries and have been attributed to patient mix, referral patterns, and the regional distribution of centers that perform MCS implanation.

However, at least in the United States, Joyce and colleagues found no evidence that regional differences in MCS implantation rates varied by patient medical factors, and such differences were maintained even after controlling for the distribution of academic medical centers (which were more likely than nonacademic centers to use MCS). Furthermore, the strong evidence of race disparities in this study was also independent of patient medical factors and other factors, including whether patients were admitted to an academic center. Interestingly, neither insurance status nor average income in the communities where patients resided affected their likelihood of receiving MCS. Neither characteristic affected the association of race with receipt of MCS.

The race and sex disparities in MCS uncovered to date likely stem from multiple factors, including referral practices and biases, uneven application of evidence-based guidelines, and patient preferences for care. Patient preferences are addressed later; noted here is that further work is needed to delineate the underlying causes of unequal access to MCS so that appropriate steps can be taken to reduce or eliminate them. At least in the more general context of care for heart failure and cardiovascular disease, there is growing evidence that interventions that facilitate care provider adherence to clinical practice guidelines and algorithms can reduce some disparities in treatments offered to patients.

Informed Consent

Informed consent is a process, not an event, followed by documentation of that process (i.e., signing of a consent form). This process has four basic elements: (1) decision-making capacity of the patient or surrogate, (2) disclosure of sufficient details of the proposed treatment by the physician, (3) demonstration of understanding of the disclosed information by the patient or surrogate, and (4) voluntary agreement to the treatment. Importantly, this process is patient centric.

Patient and Family Preferences and Decision-Making

With the shift from physician- to patient-centric informed consent, advanced heart failure patient decision-making regarding the treatment options of continuing medical therapies or agreeing to MCS implantation requires not only that clinicians fully inform patients about treatment options but also that patients share their values and preferences for treatment with clinicians, hence the term “shared decision-making.” Shared decision-making has four components: (1) at minimum, two participants (i.e., a clinician and patient), (2) sharing of information by both participants, (3) consensus building about the preferred treatment, and (4) agreement on the treatment to be implemented. These components are the pillars of shared decision-making and as a whole, can build trust, enhance readiness for decision-making, align treatment options with desired outcomes, and reduce the potential for and resolve conflict. Given the complexities and trajectory of advanced heart failure and high-stakes nature of MCS, ideally, shared decision-making is an iterative process that evolves over time, as the patient’s condition changes and patient values, preferences, and goals are clarified. The value of the iterative nature of this process is also supported by literature that suggests that advanced heart failure patient preferences for desired outcomes can change over time.

Sharing of information is predicated on effective communication between participants that is clear and accurate. Sometimes, patients have preexisting notions or do not understand information being shared (e.g., about their health status and prognosis), which can result in misconceptions. In a study of ambulatory patients with heart failure, patients overestimated their life expectancy compared with model-based predictions for survival, using the Seattle Heart Failure Model. Furthermore, greater disease severity (i.e., higher New York Heart Association [NYHA] class and lower ejection fraction) was independently related to overestimation of life expectancy. Reasons for this discordance in heart failure patient versus model estimates of survival were not clear but may have included inadequate communication between clinicians and patients, patient-specific factors (e.g., hope and optimism), and language or cultural barriers. The researchers suggested that a better understanding of prognosis and life expectancy may be important to decision-making about advanced cardiac therapies, including MCS. In follow-up, this research team conducted a qualitative, descriptive study using semistructured interviews with patients diagnosed with heart failure ( n = 24) to explore their perceptions of model-based survival estimates. They determined that the majority of these patients wanted individualized prognostic survival estimates (preferably early in their disease history), recognized the uncertainty associated with these estimates, and viewed these estimates as providing hope and control rather than provoking anxiety.

Similarly, heart failure patients need to communicate their values, preferences, and goals. Regarding the option of MCS, clinicians might ask specific questions, such as “What do you hope to get from MCS surgery?” “What are you willing to give up when you get MCS surgery?” Ask-tell-ask is one of many useful communication techniques that can be used to engage patients and families in shared decision-making conversations.

There is a growing body of evidence about shared decision-making in patients with advanced heart failure who are considering MCS as a treatment option. McIlvennan and colleagues explored the decision-making processes of advanced heart failure patients considering MCS by conducting in-depth interviews with 22 patients ( n = 15 who had DT MCS implantation and n = 7 who declined device implant). The majority of those agreeing to MCS implant used an “automatic” decision process, while some agreeing to implant and all decliners used a more “reflective” process. Patients using an “automatic” decision process cited fear of dying and wanting to live as long as possible, noting that they “had no choice.” DT MCS decision-making with minimal deliberation has been reported by other researchers. In contrast, decliners often reflected on the meaning of their lives, indicated that they did not fear death, but saw it as an option, and considered options based on their preferences for quality versus quantity of life. In a qualitative study of DT MCS decision-making and implications for caregivers ( n = 17), researchers reported that caregivers often placed the needs of their loved one ahead of their own needs, and some caregivers indicated that they felt pressure to make a decision quickly.

Decision aids, designed to improve patient decision-making, are available for use with patients considering both medical and surgical treatment options. Thompson and colleagues reported on the creation of decision aids for patients considering DT MCS. Using International Patient Decision Aid Standard guidelines, they created both paper and video DT MCS decision aids and tested them for acceptability (i.e., readability, bias, and usability). These decision aids were recently assessed by this team for effectiveness in a multisite randomized trial of 248 patients who were considering the option of DT MCS. Allen and colleagues determined that these decision aids improved patient knowledge and concordance between stated values and treatment choice at 1 month after implantation but did not improve concordance between stated values and actual treatment at 6 months.

An understanding of patient decision-making can also be gained through examining regret. Regret is “remorse or distress over a decision.” In a study of decision-making regarding MCS implantation, Blumenthal-Barby and colleagues interviewed MCS candidates and MCS patients and their caregivers (overall n = 45) and reported low levels of decisional regret, indicating that most patients and caregivers made decisions that were consistent with their values.

Psychosocial Evaluation for Mechanical Circulatory Support

Earlier, the issue of psychosocial disparities in access to MCS was addressed—that is, the issue of who is evaluated for device implantation. Although disparities in access are inherently unfair and unethical, MCS programs must legitimately weigh psychosocial as well as medical factors for each candidate for MCS therapy to appropriately select patients mostly likely to benefit from device implantation. Psychosocial factors must also be examined to determine whether psychological, behavioral, or other psychosocial interventions might usefully be offered to patients to increase their chances of favorable outcomes after MCS implantation.

The specific components of the psychosocial evaluation have received limited attention in the MCS literature. This is in contrast to the extensive scrutiny that other medical factors have received as potential criteria for the selection of patients for MCS. In general, the factors typically evaluated in potential transplantation candidates are also viewed as important for the evaluation of candidates for MCS. These elements are listed in Table 16.1 and include lifetime mental health and substance use histories; past and current level of adherence to medical regimens; cognitive status and ability to give informed consent; social history and current status, including financial circumstances; the availability of a primary family caregiver and general support from the family; and knowledge about current illness and treatment options.

An additional element that requires special consideration in MCS candidates concerns patients’ understanding of and capacity (both physical and cognitive) to operate the MCS device. Moreover, the safety of the home environment must be considered, and factors including whether reliable electricity is available and whether the home is accessible by health care personnel must be determined. Assessment of these issues can be critical for decisions about patient educational needs, for patient/family preparation for patients to live outside of the hospital with MCS, and ultimately, for decisions about patients’ eligibility for MCS.

Among the remaining elements, psychiatric and substance use history, general cognitive status, medical adherence history, and the presence of a family caregiver are most often noted as important for team decisions about patients’ need for psychosocial interventions or referrals for additional more extensive evaluation (regarding psychiatric or cognitive status, for example). These factors are also critical for team decisions about patient eligibility for MCS. For example, patients must have the cognitive capacity to understand the risks and benefits associated with MCS and any other treatment options. They must also have strong social supports: the presence of a family caregiver and availability of other supports from the family and friends are essential for guaranteeing that patients can be safely discharged to home after device implantation. Strong caregiver availability and support may mitigate potential limitations that patients may have in other areas. For example, patients with limitations in their ability to operate the MCS device may be acceptable candidates if they have extensive supports and assistance for daily functioning.

When considering psychosocial factors as eligibility criteria, it is important to distinguish whether patients are being considered for BTT, BTC, or DT. If MCS is to be used for BTT, the psychosocial criteria for transplantation candidacy would be relevant, albeit with some modifications. For example, a greater emphasis is usually placed on ensuring the availability of a family caregiver during the period of MCS, compared with the family caregiver requirements typical for transplantation eligibility. In addition, although abstinence from substance use is often important for MCS eligibility, the required duration of abstinence may be less than that typical for transplantation candidates, most often because of the urgent need for MCS. The duration requirement might instead affect whether the MCS device is implanted as BTC versus BTT. Thus, if a patient could not meet transplantation eligibility criteria regarding duration of abstinence before MCS implantation (e.g., due to medical urgency) or needed to demonstrate an enduring ability to adhere to treatment requirements, the psychosocial evaluation might result in a patient receiving MCS as BTC. Once the duration criteria are met, the patient might transition to BTT. In this regard, it is noteworthy that patients defined as BTC based on the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database between 2006 and 2011 were considerably more likely to have current substance use/abuse at the time of implantation than were BTT patients.

It has been argued that patients being considered for DT may require a somewhat different approach in the application of any psychosocial criteria, compared to BTT and BTC patients. DT patients are, by definition, not candidates for heart transplantation. Thus, the psychosocial criteria applied for heart transplantation eligibility—which evolved in response to the need to maximize the utility of scarce donor organs—may be only partially relevant. Because MCS devices are not in short supply, there may be few compelling reasons to deny patients DT based on factors that would generally preclude transplantation candidacy (e.g., continued substance use). For patients being considered for DT, the goal of applying psychosocial criteria should be to determine if patients are able, when drawing on the full range of resources that can be mustered for them, to live with MCS and manage (usually with family caregiver assistance) their complex care regimen at home. A complication, however, in “relaxing” the application of psychosocial criteria for DT patients is that some of these patients may in fact ultimately be considered for transplantation. Under such circumstances, patients would require a new evaluation of their psychosocial eligibility for transplantation, and the psychosocial standards more typically applied for transplantation candidacy then would become relevant.