The use of mechanical circulatory support (MCS) as a long-term therapy for end-stage heart failure is associated with many psychosocial considerations for both patients and their families. These considerations span the process of care: they encompass factors including evaluation, informed consent, and decision-making before implantation; health-related quality of life (HRQOL) and behavioral outcomes during and after MCS implantation; impact of psychosocial factors on clinical outcomes after MCS implantation; and end-of-life concerns. Like many other medical interventions, the success of MCS is ultimately judged by its ability not only to prolong life but also to maximize psychosocial and physical well-being. Hence, it is critical for health care providers and researchers alike to understand the key psychosocial issues that emerge at each step in the process of MCS intervention, as well as the empirical evidence available regarding them. Better understanding of the issues and related evidence is important for improved education of patients and their families, especially since long-term MCS is a viable treatment option. It is also important for the development and evaluation of new strategies to maximize psychosocial outcomes in patients receiving MCS.
This chapter discusses the relevant psychosocial issues across the process of MCS intervention, organized according to the model depicted in Fig. 16.1 . Issues are considered from the perspective of providing better clinical care, and research findings are noted that inform this care. In the final section of the chapter, the most pressing clinical and research concerns that must be addressed in future work on psychosocial factors in MCS are delineated. Throughout the chapter, although many psychosocial factors that are relevant to use of long-term MCS (i.e., MCS beyond the acute care setting) in all age groups are considered, the primary focus is on adult populations because of the increasing use of MCS in adults, either as a bridge to heart transplantation (BTT), bridge to transplantation candidacy (BTC), or permanent, “destination” therapy (DT).
Preimplantation considerations
Whether patients receive long-term MCS is determined by multiple medical and psychosocial factors. Medical indications for MCS are discussed elsewhere in this book; reviewed here are the range of psychosocial factors that appear to influence access to and patient preferences for this treatment. Then, among patients undergoing evaluation for MCS, the psychosocial issues that must be assessed in determining eligibility for MCS implantation are delineated, and procedures for ensuring patient informed consent for this treatment option are discussed.
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.
Decision-Making Capacity
Clinicians are responsible for ensuring decision-making capacity. The decision-making capacity of patients with advanced heart failure may be impaired due to mild cognitive decline, low health literacy, numeracy, and moods/emotions. It is incumbent upon clinicians to screen for these impairments in at-risk patients and integrate strategies to address them. Informed consent may also be challenging if the patient’s decision-making capacity is compromised (e.g., due to reduced level of consciousness or moderate to severe cognitive impairment) and the burden of consent falls to the next-of-kin, which is less than ideal. Families may experience decisional conflict and uncertainty about the best course of action especially if surgical risks are high and outcomes are uncertain and may be poor. Use of temporary MCS as a possible bridge to longer-term MCS or transplantation may provide time to stabilize the patient, evaluate next steps, and allow the family, and possibly the patient, time to consider options. Advance directives can provide guidance for family members who must make emergent decisions regarding treatment options on behalf of a critically ill family member.
Informing Patients, Caregivers, and Families About Treatment Options
Informing patients with advanced heart failure (i.e., stage D heart failure) and their families about therapeutic options necessarily includes discussing the patient’s current medical condition and disclosing risks, benefits, self-care, effect on lifestyle, financial costs, caregiver burden, and end-of-life considerations of the current medical plan. Conversations to inform patients about their current medical condition would include discussing advanced heart failure and its natural history (i.e., the trajectory of advanced heart failure and poor prognosis), the patient’s current health status and prognosis, likelihood of increasing symptom burden and declining functional status, poor quality of life, caregiver burden, the potential for frequent hospital readmissions, and increasing costs of care. Discussion of the current medical treatment plan typically includes optimization of heart failure therapies and ongoing management of comorbidities. It is important that patients understand the risks and benefits of medical therapy, as well as the plan for continued care, which could include supportive care (e.g., palliative care and hospice). As the patient’s heart failure worsens, discussion of new treatment options may be considered.
For patients who are hospitalized with acute heart failure, particularly if hospitalizations are recurrent, discussions would include modifications to the treatment plan (e.g., initiation of intravenous diuretics for refractory fluid retention, use of inotropes, and dose reduction or withdrawal of neurohormonal antagonists to manage symptomatic hypotension, azotemia) and use of temporary support (e.g., intraaortic balloon pumping or short-term percutaneous or extracorporeal support) in the event of refractory cardiogenic shock.
Surgical treatment options (e.g., MCS), which are reasonable to consider for an individual patient, may also be discussed. When discussing the option of MCS, it is important to discuss benefits and risks for the specific device being recommended for implantation (overall and specific to the hospital where the device will be implanted) and the implant strategy (i.e., BTT, BTC, or DT). Potential benefits of improvement in survival, quality of life, and function need to be balanced with possible risks, including device-related adverse events such as bleeding, neurological events, pump thrombosis, and infections, as well as possible worsening of serious concurrent comorbidities or development of new life-threatening comorbid conditions. Although, to some extent, risks will be patient specific, results from large published MCS trials should be included in these discussions. In addition, potential improvement in heart failure symptoms (e.g., decreased shortness of breath, peripheral edema, and fatigue), possible development of new MCS-related symptoms (e.g., bleeding, dizziness, and pain), and potential psychological morbidities (e.g., anxiety and depression) need to be discussed with patients. Length of hospitalization, recovery, and hospital readmission after MCS implantation are also important topics. Regarding implant strategy, patients need to understand that a given strategy might change after surgery. For example, patients who receive an implant as BTT and experience a catastrophic device-related complication may be removed from the waiting list for heart transplantation and the MCS device would remain in place until the end of the patient’s life. On the other hand, patients may receive MCS as DT, but contraindications to transplantation may be reversed with device therapy, and listing for transplantation may then become an option. Finally, a discussion of device durability and the option of device replacement, if beneficial and desirable, is important at the time of initial implantation.
Discussions regarding self-care and changes in lifestyle should include the topics of device management and troubleshooting, driveline dressing changes, permitted activities (e.g., return to work, home management, and driving), and activities that may not be permitted (e.g., immersion in water such as swimming). In addition, following a “heart-healthy” diet and being active, including participating in a formal rehabilitation program or home exercise program, are important topics of discussion. Furthermore, patients need to learn about important safety issues in the home environment and community, such as power supply, telephone services, and a plan for urgent/emergent return to the hospital. Financial costs associated with MCS implantation (including at the time of implantation and after discharge) are also important topics of discussion with patients and their families when deciding on therapeutic options.
Discussing end of life is difficult, but necessary, in the context of informing patients about MCS as a treatment option. When and how much information to share about end of life are individualized and based on patient characteristics (including patient preferences and goals), clinical risk factors (e.g., high surgical risk), and implant strategy. For example, a less detailed discussion of end of life may be undertaken for patients receiving MCS as BTT, whereas more information may be appropriate for patients who receive implantation as BTC or DT. An end-of-life conversation, at the appropriate time, includes a discussion of anticipated end-of-life trajectories, availability of hospice, and device deactivation.
It is generally expected that patients on MCS will have caregivers in order to be discharged from the hospital. Most caregiving for patients with major chronic illnesses is performed by family members. Thus, caregivers and family members need to be informed about MCS, so that they can learn about the caregiving role (e.g., performing driveline dressing changes, troubleshooting device malfunction, providing transportation to follow-up appointments and tests, initiating plans for emergency return to the hospital for device-related complications, and often providing emotional support). Caregivers and family members also need to be informed about the possible impact of caregiving on their lives. For example, many device programs require that a device-trained person remain close to the patient at all times, which may be challenging if the device-trained person is also employed. Multiple caregivers may help mitigate this challenge. Finally, caregivers also need to be informed that they may experience psychological sequelae, which will be discussed in the section on family caregiver well-being and quality of life.
Understanding of Treatment Options
Challenges abound in determining patient understanding of discussions on treatment options. A variety of strategies have been used, including decision-making worksheets, more informative consent forms, standardized education, decision aids, and written tests and elicitation of oral feedback, which may simply be asking a patient to repeat what (s)he heard a clinician say. Discussions with multidisciplinary team members (e.g., cardiologists, surgeons, ventricular assist device coordinators, palliative care teams, psychologists, dietitians, and social workers) are beneficial as each team member focuses on different aspects of informing patients about MCS. Additionally, advanced heart failure patients considering MCS are often encouraged to visit with a current MCS patient, to learn about MCS from a “lived experience” perspective. Participation in support groups, when available, is also highly encouraged. Written information and videos regarding device management, troubleshooting, and dressing change procedures, as well as illustrations of the device, are important educational supplements during the informed consent process. Patients also may want to see the actual hardware and accessories. It is important to recognize the possibility of influence or bias (i.e., bias toward accepting MCS therapy), without adequate discussion of risks, alternative options, and caregiver considerations when sharing information.
Agreement to Treatment Options
Finally, agreement to a treatment option assumes voluntariness that is free from manipulation or coercion (i.e., the decision is made autonomously). This final element of informed consent is predicated on the first three elements (i.e., decision-making capacity, full disclosure of treatment options, and understanding).
After being fully informed of available therapeutic options, some patients with advanced heart failure choose medical therapy, which may be viewed as a refusal of lifesaving therapy. Patients with decision-making capacity who understand the risks and benefits of medical therapy and the consequences of refusing MCS device implantation are, of course, free to make this choice. Understanding patient values, preferences, goals, culture, and background may help to clarify the patient’s choice of continuing medical therapies or undergoing MCS implantation.
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.
| Component | Areas Addressed |
|---|---|
| Mental health history and current status | Mood and anxiety disorders; suicidal ideation or past attempts; psychosis; personality disorders; treatment history |
| Substance use history and current status | Quantity, frequency, duration, and recency of use of alcohol, tobacco, and other substances; diagnosable disorder and level of impairment in daily life; treatment and rehabilitation history |
| Adherence history and current status | Adherence to components of previous and current treatment regimens for heart disease or other chronic health conditions; understanding of rationale for current regimen |
| Cognitive functioning and capacity | Orientation in person, time, and place; appearance and affect; evidence of impairments that would affect capacity to understand what will be required for care during MCS and (if relevant) after transplantation; capacity to give informed consent |
| Social history and current status | Demographics, including employment and financial circumstances; marital status; living arrangements; coping strategies for managing health issues; religious beliefs and orientation; concurrent stressors (work related, home related, other); literacy and health literacy |
| Family caregiver availability and general family supports | Presence of a family member to provide care and assistance on a daily basis; emotional supportiveness of family or close friends; understanding by family of patient’s health situation |
| Understanding of current illness and treatment options | Perceptions of medical condition; perceptions of health-related impairments in daily life; understanding of the risks and benefits of MCS; understanding of the transplant process (if relevant); attitudes and expectations about MCS, including preferences and goals |
| Capacity to operate MCS device | Understanding of basic device operation; physical and cognitive capacity to operate the device and respond to alerts/alarms; safety of the home environment for MCS operation |
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.
Psychosocial outcomes during mechanical circulatory support
Psychosocial outcomes after MCS encompass all components of patient HRQOL, as well as behavioral outcomes related to medical adherence and self-care. HRQOL is multifaceted and includes physical functional well-being, emotional and social functioning, and global quality of life perceptions. In the following sections, evidence regarding patient HRQOL and behavioral outcomes is considered, and evidence concerning family caregiver well-being is summarized. Finally, the economic burdens experienced by patients and families are important issues to address insofar as the financial costs associated with MCS ultimately may affect access to this treatment and preferences for it versus other intervention strategies.
Patient Health-Related Quality of Life
Physical Functional Health-Related Quality of Life
Over the past 20 years, there has been consistent evidence that both objective measures (e.g., exercise capacity) and subjective measures of physical functioning (e.g., perceived functional status) improve with MCS. Such improvements were noted with the earlier pulsatile devices and continue to be observed with the smaller continuous-flow devices in use today. Once patients have recovered from the immediate effects of implantation, the majority become fully ambulatory and are able to engage in routine activities of daily living. Regardless of whether they received implantation as BTT or DT, they showed marked improvements over their preimplantation baseline in functional status (e.g., NYHA class and distance traveled in the 6-minute walk test) and physiologic parameters (e.g., mean oxygen consumption levels, resting cardiac output, and mean arterial pressure). Reviews of the literature indicate that, among patients receiving MCS implantation, objectively assessed functional status and patients’ perceptions of physical well-being are better than those of individuals receiving optimal medical management. Nevertheless, MCS patients’ physical functioning, on average, remains poorer than that observed after heart transplantation, no matter whether it is assessed by subjective perceptions or objective performance measures.
An important issue is whether and how patients’ physical functional HRQOL continues to change over time after implantation. Among patients receiving MCS as BTT, Grady and coworkers found reductions in self-reported bothersome physical symptoms as early as 2 weeks after implantation, and recent reviews including studies of both BTT and DT cohorts document sustained or continued gains in patient-reported overall physical functioning and satisfaction with physical status across the first 1 to 2 years postimplantation. With regard to objective indices of physical functioning, it appears that improvement plateaus after the first several months postimplantation, although exercise-based interventions appear modestly successful at further improving these outcomes.
Despite the physical functional HRQOL benefits, MCS recipients remain impaired, on average, relative to normative, “healthy” populations. Furthermore, patients on MCS report significant physical functional difficulties and concerns in some areas. They frequently describe the onset of new physical symptoms after implantation, arising primarily from device-related adverse events. The majority of MCS recipients experience adverse events, the most common of which are bleeding, infections, and neurological events. These events frequently lead to rehospitalizations, with attendant physical deconditioning and functional decline. Complications such as stroke can lead to permanent physical disability, as well as shortened survival time. Patients report significant worries about the risk for these complications and resulting physical impairments. With respect to device-related symptoms, patients frequently report pain at the driveline exit site and difficulties sleeping due to the position of the driveline and may have concerns about and reduced satisfaction related to sexual activity due to worries about disrupting the positioning of the driveline. These subjectively reported symptoms can be objectively documented. For example, Casida and colleagues found that MCS patients not only reported poor sleep quality but also had marked sleep disruptions based on actigraphy.
Finally, it is noteworthy that studies reporting improvements in physical functional HRQOL over time focus on patients who are able to provide ongoing HRQOL data. The risk for morbidities and mortality in MCS patients remains high. Patients who are too ill or become too ill to provide HRQOL data are not captured in most studies’ analyses, and thus, physical functional HRQOL levels described among patients at 1 to 2 years postimplantation may be biased. The most accurate conclusion from work to date may be that physical functional HRQOL can show dramatic, sustained gains over time among patients on MCS, although this potential may not be achieved by all patients. Continued advances in MCS technology and patient medical management strategies may ensure that increasing proportions of patients experience these gains. Regarding patient management, it appears essential that MCS programs either provide their own exercise and rehabilitation services or overcome insurance-related or other barriers to referral of patients to external cardiac rehabilitation programs.
Psychological Health-Related Quality of Life
Psychological HRQOL encompasses emotional well-being as well as cognitive functioning. HRQOL in this domain improves with MCS, although the improvements are less striking than those observed in the physical functioning domain. With respect to emotional well-being, small case series and qualitative reports suggest that some patients’ preimplantation psychological distress levels do not abate or are high after MCS implantation. However, reports of larger cohorts (either with the earlier pulsatile devices or with continuous-flow devices) have noted that, on average, levels of depression and anxiety-related symptoms show significant and clinically significant reductions from before to after device implantation. These improvements in psychological well-being have been observed even after controlling for factors such as patients’ age and severity of illness at the time of device implantation. Among patients able to be reassessed over time, the improvements in distress levels appear to continue or are at least maintained during the first year of MCS. Among patients on BTT MCS, once they recover from the initial effects of device implantation, their emotional well-being is better and shows greater improvement from baseline (presurgical) levels compared to patients receiving optimal medical management without MCS. However, their psychological HRQOL appears poorer than that of heart transplant recipients and is lower than normative levels in healthy populations.
The occurrence of adverse events during MCS appears to have major impact on patients’ psychological HRQOL, and psychological distress is strongly linked to worries over the potential for adverse events or recurrences of those events. The presence of a diagnosable psychiatric disorder, including mood and anxiety disorders, is common in patients on MCS, with up to 80% experiencing at least one episode of disorder during MCS. Commonly reported psychological stressors include concerns about device malfunction and failure.
The sensitivity of psychological HRQOL to adverse events postimplantation (and in BTT patients, the uncertainty regarding whether and when transplantation will occur) has led to consensus recommendations that patients on MCS should be routinely monitored for psychiatric symptoms. Moreover, given effective treatments for many psychiatric disorders, it is important to promptly initiate treatment with psychotropic medications and other psychological and behavioral interventions for mental health problems once these conditions are identified.
Although there is little empirical work past the first 1 to 2 years of MCS, case reports and small case series indicate that as the duration of support lengthens, patients whose emotional well-being improved initially during MCS may go on to show pronounced declines in psychological status. These declines appear closely linked to physical health declines. For example, Tigges-Limmer and colleagues report the suicide of a patient on MCS at approximately 3 years postimplantation after a period of marked deterioration in his physical health, and despite intensive psychiatric treatment.
Cognitive functioning is also an integral component of psychological HRQOL in patients on MCS, and cognitive status has an important impact on patients’ ability to function independently. Although cognitive impairments are common in patients with end-stage heart disease, including those awaiting heart transplantation, there has been limited examination of how cognitive functioning is affected by treatment with MCS. However, because neurologic events during MCS remain relatively prevalent and can be devastating, MCS patients are at risk for new, irreversible cognitive impairments. Whether these impairments are linked to the MCS per se or are complications associated with cardiac surgery can be difficult to determine. Nevertheless, new cognitive impairments remain problematic in the MSC population.
It is therefore noteworthy that some reports have documented statistically significant, although mild, improvements in several domains of cognitive functioning (e.g., visuospatial and executive function) across the first 6 to 8 months in patients receiving BTT MCS and across as long as 24 months after patients received DT MCS. These reports noted no significant declines in any domain evaluated. These results are encouraging, although they must be tempered by the fact that, as noted earlier, patients who were too ill could not be reassessed. Thus, the findings may reflect the levels of cognitive functioning attainable in the absence of major neurologic insult.
Social Health-Related Quality of Life
Social functioning has presented assessment challenges in patients on MCS, perhaps because of the wide array of activities and concerns encompassed within this domain. Rather than systematic assessment, the literature is characterized by anecdotal and relatively general comments that patients receiving MCS are able to perform regular activities of daily living, engage in various leisure activities (e.g., going to restaurants, gardening, and engaging in sports), travel, return to work or school, or otherwise have an “active lifestyle.”
The few studies that have empirically examined patients’ ability to perform activities of daily living (including outcomes in both patients receiving pulsatile support and those with continuous flow devices) find that functioning improves from preimplantation to postimplantation and show continued gains with time. However, satisfaction with functioning and with social relationships appears to remain stable or may even decline with time. For example, Grady and colleagues observed that by the end of the first year of MCS, satisfaction with interpersonal relationships declined somewhat, and patients reported increased limitations in their ability to engage in social interactions. There have been few recent comparisons of social functioning in MCS patients versus patients receiving medical management alone, transplant recipients, or normative samples. It appears that social functioning is better in MCS recipients than in medically managed patients but may be poorer than that in transplant recipients.
Additional qualitative studies shed light on why social functioning may not show the large and sustained gains noted in other areas of HRQOL, such as physical functioning, and may appear poorer than for transplant recipients. Such work reveals the importance that patients place on structuring their daily lives so as to maintain a sense of control over their general ability to function and interact with others, and they focus on normalizing their lives through specific routines and activities. Nevertheless, patients may come to realize that, despite their improved physical status, they are in fact unable to resume social roles that they once had (e.g., returning to work) and that the ever-present device limits feelings of “normalcy.” Many patients dislike the need to rely on others for assistance with daily activities and wish that they could achieve more complete independence during MCS. Patients may feel limited by factors such as restrictions on driving, which promote continued dependence on others.
On the other hand, qualitative studies have noted that patients may experience social benefits that were unexpected and positive, including deeper intimate connections with their sexual partners. It was noted earlier that patients may have concerns about their physical ability to engage in sexual activity, but this must be balanced against findings that MCS recipients may feel emotionally closer to their partners, as well as to other family members, after they recover from implantation surgery. At the same time, body image—including distress over one’s surgical scars and seeing the device driveline—is also an important issue as patients attempt to return to daily activities and interactions with others.
Global Health-Related Quality of Life
Particularly in recent clinical trials and large series of patients on MCS, only global indices, rather than domain-specific evaluations of HRQOL, are reported. Thus, patients may be asked to complete multi-item measures that include items reflecting the full range of HRQOL (usually in the context of living with heart disease), and then a global score is computed. Alternatively, patients may be asked simply to rate their overall HRQOL. Either way, the result is a composite view that has the advantage of reflecting the “big picture” from the patient’s perspective, but that has the disadvantage of not allowing for the identification of specific areas that might be uniquely problematic for patients on MCS.
With this caveat in mind, it is noteworthy that global HRQOL generally has been found to show (1) clinically significant improvements from preimplantation to postimplantation in patients receiving both BTT and DT, a
a References .
(2) sustained or continued improvements over time during MCS, at least during the first several years of support, bb References , .
and (3) large advantages relative to equally ill patients who did not receive MCS. Nevertheless, global HRQOL in MCS patients appears poorer than that observed in transplant recipients.Given the evidence that there are important HRQOL domain-specific limitations and concerns linked to MCS, it is essential to supplement global HRQOL information with specific examination of patient self-reports in the separate physical functional, psychological, and social domains. In addition, the factors that may contribute to global HRQOL perceptions may differ from those that are the strongest determinants of domain-specific HRQOL. For example, Brouwers and colleagues found that the important correlates of mental/emotional HRQOL (e.g., female sex, and being unemployed) were not significant correlates of patients’ perceived global HRQOL or their physical functional HRQOL.
Patient Medical Adherence and Self-Care
Adherence to the postimplantation medical and self-care regimen is a domain of psychosocial outcomes distinct from patient HRQOL. Most MCS recipients are discharged to home, where they are expected to engage in a variety of self-care and monitoring activities, including those related to basic device management, medication taking, and lifestyle requirements (e.g., smoking cessation), and they must participate in required clinical follow-up.
Several qualitative reports delineate patients’ concerns and worries about their abilities to engage in self-care but suggest that feelings of confidence and self-efficacy for performing such activities increase with duration of MCS. The literature on self-care and adherence to the MCS regimen is small. However, there is evidence that patients’ perceptions of their ability to engage in self-care can improve with MCS implantation, although this is not always observed. Casida and colleagues examined adherence to the postimplantation regimen, reporting that adherence levels were high and did not vary by duration of MCS. Independence in self-care (i.e., ability to manage requirements without caregiver assistance) appeared to be slightly higher in patients who had MCS for longer durations, although the differences were not significant. Greater adherence was associated with better global HRQOL.
Family Caregiver Well-Being and Quality of Life
The impact of MCS extends well beyond the patient, to encompass the primary family caregiver and other family members. Given family caregivers’ role in assisting and providing emotional support to MCS recipients, it is important to understand both the benefits and burdens experienced by family members in order to develop educational strategies and to implement interventions to minimize strain on the family.
A recent review summarized both the growing qualitative and quantitative literatures on family caregiver outcomes. Three central findings were noted. First, caregivers experience significant psychological distress that may be as high as or higher than that observed in MCS recipients. This distress is related to concerns about the patient, concerns about the caregiver’s ability to assist the patient, and worries about the caregiver’s ability to maintain employment and other social roles. Second, caregivers report considerable burden in providing care to the MCS recipient. This burden can be associated with feelings of social isolation and may lead to declines in caregivers’ physical health and well-being. Third, caregivers develop new coping strategies and approaches to manage the tasks they have adopted in caring for the MCS recipient. The use of such strategies may mitigate caregivers’ psychological distress.
Many of the studies included in the review by Cicollini and colleagues were cross-sectional reports. A recent prospective study therefore adds to these findings by showing that, while MCS recipient global HRQOL and depression and anxiety symptoms showed significant improvement from preimplantation to postimplantation, their family caregivers’ global HRQOL worsened and the caregivers’ levels of depression and anxiety showed no change. This report followed patient-caregiver dyads only through the first 3 months postimplantation; it would be important to determine if trends for these HRQOL indicators changed with longer follow-up. Other caregiver outcomes, including perceived caregiving burden, were not examined.
Economic Burdens for the Patient and Family
Given the prevalence of heart failure in the United States, it is not surprising that the economic burden of heart failure is substantial. Costs of heart failure can be especially high for patients with advanced heart failure who become refractory to medical therapies and undergo MCS implantation either as BTT or DT. Seo et al. conducted a systematic review of the cost effectiveness of MCS as BTT versus heart transplantation without a bridge, reporting that overall, posttransplant survival and adverse events did not differ between groups, and use of MCS as BTT may be cost-effective, especially for patients with prolonged wait times who are at risk for poor outcomes while awaiting transplant. Using Markov modeling, Rogers et al. determined that compared to medically managed advanced heart failure patients, the 5-year costs of continuous-flow MCS as DT were higher ($62,856 vs. $360,407, respectively). Notably, these authors suggest that MCS costs have decreased from costs associated with first-generation devices, due to improved survival, decreased costs of implantation, and improved functional ability of patients. At 5 years, gain in quality-adjusted life years was also higher in the MCS group (1.87) versus the medically managed group (0.37). Rogers et al. concluded that, overall, the cost-effectiveness of continuous flow DT MCS has improved.
While cost-effectiveness has improved, other studies suggest that MCS is probably still not cost-effective, as per generally accepted thresholds, and that refinement of patient selection, reduction in device/surgical costs, improvement in MCS technology, reduction in adverse events, and improvement in quality of life are needed to further enhance cost-effectiveness. Selection criteria that incorporate both need and potential risk for poor outcomes after surgery can contribute to reduced costs of care. The US Centers for Medicare and Medical Services developed “acceptance criteria” as part of the Joint Commission advanced disease-specific care certification requirements for DT MCS ( Box 16.1 ). Lastly, guidelines for care of patients with MCS may help to reduce adverse events and improve outcomes and thus potentially reduce costs of care.
