Fig. 45.1
Depiction of benefits and risks through 1 year after mechanical circulatory support
Inherent to the ethical considerations of shared decision making regarding MCS as a treatment option are a discussion about discontinuing MCS and alternatives to MCS. Although the legal construct of patient autonomy does not recognize different degrees of dependence on therapies to be withdrawn, individuals may view proactive withdrawal that leads to direct patient demise as unique and emotionally difficult. Thus, a discussion about discontinuing MCS therapy should be part of the consent process prior to implantation.
Regarding alternatives to MCS, patients often do not see declining MCS as an option [5]. Few existing MCS educational materials even recognize other options or acknowledge that there needs to be a decision [6]. Therefore, it becomes even more important for clinicians to provide a parallel comparison of life with and life without MCS, a choice between two imperfect options, which can then contribute to a more engaged and realistic decision-making process. Importantly, MCS decision making may occur, while patients with progressive heart failure are actively dying and have heightened emotions with mortality salience pushed to the front of consciousness. Thus, clinicians need to attend to patients’ fear of dying. Studies have shown that patients with end-stage illness find it helpful to discuss death, and retrospectively, many prefer direct and honest communication [7].
Finally, advanced heart failure and long-term MCS – with its high degree of prognostic uncertainty and complex trade-offs between choices of medical care – demand high-quality communication. Most patients and families want accurate and honest conversations with their clinicians. These interactions require time for assessment and planning in order to determine how much information patients desire and create a supportive environment for effective communication. These discussions also require attention to both cognitive and emotional needs, as well as concerns related to health literacy.
45.2 Behavioral Evaluation
The behavioral and psychosocial evaluation is a critical component of determining whether a patient is an appropriate candidate for MCS implantation. A great deal of self-care and responsibility are required to live successfully with MCS. Patients who are not fully engaged in self-care after MCS may suffer from disastrous outcomes. Patients being evaluated for advanced therapies should evidence willingness and capacity to engage in required health behaviors, compliance with medical recommendations, sufficient social support, and cognitive and psychological stability. All of these elements should be considered when determining whether MCS will be helpful, or potentially harmful, to someone with advanced heart failure. There are two scenarios when conducting a psychosocial evaluation for MCS candidacy: bridge to transplant and destination therapy. While the evaluation is typically the same for both scenarios, MCS centers may modify criteria for patients who are being implanted for destination therapy [8, 9].
There is a dearth of research examining the standardization of psychosocial assessment criteria for MCS, especially for destination therapy MCS [8, 9]. There has been some attempt at creating standardized assessment tools [8, 9], but studies are limited by small sample sizes and single-center designs. Nonetheless, a number of consistent variables emerge that are important to consider in the psychosocial assessment of an MCS candidate.
A psychologist on a MCS team will interview the patient about his or her psychosocial history, health behaviors, compliance, social support, and psychiatric functioning. ◘ Table 45.1 provides domains of assessment topics, along with examples of specific content to assess. First, social support (practical support and emotional support) assessment is a critical part of the psychosocial assessment. The criterion for having a caregiver present 24/7 is variable among device programs and includes consideration of the patient’s functional capacity, frailty, and cognitive functioning. Meeting with caregivers can provide an understanding of their willingness and ability to provide sufficient support and care for that particular patient’s needs.
Table 45.1
Psychosocial assessment domains and questions
Domain | Example question topics |
---|---|
Social history | With whom the patient resides Employment or disability Life stressors Family and/or friends who could provide social support Occupation and health of the possible caregivers Transportation method to medical appointments |
Health behaviors | Exercise Diet (e.g., sodium and fat intake) Amount of fluids consumed per day, especially if on a fluid restriction Medical follow-up ETOH, tobacco, illicit drug use (frequency, amount, duration of use) Motivation and self-efficacy to change behaviors |
Medical adherence | Symptom reporting Medication compliance, system for medication (e.g., pillbox) Patient’s knowledge about his/her medications Medical appointment follow-up |
Psychiatric | Level of alertness and orientation Speech rhythm, rate, volume Notable cognitive deficits (e.g., difficulties with concentration or memory) History of depression, anxiety, or other psychiatric issues Current depressive or anxiety symptoms (follow diagnostic criteria) History of or current suicidal ideation Family psychiatric history Recent changes in weight Change in sleep Panic symptoms Current psychotropic medications History of therapy Typical methods of coping with stress Current understanding of their cardiac/medical status Patient’s thoughts about MCS |
While it is important to assess and reinforce adaptive health behaviors (e.g., exercise and a healthy diet), there are certain health behaviors that may be considered relative contraindications for device implantation [9]. For example, smoking tobacco may be a relative contraindication, or the patient may be strongly encouraged to quit if they are being considered for destination therapy. However, complete abstinence is typically required for someone who is a bridge-to-transplant candidate.
It is especially important to assess history and current symptoms of clinical depression and anxiety, as presence of these symptoms interact with other areas of assessment. For example, depression is associated with poorer self-care behaviors, a generally more unhealthy lifestyle, such as smoking and minimal physical activity [10], and poorer compliance with medications [11], all of which are necessary for maintaining good health with MCS. Assessing the patient’s cognitive status is also important, given that even mild cognitive impairment is a risk factor for increased mortality following surgery [12]. In addition to informally assessing the patient’s cognitive status via interview, a brief screening tool (e.g., the Montreal Cognitive Assessment [MoCA]), validated in cardiac populations [13, 14], may also be utilized to provide objective data.
Following assessment, the data should be used to formulate impressions about each of the assessment domains, and from those impressions, concrete and specific recommendations should be communicated to the MCS team. For example, if the patient is a poor historian, tangential, and seems to have difficulty processing questions, it may be recommended that the patient undergo comprehensive neuropsychological testing. If clinical depressive symptoms are present, it may be recommended that the patient continues to follow up with a health psychologist or another mental health professional, including a psychiatric consult, if psychotropic medication seems warranted.
45.3 Health-Related Quality of Life
During the period of shared decision making and evaluation for MCS, advanced heart failure patients need to be informed about postimplant outcomes. HRQOL, both before and after implant, is an important patient-centric outcome to discuss with patients and their families who are considering MCS as a treatment option (◘ Fig. 45.2). Patients with advanced heart failure have very poor HRQOL [15]. They have frequent and distressing symptoms, including fatigue, shortness of breath, paroxysmal nocturnal dyspnea, lack of energy, difficulty sleeping, daytime drowsiness, and weakness [15]. Poor HRQOL in advanced heart failure patients is associated with symptom distress [15].
Fig. 45.2
Outcomes of importance to patients
Patients need to be informed that overall HRQOL improves from before to as long as 2 years after continuous-flow MCS [16], including destination therapy [17]. Findings from the Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management (ROADMAP) study, a prospective, nonrandomized observational study of outcomes in ambulatory NYHA class IIIB/IV non-inotrope patients, demonstrated greater improvement in HRQOL in MCS patients, as compared to optimal medical management patients through 12 months [18]. Furthermore, while patients with lower INTERMACS profiles (i.e., higher severity of heart failure) had worse HRQOL prior to implant, by 12 months after implant, HRQOL improved significantly for all profiles and did not differ significantly among profiles at 6 and 12 months after implant [19]. Lastly, while patients who undergo destination therapy implantation are typically older, may have comorbidities that preclude heart transplantation, and have a higher risk for postimplant adverse events (especially if older) and lower survival, than those who are bridge to transplant, destination therapy MCS patient HRQOL nonetheless significantly improves from before to after surgery [17].
Early substantial improvement also occurs in heart failure symptomatology and domains of HRQOL. Patients report that most symptoms of heart failure (e.g., shortness of breath and peripheral edema) abate relatively soon after implant, while other symptoms (e.g., fatigue and decreased energy level) persist for several weeks to months [20]. New symptoms emerge after MCS implant (e.g., dizziness/syncope and gastrointestinal bleeding) [20]. Most patients also report significantly fewer problems with mobility, usual activities, and self-care from before to 12 months after implant [16, 19]. Patients often returned to home management, work, and leisure activities [20]. Reports of decreased anxiety/depression [18] and pain/discomfort from before to after implant were also noted, which varied somewhat by preimplant INTERMACS profile [19]. Anxiety and depression often decreased later after implant when patients had adjusted to living with MCS [20].
45.3.1 Risk Factors for Poor HRQOL After MCS
Patients and their families also need to be informed of risk factors for poor HRQOL after MCS implantation. From before to 6 months after implant, adverse events (i.e., renal dysfunction, respiratory failure, neurological dysfunction, and infection), comorbidities (i.e., chronic obstructive pulmonary disease and ascites), and having a moderate or lower likelihood of undergoing heart transplantation are significantly related to decreased HRQOL [21]. Unplanned hospital readmission is a marker of morbidity, reflecting disease and treatment-related adverse events (e.g., gastrointestinal bleeding and cardiac-related causes). From before to 1 year after MCS implant, re-hospitalization is associated with poor HRQOL after destination therapy MCS [17].