Abstract
The implantable cardioverter defibrillator (ICD) has established superiority in reducing mortality for survivors of cardiac arrest or patients at high risk of sudden death. However, because of the nature of their spontaneous, chronic, and potentiality life-treating condition, patients with an ICD are at risk of developing mild to serious psychological distress. Critical events, such as ICD shocks or ICD recalls may occur, significantly altering the course of individuals’ psychosocial adjustment; a number of studies from different countries demonstrate that patients with an ICD that experience higher emotional difficulties undergo a greater incidence of shock therapy.
A proper biopsychosocial assessment and conceptualization of the needs of patients with an ICD, and the delivery of tailored interventions is, therefore, mandatory for ensuring optimal clinical care.
Brief education sessions are effective in reducing concerns among patients with mild levels of psychosocial distress, and a continuum of treatment strategies is available as the recipients’ severity of psychological distress and associated maladaptive behavior grows, spanning in ICD support groups, individual consultations using cognitive behavioral techniques and pharmacotherapy.
Yet, while short-term positive outcomes are usually achieved, applicable and effective long-term management of psychological symptoms secondary to ICD implantation is still a challenge for healthcare providers, and the high degree of heterogeneity in content and methodology across studies has made it difficult to formulate broad conclusions on the feasibility and effectiveness of existing interventions. Further research producing valid and reliable data needs to be undertaken in order to maximize positive patient outcomes.
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Keywords
- Implantable cardioverter defibrillator
- Psychological distress
- Biopsychosocial assessment
- Psycho-educational intervention
Introduction
Clinical trials data consistently demonstrate that ICD implantation markedly improves survival in persons at high risk of Sudden Cardiac Death (SCD), and that the majority of patients with an ICD experience a desirable Quality of Life (QoL) and a high acceptance rate [1]. However, whereas somatic symptoms seem to have little or no influence on QoL [2, 3], 30–40% of patients with an ICD report mild to serious psychological distress because of the nature of their spontaneous, chronic, and potentiality life-treating condition [4]. Specifically, as activation of the device is unpredictable and sometimes painful, both meta-analysis and individual trials indicate that patients who experienced ICD shock to achieve cardioversion or defibrillation are more likely to show impaired QoL [5,6,7,8] and to engage in avoidance patterns [9, 10]. Behavioral limitations, in fact, may be prescribed, but are more often due to perceived inability and individuals’ erroneous association of the shock to those everyday life activities that take place/occur during shock (i.e., showering, gardening, working situations, driving, sexual activity and, particularly, physical exercise), even when there is no inherent connection [1]. Patients with an ICD may also fear that the device will suddenly stop functioning or operate incorrectly and therefore experience constant psychological distress [11].
Especially, recipients younger than 50 years at implantation, female patients and those with poor social support are more prone to experience adjustment difficulties to the ICD than their device-baring counterpart [12].
Distressed personality (type-D personality), the tendency to experience negative affectivity paired with social inhibition, is another risk marker for poor QoL in patients with an ICD [13]; and the severity of the disease, the presence of comorbidities, as well as a poor understanding of the therapy may furthermore make patients with and ICD more vulnerable to a number of psychological issues, such as anxiety, depression and anger [3, 14, 15].
Anxiety is a common problem for those implanted with a biomedical technology device, to the point that the term shock anxiety has been coined to indicate the particular fear and anticipation of shock that is unique to this patient population. Shock anxiety may be experienced in isolation or within the context of psychological disorders, independently from having received a shock [4]. The presence of anxiety has been documented in 13–38% of device recipients across multiple studies [4], and it may exist on a continuum from normalized fear, generalized anxiety, panic disorder, to Post Traumatic Stress Disorder (PTSD) [10].
Notably, anxiety symptoms increase avoidance behavior, fear of increasing autonomic arousal, sleep disturbances, sexual dysfunction, irritability, and difficulty concentrating [16]. Similarly, 24–46% of patients express ICD-related depression, most likely as a response to perceived physical and mental disabilities associated with daily life activities [6]. The incidence of anger is also higher in the ICD population than in the general population or other disease populations [17].
The main psychological theories explaining the appearance of distress among patients with an ICD are classical conditioning, operant conditioning, cognitive distortions and learned helplessness. Classical conditioning can be observed when recipients develop anxiety or fear (unconditioned response) that causes them to avoid the activity they were doing when a discharge occurred (unconditioned stimulus) [18], including those actions that patients once enjoyed; and the employment of consequences (or lack thereof) to modify the occurrence of the behavior contribute to maintaining avoidance patterns over time (operant conditioning). Patients implanted with a biomedical technology device may also overestimate the negative consequences of an ICD discharge or overgeneralize its occurrence; studies show that catastrophic cognitions about future events [19] are important determinants of psychological problems among patients with an ICD as well as prospective predictors of the occurrence of subsequent arrhythmias and shocks [20]. By definition, cognitive distortion refers to biased ways of thinking and perceiving reality. Individuals’ thoughts and emotions are structured in a negative and inflexible way, this results in errors of interpretation related to personal performance and judgment of external situations [21, 22]. Cognitive reactions include making faulty conclusions that the ICD is actually harmful, instead of life-saving and that physical exertion will cause the ICD to discharge, this leads to learned helplessness. The theory of learned helplessness suggests that psychological distress stems from the patients’ perceived inability to handle situations that are believed inescapable and uncontrollable [23, 24] and it is thought to be one of the main underlying causes of depression [25].
Despite the fact that the manifestation of emotional distress has been generally attributed to ICD shocks, in reality, concerns about shock, rather than the shock itself, as well as psychosocial adjustment difficulties that are typical of those living with this particular biomedical technology (i.e., distressful changes in body image due to implantation, worries about scars, poor body satisfaction) need to be carefully investigated and promptly addressed [4].
In fact, recent research demonstrates that patients who reveal device acceptance, that is “the psychological accommodation and understanding of the advantages and disadvantages of the device, the recommendation of the device to others, and the derivation of benefit in terms of biomedical, psychological, and social functioning” (p. 385) [26] have better QoL [27].
It is crucial for mental health providers to normalize recipients’ reaction to an abnormal event (ICD implantation or shock) and to articulate a clear treatment plan for recovery that may involve specific ICD- psychological interventions.
Assessment and Treatment for Patients with an ICD in Routine Clinical Practice
A proper biopsychosocial assessment of patients with an ICD and conceptualization of their needs is mandatory for ensuring effective clinical care, since it allows the implementation of tailored intervention [28]. Firstly, medical factors such as, device indication, history of device therapies, cardiac disease severity/prognosis, surgical history, neurological deficits related to hypoxia, and comorbid diseases must be considered.
Moving onto the psychosocial field, anxiety, depression, QoL, psychiatric history, risk for self-harm, coping skills, social support strengths and deficits, financial distress, as well as general and health literacy represent common domains to explore. Healthy behaviors, related to tobacco, alcohol and drug use, physical activity level, medication observance, eating habits, and monitoring of medical parameters (i.e., blood pressure, weight) that frequently influence both medical and psychosocial outcomes also maximizes identification of potential difficulties [29] and recognition of behavioral change strategies to enhance adherence to therapy and to help patients living with the device. Routine clinical assessment for patients with and ICD is summarized in Table 10.1.
Assessment Tools
Both generic and specific tools are available to measure psychological distress and adjustment in patients with an ICD, with particular attention to the level of anxiety and depression experienced by the individuals, as well as to their QoL. Table 10.2 provides a summary of the main measures of psychological concerns that are available [29].
Individuals should be screened for emotional distress before and after the device is implanted. Potential patients must be well informed about the ICD, a sincere conversation about the risk of death, focused on positive risk (i.e., ICD is superior to medication in terms of saving lives) and increased QoL associated with the device, should be carried out by cardiologists through supportive communication that conveys empathy and shows respect for the person. To provide information and opportunities for patients to verbalize fear or concerns related to the device not only enhances the patient-physician communication, but it also empowers and induces confidence in the person, as well as sets the stage for the ultimate outcome, which is the individuals’ perception of greater safety because of the ICD (i.e., patient acceptance) [1]. To this aim Eads et al. [30] suggested seven principles of rehabilitation which medical professionals must be skilled in effectively communicating in routine clinical practice [30]: (1) Defining the problem asking patients about their specific concerns about having an ICD; (2) Providing information answering individuals’ doubts or questions about the ICD; (3) Creating team support by reassuring patients with an ICD and producing an expectation of participation on the treatment team; (4) Normalizing fears as a normal reaction to ICD implantation, (5) Eliciting emotional release giving patients the opportunity to discuss troublesome issues; (6) Instilling hope that the physical discomfort and emotional distress patients are experiencing will likely diminish with time and (7) Encouraging patients to take action, thus to enhance their self-care abilities and self-efficacy.
Clinic-Based Therapeutic Intervention for Patients with and ICD
To properly detect and manage psychosocial issues in ICD clinics, cardiology practitioners should refer to the “four A’s checklist” [24]: Ask, Advise, Assist, and Arrange referral. Specifically, research shows that the primary components of patient education, relaxation/stress management training, and group social support provide benefits by increasing health and psychosocial outcomes (Table 10.3).
Brief education sessions have proven effectiveness in reducing patients’ initial concerns or post-ICD discharge distress among individuals with mild levels of psychosocial distress, but they may not be appropriate for those recipients suffering from severe psychological distress [31]. Physicians should, therefore, arrange a consultation with a mental health specialist [24] that will assess patients for clinical distress.
A continuum of treatment strategies is available for patients with an ICD experiencing psychosocial difficulties, spanning in ICD support groups, and individual consultations using cognitive behavioral techniques. Support groups can serve as an adjunctive intervention and are especially useful for those individuals with poor social support or families experiencing high levels of distress. Through education, social support, and vicarious learning, group participation provides an opportunity for normalization of fears and mobilization of coping resources [32]. However, as the severity of psychological distress and associated maladaptive behavior grows, the need for individualized psychosocial interventions increases accordingly. These may include individualized relaxation training, cognitive restructuring, and systematic desensitization. Specifically, the latter provides patients with skills to manage physiological arousal and distressing thought patterns associated with the ICD [33]. Pharmacologic approaches are also appropriate for patients with excessive levels of fear, anxiety, or depression [30].
Patients with an ICD may also express difficulties in reporting emotional problems because of embarrassment, lack of insight, or the nature of their symptoms. They may also present symptoms that do not meet specific diagnostic criteria, but that still impair their QoL and functioning.
Cognitive and Behavioural Techniques
CBT-Based Psychoeducational Intervention
Brief cognitive-behavioral interventions focused on subclinical specific behavioral or psychological symptoms may help to address mild mood impairments, treatment adherence problems, reduced health, risk behaviors, and given the uniqueness of the challenges faced by both patients with an ICD and their family, increase ICD device knowledge and acceptance [11, 34]. This type of single-session intervention is particularly helpful within a hospital setting where professional consultations need to be short term and goal oriented (Table 10.4).
Traditional Cognitive-Behavioral Interventions with Stress Management Techniques
Studies indicate that Cognitive Behavioral Therapy (CBT) and stress management frameworks are particularly well-suited for ICD-related adjustment issues [11, 35], since they provide tailored intervention strategies aimed at addressing common cognitive, affective, and behavioral difficulties experienced by patients with an ICD. This form of psychotherapy is effective not only in managing stress and symptoms related to anxiety, and minimizing catastrophic thoughts related to depressive symptoms in patients with an ICD, but also in reducing the number of arrhythmias that result in ICD discharges [36].
The CBT protocol comprises four to six sessions and has four key components: (1) patient education, (2) relaxation/stress management training, (3) cognitive reframing techniques, and (4) promotion of social support. The first component focuses on increasing the patient’s knowledge about both the device and the likelihood of ICD shocks, thus reducing the uncertainty and ambiguity that perpetuates shock-related anxiety and equipping recipients with the information needed to understand and discuss their medical condition, thus increasing their self-efficacy and QoL [37]. The second component of the CBT-driven intervention for patients with an ICD aims to help recipients identify and increase distress tolerance, and to address the psychological and physical rigors of living with cardiac disease and an ICD; and standard procedures that promote a state of deep relaxation [38] such as yoga techniques [39], diaphragmatic breathing, progressive muscle relaxation exercises and self-hypnosis may be introduced, practiced in session, and assigned as homework.
In presence of patients exhibiting a traumatic response to ICD shock, professionals might also consider the use of mindfulness-based cognitive strategies [40] and Eye Movement Desensitization and Reprocessing (EMDR) therapy [41].
Since CBT is based on the assumption that emotional and behavioral problems arise as a result of distorted or dysfunctional manners with which patients perceive events, which influence the persons’ sociability and behavior [11], the third phase of treatment makes use of cognitive reframing techniques to help patients with an ICD to identify and reframe inaccurate cognitions related to the ICD or shocks [42]. It is not uncommon, in fact, that patients with an ICD might interpret electrical discharges as a sign of device malfunctioning. Some people may also associate social activities, physical effort, and sex with the occurrence of electric shocks, thus deliberately avoiding such behaviors [10]. Finally, social support is promoted.
Patients with an ICD are further helped to cope with events and emotions that trigger their desire to engage in problematic behaviors [35] by: (a) establishing weekly goals to enable them to return to normal daily life activities; (b) forming groups to facilitate the sharing of coping strategies, feelings, experiences, and the provision of emotional support from people in similar circumstances; and (c) structuring a set of daily exercises compatible with their physical condition [35]. Evidence shows that CBT strategies also prepare patients with an ICD for future run-ins with shock and cardiac dysfunction, and that CBT is a more effective treatment for PTSD symptoms than pharmacologic therapy or even their combination [43].
Despite being considered the gold standard in the treatment of chronic conditions, evidence of the beneficial effects of CBT-based psychosocial interventions in patients with an ICD is only short-term and further research able to overcome the methodological limitations of past studies aimed at assessing its effectiveness needs to be undertaken to refine the data collected so far.
ICD Support Groups
The rapid acceleration of the use of the ICD over the past decade led health care practitioners to the development of adjunctive treatments aimed at supporting the health literacy and adjustment of patients and their families, and the most common approach by medical treatment centers has been the initiation of ICD support groups. They can take many forms, ranging from provider-led question and answer groups or didactic classes, to patient-led groups that encourage emotional expression or peer-to-peer support [29].
The active ingredients of support groups consist on the universality of the concerns of patients and the sharing of information and strategies for aiding in adaptation and encouraging psychological adjustment after receiving an ICD [44]. Lifestyle and family role changes, fear of shocks and limitations of daily life activity, battery and device failure, etc. are some of the main issues of concern that commonly arise from storytelling of ICD patients [24]. Even though the efficacy and effectiveness of ICD support groups has not been adequately investigated, they likely activate the known benefits of group interventions, such as universality of concerns, generation of hope, information sharing, and acquisition of coping skills via vicarious learning [29].
Cardiac Rehabilitation and Exercise Training
The main goal in the rehabilitation of ICD patients is to guarantee professional care during the transition period between acute therapy and ambulatory care, and to prevent re-hospitalizations. The beneficial effects of secondary prevention on the physiological and psychosocial functioning of cardiac patients are generally well-established [45].
However, the ICD has major implications on the physical and emotional status of the patients, and the referral to CR centers of patients with an ICD is usually negatively influenced by fear of inappropriate shock delivery during exercise [46]. Since negative emotions among patients with an ICD might be the cause rather than the result of arrhythmia, and that psychological distress might increase the risk of shock [47] and mortality [48], this particular patient population should receive special attention as their needs differ from those of ordinary heart patients. A comprehensive CR program including control of coronary risk factors, psycho-educational interventions and individualized exercise programs is, therefore, greatly recommended for restoring physical function and improving QoL [49].
Physical activity and exercise has a substantial role in enabling patients with an ICD to take control of their condition, and enhancing their ability to perform everyday activities (25). Sport participation is allowed at least 6 months after ICD implantation or after the most recent arrhythmic episode, in order to reduce the risk of inappropriate shock related to sinus tachycardia induced by exercise [9]. During CR, exercise training is performed safely, under careful supervision and according to the patient medical condition, thus permitting patients to overcome personal limits without adverse effects, and therefore increase their psychological and physical outcomes [50]. The cut-off heart rate for the ICD patient needs to be appropriately set by exercise testing and 24-h Holter monitoring [9].
The mode of exercise required must be similar to daily activity, in order to gain the most from exercise sessions and maintain the effect over years (Table 10.5).
However, the benefits of CR in increasing adherence to treatment recommendations among patients with an ICD are not yet established, and maintenance of physical activity in daily life still appears challenging. A long-term approach to exercise is essential to ensure greater benefits among recipients. Hospital follow-up visits and/or remote patient monitoring via telemedicine and mHealth (see Chap. 11) is thus recommended in order to maintain and improve health outcomes among patients with an ICD.
End of Life Intervention
The last stage in the treatment of patients with an ICD is a conversation regarding the deactivation of the device. The majority of implanted patients are not aware that the shock therapy can be deprogrammed and that the deactivation of the ICD allows for a more comfortable death [51]. Concerns associated with the device at the end of life include, the belief that the ICD will deliver painful shocks during the dying process, as well as ethical concerns related to turning off such a device. The basic principles of medical ethics (Autonomy, Beneficence, Non-maleficence, and Justice) must be kept in mind by healthcare professionals, since potentially conflicting at the end of life [52].
A frank discussion of ICD therapy, including the option of deactivation, must be conducted with potential recipients pre-implantation in order to ensure informed consent and address eventual doubts and concerns. A simple approach for physicians to assess patients with an ICD is to ask whether they have documented the circumstances, if any, in which they would want their ICD turned off, so as to prevent subsequent uncertainty [53]. Professionals can also advise the patients that “if at some future date, you decide you no longer want the device, it can easily be disabled”, awareness of their control over the deactivation option is empowering for patients, and at the same time provides an opportunity to contemplate their wishes. Importantly, health care providers should use an organized approach that identifies palliative needs, thus ensuring that the care plan is in alignment with patient and family preferences and goals [54].
Pharmacological Interventions
Since ICD shock is associated with adverse psychological outcomes within 30 days following the event [55], cardiologists often start psychiatric mental health medications. Patients may benefit from pharmacological intervention, but studies focusing on the cardiovascular side effects of psychotropic treatments on patients with an ICD suggest that certain classes of medications should be avoided. Physicians should, therefore, be aware of the cardiovascular risks associated with various psychotropic medications and consider their giving in conjunction with other form of psychological treatment [34].
Conclusion
Empirical data supports the feasibility and efficacy of various treatment modalities to improve the emotional well-being and to reduce device-specific distress in patients living with an ICD and their families [20]. Providers should be equipped with the knowledge to recognize symptoms of psychological difficulties among recipients, so as to provide them with information about the device, and to deliver evidence-based care in a brief consultation and longer-term clinical settings. Specifically, treatments involving cognitive-behavioral interventions and exercise training have demonstrated efficacy in improving patients’ psychological and cardiovascular health [27]. Evidence of the benefits of psychological intervention in ICD patients is most convincing for symptoms of anxiety and exercise capacity [27], but the effect of these treatments on depressive symptoms, heart rate variability, and shocks are weaker ([36, 56]). These research findings, however, should be viewed in the context of their studies, characterized by small sample sizes, high heterogeneity of participants as well as large variability in their methodological quality, and further research is warranted to increase the generalizability of research findings, in order to provide optimal care [57]. Specific attention should also be given to the choice of instruments used to evaluate the effect of the different interventions [27]. Moreover, to date, there is a lack of trials aimed at testing partner-focused interventions [58]. In fact, to ensure positive outcomes in the immediate post-ICD implantation period after returning home, clinical psychosocial attention must also be given to the patients’ support network [59], especially spouses [60]. Since the intimate partners’ experience may influence that of the recovering patient [61], it is of great importance in the healthcare context to properly assess their physical and mental health and to equipt spouses to provide effective social support [62]. Also, while short-term positive outcomes are usually achieved, to ensure effectiveness of evidence-based interventions in the long-term mental health providers need to fully understand the complex array of medical, psychological, and social factors that lead to the development and maintenance of psychological distress in patients with an ICD. In this regard, a web-based intervention may be worth considering, as it is accessible and can reach underserved populations [63]. Moreover, the impact of psychological interventions on health care utilization and the cost-effectiveness of the intervention is poorly understood in this population and should be the focus of future investigations.
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Pietrabissa, G. et al. (2017). Psycho-educational Support Interventions for Patients with an Implantable Cardioverter Defibrillator. In: Proietti, R., Manzoni, G., Pietrabissa, G., Castelnuovo, G. (eds) Psychological, Emotional, Social and Cognitive Aspects of Implantable Cardiac Devices. Springer, Cham. https://doi.org/10.1007/978-3-319-55721-2_10
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