It is now well established that the implantable cardioverter defibrillator (ICD) is an accepted means of primary and secondary prevention in those patients who are at increased risk of sudden cardiac death, arrhythmias such as Brugada syndrome, and conditions due to primary cardiomyopathies and heart failure. The data supports increased survival rates and better quality of life (QOL) by improving the ability to participate in normal daily activities and exercise programs. However, because the implantation often occurs against a complex medical background with inevitable psychological stress, all implanted patients should be considered at high risk for developing psychopathology.1 The perceived impact and choice the patient is making between fear of prolonged illness such as chronic heart failure and the possibility of sudden cardiac death versus the fear of post-implant complications, ICD shocks, and device malfunction, causes stress and anxiety.2 This may be especially true of the patient who is undergoing implant due to primary prevention. These patients are accepting an unpleasant intervention when the benefit is uncertain for the future.3 Interestingly, patients who do accept their ICD had a supportive partner and a good attitude toward technology, and have reported improved quality of life.4 Those with underlying psychological pathology, older age, unanswered concerns, and serious disease rather than device indication, correlated with poor acceptance. There are other contributing factors such as culture and communication from the referring physician that affect acceptance.4 Kapa et al found that at baseline there are significant rates of psychopathology after implantation, but the scores improved over time. The group studied was similar in demographic makeup when compared to other study groups looking at anxiety, depression, and post-traumatic stress disorder (PTSD) following device implant. The study suggests that overall the dominance of depression, anxiety, and PTSD symptoms decreased over the one-year follow-up period. The rate of anxiety and depression were lower, but the rate of PTSD was comparable to other studies. An increase in the rate of PTSD was seen after ICD storms compared to those who did not have that experience.5 Greater than 10% of patients have persistently higher levels of anxiety, depression and PTSD scores one year post ICD implant, although even those scores improved from initial implant. Kapa et al suggest these findings propose that many undiagnosed psychopathological issues may be present at the time of implant for some recipients of ICD therapy. An earlier study done by Carroll and Hamilton, which followed 41 patients over a 4-year period, concluded that mental health improved with reduced psychological distress by 6 months after implant, but physical functioning steadily declined over a 3- to 4-year period.6 Carroll suggests the reduction in physical functioning in this study may reflect the underlying cardiac disease that remained in this particular population of patients and their lack of participation in a cardiac rehabilitation program, as well as avoidance of exercise for fear of getting shocked. Patients aged younger than 50 have a common risk factor for being psychologically at risk.4 In general, the rationale for device implant usually occurs later in life, therefore making this an unexpected intrusion of life task. Other factors that have been cited in this age group are female gender, shock history, poor understanding of the device and their condition, and serious comorbid medical states.4 While intellectually the implanted patient knows the ICD is a life saver, initially they are mainly concerned with the shock. There is no way one can be prepared for that experience. Even with patient education and resource material provided by the EP team, many are totally unprepared for the shock when and if it occurs. The fear of the shock is universal for ICD patients.7 Anxiety and depression vary in this group from 13-38% and 24-48%, respectively. A shock therapy delivered is associated with increased psychological distress in the patient as well as the family, and may be the single most disturbing component of ICD therapy.7 The range of pain in various populations of ICD patients is evident; for some it is hardly noticeable and for others it is like being kicked by a horse or struck by lightning.7,8 In general on the pain scale of 0-10, it is estimated to be a 6.4 For those who receive their first shock, some have warning and some do not; some syncopize before the shock, making them unaware a shock was delivered, but others do not.9 To some, having a shock delivered is a symbol of a change in their overall health, signaling poor prognosis or a change in quality of life. To find that the shock was delivered inappropriately is even more distressing, and may trigger mistrust in the device’s accuracy and effectiveness.10 Although new strategies including device programming have reduced the number of inappropriate shocks, still approximately 11.5% of patients who have devices for primary prevention receive at least one inappropriate shock, and at least 31.2% of all shocks are inappropriate.4 Data suggest hyperalgesia is strongly associated with a higher estimate of pain from the shock experience. Patients who have a second shock during the same arrhythmia event perceive the second shock as more uncomfortable than the first.7 Repeated shocks over time have been associated with decreased QOL.6 Patients begin to display evidence of vigilance and are afraid to participate in any activity, thinking it will trigger another shock.7,11 Interestingly, in 2006, Baumert and colleagues found that repetitive shocks, numbering more than one, elevated anxiety symptoms substantially and increased pain threshold. This reaction is temporary, an alarm reaction to a threatening event that decreases pain perception, whereas anxiety is associated with apprehensive anticipation of pain, resulting in hypervigilance and somatic scanning subsequently increasing the intensity of pain.7 The ICD patient may experience reduced quality of life, anxiety, depression, fears and phobias, and post-traumatic stress syndrome among other psychological changes.12 There is some controversy as to whether the shock experience initiates emotional distress right away. In the Canadian Implantable Defibrillator Study, the results suggest it takes greater than five shocks to cause stress, while in the AVID (Antiarrhythmics Versus Implantable Defibrillator) trial, one shock was all it took.4,13 There are also indications that suggest that distress leads to arrhythmias, thus leading to more shocks.13 The Primary Prevention Parameters Evaluation (PREPARE) study, of which 147 of 700 participants were female, demonstrated that tactical programming and ATP reduced the incidence of shocks to 9% versus 17% in primary prevention patients over a one-year period.4 Personality traits such as the type D personality also play a role in whether the patient may be more at risk for anxiety and depression.14 The type D or distressed personality is characterized by the tendency to experience negative emotions and to display avoidance behaviors such as avoiding social inhibition. These patients have reported impaired QOL both at implant and three months following.4,14 Several studies indicate that those who are unable to express their emotions are more prone to anxiety and depression,15,16 which can translate to an increased risk for arrhythmias and shock. While adults have a higher proportion of implants, a significant number of children and adolescents are implanted with ICDs, more often as secondary prevention. Children and young adults seem to be more likely to receive a shock, both appropriate and inappropriate. Lead-related complications are also more likely to occur in the younger population.10 Recent data examining ICD outcomes in the younger patient population with hypertrophic cardiomyopathy indicated that 71.4% of secondary prevention patients received an ICD shock versus 11% in an adult sample.10 According to other research, young patients received a higher proportion of inappropriate shock, about 38% more, than adults.10 It is thought that the young ICD patient is at high risk for psychosocial challenges because of the many lifestyle interruptions and adjustment to the knowledge they have a life-threatening arrhythmia. Although research suggests that young patients adjust well to having a device, anxiety can be especially problematic in these patients due to the propensity for increased number of shocks.10 Women have a unique set of issues related to having an ICD implant. According to data presented by Vazquez et al, women under the age of 50 may be at higher risk for developing psychological complications associated with shock and death anxiety as well as body image issues, suggesting that the experience of having an ICD for women is quite different from men.11 Women have more often reported to display worse mental, physical, and health-related QOL issues following cardiac diagnosis and intervention, especially when it comes to device implantation. For example, device placement and the related scar cause body image and sexuality issues.11 Additionally, receiving a shock may cause anxiety, instigating development of avoidance behaviors and the perception that limiting normal daily activities will inhibit another shock.11 Device recall can have an adverse effect on the patient’s perception of the safety and security that the ICD is there to provide. Media coverage of device and lead recall can shake perceived confidence in the device.4 Study results regarding the effect of recall are mixed for patients. One study suggested patients who received information regarding the recall were more anxious.10 The last frontier, if you will, is approaching the ICD patient with end of life issues. In most instances, the conversation regarding deactivation of the device is not addressed. Only 27 out of 100 patients had a discussion with their health care provider regarding deactivation of the device.4,17 End of life considerations in the realm of electrophysiology is concentrated on prevention of unnecessary shocks by deactivating the device. The majority of implanted patients are not even aware that the shock therapy can be programmed off.17 Lack of knowledge as to what the device can and cannot do may be a contributing factor in whether the patients ask questions regarding device therapy and what happens at the end of life.17 Deactivation of the ICD at end of life is an intervention that allows a more comfortable death. The full engagement of the patient and family are desired when discussing this very personal issue. One third of patients get shocked in the last minutes of life. The patient’s perception of quality of death should set the framework for this discussion.4 Clinicians may begin to approach this subject by establishing goals of care; therefore, deactivation of the device can be seen in the context of other goals for health care, keeping in line with their overall wishes as their medical condition changes.17 Intervention Education should be part of any intervention; preparing the patient before and after implant can avoid misconceptions.4,9,13,18 Those that have an opportunity to ask questions have better psychosocial outcomes.8,9 Research supports that acceptance of the device translates into better quality of life.4 Patients also need health care management akin to management of any chronic disease. Implementation of strategies of behavior change to encompass adherence to medical therapy, dietary change, weight management, stress management and health risk behaviors (e.g., smoking) are needed to successfully help these patients to adapt to living with the device.4 A patient-specific plan may help to support and educate the patient pre and post implant. This plan should have several key components, including: • patient education providing information on the device, how it functions, the importance of follow-up, and everyday living with the device and limitations; • psychosocial information, such as the challenges of living with the device and cardiac disease, and reassurance that there is support to help the patient cope and have hope; • activity prescriptions, including discussions directed toward taking part in activities for improved QOL to the patient, ensuring confidence in being able to be active; • recall events, and developing a plan to communicate and manage changes that may occur in device reliability; • a shock plan, including how the patient should communicate once they have received a shock, efforts to reduce repeated shock with an emphasis on their return to previous QOL.4 Know your patient. Sears et al have set forth a clinically based psychosocial assessment strategy as a guide to psychological management of the ICD patient. This includes: • assessment of risk factors, age Conclusion Shock, age, gender, underlying pathology, industry recalls, and increased indications all have a profound effect on the psychological well-being of ICD patients. The majority of ICD patients experience a desirable quality of life and a high acceptance rate. However, 30-50 percent of patients report some degree of negative effect such as fear, anxiety, and depression at some point during their implanted life. Additionally, lifestyle changes that affect driving, sexual activity, social interactions, physical appearance and physical activity further complicate the life of the recipient. Younger implanted patients, those aged less than 50, those with undiagnosed psychological issues, women, and those who experience a high rate of shocks have been identified as being at special risk for development of psychological distress and poor physical outcomes.9,11,13 What have we learned? Recent research has helped us better identify those at risk and suggests while there are no concrete answers as to what the best methods are to support our patients, the evidence implies that we are going in the right direction. It is important to recognize the patient at risk for psychological issues and address them early on. The population at risk may already have psychological pathology that has not been identified. This, coupled with the stress of today’s fast-paced lifestyle and social pressures, makes it even more important to identify those at risk early. We have learned that there is no one right intervention, but many that are helpful. Assessing your patient’s individual needs and using the evidence will more than likely lead you to one or more that will be most helpful to your patient at risk. Finding the right setting to address these patients is difficult. It has been suggested that no one setting is the best. The number of patients receiving implants has risen and will continue to increase given the expanded indications for implant. Research continues, and patients will benefit as we clinicians continue to seek what is best.