© 2003 by European Society of Cardiology
Implantable cardioverter defibrillator recipients: quality of life in recipients with and without ICD shock delivery
A prospective study
1Research Group Psychology of Health and Illness, University Medical Centre Utrecht The Netherlands; 2Heart Lung Institute, University Medical Centre Utrecht The Netherlands; 3Department of Cardiology, Heart Lung Centre Utrecht The Netherlands
Manuscript submitted 26 November 2002. Accepted after revision 15 June 2003.
Correspondence: Helena C. M. Kamphuis, Stratenum, Research Group Psychology of Health and Illness, University Medical Centre Utrecht, P.O. Box 85060, 3508 AB Utrecht, The Netherlands. E-mail: h.c.m.kamphuis{at}med.uu.nl
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Abstract |
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AIMS: The experiences of patients who received shocks from their implantable cardioverter defibrillator (ICD) and how these events affect their overall adjustment are poorly understood. Our goal was to evaluate quality of life and psychological well-being, and the prevalence of, and changes in, depression and anxiety of patients who did or did not experience defibrillatory shocks in the first 12 months after ICD implantation. In total 167 patients were monitored after discharge. Four self-administered questionnaires were used. The first assessment took place before ICD implantation, the remaining three at 1, 6 and 12 months after discharge.
RESULTS: We classified patients into three shock groups and one no shock group. A small group of ICD recipients (26%) received ICD shock delivery, usually during the last 6 months of the study. Borderline significant differences were found within the groups over time regarding physical role limitations (P<0.051). Those who experienced shocks throughout the year (group 1) felt more limited in their daily activities due to physical or mental problems. All groups reported an improvement in their health (P<0.001). Overall quality of life did not change significantly after 6 months. Anxiety and depression did not change significantly over time. In total 22–66% of patients reported clinically significant depressive symptoms throughout the first year, and 31–83% clinically significant symptoms of anxiety. ICD recipients who had experienced a shock were significantly more anxious one year postdischarge than those who had not received a shock.
CONCLUSIONS: Overall quality of life and psychological well-being did not change in ICD recipients, irrespective of whether they experienced defibrillatory shocks. The high prevalence of depression and anxiety can be interpreted as a response to the perceived physical and mental problems regarding daily activities. Our data indicate that patients who have experienced an ICD shock do not adapt well to living with an ICD, they are more anxious than ICD recipients who received no shocks. However, the anticipation of having another shock after experiencing one is less stressful than that of the first shock. We conclude that the lasting psychological distress will not dissipate spontaneously or naturally and that psychosocial interventions may be warranted.
Key Words: ICDs, defibrillation shocks, quality of life
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Introduction |
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The experiences of those who are faced with the unpredictable firing of their implantable cardioverter defibrillator (ICD) and how these events affect their overall adjustment have hardly been studied. In Netherlands more than 50,000 deaths a year are due to cardiovascular disease alone, accounting for 37% of all deaths[1]
. In recent years treatment after cardiac arrest has significantly improved survival during follow-up. The antiarrhythmics vs implantable defibrillators (AVID) Clinical Trial investigators concluded that in patients resuscitated from near-fatal ventricular arrhythmias, the ICD is superior to antiarrhythmic drugs for increasing overall survival. In a period of 3 years 36% of the patients who had received antiarrhythmic drug therapy had died, as opposed to 25% in the ICD group[2]. Although the number of indications for ICD therapy is increasing in Netherlands, ICD therapy is currently used primarily for survivors of cardiac arrest due to life-threatening arrhythmias.
The average ICD recipient has typically been exposed to mood-destabilizing experiences such as surviving sudden cardiac arrest, undergoing long hospitalization and invasive electrophysiological testing[3]. Moreover, the patient is confronted with the unpredictability of the reoccurrence of malignant arrhythmias. During hospitalization the patient is probably confronted with his/her mortality, sometimes for the first time, and the future becomes more uncertain[4].
The World Health Organization (WHO) has defined health as total physical, psychological and social well-being. Following the WHO definition of health, three dimensions are considered relevant for patient-perceived quality of life: physical, emotional and social functioning. In this study we chose to focus on psychological well-being but did not consider it as a separate entity. Although quality of life after ICD implantation is reported to remain unchanged[5–8] or to improve[9], little is known about the long-term effect of having an ICD and how patients perceive their quality of life. Negative emotions are associated with the unpredictability, and frequency of ICD shock delivery, and depressed mood, anger, anxiety and uncertainty are common feelings reported by patients with an ICD[10–15]. According to Heller et al.[10], 20–58% of ICD recipients are depressed, although relatively few patients receive psychiatric medication either before (13%) or after (17%) ICD placement. Pycha and Calabrese found that approximately 15–35% of ICD patients were anxious and depressed during the first few years following implantation[16]. Other studies showed that the occurrence of ICD shock delivery has no influence on quality of life and psychological distress[5,17,18]. Most patients adapt well to living with an ICD[19]. In the late 1990s, Hegel et al.[20] and Dougherty[21] suggested that more research should target the psychological reactions and adjustments to ICD implantation.
The above results suggest that additional evidence from a longitudinal perspective is needed. Our goal was to evaluate quality of life, depression and anxiety in patients who did or did not experience ICD shock delivery in the first 12 months after ICD implantation.
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Methods |
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Study design and questionnaires
A 12-month longitudinal study was carried out over 48 months at three major university hospitals and one general hospital. The study was approved by the Committee for Ethics in Medical Investigations in all hospitals. For this study 180 patients were approached during 1998 and 1999. During the data collection period 13 patients refused to participate in the study. The sample consisted of 167 consecutive patients who were admitted to the hospitals after an out-of-hospital cardiac arrest. Of all 167 cardiac arrest survivors, 132 (79%) received ICD treatment and 35 (21%) received other treatment, namely, antiarrhythmic drugs, revascularization or surgery. As we also wanted to examine whether the treatment as such had an effect on quality of life we included the control group in our comparison.
All patients completed a questionnaire shortly after admission (before extensive cardiac evaluation), and at 1, 6 and 12 months after discharge. Information regarding patients' quality of life and psychological well-being was collected by using the RAND-36, Heart Patient Psychological Questionnaire (HPPQ), State–Trait Anxiety Inventory (STAI) and Centre for Epidemiologic Studies Depression Scale (CES-D). The questionnaire also contained items about sociodemographic characteristics and medical history.
Generic quality of life was measured with the RAND-36[22,23], which contains 36 items with a 4-point Likert scale. For all nine subscales, low scores indicate poor physical functioning, social limitations (due to physical and mental problems), physical and mental limitations (due to problems with work or other daily activities), nervousness, depression, tiredness, exhaustion and pain.
Well-being was measured with a disease-specific questionnaire. The HPPQ is a questionnaire developed for heart patients in general. The HPPQ[24–26] comprises 52 items scored on a 3-point Likert scale. Four dimensions are measured: well-being, feelings of being disabled, displeasure and social inhibition. A high score on the well-being dimension indicates a high degree of well-being, whereas high scores on the other three dimensions indicate a worse condition[27].
Anxiety was measured with the STAI[28], which consists of 40 items with a 4-point Likert scale. The trait measure (20 items) reflects a more stable personality characteristic, while the state measure (20 items) reflects a transient characteristic[20]. Spielberger et al. suggested a threshold value for the sumscore of 40 for both scales, all higher scores indicating that clinically significant anxiety should be suspected[29].
Depression was measured with the CES-D, which consists of 20 items scored on a 4-point Likert scale[30]. A cut-off score of 
16 is used to identify patients with probable clinical depression[31].
Statistics
The data were analysed using the statistical package SPSS for Windows, version 10[32]. Multivariate analyses of variance (MANOVA) for repeated measures were used for the comparison of the average scores of the RAND-36, the HPPQ, the CES-D and the STAI over time[33,34]. The independent variable was whether the patient had received an ICD shock delivery. To determine the effect of the independent variable, pre-treatment scores and the scores one month after discharge were used as covariates, as patients could only report whether they had experienced an ICD shock delivery retrospectively, at 6 and 12 months after discharge.
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Results |
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Patient characteristics are given in Table 1. ICD recipients were primarily male, married, received secondary education and were either unemployed or retired. Slightly less than half of all ICD recipients had a myocardial infarction before their cardiac arrest. No significant differences were found between the ICD group and the no ICD group, except for age. Patients with an ICD were significantly (P=0.04) younger than patients without an ICD (respectively; mean age 55.24, range 41.5–68.9 vs mean age 61.04, range 48.2–73.8). When comparing those who had shocks with those who experienced no shocks we found no significant differences regarding age, gender, work, marital status and education.
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To examine the impact of shock delivery on quality of life, patients were categorized according to the number of shocks received (Table 2). Those who experienced shocks before the 6 and 12 months' assessments were allocated to group 1. ICD recipients in group 1 experienced shocks during both time intervals. Group 2 consisted of those patients who only experienced shocks during the first time span of this study (0–6 months postdischarge). Those in group 3 experienced ICD shock delivery only during the last 6 months of the study (second time span: 6–12 months postdischarge). The fourth group consisted of those patients who did not experience ICD shock delivery. Of all ICD recipients, 26% received ICD shock delivery at some time during the first year after discharge from the hospital of whom 6% had more than three shocks. Most of them received an ICD shock between 6 and 12 months after discharge.
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The mean values and standard deviations of the quality of life parameters are shown in Table 3. As the pre-treatment scores and the scores at 1-month postdischarge were used as covariates, the focus of the MANOVA was primarily on the period from 6 to 12 months postdischarge. With regard to generic quality of life (RAND-36), differences in physical role limitations occurred over time in all patient groups (P=0.051). Patients who experienced ICD shock delivery during both time spans (0–6 and 6–12 months) (group 1) felt more limited in their daily activities (a decrease in physical role limitations), whereas patients who had not had ICD shocks (group 4) experienced no change. Physical role limitations improved with time in the other groups. All groups reported a significant (P<0.001) improvement in health (subscale health change) and experienced less pain between 6 and 12 months postdischarge (P=0.067).
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Mental health did not change significantly over time in any group, however it decreased in group 2 between 6 and 12 months postdischarge. Although health perception also did not change significantly over time and there were no differences between the groups, patients in group 1 reported a diminished perceived health 6–12 months after discharge whereas the other groups reported a slight improvement. The same applied for physical functioning.
The psychological well-being questionnaire (HPPQ) did not reveal differences between groups. Well-being deteriorated in all groups over time (P<0.001) whereas there was an improvement in feelings of disability (P<0.001). A further refinement: patients in both group 1 and group 4 indicated that they felt more handicapped than patients in the other two groups.
Overall anxiety and depressive symptoms did not change significantly over time in any group. The prevalence of clinically relevant anxiety and depression is shown in Table 4. Patients in groups 1 and 3 were more susceptible to clinically relevant depression and anxiety.
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Discussion |
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There are few prospective studies addressing quality of life and psychological recovery over time in ICD recipients who have experienced ICD shock delivery. The principal goal of the present prospective study was to determine the effect of receiving ICD shock delivery on quality of life and psychological well-being, by comparing patients who received an ICD shock with those who did not.
This is the first study in which the group which received ICD shocks was separately considered and a control group of patients which had no ICD was included. We distinguished between patients who had received early or late ICD shocks or shocks at both stages because we believe that the time of ICD shock delivery influences the quality of life. ICD recipients who experienced ICD shock delivery were more depressed and anxious than those who did not experience a shock (group 4 and control group). Interestingly, patients who experienced ICD shock delivery during the first 6 months (group 2) of the study were more depressed and anxious between 6 and 12 months postdischarge than the patients in the other groups.
Our study took into account that patient-perceived quality of life during hospitalization and 1-month postdischarge could influence quality of life at 6 and 12 months. Patients were not able to report on their experience with ICD shocks until 6 months after they were discharged. But, as we did not want to lose the impact of the quality of life outcome during hospitalization and one-month postdischarge, we used the data as covariates in a multivariate analysis. This distinguishes our study from all previous studies. We also tested whether our research design influenced the outcome by repeating the MANOVA incorporating all measuring points. No significant differences were found between the groups over time.
Although patients who experienced an ICD shock had a poorer quality of life, especially those patients who experienced a shock during the two time spans (group 1), overall quality of life did not change significantly between 6 and 12 months postdischarge in any group, Schron et al.[35] found that shocks were associated with reduced quality of life in ICD recipients. We found a significant change over time within the groups regarding physical role limitations. Those patients who experienced shocks during both time spans (group 1) felt more limited in their daily activities (a decrease in physical role limitations) compared with the other groups. This is consistent with the findings of Reid et al.[36] and Schron et al.[35].
All patients in our study reported a significant improvement in their health (subscale health change), but this was not perceived as such (subscale health perception). The subscale health perception comprises five questions and mainly focuses on how patients compare their health with that of others. One retrospective question assesses health status (health change): the patient was asked to compare his/her health at the time of assessment with that of a year earlier. The different outcomes may be due to a response shift, in that perceived quality of life changes due to experiences and comparisons patients make. In future research we need to focus more on this possible response shift.
We found that most of the improvement occurred during the first 6 months postdischarge. With regard to quality of life, this may be because patients were often hospitalized for a long time, 2–3 months, and were glad to be back home. All patients groups reported extremely low scores indicating poor quality of life on all subscales of the RAND-36 except for pain. Baseline quality of life measures were worse than the mean values in the general healthy adult population in the Netherlands[22]. It is most likely that quality of life declined during the long hospitalization as this period is a very stressful time for patients. After 6 months postdischarge, quality of life did not further improve. A limitation of this study is that we were unable to assess quality of life directly after resuscitation. A possible explanation for the improvement reported in the first 6 months is that patients feel relieved to have survived the cardiac arrest and feel safer due to the treatment they have received. Before conclusions can be drawn about whether patients adapt well to their new situation in the long run, quality of life should be assessed for a longer period, up to 2–5 years after discharge.
Physical functioning did not change in any group 6–12 months after discharge in our study. Schron et al.[35] using the Medical Outcomes Short Form 36-item questionnaire (SF-36), which is comparable to the RAND-36[22], found that physical functioning and mental well-being reduced over time in those who experienced an ICD shock delivery. We found that mental health (a subscale of the RAND-36) became worse for those patients who experienced a shock during the first 6 months after discharge.
Our study sample was relatively large compared with that of earlier studies. In our sample, 26% experienced a shock in the first year after implantation, which is less than reported in other studies (Schron et al.: 39% [ICD recipients n=373]; Reid et al.: 54%[36] [ICD recipients n=87])[35]. Furthermore, those who had received a shock felt more limited in their daily activities and were more susceptible to depression and anxiety. This finding is in agreement with results from previous studies in which ICD shock delivery was shown to be associated with increased psychological distress[15,37]. However, Chevalier et al.[9] did not find any association between ICD shock delivery and psychological well-being.
In our study, between 22% and 66% of patients could be diagnosed as having possible clinical depression (using the cut-off score 16 on the CES-D) from discharge till 12 months after implantation. This outcome is consistent with that of Heller[38] and Pycha and Calabrese[16]. Many of our patients (31–83%) in both shock and non-shock groups reported clinically relevant anxiety, a percentage similar to that reported by Herbst et al.[5]. This is most likely because all groups had survived a life-threatening event. All patients who had experienced ICD shock delivery were more anxious than those who had no shocks. The prevalence of depression shows another picture: the anticipation of having another shock is less stressful than the anticipation of experiencing the first shock.
Like Dougherty[15] we found that ICD recipients became less anxious with time when they had not experienced an ICD shock delivery in the first year after implantation. However, in our study ICD recipients who had received an ICD shock became more anxious with time. We found that one year postdischarge, ICD recipients who had received an ICD shock were significantly (P=0.046) more anxious than those who had not received a shock. In another study, patients who experienced ICD discharge were more anxious than ICD recipients who did not experience ICD discharges or patients without an ICD (treated with antiarrhythmic medication)[12].
Sears et al.[39] reported on health care providers' (physicians and nurses) perceptions of the psychosocial impact of having an ICD. They found that health care providers felt less comfortable in managing the emotional concerns of ICD recipients than more traditional health care and lifestyle concerns. The outcome of our study indicates health care providers should pay attention to the emotional concerns of ICD recipients and especially to those who have experienced ICD shock delivery during the return visits to the outpatient clinics. Our results indicate that psychological distress will not dissipate naturally over time. Psychosocial interventions by healthcare professionals may be warranted 6 months after discharge from the hospital. Whether psychological distress can be managed and/or decreased by psychosocial interventions should be studied in future research.
More needs to be understood about the emotional reactions to having an ICD and receiving ICD shocks. Strong emotional reactions having survived cardiac arrest and having an ICD are to be expected. The emotions expressed are likely to hold clues on how individuals adapt to their situation. Our data suggest that people who have experienced an ICD shock do not adapt well to living with an ICD. To understand further how patients adapt to their new situation, more attention should be paid to personality structure, coping skills, past psychopathology and life experiences.
There were several limitations of this study. The influence of social support, evaluation of cognitive and bio-medical performance, ICD complications, mobility (such as the effect of driving restrictions) and drug therapy were not taken into account. In future research these variables should be studied. At the time of data collection little was known of the possible cerebral effects (like memory loss or brain damage) on perceived quality of life. Also it was not a standard practice to test cognitive performance of cardiac arrest survivors either during hospitalization or during the first year after ICD implantation. Therefore, the effect of cognitive performance on quality of life could not be studied.
In future research we need to specify the necessity of reporting the functional status, severity of heart disease, whether the ICD shock discharge was appropriate and ICD related complications in the patients' medical record to healthcare professionals. During the patient record review we found that not all records were complete. The influence of these variables on patients' perceived health and well-being could, therefore, not be included in the analysis of the data. In future research the assessment of quality of life of ICD recipients by healthcare professionals and the medical status of the patient compared with how patients perceive their quality of life should be studied.
Another limitation was that the control group remained small. This was because we only allowed patients with an out-of-hospital cardiac arrest due to life-threatening arrhythmias to participate in the study. We wanted a homogeneous patient group. At the start of the data collection we expected that more patients would be treated otherwise, like receiving medication as therapy, however, during the data collection period ICD therapy became the first-choice therapy for cardiac arrest survivors, therefore the control group remained small.
It is difficult to compare our findings with other studies because of differences in study methodology: most studies are cross-sectional. Moreover, studies with quality of life scores measured before ICD implantation are rare. Additionally, the studies reviewed have used different instruments (questionnaires) to measure quality of life, making it hard to compare our outcome with that of other studies. In future studies the emphasis should be on using the same instruments to measure quality of life, depression and anxiety. Furthermore, the use of a homogeneous definition of quality of life would be practical.
Our study concentrated on patient-perceived quality of life and (psychological) well-being, rather than on the impact of disease-related variables (like functional status, ICD complications and severity of heart disease). We can conclude that from a patient's perspective, quality of life is not influenced by the choice of treatment; however, quality of life is influenced by ICD shock delivery. It can be concluded that having survived cardiac arrest and having had an ICD shock have a major impact on the quality of life.
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Acknowledgements |
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This study was supported by grants from the Dutch Heart Foundation and the University Medical Center Utrecht. We wish to thank I. Hofstede, H. Klomp, M. de Beijer and B. Schoonderwoerd for their active participation in the data collection for this study. We would also like to thank C. Kruitwagen for his statistical contribution and advice. We are indebted to B. Dijkman and J. Smeets, cardiologists of the University Hospital Maastricht, I.C. van Gelder, cardiologist of the University Hospital Groningen and N.M. van Hemel and E.F.D. Wever, cardiologists from the St. Antonius Hospital Nieuwegein for allowing patient recruitment to take place in the departments of cardiology. Most importantly, we thank the patients who participated in the study.
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Footnotes |
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Grant from The Netherlands Heart Foundation (97.012).
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References |
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 A. K. Gehi, D. Mehta, and J. A. Gomes Evaluation and Management of Patients After Implantable Cardioverter-Defibrillator Shock JAMA, December 20, 2006; 296(23): 2839 - 2847. [Abstract] [Full Text] [PDF]
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 F. S. Luyster, J. W. Hughes, D. Waechter, and R. Josephson Resource loss predicts depression and anxiety among patients treated with an implantable cardioverter defibrillator. Psychosom Med, September 1, 2006; 68(5): 794 - 800. [Abstract] [Full Text] [PDF]
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J. Baumert, C. Schmitt, and K.-H. Ladwig Psychophysiologic and Affective Parameters Associated With Pain Intensity of Cardiac Cardioverter Defibrillator Shock Discharges Psychosom Med, July 1, 2006; 68(4): 591 - 597. [Abstract] [Full Text] [PDF]
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S. J. Connolly, P. Dorian, R. S. Roberts, M. Gent, S. Bailin, E. S. Fain, K. Thorpe, J. Champagne, M. Talajic, B. Coutu, et al. Comparison of {beta}-Blockers, Amiodarone Plus {beta}-Blockers, or Sotalol for Prevention of Shocks From Implantable Cardioverter Defibrillators: The OPTIC Study: A Randomized Trial JAMA, January 11, 2006; 295(2): 165 - 171. [Abstract] [Full Text] [PDF]
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