American Journal of Critical Care. 2008;17: 222-230
Copyright © 2008 by the American Association of Critical-Care Nurses.
CE Article
Long-term Effects of Implanted Cardioverter-Defibrillators on Health Status, Quality of Life, and Psychological State
By
Diane L. Carroll, PhD, CNS-BC and
Glenys A. Hamilton, RN, DNSc.
Diane L. Carroll is the Yvonne L. Munn Nurse Researcher at Yvonne L. Munn Center for Nursing Research, Institute for Patient Care, Massachusetts General Hospital, Boston. Glenys A. Hamilton is a research consultant for Ullevål University Hospital and Aker University Hospital in Oslo, Norway.
Corresponding author: Diane L. Carroll, PhD, CNS-BC, Yvonne L. Munn Center for Nursing Research, Professional Office Building 429, Massachusetts General Hospital, 275 Cambridge St, Boston, MA 02114 (e-mail: dcarroll3{at}partners.org).
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Abstract
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Background Living with an implanted cardioverter-defibrillator increases survival, but the effects of the device on health status, quality of life, and psychological state over time are not clear.
Objectives To investigate changes in health status, quality of life, and psychological state associated with implantation of a cardioverter-defibrillator from implantation to 4 years later.
Methods A prospective, longitudinal design was used to measure changes in scores on the Short Form 36 of the Medical Outcomes Study, the Quality of Life Index–Cardiac III, and the Profile of Moods States short form at implantation, 6 months, and 1, 2, 3, and 4 years later.
Results A total of 30 men and 11 women (mean age, 60.4 years) completed all 4 years of follow-up. The physical and mental health composite summary scores of the Short Form 36 changed significantly over time; the mental health score improved (F = 2.95; P = .03), and the physical score worsened (F = 3.69; P = .003). Scores on the Quality of Life Index–Cardiac III did not change significantly. Negative moods were significantly fewer, and the total psychological distress score was significantly lower (F = 10.21; P < .001) during the 4 years of follow-up.
Conclusions Patients had improved mental health and reduced psychological distress by 6 months after implantation. Perception of physical health declined during the 4 years after implantation; the role physical subscore of the Short Form 36 indicated significant improvement in functioning at 6 months and a trend toward reduced functioning at 3 and 4 years after implantation.
Notice to CE enrollees: A closed-book, multiple-choice examination following this article tests your understanding of the following objectives:- Describe the indications for placement of an implantable cardioverter-defibrillator (ICD) and the population of patients for whom this treatment is appropriate
- Identify the emotional and physical responses most commonly experienced by ICD recipients
- Discuss clinical implications for nurses caring for ICD recipients
To read this article and take the CE test online, visit www.ajcconline.org and click "CE Articles in This Issue." No CE test fee for AACN members.
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Although the risk for sudden cardiac death (SCD) has declined during the 20th century, more than 400000 people in the United States die each year of SCD.1 Coronary heart disease is the major risk factor for SCD. Population-based studies2 suggest that as many as 50% of those who experience SCD may not have had coronary heart disease diagnosed previously. In addition, the percentage of SCDs increased from 38% in 1989 to 47% in 1999, and concern has grown regarding the increased rate of SCD in women between the ages of 35 and 44 years.3–5
Research on SCD has focused on the development of treatments. Today, the optimal treatment for patients who survive SCD or are at risk for SCD is placement of an implantable cardioverter-defibrillator (ICD). In high-risk patients with cardiac disease, use of a ICD has decreased mortality 30% to 54% by reducing the incidence of SCD.6,7 An ICD is now the standard of care for patients with a history of SCD and patients with reduced ventricular function after myocardial infarction. Clinical trials8–11 are revealing other indications in patients with heart failure and those with nonischemic and autosomal-dominant cardiomyopathy.
Health care providers now have 25 years of experience and success with the ICD. This device has evolved from a large, nonprogrammable device implanted through a thoracotomy incision to devices that incorporate sophisticated detection, biventricular pacing, tiered therapy of antitachycardia pacing, low-energy shock, and high-energy defibrillation and are implanted by less invasive procedures.
As ICD technology improves and the indications for use expand, efforts to understand the impact of living with an ICD can improve the physical and mental health outcomes of patients who have these devices. The lack of longitudinal data on changes in physical and mental outcomes is a gap in our knowledge about ICD recipients. Therefore, the purpose of this study was to measure the changes over time in health status, quality of life, and psychological state from time of ICD implantation to 6 months and 1, 2, 3, and 4 years after implantation.
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Background
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Conceptual Framework
Various measures have been used to determine the multidimensional aspects of the quality of life in ICD recipients. These measures have included assessments of physical and psychological state, sickness impact, symptoms, awareness of the ICD, and ICD device shock(s). For this study, we used a tiered approach12: a generic measure of health status; a cardiac disease–specific measure for quality of life; and a population-specific measure to assess psychological distress, a common comorbid response that indicates the multidimensional and dynamic nature of the components of quality of life for ICD recipients. With this approach, we can measure the multidimensional aspects related to quality of life.
| More than 400 000 Americans die each year of sudden cardiac death.
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Conceptualization and measurement of quality of life are challenging. A definition of quality of life has existed for nearly 50 years and embodies a shared consensus that quality of life is a broad-ranging concept that is multidimensional, dynamic, and quantifiable by self-report. Quality of life was defined as "a state of complete physical, mental, and social well-being and not merely the absence of disease or infirmity."13 Much research has been done on what quality of life comprises. Szabo,14 on behalf of the World Health Organization quality of life group, included 6 domains to be considered in measuring quality of life: physical, psychological, level of independence, social relationships, environment, and spirituality/religion/personal beliefs.
Health Status
Schron et al15 reported health status as a secondary end point in patients participating in the Antiarrhythmics Versus Implantable Defibrillators trial, a comparison of antiarrhythmic drug therapy with ICD placement.16 On the Medical Outcomes Study Short Form-36 (SF-36), composite summary scores for mental health at implantation were lower (P =.006) in 413 patients who received an ICD (mean, 45.9; SD, 11.8) than in 384 patients who received antiarrhythmic drug therapy (mean, 47.5; SD 11.5). During the 12 months of follow-up, no further differences were noted between these groups on measurements of health status at 3, 6, and 12 months after implantation.
In an assessment17 of the SF-36 subscale scores of 74 ICD recipients, general health and social functioning decreased from 3 to 12 months after insertion of an ICD. During this period, 49% of the ICD recipients had received a shock from the device.17 Receiving such a shock can affect general health perception.18
| Quality of life decreases if the device delivers a shock, especially if multiple shocks are delivered.
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Quality of Life
Thomas et al19 found that the quality of life of ICD recipients was less than that of the general population but similar to that of other patients with various types of cardiovascular disease. The quality of life of ICD recipients is similar to that in patients who have SCD treated with drugs.15–20
Quality of life decreases the longer an ICD is in place; acceptance of the ICD is thought to be a key factor.21–24 Numerous studies15,18,23,25–32 have shown that quality of life decreases if the device delivers a shock, especially if multiple shocks are delivered.
Psychological State
Anxiety and depression are associated with poorer quality of life in ICD recipients.24,28,33–37 Sears et al38 reported that 24% to 87% of ICD recipients experienced some degree of anxiety; up to 38% had clinically diagnosed anxiety, and 9% to 15% had clinically diagnosed depression. Other negative moods, notably anger, also increased after ICD implantation and were highest at the time of implantation.28,39–41 Factors associated with the poorer quality of life after ICD implantation include younger age, being female, lack of social support, multiple comorbid conditions, symptoms (specifically pain and sleep disturbance), reduced physical functioning, and ICD shock.23,30,42–44
| Mental health composite summary scores improved significantly from device implantation to 4 years later.
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Adjustment after ICD implantation is influenced by the actual activation of the ICD to provide a shock. After an ICD shock, increases in anxiety, depression, and fear have been noted.17,35,43,45,46 Receiving a shock alters coping, shakes confidence, and creates uncertainty as to when and where the ICD may shock again. Fear leads to decreases in physical and social functioning because patients hope that the changes will reduce the number of future ICD shocks. Such adjustments are an attempt to limit with whom and where the patients might be when the next ICD shock occurs.
Some data18,38 indicate that ICD recipients experience poorer quality of life than the general population does and experience more anxiety and depression than do other patients with cardiovascular disease. In addition, patients who experience an ICD shock have further losses in mental health and quality of life and have more fear than do ICD patients who do not receive shocks.17 As more patients in the United States have an ICD placed, knowledge of the immediate and long-term effects on quality of life is needed.
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Methods
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A prospective, descriptive, repeated-measures design was used to investigate the changes in health status, quality of life, and psychological state during the 4 years after ICD implantation.
Sample
During a period of 15 months, 81 patients were approached and asked to participate in this study. A total of 70 agreed to participate. All 70 were able to speak and read English, were admitted to the hospital for first-time implantation of an ICD, were able to provide informed consent (no cognitive impairment), and had a telephone at home to complete the follow-up data collection.
Procedure
Patients admitted to Massachusetts General Hospital in Boston for treatment of SCD and patients at risk for SCD were potential participants. Individual patients were approached after the study was approved by the human research committee. All potential participants who met the study criteria were given an explanation of the study and a consent form. For those who agreed to participate and signed a consent form, data were collected during hospital admission by personal interview and over the telephone at 6 months and 1, 2, 3, and 4 years after ICD implantation.
Instruments
In this tiered approach to measuring quality of life, the SF-36 was used as the generic measure of health status, the Quality of Life Index–Cardiac III (CQLI-3) as a cardiac-specific measure of quality of life, and the Profile of Moods Status short form (POMS) as a population-specific measure because of the known psychological distress common in patients receiving an ICD.
The SF-36 has established validity and reliability.47 It is constructed to represent 2 of the most important health concepts included on the Medical Outcomes Study: physical health and mental health. The composite summary score for physical health is the combined score from the subscales used to measure physical functioning, role functioning (physical), bodily pain, and general health measures; the composite summary score for mental health is the combined score from the subscales used to measure vitality, social functioning, role functioning (mental), and mental health. Health transition, a single item, indicates changes in health perception compared with the previous measurement. Each subscale and composite score is reported on a scale from 0 to 100; higher scores indicate improved physical and mental health. A lower health transition score indicates better health perception. The Cronbach
for the SF-36 in this study was 0.88 for the composite summary score for physical health and 0.87 for the composite summary score for mental health.
The CQLI-3 is used to assess patients subjective evaluation of satisfaction with the domains and the importance of these domains to quality of life.48 Satisfaction and importance are examined through the domains of physical functioning, socioeconomic status, psychological/spiritual state, and family life. Participants respond to 2 scales on life domains: 38 items used to rate satisfaction on a 6-point Likert scale ranging from 1 (very dissatisfied) to 6 (very satisfied), and then the same 38 items to rate importance on a 6-point Likert scale ranging from 1 (very unimportant) to 6 (very important). Scores range from 0 to 30; higher scores indicate better quality of life. Scores are calculated by weighting the satisfaction responses with the importance responses to reflect how satisfied patients are with these aspects of their lives. The adjustment of satisfaction responses corrected for the various influence of values therefore produces a more accurate reflection of quality of life.49
Published Cronbach
for the CQLI-3 was 0.98 overall.48 Concurrent validity, the correlation between the overall score and the Campbell life satisfaction, for the CQLI-3 was 0.93.45 In this study, the Cronbach
was 0.84 for health and functioning, 0.52 for socioeconomic status, 0.85 for psychological/spiritual state, 0.79 for family, and 0.86 for the total CQLI-3.
The POMS short form is a 30-item instrument with 6 subscales used to measure the mood states of anger-hostility, tension-anxiety, depression-dejection, vigor-activity, fatigue-inertia, and confusion-bewilderment. Responses are scored on a 5-point Likert-type scale ranging from 0 (not at all) to 4 (extremely) for each mood. A total score is obtained by summing 5 of the subscale scores and subtracting the vigor subscale score. Higher scores indicate the presence of negative moods. The total score reflects negative mood states and is associated with psychological distress.
Scores on the POMS short form correlate strongly with scores on the 65-item POMS instrument (r=0.95). The psychometric properties of the POMS have content and construct validity as well as high test-retest reliability.50 In this study, the Cronbach
ranged from 0.85 to 0.97, with a Cronbach
of 0.89 for the total score.
Analysis
The data were entered into the SPSS statistical package (Version 14.0, SPSS Inc, Chicago, Illinois) for scoring of the instruments. Descriptive statistics were used for the demographic and clinical data. Because the attrition rate was 41% (29 patients), differences between those patients who completed the study and those who did not (death and lost to follow-up) were calculated for the clinical and demographic variables and study measures at ICD implantation.
Repeated-measures analysis of variance was used to compare mean scores between the different measurement times of ICD implantation: 6 months and 1, 2, 3, and 4 years after discharge. The level of significance was set at P < .05.
| Physical functioning was significantly reduced among ICD recipients.
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Results
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A total of 70 patients completed the questionnaires when the ICD was implanted. During the study period, 1 patient (1%) had the ICD explanted with heart transplantation, 10 patients (14%) died, and 18 patients (26%) refused to continue to participate during the 4 years of contact. A total of 4 patients (6%) withdrew consent or died between implantation and 6 months after implantation, 8 (11%) between 6 months and 1 year after implantation, 4 (6%) between 1 and 2 years, 9 (13%) between 2 and 3 years, and 4 (6%) between 3 and 4 years after implantation. Therefore, a total of 41 patients completed data collection at all 6 time points. Compared with the patients who did not complete all data collection, these 41 patients were younger, were working at the time of implantation, had an increased incidence of heart failure and coronary bypass surgery, had higher levels of physical health as measured by the SF-36, and had a higher socioeconomic level as measured by the CQLI-3.
Demographic and clinical variables at implantation are given in Table 1
. Mean age was 60.4 years (range, 21–84). Most (90%) of the participants were white, and more than half were currently employed or had previously been employed in professional or managerial positions. Among the 41 patients, 8 (20%), who were at risk but had not had SCD, had an ICD implanted for primary prevention, and 33 (80%), who had already experienced SCD, had an ICD implanted for secondary prevention.51 The most frequently reported signs or symptoms that led to hospitalization and ICD placement were syncope (39%), shortness of breath (27%), palpitations (24%), lightheadedness (15%), and/or chest pain (10%).
A total of 71% of the patients had documented coronary heart disease, and 29% had genetically based anomalies that were the potential source of SCD. Mean left ventricular ejection fraction was 39% (range, 10%-70%), indicating a sample (n = 39) with modest myocardial dysfunction, with a mean New York Heart Association class of 2.0, indicating mild effect on function.
As shown in Table 2
, the composite summary score for mental health of the SF-36 improved significantly from 44.5 to 48.4 from ICD implantation to year 3, declining to 47.5 in year 4 (F =2.95, P =.03). Analysis by subscale showed significant improvements in the mental health subscale (F = 2.40, P = .04) and reductions in the vitality subscales (F = 2.83, P = .03).
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Table 2 Scores and repeated measures on the Medical Outcomes Study Short Form-36 for patients with an implantable cardioverter-defibrillator (n = 35)
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The composite summary score for physical health of the SF-36 declined during the 4 years: the score was 46.2 at ICD implantation and 42.5 at year 4 (F = 3.69, P = .003). Analysis by subscale showed significant changes in the role physical subscale (F =4.43, P =.001) and general health subscales (F =3.21, P =.02). The health transition score improved from implantation to 6 and 12 months after implantation, but this score worsened from year 2 to year 4, although it did not reach the baseline score (F =8.28, P <.001).
During the 4 years, the domains did not change significantly, as measured by the CQLI-3. These scores represent a modest level of quality of life (Table 3
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Table 3 Scores and repeated measures on Quality of Life Index–Cardiac III for patients with an implantable cardioverter-defibrillator (n = 24)
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The POMS analysis (Table 4
) for the 6 subscales indicated that the scores for tension, anger, depression, fatigue, and confusion all improved during the 4 years. The vigor scale showed significant reduction (higher is more vigorous) during the 4 years, with the lowest scores reported at 3 and 4 years after placement of the ICD (F = 3.53, P = .004). The total score was significantly higher at implantation when compared with all other data points (F = 10.21; P < .001).
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Table 4 Scores and repeated measures on the Profile of Mood States for patients with an implantable cardioverter-defibrillator (n = 40)
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When repeated-measures analysis of variance showed significant changes in the SF-36 and POMS scores, t tests were done to compare each time period to determine the time at which changes in study variables were significant. The significant changes in the scores occurred between the time of implantation and 6 months after implantation (Table 5
). The role physical subscale showed a downward trend between 3 and 4 years after implantation of the ICD.
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Table 5 Scores and significant post hoc analyses of the Medical Outcomes Study Short Form-36 and the Profile of Mood States from implantation to 6 months later for patients with an implantable cardioverter-defibrillatora
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Discussion
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We determined health status, quality of life, and psychological states from the time of hospitalization for ICD implantation and annually for 4 years. In a previous study,35 ICD recipients were followed up for shorter times of adjustment, up to 12 months, with no data available after 1 year. Our study is one of the first in which ICD recipients were followed up longitudinally for more than 2 years. Health status as measured by the SF-36 has been used in a variety of studies of ICD recipients. Scores for our patients at the time of hospitalization for placement of an ICD were lower than those reported for the general population for role physical, vitality, social functioning, and role emotional, indicating perceived disability and lack of well being.52 Our findings indicated an improvement in the composite summary score for mental health from the time of ICD implantation to 4 years later. Some studies in which ICD recipients were followed up for as long as 1 year had mixed results, with improvement in some of the mental health subscales of SF-36; other studies have indicated no change in scores on the mental health subscales.16,27,53,54 Our patients had significant reductions in physical functioning. This reduction may reflect the underlying cardiovascular disease still present in these ICD recipients, their lack of participation in cardiac rehabilitation, and their avoidance of exercise because they feared activating the ICD.55
| Psychological adjustment does occur over time in ICD recipients
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Quality of life as measured with the CQLI-3 did not differ over time. Other investigators13,20,56 who used this questionnaire also found no differences between SCD survivors according to treatment option (ICD vs drug therapy), although older patients with an ICD had lower scores on the physical functioning domain of the CQLI-3. Flemme et al46 reported declines in the domains of psychospiritual, socioeconomic, and family domains at 1 year after ICD implantation as indicated by CQLI-3 scores, but at a minimum of 5 years additional follow-up, all these domain scores were similar to the scores at the time of implantation.
Improvements in all of the negative psychological moods we measured may explain the improvements in the composite summary score for mental health of the SF-36. The POMS scores indicated significant reductions within 6 months of ICD implantation in tension, depression, anger, and fatigue, indicating resolution of negative moods associated with ICD implantation. Other researchers28,38–41 reported higher anxiety and depression with poor quality of life in ICD recipients. The improved psychological state in our patients may explain the lack of changes in CQLI-3 scores and the improvement in the mental health composite summary score on the SF-36.
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Limitations
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The limitations of the study are related to a lack of adequate power to detect differences and measurement. The loss of participants due to death, explantation of the ICD, and unwillingness to participate for the entire 4 years is a potential source of bias; possibly sicker, older ICD recipients were unwilling to continue in the study. In addition, the convenience sample was homogeneous with regard to ethnic and racial diversity; therefore, the generalizability of the results is limited to whites.
The choice of measurements of health status, quality of life, and psychological state was based on a tiered approach to assess health status in general, to measure quality of life by using a disease-specific questionnaire, and to assess the known comorbid condition of psychological distress so that various domains of quality of life could be measured in patients with an ICD. Specifically, the CQLI-3 may not be sensitive enough to detect change in our sample because of the generic nature of the instrument and the burden in completing it. The use of these 3 questionnaires may have prevented the identification of other areas of human responses more appropriate to ICD recipients.
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Implications for Practice
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The psychological adjustment over time in ICD recipients is the "good news story" that health care providers can share with new ICD recipients who appear emotionally vulnerable at the time of ICD implantation. With social support as a predictor of improvements in quality of life in ICD recipients,57 the use of programs that allow ICD recipients to interact with others who have an ICD are key to help recipients and their family members achieve psychological adjustment. Cognitive behavioral therapy, counseling, psychoeducational programs, support groups, and Internet access to other ICD recipients can be used as support mechanisms to reduce psychological distress known to occur in new ICD recipients.45,58–60
The reduction in physical functioning calls for further study. The possibility of developing structured interventions through cardiac rehabilitation programs to improve physical health also is worthy of further research. In a small pilot study61 of aerobic exercise in 10 ICD recipients, cardiorespiratory fitness and heart rate variability improved during the 8-week training program, and no ICD shocks occurred during exercise.
One predictor of improved physical functioning is social support, which could be available in a cardiac rehabilitation program.24,57 Dougherty et al58 reported that an educational-psychological based telephone intervention reduced the level of physical signs and symptoms, although physical activity was not directly measured. Future research with measurement of benefits and risks of an aerobic exercise program is needed to verify that cardiac rehabilitation is safe and effective for ICD recipients. These data would provide an analysis of safety, feasibility, and effectiveness to health insurers, who may consider coverage for these programs for ICD recipients.
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Conclusions
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Mental health improved and psychological distress decreased in the first 4 years after ICD implantation. These data indicate that after 1 year, ICD recipients appear to accept life with an ICD. The reductions in physical functioning are worrisome and indicate an area for further research. Programs developed by nurses to provide social support and exercise training may offer benefits to the increasing number of ICD recipients.
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FINANCIAL DISCLOSURES
This study was funded by Sigma Theta Tau, International, Alpha Chi Chapter and Eta Tau Chapter, and the American Association of Critical Care Nurses, Medtronic-Physio-Control Grant.
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Task force members, J. Vijgen, G. Botto, J. Camm, C.-J. Hoijer, W. Jung, J.-Y. Le Heuzey, A. Lubinski, T. M. Norekval, M. Santomauro, et al.
Consensus statement of the European Heart Rhythm Association: updated recommendations for driving by patients with implantable cardioverter defibrillators
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