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American Journal of Critical Care. 2006;15: 389-398
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Quality of Life and Psychological Status of Patients With Implantable Cardioverter Defibrillators

By Sue Ann Thomas, RN, PhD, Erika Friedmann, PhD, Chi-Wen Kao, RN, MS, Pia Inguito, RN, MS, Matthew Metcalf, PharmD, Frances J. Kelley, RN, PhD, FNP and Steven S. Gottlieb, MD.. From the Schools of Nursing (SAT, EF, C-WK, PI), Pharmacy (MM), and Medicine (SSG), University of Maryland, Baltimore, Md, and the School of Nursing and Health Studies, Georgetown University, Washington, DC (FJK).


   Abstract
Top
 Abstract
Methods
 Results
 Summary and Conclusion
 References
 
• Background Implantable cardioverter defibrillators reduce mortality in patients at high risk for sudden cardiac death and in patients with heart failure. Patients with defibrillators often experience psychological distress and poor quality of life, which can potentiate pathological processes that increase the risk for sudden cardiac death. To achieve the full benefits of the defibrillators, patients must maintain their psychological status and quality of life.

• Objectives To review the research on psychological status and quality of life of patients with implantable cardioverter defibrillators and suggest nursing interventions to improve the patients’ health.

• Method Searches of PubMed were used to find articles on depression, anxiety, and quality of life in patients with implantable cardioverter defibrillators.

• Results Poor quality of life is associated with anxiety and depression in patients with implantable cardioverter defibrillators. Discharges of the devices have adverse consequences for patients’ psychological status and quality of life. Younger patients are at highest risk for psychological distress and poor quality of life after implantation. Longitudinal research would facilitate determining the course of the changes in psychological status and quality of life during the time patients have the defibrillators. More intensive intervention may be necessary for the most vulnerable recipients: patients who are young, have experienced shocks, and are in psychological distress.

• Conclusions Poor quality of life and depression are common in patients with implantable cardioverter defibrillators. Nursing interventions to reduce psychological distress and improve quality of life may reduce morbidity and mortality in these patients. Additional research is needed to determine effective interventions.

Sudden cardiac death (SCD) is a major health problem in the United States, causing approximately 300 000 to 400 000 deaths annually.1 Most SCDs are triggered by a ventricular arrhythmia.2 More than 95% of patients who experience SCD die before they reach the hospital.3 Survival is possible only if effective treatment is available in the first 10 minutes after cardiac arrest.4

Implantable cardioverter defibrillators (ICDs) are effective at reducing mortality in patients at high risk for SCD5–7 and in patients with heart failure.8 The Multicenter Automatic Defibrillator Implantation Trial (MADIT)6 was the first randomized trial in which investigators directly compared use of ICDs with conventional pharmacological therapy, primarily amiodarone. A total of 196 patients with coronary heart disease with asymptomatic unsustained ventricular tachycardia were studied. Compared with mortality in the medication group, the mortality of patients in the ICD group was reduced by 54%. In MADIT-II,5 investigators examined the prophylactic use of ICDs or conventional therapy in 1232 patients after myocardial infarction who had impaired ventricular function but no arrhythmias. Patients with ICDs had a 31% reduction in mortality, which was solely due to reduction in SCD.


Implantable cardioverter defibrillators reduce mortality in patients at high risk of sudden cardiac death and patients with heart failure.

 

In the Antiarrhythmics Versus Implanted Defibrillators (AVID) trial (N = 1116 patients),7 investigators examined the effectiveness of ICDs in patients who were resuscitated from nearly fatal ventricular fibrillation or who had symptomatic sustained ventricular tachycardia and hemodynamic compromise. Patients who received medication (amiodarone or sotalol) experienced 31% increased mortality at 3 years compared with those who received ICDs. The 3-year survival was 84% for patients with ICDs and 76% for patients taking antiarrhythmic medications. The difference in survival was due to differences in the number of deaths due to arrhythmias.

Because of the improved survival in the ICD groups, all 3 clinical trials5–7 were stopped prematurely by their data safety and monitoring boards.

Recently, researchers in the Sudden Cardiac Death in Heart Failure Trial8 evaluated the use of ICDs versus conventional therapy plus placebo versus conventional therapy plus amiodarone in 2521 patients who were at increased risk for SCD because of heart failure but who did not have documented ventricular dysrhythmias. The mortality of patients who received ICDs was 25% less than those who received conventional therapy plus amiodarone or conventional therapy plus placebo.

The positive results of these clinical trials,5–8 improved technology, and ease of insertion of ICDs9 are leading to a rapid expansion of the use of these devices. Although ICDs clearly reduce mortality, the effects of the devices on psychological status and quality of life (QOL) are equivocal.

Disruption in psychological status or QOL potentiates pathological processes that increase the risk for SCD in patients who receive ICDs. The full benefits of ICDs can be achieved only when each patient’s psychosocial status and QOL are maintained. The process by which psychosocial and QOL factors contribute to cardiac morbidity and mortality is described in the holistic cardiovascular model of Thomas et al10 (see FigureGo). This model is based on the early work of Engle,11 Audy,12 and pioneers of cardiovascular stress models13–16 in which the combination of social, psychological, and physiological factors interact within the individual to determine health. Within all 3 realms, chronic states and acute changes affect all other realms and cardiovascular health status and QOL. Psychosocial factors either promote health by moderating pathological processes or promote disease by enhancing the processes. Nursing interventions to improve psychosocial health and QOL may decrease morbidity and mortality in patients with ICDs. We reviewed the research that addresses psychological status and QOL of patients with ICDs, and we suggest a role for nurses to intervene to improve the health of these patients.


Figure 1
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  		Holistic model of cardiovascular health.

 

   Methods
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 Abstract
 Methods
Results
 Summary and Conclusion
 References
 
We searched PubMed (1966 through April 2005) for articles in English on psychological status, depression, or QOL in patients with ICDs. We used the terms "implant AND defibrillator" plus "psychological," "depression," "anxiety," or "quality of life." We also scrutinized all references in the articles we obtained and the article "Cognitive Behavioural Therapy for Patients With Implantable Cardioverter Defibrillators"17 in the Cochrane Database of Systematic Reviews for additional articles missed by the electronic database searches. Because previous review articles10,18,19 addressed psychological distress in patients with ICDs, the findings of the reviews were summarized, and only key articles were reviewed in depth.


   Results
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Summary and Conclusion
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A total of 16 studies2,20–34 met the inclusion criteria related to quality of life and ICDs. Each study was abstracted to determine details of the sample size, the tools used to measure QOL, and major findings (Table 1Go). Each study was evaluated with an 8-category methodological quality scale based on the criteria of Moher et al35 and Jadad et al36 for evaluating clinical trial research (Table 2Go). All 16 studies included descriptions of the demographic and disease characteristics of the sample, 13 had at least 50 subjects with ICDs, and 8 included a control or a comparison group, 4 of which included random assignment to the ICD group. A total of 9 of the studies were longitudinal, and 8 of the 9 had mean follow-up periods of 1 year of more. The inclusion criteria were described in all of the studies; 9 studies also specified at least a single exclusion criterion. All studies included appropriate statistics for examining the studies’ hypotheses.


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  		Table 1 Summary of sample, tools used to assess QOL, and findings for studies of quality of life related to ICDs

 

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  		Table 2 Methodological quality indicators for studies of quality of life related to implantable cardioverter defibrillators*

 
Quality of Life
The QOL of patients who receive ICDs is often poor compared with the general population. Reduced QOL in patients with these devices may be due to the underlying disease or to the presence of the ICD. Fourteen studies20–29,31–34 addressed the long-term impact of ICDs on patients’ QOL. Among the 14, seven studies20,21,24,25,28,33,34 did not include comparison groups. In these 7, ICD implantation brought about desirable QOL for most recipients in 2 studies,21,28 did not improve QOL in 2 studies,33,34 and worsened QOL in 1 study.25 In 2 studies,20,24 QOL of ICD patients differed according to the New York Heart Association (NYHA) class of disease or age. QOL improved after ICD implantation for NYHA class III and class IV patients but not for NYHA class II patients.24 Physical QOL of younger patients improved during 1 year after implantation but did not change in older patients.20


The quality of life in patients with an ICD is often poor compared with that in the general population.

 

In 7 studies,22,23,26,27,29,31,32 the QOL of patients with ICDs was compared with that of similar patients receiving other treatments. In 6 of the 7 studies, the QOL was similar between patients with and without ICDs. The QOL of patients with ICDs did not differ from those who received drug therapy22,26,29,32 or pacemakers27 or who had coronary artery disease.31 In 1 study,23 the QOL of ICD recipients was better than that of similar patients receiving pharmacological therapy.23 In contrast, among patients who had coronary artery bypass graft surgery who received ICDs, the QOL was worse than in those who did not receive the devices.30


Quality of life among ICD recipients did not differ from quality of life in heart failure patients receiving drug therapy or pacemakers.

 

Psychological Distress
Three extensive literature reviews10,18,19 cover ICD-specific psychological distress after ICD implantation, such as excessive worry or fears about ICDs and high levels of depression and anxiety. Currently, no clear consensus exists on the relative contributions of the underlying ventricular arrhythmia and the ICD experience to the psychological distress experienced by patients with ICDs.

Psychological Distress and QOL
Increased psychological distress was related to poorer QOL in 3 studies2,31,37 of patients with ICDs. Both depression and anxiety were significant independent predictors of QOL and global index of QOL in 32 ICD recipients; higher anxiety and depression were associated with poorer QOL.37 Similarly, poor QOL was related to increased anxiety and depression in patients (n = 63) with ICDs for a mean of 1.4 years.31 Social support and trait anxiety were independent predictors of disease-specific mental QOL among 58 patients with ICDs.2 Lower social support and higher anxiety were associated with poorer QOL; social support was the only independent predictor of disease specific to physical health QOL.2

Shocks and QOL
The ICD experience and its impact on QOL appear to differ between patients who do and those who do not experience ICD shocks. The results of a study2 of 58 ICD patients supported the relationship of ICD discharges to poor mental health, but not physical health. The number of ICD discharges was a significant independent predictor of mental but not physical health QOL. The relationship between ICD shocks and QOL also was examined in 3 large clinical trials.23,26,30 Shocks were associated with reduced mental well-being and physical QOL as measured with the Medical Outcomes Short Form 36 (SF-36) among 416 patients who had survived for 1 year after ICD implantation.26 An analysis of data for the second year after ICD implantation indicated that changes in QOL were similar in patients who received fewer than 5 shocks and patients who received more shocks.26 In another study,23 QOL improved during 1 year among 156 patients who received fewer than 5 shocks, but did not improve among those who received 5 or more shocks. In contrast, among 262 ICD patients 6 months after coronary artery bypass graft, the QOL of the patients who received shocks did not differ from that of those who did not receive shocks.30 Differences in QOL according to shock status most likely are due to both time since ICD implantation and shock status.

Shocks and Psychological Status
A preponderance of evidence indicates that ICD discharges have adverse psychological consequences. Discharges were related to depression and anxiety among 39 patients with ICDs38 and to reports of anger, anxiety, depression, and stress among 15 patients with ICDs who survived sudden cardiac arrest.39 In a study40 of 57 patients with ICDs, those who had experienced 5 or more shocks had higher state anxiety than did those who had experienced fewer shocks. The frequency of shocks also was associated with anxiety and depression among 63 patients who had lived with ICDs for a mean of 1.4 years.31 The effects of shocks on patients with ICDs were evaluated in 2 studies.37,39 In the first study,41 patients with ICDs who were shocked reported higher anger, anxiety, depression, and stress than did patients who were not shocked. In contrast, Chevalier et al37 found no differences in anxiety or depression between patients with ICDs who had received shocks and those who had not. The patients who experienced shocks had had their ICDs for significantly longer than the patients who did not receive shocks (32.1 months vs 18.9 months, respectively).37


The ICD experience and impact on quality of life is different in patients who do and do not experience ICD shocks. Increased frequency of ICD discharges results in greater anxiety and depression.

 

Changes in anxiety and depression with time differed between patients who did and those who did not receive shocks. Dougherty39 used the Profile of Mood States questionnaire to measure anxiety and depression in patients with ICDs during the year after implantation. Anxiety was highest at the time of discharge from the hospital and gradually decreased at 6 and 12 months for patients who did not receive shocks. Among patients who received shocks, anxiety remained about the same throughout the first year after implantation. Those who received shocks reported higher anxiety 1 year after implantation than did those who did not receive shocks.

Similarly, patients who did not receive shocks reported their highest depression at the time of discharge from the hospital, and the depression gradually decreased at 6 and 12 months after discharge. Patients who received shocks reported gradually increasing levels of depression throughout the first year after ICD implantation.39 The AVID trial26 was the largest study in which psychological status and ICD shocks were examined. Among 416 patients with ICDs enrolled in the trial for more than 1 year, having shocks was associated with increased concerns by the patients.

Wallace et al2 examined the relationships among psychological status, social support, shocks, and QOL in a study of 58 ICD patients. Level of trait anxiety, social support, and number of ICD discharges were significant independent predictors of mental but not physical health QOL. Low anxiety, high social support, and no shocks were predictive of the best QOL.

Age and QOL
The relationship between age and QOL in patients with ICDs was examined in 3 studies.20,32,33 In a group of 45 patients with a mean age of 61 years, being younger was associated with poorer QOL a minimum of 3 months after ICD implantation, as assessed with the Sickness Impact Profile.32 Among ICD recipients (n = 70) at least 3 months after implantation, those aged than 63 years reported better QOL as measured with the Quality-of-Life Index than did younger patients.33 A longitudinal study20 of 70 ICD recipients revealed different patterns. Physical QOL (measured by using the SF-36) was worse in patients aged more than 62 years than in younger patients during hospitalization for implantation and 6 and 12 months after implantation. The physical QOL of the younger patients improved during the year after implantation but did not change in the older group. Mental QOL measured with the SF-36 did not differ by age at any time.

Time Since ICD Implantation
The relationship between time since ICD implantation and QOL was examined in a cross-sectional study2 and in several longitudinal studies.21,25,26,28,34 In the cross-sectional study of 58 patients (44 men, 14 women) with ICDs for 1 to 4 years, the number of years since ICD was predictive of general QOL independent of a patient’s age. Patients’ QOL, as assessed with the AVID checklist, was lower the longer the ICD was in place. In this study,2 mean time after ICD implantation was just less than 2 years; 71% of the participants were assessed between 12 and 24 months after implantation.

In 2 longitudinal studies26,34 with 1-year follow-up, QOL decreased within the first 3 to 6 months after ICD insertion and returned to preinsertion level within 1 year. In the AVID clinical trial,26 which included 4 measures of QOL for 416 ICD recipients who had already survived 1 year, physical QOL (measured by using the SF-36) improved and patients’ concerns (measured by using a patient concerns checklist) decreased 3 months, 6 months, and 12 months after implantation. There were no significant time trends in mental QOL as measured with the SF-36 or the Quality-of-Life Index. In the second study,34 the Sickness Impact Profile was used to evaluate the QOL of 21 patients before and 6 and 12 months after the implantation of an ICD. Both the psychosocial dimension and the overall scores on the Sickness Impact Profile decreased at 6 months but returned to preinsertion levels by 12 months.

In 2 additional studies,25,28 changes in QOL 12 months after insertion were detected. The QOL (measured by using the SF-36) of 74 Australian recipients of ICDs tended to worsen during the 12 months after implantation.25 In 56 patients with ICDs, most QOL domains measured by using the Quality-of-Life Index improved from the time before implantation to 12 months after implantation. In contrast, fear, embarrassment, suffering, and family consequences worsened during the period of 3 to 12 months after implantation.28

In the only longitudinal study21 ending 6 months after ICD implantation, QOL (measured by using the SF-36) of 150 patients improved from baseline to 6 months after implantation, irrespective of shock and NYHA class.

Patterns of shocks as discussed earlier may explain apparently conflicting reports about changes in QOL after ICD implantation and shock status. Studies with short follow-up periods may not include sufficient variability in the number of shocks per patient to allow this assessment.

Longitudinal Studies of Patients’ Characteristics and QOL
Longitudinal studies24,25 were used to address the relationship of patients’ sex and severity of heart failure to the changes in QOL over time. In a study25 of 74 ICD patients (62 men, 12 women), men reported better scores on the emotional subscale of the SF-36 at 3 months after ICD implantation than women did. Women reported better scores on the general health subscale at 3 and 12 months. In the second study,24 the Minnesota Living With Heart Failure questionnaire was used to evaluate QOL in 81 patients with ICDs. Patients with NYHA class III/IV heart failure reported significant improvement in QOL at 1 month and 3 months follow-up after ICD implantation. Patients with NYHA class II heart failure had no change in QOL at these times.


   Summary and Conclusion
Top
 Abstract
 Methods
 Results
 Summary and Conclusion
References
 
Substantial evidence indicates that patients with ICDs experience psychological distress10,18,19 and reduced QOL.25,33,34 On the basis of studies in which the psychosocial status10,18,19 and QOL22,26,27,29,31,32 of patients with ICDs were compared with those of similar patients without ICDs, it appears that the patients with ICDs have similar decreases in QOL. QOL also changes during the course of ICD therapy.27 Impaired QOL is associated with anxiety and depression in patients with ICDs.38–41

Although QOL and psychological status both have been examined in patients with ICDs, the interrelationships among these variables were examined in only a few studies. The 2 studies31,37 of QOL and psychological status in ICD patients support the relationship between these variables. In the study by Chevalier et al,37 higher anxiety was associated with poorer overall QOL; in the study by Herrmann et al,31 psychologically distressed patients—those who were anxious and depressed—had poorer QOL than did other ICD recipients.

ICD discharges adversely affect both psychological status26,31,38–41 and QOL.2,26,28,30 Patients who experience ICD shocks are more anxious and depressed and have poorer QOL than do patients who do not experience shocks. The course of changes in psychological status and QOL after ICD implantation also differs according to shock experience.

Age at the time of ICD insertion was negatively related to QOL and psychological status in cross-sectional studies.32,33 Younger adults with ICDs have worse QOL and more psychological distress than do older adults.32,33 A review42 of studies on the psychological status and QOL of children, adolescents, and adults aged less than 50 years with ICDs indicated that these patients experience increased stress associated with ICDs, but minor limitations in daily activities.


Younger adults with ICDs have worse quality of life and more psychological distress than older adults do.

 

The cross-sectional data37 indicate that patients who have ICDs for longer periods have more symptoms of depression. In these patients, depression is more predictive than anxiety of poor QOL. Additional longitudinal research is needed to evaluate the relative contributions of underlying disease status, age, ICD implantation, time since implantation, and ICD discharges on psychosocial status and QOL in patients who have ICDs for long periods.

Depression is clearly linked to increases in morbidity and mortality in patients after myocardial infarction.43–46 Because all patients with ICDs have underlying cardiovascular disease, it is crucial that these links between psychological distress and SCD be examined further.

In most of the longitudinal studies in which QOL and psychological status of ICD recipients were monitored, the patients were followed-up for only the first year after implantation. As ICDs are implanted earlier in the disease process, patients will live with ICDs in place for many years. Younger patients (<65 years old) with ICDs already experience more distress than do older patients with the devices. It would be useful to assess the course of changes in psychological status and QOL in these patients as they grow older.

Our review of the literature was restricted to research on patients who received ICDs as secondary prevention because of life-threatening arrhythmias. As ICD use becomes more common for primary prevention, it will be important to evaluate whether the psychosocial and QOL impact of ICDs in patients with signs and symptoms of life-threatening arrhythmias differs from the impact in patients without such signs and symptoms.


Patients with ICDs should discuss their experiences with others who have similar experiences.

 

Use of programs developed and implemented by nurses may decrease depression and improve QOL of ICD recipients. The ICD experience is unique. Patients with ICDs have expressed their need to discuss their experiences with others with similar experiences.47 Patients who receive ICD shocks are more vulnerable to psychological distress and poor QOL and may have greater needs for support than patients who do not receive shocks.27 Support groups have been beneficial for reducing stress and enhancing adjustment of patients with ICDs.48–51 These groups provide ICD recipients with information, encouragement, and therapeutic friendship through group camaraderie. An online patient-initiated unmoderated chat room, The Zapper,52 provides an opportunity for ICD recipients to share experiences and other resources for patients with ICDs. This resource may be especially beneficial for patients without access to local support groups.


   ACKNOWLEDGMENTS
 
This research was supported in part by grant R01 NR07613 from the National Institute of Nursing Research and by a grant from Medtronic, Inc, Minneapolis, Minn. Dr Gottlieb has received research grants from Medtronic and has served as a consultant to Guidant Corp, Indianapolis, Ind.

To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA 92656. Phone, (800) 809-2273 or (949) 362-2050 (ext 532); fax, (949) 362-2049; e-mail, reprints{at}aacn.org.


   REFERENCES
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