Quality of Life and Psychological Status of Patients With Implantable Cardioverter Defibrillators

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; Steven S. Gottlieb, MD 

Am J Crit Care.  2006;15(4):389-398.  ?2006 American Association of Critical-Care Nurses
Posted 09/29/2006

Abstract and Introduction

Abstract

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.

Introduction

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 SCD[5-7] 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.

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 trials[5-7] were stopped prematurely by their data safety and monitoring boards.

Recently, researchers in the Sudden Cardiac Death in Heart Failure Trial[8] 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 ICDs[9] 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 al[10] (see Figure). This model is based on the early work of Engle,[11] Audy,[12] and pioneers of cardiovascular stress models[13-16] 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. 

Holistic model of cardiovascular health.

     

Methods

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 articles[10,18,19] addressed psychological distress in patients with ICDs, the findings of the reviews were summarized, and only key articles were reviewed in depth.

Results

A total of 16 studies[2,20-34] 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 1 ). Each study was evaluated with an 8-category methodological quality scale based on the criteria of Moher et al[35] and Jadad et al[36] for evaluating clinical trial research ( Table 2 ). 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.

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 studies[20-29,31-34] addressed the long-term impact of ICDs on patients' QOL. Among the 14, seven studies[20,21,24,25,28,33,34] 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]

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 therapy[22,26,29,32] or pacemakers[27] 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]

Psychological Distress

Three extensive literature reviews[10,18,19] 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 studies[2,31,37] 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 study[2] 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 wellbeing 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 ICDs[38] and to reports of anger, anxiety, depression, and stress among 15 patients with ICDs who survived sudden cardiac arrest.[39] In a study[40] 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 al[37] 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]

Changes in anxiety and depression with time differed between patients who did and those who did not receive shocks. Dougherty[39] 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 trial[26] 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 al[2] 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 study[20] 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 study[2] 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 studies[26,34] 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 study[21] 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 studies[24,25] were used to address the relationship of patients' sex and severity of heart failure to the changes in QOL over time. In a study[25] 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

Substantial evidence indicates that patients with ICDs experience psychological distress[10,18,19] and reduced QOL.[25,33,34] On the basis of studies in which the psychosocial status[10,18,19] and QOL[22,26,27,29,31,32] 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 studies[31,37] 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 status[26,31,38-41] 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 review[42] 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.

The cross-sectional data[37] 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.

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.


Table 1. Summary of Sample, Tools Used to Assess QOL, and Findings for Studies of Quality of Life Related to ICDs


Reference Year of publication Sample Measurement Findings
Hamilton and Carroll[20] 2004 70 ICD patients SF-36
QOL Index
Mental component scores did not differ significantly between younger patients and older patients
Scores on the QOL Index differed significantly between younger patients and older patients in the physical function scores over time
Newman et al[21] 2003 150 ICD patients SF-36 QOL improved with time from baseline to 6 months after implantation
Symptoms frequency, disease severity, and the number of symptoms improved from baseline to 3 months after implantation and from baseline to 6 months after implantation
Strickberger et al[22] 2003 51 ICD patients
52 amiodarone patients
Quality of Well-Being Schedule QOL and the level of anxiety at baseline and at 1 year were similar among patients treated with amiodarone or an ICD
Irvine et al[23] 2002 157 ICD patients
160 amiodarone patients
Nottingham Health Profile (measure of health-related QOL) QOL improved significantly more with time in patients treated with ICD than in patients treated with amiodarone
Kuhlkamp[24] 2002 81 ICD patients Minnesota Living With Heart Failure questionnaire QOL improved significantly in patients with New York Heart Association functional class III or class IV disease but did not change in patients with class II disease
Pelletier et al[25] 2002 74 ICD patients SF-36* QOL at 3 months after implantation was best for social function and worst for physical role and at 12 months after implantation was best for body pain and poorest for physical role and general health
QOL decreased significantly over time, leading to worsening in general health
Schron et al[26] 2002 416 ICD patients
384 amiodarone patients
SF-36 QOL Index Patients treated with ICD and amiodarone had similar alterations in self-perceived QOL during 1 year of follow-up
Wallace et al[2] 2002 58 ICD patients SF-12 Generic physical QOL continued to decrease as the number of years since implantation increased
Lower generic mental health QOL was related to the lower level of social support, the high level of anxiety, and a greater number of ICD discharges
Duru et al[27] 2001 76 ICD patients
76 pacemaker patients
SF-36 QOL was similar between patients treated with ICDs and patients treated with pacemakers
Flemme et al[28] 2001 56 ICD patients QOL Index Satisfaction within the domains of health functioning, psychological-spiritual, and family increased over time and were higher 12 months after implantation than they were before implantation
Herbst et al[29] 1999 35 patients treated with medication only
24 ICD patients
25 patients treated with medication and ICD
73 patients in control group
SF-36 Analysis of QOL scales revealed no significant multivariate interaction between ICD group and drug group after controlling for age, education, sex, disease severity, and duration of treatment
No significant multivariate main effect was found for either the ICD group or the drug group
Namerow et al[30] 1999 262 ICD patients
228 patients in control group
SF-36? Compared with patients in the ICD group, patients in the control group felt that their health had improved more during the preceding year
Herrmann et al[31] 1997 63 ICD patients
112 patients with coronary artery disease
QOL Profile for the Chronically Ill QOL scores did not differ significantly between ICD patients and patients with coronary artery disease without ICDs
Arteaga and Windle[32] 1995 45 ICD patients
30 amiodarone patients
29 patients in control group
QOL Index Sickness Impact Profile Patients with ICDs had better scores on the QOL Index than did the control group
Scores on the QOL Index did not differ between the ICD group and the amiodarone group
Scores on the Sickness Impact Profile did not differ significantly between the ICD group and the control group or between ICD patients and amiodarone patients
Bainger and Fernsler[33] 1995 70 ICD patients QOL Index QOL in the psychological-spiritual domain decreased after implantation
May et al[34] 1995 21 ICD patients Sickness Impact Profile QOL at 6 months after implantation was significantly worse than before implantation; however, by 12 months after implantation, QOL returned to preimplant level

Abbreviations: ICD = implantable cardioverter defibrillator; QOL = quality of life; SF-36 = Medical Outcomes Short Form 36.
*Australian version of the SF-36.
?7 subscales of the SF-36.

 

Table 2. Methodological Quality Indicators for Studies of Quality of Life Related to Implantable Cardioverter Defibrillators*


Reference No. of subjects with defibrillator ≥50 Control or comparison group included Random assignment to control or comparison group Type of design Years of follow-up Inclusion and exclusion criteria provided Statistical analysis used to test main hypothesis
Hamilton and Carroll[20] Yes No NA Longitudinal 1 Inclusion only Repeated measures ANOVA
Newman et al[21] Yes No NA Longitudinal ≥1 Inclusion and exclusion Repeated measures ANOVA
Strickberger et al[22] Yes Yes Yes Longitudinal 2 (SD 1.3) Inclusion and exclusion Survival
Irvine et al[23] Yes Yes Yes Longitudinal 1 Inclusion and exclustion Repeated measures ANOVA
Kuhlkamp[24] Yes No NA Longitudinal <1 Inclusion A t test
Pelletier et al[25] Yes No NA Longitudinal 1 Inclusion and exclusion Nonparametric equivalent of a t test
Schron et al[26] Yes Yes Yes Longitudinal 1 Inclusion and exclusion Generalized estimating equations
Wallace et al[2] Yes No NA Cross-sectional NA Inclusion Regression analysis
Duru et al[27] Yes Yes No Cross-sectional NA Inclusion χ2 test
ANOVA
Flemme et al[28] Yes No NA Longitudinal 1 Inclusion and exclusion Nonparametric t test
Nonparametric ANOVA
Herbst et al[29] No Yes No Cross-sectional NA Inclusion and exclusion Analysis of covariance
Namerow et al[30] Yes Yes Yes Cross-sectional NA Inclusion and exclusion ANOVA
Herrmann et al[31] Yes Yes No Cross-sectional NA Inclusion ANOVA
Arteaga and Windle[32] No Yes No Cross-sectional NA Inclusion ANOVA
Correlations
Bainger and Fernsler[33] Yes No NA Cross-sectional? NA Inclusion and exclusion A t test
Repeated measures ANOVA
May et al[34] No No NA Longitudinal 1 Inclusion A t test

Abbreviations: ANOVA = analysis of variance; NA = not applicable.
*All studies included a description of the subjects.
?Cross-sectional data collected prospectively; retrospective data obtained about status before implantation of cardioverter defibrillator (4-82 months before cross-sectional assessment).

 



References

  1. Myerburg RJ. Sudden cardiac death: exploring the limits of our knowledge. J Cardiovasc Electrophysiol. 2001;12:369-381.
  2. Wallace RL, Sears SF Jr, Lewis TS, Griffis JT, Curtis A, Conti JB. Predictors of quality of life in long-term recipients of implantable cardioverter defibrillators. J Cardiopulm Rehabil. 2002;22:278-281.
  3. Zhang J. Sudden cardiac death: implantable cardioverter defibrillators and pharmacological treatments. Crit Care Nurs Q. 2003;26:45-49.
  4. Myerburg RJ. Cardiac arrest and sudden cardiac death. In: Braunwald E, Zipes DP, Libby P, eds. Heart Disease: A Textbook of Cardiovascular Medicine. 6th ed. Philadelphia, Pa: WB Saunders Co; 1997:742-779.
  5. Greenberg H, Case RB, Moss AJ, Brown MW, Carroll ER, Andrews ML. Analysis of mortality events in the Multicenter Automatic Defibrillator Implantation Trial (MADIT-II). J Am Coll Cardiol. 2004;43:1459-1465.
  6. Moss AJ, Hall J, Cannon DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med. 1996;335:1933-1940.
  7. The Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial Executive Committee. Are implantable cardioverter-defibrillators or drugs more effective in prolonging life? Am J Cardiol. 1997;79:661-663.
  8. Bardy GH, Lee KL, Mark DB, et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure [published correction appears in N Engl J Med. 2005;352:2146]. N Engl J Med. 2005;352:225-237.
  9. Bardy GH, Hofer B, Johnson G, et al. Implantable transvenous cardioverter-defibrillators. Circulation. 1993;87:1152-1168.
  10. Thomas SA, Friedmann E, Kelley FJ. Living with an implantable cardioverter-defibrillator: a review of the current literature related to psychosocial factors. AACN Clin Issues. 2001;12:156-163.
  11. Engle GL. Sudden and rapid death during psychological stress: folklore or folk wisdom? Ann Intern Med. 1971;74:771-782.
  12. Audy JR. Measurement and diagnosis of health. In: Shepard P, McKinley D, eds. Environ/Mental Essays on the Planet as a Home. Boston Mass: Houghton Mifflin; 1971:140-162.
  13. Skinner JE, Reed JC. Blockade of frontocortical-brain stem pathway prevents ventricular fibrillation of ischemic heart. Am J Physiol. 1981;240:H156-H163.
  14. Skinner JE. Regulation of cardiac vulnerability by the cerebral defense system. J Am Coll Cardiol. 1985;5(6 suppl):88B-94B.
  15. Lown B, Verrier RL, Corbalan R. Psychological stress and thresholds of repetitive ventricular response. Science. 1973;182:834-836.
  16. Selye H. The Stress of Life. New York, NY: McGraw-Hill; 1956.
  17. Johnson B, Francis J. Cognitive behavioural therapy for patients with implantable cardioverter defibrillators. Cochrane Database Syst Rev. 2005;3.
  18. Burke JL, Hallas CN, Clark-Carter D, White D, Connelly D. The psychosocial impact of the implantable cardioverter defibrillator: a meta-analytic review. Br J Health Psychol. 2003;8:165-178.
  19. Sears SF Jr, Todaro JF, Lewis TS, Sotile W, Conti JB. Examining the psychosocial impact of implantable cardioverter defibrillators: a literature review. Clin Cardiol. 1999;22:481-489.
  20. Hamilton GA, Carroll DL. The effects of age on quality of life in implantable cardioverter defibrillator recipients. J Clin Nurs. 2004;13:194-200.
  21. Newman DM, Dorian P, Paquette M, et al. Effect of an implantable cardioverter defibrillator with atrial detection and shock therapies on patient-perceived, health-related quality of life. Am Heart J. 2003;145:841-846.
  22. Strickberger SA, Hummel JD, Bartlett TG, et al. Amiodarone versus implantable cardioverter-defibrillator: randomized trial in patients with non-ischemic dilated cardiomyopathy and asymptomatic nonsustained ventricular tachycardia?AMIOVIRT. J Am Coll Cardiol. 2003;41:1707-1712.
  23. Irvine J, Dorian P, Baker B, et al. Quality of life in the Canadian Implantable Defibrillator Study (CIDS). Am Heart J. 2002;144:282-289.
  24. Kuhlkamp V. Initial experience with an implantable cardioverter-defibrillator incorporating cardiac resynchronization therapy. J Am Coll Cardiol. 2002;39:790-797.
  25. Pelletier D, Gallagher R, Mitten-Lewis S, McKinley S, Squire J. Australian implantable cardiac defibrillator recipients: quality-of-life issues. Int J Nurs Pract. 2002;8:68-74.
  26. Schron EB, Exner DV, Yao Q, et al. Quality of life in the Antiarrhythmics Versus Implantable Defibrillator trial: impact of therapy and influences of adverse symptoms and defibrillator shocks. Circulation. 2002;105:589-594.
  27. Duru F, Buchi S, Klaghofer R, et al. How different from pacemaker patients are recipients of implantable cardioverter-defibrillators with respect to psychosocial adaptation, affective disorders, and quality of life? Heart. 2001;85:375-379.
  28. Flemme I, Bolse K, Ivarsson A, et al. Life situation of patients with an implantable cardioverter defibrillator: a descriptive longitudinal study. J Clin Nurs. 2001;10:563-572.
  29. Herbst JH, Goodman M, Feldstein S, Reilly JM. Health-related quality-of-life assessment of patients with life-threatening ventricular arrhythmias. Pacing Clin Electrophysiol. 1999;22:915-926.
  30. Namerow PB, Firth BR, Heywood GM, Windle JR, Parides MK. Quality-of-life six months after CABG surgery in patients randomized to ICD versus no ICD therapy: findings from the CABG Patch Trial. Pacing Clin Electrophysiol. 1999;22:1305-1313.
  31. Herrmann C, von zur Muhen F, Schaumann A, et al. Standardized assessment of psychological well-being and quality-of-life in patients with implanted defibrillators. Pacing Clin Electrophysiol. 1997;20:95-103.
  32. Arteaga WJ, Windle JR. The quality of life of patients with life-threatening arrhythmias. Arch Intern Med. 1995;155:2086-2091.
  33. Bainger EM, Fernsler JI. Perceived quality of life before and after implantation of an internal cardioverter defibrillator. Am J Crit Care. 1995;4:36-43.
  34. May CD, Smith PR, Murdock CJ, Davies MJE. The impact of implantable cardioverter defibrillator on quality-of-life. Pacing Clin Electrophysiol. 1995;18:1411-1418.
  35. Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials: an annotated bibliography of scales and checklists. Control Clin Trials. 1995;16:62-73.
  36. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials. 1996;17:1-12.
  37. Chevalier P, Verrier P, Kirkorian G, Touboul P, Cottroux J. Improved appraisal of the quality of life in patients with automatic implantable cardioverter defibrillator: a psychometric study. Psychother Psychosom. 1996;65:49-56.
  38. Schuster PM, Phillips S, Dillon DL, Tomich PL. The psychosocial and physiological experiences of patients with an implantable cardioverter defibrillator. Rehabil Nurs. 1998;23:30-37.
  39. Dougherty CM. Psychological reactions and family adjustment in shock versus no shock groups after implantation of internal cardioverter defibrillator. Heart Lung. 1995;24:281-291.
  40. Luderitz B, Jung W, Deister A, Marneros A, Manz M. Patient acceptance of the implantable cardioverter defibrillator in ventricular tachyarrhythmias. Pacing Clin Electrophysiol. 1993;16:1815-1821.
  41. Keren R, Aarons D, Veltri EP. Anxiety and depression in patients with life-threatening ventricular arrhythmias: impact of the implantable cardioverter-defibrillator. Pacing Clin Electrophysiol. 1991;14:181-187.
  42. Sears SF Jr, Burns JL, Handberg E, Sotile WM, Conti JB. Young at heart: understanding the unique psychosocial adjustment of young implantable cardioverter defibrillator recipients. Pacing Clin Electrophysiol. 2001; 24:1113-1117
  43. Frasure-Smith N, Prince R. The Ischemic Heart Disease Life Stress Monitoring Program: impact on mortality. Psychosom Med. 1985;47:431-445.
  44. Thomas SA, Friedmann E, Wimbush F, Schron EB. Psychological factors and survival in the Cardiac Arrhythmia Suppression Trial (CAST): a reexamination. Am J Crit Care. 1997;6:116-126.
  45. Rozanski A, Blumenthal JA, Kaplan J. Impact of psychological factors on the pathogenesis of cardiovascular disease and implications for therapy. Circulation. 1999;99:2192-217.
  46. Ruo B, Rumsfeld JS, Hlatky MA, Liu H, Browner WS, Whooley MA. Depressive symptoms and health-related quality of life: the Heart and Soul Study. JAMA. 2003;290:215-221.
  47. Ocampo CM. Living with an implantable cardioverter defibrillator: impact on the patient, family, and society. Nurs Clin North Am. 2000;35:1019-1030.
  48. Badger JM, Morris PL. Observations of a support group for automatic implantable cardioverter-defibrillator recipients and their spouses. Heart Lung. 1989;18:238-243.
  49. DeBasio N, Rodenhausen N. The group experience: meeting the psychological needs of patients with ventricular tachycardia. Heart Lung. 1984; 13:597-602.
  50. Dickerson SS, Posluszny M, Kennedy MC. Help seeking in a support group for recipients of implantable cardioverter defibrillators and their support persons. Heart Lung. 2000;29:87-96.
  51. Molchany CA, Peterson KA. The psychosocial effects of support group intervention on AICD recipients and their significant others. Prog Cardiovasc Nurs. Spring 1994;9:23-29.
  52. The Zapper. Newsletter for cardioverter defibrillator implant recipients, families, and caregivers. Available at: http://www.zaplife.org. Accessed April 14, 2006.
Funding Information

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.

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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)

Disclosure: Dr Gottlieb has received research grants from Medtronic and has served as a consultant to Guidant Corp, Indianapolis, Ind.